<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01676909</url>
  </required_header>
  <id_info>
    <org_study_id>IIR 11-276</org_study_id>
    <nct_id>NCT01676909</nct_id>
  </id_info>
  <brief_title>Wellness Self-Management</brief_title>
  <official_title>A Hybrid Effectiveness-Implementation Trial of a Wellness Self-Management Program</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VA Office of Research and Development</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>VA Office of Research and Development</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Veterans with schizophrenia, other serious mental illnesses (SMI), and Post Traumatic Stress&#xD;
      Disorder (PTSD) are at elevated risk for co-occurring chronic medical conditions resulting in&#xD;
      increased risk of disability, high health care spending, reduced quality of life and early&#xD;
      mortality. Physical wellness is increasingly recognized as a key component of the VA's&#xD;
      commitment to developing recovery-oriented and Veteran-centered mental health treatment.&#xD;
      There is also growing recognition of the value of interventions that promote and improve&#xD;
      patient self-management of chronic medical conditions. Building on the established efficacy&#xD;
      of consumer facilitated medical illness self-management programming used in the general&#xD;
      population and two recent adaptations for use with SMI adults in the public health sector&#xD;
      (including the investigators' own evaluation of an intervention called Living Well), the&#xD;
      investigators propose to complete a randomized controlled effectiveness trial of the Living&#xD;
      Well intervention and simultaneously conduct a well specified process evaluation to optimize&#xD;
      knowledge accrual regarding important factors that may improve future adoption,&#xD;
      implementation and sustainability of the Living Well intervention in the VA system of care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background:&#xD;
&#xD;
      Veterans with schizophrenia, other serious mental illnesses (SMI), and Post Traumatic Stress&#xD;
      Disorder (PTSD) are at elevated risk for co-occurring chronic medical conditions resulting in&#xD;
      increased risk of disability, high health care spending, reduced quality of life and early&#xD;
      mortality. Physical wellness is increasingly recognized as a key component of the VA's&#xD;
      commitment to developing recovery-oriented and Veteran-centered mental health treatment.&#xD;
      There is also growing recognition of the value of interventions that promote and improve&#xD;
      patient self-management of chronic medical conditions. Building on the established efficacy&#xD;
      of consumer facilitated medical illness self-management programming used in the general&#xD;
      population and two recent adaptations for use with SMI adults in the public health sector&#xD;
      (including the investigators' own evaluation of an intervention called Living Well), the&#xD;
      investigators propose to complete a randomized controlled effectiveness trial of the Living&#xD;
      Well intervention and simultaneously conduct a well specified process evaluation to optimize&#xD;
      knowledge accrual regarding important factors that may improve future adoption,&#xD;
      implementation and sustainability of the Living Well intervention in the VA system of care.&#xD;
&#xD;
      Aims:&#xD;
&#xD;
      Primary AIM 1: Complete a randomized controlled effectiveness trial of the Living Well&#xD;
      intervention with 242 Veterans with mental illness and at least one co-occurring chronic&#xD;
      medical condition and evaluate the intervention's effects on functional and service related&#xD;
      outcomes. The investigators hypothesize that those randomized to the Living Well intervention&#xD;
      will, in comparison to those randomized to a medical illness education and support group,&#xD;
      demonstrate improved general health functioning including physical and emotional functioning&#xD;
      as well as reduced rates of medical emergency room visits for management of a chronic medical&#xD;
      condition. The investigators will also evaluate intervention effects on more proximal&#xD;
      attitudinal and behavioral outcomes and assess how these factors mediate improvement in the&#xD;
      functional and services related outcomes.&#xD;
&#xD;
      Primary AIM 2: Complete a well specified process evaluation based on the RE-AIM evaluation&#xD;
      framework to better understand contextual factors that can improve the Reach, Effectiveness,&#xD;
      Adoption, Implementation and Maintenance which together determine the potential public health&#xD;
      impact of the Living Well intervention.&#xD;
&#xD;
      Methods:&#xD;
&#xD;
      A mix of temporally overlapping quantitative and qualitative methods will be used to maximize&#xD;
      integration and synthesis of data streams across the two aims to optimize knowledge accrual.&#xD;
&#xD;
      Impact:&#xD;
&#xD;
      Despite the growing recognition that self-management strategies hold enormous promise for&#xD;
      improving quality and outcomes of care for chronic medical illnesses, and the fact that&#xD;
      self-management is gaining prominence as a mental health recovery oriented treatment focus,&#xD;
      there are currently no evidence-based peer facilitated medical illness self-management&#xD;
      interventions available for dissemination within the VA mental health system. The proposed&#xD;
      study is designed to both generate evidence supporting the effectiveness of a peer&#xD;
      co-facilitated intervention and to help speed throughput to public health impact by&#xD;
      collecting important contextual information about factors that may improve future&#xD;
      dissemination and implementation efforts.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2013</start_date>
  <completion_date type="Actual">December 31, 2016</completion_date>
  <primary_completion_date type="Actual">December 31, 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Short Form-12 (SF-12) General Health (Norm Based)</measure>
    <time_frame>Baseline, Post-intervention (3 months after baseline)</time_frame>
    <description>12-item Short-Form Health Survey. Possible subscale scores range from 0 to 100, with higher scores indicating greater well-being.The SF-12 (39), a widely used standardized instrument with strong psychometric properties, will be used to assess self-perceptions of general health functioning across multiple dimensions (including general, physical and emotional/psychiatric functioning). The SF-12 has shown good internal, consistency, stability, and concurrent validity in outpatients with serious mental illness.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Short-Form 12 (SF-12) Physical Scale (Norm Based)</measure>
    <time_frame>Baseline, Post-intervention (3 months after baseline)</time_frame>
    <description>12-item Short-Form Health Survey. Possible subscale scores range from 0 to 100, with higher scores indicating greater well-being. The SF-12 , a widely used standardized instrument with strong psychometric properties, will be used to assess self-perceptions of general health functioning across multiple dimensions (including general, physical and emotional/psychiatric functioning). The SF-12 has shown good internal, consistency, stability, and concurrent validity in outpatients with serious mental illness.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Short-Form 12 (SF-12) Mental Scale (Norm Based)</measure>
    <time_frame>Baseline, Post-intervention (3 months after baseline)</time_frame>
    <description>12-item Short-Form Health Survey. Possible subscale scores range from 0 to 100, with higher scores indicating greater well-being. The SF-12 , a widely used standardized instrument with strong psychometric properties, will be used to assess self-perceptions of general health functioning across multiple dimensions (including general, physical and emotional/psychiatric functioning). The SF-12 has shown good internal, consistency, stability, and concurrent validity in outpatients with serious mental illness.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>ER Visit Between Baseline and the 6-month Follow-up</measure>
    <time_frame>Baseline, Follow-up (6-months after baseline)</time_frame>
    <description>Emergency Room Visit during the approximate 6-month period between baseline and the follow-up visit.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Illness Management Self-Efficacy</measure>
    <time_frame>Baseline, Post-intervention (3 months after baseline)</time_frame>
    <description>This questionnaire is based on the items used in the original Chronic Disease Self-Management Program (CDSMP) as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have strong test-retest reliability and internal consistency as well. This subscale consists of 2 items with possible responses ranging from Never (0) to Always (5). Combined scores from these 2 items may range from 0-10 on this subscale, higher scores indicating greater frequency.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Activation Measure</measure>
    <time_frame>Baseline, Post-intervention (3 months after baseline)</time_frame>
    <description>This 13-item questionnaire measures an individual's perceived ability to manage his or her illness and health behaviors and act as an effective patient. Responses range from Disagree Strongly (1) to Agree Strongly (4). Respondents must complete at least 10 of the 13 questions to obtain a reliable score. Scores may range from 0-100 with higher scores interpreted as greater ability to manage one's own illness. The measure has demonstrated reliability and validity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measure of Self-Management Behaviors - General Self-Management Behaviors Subscale</measure>
    <time_frame>Baseline, Post-intervention (3 months after baseline)</time_frame>
    <description>This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The General Self-Management Behaviors Subscale consists of 2 items with responses ranging from Never (0) to Always (5). Combined scores from these 2 items may range from 0-10 on this subscale, higher scores indicating greater frequency of using the behavior indicating greater self-management behavior.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measure of Self-Management Behaviors - Making Better Use of Health Care Subscale</measure>
    <time_frame>Baseline, Post-intervention (3 months after baseline)</time_frame>
    <description>This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Making Better Use of Health Care Subscale consists of 4 items with responses ranging from Never (0) to Always (5).Combined scores from these 4 items may range from 0-20 on this subscale, higher scores indicating greater frequency of using the behavior indicating greater self-management behavior.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measure of Self-Management Behaviors - Behavioral and Cognitive Symptom Management Subscale</measure>
    <time_frame>Baseline, Post-intervention (3 months after baseline)</time_frame>
    <description>This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Behavioral and Cognitive Symptom Management Subscale consists of 6 items with responses ranging from Never (0) to Always (5). Combined scores from these 4 items may range from 0-30 on this subscale, higher scores indicating greater frequency or using the behavior indicating greater self-management.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measure of Self-Management Behaviors - Accessing Social Support Subscale</measure>
    <time_frame>Baseline, Post-intervention (3 months after baseline)</time_frame>
    <description>This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Accessing Social Support Subscale consists of 2 items with responses ranging from Never (0) to Always (5). Combined scores from these 2 items may range from 0-10 on this subscale, higher scores indicating greater frequency of using the behavior indicating greater self-management behavior.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measure of Self-Management Behaviors - Physical Activity Subscale</measure>
    <time_frame>Baseline, Post-intervention (3 months after baseline)</time_frame>
    <description>This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Physical Activity Subscale consists of 2 items with responses ranging from Never (0) to Always (5). Combined scores from these 2 items may range from 0-10 on this subscale, higher scores indicating greater frequency of using the behavior indicating greater self-management behavior.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measure of Self-Management Behaviors - Healthy Eating Subscale</measure>
    <time_frame>Baseline, Post-intervention (3 months after baseline)</time_frame>
    <description>This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Healthy Eating Subscale consists of 2 items with responses ranging from Never (0) to Always (5). Combined scores from these 2 items may range from 0-10 on this subscale, higher scores indicating greater frequency of using the behavior indicating greater self-management behavior.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Short Form-12 (SF-12) General Health (Norm Based)</measure>
    <time_frame>Baseline, Post-Intervention (3 months after baseline), Follow-Up (6 months after baseline)</time_frame>
    <description>12-item Short-Form Health Survey. Possible subscale scores range from 0 to 100, with higher scores indicating greater well-being.The SF-12 (39), a widely used standardized instrument with strong psychometric properties, will be used to assess self-perceptions of general health functioning across multiple dimensions (including general, physical and emotional/psychiatric functioning). The SF-12 has shown good internal, consistency, stability, and concurrent validity in outpatients with serious mental illness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Short-Form 12 (SF-12) Physical Scale (Norm Based)</measure>
    <time_frame>Baseline, Post-Intervention (3 months after baseline), Follow-Up (6 months after baseline)</time_frame>
    <description>12-item Short-Form Health Survey. Possible subscale scores range from 0 to 100, with higher scores indicating greater well-being. The SF-12 , a widely used standardized instrument with strong psychometric properties, will be used to assess self-perceptions of general health functioning across multiple dimensions (including general, physical and emotional/psychiatric functioning). The SF-12 has shown good internal, consistency, stability, and concurrent validity in outpatients with serious mental illness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Short-Form 12 (SF-12) Mental Scale (Norm Based)</measure>
    <time_frame>Baseline, Post-Intervention (3 months after baseline), Follow-Up (6 months after baseline)</time_frame>
    <description>12-item Short-Form Health Survey. Possible subscale scores range from 0 to 100, with higher scores indicating greater well-being. The SF-12 , a widely used standardized instrument with strong psychometric properties, will be used to assess self-perceptions of general health functioning across multiple dimensions (including general, physical and emotional/psychiatric functioning). The SF-12 has shown good internal, consistency, stability, and concurrent validity in outpatients with serious mental illness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Illness Management Self-Efficacy</measure>
    <time_frame>Baseline, Post-Intervention (3 months after baseline), Follow-Up (6 months after baseline)</time_frame>
    <description>This questionnaire is based on the items used in the original Chronic Disease Self-Management Program (CDSMP) as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have strong test-retest reliability and internal consistency as well. This subscale consists of 2 items with possible responses ranging from Never (0) to Always (5). Combined scores may range from 0-10 on this subscale, higher scores indicate greater self-efficacy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Activation Measure</measure>
    <time_frame>Baseline, Post-Intervention (3 months after baseline), Follow up (6 months after baseline)</time_frame>
    <description>This 13-item questionnaire measures an individual's perceived ability to manage his or her illness and health behaviors and act as an effective patient. Responses range from Disagree Strongly (1) to Agree Strongly (4). Respondents must complete at least 10 of the 13 questions to obtain a reliable score. Scores may range from 0-100 with higher scores interpreted as greater ability to manage one's own illness. The measure has demonstrated reliability and validity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measure of Self-Management Behaviors - General Self-Management Behaviors Subscale</measure>
    <time_frame>Baseline, Post-Intervention (3 months after baseline), Follow up (6 months after baseline)</time_frame>
    <description>This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The General Self-Management Behaviors Subscale consists of 2 items with responses ranging from Never (0) to Always (5). Combined scores may range from 0-10 on this subscale, higher scores indicate greater frequency of the behavior indicating greater self-management behavior.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measure of Self-Management Behaviors - Making Better Use of Health Care Subscale</measure>
    <time_frame>Baseline, Post-Intervention (3 months after baseline), Follow-up (6 months after baseline)</time_frame>
    <description>This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Making Better Use of Health Care Subscale consists of 4 items with responses ranging from Never (0) to Always (5). Scores may range from 0-20 on this subscale, higher scores indicate greater frequency of behavior indicating greater self-management behavior.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measure of Self-Management Behaviors - Behavioral and Cognitive Symptom Management Subscale</measure>
    <time_frame>Baseline, Post-Intervention, Follow-up (6 months after baseline)</time_frame>
    <description>This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Behavioral and Cognitive Symptom Management Subscale consists of 6 items with responses ranging from Never (0) to Always (5). Scores may range from 0-30 on this subscale, higher scores indicate greater frequency of using the behavior indicating greater self-management behavior.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measure of Self-Management Behaviors - Accessing Social Support Subscale</measure>
    <time_frame>Baseline, Post-Intervention (3 months after baseline), Follow-up (6 months after baseline)</time_frame>
    <description>This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Accessing Social Support Subscale consists of 2 items with responses ranging from Never (0) to Always (5). Combined scores may range from 0-10 on this subscale, higher scores indicate greater frequency of using the behavior indicating greater self-management behavior.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measure of Self-Management Behaviors - Physical Activity Subscale</measure>
    <time_frame>Baseline, Post-Intervention (3 months after baseline), Follow-up (6 months after baseline)</time_frame>
    <description>This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Physical Activity Subscale consists of 2 items with responses ranging from Never (0) to Always (5). Combined scores may range from 0-10 on this subscale, higher scores indicate greater frequency of using the behavior indicating greater self-management.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measure of Self-Management Behaviors - Healthy Eating Subscale</measure>
    <time_frame>Baseline, Post-Intervention (3 months after baseline), Follow-up (6 months after baseline)</time_frame>
    <description>This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Healthy Eating Subscale consists of 2 items with responses ranging from Never (0) to Always (5).Combined scores may range from 0-10 on this subscale, higher scores indicate greater frequency of using the behavior indicating greater self-management behavior.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Morisky Medication Adherence Scale</measure>
    <time_frame>Baseline, Post-intervention (3 months after baseline)</time_frame>
    <description>This 4 item self-reported medication adherence scale was developed from a well validated 8-item scale with responses ranging from Never (0) to Very Often (4) to to better capture barriers surrounding adherence behavior. This new scale has demonstrated psychometric properties. Possible scores range from 0 to 16, with higher scores indicating greater adherence. The distribution was skewed so a square root transformation was applied before analysis.</description>
  </other_outcome>
  <other_outcome>
    <measure>Multidimensional Health Locus of Control (HLOC)</measure>
    <time_frame>Baseline, Post-intervention (3 months after baseline)</time_frame>
    <description>Measured with a subscale of the Multidimensional Health Locus of Control. Possible scores range from 0 to 36, with higher scores indicating greater internal locus of control. An 18 item questionnaire with responses ranging on a 6 point Likert scale from Strongly Disagree to Strongly Agree that asks about self-perceived control over one's health, illnesses, and ability to take an active role in one's health.</description>
