<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/NCT04504903</url>
  </required_header>
  <id_info>
    <org_study_id>IIR 19-176</org_study_id>
    <nct_id>NCT04504903</nct_id>
  </id_info>
  <brief_title>Cognitive Behavioral Therapy to Improve Work and Wellness in Veterans With Mental Illness</brief_title>
  <acronym>WORKWELL</acronym>
  <official_title>Work as a Determinant of Health: A Pragmatic Trial of Enhanced Cognitive Behavioral Therapy to Bolster Competitive Work and Wellness in Veterans With Serious Mental Illness (WORKWELL)</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>Yes</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>
      Vocational instability in Veterans with serious mental illness (SMI) is pervasive, costly,&#xD;
      and harmful. Over 75% of Veterans with SMI are unemployed, resulting in economic difficulties&#xD;
      and trouble meeting basic needs. Overall, among adults with depression, work dysfunction&#xD;
      results in a 36 to 51 billion dollar loss annually. Unemployed Veterans with SMI also suffer&#xD;
      major health consequences, including a more severe course of illness and poor recovery over&#xD;
      time, leading to increased inpatient and emergency service use. The WORKWELL study will&#xD;
      synergistically address these deficits in health, recovery, and work functioning by testing&#xD;
      the Cognitive Behavioral Therapy for Work Success (CBTw) intervention. Using a pragmatic&#xD;
      design, this project will address work as a major social determinant of health and close the&#xD;
      health disparity gap among people with SMI. Further, through promotion of work and healthy&#xD;
      thinking, CBTw holds promise to reduce risk of suicide among vulnerable veterans with SMI.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Project background: Work is a major social determinant of health. In people with serious&#xD;
      mental illness (SMI), work is associated with better wellbeing, physical and mental health,&#xD;
      quality of life, and may prevent the onset of disability. Among Veterans with SMI, work is a&#xD;
      protective factor against suicide.&#xD;
&#xD;
      Most veterans with SMI are unemployed and suffer substantially worse health and recovery&#xD;
      across key domains. Despite quality VHA vocational services, such as supported employment&#xD;
      (SE), two-thirds or more of Veterans who receive these services experience work dysfunction.&#xD;
      A probable explanation lies in unsolved cognitive and behavioral barriers, such as low&#xD;
      work-related self-efficacy, ineffective coping skills, little hope that work is attainable,&#xD;
      poor work motivation and sense of self.&#xD;
&#xD;
      The Cognitive Behavioral Therapy for Work Success (CBTw) intervention was designed to target&#xD;
      these problems and augment VHA SE services to synergistically improve work, as well as health&#xD;
      and recovery, in Veterans with SMI. In an open trial pilot, CBTw was associated with&#xD;
      significant increases in hours worked and wages earned and the majority of CBTw participants&#xD;
      became steady workers. Veterans also experienced improvements in symptoms, recovery, and&#xD;
      quality of life.&#xD;
&#xD;
      Project goals: Using Hybrid 1 RCT design, this project will test the effects of CBTw on&#xD;
      competitive work and health and recovery outcomes over a 12-month study period at 3 VA SE&#xD;
      programs. Informed by the RE-AIM framework, an implementation evaluation will examine the&#xD;
      success of using SE staff to deliver CBTw, barriers and facilitators to implementation, and&#xD;
      strategies utilized.&#xD;
&#xD;
      Relevance to priorities: This project has high implementation potential and is responsive to&#xD;
      the VHA priority regarding Health Equity, as it will address work functioning, an under&#xD;
      studied social determinant of health. WORKWELL also holds promise to improve health and&#xD;
      recovery outcomes among Veterans with SMI, another HSR&amp;D area of emphasis. Lastly, this study&#xD;
      is consistent with the goal of finding novel strategies toward suicide prevention among&#xD;
      vulnerable Veteran groups, including those with SMI.&#xD;
&#xD;
      Objectives: Aim 1: Test the effects of CBTw + SE compared to a control of psychoeducation +&#xD;
      SE on work. Hypotheses: Participants in the CBTw+ SE arm will work significantly more total&#xD;
      weeks in competitive jobs (primary study outcome) and will be more likely to become steady&#xD;
      workers.&#xD;
&#xD;
      Aim 2: Test the effects of CBTw + SE on health and recovery. Hypotheses: Participants in the&#xD;
      CBTw + SE arm will have greater improvements on subjective recovery and health-related&#xD;
      quality of life, and decreases in symptoms, suicidal ideation, and inpatient service&#xD;
      utilization.&#xD;
&#xD;
      Aim 3: Guided by the RE-AIM implementation science framework, conduct an evaluation of the&#xD;
      implementation of CBTw, including examination of the feasibility of using SE staff to deliver&#xD;
      CBTw, and related barriers and facilitators. The objective is to spur future wide scale CBTw&#xD;
      implementation.&#xD;
&#xD;
      Project Methods: WORKWELL is a pragmatic, Hybrid 1 design RCT. CBTw will be tested at 3 SE&#xD;
      sites-Roudebush VA Medical Center, the Edward J. Hines VA Medical Center, and the VA St.&#xD;
