<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/NCT04481737</url>
  </required_header>
  <id_info>
    <org_study_id>D20155</org_study_id>
    <nct_id>NCT04481737</nct_id>
  </id_info>
  <brief_title>Peer-delivered and Technology-Assisted Integrated Illness Management and Recovery</brief_title>
  <official_title>Peer-delivered and Technology-Assisted Integrated Illness Management and Recovery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dartmouth-Hitchcock Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Harvard University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Vinfen</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Dartmouth-Hitchcock Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Adults with serious mental illness (SMI) are disproportionately affected by medical&#xD;
      comorbidity, earlier onset of disease, and 10 to 25 years reduced life expectancy compared to&#xD;
      the general population. These high rates of morbidity and early mortality are associated with&#xD;
      inadequately managed medical and psychiatric illnesses. A recent systematic review found nine&#xD;
      effective self-management interventions that address medical and psychiatric illnesses in&#xD;
      adults with SMI. However, there has been limited adoption of these interventions due to both&#xD;
      provider and consumer-based factors. Provider-based barriers consist of the lack of an&#xD;
      adequate workforce with the capacity, time, and knowledge of effective approaches to&#xD;
      self-management support for adults with SMI and chronic health conditions. Consumer-based&#xD;
      barriers associated with limited participation in self-management programs include lack of&#xD;
      access, engagement, and ongoing community-based support for persons with SMI. Peer support&#xD;
      specialists have the potential to address these barriers as they comprise one of the fastest&#xD;
      growing sectors of the mental health workforce, have &quot;lived experience&quot; in self-management&#xD;
      practices, and offer access to support in the community. However, challenges need to be&#xD;
      resolved for peers to be effective providers of evidence-based interventions. For example,&#xD;
      peers are frequently trained to provide &quot;peer support&quot; described as &quot;giving and receiving&#xD;
      help founded on key principles of respect, shared responsibility, and mutual agreement of&#xD;
      what is helpful&quot;. Peer support has been associated with increased sense of control, ability&#xD;
      to make changes, and decreased psychiatric symptoms. Despite benefits, peer support does not&#xD;
      adhere to evidence-based practices for psychiatric and medical self-management and does not&#xD;
      follow protocols that ensure fidelity and systematically monitor outcomes. The investigators&#xD;
      hypothesize that mobile technology has the potential to overcome these limitations of peer&#xD;
      support by providing real-time guidance in fidelity adherent delivery of a peer-delivered,&#xD;
      technology-assisted evidence-based self-management intervention (PDTA-IIMR). The investigator&#xD;
      will build the necessary expertise to pursue a career developing and testing novel approaches&#xD;
      to peer-delivered evidence-based self-management interventions. Training will include:&#xD;
      development of peer-delivered interventions; development and design of mobile&#xD;
      health-supported interventions; and intervention clinical trials research. Concurrently, this&#xD;
      study includes refinement of the intervention protocol with input from peers and consumers&#xD;
      and conducting a pilot study evaluating the feasibility and potential effectiveness of&#xD;
      PDTA-IIMR compared to routine peer support for N=6 peers and N=40 adults with SMI and chronic&#xD;
      health conditions. Outcomes include feasibility, medical and psychiatric self-management&#xD;
      skills, functional ability, and mortality risk factors and examine self-efficacy and social&#xD;
      support as mechanisms on outcomes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">February 1, 2021</start_date>
  <completion_date type="Anticipated">October 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">October 31, 2023</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>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in number of study drop-outs, attendance, and adherence from baseline to 3-months</measure>
    <time_frame>Baseline and 3-months</time_frame>
    <description>Review case notes written by peer support specialists to examine count data on attrition, attendance, and patient adherence.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in average fidelity scores</measure>
    <time_frame>Baseline and 3-months</time_frame>
    <description>Peer Support specialists will independently rate themselves after each session using the PDTA-IIMR fidelity scale. The standards used for establishing the items and ratings were determined by expert sources and empirical research.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline mortality risk index to 3-months and 6-month follow-up</measure>
    <time_frame>Baseline, 3-months, and 6-months</time_frame>
    <description>Avoidable Mortality Risk Index includes an examination of modifiable risk factors include: smoking; high blood pressure; excess body weight; high blood glucose; high cholesterol; high alcohol intake; low physical activity; poor diet.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline self efficacy to 3-months and 6-month follow-up</measure>
