xml: <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/NCT05975008</url>
    </required_header>
    <id_info>
      <org_study_id>PPO 22-150</org_study_id>
      <nct_id>NCT05975008</nct_id>
    </id_info>
    <brief_title>Pilot Testing a Virtual Mindfulness-Based Intervention to Improve Veterans' Health</brief_title>
    <acronym>RECLAIM</acronym>
    <official_title>Pilot Testing a Virtual Mindfulness-Based Intervention Aimed at Improving Reintegrating Veterans' Health Outcomes</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>
        The purpose of this study is to test a mindfulness-based intervention to reduce depressive&#xD;
        symptoms and improve Veterans' community reintegration.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The overarching goal of the proposed project is to use mindfulness practices to reduce&#xD;
        depression and improve community reintegration among post-9/11 Veterans. This proposal&#xD;
        focuses on the REconnecting to Civilian Life using Activities that Improve Mindfulness&#xD;
        (RECLAIM) intervention. RECLAIM is a virtual multi-component, mindfulness-based intervention&#xD;
        developed by the study team in collaboration with VA clinicians, post-9/11 Veterans, and&#xD;
        stakeholders and guided by the VA Whole Health framework. The proposed project builds on&#xD;
        preliminary pilot work and a Small Award Initiative for Impact (SWIFT) pilot project funded&#xD;
        by the VA HSR&amp;D Center of Innovation. In the SWIFT pilot, the investigators refined the&#xD;
        RECLAIM content and tested the feasibility of virtual delivery with a small sample (N=18)&#xD;
        using a single arm pre/post-test design. The proposed pilot project builds on preliminary&#xD;
        work by (1) testing the refined intervention in a randomized controlled design to assess&#xD;
        feasibility of recruitment for a randomized trial, (2) randomization, (3) retention in both&#xD;
        study arms, and (4) intervention acceptability. Findings from the proposed project will&#xD;
        support a HSR&amp;D Investigator Initiated Research Merit award application that will assess the&#xD;
        effectiveness of RECLAIM while simultaneously planning for implementation in a Hybrid Type I&#xD;
        trial. The following are the specific aims for this pilot project.&#xD;
  &#xD;
        Aim 1: Conduct a randomized controlled pilot study to assess feasibility of the RECLAIM&#xD;
        intervention. The investigators will conduct a two-arm randomized pilot study. Veterans&#xD;
        (N=48) will be randomized to either the intervention arm (i.e., virtually delivered RECLAIM)&#xD;
        or a control arm (i.e., psychoeducation materials). The investigators will assess&#xD;
        intervention feasibility, including recruitment, randomization, administration and completion&#xD;
        of outcome assessments, treatment engagement, and retention in both the intervention and&#xD;
        control study arms.&#xD;
  &#xD;
        Aim 2: Conduct qualitative interviews to assess acceptability of RECLAIM. A purposefully&#xD;
        sampled subgroup (i.e., based on attendance) of RECLAIM participants (i.e., Veterans from the&#xD;
        intervention arm; N=16) will engage in a qualitative interview to explore experiences in&#xD;
        RECLAIM, including perceived strengths and suggestions for future improvements.&#xD;
  &#xD;
        Aim 3: Refine and finalize the RECLAIM intervention. As findings emerge from the Aim 1 pilot&#xD;
        test and Aim 2 interviews with Veteran participants, the investigators will iteratively&#xD;
        update the RECLAIM protocol manual and testing procedures (i.e., randomization, control group&#xD;
        materials). The investigators will consult with the Patient Advisory Council of the&#xD;
        Indianapolis VAMC to gather Veteran feedback on the revised RECLAIM protocol manual, as well&#xD;
        as partners (e.g., Patient Centered Care and Cultural Transformation). These actions will&#xD;
        help refine the study methods, design, and intervention in anticipation of a larger trial.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 1, 2023</start_date>
    <completion_date type="Anticipated">January 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">August 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>This is a pilot randomized controlled trial. Intervention arm participants will participate in the 8-week intervention. Control group participants will receive psychoeducation materials that the intervention group will also receive.</intervention_model_description>
      <primary_purpose>Health Services Research</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Military to Civilian Questionnaire</measure>
      <time_frame>30 days</time_frame>
      <description>The Military to Civilian Questionnaire (M2C-Q) is an empirically validated self-report scale that measures general difficulty in readjusting to civilian life by assessing important indicators of reintegration challenges over the past 30 days including social/health behaviors, specifically interpersonal relationships; productivity at school, work, or home; community participation; self-care; leisure; and perceived meaning in life.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Patient Health Questionnaire</measure>
      <time_frame>2 weeks</time_frame>
      <description>The Patient Health Questionnaire (PHQ-9) is a reliable and valid 9-item measure of depression severity used to screen, diagnose, monitor, and measure the severity of depression.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Generalized Anxiety Disorder Scale</measure>
