Recruiting

STEP-Home-SP

Sponsor:

VA Office of Research and Development

Code:

NCT05995678

Conditions

TBI

Suicide Prevention

Veterans

PTSD

Transdiagnostic

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

STEP-Home-SP

Transition Assistance Program

VA Solid Start

Study Details

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

Study ID

NCT05995678

Start date

Mar 1, 2024

Status verified date

Mar, 2026

Completion date

May 31, 2027

Anticipated

Primary completion date

May 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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

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.

Interventions

STEP-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.

Transition 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.

VA 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 outcome measure

  • Feasibility- recruitment interest [ Time Frame: Through study completion, an average of one year. ]
  • Feasibility- enrollment [ Time Frame: Through study completion, an average of one year. ]
  • Feasibility- qualitative via Narrative Evaluation of Intervention Interview [ Time Frame: Through study completion, an average of 3 months. ]
  • Feasibility- Treatment Fidelity/adherence [ Time Frame: Through study completion, an average of 1 week. ]
  • Acceptability- Veteran adherence [ Time Frame: Through study completion, an average of one year. ]
  • Acceptability- Quantitative satisfaction via Client satisfaction questionnaire Change [ Time Frame: Assessed at baseline (0 weeks), T4 (after 12 weeks), and T5 (after 24 weeks) ]
  • 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) ]

Central Contacts and Locations

Central contacts

Catherine B Fortier, PhD

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

Locations

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

Recruiting

Boston, Massachusetts, United States, 02130-4817

Contacts

Catherine B Fortier, PhD

857-364-4361catherine.fortier@va.gov

Principal Investigator:

Catherine B Fortier, PhD

More Information

Sponsor

VA Office of Research and Development

Last update posted

Mar 6, 2026

Last verified

Mar, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-03-06.