  </other_outcome>
  <other_outcome>
    <measure>Maryland Assessment of Recovery Scale (MARS)</measure>
    <time_frame>Baseline, Post-intervention (3 months after baseline)</time_frame>
    <description>The MARS a 25-item self-report measure of recovery. Items are rated on a 5-point Likert scale ranging from not at all (1) to very much (5). The MARS has been shown to have good internal consistency (alpha=.95) and test-retest reliability (r = .868). Combined scores may range from 25-125, higher scores indicate greater self-reported recovery.</description>
  </other_outcome>
  <other_outcome>
    <measure>Morisky Medication Adherence Scale</measure>
    <time_frame>Baseline, Follow-up (6 months after baseline)</time_frame>
    <description>Possible scores range from 0 to 16, with higher scores indicating greater adherence. The distribution was skewed so a square root transformation was applied before analysis.</description>
  </other_outcome>
  <other_outcome>
    <measure>Multidimensional Health Locus of Control (HLOC)</measure>
    <time_frame>Baseline, Post-Intervention (3 months after baseline), Follow-up (6 months after baseline)</time_frame>
    <description>Measured with a subscale of the Multidimensional Health Locus of Control. Possible scores range from 0 to 36, with higher scores indicating greater internal locus of control. An 18 item questionnaire with responses ranging on a 6 point Likert scale from Strongly Disagree to Strongly Agree that asks about self-perceived control over one's health, illnesses, and ability to take an active role in one's health.</description>
  </other_outcome>
  <other_outcome>
    <measure>Maryland Assessment of Recovery Scale (MARS)</measure>
    <time_frame>Baseline, Post-Invention (3 months after baseline), Follow-up (6 months after baseline)</time_frame>
    <description>The MARS a 25-item self-report measure of recovery. Items are rated on a 5-point Likert scale of not at all (1) to very much (5). Combined scores may range from 25-125, higher scores indicate greater self-reported recovery. The MARS has been shown to have good internal consistency (alpha=.95) and test-retest reliability (r = .868)</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">262</enrollment>
  <condition>Mental Illness</condition>
  <condition>Chronic Medical Illness</condition>
  <arm_group>
    <arm_group_label>Living Well</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This study will involve a clinical trial of Living Well (LW), a 12-session, peer co-led, group intervention designed to help veterans with co-occurring Serious Mental Illnesses and Chronic Medical Conditions learn techniques for better health management and ways to live a healthier lifestyle. Key topics that will be discussed are medication side effects, how symptoms of mental illness may affect veterans' ability to manage their medical conditions, effects of substance use on medical and mental health functioning, learning ways to eat healthier and exercise, and how to communicate more effectively with care providers. After completing the 12 weekly groups, participants will return to complete once monthly booster group sessions for the next three months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Medical Illness Education &amp; Support Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>We selected a comparison condition that would provide parallel focus (i.e. medical illness) but not include use of the core ingredients undergirding the Living Well intervention including behavioral action planning, problem solving, in-session and between session practice using specific disease self-management techniques and involvement of peer co-facilitators to enhance modeling and improve self-efficacy and activation. As with Living Well, the content of the intervention will have broad applicability across diverse chronic disease conditions. The comparison condition will be a once-weekly support and education group focusing on living with a chronic medical condition.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Living Well</intervention_name>
    <description>This study will involve a clinical trial of Living Well (LW), a 12-session, peer co-led, group intervention designed to help veterans with co-occurring Serious Mental Illnesses and Chronic Medical Conditions learn techniques for better health management and ways to live a healthier lifestyle. Key topics that will be discussed are medication side effects, how symptoms of mental illness may affect veterans' ability to manage their medical conditions, effects of substance use on medical and mental health functioning, learning ways to eat healthier and exercise, and how to communicate more effectively with care providers. There will be 3 booster sessions after the 12 sessions, once a month for 3 months.</description>
    <arm_group_label>Living Well</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Medical Illness Education &amp; Support Group</intervention_name>
    <description>The comparison condition will be a general Medical Illness Education and Support (MIES) group that will discuss common challenges experienced by those living with a wide range of chronic illnesses and behavioral and lifestyle management techniques that may help veterans to better handle chronic medical conditions that also meets for 12 weeks.</description>
    <arm_group_label>Medical Illness Education &amp; Support Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  a diagnosis of schizophrenia/ schizoaffective disorder&#xD;
&#xD;
          -  bipolar disorder&#xD;
&#xD;
          -  major depression with psychotic features&#xD;
&#xD;
          -  post traumatic stress disorder&#xD;
&#xD;
          -  or psychosis not otherwise specified (NOS)&#xD;
&#xD;
          -  age between 18 and 80&#xD;
&#xD;
          -  chart documented presence of at least one of the following chronic medical conditions:&#xD;
&#xD;
               -  a respiratory condition (e.g. asthma, COPD)&#xD;
&#xD;
               -  diabetes&#xD;
&#xD;
               -  arthritis&#xD;
&#xD;
               -  cardiovascular condition (e.g. congestive heart failure, hypertension, etc.)&#xD;
&#xD;
          -  receiving mental health services at a designated study site&#xD;
&#xD;
          -  willing and able to provide consent to participate&#xD;
&#xD;
          -  deemed clinically stable enough to participate in the study by a treatment provider&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe or profound mental retardation&#xD;
&#xD;
          -  Because participants must be able to attend the intervention if assigned to either&#xD;
             condition, we will also require potential participants to verify their availability&#xD;
             during screening&#xD;
&#xD;
          -  Participation in current ongoing study 'Reducing Internalized Stigma in People with&#xD;
             Serious Mental Illness&quot;&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Richard W Goldberg, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Washington DC VA Medical Center, Washington, DC</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20422</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>July 2, 2012</study_first_submitted>
  <study_first_submitted_qc>August 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 31, 2012</study_first_posted>
  <results_first_submitted>January 2, 2018</results_first_submitted>
  <results_first_submitted_qc>February 27, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">June 6, 2019</results_first_posted>
  <last_update_submitted>February 27, 2019</last_update_submitted>
  <last_update_submitted_qc>February 27, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 6, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>self-management</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mental Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>May 1, 2015</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/09/NCT01676909/Prot_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>262 participants were enrolled in the study prior to randomization. 20 participants were not able to be randomized due to attrition resulting in a final study sample of 242.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Living Well</title>
          <description>Living Well (LW) will be implemented as a 12-session, peer co-led, group intervention (4-8 persons) designed to help veterans with co-occurring Serious Mental Illnesses and Chronic Medical Conditions learn techniques for better health management and ways to live a healthier lifestyle. Key topics that will be discussed are medication side effects, how symptoms of mental illness may affect veterans' ability to manage their medical conditions, effects of substance use on medical and mental health functioning, learning ways to eat healthier and exercise, and how to communicate more effectively with care providers. Groups will meet weekly for 75 minutes for three months (12 sessions). There will be 3 booster sessions after the 12 sessions, once a month for 3 months.</description>
        </group>
        <group group_id="P2">
          <title>Medical Illness Education and Support Group</title>
          <description>The comparison condition, Medical Illness Education and Support (MIES) group, will discuss common challenges experienced by those living with a wide range of chronic illnesses and behavioral and lifestyle management techniques that may help veterans to better handle chronic medical conditions. Each of the 12 sessions will follow a basic structure that includes a review of the material presented in the previous session, new education content and discussion.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="124"/>
                <participants group_id="P2" count="118"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Post-Treatment Assessment</title>
              <participants_list>
                <participants group_id="P1" count="105">19 not completed (3 withdrawn, 15 timed out, 1 declined)</participants>
                <participants group_id="P2" count="107">11 not completed (5 withdrawn, 6 timed out)</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="106">18 not completed (3 withdrawn, 15 timed out)</participants>
                <participants group_id="P2" count="104">14 not completed (5 withdrawn, 9 timed out</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
                <participants group_id="P2" count="14"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="5"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Living Well</title>
          <description>Living Well (LW) will be implemented as a 12-session, peer co-led, group intervention (4-8 persons) designed to help veterans with co-occurring Serious Mental Illnesses and Chronic Medical Conditions learn techniques for better health management and ways to live a healthier lifestyle. Key topics that will be discussed are medication side effects, how symptoms of mental illness may affect veterans' ability to manage their medical conditions, effects of substance use on medical and mental health functioning, learning ways to eat healthier and exercise, and how to communicate more effectively with care providers. Groups will meet weekly for 75 minutes for three months (12 sessions). There will be 3 booster sessions after the 12 sessions, once a month for 3 months.</description>
        </group>
        <group group_id="B2">
          <title>Medical Illness Education and Support Group</title>
          <description>The comparison condition, Medical Illness Education and Support (MIES) group, will discuss common challenges experienced by those living with a wide range of chronic illnesses and behavioral and lifestyle management techniques that may help veterans to better handle chronic medical conditions. Each of the 12 sessions will follow a basic structure that includes a review of the material presented in the previous session, new education content and discussion.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="124"/>
            <count group_id="B2" value="118"/>
            <count group_id="B3" value="242"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="58.5" spread="7.6"/>
                    <measurement group_id="B2" value="57.0" spread="7.8"/>
                    <measurement group_id="B3" value="57.8" spread="7.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="32"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="107"/>
                    <measurement group_id="B2" value="103"/>
                    <measurement group_id="B3" value="210"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="118"/>
                    <measurement group_id="B2" value="117"/>
                    <measurement group_id="B3" value="235"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="82"/>
                    <measurement group_id="B2" value="69"/>
                    <measurement group_id="B3" value="151"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                    <measurement group_id="B2" value="38"/>
                    <measurement group_id="B3" value="69"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Short Form-12 (SF-12) General Health (Norm Based)</title>
        <description>12-item Short-Form Health Survey. Possible subscale scores range from 0 to 100, with higher scores indicating greater well-being.The SF-12 (39), a widely used standardized instrument with strong psychometric properties, will be used to assess self-perceptions of general health functioning across multiple dimensions (including general, physical and emotional/psychiatric functioning). The SF-12 has shown good internal, consistency, stability, and concurrent validity in outpatients with serious mental illness.</description>
        <time_frame>Baseline, Post-intervention (3 months after baseline)</time_frame>
        <population>Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.</population>
        <group_list>
          <group group_id="O1">
            <title>Living Well</title>
            <description>Living Well (LW) will be implemented as a 12-session, peer co-led, group intervention (4-8 persons) designed to help veterans with co-occurring Serious Mental Illnesses and Chronic Medical Conditions learn techniques for better health management and ways to live a healthier lifestyle. Key topics that will be discussed are medication side effects, how symptoms of mental illness may affect veterans' ability to manage their medical conditions, effects of substance use on medical and mental health functioning, learning ways to eat healthier and exercise, and how to communicate more effectively with care providers. Groups will meet weekly for 75 minutes for three months (12 sessions). There will be 3 booster sessions after the 12 sessions, once a month for 3 months.</description>
          </group>
          <group group_id="O2">
            <title>Medical Illness Education and Support Group</title>
            <description>The comparison condition, Medical Illness Education and Support (MIES) group, will discuss common challenges experienced by those living with a wide range of chronic illnesses and behavioral and lifestyle management techniques that may help veterans to better handle chronic medical conditions. Each of the 12 sessions will follow a basic structure that includes a review of the material presented in the previous session, new education content and discussion.</description>
          </group>
        </group_list>
        <measure>
          <title>Short Form-12 (SF-12) General Health (Norm Based)</title>
          <description>12-item Short-Form Health Survey. Possible subscale scores range from 0 to 100, with higher scores indicating greater well-being.The SF-12 (39), a widely used standardized instrument with strong psychometric properties, will be used to assess self-perceptions of general health functioning across multiple dimensions (including general, physical and emotional/psychiatric functioning). The SF-12 has shown good internal, consistency, stability, and concurrent validity in outpatients with serious mental illness.</description>
          <population>Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="124"/>
                <count group_id="O2" value="118"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="124"/>
                    <count group_id="O2" value="118"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.4" spread="12.0"/>
                    <measurement group_id="O2" value="38.9" spread="12.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-intervention</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="105"/>
                    <count group_id="O2" value="107"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.5" spread="11.3"/>
                    <measurement group_id="O2" value="41.6" spread="12.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>To test hypothesis 1, regarding the three SF-12 subscales, a linear mixed effects models was used. All available data were used from all three assessment time points. Group, time, and group-by-time terms were included in the model. To test for a group difference in mean change from baseline to post-intervention, the significance test of the group-by-post-intervention coefficient was performed. A logistic mixed model for change in proportion with an ED visit was used to test hypothesis 2.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.362</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Short-Form 12 (SF-12) Physical Scale (Norm Based)</title>
        <description>12-item Short-Form Health Survey. Possible subscale scores range from 0 to 100, with higher scores indicating greater well-being. The SF-12 , a widely used standardized instrument with strong psychometric properties, will be used to assess self-perceptions of general health functioning across multiple dimensions (including general, physical and emotional/psychiatric functioning). The SF-12 has shown good internal, consistency, stability, and concurrent validity in outpatients with serious mental illness.</description>
        <time_frame>Baseline, Post-intervention (3 months after baseline)</time_frame>
        <population>Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.</population>
        <group_list>
          <group group_id="O1">
            <title>Living Well</title>
            <description>Living Well (LW) will be implemented as a 12-session, peer co-led, group intervention (4-8 persons) designed to help veterans with co-occurring Serious Mental Illnesses and Chronic Medical Conditions learn techniques for better health management and ways to live a healthier lifestyle. Key topics that will be discussed are medication side effects, how symptoms of mental illness may affect veterans' ability to manage their medical conditions, effects of substance use on medical and mental health functioning, learning ways to eat healthier and exercise, and how to communicate more effectively with care providers. Groups will meet weekly for 75 minutes for three months (12 sessions). There will be 3 booster sessions after the 12 sessions, once a month for 3 months.</description>
          </group>
          <group group_id="O2">
            <title>Medical Illness Education and Support Group</title>
            <description>The comparison condition, Medical Illness Education and Support (MIES) group, will discuss common challenges experienced by those living with a wide range of chronic illnesses and behavioral and lifestyle management techniques that may help veterans to better handle chronic medical conditions. Each of the 12 sessions will follow a basic structure that includes a review of the material presented in the previous session, new education content and discussion.</description>
          </group>
        </group_list>
        <measure>
          <title>Short-Form 12 (SF-12) Physical Scale (Norm Based)</title>
          <description>12-item Short-Form Health Survey. Possible subscale scores range from 0 to 100, with higher scores indicating greater well-being. The SF-12 , a widely used standardized instrument with strong psychometric properties, will be used to assess self-perceptions of general health functioning across multiple dimensions (including general, physical and emotional/psychiatric functioning). The SF-12 has shown good internal, consistency, stability, and concurrent validity in outpatients with serious mental illness.</description>
          <population>Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="124"/>
                <count group_id="O2" value="118"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="124"/>
                    <count group_id="O2" value="118"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.2" spread="10.4"/>
                    <measurement group_id="O2" value="38.6" spread="11.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-intervention</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="105"/>
                    <count group_id="O2" value="107"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.0" spread="10.3"/>
                    <measurement group_id="O2" value="40.2" spread="11.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>To test hypothesis 1, regarding the three SF-12 subscales, a linear mixed effects models was used. All available data were used from all three assessment time points. Group, time, and group-by-time terms were included in the model. To test for a group difference in mean change from baseline to post-intervention, the significance test of the group-by-post-intervention coefficient was performed. A logistic mixed model for change in proportion with an ED visit was used to test hypothesis 2.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.026</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Short-Form 12 (SF-12) Mental Scale (Norm Based)</title>