      <time_frame>2 weeks</time_frame>
      <description>The Generalized Anxiety Disorder Scale (GAD-7) is a brief 7-item measure for assessing generalized anxiety disorder.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The Veterans RAND Health Survey</measure>
      <time_frame>4 weeks</time_frame>
      <description>The Veterans RAND Health Survey (VR-12) is a brief, self-administered health survey primarily used to measure health related quality of life.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Five Facet Mindfulness Questionnaire</measure>
      <time_frame>2 months</time_frame>
      <description>The Five Facet Mindfulness Questionnaire (FFMQ) is a 15-item scale to measure five factors of mindfulness: (1) Observing; (2) Describing; (3) Acting with awareness; (4) Non-judging of inner experience; and (5) Non-reactivity to inner experience.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">48</enrollment>
    <condition>Depression</condition>
    <arm_group>
      <arm_group_label>RECLAIM intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Eight sessions of a brief mindfulness-based intervention that meets weekly in a virtual setting.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Psychoeducation materials only</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>We will use a psychoeducation-only control group. They will only receive psychoeducational materials (e.g., suggested readings, podcasts, blogs). These are the same materials that the intervention arm participants will receive.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>RECLAIM - Reconnecting to Civilian Life using Activities that Improve Mindfulness</intervention_name>
      <description>Brief virtual mindfulness-based intervention</description>
      <arm_group_label>RECLAIM intervention</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Veteran participants must:&#xD;
  &#xD;
            -  be between 18-44 years old&#xD;
  &#xD;
            -  have served (a) active duty and/or (b) in the National Guard/Reserves, after October&#xD;
               2001 (can still be in the National Guard or Reservist)&#xD;
  &#xD;
            -  be enrolled in VHA care&#xD;
  &#xD;
            -  endorse at least &quot;some&quot; difficulty adjusting to civilian life to be eligible for&#xD;
               participation. Difficulty adjusting to civilian life (i.e., reintegration challenges)&#xD;
               will be assessed using the Military to Civilian Questionnaire (M2C-Q). For this study,&#xD;
               &quot;some&quot; difficulty will be defined as a mean M2C-Q score of 2; the M2C-Q developers&#xD;
               established a score of 2 as indicative of &quot;some&quot; reintegration difficulty and, as&#xD;
               such, this is the score we will use in the current study.&#xD;
  &#xD;
            -  endorse at least a moderate level of depression. We will use the Patient Health&#xD;
               Questionnaire (PHQ-9). to assess the presence and severity of depressive symptoms&#xD;
               among potential Veteran participants. Moderate depression is defined as a score of&#xD;
               10-14 on the PHQ-9. This strategy for eligibility criteria optimally positions us to&#xD;
               target Veterans who will likely benefit most from RECLAIM and to detect intervention&#xD;
               effects in a future fully-powered follow-up trial.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Veterans will not be immediately excluded from participation in the study; the study&#xD;
               team will consult with the Roudebush Suicide Prevention Team and/or the Veterans' care&#xD;
               provider to determine whether continued study participation is appropriate.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>44 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Sarah A Shue, PhD MS BA</last_name>
      <role>Principal Investigator</role>
      <affiliation>Richard L. Roudebush VA Medical Center, Indianapolis, IN</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Sarah A Shue, PhD MS BA</last_name>
      <phone>(317) 988-9762</phone>
      <email>sarah.shue@va.gov</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Ai-Nghia L Do, BA</last_name>
      <email>ai-nghia.do@va.gov</email>
    </overall_contact_backup>
    <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>
      <contact>
        <last_name>Angela L Rollins, PhD</last_name>
        <phone>317-679-0434</phone>
        <email>Angela.Rollins@va.gov</email>
      </contact>
      <contact_backup>
        <last_name>Linda A Collins, BS CRA</last_name>
        <phone>(317) 988-2722</phone>
        <email>linda.collins4@va.gov</email>
      </contact_backup>
      <investigator>
        <last_name>Sarah A Shue, PhD MS BA</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>July 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>July 26, 2023</last_update_submitted>
    <last_update_submitted_qc>July 26, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 3, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>mindfulness</keyword>
    <keyword>mental health</keyword>
    <keyword>community reintegration</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Depression</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05975008
  org study id: PPO 22-150
  nct id: NCT05975008
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  The purpose of this study is to test a mindfulness-based intervention to reduce depressive
        symptoms and improve Veterans' community reintegration.