    <time_frame>Baseline, 3-months, and 6-months</time_frame>
    <description>Self-Efficacy for Managing Chronic Disease. Self-Efficacy for Managing Chronic Disease is a six-item scale that assesses domains of self-efficacy: symptom control, role function, emotional functioning, and communicating with physicians. Higher scores indicate greater self-efficacy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline social support to 3-months and 6-month follow-up</measure>
    <time_frame>Baseline, 3-months, and 6-months</time_frame>
    <description>Medical Outcomes Study Social Support Survey. Medical Outcomes Study Social Support is a 19-item scale that assesses domains of social support: emotional/informational, tangible, affection, and positive social interaction. Higher scores indicate higher levels of social support.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline mental health self-management skills to 3-months and 6-month follow-up</measure>
    <time_frame>Baseline, 3-months, and 6-months</time_frame>
    <description>Illness Management and Recovery Scale. The Illness Management and Recovery Scale is a valid, reliable 15-item scale that assesses domains of illness management. Each item addresses psychiatric illness, management, and recovery. Higher scores equate to higher ability to manage psychiatric conditions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline medical self-management skills to 3-months and 6-month follow-up</measure>
    <time_frame>Baseline, 3-months, and 6-months</time_frame>
    <description>Self-Rated Abilities for Health Practices Scale.The Self-Rated Abilities for Health Practices Scale is a 28-item scale that assesses confidence to execute health practices that has shown reliability and validity with adults with disabilities. This scale includes four subscales: exercise, nutrition, responsible health practice, and psychological well-being. Higher scores indicate higher levels of self-efficacy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline functional ability to 3-months and 6-month follow-up</measure>
    <time_frame>Baseline, 3-months, and 6-months</time_frame>
    <description>PROMIS Global Health. The PROMIS Global Health includes 10-items that measures five core PROMIS domains (physical function, pain, fatigue, emotional distress, social health). The measure is agnostic, rather than disease-specific, and commonly used to show an individuals' assessment of their overall health. Higher scores indicate better functional ability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline disability to 3-months and 6-month follow-up</measure>
    <time_frame>Baseline, 3-months, and 6-months</time_frame>
    <description>London Handicap Scale. The London Handicap Scale measures health status and includes domains of independent living skills: mobility, physical independence, occupation, social integration, orientation, and economic self-sufficiency. Higher scores indicate better functional ability.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline level of cardiovascular disease risk to 3-months and 6-month follow-up</measure>
    <time_frame>Baseline, 3-months, and 6-months</time_frame>
    <description>Framingham Risk Score. Framingham Risk Score includes risk factors: age; sex; LDL cholesterol; HDL cholesterol; blood pressure; diabetes; and smoking. A higher score indicates worse outcomes.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change from baseline level of loneliness to 3-months and 6-month follow-up</measure>
    <time_frame>Baseline, 3-months, and 6-months</time_frame>
    <description>UCLA Loneliness Scale. For loneliness each of the three-item version of the UCLA Loneliness Scale are rated on a four-point scale, with higher values indicative of greater loneliness. Items asked about how often individuals felt left out and isolated from others, and how often they felt that there are people that really understand them or that they can talk to.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change from baseline patient satisfaction to 3-months and 6-month follow-up</measure>
    <time_frame>Baseline, 3-months, and 6-months</time_frame>
    <description>Adult Patient Satisfaction Survey. The 36-item Adult Patient Satisfaction Survey designed to measure patient satisfaction in receiving mental health services in a community-based mental health system. Higher scores indicate greater patient satisfaction.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Schizophrenia</condition>
  <condition>Bipolar Disorder</condition>
  <condition>Major Depressive Disorder, Recurrent</condition>
  <condition>Obesity</condition>
  <condition>Cardiovascular Diseases</condition>
  <condition>Diabetes</condition>
  <condition>Smoking</condition>
  <condition>Blood Pressure Disorders</condition>
  <condition>Cholesterol, Elevated</condition>
  <arm_group>
    <arm_group_label>PDTA-IIMR</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Peer support</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Peer-delivered and Technology Support Integrated Illness Management and Recovery</intervention_name>
    <description>PDTA-IIMR is delivered by a peer support specialist with the use of guided IIMR eModules and a smartphone application designed to complement in-person eModule sessions. The eModules are designed to be reviewed with a peer support specialist and consumer during one-hour, weekly, telephonic sessions in a community setting. Each eModule includes videos and experiential learning tasks on psychoeducation and coping skills training.</description>
