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/NCT05995678</url>
    </required_header>
    <id_info>
      <org_study_id>D4535-R</org_study_id>
      <nct_id>NCT05995678</nct_id>
    </id_info>
    <brief_title>A Mixed Methods Pilot Trial of the STEP Home Workshop to Improve Reintegration and Reduce Suicide Risk for Recently Transitioned Veterans</brief_title>
    <acronym>SH-SP</acronym>
    <official_title>A Mixed Methods Pilot Trial of the STEP Home Workshop to Improve Reintegration and Reduce Suicide Risk for Recently Transitioned Veterans</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>
        Risk of Veteran suicide is elevated during the first year of transition from military service&#xD;
        to civilian life. Most Veteran suicides occur among Veterans who are not connected to VA&#xD;
        healthcare. Suicide prevention and connection to care are therefore critical for recently&#xD;
        transitioning Veterans. Transitioning Veterans require services to provide them with suicide&#xD;
        prevention education, skills to manage their transition effectively, and support in their&#xD;
        access to VA healthcare. Convenient, accessible, palatable, patient-centered care options&#xD;
        that are cost-effective, easy to implement nationwide, and target domains known to mitigate&#xD;
        suicide risk are needed during this critical transition period. This proposal would bridge&#xD;
        this important healthcare gap using STEP-Home-SP, a transdiagnostic, non-stigmatizing,&#xD;
        skills-based workshop. STEP-Home-SP will provide Veterans with suicide prevention education,&#xD;
        skills to improve transition, support to access VA care, and a platform to decrease social&#xD;
        isolation early in their military to civilian transition, thereby reducing suicide risk&#xD;
        downstream.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Veterans face a &quot;deadly gap&quot; during their first year of transition from military to civilian&#xD;
        life with limited available psychiatric services and increased suicide risk factors. During&#xD;
        this critical transition period, Veteran suicide rate is double that of active service&#xD;
        members and the general Veteran population. An average of 20 Veterans die from suicide each&#xD;
        day, but only 6 of the 20 use VA services. VA care engagement has been shown to mitigate&#xD;
        suicide risk; therefore, promoting engagement during the &quot;deadly gap&quot; could be essential to&#xD;
        suicide prevention. Transitioning Veterans require outreach and services to provide them with&#xD;
        support in their access to VA healthcare, suicide prevention education, and skills to manage&#xD;
        their transition effectively. This proposal would bridge this important healthcare gap using&#xD;
        STEP-Home. STEP-Home is an evidence-based, transdiagnostic, video telehealth rehabilitation&#xD;
        workshop to improve reintegration, social support, and functioning among Veterans with high&#xD;
        clinical comorbidity. STEP-Home is non-clinical, cost-effective, and skills-focused to&#xD;
        maximally engage Veterans not participating in treatment who may be resistant to traditional&#xD;
        &quot;mental health&quot; diagnostically focused approaches. To date, STEP-Home has not been adapted&#xD;
        for the unique needs of recently transitioning Veterans or augmented for suicide prevention.&#xD;
        This proposal will adapt and refine STEP-Home specifically for recently transitioning&#xD;
        Veterans and add suicide prevention content and skills to create STEP-Home-SP. The proposed&#xD;
        pilot study is designed to support STEP-Home and suicide prevention content experts in their&#xD;
        refinement and evaluation of STEP-Home-SP. The investigators will utilize the VA/Department&#xD;
        of Defense Identity Repository (VADIR) to recruit recently transitioned Veterans nationwide.&#xD;
        In Aim 1, the investigators will develop STEP-Home-SP by adapting the STEP-Home telehealth&#xD;
        intervention to specifically target recently transitioned Veterans and augment the workshop&#xD;
        to include suicide prevention. In Aim 2, the investigators will conduct a two-arm&#xD;
        proof-of-concept acceptability and feasibility randomized controlled trial (RCT) of&#xD;
        STEP-Home-SP versus Enhanced Usual Care (EUC=current standard of care + educational packet on&#xD;
        suicide risk and connection to VA care) in recently transitioned Veterans. Lastly, the&#xD;
        investigators will explore reintegration status, VA care initiation, and candidate outcomes&#xD;
        for STEP-Home-SP relative to EUC to inform a future full-scale RCT. If successful, fostering&#xD;
        social, vocational, and community connection; building emotion regulation and impulse control&#xD;
        skills; facilitating safety planning; and providing education and access to VA care upstream&#xD;
        should result in decreased suicide risk during this critical transition and beyond.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">April 1, 2024</start_date>
    <completion_date type="Anticipated">May 31, 2027</completion_date>