  The overarching goal of the proposed project is to use mindfulness practices to reduce
        depression and improve community reintegration among post-9/11 Veterans. This proposal
        focuses on the REconnecting to Civilian Life using Activities that Improve Mindfulness
        (RECLAIM) intervention. RECLAIM is a virtual multi-component, mindfulness-based intervention
        developed by the study team in collaboration with VA clinicians, post-9/11 Veterans, and
        stakeholders and guided by the VA Whole Health framework. The proposed project builds on
        preliminary pilot work and a Small Award Initiative for Impact (SWIFT) pilot project funded
        by the VA HSR&D Center of Innovation. In the SWIFT pilot, the investigators refined the
        RECLAIM content and tested the feasibility of virtual delivery with a small sample (N=18)
        using a single arm pre/post-test design. The proposed pilot project builds on preliminary
        work by (1) testing the refined intervention in a randomized controlled design to assess
        feasibility of recruitment for a randomized trial, (2) randomization, (3) retention in both
        study arms, and (4) intervention acceptability. Findings from the proposed project will
        support a HSR&D Investigator Initiated Research Merit award application that will assess the
        effectiveness of RECLAIM while simultaneously planning for implementation in a Hybrid Type I
        trial. The following are the specific aims for this pilot project.
  
        Aim 1: Conduct a randomized controlled pilot study to assess feasibility of the RECLAIM
        intervention. The investigators will conduct a two-arm randomized pilot study. Veterans
        (N=48) will be randomized to either the intervention arm (i.e., virtually delivered RECLAIM)
        or a control arm (i.e., psychoeducation materials). The investigators will assess
        intervention feasibility, including recruitment, randomization, administration and completion
        of outcome assessments, treatment engagement, and retention in both the intervention and
        control study arms.
  
        Aim 2: Conduct qualitative interviews to assess acceptability of RECLAIM. A purposefully
        sampled subgroup (i.e., based on attendance) of RECLAIM participants (i.e., Veterans from the
        intervention arm; N=16) will engage in a qualitative interview to explore experiences in
        RECLAIM, including perceived strengths and suggestions for future improvements.
  
        Aim 3: Refine and finalize the RECLAIM intervention. As findings emerge from the Aim 1 pilot
        test and Aim 2 interviews with Veteran participants, the investigators will iteratively
        update the RECLAIM protocol manual and testing procedures (i.e., randomization, control group
        materials). The investigators will consult with the Patient Advisory Council of the
        Indianapolis VAMC to gather Veteran feedback on the revised RECLAIM protocol manual, as well
        as partners (e.g., Patient Centered Care and Cultural Transformation). These actions will
        help refine the study methods, design, and intervention in anticipation of a larger trial.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: This is a pilot randomized controlled trial. Intervention arm participants will participate in the 8-week intervention. Control group participants will receive psychoeducation materials that the intervention group will also receive.
  primary purpose: Health Services Research
  masking: Single (Participant)
  measure: Military to Civilian Questionnaire
  time frame: 30 days
  description: The Military to Civilian Questionnaire (M2C-Q) is an empirically validated self-report scale that measures general difficulty in readjusting to civilian life by assessing important indicators of reintegration challenges over the past 30 days including social/health behaviors, specifically interpersonal relationships; productivity at school, work, or home; community participation; self-care; leisure; and perceived meaning in life.
  measure: Patient Health Questionnaire
  time frame: 2 weeks
  description: The Patient Health Questionnaire (PHQ-9) is a reliable and valid 9-item measure of depression severity used to screen, diagnose, monitor, and measure the severity of depression.
  measure: Generalized Anxiety Disorder Scale
  time frame: 2 weeks
  description: The Generalized Anxiety Disorder Scale (GAD-7) is a brief 7-item measure for assessing generalized anxiety disorder.
  measure: The Veterans RAND Health Survey
  time frame: 4 weeks
  description: The Veterans RAND Health Survey (VR-12) is a brief, self-administered health survey primarily used to measure health related quality of life.
  measure: Five Facet Mindfulness Questionnaire
  time frame: 2 months
  description: The Five Facet Mindfulness Questionnaire (FFMQ) is a 15-item scale to measure five factors of mindfulness: (1) Observing; (2) Describing; (3) Acting with awareness; (4) Non-judging of inner experience; and (5) Non-reactivity to inner experience.
  arm group label: RECLAIM intervention
  arm group type: Experimental
  description: Eight sessions of a brief mindfulness-based intervention that meets weekly in a virtual setting.
  arm group label: Psychoeducation materials only
  arm group type: No Intervention
  description: We will use a psychoeducation-only control group. They will only receive psychoeducational materials (e.g., suggested readings, podcasts, blogs). These are the same materials that the intervention arm participants will receive.
  intervention type: Behavioral
  intervention name: RECLAIM - Reconnecting to Civilian Life using Activities that Improve Mindfulness
  description: Brief virtual mindfulness-based intervention
  arm group label: RECLAIM intervention
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 44 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Sarah A Shue, PhD MS BA
  role: Principal Investigator
  affiliation: Richard L. Roudebush VA Medical Center, Indianapolis, IN
  last name: Sarah A Shue, PhD MS BA
  phone: (317) 988-9762
  email: sarah.shue@va.gov
  last name: Ai-Nghia L Do, BA
  email: ai-nghia.do@va.gov
  facility: 
  contact: 
  contact backup: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Depression
  sharing ipd: No