A Mixed Methods Pilot Trial of the STEP Home Workshop to Improve Reintegration and Reduce Suicide Risk for Recently Transitioned Veterans

Browse trials for

• Suicide Prevention 190
• Stress Disorders, Post-Traumatic 2,237

Keywords

• Veterans
• TBI
• Transdiagnostic
• Intervention
• Suicide Prevention
• PTSD
• Reintegration

Suicide Prevention

190 studies on the registry are indexed under Suicide Prevention; 87 are open to participants now.

This study's planned enrollment of 120 is below the median of 150 across 169 interventional studies indexed under Suicide Prevention.

Lead sponsor

VA Office of Research and Development is the lead sponsor of 1,733 studies on the registry; 396 are open to participants now.

Of its 206 completed or terminated interventional studies of FDA-regulated products, 180 (87%) have results posted.

Study arms

• Experimental
  STEP-Home-SP + Usual Care

  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

  Behavioral: STEP-Home-SP · Behavioral: Transition Assistance Program · Behavioral: VA Solid Start

• Active comparator
  Usual Care

  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.

  Behavioral: Transition Assistance Program · Behavioral: VA Solid Start

Interventions

• BehavioralSTEP-Home-SP

  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.

• BehavioralTransition Assistance Program

  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.

  Also known as: TAP

• BehavioralVA Solid Start

  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.

Primary outcomes

1. Feasibility- recruitment interest

   ratio interested of those approached for the workshop

   Time frame: Through study completion, an average of one year.

2. Feasibility- enrollment

   Ratio enrolled (consented) of those approached, greater than 20% of those interested enroll in the proposed time frame

   Time frame: Through study completion, an average of one year.

3. Feasibility- qualitative via Narrative Evaluation of Intervention Interview

   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.

   Time frame: Through study completion, an average of 3 months.

4. Feasibility- Treatment Fidelity/adherence

   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).

   Time frame: Through study completion, an average of 1 week.

5. Acceptability- Veteran adherence

   Attendance rate for the 12-session workshop

   Time frame: Through study completion, an average of one year.

6. Acceptability- Quantitative satisfaction via Client satisfaction questionnaire Change

   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.

   Time frame: Assessed at baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)

7. Reintegration status- Military to Civilian Questionnaire (M2CQ) Change

   16 questions are answered on a scale from 0 (no difficulty) to 4 (extreme difficulty), with lower scores indicating more successful reintegration.

   Time frame: Assessed at screening, baseline (0 weeks), T4 (after 12 weeks) and T5 (after 24 weeks)

Secondary outcomes

1. Engagement in VA Care

   Electronic medical record data (if available) showing occurrence of one or more healthcare appointments

   Time frame: Assessed at baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)

Other outcomes

1. Difficulties in Emotional Regulation Scale (DERS)

   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.

   Time frame: Assessed at baseline (0 weeks), T2 (after 4 weeks), T3 (after 8 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)

2. Problem Solving Inventory (PSI)

   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.

   Time frame: Assessed at baseline (0 weeks), T2 (after 4 weeks), T3 (after 8 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)

3. Attention-Related Cognitive Errors Scale (ARCES)

   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.

   Time frame: Assessed at baseline (0 weeks), T2 (after 4 weeks), T3 (after 8 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)

4. Suicidal Ideation- The Columbia-Suicide Severity Rating Scale (C-SSRS)

   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.

   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.

5. Post-deployment Readjustment Inventory (PDRI)

   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.

   Time frame: Assessed at screening, baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)

6. State-Trait Anger Expression Inventory (STAXI-2)

   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.

   Time frame: Assessed at screening, baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)

7. Functional status measured using the WHO Disability Assessment Schedule 2.0 12-item (WHODAS-2.0)

   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.

   Time frame: Assessed at baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)

8. Stigma- Perceived Barriers to Care Survey

   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.

   Time frame: Assessed at baseline (0 weeks), T2 (after 4 weeks), T3 (after 8 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)

9. Quality of Life Scale (QOLS)

   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.

   Time frame: Assessed at baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)

10. Psychosocial Functioning- The Brief Inventory of Psychosocial Functioning (IPF-Brief)

    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.

    Time frame: Assessed at baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)

11. Social support subscale of the Deployment Risk and Resilience Inventory (DRRI-2)

    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.

    Time frame: Assessed at baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)

12. Interpersonal Needs Questionnaire (INQ)

    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.

    Time frame: Assessed at baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)

13. Depression- Patient Health Questionnaire (PHQ-9)

    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.

    Time frame: Assessed at baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)

14. Hopelessness- Beck Hopelessness Scale

    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.

    Time frame: Assessed at baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)

15. Self-injurious thoughts and behaviors interview (SITBI)

    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.

    Time frame: Assessed at baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)

16. Suicide Coping/Safety Behaviors- Suicide Related Coping Scale (SRCS)

    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.

    Time frame: Assessed at baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)

17. Gateway to vocational and community activities- Treatment & Activities Survey

    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.

    Time frame: Assessed at baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks)

18. Kessler-6 brief mental health screen

    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.

    Time frame: Baseline (0 weeks)

Individual participant data

Plan to share: No — No additional IPD will be shared besides the deidentified/anonymized data set and data dictionary will be shared.