    <primary_completion_date type="Anticipated">May 31, 2027</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>Following T1 baseline assessment, participants will be randomized to STEP-Home-SP + Usual Care or Usual Care (UC) using randomly permuted block sizes stratified by presence or absence of SI.</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Feasibility- recruitment interest</measure>
      <time_frame>Through study completion, an average of one year.</time_frame>
      <description>ratio interested of those approached for the workshop</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Feasibility- enrollment</measure>
      <time_frame>Through study completion, an average of one year.</time_frame>
      <description>Ratio enrolled (consented) of those approached, greater than 20% of those interested enroll in the proposed time frame</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Feasibility- qualitative via Narrative Evaluation of Intervention Interview</measure>
      <time_frame>Through study completion, an average of 3 months.</time_frame>
      <description>Identification of challenges and facilitators during the recruitment process as assessed by study staff as well as feedback from focus group participants generated using the Narrative Evaluation of Intervention Interview (NEII). This is an interview composed of 16 open ended questions that allows participants to evaluate the process and outcomes of the intervention. Reviewers will generate a list of themes based on the responses to this interview.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Feasibility- Treatment Fidelity/adherence</measure>
      <time_frame>Through study completion, an average of 1 week.</time_frame>
      <description>Supervisor and therapist Likert rating of adherence to content for core skills and treatment modules, less than 20% deviations on a treatment fidelity scale. Lower scores indicate stronger treatment fidelity, with each question being answered on a scale from 1 (Strongly Agree) to 5 (Strongly Disagree).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Acceptability- Veteran adherence</measure>
      <time_frame>Through study completion, an average of one year.</time_frame>
      <description>Attendance rate for the 12-session workshop</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Acceptability- Quantitative satisfaction via Client satisfaction questionnaire Change</measure>
      <time_frame>Assessed at baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)</time_frame>
      <description>Client satisfaction questionnaire (CSQ-8), total scores range from 8 to 32 with higher scores indicating higher satisfaction. A priori criteria is that greater than 80% of participants will score greater that a 24 on the CSQ-8.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Reintegration status- Military to Civilian Questionnaire (M2CQ) Change</measure>
      <time_frame>Assessed at screening, baseline (0 weeks), T4 (after 12 weeks) and T5 (after 24 weeks)</time_frame>
      <description>16 questions are answered on a scale from 0 (no difficulty) to 4 (extreme difficulty), with lower scores indicating more successful reintegration.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Engagement in VA Care</measure>
      <time_frame>Assessed at baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)</time_frame>
      <description>Electronic medical record data (if available) showing occurrence of one or more healthcare appointments</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Difficulties in Emotional Regulation Scale (DERS)</measure>
      <time_frame>Assessed at baseline (0 weeks), T2 (after 4 weeks), T3 (after 8 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)</time_frame>
      <description>36 statements are each ranked on the following scale by participants: 1 almost never (0-10%), 2 sometimes (11-35%), 3 about half the time (36-55%), 4 most of the time (66-90%), or 5 almost always (91-100%). This produces scores for 6 subscales: nonacceptance of emotional responses; difficulty engaging in goal-directed behavior; impulse control difficulties; lack of emotional awareness; limited access to emotion regulation strategies; lack of emotional clarity.</description>
    </other_outcome>
    <other_outcome>
      <measure>Problem Solving Inventory (PSI)</measure>
      <time_frame>Assessed at baseline (0 weeks), T2 (after 4 weeks), T3 (after 8 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)</time_frame>
      <description>Participants rank 35 statements on a Likert scale from 1 (strongly agree) to 6 (strongly disagree). This generates a total score and 3 subscale scores for the following categories: Approach Avoidance, Personal Control, and Problem Solving Confidence.</description>
    </other_outcome>
    <other_outcome>
      <measure>Attention-Related Cognitive Errors Scale (ARCES)</measure>
      <time_frame>Assessed at baseline (0 weeks), T2 (after 4 weeks), T3 (after 8 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)</time_frame>
      <description>12 questions are ranked on a Likert Scale from 1 (never) to 5 (very often) with higher scores indicating more frequent attention related cognitive errors.</description>
    </other_outcome>
    <other_outcome>
      <measure>Suicidal Ideation- The Columbia-Suicide Severity Rating Scale (C-SSRS)</measure>
      <time_frame>Assessed at screening, baseline (0 weeks), T2 (after 4 weeks), T3 (after 8 weeks), T4 (after 12 weeks), and T5 (after 24 weeks). Will also be administered as needed following workshop sessions.</time_frame>