    <arm_group_label>PDTA-IIMR</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Peer support</intervention_name>
    <description>Peer support is a non-manualized form of social support, frequently coupled with instrumental support, that is mutually offered or provided by persons having a mental health condition to others sharing a similar mental health condition to bring about a desired social or personal change. Peer support specialists are provided with 1-hour of supervision each week</description>
    <arm_group_label>Peer support</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Consumer Inclusion Criteria&#xD;
&#xD;
        Consumer eligibility includes the following:&#xD;
&#xD;
          -  (1) participants will be adults age 18 or older who have a chart DSM-V Axis I&#xD;
             diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, persistent&#xD;
             major depressive disorder (diagnosis will be verified using the Mini-International&#xD;
             Neuropsychiatric Interview);&#xD;
&#xD;
          -  (2) have been enrolled in treatment for at least 3 months;&#xD;
&#xD;
          -  (3) a chart diagnosis of a medical diagnosis of cardiovascular disease, obesity,&#xD;
             diabetes, or chronic obstructive pulmonary disease;&#xD;
&#xD;
          -  (4) speak and read English; and&#xD;
&#xD;
          -  (5) voluntary informed consent for participation in the study by the participant.&#xD;
&#xD;
        Consumer Exclusion Criteria&#xD;
&#xD;
        Consumer participants will be excluded based on the following criteria:&#xD;
&#xD;
          -  (1) chart diagnosis of dementia or documented cognitive impairment as indicated by the&#xD;
             Mini Mental State Examination score &lt;24;&#xD;
&#xD;
          -  (2) major visual, hearing, or motor impairment (measured by potential participants'&#xD;
             ability to use a smartphone);&#xD;
&#xD;
          -  (3) currently residing in a nursing home;&#xD;
&#xD;
          -  (4) terminal illness expected to result of death of participant within one year; or&#xD;
&#xD;
          -  (5) consumers with two or more emergency room or hospitalizations in the last 6 months&#xD;
             or as determined by the clinical team to be psychiatrically or medically unstable;&#xD;
&#xD;
        Peer Inclusion Criteria&#xD;
&#xD;
        Peer eligibility includes the following:&#xD;
&#xD;
          -  (1) Massachusetts certified peer specialist (i.e., to qualify to be a Massachusetts&#xD;
             certified peer specialist a person must self-report any mental health diagnosis, be in&#xD;
             active treatment, and complete an 80 hour training that includes classes, small group&#xD;
             activities, and homework on fundamentals of peer support, cross-cultural partnering,&#xD;
             and human experience language. All certified peer specialists must pass a written&#xD;
             examination);&#xD;
&#xD;
          -  (2) a clinical history of improved psychiatric and medical self-management in the past&#xD;
             6 months;&#xD;
&#xD;
          -  (3) speak and read English;&#xD;
&#xD;
          -  (4) willing to use technology to deliver an intervention;&#xD;
&#xD;
          -  (5) must provide voluntary informed consent for participation in the study; and&#xD;
&#xD;
          -  (6) have worked as a certified peer specialist with people with SMI for 1+ years.&#xD;
&#xD;
        Peer Exclusion Criteria&#xD;
&#xD;
        Peer participants will be excluded based on the following criteria:&#xD;
&#xD;
          -  (1) chart diagnosis of dementia or documented cognitive impairment as indicated by the&#xD;
             Mini Mental State Examination score &lt;24;&#xD;
&#xD;
          -  (2) major visual, hearing, or motor impairment (measured by potential participants'&#xD;
             ability to use a tablet); and&#xD;
&#xD;
          -  (3) certified peer specialists with two or more emergency room or hospitalizations in&#xD;
             the last 6 months or as determined by the clinical team to be psychiatrically or&#xD;
             medically unstable.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Vinfen</name>
      <address>
        <city>Cambridge</city>
        <state>Massachusetts</state>
        <zip>02141</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>July 10, 2020</study_first_submitted>
  <study_first_submitted_qc>July 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 22, 2020</study_first_posted>
  <last_update_submitted>February 21, 2023</last_update_submitted>
  <last_update_submitted_qc>February 21, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Dartmouth-Hitchcock Medical Center</investigator_affiliation>
    <investigator_full_name>Karen L. Fortuna</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</mesh_term>
    <mesh_term>Hypercholesterolemia</mesh_term>
    <mesh_term>Schizophrenia</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
    <mesh_term>Depressive Disorder, Major</mesh_term>
    <mesh_term>Bipolar Disorder</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Tools (data, assays, libraries, research tools, reagents, model organisms, etc.) will be made available, in accordance with the NIH Data Sharing Policy (http://grants.nih.gov/grants/policy/data_sharing) and Model Organism Sharing Policy (http://grants.nih.gov/grants/policy/model_organism/index.htm), to all researchers in both the private and public sector free or for a nominal charge and with minimal restriction. In some cases the Trustees of Dartmouth College (the institution) may determine that the public and the research community are better served by a licensing program whether or not patents have been filed. This may be relevant, for example, if a tool is best distributed under license to guarantee reagent availability and quality.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT04481737
