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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorVA Office of Research and Development

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Recently transitioned Veterans within three years of separation from military service

Self-reported functional impairment or reintegration difficulties as measured by the Military-to-Civilian Questionnaire (any item score > 1 indicating "some difficulty"; M2CQ; [71])

Sufficient English fluency

Agree to participate (informed consent/HIPAA)

Disqualifiers

Active psychosis

Imminent or acute high suicide risk requiring immediate crisis intervention (low-moderate non-imminent risk for suicide is allowed)

Current moderate or severe substance use disorder

Neurological diagnosis excluding TBI

Trial design

Design model

Parallel

Treatments tested in this trial

  • STEP-Home-SP

    Behavioral

    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.

  • Transition Assistance Program

    Behavioral

    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.

  • VA Solid Start

    Behavioral

    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.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: STEP-Home-SP + Usual CareExperimental treatment 3 interventions
Group B: Usual CareActive comparator 2 interventions

Trial outcomes

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.

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.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.