      <description>Participants are asked 5 questions designed to assess severity of suicide risk. Questions are answered yes or no, with endorsement of active suicidal ideation with intent being considered high risk and suicidal ideation without intent considered moderate risk.</description>
    </other_outcome>
    <other_outcome>
      <measure>Post-deployment Readjustment Inventory (PDRI)</measure>
      <time_frame>Assessed at screening, baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)</time_frame>
      <description>36 statements are ranked by participants on a scale from 1 (not at all) to 5 (extremely). Total score is calculated by the sum of each of the subscales: Career, Health, Intimate relationships, social readjustment, concerns about deployment, and PTSD symptoms. Higher scores indicate less successful post-deployment readjustment.</description>
    </other_outcome>
    <other_outcome>
      <measure>State-Trait Anger Expression Inventory (STAXI-2)</measure>
      <time_frame>Assessed at screening, baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)</time_frame>
      <description>Measures the experience, expression, and control of anger. Participants rank each of the statements on a scale of 1 (not at all) to 4 (very much so) for section 1 and 1 (almost never) to 4 (almost always) for sections 2 and 3. Higher scores indicate high experience/expression and low control of anger.</description>
    </other_outcome>
    <other_outcome>
      <measure>Functional status measured using the WHO Disability Assessment Schedule 2.0 12-item (WHODAS-2.0)</measure>
      <time_frame>Assessed at baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)</time_frame>
      <description>Participants indicate how much difficulty they have had in the last 30 days for each of the statements on the assessment on a scale from 0 (none) to 4 (Extreme/cannot do). Higher scores indicate greater levels of disability.</description>
    </other_outcome>
    <other_outcome>
      <measure>Stigma- Perceived Barriers to Care Survey</measure>
      <time_frame>Assessed at baseline (0 weeks), T2 (after 4 weeks), T3 (after 8 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)</time_frame>
      <description>Participants rank each of the survey items on the scale from 1 (strongly agree) to 5 (strongly disagree) with lower scores indicating that the item is a greater barrier to care.</description>
    </other_outcome>
    <other_outcome>
      <measure>Quality of Life Scale (QOLS)</measure>
      <time_frame>Assessed at baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)</time_frame>
      <description>Participants answer each question on a 7 point scale. It is scored by adding up the score on each item to get a minimum potential score of 16 and a maximum total score of 112. Higher scores indicate a higher quality of life.</description>
    </other_outcome>
    <other_outcome>
      <measure>Psychosocial Functioning- The Brief Inventory of Psychosocial Functioning (IPF-Brief)</measure>
      <time_frame>Assessed at baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)</time_frame>
      <description>Participants rank each of the 7 statements based on their overall experience over the past month on a scale from 0 (not at all) to 6 (very much). 7 is marked if the statement is not applicable. Higher scores indicate more impaired psychosocial functioning.</description>
    </other_outcome>
    <other_outcome>
      <measure>Social support subscale of the Deployment Risk and Resilience Inventory (DRRI-2)</measure>
      <time_frame>Assessed at baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)</time_frame>
      <description>Participants rank each of the ten questions from this subscale on a scale from 1 (Strongly Disagree) to 5 (Strongly Agree) and total subscale score is calculated by adding up the responses from each of the questions. Lower scores indicate lower levels of social support.</description>
    </other_outcome>
    <other_outcome>
      <measure>Interpersonal Needs Questionnaire (INQ)</measure>
      <time_frame>Assessed at baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)</time_frame>
      <description>Each of the 15 questions are answered on a scale from 1 (Not at all true for me) to 7 (very true for me). 6 out of the 15 questions are reverse coded. Higher scores indicate that more interpersonal needs are not met.</description>
    </other_outcome>
    <other_outcome>
      <measure>Depression- Patient Health Questionnaire (PHQ-9)</measure>
      <time_frame>Assessed at baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)</time_frame>
      <description>Participants rank 9 questions on a scale from 0 (not at all) to 3 (Nearly every day) based on how often in the last 2 weeks they have been bothered by the problems listed. Then they rate the severity of the difficulty any problems they have experienced are causing on a scale from &quot;not difficult at all&quot; to &quot;extremely difficult.&quot; Higher scores indicate higher depression severity.</description>
    </other_outcome>
    <other_outcome>
      <measure>Hopelessness- Beck Hopelessness Scale</measure>
      <time_frame>Assessed at baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)</time_frame>
      <description>Participants answer 20 true or false questions that are scored based on an answer key. Answers that indicate hopelessness are added up, with higher scores indicating higher levels of hopelessness/pessimism.</description>