org study id: D20155
nct id: NCT04481737
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Adults with serious mental illness (SMI) are disproportionately affected by medical
      comorbidity, earlier onset of disease, and 10 to 25 years reduced life expectancy compared to
      the general population. These high rates of morbidity and early mortality are associated with
      inadequately managed medical and psychiatric illnesses. A recent systematic review found nine
      effective self-management interventions that address medical and psychiatric illnesses in
      adults with SMI. However, there has been limited adoption of these interventions due to both
      provider and consumer-based factors. Provider-based barriers consist of the lack of an
      adequate workforce with the capacity, time, and knowledge of effective approaches to
      self-management support for adults with SMI and chronic health conditions. Consumer-based
      barriers associated with limited participation in self-management programs include lack of
      access, engagement, and ongoing community-based support for persons with SMI. Peer support
      specialists have the potential to address these barriers as they comprise one of the fastest
      growing sectors of the mental health workforce, have "lived experience" in self-management
      practices, and offer access to support in the community. However, challenges need to be
      resolved for peers to be effective providers of evidence-based interventions. For example,
      peers are frequently trained to provide "peer support" described as "giving and receiving
      help founded on key principles of respect, shared responsibility, and mutual agreement of
      what is helpful". Peer support has been associated with increased sense of control, ability
      to make changes, and decreased psychiatric symptoms. Despite benefits, peer support does not
      adhere to evidence-based practices for psychiatric and medical self-management and does not
      follow protocols that ensure fidelity and systematically monitor outcomes. The investigators
      hypothesize that mobile technology has the potential to overcome these limitations of peer
      support by providing real-time guidance in fidelity adherent delivery of a peer-delivered,
      technology-assisted evidence-based self-management intervention (PDTA-IIMR). The investigator
      will build the necessary expertise to pursue a career developing and testing novel approaches
      to peer-delivered evidence-based self-management interventions. Training will include:
      development of peer-delivered interventions; development and design of mobile
      health-supported interventions; and intervention clinical trials research. Concurrently, this
      study includes refinement of the intervention protocol with input from peers and consumers
      and conducting a pilot study evaluating the feasibility and potential effectiveness of
      PDTA-IIMR compared to routine peer support for N=6 peers and N=40 adults with SMI and chronic
      health conditions. Outcomes include feasibility, medical and psychiatric self-management
      skills, functional ability, and mortality risk factors and examine self-efficacy and social
      support as mechanisms on outcomes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Change in number of study drop-outs, attendance, and adherence from baseline to 3-months
time frame: Baseline and 3-months
description: Review case notes written by peer support specialists to examine count data on attrition, attendance, and patient adherence.
measure: Change in average fidelity scores
time frame: Baseline and 3-months
description: Peer Support specialists will independently rate themselves after each session using the PDTA-IIMR fidelity scale. The standards used for establishing the items and ratings were determined by expert sources and empirical research.
measure: Change from baseline mortality risk index to 3-months and 6-month follow-up
time frame: Baseline, 3-months, and 6-months
description: Avoidable Mortality Risk Index includes an examination of modifiable risk factors include: smoking; high blood pressure; excess body weight; high blood glucose; high cholesterol; high alcohol intake; low physical activity; poor diet.
measure: Change from baseline self efficacy to 3-months and 6-month follow-up
time frame: Baseline, 3-months, and 6-months
description: Self-Efficacy for Managing Chronic Disease. Self-Efficacy for Managing Chronic Disease is a six-item scale that assesses domains of self-efficacy: symptom control, role function, emotional functioning, and communicating with physicians. Higher scores indicate greater self-efficacy.
measure: Change from baseline social support to 3-months and 6-month follow-up
time frame: Baseline, 3-months, and 6-months
description: Medical Outcomes Study Social Support Survey. Medical Outcomes Study Social Support is a 19-item scale that assesses domains of social support: emotional/informational, tangible, affection, and positive social interaction. Higher scores indicate higher levels of social support.