      Louis Health Care System. 276 unemployed Veterans with SMI will be randomly assigned to&#xD;
      receive CBTw plus SE or a control of psychoeducation plus SE. Outcomes including total weeks&#xD;
      worked in competitive jobs (primary), achievement of steady work, symptoms, recovery, health&#xD;
      related quality of life, suicidal ideation, and service utilization will be assessed at&#xD;
      posttreatment (12 weeks), 6 months (primary endpoint), and 9 months (to examine sustained&#xD;
      effects). Primary work outcomes will be collected monthly over a 12-month period. CBTw&#xD;
      implementation planning, training, and consultation will be provided. CBTw implementation&#xD;
      (fidelity), barriers and facilitators to implementation, and other RE-AIM elements will be&#xD;
      examined using mixed methods.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 1, 2021</start_date>
  <completion_date type="Anticipated">September 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2024</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>
    <intervention_model_description>Unemployed participants with serious mental illness will be randomized to receive group-based cognitive behavioral therapy geared toward improving competitive work outcomes or a time and format matched psychoeducation intervention</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Research personnel conducting outcomes assessments will be blinded to condition assignment</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Total weeks worked in competitive jobs change</measure>
    <time_frame>baseline to 12 months</time_frame>
    <description>Outcome measure will be mean number of weeks worked in competitive jobs. The primary endpoint is 6 months (primary comparison will be baseline to 6 months). Competitive jobs are regular jobs open to all that pay at least minimum wage. More total weeks worked in competitive jobs is indicative of a positive outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Achievement of steady competitive work change</measure>
    <time_frame>baseline to 12 months</time_frame>
    <description>Outcome measure of steady competitive work is defined as working at least 50% of the study period as assessed at the 12 month follow up period. Achievement of steady competitive work is a positive outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cross-Cutting Symptom Measure (CCSM) change</measure>
    <time_frame>baseline to 9 months</time_frame>
    <description>Outcome measure is a 23-item, Likert response (scored on a 0 to 4 scale), self-rated instrument that assesses 13 domains of psychiatric symptoms(e.g., depression, anxiety, psychosis, mania, sleep problems, self-harm, substance use, etc.) with higher scores indicating more severe total symptoms. Total scores range from 0 to 92.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>12-item Short Form Survey (SF-12) change</measure>
    <time_frame>baseline to 9 months</time_frame>
    <description>The SF-12 outcome measure will assess health-related quality of life and is comprised of the Physical Component Summary (PCS) and Mental Component Summary (MCS). Total scores range from 0 to 100 with higher scores indicating higher health-related quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Scale for Suicidal Ideation change</measure>
    <time_frame>baseline to 9 months</time_frame>
    <description>Outcome measure is a 21-item interviewer rated measure of a continuum of suicidal ideation, including thoughts, attitudes, plans, and behaviors. Total scores range from 0 to 42 with higher scores indicating more suicidal ideation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recovery Assessment Scale change</measure>
    <time_frame>baseline to 9 months</time_frame>
    <description>Outcome measure is a 41 item self report survey that will assess subjective recovery attitudes. Total scores range from 41 to 164 with higher scores indicating higher levels of subjective recovery.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">278</enrollment>
  <condition>Posttraumatic Stress Disorders</condition>
  <arm_group>
    <arm_group_label>Cognitive Behavioral Therapy For Work Success (CBTw)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Veterans will participate in 12 weekly group sessions to discuss thoughts, feelings, and behaviors that promote work success in the community</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Psychoeducation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Veterans in the control group will participate in 12 weekly group sessions in which they will learn more about their mental health conditions.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive Behavioral Therapy For Work Success (CBTw)</intervention_name>
    <description>Veterans will go to 12 weekly group sessions and will learn healthy thinking about work, positive behavioral coping related to work, and will form a work success plan based on their work goals.</description>
    <arm_group_label>Cognitive Behavioral Therapy For Work Success (CBTw)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Psychoeducation</intervention_name>
    <description>Veterans will go to 12 weekly group sessions and will learn more information about their mental health conditions. Psychoeducation modules are from the Illness Management and Recovery program.</description>