    </other_outcome>
    <other_outcome>
      <measure>Self-injurious thoughts and behaviors interview (SITBI)</measure>
      <time_frame>Assessed at baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)</time_frame>
      <description>This interview asks a wide variety of questions related to suicidal ideations, plans, gestures, attempts, and non-suicidal self injurious behaviors. There are 72 possible questions, but some are only asked if a specific behavior is endorsed. Higher scores indicate higher levels of thoughts and feelings related to suicide and self-injurious behaviors.</description>
    </other_outcome>
    <other_outcome>
      <measure>Suicide Coping/Safety Behaviors- Suicide Related Coping Scale (SRCS)</measure>
      <time_frame>Assessed at baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)</time_frame>
      <description>Participants answer 17 questions on a 5 point Likert scale from 0-4 (Strongly Disagree to Strongly Agree). Total score is determined by reverse scoring negatively worded items and then summing the items. Higher scores indicate better coping skills.</description>
    </other_outcome>
    <other_outcome>
      <measure>Gateway to vocational and community activities- Treatment &amp; Activities Survey</measure>
      <time_frame>Assessed at baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)</time_frame>
      <description>Treatment &amp; Activities Survey developed by STEP-Home staff asks participants to list the types of treatment (psychotherapy, medication, group therapy) that they have participated in within the last month, what they receive the treatment for, and whether it is administered by the VA or outside of the VA. Participants also answer if they have participated in other activities in the last month (school, work, community, etc.) and whether those activities are at or outside of the VA.</description>
    </other_outcome>
    <other_outcome>
      <measure>Kessler-6 brief mental health screen</measure>
      <time_frame>Baseline (0 weeks)</time_frame>
      <description>The Kessler Psychological Distress Scale (K6) is a 6 item measure of participants' emotional state. Questions are scored from 0 (none of the time) to 4 (all of the time) with a minimum score of 0 and a maximum score of 24. Higher scores indicate higher levels of psychological distress.</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">120</enrollment>
    <condition>TBI</condition>
    <condition>Suicide Prevention</condition>
    <condition>Veterans</condition>
    <condition>PTSD</condition>
    <condition>Transdiagnostic</condition>
    <condition>Anger</condition>
    <arm_group>
      <arm_group_label>STEP-Home-SP + Usual Care</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The core skills of emotional regulation and problem solving are introduced and integrated throughout all Veteran-specific reintegration content modules for practice and repetition for 12 weeks. Attention training augments emotional regulation and problem solving core skills and is interspersed throughout group and individual sessions. Additional 30-minute individual skill building and goal setting sessions occur ~4-6 times based on individual Veteran needs</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Usual Care</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>UC will include the Transition Assistance Program (TAP) as scheduled by DOD prior to military separation, VA Solid Start post-separation, and educational augmentation post-separation.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>STEP-Home-SP</intervention_name>
      <description>This group will meet for ~1.5 hours/week for 12 weeks. The core skills of Emotional Regulation (ER) and Problem Solving (PS) are introduced and then integrated throughout all Veteran-specific content modules for practice and repetition for 12 weeks. Attention training augments ER and PS skills and is interspersed throughout the group and individual sessions. Additional 30-minute individual skills building and goal setting sessions occur up to 6 times based on individual Veteran needs. STEP-Home staff will work in pairs to run workshops per established protocols. Workshops will be conducted via VA approved video telehealth.</description>
      <arm_group_label>STEP-Home-SP + Usual Care</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Transition Assistance Program</intervention_name>
      <description>Provides training, skills, and information to help transitioning service members and their families prepare for the military to civilian transition. Each service member works with a TAP counselor to identify needs and post transition goals to build an Individual Transition Plan, in addition to TAP core curriculum courses.</description>
      <arm_group_label>STEP-Home-SP + Usual Care</arm_group_label>
      <arm_group_label>Usual Care</arm_group_label>
      <other_name>TAP</other_name>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>VA Solid Start</intervention_name>
      <description>VA Solid Start includes a series of outreach calls and emails to all Veterans at 90-, 180-, and 365-days post service separation. Callers follow a standard script to describe services available through VA and provide contact information for desired services.</description>
      <arm_group_label>STEP-Home-SP + Usual Care</arm_group_label>