        <description>12-item Short-Form Health Survey. Possible subscale scores range from 0 to 100, with higher scores indicating greater well-being. The SF-12 , a widely used standardized instrument with strong psychometric properties, will be used to assess self-perceptions of general health functioning across multiple dimensions (including general, physical and emotional/psychiatric functioning). The SF-12 has shown good internal, consistency, stability, and concurrent validity in outpatients with serious mental illness.</description>
        <time_frame>Baseline, Post-intervention (3 months after baseline)</time_frame>
        <population>Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.</population>
        <group_list>
          <group group_id="O1">
            <title>Living Well</title>
            <description>Living Well (LW) will be implemented as a 12-session, peer co-led, group intervention (4-8 persons) designed to help veterans with co-occurring Serious Mental Illnesses and Chronic Medical Conditions learn techniques for better health management and ways to live a healthier lifestyle. Key topics that will be discussed are medication side effects, how symptoms of mental illness may affect veterans' ability to manage their medical conditions, effects of substance use on medical and mental health functioning, learning ways to eat healthier and exercise, and how to communicate more effectively with care providers. Groups will meet weekly for 75 minutes for three months (12 sessions). There will be 3 booster sessions after the 12 sessions, once a month for 3 months.</description>
          </group>
          <group group_id="O2">
            <title>Medical Illness Education and Support Group</title>
            <description>The comparison condition, Medical Illness Education and Support (MIES) group, will discuss common challenges experienced by those living with a wide range of chronic illnesses and behavioral and lifestyle management techniques that may help veterans to better handle chronic medical conditions. Each of the 12 sessions will follow a basic structure that includes a review of the material presented in the previous session, new education content and discussion.</description>
          </group>
        </group_list>
        <measure>
          <title>Short-Form 12 (SF-12) Mental Scale (Norm Based)</title>
          <description>12-item Short-Form Health Survey. Possible subscale scores range from 0 to 100, with higher scores indicating greater well-being. The SF-12 , a widely used standardized instrument with strong psychometric properties, will be used to assess self-perceptions of general health functioning across multiple dimensions (including general, physical and emotional/psychiatric functioning). The SF-12 has shown good internal, consistency, stability, and concurrent validity in outpatients with serious mental illness.</description>
          <population>Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="124"/>
                <count group_id="O2" value="118"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="124"/>
                    <count group_id="O2" value="118"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.3" spread="11.9"/>
                    <measurement group_id="O2" value="40.7" spread="11.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-intervention</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="105"/>
                    <count group_id="O2" value="107"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.0" spread="11.4"/>
                    <measurement group_id="O2" value="40.5" spread="11.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>To test hypothesis 1, regarding the three SF-12 subscales, a linear mixed effects models was used. All available data were used from all three assessment time points. Group, time, and group-by-time terms were included in the model. To test for a group difference in mean change from baseline to post-intervention, the significance test of the group-by-post-intervention coefficient was performed. A logistic mixed model for change in proportion with an ED visit was used to test hypothesis 2.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.032</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>ER Visit Between Baseline and the 6-month Follow-up</title>
        <description>Emergency Room Visit during the approximate 6-month period between baseline and the follow-up visit.</description>
        <time_frame>Baseline, Follow-up (6-months after baseline)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Living Well</title>
            <description>Living Well (LW) will be implemented as a 12-session, peer co-led, group intervention (4-8 persons) designed to help veterans with co-occurring Serious Mental Illnesses and Chronic Medical Conditions learn techniques for better health management and ways to live a healthier lifestyle. Key topics that will be discussed are medication side effects, how symptoms of mental illness may affect veterans' ability to manage their medical conditions, effects of substance use on medical and mental health functioning, learning ways to eat healthier and exercise, and how to communicate more effectively with care providers. Groups will meet weekly for 75 minutes for three months (12 sessions). There will be 3 booster sessions after the 12 sessions, once a month for 3 months.</description>
          </group>
          <group group_id="O2">
            <title>Medical Illness Education and Support Group</title>
            <description>The comparison condition, Medical Illness Education and Support (MIES) group, will discuss common challenges experienced by those living with a wide range of chronic illnesses and behavioral and lifestyle management techniques that may help veterans to better handle chronic medical conditions. Each of the 12 sessions will follow a basic structure that includes a review of the material presented in the previous session, new education content and discussion.</description>
          </group>
        </group_list>
        <measure>
          <title>ER Visit Between Baseline and the 6-month Follow-up</title>
          <description>Emergency Room Visit during the approximate 6-month period between baseline and the follow-up visit.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="124"/>
                <count group_id="O2" value="118"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49"/>
                    <measurement group_id="O2" value="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 month follow-up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47"/>
                    <measurement group_id="O2" value="48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>A logistic mixed effects model over two 6-month time periods (prior to baseline and between baseline and the 6-month follow-up visit) was used. Terms in the model included group, binary time (pre-f/u versus pre-baseline), and group by time interaction. Two-sided alpha = .05 level tests were used. The hypothesis that the proportion with ER visits would decrease in the Living Well group versus the control group was tests by test of the interaction term.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>.64</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Illness Management Self-Efficacy</title>
        <description>This questionnaire is based on the items used in the original Chronic Disease Self-Management Program (CDSMP) as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have strong test-retest reliability and internal consistency as well. This subscale consists of 2 items with possible responses ranging from Never (0) to Always (5). Combined scores from these 2 items may range from 0-10 on this subscale, higher scores indicating greater frequency.</description>
        <time_frame>Baseline, Post-intervention (3 months after baseline)</time_frame>
        <population>Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.</population>
        <group_list>
          <group group_id="O1">
            <title>Living Well</title>
            <description>Living Well (LW) will be implemented as a 12-session, peer co-led, group intervention (4-8 persons) designed to help veterans with co-occurring Serious Mental Illnesses and Chronic Medical Conditions learn techniques for better health management and ways to live a healthier lifestyle. Key topics that will be discussed are medication side effects, how symptoms of mental illness may affect veterans' ability to manage their medical conditions, effects of substance use on medical and mental health functioning, learning ways to eat healthier and exercise, and how to communicate more effectively with care providers. Groups will meet weekly for 75 minutes for three months (12 sessions). There will be 3 booster sessions after the 12 sessions, once a month for 3 months.</description>
          </group>
          <group group_id="O2">
            <title>Medical Illness Education and Support Group</title>
            <description>The comparison condition, Medical Illness Education and Support (MIES) group, will discuss common challenges experienced by those living with a wide range of chronic illnesses and behavioral and lifestyle management techniques that may help veterans to better handle chronic medical conditions. Each of the 12 sessions will follow a basic structure that includes a review of the material presented in the previous session, new education content and discussion.</description>
          </group>
        </group_list>
        <measure>
          <title>Illness Management Self-Efficacy</title>
          <description>This questionnaire is based on the items used in the original Chronic Disease Self-Management Program (CDSMP) as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have strong test-retest reliability and internal consistency as well. This subscale consists of 2 items with possible responses ranging from Never (0) to Always (5). Combined scores from these 2 items may range from 0-10 on this subscale, higher scores indicating greater frequency.</description>
          <population>Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="124"/>
                <count group_id="O2" value="118"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="124"/>
                    <count group_id="O2" value="118"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.5" spread="2.1"/>
                    <measurement group_id="O2" value="5.5" spread="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-intervention</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="105"/>
                    <count group_id="O2" value="107"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.2" spread="1.9"/>
                    <measurement group_id="O2" value="5.4" spread="2.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;.0001</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Activation Measure</title>
        <description>This 13-item questionnaire measures an individual's perceived ability to manage his or her illness and health behaviors and act as an effective patient. Responses range from Disagree Strongly (1) to Agree Strongly (4). Respondents must complete at least 10 of the 13 questions to obtain a reliable score. Scores may range from 0-100 with higher scores interpreted as greater ability to manage one's own illness. The measure has demonstrated reliability and validity.</description>
        <time_frame>Baseline, Post-intervention (3 months after baseline)</time_frame>
        <population>Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.</population>
        <group_list>
          <group group_id="O1">
            <title>Living Well</title>
            <description>Living Well (LW) will be implemented as a 12-session, peer co-led, group intervention (4-8 persons) designed to help veterans with co-occurring Serious Mental Illnesses and Chronic Medical Conditions learn techniques for better health management and ways to live a healthier lifestyle. Key topics that will be discussed are medication side effects, how symptoms of mental illness may affect veterans' ability to manage their medical conditions, effects of substance use on medical and mental health functioning, learning ways to eat healthier and exercise, and how to communicate more effectively with care providers. Groups will meet weekly for 75 minutes for three months (12 sessions). There will be 3 booster sessions after the 12 sessions, once a month for 3 months.</description>
          </group>
          <group group_id="O2">
            <title>Medical Illness Education and Support Group</title>
            <description>The comparison condition, Medical Illness Education and Support (MIES) group, will discuss common challenges experienced by those living with a wide range of chronic illnesses and behavioral and lifestyle management techniques that may help veterans to better handle chronic medical conditions. Each of the 12 sessions will follow a basic structure that includes a review of the material presented in the previous session, new education content and discussion.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Activation Measure</title>
          <description>This 13-item questionnaire measures an individual's perceived ability to manage his or her illness and health behaviors and act as an effective patient. Responses range from Disagree Strongly (1) to Agree Strongly (4). Respondents must complete at least 10 of the 13 questions to obtain a reliable score. Scores may range from 0-100 with higher scores interpreted as greater ability to manage one's own illness. The measure has demonstrated reliability and validity.</description>
          <population>Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="124"/>
                <count group_id="O2" value="118"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="124"/>
                    <count group_id="O2" value="118"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60.8" spread="15.2"/>
                    <measurement group_id="O2" value="58.8" spread="14.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-intervention</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="105"/>
                    <count group_id="O2" value="107"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="64.3" spread="14.0"/>
                    <measurement group_id="O2" value="58.9" spread="14.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.038</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Measure of Self-Management Behaviors - General Self-Management Behaviors Subscale</title>
        <description>This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The General Self-Management Behaviors Subscale consists of 2 items with responses ranging from Never (0) to Always (5). Combined scores from these 2 items may range from 0-10 on this subscale, higher scores indicating greater frequency of using the behavior indicating greater self-management behavior.</description>
        <time_frame>Baseline, Post-intervention (3 months after baseline)</time_frame>
        <population>Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.</population>
        <group_list>
          <group group_id="O1">
            <title>Living Well</title>
            <description>Living Well (LW) will be implemented as a 12-session, peer co-led, group intervention (4-8 persons) designed to help veterans with co-occurring Serious Mental Illnesses and Chronic Medical Conditions learn techniques for better health management and ways to live a healthier lifestyle. Key topics that will be discussed are medication side effects, how symptoms of mental illness may affect veterans' ability to manage their medical conditions, effects of substance use on medical and mental health functioning, learning ways to eat healthier and exercise, and how to communicate more effectively with care providers. Groups will meet weekly for 75 minutes for three months (12 sessions). There will be 3 booster sessions after the 12 sessions, once a month for 3 months.</description>
          </group>
          <group group_id="O2">
            <title>Medical Illness Education and Support Group</title>
            <description>The comparison condition, Medical Illness Education and Support (MIES) group, will discuss common challenges experienced by those living with a wide range of chronic illnesses and behavioral and lifestyle management techniques that may help veterans to better handle chronic medical conditions. Each of the 12 sessions will follow a basic structure that includes a review of the material presented in the previous session, new education content and discussion.</description>
          </group>
        </group_list>
        <measure>
          <title>Measure of Self-Management Behaviors - General Self-Management Behaviors Subscale</title>
          <description>This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The General Self-Management Behaviors Subscale consists of 2 items with responses ranging from Never (0) to Always (5). Combined scores from these 2 items may range from 0-10 on this subscale, higher scores indicating greater frequency of using the behavior indicating greater self-management behavior.</description>
          <population>Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="124"/>
                <count group_id="O2" value="118"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="124"/>
                    <count group_id="O2" value="118"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.7" spread="1.1"/>
                    <measurement group_id="O2" value="2.3" spread="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-intervention</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="105"/>
                    <count group_id="O2" value="107"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.9" spread="1.2"/>
                    <measurement group_id="O2" value="2.6" spread="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.544</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Measure of Self-Management Behaviors - Making Better Use of Health Care Subscale</title>
        <description>This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Making Better Use of Health Care Subscale consists of 4 items with responses ranging from Never (0) to Always (5).Combined scores from these 4 items may range from 0-20 on this subscale, higher scores indicating greater frequency of using the behavior indicating greater self-management behavior.</description>
        <time_frame>Baseline, Post-intervention (3 months after baseline)</time_frame>
        <population>Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.</population>
        <group_list>
          <group group_id="O1">
            <title>Living Well</title>
            <description>Living Well (LW) will be implemented as a 12-session, peer co-led, group intervention (4-8 persons) designed to help veterans with co-occurring Serious Mental Illnesses and Chronic Medical Conditions learn techniques for better health management and ways to live a healthier lifestyle. Key topics that will be discussed are medication side effects, how symptoms of mental illness may affect veterans' ability to manage their medical conditions, effects of substance use on medical and mental health functioning, learning ways to eat healthier and exercise, and how to communicate more effectively with care providers. Groups will meet weekly for 75 minutes for three months (12 sessions). There will be 3 booster sessions after the 12 sessions, once a month for 3 months.</description>
          </group>
          <group group_id="O2">
            <title>Medical Illness Education and Support Group</title>
            <description>The comparison condition, Medical Illness Education and Support (MIES) group, will discuss common challenges experienced by those living with a wide range of chronic illnesses and behavioral and lifestyle management techniques that may help veterans to better handle chronic medical conditions. Each of the 12 sessions will follow a basic structure that includes a review of the material presented in the previous session, new education content and discussion.</description>
          </group>
        </group_list>
        <measure>
          <title>Measure of Self-Management Behaviors - Making Better Use of Health Care Subscale</title>
          <description>This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Making Better Use of Health Care Subscale consists of 4 items with responses ranging from Never (0) to Always (5).Combined scores from these 4 items may range from 0-20 on this subscale, higher scores indicating greater frequency of using the behavior indicating greater self-management behavior.</description>
          <population>Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="124"/>
                <count group_id="O2" value="118"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="124"/>
                    <count group_id="O2" value="118"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.9" spread="1.4"/>
                    <measurement group_id="O2" value="2.5" spread="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-intervention</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="105"/>
                    <count group_id="O2" value="107"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.3" spread="1.2"/>