    <arm_group_label>Psychoeducation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Unemployment, defined as no current participation in a competitive job&#xD;
&#xD;
          -  A competitive work goal, which denotes a goal of a regular job in the community that&#xD;
             pays at least minimum wage&#xD;
&#xD;
          -  Presence of a serious mental illness including one or more of the following&#xD;
             conditions:&#xD;
&#xD;
               -  major depression&#xD;
&#xD;
               -  bipolar disorders&#xD;
&#xD;
               -  schizophrenia&#xD;
&#xD;
               -  schizoaffective disorder&#xD;
&#xD;
               -  posttraumatic stress disorder (PTSD)&#xD;
&#xD;
          -  Currently enrolled in and receiving VA vocational rehabilitation services&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous participation in cognitive behavioral therapy intervention geared toward work&#xD;
&#xD;
          -  Presence of a severe medical or cognitive impairment that will prevent participation&#xD;
             in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marina Elizabeth Kukla, PhD MS BS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Richard L. Roudebush VA Medical Center, Indianapolis, IN</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Kenneth C Weber, MEd</last_name>
    <role>Principal Investigator</role>
    <affiliation>Edward Hines Jr. VA Hospital, Hines, IL</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Marina E Kukla, PhD MS BS</last_name>
    <phone>(317) 988-3330</phone>
    <email>marina.kukla2@va.gov</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Nancy H Henry, BA</last_name>
    <email>nancy.henry2@va.gov</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Edward Hines Jr. VA Hospital, Hines, IL</name>
      <address>
        <city>Hines</city>
        <state>Illinois</state>
        <zip>60141-5000</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kenneth Weber, MEd</last_name>
      <phone>708-202-8387</phone>
      <phone_ext>27897</phone_ext>
    </contact>
  </location>
  <location>
    <facility>
      <name>Richard L. Roudebush VA Medical Center, Indianapolis, IN</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202-2884</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sara R Pierce, BS BS</last_name>
      <phone>(317) 988-9498</phone>
      <email>sara.pierce4@va.gov</email>
    </contact>
    <contact_backup>
      <last_name>Nancy H Henry, BA</last_name>
      <email>nancy.henry2@va.gov</email>
    </contact_backup>
    <investigator>
      <last_name>Marina Elizabeth Kukla, PhD MS BS</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>St. Louis VA Medical Center John Cochran Division, St. Louis, MO</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63106</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jessica Hatfield, MS</last_name>
      <phone>314-652-4100</phone>
      <phone_ext>55485</phone_ext>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>August 4, 2020</study_first_submitted>
  <study_first_submitted_qc>August 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <last_update_submitted>December 7, 2022</last_update_submitted>
  <last_update_submitted_qc>December 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 9, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Rehabilitation, Vocational</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stress Disorders, Post-Traumatic</mesh_term>
    <mesh_term>Mental Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Upon request, the Research Service will consider requests for the final data sets underlying the publications to be provided to the public. The limited dataset will include de-identified data relevant to the specific request. Independent research groups can view relevant data to evaluate the extent that data sources support conclusions made by authors in published studies as well as observe additional emergent themes and view supplemental details that might not be included in publications.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>The data will become available once the study team completes all analyses.</ipd_time_frame>
    <ipd_access_criteria>The Research Service will evaluate individual requests.</ipd_access_criteria>
  </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/NCT04504903
org study id: IIR 19-176
nct id: NCT04504903
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
Vocational instability in Veterans with serious mental illness (SMI) is pervasive, costly,
      and harmful. Over 75% of Veterans with SMI are unemployed, resulting in economic difficulties
      and trouble meeting basic needs. Overall, among adults with depression, work dysfunction
      results in a 36 to 51 billion dollar loss annually. Unemployed Veterans with SMI also suffer
      major health consequences, including a more severe course of illness and poor recovery over
      time, leading to increased inpatient and emergency service use. The WORKWELL study will
      synergistically address these deficits in health, recovery, and work functioning by testing
      the Cognitive Behavioral Therapy for Work Success (CBTw) intervention. Using a pragmatic
      design, this project will address work as a major social determinant of health and close the
      health disparity gap among people with SMI. Further, through promotion of work and healthy
      thinking, CBTw holds promise to reduce risk of suicide among vulnerable veterans with SMI.