measure: Change from baseline mental health self-management skills to 3-months and 6-month follow-up
time frame: Baseline, 3-months, and 6-months
description: Illness Management and Recovery Scale. The Illness Management and Recovery Scale is a valid, reliable 15-item scale that assesses domains of illness management. Each item addresses psychiatric illness, management, and recovery. Higher scores equate to higher ability to manage psychiatric conditions.
measure: Change from baseline medical self-management skills to 3-months and 6-month follow-up
time frame: Baseline, 3-months, and 6-months
description: Self-Rated Abilities for Health Practices Scale.The Self-Rated Abilities for Health Practices Scale is a 28-item scale that assesses confidence to execute health practices that has shown reliability and validity with adults with disabilities. This scale includes four subscales: exercise, nutrition, responsible health practice, and psychological well-being. Higher scores indicate higher levels of self-efficacy.
measure: Change from baseline functional ability to 3-months and 6-month follow-up
time frame: Baseline, 3-months, and 6-months
description: PROMIS Global Health. The PROMIS Global Health includes 10-items that measures five core PROMIS domains (physical function, pain, fatigue, emotional distress, social health). The measure is agnostic, rather than disease-specific, and commonly used to show an individuals' assessment of their overall health. Higher scores indicate better functional ability.
measure: Change from baseline disability to 3-months and 6-month follow-up
time frame: Baseline, 3-months, and 6-months
description: London Handicap Scale. The London Handicap Scale measures health status and includes domains of independent living skills: mobility, physical independence, occupation, social integration, orientation, and economic self-sufficiency. Higher scores indicate better functional ability.
measure: Change from baseline level of cardiovascular disease risk to 3-months and 6-month follow-up
time frame: Baseline, 3-months, and 6-months
description: Framingham Risk Score. Framingham Risk Score includes risk factors: age; sex; LDL cholesterol; HDL cholesterol; blood pressure; diabetes; and smoking. A higher score indicates worse outcomes.
measure: Change from baseline level of loneliness to 3-months and 6-month follow-up
time frame: Baseline, 3-months, and 6-months
description: UCLA Loneliness Scale. For loneliness each of the three-item version of the UCLA Loneliness Scale are rated on a four-point scale, with higher values indicative of greater loneliness. Items asked about how often individuals felt left out and isolated from others, and how often they felt that there are people that really understand them or that they can talk to.
measure: Change from baseline patient satisfaction to 3-months and 6-month follow-up
time frame: Baseline, 3-months, and 6-months
description: Adult Patient Satisfaction Survey. The 36-item Adult Patient Satisfaction Survey designed to measure patient satisfaction in receiving mental health services in a community-based mental health system. Higher scores indicate greater patient satisfaction.
arm group label: PDTA-IIMR
arm group type: Experimental
arm group label: Peer support
arm group type: Active Comparator
intervention type: Behavioral
intervention name: Peer-delivered and Technology Support Integrated Illness Management and Recovery
description: PDTA-IIMR is delivered by a peer support specialist with the use of guided IIMR eModules and a smartphone application designed to complement in-person eModule sessions. The eModules are designed to be reviewed with a peer support specialist and consumer during one-hour, weekly, telephonic sessions in a community setting. Each eModule includes videos and experiential learning tasks on psychoeducation and coping skills training.
arm group label: PDTA-IIMR
intervention type: Behavioral
intervention name: Peer support
description: Peer support is a non-manualized form of social support, frequently coupled with instrumental support, that is mutually offered or provided by persons having a mental health condition to others sharing a similar mental health condition to bring about a desired social or personal change. Peer support specialists are provided with 1-hour of supervision each week
arm group label: Peer support
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Dartmouth-Hitchcock Medical Center
investigator full name: Karen L. Fortuna
investigator title: Assistant Professor
mesh term: Cardiovascular Diseases
mesh term: Hypercholesterolemia
mesh term: Schizophrenia
mesh term: Depressive Disorder
mesh term: Depressive Disorder, Major
mesh term: Bipolar Disorder
sharing ipd: Yes
ipd description: Tools (data, assays, libraries, research tools, reagents, model organisms, etc.) will be made available, in accordance with the NIH Data Sharing Policy (http://grants.nih.gov/grants/policy/data_sharing) and Model Organism Sharing Policy (http://grants.nih.gov/grants/policy/model_organism/index.htm), to all researchers in both the private and public sector free or for a nominal charge and with minimal restriction. In some cases the Trustees of Dartmouth College (the institution) may determine that the public and the research community are better served by a licensing program whether or not patents have been filed. This may be relevant, for example, if a tool is best distributed under license to guarantee reagent availability and quality.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code