                    <measurement group_id="O2" value="2.9" spread="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.699</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Measure of Self-Management Behaviors - Behavioral and Cognitive Symptom Management Subscale</title>
        <description>This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Behavioral and Cognitive Symptom Management Subscale consists of 6 items with responses ranging from Never (0) to Always (5). Combined scores from these 4 items may range from 0-30 on this subscale, higher scores indicating greater frequency or using the behavior indicating greater self-management.</description>
        <time_frame>Baseline, Post-intervention (3 months after baseline)</time_frame>
        <population>Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.</population>
        <group_list>
          <group group_id="O1">
            <title>Living Well</title>
            <description>Living Well (LW) will be implemented as a 12-session, peer co-led, group intervention (4-8 persons) designed to help veterans with co-occurring Serious Mental Illnesses and Chronic Medical Conditions learn techniques for better health management and ways to live a healthier lifestyle. Key topics that will be discussed are medication side effects, how symptoms of mental illness may affect veterans' ability to manage their medical conditions, effects of substance use on medical and mental health functioning, learning ways to eat healthier and exercise, and how to communicate more effectively with care providers. Groups will meet weekly for 75 minutes for three months (12 sessions). There will be 3 booster sessions after the 12 sessions, once a month for 3 months.</description>
          </group>
          <group group_id="O2">
            <title>Medical Illness Education and Support Group</title>
            <description>The comparison condition, Medical Illness Education and Support (MIES) group, will discuss common challenges experienced by those living with a wide range of chronic illnesses and behavioral and lifestyle management techniques that may help veterans to better handle chronic medical conditions. Each of the 12 sessions will follow a basic structure that includes a review of the material presented in the previous session, new education content and discussion.</description>
          </group>
        </group_list>
        <measure>
          <title>Measure of Self-Management Behaviors - Behavioral and Cognitive Symptom Management Subscale</title>
          <description>This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Behavioral and Cognitive Symptom Management Subscale consists of 6 items with responses ranging from Never (0) to Always (5). Combined scores from these 4 items may range from 0-30 on this subscale, higher scores indicating greater frequency or using the behavior indicating greater self-management.</description>
          <population>Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="124"/>
                <count group_id="O2" value="118"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="124"/>
                    <count group_id="O2" value="118"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.2" spread="1.1"/>
                    <measurement group_id="O2" value="2.2" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-intervention</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="105"/>
                    <count group_id="O2" value="107"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5" spread="1.0"/>
                    <measurement group_id="O2" value="2.2" spread="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.006</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Measure of Self-Management Behaviors - Accessing Social Support Subscale</title>
        <description>This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Accessing Social Support Subscale consists of 2 items with responses ranging from Never (0) to Always (5). Combined scores from these 2 items may range from 0-10 on this subscale, higher scores indicating greater frequency of using the behavior indicating greater self-management behavior.</description>
        <time_frame>Baseline, Post-intervention (3 months after baseline)</time_frame>
        <population>Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.</population>
        <group_list>
          <group group_id="O1">
            <title>Living Well</title>
            <description>Living Well (LW) will be implemented as a 12-session, peer co-led, group intervention (4-8 persons) designed to help veterans with co-occurring Serious Mental Illnesses and Chronic Medical Conditions learn techniques for better health management and ways to live a healthier lifestyle. Key topics that will be discussed are medication side effects, how symptoms of mental illness may affect veterans' ability to manage their medical conditions, effects of substance use on medical and mental health functioning, learning ways to eat healthier and exercise, and how to communicate more effectively with care providers. Groups will meet weekly for 75 minutes for three months (12 sessions). There will be 3 booster sessions after the 12 sessions, once a month for 3 months.</description>
          </group>
          <group group_id="O2">
            <title>Medical Illness Education and Support Group</title>
            <description>The comparison condition, Medical Illness Education and Support (MIES) group, will discuss common challenges experienced by those living with a wide range of chronic illnesses and behavioral and lifestyle management techniques that may help veterans to better handle chronic medical conditions. Each of the 12 sessions will follow a basic structure that includes a review of the material presented in the previous session, new education content and discussion.</description>
          </group>
        </group_list>
        <measure>
          <title>Measure of Self-Management Behaviors - Accessing Social Support Subscale</title>
          <description>This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Accessing Social Support Subscale consists of 2 items with responses ranging from Never (0) to Always (5). Combined scores from these 2 items may range from 0-10 on this subscale, higher scores indicating greater frequency of using the behavior indicating greater self-management behavior.</description>
          <population>Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="124"/>
                <count group_id="O2" value="118"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="124"/>
                    <count group_id="O2" value="118"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.3" spread="1.4"/>
                    <measurement group_id="O2" value="2.3" spread="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-intervention</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="105"/>
                    <count group_id="O2" value="107"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.4" spread="1.3"/>
                    <measurement group_id="O2" value="2.4" spread="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.762</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Measure of Self-Management Behaviors - Physical Activity Subscale</title>
        <description>This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Physical Activity Subscale consists of 2 items with responses ranging from Never (0) to Always (5). Combined scores from these 2 items may range from 0-10 on this subscale, higher scores indicating greater frequency of using the behavior indicating greater self-management behavior.</description>
        <time_frame>Baseline, Post-intervention (3 months after baseline)</time_frame>
        <population>Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.</population>
        <group_list>
          <group group_id="O1">
            <title>Living Well</title>
            <description>Living Well (LW) will be implemented as a 12-session, peer co-led, group intervention (4-8 persons) designed to help veterans with co-occurring Serious Mental Illnesses and Chronic Medical Conditions learn techniques for better health management and ways to live a healthier lifestyle. Key topics that will be discussed are medication side effects, how symptoms of mental illness may affect veterans' ability to manage their medical conditions, effects of substance use on medical and mental health functioning, learning ways to eat healthier and exercise, and how to communicate more effectively with care providers. Groups will meet weekly for 75 minutes for three months (12 sessions). There will be 3 booster sessions after the 12 sessions, once a month for 3 months.</description>
          </group>
          <group group_id="O2">
            <title>Medical Illness Education and Support Group</title>
            <description>The comparison condition, Medical Illness Education and Support (MIES) group, will discuss common challenges experienced by those living with a wide range of chronic illnesses and behavioral and lifestyle management techniques that may help veterans to better handle chronic medical conditions. Each of the 12 sessions will follow a basic structure that includes a review of the material presented in the previous session, new education content and discussion.</description>
          </group>
        </group_list>
        <measure>
          <title>Measure of Self-Management Behaviors - Physical Activity Subscale</title>
          <description>This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Physical Activity Subscale consists of 2 items with responses ranging from Never (0) to Always (5). Combined scores from these 2 items may range from 0-10 on this subscale, higher scores indicating greater frequency of using the behavior indicating greater self-management behavior.</description>
          <population>Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="124"/>
                <count group_id="O2" value="118"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="124"/>
                    <count group_id="O2" value="118"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.3" spread="1.3"/>
                    <measurement group_id="O2" value="2.3" spread="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-intervention</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="105"/>
                    <count group_id="O2" value="107"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.7" spread="1.3"/>
                    <measurement group_id="O2" value="2.4" spread="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.326</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Measure of Self-Management Behaviors - Healthy Eating Subscale</title>
        <description>This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Healthy Eating Subscale consists of 2 items with responses ranging from Never (0) to Always (5). Combined scores from these 2 items may range from 0-10 on this subscale, higher scores indicating greater frequency of using the behavior indicating greater self-management behavior.</description>
        <time_frame>Baseline, Post-intervention (3 months after baseline)</time_frame>
        <population>Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.</population>
        <group_list>
          <group group_id="O1">
            <title>Living Well</title>
            <description>Living Well (LW) will be implemented as a 12-session, peer co-led, group intervention (4-8 persons) designed to help veterans with co-occurring Serious Mental Illnesses and Chronic Medical Conditions learn techniques for better health management and ways to live a healthier lifestyle. Key topics that will be discussed are medication side effects, how symptoms of mental illness may affect veterans' ability to manage their medical conditions, effects of substance use on medical and mental health functioning, learning ways to eat healthier and exercise, and how to communicate more effectively with care providers. Groups will meet weekly for 75 minutes for three months (12 sessions). There will be 3 booster sessions after the 12 sessions, once a month for 3 months.</description>
          </group>
          <group group_id="O2">
            <title>Medical Illness Education and Support Group</title>
            <description>The comparison condition, Medical Illness Education and Support (MIES) group, will discuss common challenges experienced by those living with a wide range of chronic illnesses and behavioral and lifestyle management techniques that may help veterans to better handle chronic medical conditions. Each of the 12 sessions will follow a basic structure that includes a review of the material presented in the previous session, new education content and discussion.</description>
          </group>
        </group_list>
        <measure>
          <title>Measure of Self-Management Behaviors - Healthy Eating Subscale</title>
          <description>This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Healthy Eating Subscale consists of 2 items with responses ranging from Never (0) to Always (5). Combined scores from these 2 items may range from 0-10 on this subscale, higher scores indicating greater frequency of using the behavior indicating greater self-management behavior.</description>
          <population>Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="124"/>
                <count group_id="O2" value="118"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="124"/>
                    <count group_id="O2" value="118"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.6" spread="1.3"/>
                    <measurement group_id="O2" value="2.5" spread="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-intervention</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="105"/>
                    <count group_id="O2" value="107"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.0" spread="1.1"/>
                    <measurement group_id="O2" value="2.7" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.667</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Short Form-12 (SF-12) General Health (Norm Based)</title>
        <description>12-item Short-Form Health Survey. Possible subscale scores range from 0 to 100, with higher scores indicating greater well-being.The SF-12 (39), a widely used standardized instrument with strong psychometric properties, will be used to assess self-perceptions of general health functioning across multiple dimensions (including general, physical and emotional/psychiatric functioning). The SF-12 has shown good internal, consistency, stability, and concurrent validity in outpatients with serious mental illness.</description>
        <time_frame>Baseline, Post-Intervention (3 months after baseline), Follow-Up (6 months after baseline)</time_frame>
        <population>Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.</population>
        <group_list>
          <group group_id="O1">
            <title>Living Well</title>
            <description>Living Well (LW) will be implemented as a 12-session, peer co-led, group intervention (4-8 persons) designed to help veterans with co-occurring Serious Mental Illnesses and Chronic Medical Conditions learn techniques for better health management and ways to live a healthier lifestyle. Key topics that will be discussed are medication side effects, how symptoms of mental illness may affect veterans' ability to manage their medical conditions, effects of substance use on medical and mental health functioning, learning ways to eat healthier and exercise, and how to communicate more effectively with care providers. Groups will meet weekly for 75 minutes for three months (12 sessions). There will be 3 booster sessions after the 12 sessions, once a month for 3 months.</description>
          </group>
          <group group_id="O2">
            <title>Medical Illness Education and Support Group</title>
            <description>The comparison condition, Medical Illness Education and Support (MIES) group, will discuss common challenges experienced by those living with a wide range of chronic illnesses and behavioral and lifestyle management techniques that may help veterans to better handle chronic medical conditions. Each of the 12 sessions will follow a basic structure that includes a review of the material presented in the previous session, new education content and discussion.</description>
          </group>
        </group_list>
        <measure>
          <title>Short Form-12 (SF-12) General Health (Norm Based)</title>
          <description>12-item Short-Form Health Survey. Possible subscale scores range from 0 to 100, with higher scores indicating greater well-being.The SF-12 (39), a widely used standardized instrument with strong psychometric properties, will be used to assess self-perceptions of general health functioning across multiple dimensions (including general, physical and emotional/psychiatric functioning). The SF-12 has shown good internal, consistency, stability, and concurrent validity in outpatients with serious mental illness.</description>
          <population>Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="124"/>
                <count group_id="O2" value="118"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="124"/>
                    <count group_id="O2" value="118"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.4" spread="12.0"/>
                    <measurement group_id="O2" value="38.9" spread="12.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-intervention</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="105"/>
                    <count group_id="O2" value="107"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.5" spread="11.3"/>
                    <measurement group_id="O2" value="41.6" spread="12.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Follow-up</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="106"/>
                    <count group_id="O2" value="104"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.9" spread="12.0"/>
                    <measurement group_id="O2" value="39.2" spread="12.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.142</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Short-Form 12 (SF-12) Physical Scale (Norm Based)</title>
        <description>12-item Short-Form Health Survey. Possible subscale scores range from 0 to 100, with higher scores indicating greater well-being. The SF-12 , a widely used standardized instrument with strong psychometric properties, will be used to assess self-perceptions of general health functioning across multiple dimensions (including general, physical and emotional/psychiatric functioning). The SF-12 has shown good internal, consistency, stability, and concurrent validity in outpatients with serious mental illness.</description>
        <time_frame>Baseline, Post-Intervention (3 months after baseline), Follow-Up (6 months after baseline)</time_frame>
        <population>Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.</population>
        <group_list>
          <group group_id="O1">
            <title>Living Well</title>
            <description>Living Well (LW) will be implemented as a 12-session, peer co-led, group intervention (4-8 persons) designed to help veterans with co-occurring Serious Mental Illnesses and Chronic Medical Conditions learn techniques for better health management and ways to live a healthier lifestyle. Key topics that will be discussed are medication side effects, how symptoms of mental illness may affect veterans' ability to manage their medical conditions, effects of substance use on medical and mental health functioning, learning ways to eat healthier and exercise, and how to communicate more effectively with care providers. Groups will meet weekly for 75 minutes for three months (12 sessions). There will be 3 booster sessions after the 12 sessions, once a month for 3 months.</description>
          </group>
          <group group_id="O2">
            <title>Medical Illness Education and Support Group</title>
            <description>The comparison condition, Medical Illness Education and Support (MIES) group, will discuss common challenges experienced by those living with a wide range of chronic illnesses and behavioral and lifestyle management techniques that may help veterans to better handle chronic medical conditions. Each of the 12 sessions will follow a basic structure that includes a review of the material presented in the previous session, new education content and discussion.</description>
          </group>
        </group_list>
        <measure>
          <title>Short-Form 12 (SF-12) Physical Scale (Norm Based)</title>
          <description>12-item Short-Form Health Survey. Possible subscale scores range from 0 to 100, with higher scores indicating greater well-being. The SF-12 , a widely used standardized instrument with strong psychometric properties, will be used to assess self-perceptions of general health functioning across multiple dimensions (including general, physical and emotional/psychiatric functioning). The SF-12 has shown good internal, consistency, stability, and concurrent validity in outpatients with serious mental illness.</description>
          <population>Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="124"/>
                <count group_id="O2" value="118"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="124"/>
                    <count group_id="O2" value="118"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.2" spread="10.4"/>
                    <measurement group_id="O2" value="38.6" spread="11.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-intervention</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="105"/>