      <arm_group_label>Usual Care</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Recently transitioned Veterans within one year of separation from military service&#xD;
  &#xD;
            -  Self-reported functional impairment or reintegration difficulties as measured by the&#xD;
               Military-to-Civilian Questionnaire (any item score &gt; 1 indicating &quot;some difficulty&quot;;&#xD;
               M2CQ; [71])&#xD;
  &#xD;
            -  Sufficient English fluency&#xD;
  &#xD;
            -  Agree to participate (informed consent/HIPAA)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Active psychosis&#xD;
  &#xD;
            -  Imminent or acute high suicide risk requiring immediate crisis intervention&#xD;
               (low-moderate non-imminent risk for suicide is allowed)&#xD;
  &#xD;
            -  Current moderate or severe substance use disorder&#xD;
  &#xD;
            -  Neurological diagnosis excluding TBI&#xD;
  &#xD;
                 -  Participants with mild substance use disorder will be allowed&#xD;
  &#xD;
                 -  Substance use is a common behavior that may contribute to reintegration&#xD;
                    difficulties and suicide risk&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Catherine B Fortier, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Catherine B Fortier, PhD</last_name>
      <phone>(857) 364-4361</phone>
      <email>catherine.fortier@va.gov</email>
    </overall_contact>
    <location>
      <facility>
        <name>VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA</name>
        <address>
          <city>Boston</city>
          <state>Massachusetts</state>
          <zip>02130-4817</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Catherine B Fortier, PhD</last_name>
        <phone>857-364-4361</phone>
        <email>catherine.fortier@va.gov</email>
      </contact>
      <investigator>
        <last_name>Catherine B Fortier, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>June 20, 2023</study_first_submitted>
    <study_first_submitted_qc>August 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Veterans</keyword>
    <keyword>TBI</keyword>
    <keyword>Transdiagnostic</keyword>
    <keyword>Intervention</keyword>
    <keyword>Suicide Prevention</keyword>
    <keyword>PTSD</keyword>
    <keyword>Reintegration</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Suicide</mesh_term>
      <mesh_term>Suicide Prevention</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>No additional IPD will be shared besides the deidentified/anonymized data set and data dictionary will be shared.</ipd_description>
    </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/NCT05995678
  org study id: D4535-R
  nct id: NCT05995678
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  Risk of Veteran suicide is elevated during the first year of transition from military service
        to civilian life. Most Veteran suicides occur among Veterans who are not connected to VA
        healthcare. Suicide prevention and connection to care are therefore critical for recently
        transitioning Veterans. Transitioning Veterans require services to provide them with suicide
        prevention education, skills to manage their transition effectively, and support in their
        access to VA healthcare. Convenient, accessible, palatable, patient-centered care options
        that are cost-effective, easy to implement nationwide, and target domains known to mitigate
        suicide risk are needed during this critical transition period. This proposal would bridge
        this important healthcare gap using STEP-Home-SP, a transdiagnostic, non-stigmatizing,
        skills-based workshop. STEP-Home-SP will provide Veterans with suicide prevention education,
        skills to improve transition, support to access VA care, and a platform to decrease social
        isolation early in their military to civilian transition, thereby reducing suicide risk
        downstream.
  Veterans face a "deadly gap" during their first year of transition from military to civilian
        life with limited available psychiatric services and increased suicide risk factors. During
        this critical transition period, Veteran suicide rate is double that of active service
        members and the general Veteran population. An average of 20 Veterans die from suicide each
        day, but only 6 of the 20 use VA services. VA care engagement has been shown to mitigate
        suicide risk; therefore, promoting engagement during the "deadly gap" could be essential to
        suicide prevention. Transitioning Veterans require outreach and services to provide them with
        support in their access to VA healthcare, suicide prevention education, and skills to manage
        their transition effectively. This proposal would bridge this important healthcare gap using
        STEP-Home. STEP-Home is an evidence-based, transdiagnostic, video telehealth rehabilitation
        workshop to improve reintegration, social support, and functioning among Veterans with high
        clinical comorbidity. STEP-Home is non-clinical, cost-effective, and skills-focused to
        maximally engage Veterans not participating in treatment who may be resistant to traditional
        "mental health" diagnostically focused approaches. To date, STEP-Home has not been adapted
        for the unique needs of recently transitioning Veterans or augmented for suicide prevention.
