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

NCT05995678 | Recruiting DMC

• 2 other identifiers: D4535-RRX004535
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

TBI; Suicide Prevention; Veterans; PTSD; Transdiagnostic; Anger

Keywords

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

Outcome Measures

Primary Outcomes (7)

• Feasibility- recruitment interest

  ratio interested of those approached for the workshop

  Through study completion, an average of one year.

• Feasibility- enrollment

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

  Through study completion, an average of one year.

• 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.

  Through study completion, an average of 3 months.

• 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).

  Through study completion, an average of 1 week.

• Acceptability- Veteran adherence

  Attendance rate for the 12-session workshop

  Through study completion, an average of one year.

• 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.

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

• 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.

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

Secondary Outcomes (1)

• Engagement in VA Care

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

Other Outcomes (18)

• Difficulties in Emotional Regulation Scale (DERS)

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

• Problem Solving Inventory (PSI)

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

• Attention-Related Cognitive Errors Scale (ARCES)

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

Study Arms (2)

STEP-Home-SP + Usual Care

EXPERIMENTAL

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

Usual Care

ACTIVE COMPARATOR

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

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.

STEP-Home-SP + Usual Care

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.

Also known as: TAP

STEP-Home-SP + Usual Care; Usual Care

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.

STEP-Home-SP + Usual Care; Usual Care

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• Participants with mild substance use disorder will be allowed
• Substance use is a common behavior that may contribute to reintegration difficulties and suicide risk

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Boston, Massachusetts, 02130-4817, United States

RECRUITING

MeSH Terms

Conditions

Suicide Prevention; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Catherine B Fortier, PhD

  VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Catherine B Fortier, PhD

CONTACT

(857) 364-4361; catherine.fortier@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 20, 2023
• First Posted: August 16, 2023
• Study Start: March 1, 2024
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)