                    <count group_id="O2" value="107"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.0" spread="10.3"/>
                    <measurement group_id="O2" value="40.2" spread="11.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Follow-up</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="106"/>
                    <count group_id="O2" value="104"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="40.3" spread="10.2"/>
                    <measurement group_id="O2" value="38.4" spread="12.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.342</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Short-Form 12 (SF-12) Mental Scale (Norm Based)</title>
        <description>12-item Short-Form Health Survey. Possible subscale scores range from 0 to 100, with higher scores indicating greater well-being. The SF-12 , a widely used standardized instrument with strong psychometric properties, will be used to assess self-perceptions of general health functioning across multiple dimensions (including general, physical and emotional/psychiatric functioning). The SF-12 has shown good internal, consistency, stability, and concurrent validity in outpatients with serious mental illness.</description>
        <time_frame>Baseline, Post-Intervention (3 months after baseline), Follow-Up (6 months after baseline)</time_frame>
        <population>Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.</population>
        <group_list>
          <group group_id="O1">
            <title>Living Well</title>
            <description>Living Well (LW) will be implemented as a 12-session, peer co-led, group intervention (4-8 persons) designed to help veterans with co-occurring Serious Mental Illnesses and Chronic Medical Conditions learn techniques for better health management and ways to live a healthier lifestyle. Key topics that will be discussed are medication side effects, how symptoms of mental illness may affect veterans' ability to manage their medical conditions, effects of substance use on medical and mental health functioning, learning ways to eat healthier and exercise, and how to communicate more effectively with care providers. Groups will meet weekly for 75 minutes for three months (12 sessions). There will be 3 booster sessions after the 12 sessions, once a month for 3 months.</description>
          </group>
          <group group_id="O2">
            <title>Medical Illness Education and Support Group</title>
            <description>The comparison condition, Medical Illness Education and Support (MIES) group, will discuss common challenges experienced by those living with a wide range of chronic illnesses and behavioral and lifestyle management techniques that may help veterans to better handle chronic medical conditions. Each of the 12 sessions will follow a basic structure that includes a review of the material presented in the previous session, new education content and discussion.</description>
          </group>
        </group_list>
        <measure>
          <title>Short-Form 12 (SF-12) Mental Scale (Norm Based)</title>
          <description>12-item Short-Form Health Survey. Possible subscale scores range from 0 to 100, with higher scores indicating greater well-being. The SF-12 , a widely used standardized instrument with strong psychometric properties, will be used to assess self-perceptions of general health functioning across multiple dimensions (including general, physical and emotional/psychiatric functioning). The SF-12 has shown good internal, consistency, stability, and concurrent validity in outpatients with serious mental illness.</description>
          <population>Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="124"/>
                <count group_id="O2" value="118"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="124"/>
                    <count group_id="O2" value="118"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41.3" spread="11.9"/>
                    <measurement group_id="O2" value="40.7" spread="11.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-intervention</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="105"/>
                    <count group_id="O2" value="107"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.0" spread="11.4"/>
                    <measurement group_id="O2" value="40.5" spread="11.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Follow-up</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="106"/>
                    <count group_id="O2" value="104"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.7" spread="11.5"/>
                    <measurement group_id="O2" value="41.5" spread="12.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.563</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Illness Management Self-Efficacy</title>
        <description>This questionnaire is based on the items used in the original Chronic Disease Self-Management Program (CDSMP) as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have strong test-retest reliability and internal consistency as well. This subscale consists of 2 items with possible responses ranging from Never (0) to Always (5). Combined scores may range from 0-10 on this subscale, higher scores indicate greater self-efficacy.</description>
        <time_frame>Baseline, Post-Intervention (3 months after baseline), Follow-Up (6 months after baseline)</time_frame>
        <population>Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.</population>
        <group_list>
          <group group_id="O1">
            <title>Living Well</title>
            <description>Living Well (LW) will be implemented as a 12-session, peer co-led, group intervention (4-8 persons) designed to help veterans with co-occurring Serious Mental Illnesses and Chronic Medical Conditions learn techniques for better health management and ways to live a healthier lifestyle. Key topics that will be discussed are medication side effects, how symptoms of mental illness may affect veterans' ability to manage their medical conditions, effects of substance use on medical and mental health functioning, learning ways to eat healthier and exercise, and how to communicate more effectively with care providers. Groups will meet weekly for 75 minutes for three months (12 sessions). There will be 3 booster sessions after the 12 sessions, once a month for 3 months.</description>
          </group>
          <group group_id="O2">
            <title>Medical Illness Education and Support Group</title>
            <description>The comparison condition, Medical Illness Education and Support (MIES) group, will discuss common challenges experienced by those living with a wide range of chronic illnesses and behavioral and lifestyle management techniques that may help veterans to better handle chronic medical conditions. Each of the 12 sessions will follow a basic structure that includes a review of the material presented in the previous session, new education content and discussion.</description>
          </group>
        </group_list>
        <measure>
          <title>Illness Management Self-Efficacy</title>
          <description>This questionnaire is based on the items used in the original Chronic Disease Self-Management Program (CDSMP) as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have strong test-retest reliability and internal consistency as well. This subscale consists of 2 items with possible responses ranging from Never (0) to Always (5). Combined scores may range from 0-10 on this subscale, higher scores indicate greater self-efficacy.</description>
          <population>Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="124"/>
                <count group_id="O2" value="118"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="124"/>
                    <count group_id="O2" value="118"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.5" spread="2.1"/>
                    <measurement group_id="O2" value="5.5" spread="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-intervention</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="105"/>
                    <count group_id="O2" value="107"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.2" spread="1.9"/>
                    <measurement group_id="O2" value="5.4" spread="2.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Follow-up</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="106"/>
                    <count group_id="O2" value="104"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.0" spread="2.0"/>
                    <measurement group_id="O2" value="5.4" spread="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.004</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Activation Measure</title>
        <description>This 13-item questionnaire measures an individual's perceived ability to manage his or her illness and health behaviors and act as an effective patient. Responses range from Disagree Strongly (1) to Agree Strongly (4). Respondents must complete at least 10 of the 13 questions to obtain a reliable score. Scores may range from 0-100 with higher scores interpreted as greater ability to manage one's own illness. The measure has demonstrated reliability and validity</description>
        <time_frame>Baseline, Post-Intervention (3 months after baseline), Follow up (6 months after baseline)</time_frame>
        <population>Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.</population>
        <group_list>
          <group group_id="O1">
            <title>Living Well</title>
            <description>Living Well (LW) will be implemented as a 12-session, peer co-led, group intervention (4-8 persons) designed to help veterans with co-occurring Serious Mental Illnesses and Chronic Medical Conditions learn techniques for better health management and ways to live a healthier lifestyle. Key topics that will be discussed are medication side effects, how symptoms of mental illness may affect veterans' ability to manage their medical conditions, effects of substance use on medical and mental health functioning, learning ways to eat healthier and exercise, and how to communicate more effectively with care providers. Groups will meet weekly for 75 minutes for three months (12 sessions). There will be 3 booster sessions after the 12 sessions, once a month for 3 months.</description>
          </group>
          <group group_id="O2">
            <title>Medical Illness Education and Support Group</title>
            <description>The comparison condition, Medical Illness Education and Support (MIES) group, will discuss common challenges experienced by those living with a wide range of chronic illnesses and behavioral and lifestyle management techniques that may help veterans to better handle chronic medical conditions. Each of the 12 sessions will follow a basic structure that includes a review of the material presented in the previous session, new education content and discussion.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Activation Measure</title>
          <description>This 13-item questionnaire measures an individual's perceived ability to manage his or her illness and health behaviors and act as an effective patient. Responses range from Disagree Strongly (1) to Agree Strongly (4). Respondents must complete at least 10 of the 13 questions to obtain a reliable score. Scores may range from 0-100 with higher scores interpreted as greater ability to manage one's own illness. The measure has demonstrated reliability and validity</description>
          <population>Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="124"/>
                <count group_id="O2" value="118"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="124"/>
                    <count group_id="O2" value="118"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60.8" spread="15.2"/>
                    <measurement group_id="O2" value="58.8" spread="14.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-intervention</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="105"/>
                    <count group_id="O2" value="107"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="64.3" spread="14.0"/>
                    <measurement group_id="O2" value="58.9" spread="14.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Follow-up</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="106"/>
                    <count group_id="O2" value="104"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63.4" spread="14.6"/>
                    <measurement group_id="O2" value="60.5" spread="16.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.727</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Measure of Self-Management Behaviors - General Self-Management Behaviors Subscale</title>
        <description>This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The General Self-Management Behaviors Subscale consists of 2 items with responses ranging from Never (0) to Always (5). Combined scores may range from 0-10 on this subscale, higher scores indicate greater frequency of the behavior indicating greater self-management behavior.</description>
        <time_frame>Baseline, Post-Intervention (3 months after baseline), Follow up (6 months after baseline)</time_frame>
        <population>Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.</population>
        <group_list>
          <group group_id="O1">
            <title>Living Well</title>
            <description>Living Well (LW) will be implemented as a 12-session, peer co-led, group intervention (4-8 persons) designed to help veterans with co-occurring Serious Mental Illnesses and Chronic Medical Conditions learn techniques for better health management and ways to live a healthier lifestyle. Key topics that will be discussed are medication side effects, how symptoms of mental illness may affect veterans' ability to manage their medical conditions, effects of substance use on medical and mental health functioning, learning ways to eat healthier and exercise, and how to communicate more effectively with care providers. Groups will meet weekly for 75 minutes for three months (12 sessions). There will be 3 booster sessions after the 12 sessions, once a month for 3 months.</description>
          </group>
          <group group_id="O2">
            <title>Medical Illness Education and Support Group</title>
            <description>The comparison condition, Medical Illness Education and Support (MIES) group, will discuss common challenges experienced by those living with a wide range of chronic illnesses and behavioral and lifestyle management techniques that may help veterans to better handle chronic medical conditions. Each of the 12 sessions will follow a basic structure that includes a review of the material presented in the previous session, new education content and discussion.</description>
          </group>
        </group_list>
        <measure>
          <title>Measure of Self-Management Behaviors - General Self-Management Behaviors Subscale</title>
          <description>This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The General Self-Management Behaviors Subscale consists of 2 items with responses ranging from Never (0) to Always (5). Combined scores may range from 0-10 on this subscale, higher scores indicate greater frequency of the behavior indicating greater self-management behavior.</description>
          <population>Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="124"/>
                <count group_id="O2" value="118"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="124"/>
                    <count group_id="O2" value="118"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.7" spread="1.1"/>
                    <measurement group_id="O2" value="2.3" spread="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-intervention</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="105"/>
                    <count group_id="O2" value="107"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.9" spread="1.2"/>
                    <measurement group_id="O2" value="2.6" spread="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Follow-up</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="106"/>
                    <count group_id="O2" value="104"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.9" spread="1.2"/>
                    <measurement group_id="O2" value="2.5" spread="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.446</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Measure of Self-Management Behaviors - Making Better Use of Health Care Subscale</title>
        <description>This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Making Better Use of Health Care Subscale consists of 4 items with responses ranging from Never (0) to Always (5). Scores may range from 0-20 on this subscale, higher scores indicate greater frequency of behavior indicating greater self-management behavior.</description>
        <time_frame>Baseline, Post-Intervention (3 months after baseline), Follow-up (6 months after baseline)</time_frame>
        <population>Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.</population>
        <group_list>
          <group group_id="O1">
            <title>Living Well</title>
            <description>Living Well (LW) will be implemented as a 12-session, peer co-led, group intervention (4-8 persons) designed to help veterans with co-occurring Serious Mental Illnesses and Chronic Medical Conditions learn techniques for better health management and ways to live a healthier lifestyle. Key topics that will be discussed are medication side effects, how symptoms of mental illness may affect veterans' ability to manage their medical conditions, effects of substance use on medical and mental health functioning, learning ways to eat healthier and exercise, and how to communicate more effectively with care providers. Groups will meet weekly for 75 minutes for three months (12 sessions). There will be 3 booster sessions after the 12 sessions, once a month for 3 months.</description>
          </group>
          <group group_id="O2">
            <title>Medical Illness Education and Support Group</title>
            <description>The comparison condition, Medical Illness Education and Support (MIES) group, will discuss common challenges experienced by those living with a wide range of chronic illnesses and behavioral and lifestyle management techniques that may help veterans to better handle chronic medical conditions. Each of the 12 sessions will follow a basic structure that includes a review of the material presented in the previous session, new education content and discussion.</description>
          </group>
        </group_list>
        <measure>
          <title>Measure of Self-Management Behaviors - Making Better Use of Health Care Subscale</title>
          <description>This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Making Better Use of Health Care Subscale consists of 4 items with responses ranging from Never (0) to Always (5). Scores may range from 0-20 on this subscale, higher scores indicate greater frequency of behavior indicating greater self-management behavior.</description>
          <population>Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="124"/>
                <count group_id="O2" value="118"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="124"/>
                    <count group_id="O2" value="118"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.9" spread="1.4"/>
                    <measurement group_id="O2" value="2.5" spread="1.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-intervention</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="105"/>
                    <count group_id="O2" value="107"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.3" spread="1.2"/>
                    <measurement group_id="O2" value="2.9" spread="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Follow-up</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="106"/>
                    <count group_id="O2" value="104"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.3" spread="1.3"/>
                    <measurement group_id="O2" value="3.0" spread="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.459</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Measure of Self-Management Behaviors - Behavioral and Cognitive Symptom Management Subscale</title>
        <description>This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Behavioral and Cognitive Symptom Management Subscale consists of 6 items with responses ranging from Never (0) to Always (5). Scores may range from 0-30 on this subscale, higher scores indicate greater frequency of using the behavior indicating greater self-management behavior.</description>
        <time_frame>Baseline, Post-Intervention, Follow-up (6 months after baseline)</time_frame>
        <population>Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.</population>
        <group_list>
          <group group_id="O1">
            <title>Living Well</title>
            <description>Living Well (LW) will be implemented as a 12-session, peer co-led, group intervention (4-8 persons) designed to help veterans with co-occurring Serious Mental Illnesses and Chronic Medical Conditions learn techniques for better health management and ways to live a healthier lifestyle. Key topics that will be discussed are medication side effects, how symptoms of mental illness may affect veterans' ability to manage their medical conditions, effects of substance use on medical and mental health functioning, learning ways to eat healthier and exercise, and how to communicate more effectively with care providers. Groups will meet weekly for 75 minutes for three months (12 sessions). There will be 3 booster sessions after the 12 sessions, once a month for 3 months.</description>