        This proposal will adapt and refine STEP-Home specifically for recently transitioning
        Veterans and add suicide prevention content and skills to create STEP-Home-SP. The proposed
        pilot study is designed to support STEP-Home and suicide prevention content experts in their
        refinement and evaluation of STEP-Home-SP. The investigators will utilize the VA/Department
        of Defense Identity Repository (VADIR) to recruit recently transitioned Veterans nationwide.
        In Aim 1, the investigators will develop STEP-Home-SP by adapting the STEP-Home telehealth
        intervention to specifically target recently transitioned Veterans and augment the workshop
        to include suicide prevention. In Aim 2, the investigators will conduct a two-arm
        proof-of-concept acceptability and feasibility randomized controlled trial (RCT) of
        STEP-Home-SP versus Enhanced Usual Care (EUC=current standard of care + educational packet on
        suicide risk and connection to VA care) in recently transitioned Veterans. Lastly, the
        investigators will explore reintegration status, VA care initiation, and candidate outcomes
        for STEP-Home-SP relative to EUC to inform a future full-scale RCT. If successful, fostering
        social, vocational, and community connection; building emotion regulation and impulse control
        skills; facilitating safety planning; and providing education and access to VA care upstream
        should result in decreased suicide risk during this critical transition and beyond.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Following T1 baseline assessment, participants will be randomized to STEP-Home-SP + Usual Care or Usual Care (UC) using randomly permuted block sizes stratified by presence or absence of SI.
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Feasibility- recruitment interest
  time frame: Through study completion, an average of one year.
  description: ratio interested of those approached for the workshop
  measure: Feasibility- enrollment
  time frame: Through study completion, an average of one year.
  description: Ratio enrolled (consented) of those approached, greater than 20% of those interested enroll in the proposed time frame
  measure: Feasibility- qualitative via Narrative Evaluation of Intervention Interview
  time frame: Through study completion, an average of 3 months.
  description: Identification of challenges and facilitators during the recruitment process as assessed by study staff as well as feedback from focus group participants generated using the Narrative Evaluation of Intervention Interview (NEII). This is an interview composed of 16 open ended questions that allows participants to evaluate the process and outcomes of the intervention. Reviewers will generate a list of themes based on the responses to this interview.
  measure: Feasibility- Treatment Fidelity/adherence
  time frame: Through study completion, an average of 1 week.
  description: Supervisor and therapist Likert rating of adherence to content for core skills and treatment modules, less than 20% deviations on a treatment fidelity scale. Lower scores indicate stronger treatment fidelity, with each question being answered on a scale from 1 (Strongly Agree) to 5 (Strongly Disagree).
  measure: Acceptability- Veteran adherence
  time frame: Through study completion, an average of one year.
  description: Attendance rate for the 12-session workshop
  measure: Acceptability- Quantitative satisfaction via Client satisfaction questionnaire Change
  time frame: Assessed at baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)
  description: Client satisfaction questionnaire (CSQ-8), total scores range from 8 to 32 with higher scores indicating higher satisfaction. A priori criteria is that greater than 80% of participants will score greater that a 24 on the CSQ-8.
  measure: Reintegration status- Military to Civilian Questionnaire (M2CQ) Change
  time frame: Assessed at screening, baseline (0 weeks), T4 (after 12 weeks) and T5 (after 24 weeks)
  description: 16 questions are answered on a scale from 0 (no difficulty) to 4 (extreme difficulty), with lower scores indicating more successful reintegration.
  measure: Engagement in VA Care
  time frame: Assessed at baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)
  description: Electronic medical record data (if available) showing occurrence of one or more healthcare appointments
  measure: Difficulties in Emotional Regulation Scale (DERS)
  time frame: Assessed at baseline (0 weeks), T2 (after 4 weeks), T3 (after 8 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)
  description: 36 statements are each ranked on the following scale by participants: 1 almost never (0-10%), 2 sometimes (11-35%), 3 about half the time (36-55%), 4 most of the time (66-90%), or 5 almost always (91-100%). This produces scores for 6 subscales: nonacceptance of emotional responses; difficulty engaging in goal-directed behavior; impulse control difficulties; lack of emotional awareness; limited access to emotion regulation strategies; lack of emotional clarity.