Project background: Work is a major social determinant of health. In people with serious
      mental illness (SMI), work is associated with better wellbeing, physical and mental health,
      quality of life, and may prevent the onset of disability. Among Veterans with SMI, work is a
      protective factor against suicide.

      Most veterans with SMI are unemployed and suffer substantially worse health and recovery
      across key domains. Despite quality VHA vocational services, such as supported employment
      (SE), two-thirds or more of Veterans who receive these services experience work dysfunction.
      A probable explanation lies in unsolved cognitive and behavioral barriers, such as low
      work-related self-efficacy, ineffective coping skills, little hope that work is attainable,
      poor work motivation and sense of self.

      The Cognitive Behavioral Therapy for Work Success (CBTw) intervention was designed to target
      these problems and augment VHA SE services to synergistically improve work, as well as health
      and recovery, in Veterans with SMI. In an open trial pilot, CBTw was associated with
      significant increases in hours worked and wages earned and the majority of CBTw participants
      became steady workers. Veterans also experienced improvements in symptoms, recovery, and
      quality of life.

      Project goals: Using Hybrid 1 RCT design, this project will test the effects of CBTw on
      competitive work and health and recovery outcomes over a 12-month study period at 3 VA SE
      programs. Informed by the RE-AIM framework, an implementation evaluation will examine the
      success of using SE staff to deliver CBTw, barriers and facilitators to implementation, and
      strategies utilized.

      Relevance to priorities: This project has high implementation potential and is responsive to
      the VHA priority regarding Health Equity, as it will address work functioning, an under
      studied social determinant of health. WORKWELL also holds promise to improve health and
      recovery outcomes among Veterans with SMI, another HSR&D area of emphasis. Lastly, this study
      is consistent with the goal of finding novel strategies toward suicide prevention among
      vulnerable Veteran groups, including those with SMI.

      Objectives: Aim 1: Test the effects of CBTw + SE compared to a control of psychoeducation +
      SE on work. Hypotheses: Participants in the CBTw+ SE arm will work significantly more total
      weeks in competitive jobs (primary study outcome) and will be more likely to become steady
      workers.

      Aim 2: Test the effects of CBTw + SE on health and recovery. Hypotheses: Participants in the
      CBTw + SE arm will have greater improvements on subjective recovery and health-related
      quality of life, and decreases in symptoms, suicidal ideation, and inpatient service
      utilization.

      Aim 3: Guided by the RE-AIM implementation science framework, conduct an evaluation of the
      implementation of CBTw, including examination of the feasibility of using SE staff to deliver
      CBTw, and related barriers and facilitators. The objective is to spur future wide scale CBTw
      implementation.

      Project Methods: WORKWELL is a pragmatic, Hybrid 1 design RCT. CBTw will be tested at 3 SE
      sites-Roudebush VA Medical Center, the Edward J. Hines VA Medical Center, and the VA St.