          </group>
          <group group_id="O2">
            <title>Medical Illness Education and Support Group</title>
            <description>The comparison condition, Medical Illness Education and Support (MIES) group, will discuss common challenges experienced by those living with a wide range of chronic illnesses and behavioral and lifestyle management techniques that may help veterans to better handle chronic medical conditions. Each of the 12 sessions will follow a basic structure that includes a review of the material presented in the previous session, new education content and discussion.</description>
          </group>
        </group_list>
        <measure>
          <title>Measure of Self-Management Behaviors - Behavioral and Cognitive Symptom Management Subscale</title>
          <description>This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Behavioral and Cognitive Symptom Management Subscale consists of 6 items with responses ranging from Never (0) to Always (5). Scores may range from 0-30 on this subscale, higher scores indicate greater frequency of using the behavior indicating greater self-management behavior.</description>
          <population>Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="124"/>
                <count group_id="O2" value="118"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="124"/>
                    <count group_id="O2" value="118"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.2" spread="1.1"/>
                    <measurement group_id="O2" value="2.2" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-intervention</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="105"/>
                    <count group_id="O2" value="107"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5" spread="1.0"/>
                    <measurement group_id="O2" value="2.2" spread="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Follow-up</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="106"/>
                    <count group_id="O2" value="104"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5" spread="1.1"/>
                    <measurement group_id="O2" value="2.3" spread="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.038</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Measure of Self-Management Behaviors - Accessing Social Support Subscale</title>
        <description>This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Accessing Social Support Subscale consists of 2 items with responses ranging from Never (0) to Always (5). Combined scores may range from 0-10 on this subscale, higher scores indicate greater frequency of using the behavior indicating greater self-management behavior.</description>
        <time_frame>Baseline, Post-Intervention (3 months after baseline), Follow-up (6 months after baseline)</time_frame>
        <population>Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.</population>
        <group_list>
          <group group_id="O1">
            <title>Living Well</title>
            <description>Living Well (LW) will be implemented as a 12-session, peer co-led, group intervention (4-8 persons) designed to help veterans with co-occurring Serious Mental Illnesses and Chronic Medical Conditions learn techniques for better health management and ways to live a healthier lifestyle. Key topics that will be discussed are medication side effects, how symptoms of mental illness may affect veterans' ability to manage their medical conditions, effects of substance use on medical and mental health functioning, learning ways to eat healthier and exercise, and how to communicate more effectively with care providers. Groups will meet weekly for 75 minutes for three months (12 sessions). There will be 3 booster sessions after the 12 sessions, once a month for 3 months.</description>
          </group>
          <group group_id="O2">
            <title>Medical Illness Education and Support Group</title>
            <description>The comparison condition, Medical Illness Education and Support (MIES) group, will discuss common challenges experienced by those living with a wide range of chronic illnesses and behavioral and lifestyle management techniques that may help veterans to better handle chronic medical conditions. Each of the 12 sessions will follow a basic structure that includes a review of the material presented in the previous session, new education content and discussion.</description>
          </group>
        </group_list>
        <measure>
          <title>Measure of Self-Management Behaviors - Accessing Social Support Subscale</title>
          <description>This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Accessing Social Support Subscale consists of 2 items with responses ranging from Never (0) to Always (5). Combined scores may range from 0-10 on this subscale, higher scores indicate greater frequency of using the behavior indicating greater self-management behavior.</description>
          <population>Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="124"/>
                <count group_id="O2" value="118"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="124"/>
                    <count group_id="O2" value="118"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.3" spread="1.4"/>
                    <measurement group_id="O2" value="2.3" spread="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-intervention</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="105"/>
                    <count group_id="O2" value="107"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.4" spread="1.3"/>
                    <measurement group_id="O2" value="2.4" spread="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Follow-up</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="106"/>
                    <count group_id="O2" value="104"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.2" spread="1.3"/>
                    <measurement group_id="O2" value="2.3" spread="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.238</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Measure of Self-Management Behaviors - Physical Activity Subscale</title>
        <description>This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Physical Activity Subscale consists of 2 items with responses ranging from Never (0) to Always (5). Combined scores may range from 0-10 on this subscale, higher scores indicate greater frequency of using the behavior indicating greater self-management.</description>
        <time_frame>Baseline, Post-Intervention (3 months after baseline), Follow-up (6 months after baseline)</time_frame>
        <population>Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.</population>
        <group_list>
          <group group_id="O1">
            <title>Living Well</title>
            <description>Living Well (LW) will be implemented as a 12-session, peer co-led, group intervention (4-8 persons) designed to help veterans with co-occurring Serious Mental Illnesses and Chronic Medical Conditions learn techniques for better health management and ways to live a healthier lifestyle. Key topics that will be discussed are medication side effects, how symptoms of mental illness may affect veterans' ability to manage their medical conditions, effects of substance use on medical and mental health functioning, learning ways to eat healthier and exercise, and how to communicate more effectively with care providers. Groups will meet weekly for 75 minutes for three months (12 sessions). There will be 3 booster sessions after the 12 sessions, once a month for 3 months.</description>
          </group>
          <group group_id="O2">
            <title>Medical Illness Education and Support Group</title>
            <description>The comparison condition, Medical Illness Education and Support (MIES) group, will discuss common challenges experienced by those living with a wide range of chronic illnesses and behavioral and lifestyle management techniques that may help veterans to better handle chronic medical conditions. Each of the 12 sessions will follow a basic structure that includes a review of the material presented in the previous session, new education content and discussion.</description>
          </group>
        </group_list>
        <measure>
          <title>Measure of Self-Management Behaviors - Physical Activity Subscale</title>
          <description>This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Physical Activity Subscale consists of 2 items with responses ranging from Never (0) to Always (5). Combined scores may range from 0-10 on this subscale, higher scores indicate greater frequency of using the behavior indicating greater self-management.</description>
          <population>Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="124"/>
                <count group_id="O2" value="118"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="124"/>
                    <count group_id="O2" value="118"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.3" spread="1.3"/>
                    <measurement group_id="O2" value="2.3" spread="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-intervention</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="105"/>
                    <count group_id="O2" value="107"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.7" spread="1.3"/>
                    <measurement group_id="O2" value="2.4" spread="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Follow-up</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="106"/>
                    <count group_id="O2" value="104"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.8" spread="1.3"/>
                    <measurement group_id="O2" value="2.2" spread="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.011</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Measure of Self-Management Behaviors - Healthy Eating Subscale</title>
        <description>This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Healthy Eating Subscale consists of 2 items with responses ranging from Never (0) to Always (5).Combined scores may range from 0-10 on this subscale, higher scores indicate greater frequency of using the behavior indicating greater self-management behavior.</description>
        <time_frame>Baseline, Post-Intervention (3 months after baseline), Follow-up (6 months after baseline)</time_frame>
        <population>Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.</population>
        <group_list>
          <group group_id="O1">
            <title>Living Well</title>
            <description>Living Well (LW) will be implemented as a 12-session, peer co-led, group intervention (4-8 persons) designed to help veterans with co-occurring Serious Mental Illnesses and Chronic Medical Conditions learn techniques for better health management and ways to live a healthier lifestyle. Key topics that will be discussed are medication side effects, how symptoms of mental illness may affect veterans' ability to manage their medical conditions, effects of substance use on medical and mental health functioning, learning ways to eat healthier and exercise, and how to communicate more effectively with care providers. Groups will meet weekly for 75 minutes for three months (12 sessions). There will be 3 booster sessions after the 12 sessions, once a month for 3 months.</description>
          </group>
          <group group_id="O2">
            <title>Medical Illness Education and Support Group</title>
            <description>The comparison condition, Medical Illness Education and Support (MIES) group, will discuss common challenges experienced by those living with a wide range of chronic illnesses and behavioral and lifestyle management techniques that may help veterans to better handle chronic medical conditions. Each of the 12 sessions will follow a basic structure that includes a review of the material presented in the previous session, new education content and discussion.</description>
          </group>
        </group_list>
        <measure>
          <title>Measure of Self-Management Behaviors - Healthy Eating Subscale</title>
          <description>This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Healthy Eating Subscale consists of 2 items with responses ranging from Never (0) to Always (5).Combined scores may range from 0-10 on this subscale, higher scores indicate greater frequency of using the behavior indicating greater self-management behavior.</description>
          <population>Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="124"/>
                <count group_id="O2" value="118"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="124"/>
                    <count group_id="O2" value="118"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.6" spread="1.3"/>
                    <measurement group_id="O2" value="2.5" spread="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-intervention</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="105"/>
                    <count group_id="O2" value="107"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.0" spread="1.1"/>
                    <measurement group_id="O2" value="2.7" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Follow-up</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="106"/>
                    <count group_id="O2" value="104"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.9" spread="1.1"/>
                    <measurement group_id="O2" value="2.8" spread="1.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.709</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Morisky Medication Adherence Scale</title>
        <description>This 4 item self-reported medication adherence scale was developed from a well validated 8-item scale with responses ranging from Never (0) to Very Often (4) to to better capture barriers surrounding adherence behavior. This new scale has demonstrated psychometric properties. Possible scores range from 0 to 16, with higher scores indicating greater adherence. The distribution was skewed so a square root transformation was applied before analysis.</description>
        <time_frame>Baseline, Post-intervention (3 months after baseline)</time_frame>
        <population>Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.</population>
        <group_list>
          <group group_id="O1">
            <title>Living Well</title>
            <description>Living Well (LW) will be implemented as a 12-session, peer co-led, group intervention (4-8 persons) designed to help veterans with co-occurring Serious Mental Illnesses and Chronic Medical Conditions learn techniques for better health management and ways to live a healthier lifestyle. Key topics that will be discussed are medication side effects, how symptoms of mental illness may affect veterans' ability to manage their medical conditions, effects of substance use on medical and mental health functioning, learning ways to eat healthier and exercise, and how to communicate more effectively with care providers. Groups will meet weekly for 75 minutes for three months (12 sessions). There will be 3 booster sessions after the 12 sessions, once a month for 3 months..</description>
          </group>
          <group group_id="O2">
            <title>Medical Illness Education and Support Group</title>
            <description>The comparison condition, Medical Illness Education and Support (MIES) group, will discuss common challenges experienced by those living with a wide range of chronic illnesses and behavioral and lifestyle management techniques that may help veterans to better handle chronic medical conditions. Each of the 12 sessions will follow a basic structure that includes a review of the material presented in the previous session, new education content and discussion.</description>
          </group>
        </group_list>
        <measure>
          <title>Morisky Medication Adherence Scale</title>
          <description>This 4 item self-reported medication adherence scale was developed from a well validated 8-item scale with responses ranging from Never (0) to Very Often (4) to to better capture barriers surrounding adherence behavior. This new scale has demonstrated psychometric properties. Possible scores range from 0 to 16, with higher scores indicating greater adherence. The distribution was skewed so a square root transformation was applied before analysis.</description>
          <population>Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="124"/>
                <count group_id="O2" value="118"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="124"/>
                    <count group_id="O2" value="118"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.4" spread="1.0"/>
                    <measurement group_id="O2" value="1.5" spread="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-intervention</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="105"/>
                    <count group_id="O2" value="107"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2" spread="1.0"/>
                    <measurement group_id="O2" value="1.5" spread="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.134</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Multidimensional Health Locus of Control (HLOC)</title>
        <description>Measured with a subscale of the Multidimensional Health Locus of Control. Possible scores range from 0 to 36, with higher scores indicating greater internal locus of control. An 18 item questionnaire with responses ranging on a 6 point Likert scale from Strongly Disagree to Strongly Agree that asks about self-perceived control over one's health, illnesses, and ability to take an active role in one's health.</description>
        <time_frame>Baseline, Post-intervention (3 months after baseline)</time_frame>
        <population>Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.</population>
        <group_list>
          <group group_id="O1">
            <title>Living Well</title>
            <description>Living Well (LW) will be implemented as a 12-session, peer co-led, group intervention (4-8 persons) designed to help veterans with co-occurring Serious Mental Illnesses and Chronic Medical Conditions learn techniques for better health management and ways to live a healthier lifestyle. Key topics that will be discussed are medication side effects, how symptoms of mental illness may affect veterans' ability to manage their medical conditions, effects of substance use on medical and mental health functioning, learning ways to eat healthier and exercise, and how to communicate more effectively with care providers. Groups will meet weekly for 75 minutes for three months (12 sessions). There will be 3 booster sessions after the 12 sessions, once a month for 3 months.</description>
          </group>
          <group group_id="O2">
            <title>Medical Illness Education and Support Group</title>
            <description>The comparison condition, Medical Illness Education and Support (MIES) group, will discuss common challenges experienced by those living with a wide range of chronic illnesses and behavioral and lifestyle management techniques that may help veterans to better handle chronic medical conditions. Each of the 12 sessions will follow a basic structure that includes a review of the material presented in the previous session, new education content and discussion.</description>
          </group>
        </group_list>
        <measure>
          <title>Multidimensional Health Locus of Control (HLOC)</title>
          <description>Measured with a subscale of the Multidimensional Health Locus of Control. Possible scores range from 0 to 36, with higher scores indicating greater internal locus of control. An 18 item questionnaire with responses ranging on a 6 point Likert scale from Strongly Disagree to Strongly Agree that asks about self-perceived control over one's health, illnesses, and ability to take an active role in one's health.</description>
          <population>Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="124"/>
                <count group_id="O2" value="118"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="124"/>
                    <count group_id="O2" value="118"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.4" spread="5.9"/>
                    <measurement group_id="O2" value="26.1" spread="5.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-intervention</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="105"/>
                    <count group_id="O2" value="107"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.0" spread="4.8"/>
                    <measurement group_id="O2" value="25.5" spread="6.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.045</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Maryland Assessment of Recovery Scale (MARS)</title>
        <description>The MARS a 25-item self-report measure of recovery. Items are rated on a 5-point Likert scale ranging from not at all (1) to very much (5). The MARS has been shown to have good internal consistency (alpha=.95) and test-retest reliability (r = .868). Combined scores may range from 25-125, higher scores indicate greater self-reported recovery.</description>
        <time_frame>Baseline, Post-intervention (3 months after baseline)</time_frame>
        <population>Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.</population>
        <group_list>
          <group group_id="O1">
            <title>Living Well</title>