  measure: Problem Solving Inventory (PSI)
  time frame: Assessed at baseline (0 weeks), T2 (after 4 weeks), T3 (after 8 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)
  description: Participants rank 35 statements on a Likert scale from 1 (strongly agree) to 6 (strongly disagree). This generates a total score and 3 subscale scores for the following categories: Approach Avoidance, Personal Control, and Problem Solving Confidence.
  measure: Attention-Related Cognitive Errors Scale (ARCES)
  time frame: Assessed at baseline (0 weeks), T2 (after 4 weeks), T3 (after 8 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)
  description: 12 questions are ranked on a Likert Scale from 1 (never) to 5 (very often) with higher scores indicating more frequent attention related cognitive errors.
  measure: Suicidal Ideation- The Columbia-Suicide Severity Rating Scale (C-SSRS)
  time frame: Assessed at screening, baseline (0 weeks), T2 (after 4 weeks), T3 (after 8 weeks), T4 (after 12 weeks), and T5 (after 24 weeks). Will also be administered as needed following workshop sessions.
  description: Participants are asked 5 questions designed to assess severity of suicide risk. Questions are answered yes or no, with endorsement of active suicidal ideation with intent being considered high risk and suicidal ideation without intent considered moderate risk.
  measure: Post-deployment Readjustment Inventory (PDRI)
  time frame: Assessed at screening, baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)
  description: 36 statements are ranked by participants on a scale from 1 (not at all) to 5 (extremely). Total score is calculated by the sum of each of the subscales: Career, Health, Intimate relationships, social readjustment, concerns about deployment, and PTSD symptoms. Higher scores indicate less successful post-deployment readjustment.
  measure: State-Trait Anger Expression Inventory (STAXI-2)
  time frame: Assessed at screening, baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)
  description: Measures the experience, expression, and control of anger. Participants rank each of the statements on a scale of 1 (not at all) to 4 (very much so) for section 1 and 1 (almost never) to 4 (almost always) for sections 2 and 3. Higher scores indicate high experience/expression and low control of anger.
  measure: Functional status measured using the WHO Disability Assessment Schedule 2.0 12-item (WHODAS-2.0)
  time frame: Assessed at baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)
  description: Participants indicate how much difficulty they have had in the last 30 days for each of the statements on the assessment on a scale from 0 (none) to 4 (Extreme/cannot do). Higher scores indicate greater levels of disability.
  measure: Stigma- Perceived Barriers to Care Survey
  time frame: Assessed at baseline (0 weeks), T2 (after 4 weeks), T3 (after 8 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)
  description: Participants rank each of the survey items on the scale from 1 (strongly agree) to 5 (strongly disagree) with lower scores indicating that the item is a greater barrier to care.
  measure: Quality of Life Scale (QOLS)
  time frame: Assessed at baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)
  description: Participants answer each question on a 7 point scale. It is scored by adding up the score on each item to get a minimum potential score of 16 and a maximum total score of 112. Higher scores indicate a higher quality of life.
  measure: Psychosocial Functioning- The Brief Inventory of Psychosocial Functioning (IPF-Brief)
  time frame: Assessed at baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)
  description: Participants rank each of the 7 statements based on their overall experience over the past month on a scale from 0 (not at all) to 6 (very much). 7 is marked if the statement is not applicable. Higher scores indicate more impaired psychosocial functioning.
  measure: Social support subscale of the Deployment Risk and Resilience Inventory (DRRI-2)
  time frame: Assessed at baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)
  description: Participants rank each of the ten questions from this subscale on a scale from 1 (Strongly Disagree) to 5 (Strongly Agree) and total subscale score is calculated by adding up the responses from each of the questions. Lower scores indicate lower levels of social support.
  measure: Interpersonal Needs Questionnaire (INQ)
  time frame: Assessed at baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)
  description: Each of the 15 questions are answered on a scale from 1 (Not at all true for me) to 7 (very true for me). 6 out of the 15 questions are reverse coded. Higher scores indicate that more interpersonal needs are not met.
  measure: Depression- Patient Health Questionnaire (PHQ-9)
  time frame: Assessed at baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)
  description: Participants rank 9 questions on a scale from 0 (not at all) to 3 (Nearly every day) based on how often in the last 2 weeks they have been bothered by the problems listed. Then they rate the severity of the difficulty any problems they have experienced are causing on a scale from "not difficult at all" to "extremely difficult." Higher scores indicate higher depression severity.