      Louis Health Care System. 276 unemployed Veterans with SMI will be randomly assigned to
      receive CBTw plus SE or a control of psychoeducation plus SE. Outcomes including total weeks
      worked in competitive jobs (primary), achievement of steady work, symptoms, recovery, health
      related quality of life, suicidal ideation, and service utilization will be assessed at
      posttreatment (12 weeks), 6 months (primary endpoint), and 9 months (to examine sustained
      effects). Primary work outcomes will be collected monthly over a 12-month period. CBTw
      implementation planning, training, and consultation will be provided. CBTw implementation
      (fidelity), barriers and facilitators to implementation, and other RE-AIM elements will be
      examined using mixed methods.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Unemployed participants with serious mental illness will be randomized to receive group-based cognitive behavioral therapy geared toward improving competitive work outcomes or a time and format matched psychoeducation intervention
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Research personnel conducting outcomes assessments will be blinded to condition assignment
measure: Total weeks worked in competitive jobs change
time frame: baseline to 12 months
description: Outcome measure will be mean number of weeks worked in competitive jobs. The primary endpoint is 6 months (primary comparison will be baseline to 6 months). Competitive jobs are regular jobs open to all that pay at least minimum wage. More total weeks worked in competitive jobs is indicative of a positive outcome.
measure: Achievement of steady competitive work change
time frame: baseline to 12 months
description: Outcome measure of steady competitive work is defined as working at least 50% of the study period as assessed at the 12 month follow up period. Achievement of steady competitive work is a positive outcome.
measure: Cross-Cutting Symptom Measure (CCSM) change
time frame: baseline to 9 months
description: Outcome measure is a 23-item, Likert response (scored on a 0 to 4 scale), self-rated instrument that assesses 13 domains of psychiatric symptoms(e.g., depression, anxiety, psychosis, mania, sleep problems, self-harm, substance use, etc.) with higher scores indicating more severe total symptoms. Total scores range from 0 to 92.
measure: 12-item Short Form Survey (SF-12) change
time frame: baseline to 9 months
description: The SF-12 outcome measure will assess health-related quality of life and is comprised of the Physical Component Summary (PCS) and Mental Component Summary (MCS). Total scores range from 0 to 100 with higher scores indicating higher health-related quality of life.
measure: Scale for Suicidal Ideation change
time frame: baseline to 9 months
description: Outcome measure is a 21-item interviewer rated measure of a continuum of suicidal ideation, including thoughts, attitudes, plans, and behaviors. Total scores range from 0 to 42 with higher scores indicating more suicidal ideation.
measure: Recovery Assessment Scale change
time frame: baseline to 9 months
description: Outcome measure is a 41 item self report survey that will assess subjective recovery attitudes. Total scores range from 41 to 164 with higher scores indicating higher levels of subjective recovery.
arm group label: Cognitive Behavioral Therapy For Work Success (CBTw)
arm group type: Experimental
description: Veterans will participate in 12 weekly group sessions to discuss thoughts, feelings, and behaviors that promote work success in the community
arm group label: Psychoeducation
arm group type: Active Comparator
description: Veterans in the control group will participate in 12 weekly group sessions in which they will learn more about their mental health conditions.
intervention type: Behavioral
intervention name: Cognitive Behavioral Therapy For Work Success (CBTw)
description: Veterans will go to 12 weekly group sessions and will learn healthy thinking about work, positive behavioral coping related to work, and will form a work success plan based on their work goals.
arm group label: Cognitive Behavioral Therapy For Work Success (CBTw)
intervention type: Behavioral
intervention name: Psychoeducation
description: Veterans will go to 12 weekly group sessions and will learn more information about their mental health conditions. Psychoeducation modules are from the Illness Management and Recovery program.
arm group label: Psychoeducation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Marina Elizabeth Kukla, PhD MS BS
role: Principal Investigator
affiliation: Richard L. Roudebush VA Medical Center, Indianapolis, IN
last name: Kenneth C Weber, MEd
role: Principal Investigator
affiliation: Edward Hines Jr. VA Hospital, Hines, IL
last name: Marina E Kukla, PhD MS BS
phone: (317) 988-3330
email: marina.kukla2@va.gov
last name: Nancy H Henry, BA
email: nancy.henry2@va.gov
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Stress Disorders, Post-Traumatic
mesh term: Mental Disorders
sharing ipd: Yes
ipd description: Upon request, the Research Service will consider requests for the final data sets underlying the publications to be provided to the public. The limited dataset will include de-identified data relevant to the specific request. Independent research groups can view relevant data to evaluate the extent that data sources support conclusions made by authors in published studies as well as observe additional emergent themes and view supplemental details that might not be included in publications.
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd time frame: The data will become available once the study team completes all analyses.
ipd access criteria: The Research Service will evaluate individual requests.