            <description>Living Well (LW) will be implemented as a 12-session, peer co-led, group intervention (4-8 persons) designed to help veterans with co-occurring Serious Mental Illnesses and Chronic Medical Conditions learn techniques for better health management and ways to live a healthier lifestyle. Key topics that will be discussed are medication side effects, how symptoms of mental illness may affect veterans' ability to manage their medical conditions, effects of substance use on medical and mental health functioning, learning ways to eat healthier and exercise, and how to communicate more effectively with care providers. Groups will meet weekly for 75 minutes for three months (12 sessions). There will be 3 booster sessions after the 12 sessions, once a month for 3 months.</description>
          </group>
          <group group_id="O2">
            <title>Medical Illness Education and Support Group</title>
            <description>The comparison condition, Medical Illness Education and Support (MIES) group, will discuss common challenges experienced by those living with a wide range of chronic illnesses and behavioral and lifestyle management techniques that may help veterans to better handle chronic medical conditions. Each of the 12 sessions will follow a basic structure that includes a review of the material presented in the previous session, new education content and discussion.</description>
          </group>
        </group_list>
        <measure>
          <title>Maryland Assessment of Recovery Scale (MARS)</title>
          <description>The MARS a 25-item self-report measure of recovery. Items are rated on a 5-point Likert scale ranging from not at all (1) to very much (5). The MARS has been shown to have good internal consistency (alpha=.95) and test-retest reliability (r = .868). Combined scores may range from 25-125, higher scores indicate greater self-reported recovery.</description>
          <population>Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="124"/>
                <count group_id="O2" value="118"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="124"/>
                    <count group_id="O2" value="118"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.9" spread="0.7"/>
                    <measurement group_id="O2" value="3.8" spread="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-intervention</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="105"/>
                    <count group_id="O2" value="107"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.0" spread="0.7"/>
                    <measurement group_id="O2" value="3.8" spread="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.099</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Morisky Medication Adherence Scale</title>
        <description>Possible scores range from 0 to 16, with higher scores indicating greater adherence. The distribution was skewed so a square root transformation was applied before analysis.</description>
        <time_frame>Baseline, Follow-up (6 months after baseline)</time_frame>
        <population>Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.</population>
        <group_list>
          <group group_id="O1">
            <title>Living Well</title>
            <description>Living Well (LW) will be implemented as a 12-session, peer co-led, group intervention (4-8 persons) designed to help veterans with co-occurring Serious Mental Illnesses and Chronic Medical Conditions learn techniques for better health management and ways to live a healthier lifestyle. Key topics that will be discussed are medication side effects, how symptoms of mental illness may affect veterans' ability to manage their medical conditions, effects of substance use on medical and mental health functioning, learning ways to eat healthier and exercise, and how to communicate more effectively with care providers. Groups will meet weekly for 75 minutes for three months (12 sessions). There will be 3 booster sessions after the 12 sessions, once a month for 3 months..</description>
          </group>
          <group group_id="O2">
            <title>Medical Illness Education and Support Group</title>
            <description>The comparison condition, Medical Illness Education and Support (MIES) group, will discuss common challenges experienced by those living with a wide range of chronic illnesses and behavioral and lifestyle management techniques that may help veterans to better handle chronic medical conditions. Each of the 12 sessions will follow a basic structure that includes a review of the material presented in the previous session, new education content and discussion.</description>
          </group>
        </group_list>
        <measure>
          <title>Morisky Medication Adherence Scale</title>
          <description>Possible scores range from 0 to 16, with higher scores indicating greater adherence. The distribution was skewed so a square root transformation was applied before analysis.</description>
          <population>Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="124"/>
                <count group_id="O2" value="118"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="124"/>
                    <count group_id="O2" value="118"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.4" spread="1.0"/>
                    <measurement group_id="O2" value="1.5" spread="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-intervention</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="105"/>
                    <count group_id="O2" value="107"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2" spread="1.0"/>
                    <measurement group_id="O2" value="1.5" spread="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Follow-up</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="106"/>
                    <count group_id="O2" value="104"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.2" spread="1.0"/>
                    <measurement group_id="O2" value="1.4" spread="0.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.852</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Multidimensional Health Locus of Control (HLOC)</title>
        <description>Measured with a subscale of the Multidimensional Health Locus of Control. Possible scores range from 0 to 36, with higher scores indicating greater internal locus of control. An 18 item questionnaire with responses ranging on a 6 point Likert scale from Strongly Disagree to Strongly Agree that asks about self-perceived control over one's health, illnesses, and ability to take an active role in one's health.</description>
        <time_frame>Baseline, Post-Intervention (3 months after baseline), Follow-up (6 months after baseline)</time_frame>
        <population>Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.</population>
        <group_list>
          <group group_id="O1">
            <title>Living Well</title>
            <description>Living Well (LW) will be implemented as a 12-session, peer co-led, group intervention (4-8 persons) designed to help veterans with co-occurring Serious Mental Illnesses and Chronic Medical Conditions learn techniques for better health management and ways to live a healthier lifestyle. Key topics that will be discussed are medication side effects, how symptoms of mental illness may affect veterans' ability to manage their medical conditions, effects of substance use on medical and mental health functioning, learning ways to eat healthier and exercise, and how to communicate more effectively with care providers. Groups will meet weekly for 75 minutes for three months (12 sessions). There will be 3 booster sessions after the 12 sessions, once a month for 3 months.</description>
          </group>
          <group group_id="O2">
            <title>Medical Illness Education and Support Group</title>
            <description>The comparison condition, Medical Illness Education and Support (MIES) group, will discuss common challenges experienced by those living with a wide range of chronic illnesses and behavioral and lifestyle management techniques that may help veterans to better handle chronic medical conditions. Each of the 12 sessions will follow a basic structure that includes a review of the material presented in the previous session, new education content and discussion.</description>
          </group>
        </group_list>
        <measure>
          <title>Multidimensional Health Locus of Control (HLOC)</title>
          <description>Measured with a subscale of the Multidimensional Health Locus of Control. Possible scores range from 0 to 36, with higher scores indicating greater internal locus of control. An 18 item questionnaire with responses ranging on a 6 point Likert scale from Strongly Disagree to Strongly Agree that asks about self-perceived control over one's health, illnesses, and ability to take an active role in one's health.</description>
          <population>Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="124"/>
                <count group_id="O2" value="118"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="124"/>
                    <count group_id="O2" value="118"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.4" spread="5.9"/>
                    <measurement group_id="O2" value="26.1" spread="5.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-intervention</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="105"/>
                    <count group_id="O2" value="107"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.0" spread="4.8"/>
                    <measurement group_id="O2" value="25.5" spread="6.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Follow-up</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="106"/>
                    <count group_id="O2" value="104"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.6" spread="5.4"/>
                    <measurement group_id="O2" value="25.7" spread="5.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.285</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Maryland Assessment of Recovery Scale (MARS)</title>
        <description>The MARS a 25-item self-report measure of recovery. Items are rated on a 5-point Likert scale of not at all (1) to very much (5). Combined scores may range from 25-125, higher scores indicate greater self-reported recovery. The MARS has been shown to have good internal consistency (alpha=.95) and test-retest reliability (r = .868)</description>
        <time_frame>Baseline, Post-Invention (3 months after baseline), Follow-up (6 months after baseline)</time_frame>
        <population>Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.</population>
        <group_list>
          <group group_id="O1">
            <title>Living Well</title>
            <description>Living Well (LW) will be implemented as a 12-session, peer-led, group intervention (4-8 persons) designed to help veterans with co-occurring Serious Mental Illnesses and Chronic Medical Conditions learn techniques for better health management and ways to live a healthier lifestyle. Key topics that will be discussed are medication side effects, how symptoms of mental illness may affect veterans' ability to manage their medical conditions, effects of substance use on medical and mental health functioning, learning ways to eat healthier, and how to communicate more effectively with care providers. Groups will meet weekly for 75 minutes for three months (12 sessions). There will be 3 booster sessions after the 12 sessions, once a month for 3 months.</description>
          </group>
          <group group_id="O2">
            <title>Medical Illness Education and Support Group</title>
            <description>The comparison condition, Medical Illness Education and Support (MIES) group, will discuss common challenges experienced by those living with a wide range of chronic illnesses and behavioral and lifestyle management techniques that may help veterans to better handle chronic medical conditions. Each of the 12 sessions will follow a basic structure that includes a review of the material presented in the previous session, new education content and discussion.</description>
          </group>
        </group_list>
        <measure>
          <title>Maryland Assessment of Recovery Scale (MARS)</title>
          <description>The MARS a 25-item self-report measure of recovery. Items are rated on a 5-point Likert scale of not at all (1) to very much (5). Combined scores may range from 25-125, higher scores indicate greater self-reported recovery. The MARS has been shown to have good internal consistency (alpha=.95) and test-retest reliability (r = .868)</description>
          <population>Due to participant attrition, the number of participants analyzed at each time point decreased from the original baseline number.</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="124"/>
                <count group_id="O2" value="118"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="124"/>
                    <count group_id="O2" value="118"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.9" spread="0.7"/>
                    <measurement group_id="O2" value="3.8" spread="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-intervention</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="105"/>
                    <count group_id="O2" value="107"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.0" spread="0.7"/>
                    <measurement group_id="O2" value="3.8" spread="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Follow-up</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="106"/>
                    <count group_id="O2" value="104"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.0" spread="0.7"/>
                    <measurement group_id="O2" value="3.8" spread="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>The same mixed model used for testing hypothesis 1 was used to test treatment effects on secondary scale outcomes (Hypothesis 3: health-related self-efficacy, patient activation; Hypothesis 4: six subscales of the Measure of Self-Management Behaviors) and several other pre-specified outcomes. To test for a group difference in mean change from baseline to follow-up (hypothesis 5) on all primary and secondary outcomes, the significance test of the group-by-follow-up coefficient was performed.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.222</p_value>
            <method>Mixed Models Analysis</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events assessed from time of enrollment to follow-up assessment (~9 months) for each participant. Total duration of reported events during recruitment and follow-up of study assessments is about 2 years, 8 months.</time_frame>
      <desc>The reported All-Cause Mortality Affected and At Risk is zero as this study was deemed minimal risk and mortality due to study participation was not anticipated. In addition, there were no unanticipated deaths due to study participation.</desc>
      <group_list>
        <group group_id="E1">
          <title>Living Well</title>
          <description>Living Well (LW) will be implemented as a 12-session, peer-led, group intervention (4-8 persons) designed to help veterans with co-occurring Serious Mental Illnesses and Chronic Medical Conditions learn techniques for better health management and ways to live a healthier lifestyle. Key topics that will be discussed are medication side effects, how symptoms of mental illness may affect veterans' ability to manage their medical conditions, effects of substance use on medical and mental health functioning, learning ways to eat healthier, and how to communicate more effectively with care providers. Groups will meet weekly for 75 minutes for three months (12 sessions). There will be 3 booster sessions after the 12 sessions, once a month for 3 months.</description>
        </group>
        <group group_id="E2">
          <title>Medical Illness Education and Support Group</title>
          <description>The comparison condition, Medical Illness Education and Support (MIES) group, will discuss common challenges experienced by those living with a wide range of chronic illnesses and behavioral and lifestyle management techniques that may help veterans to better handle chronic medical conditions. Each of the 12 sessions will follow a basic structure that includes a review of the material presented in the previous session, new education content and discussion.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="124"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="118"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="124"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="118"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="39" subjects_at_risk="124"/>
                <counts group_id="E2" subjects_affected="30" subjects_at_risk="118"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Hospitalization</sub_title>
                <description>Medical or mental health hospitalizations reported during assessment, over the phone, or in group.</description>
                <counts group_id="E1" events="53" subjects_affected="39" subjects_at_risk="124"/>
                <counts group_id="E2" events="39" subjects_affected="30" subjects_at_risk="118"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Mary Brighid Walsh</name_or_title>
      <organization>Department of Veterans Affairs, VAMHCS MIRECC</organization>
      <phone>410-637-1860</phone>
      <email>marybrighid.walsh@va.gov</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01676909
org study id: IIR 11-276
nct id: NCT01676909
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Veterans with schizophrenia, other serious mental illnesses (SMI), and Post Traumatic Stress
      Disorder (PTSD) are at elevated risk for co-occurring chronic medical conditions resulting in
      increased risk of disability, high health care spending, reduced quality of life and early
      mortality. Physical wellness is increasingly recognized as a key component of the VA's
      commitment to developing recovery-oriented and Veteran-centered mental health treatment.
      There is also growing recognition of the value of interventions that promote and improve
      patient self-management of chronic medical conditions. Building on the established efficacy
      of consumer facilitated medical illness self-management programming used in the general
      population and two recent adaptations for use with SMI adults in the public health sector
      (including the investigators' own evaluation of an intervention called Living Well), the
      investigators propose to complete a randomized controlled effectiveness trial of the Living
      Well intervention and simultaneously conduct a well specified process evaluation to optimize
      knowledge accrual regarding important factors that may improve future adoption,
      implementation and sustainability of the Living Well intervention in the VA system of care.
Background:

      Veterans with schizophrenia, other serious mental illnesses (SMI), and Post Traumatic Stress
      Disorder (PTSD) are at elevated risk for co-occurring chronic medical conditions resulting in
      increased risk of disability, high health care spending, reduced quality of life and early
      mortality. Physical wellness is increasingly recognized as a key component of the VA's
      commitment to developing recovery-oriented and Veteran-centered mental health treatment.
      There is also growing recognition of the value of interventions that promote and improve
      patient self-management of chronic medical conditions. Building on the established efficacy
      of consumer facilitated medical illness self-management programming used in the general
      population and two recent adaptations for use with SMI adults in the public health sector
      (including the investigators' own evaluation of an intervention called Living Well), the
      investigators propose to complete a randomized controlled effectiveness trial of the Living
      Well intervention and simultaneously conduct a well specified process evaluation to optimize
      knowledge accrual regarding important factors that may improve future adoption,
      implementation and sustainability of the Living Well intervention in the VA system of care.

      Aims:

      Primary AIM 1: Complete a randomized controlled effectiveness trial of the Living Well
      intervention with 242 Veterans with mental illness and at least one co-occurring chronic
      medical condition and evaluate the intervention's effects on functional and service related
      outcomes. The investigators hypothesize that those randomized to the Living Well intervention
      will, in comparison to those randomized to a medical illness education and support group,
      demonstrate improved general health functioning including physical and emotional functioning
      as well as reduced rates of medical emergency room visits for management of a chronic medical
      condition. The investigators will also evaluate intervention effects on more proximal
      attitudinal and behavioral outcomes and assess how these factors mediate improvement in the
      functional and services related outcomes.

      Primary AIM 2: Complete a well specified process evaluation based on the RE-AIM evaluation
      framework to better understand contextual factors that can improve the Reach, Effectiveness,
      Adoption, Implementation and Maintenance which together determine the potential public health
      impact of the Living Well intervention.

      Methods:

      A mix of temporally overlapping quantitative and qualitative methods will be used to maximize
      integration and synthesis of data streams across the two aims to optimize knowledge accrual.