  measure: Hopelessness- Beck Hopelessness Scale
  time frame: Assessed at baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)
  description: Participants answer 20 true or false questions that are scored based on an answer key. Answers that indicate hopelessness are added up, with higher scores indicating higher levels of hopelessness/pessimism.
  measure: Self-injurious thoughts and behaviors interview (SITBI)
  time frame: Assessed at baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)
  description: This interview asks a wide variety of questions related to suicidal ideations, plans, gestures, attempts, and non-suicidal self injurious behaviors. There are 72 possible questions, but some are only asked if a specific behavior is endorsed. Higher scores indicate higher levels of thoughts and feelings related to suicide and self-injurious behaviors.
  measure: Suicide Coping/Safety Behaviors- Suicide Related Coping Scale (SRCS)
  time frame: Assessed at baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)
  description: Participants answer 17 questions on a 5 point Likert scale from 0-4 (Strongly Disagree to Strongly Agree). Total score is determined by reverse scoring negatively worded items and then summing the items. Higher scores indicate better coping skills.
  measure: Gateway to vocational and community activities- Treatment & Activities Survey
  time frame: Assessed at baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)
  description: Treatment & Activities Survey developed by STEP-Home staff asks participants to list the types of treatment (psychotherapy, medication, group therapy) that they have participated in within the last month, what they receive the treatment for, and whether it is administered by the VA or outside of the VA. Participants also answer if they have participated in other activities in the last month (school, work, community, etc.) and whether those activities are at or outside of the VA.
  measure: Kessler-6 brief mental health screen
  time frame: Baseline (0 weeks)
  description: The Kessler Psychological Distress Scale (K6) is a 6 item measure of participants' emotional state. Questions are scored from 0 (none of the time) to 4 (all of the time) with a minimum score of 0 and a maximum score of 24. Higher scores indicate higher levels of psychological distress.
  arm group label: STEP-Home-SP + Usual Care
  arm group type: Experimental
  description: The core skills of emotional regulation and problem solving are introduced and integrated throughout all Veteran-specific reintegration content modules for practice and repetition for 12 weeks. Attention training augments emotional regulation and problem solving core skills and is interspersed throughout group and individual sessions. Additional 30-minute individual skill building and goal setting sessions occur ~4-6 times based on individual Veteran needs
  arm group label: Usual Care
  arm group type: Active Comparator
  description: UC will include the Transition Assistance Program (TAP) as scheduled by DOD prior to military separation, VA Solid Start post-separation, and educational augmentation post-separation.
  intervention type: Behavioral
  intervention name: STEP-Home-SP
  description: This group will meet for ~1.5 hours/week for 12 weeks. The core skills of Emotional Regulation (ER) and Problem Solving (PS) are introduced and then integrated throughout all Veteran-specific content modules for practice and repetition for 12 weeks. Attention training augments ER and PS skills and is interspersed throughout the group and individual sessions. Additional 30-minute individual skills building and goal setting sessions occur up to 6 times based on individual Veteran needs. STEP-Home staff will work in pairs to run workshops per established protocols. Workshops will be conducted via VA approved video telehealth.
  arm group label: STEP-Home-SP + Usual Care
  intervention type: Behavioral
  intervention name: Transition Assistance Program
  description: Provides training, skills, and information to help transitioning service members and their families prepare for the military to civilian transition. Each service member works with a TAP counselor to identify needs and post transition goals to build an Individual Transition Plan, in addition to TAP core curriculum courses.
  arm group label: STEP-Home-SP + Usual Care
  arm group label: Usual Care
  other name: TAP
  intervention type: Behavioral
  intervention name: VA Solid Start
  description: VA Solid Start includes a series of outreach calls and emails to all Veterans at 90-, 180-, and 365-days post service separation. Callers follow a standard script to describe services available through VA and provide contact information for desired services.
  arm group label: STEP-Home-SP + Usual Care
  arm group label: Usual Care
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Catherine B Fortier, PhD
  role: Principal Investigator
  affiliation: VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
  last name: Catherine B Fortier, PhD
  phone: (857) 364-4361
  email: catherine.fortier@va.gov
  facility: 
  contact: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Suicide
  mesh term: Suicide Prevention
  sharing ipd: No
  ipd description: No additional IPD will be shared besides the deidentified/anonymized data set and data dictionary will be shared.