      Impact:

      Despite the growing recognition that self-management strategies hold enormous promise for
      improving quality and outcomes of care for chronic medical illnesses, and the fact that
      self-management is gaining prominence as a mental health recovery oriented treatment focus,
      there are currently no evidence-based peer facilitated medical illness self-management
      interventions available for dissemination within the VA mental health system. The proposed
      study is designed to both generate evidence supporting the effectiveness of a peer
      co-facilitated intervention and to help speed throughput to public health impact by
      collecting important contextual information about factors that may improve future
      dissemination and implementation efforts.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Single (Investigator)
measure: Short Form-12 (SF-12) General Health (Norm Based)
time frame: Baseline, Post-intervention (3 months after baseline)
description: 12-item Short-Form Health Survey. Possible subscale scores range from 0 to 100, with higher scores indicating greater well-being.The SF-12 (39), a widely used standardized instrument with strong psychometric properties, will be used to assess self-perceptions of general health functioning across multiple dimensions (including general, physical and emotional/psychiatric functioning). The SF-12 has shown good internal, consistency, stability, and concurrent validity in outpatients with serious mental illness.
measure: Short-Form 12 (SF-12) Physical Scale (Norm Based)
time frame: Baseline, Post-intervention (3 months after baseline)
description: 12-item Short-Form Health Survey. Possible subscale scores range from 0 to 100, with higher scores indicating greater well-being. The SF-12 , a widely used standardized instrument with strong psychometric properties, will be used to assess self-perceptions of general health functioning across multiple dimensions (including general, physical and emotional/psychiatric functioning). The SF-12 has shown good internal, consistency, stability, and concurrent validity in outpatients with serious mental illness.
measure: Short-Form 12 (SF-12) Mental Scale (Norm Based)
time frame: Baseline, Post-intervention (3 months after baseline)
description: 12-item Short-Form Health Survey. Possible subscale scores range from 0 to 100, with higher scores indicating greater well-being. The SF-12 , a widely used standardized instrument with strong psychometric properties, will be used to assess self-perceptions of general health functioning across multiple dimensions (including general, physical and emotional/psychiatric functioning). The SF-12 has shown good internal, consistency, stability, and concurrent validity in outpatients with serious mental illness.
measure: ER Visit Between Baseline and the 6-month Follow-up
time frame: Baseline, Follow-up (6-months after baseline)
description: Emergency Room Visit during the approximate 6-month period between baseline and the follow-up visit.
measure: Illness Management Self-Efficacy
time frame: Baseline, Post-intervention (3 months after baseline)
description: This questionnaire is based on the items used in the original Chronic Disease Self-Management Program (CDSMP) as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have strong test-retest reliability and internal consistency as well. This subscale consists of 2 items with possible responses ranging from Never (0) to Always (5). Combined scores from these 2 items may range from 0-10 on this subscale, higher scores indicating greater frequency.
measure: Patient Activation Measure
time frame: Baseline, Post-intervention (3 months after baseline)
description: This 13-item questionnaire measures an individual's perceived ability to manage his or her illness and health behaviors and act as an effective patient. Responses range from Disagree Strongly (1) to Agree Strongly (4). Respondents must complete at least 10 of the 13 questions to obtain a reliable score. Scores may range from 0-100 with higher scores interpreted as greater ability to manage one's own illness. The measure has demonstrated reliability and validity.
measure: Measure of Self-Management Behaviors - General Self-Management Behaviors Subscale
time frame: Baseline, Post-intervention (3 months after baseline)
description: This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The General Self-Management Behaviors Subscale consists of 2 items with responses ranging from Never (0) to Always (5). Combined scores from these 2 items may range from 0-10 on this subscale, higher scores indicating greater frequency of using the behavior indicating greater self-management behavior.
measure: Measure of Self-Management Behaviors - Making Better Use of Health Care Subscale
time frame: Baseline, Post-intervention (3 months after baseline)
description: This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Making Better Use of Health Care Subscale consists of 4 items with responses ranging from Never (0) to Always (5).Combined scores from these 4 items may range from 0-20 on this subscale, higher scores indicating greater frequency of using the behavior indicating greater self-management behavior.
measure: Measure of Self-Management Behaviors - Behavioral and Cognitive Symptom Management Subscale
time frame: Baseline, Post-intervention (3 months after baseline)
description: This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Behavioral and Cognitive Symptom Management Subscale consists of 6 items with responses ranging from Never (0) to Always (5). Combined scores from these 4 items may range from 0-30 on this subscale, higher scores indicating greater frequency or using the behavior indicating greater self-management.
measure: Measure of Self-Management Behaviors - Accessing Social Support Subscale
time frame: Baseline, Post-intervention (3 months after baseline)
description: This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Accessing Social Support Subscale consists of 2 items with responses ranging from Never (0) to Always (5). Combined scores from these 2 items may range from 0-10 on this subscale, higher scores indicating greater frequency of using the behavior indicating greater self-management behavior.
measure: Measure of Self-Management Behaviors - Physical Activity Subscale
time frame: Baseline, Post-intervention (3 months after baseline)
description: This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Physical Activity Subscale consists of 2 items with responses ranging from Never (0) to Always (5). Combined scores from these 2 items may range from 0-10 on this subscale, higher scores indicating greater frequency of using the behavior indicating greater self-management behavior.
measure: Measure of Self-Management Behaviors - Healthy Eating Subscale
time frame: Baseline, Post-intervention (3 months after baseline)
description: This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Healthy Eating Subscale consists of 2 items with responses ranging from Never (0) to Always (5). Combined scores from these 2 items may range from 0-10 on this subscale, higher scores indicating greater frequency of using the behavior indicating greater self-management behavior.
measure: Short Form-12 (SF-12) General Health (Norm Based)
time frame: Baseline, Post-Intervention (3 months after baseline), Follow-Up (6 months after baseline)
description: 12-item Short-Form Health Survey. Possible subscale scores range from 0 to 100, with higher scores indicating greater well-being.The SF-12 (39), a widely used standardized instrument with strong psychometric properties, will be used to assess self-perceptions of general health functioning across multiple dimensions (including general, physical and emotional/psychiatric functioning). The SF-12 has shown good internal, consistency, stability, and concurrent validity in outpatients with serious mental illness.
measure: Short-Form 12 (SF-12) Physical Scale (Norm Based)
time frame: Baseline, Post-Intervention (3 months after baseline), Follow-Up (6 months after baseline)
description: 12-item Short-Form Health Survey. Possible subscale scores range from 0 to 100, with higher scores indicating greater well-being. The SF-12 , a widely used standardized instrument with strong psychometric properties, will be used to assess self-perceptions of general health functioning across multiple dimensions (including general, physical and emotional/psychiatric functioning). The SF-12 has shown good internal, consistency, stability, and concurrent validity in outpatients with serious mental illness.
measure: Short-Form 12 (SF-12) Mental Scale (Norm Based)
time frame: Baseline, Post-Intervention (3 months after baseline), Follow-Up (6 months after baseline)
description: 12-item Short-Form Health Survey. Possible subscale scores range from 0 to 100, with higher scores indicating greater well-being. The SF-12 , a widely used standardized instrument with strong psychometric properties, will be used to assess self-perceptions of general health functioning across multiple dimensions (including general, physical and emotional/psychiatric functioning). The SF-12 has shown good internal, consistency, stability, and concurrent validity in outpatients with serious mental illness.
measure: Illness Management Self-Efficacy
time frame: Baseline, Post-Intervention (3 months after baseline), Follow-Up (6 months after baseline)
description: This questionnaire is based on the items used in the original Chronic Disease Self-Management Program (CDSMP) as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have strong test-retest reliability and internal consistency as well. This subscale consists of 2 items with possible responses ranging from Never (0) to Always (5). Combined scores may range from 0-10 on this subscale, higher scores indicate greater self-efficacy.
measure: Patient Activation Measure
time frame: Baseline, Post-Intervention (3 months after baseline), Follow up (6 months after baseline)
description: This 13-item questionnaire measures an individual's perceived ability to manage his or her illness and health behaviors and act as an effective patient. Responses range from Disagree Strongly (1) to Agree Strongly (4). Respondents must complete at least 10 of the 13 questions to obtain a reliable score. Scores may range from 0-100 with higher scores interpreted as greater ability to manage one's own illness. The measure has demonstrated reliability and validity
measure: Measure of Self-Management Behaviors - General Self-Management Behaviors Subscale
time frame: Baseline, Post-Intervention (3 months after baseline), Follow up (6 months after baseline)
description: This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The General Self-Management Behaviors Subscale consists of 2 items with responses ranging from Never (0) to Always (5). Combined scores may range from 0-10 on this subscale, higher scores indicate greater frequency of the behavior indicating greater self-management behavior.
measure: Measure of Self-Management Behaviors - Making Better Use of Health Care Subscale
time frame: Baseline, Post-Intervention (3 months after baseline), Follow-up (6 months after baseline)
description: This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Making Better Use of Health Care Subscale consists of 4 items with responses ranging from Never (0) to Always (5). Scores may range from 0-20 on this subscale, higher scores indicate greater frequency of behavior indicating greater self-management behavior.
measure: Measure of Self-Management Behaviors - Behavioral and Cognitive Symptom Management Subscale
time frame: Baseline, Post-Intervention, Follow-up (6 months after baseline)
description: This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Behavioral and Cognitive Symptom Management Subscale consists of 6 items with responses ranging from Never (0) to Always (5). Scores may range from 0-30 on this subscale, higher scores indicate greater frequency of using the behavior indicating greater self-management behavior.
measure: Measure of Self-Management Behaviors - Accessing Social Support Subscale
time frame: Baseline, Post-Intervention (3 months after baseline), Follow-up (6 months after baseline)
description: This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Accessing Social Support Subscale consists of 2 items with responses ranging from Never (0) to Always (5). Combined scores may range from 0-10 on this subscale, higher scores indicate greater frequency of using the behavior indicating greater self-management behavior.
measure: Measure of Self-Management Behaviors - Physical Activity Subscale
time frame: Baseline, Post-Intervention (3 months after baseline), Follow-up (6 months after baseline)
description: This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Physical Activity Subscale consists of 2 items with responses ranging from Never (0) to Always (5). Combined scores may range from 0-10 on this subscale, higher scores indicate greater frequency of using the behavior indicating greater self-management.
measure: Measure of Self-Management Behaviors - Healthy Eating Subscale
time frame: Baseline, Post-Intervention (3 months after baseline), Follow-up (6 months after baseline)
description: This questionnaire is based on the items used in the original CDSMP as part of that groups extensive evaluation of the curriculum. The original CDSMP measure has been shown to have adequate psychometric properties; the range of test-retest coefficients for the original illness management scales was .56 to .92, with internal-consistency coefficients ranging from .70 to .75. The Healthy Eating Subscale consists of 2 items with responses ranging from Never (0) to Always (5).Combined scores may range from 0-10 on this subscale, higher scores indicate greater frequency of using the behavior indicating greater self-management behavior.
measure: Morisky Medication Adherence Scale
time frame: Baseline, Post-intervention (3 months after baseline)
description: This 4 item self-reported medication adherence scale was developed from a well validated 8-item scale with responses ranging from Never (0) to Very Often (4) to to better capture barriers surrounding adherence behavior. This new scale has demonstrated psychometric properties. Possible scores range from 0 to 16, with higher scores indicating greater adherence. The distribution was skewed so a square root transformation was applied before analysis.
measure: Multidimensional Health Locus of Control (HLOC)
time frame: Baseline, Post-intervention (3 months after baseline)
description: Measured with a subscale of the Multidimensional Health Locus of Control. Possible scores range from 0 to 36, with higher scores indicating greater internal locus of control. An 18 item questionnaire with responses ranging on a 6 point Likert scale from Strongly Disagree to Strongly Agree that asks about self-perceived control over one's health, illnesses, and ability to take an active role in one's health.
measure: Maryland Assessment of Recovery Scale (MARS)
time frame: Baseline, Post-intervention (3 months after baseline)
description: The MARS a 25-item self-report measure of recovery. Items are rated on a 5-point Likert scale ranging from not at all (1) to very much (5). The MARS has been shown to have good internal consistency (alpha=.95) and test-retest reliability (r = .868). Combined scores may range from 25-125, higher scores indicate greater self-reported recovery.
measure: Morisky Medication Adherence Scale
time frame: Baseline, Follow-up (6 months after baseline)
description: Possible scores range from 0 to 16, with higher scores indicating greater adherence. The distribution was skewed so a square root transformation was applied before analysis.
measure: Multidimensional Health Locus of Control (HLOC)
time frame: Baseline, Post-Intervention (3 months after baseline), Follow-up (6 months after baseline)
description: Measured with a subscale of the Multidimensional Health Locus of Control. Possible scores range from 0 to 36, with higher scores indicating greater internal locus of control. An 18 item questionnaire with responses ranging on a 6 point Likert scale from Strongly Disagree to Strongly Agree that asks about self-perceived control over one's health, illnesses, and ability to take an active role in one's health.
measure: Maryland Assessment of Recovery Scale (MARS)
time frame: Baseline, Post-Invention (3 months after baseline), Follow-up (6 months after baseline)
description: The MARS a 25-item self-report measure of recovery. Items are rated on a 5-point Likert scale of not at all (1) to very much (5). Combined scores may range from 25-125, higher scores indicate greater self-reported recovery. The MARS has been shown to have good internal consistency (alpha=.95) and test-retest reliability (r = .868)
arm group label: Living Well
arm group type: Experimental
description: This study will involve a clinical trial of Living Well (LW), a 12-session, peer co-led, group intervention designed to help veterans with co-occurring Serious Mental Illnesses and Chronic Medical Conditions learn techniques for better health management and ways to live a healthier lifestyle. Key topics that will be discussed are medication side effects, how symptoms of mental illness may affect veterans' ability to manage their medical conditions, effects of substance use on medical and mental health functioning, learning ways to eat healthier and exercise, and how to communicate more effectively with care providers. After completing the 12 weekly groups, participants will return to complete once monthly booster group sessions for the next three months.
arm group label: Medical Illness Education & Support Group
arm group type: Active Comparator
description: We selected a comparison condition that would provide parallel focus (i.e. medical illness) but not include use of the core ingredients undergirding the Living Well intervention including behavioral action planning, problem solving, in-session and between session practice using specific disease self-management techniques and involvement of peer co-facilitators to enhance modeling and improve self-efficacy and activation. As with Living Well, the content of the intervention will have broad applicability across diverse chronic disease conditions. The comparison condition will be a once-weekly support and education group focusing on living with a chronic medical condition.
intervention type: Behavioral
intervention name: Living Well
description: This study will involve a clinical trial of Living Well (LW), a 12-session, peer co-led, group intervention designed to help veterans with co-occurring Serious Mental Illnesses and Chronic Medical Conditions learn techniques for better health management and ways to live a healthier lifestyle. Key topics that will be discussed are medication side effects, how symptoms of mental illness may affect veterans' ability to manage their medical conditions, effects of substance use on medical and mental health functioning, learning ways to eat healthier and exercise, and how to communicate more effectively with care providers. There will be 3 booster sessions after the 12 sessions, once a month for 3 months.
arm group label: Living Well
intervention type: Behavioral
intervention name: Medical Illness Education & Support Group
description: The comparison condition will be a general Medical Illness Education and Support (MIES) group that will discuss common challenges experienced by those living with a wide range of chronic illnesses and behavioral and lifestyle management techniques that may help veterans to better handle chronic medical conditions that also meets for 12 weeks.
arm group label: Medical Illness Education & Support Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Richard W Goldberg, PhD
role: Principal Investigator
affiliation: Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
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country: United States
responsible party type: Sponsor
mesh term: Mental Disorders
sharing ipd: No
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