NCT05995678 A Mixed Methods Pilot Trial of the STEP Home Workshop to Improve Reintegration and Reduce Suicide Risk for Recently Transitioned Veterans
| NCT ID | NCT05995678 |
| Status | Recruiting |
| Phase | — |
| Sponsor | VA Office of Research and Development |
| Condition | TBI |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2024-03-01 |
| Primary Completion | 2027-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2024-03-01 with a primary completion date of 2027-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Catherine B Fortier, PhD
PRINCIPAL INVESTIGATOR
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Frequently Asked Questions
Who can join the NCT05995678 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying TBI. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05995678 currently recruiting?
Yes, NCT05995678 is actively recruiting participants. Contact the research team at catherine.fortier@va.gov for enrollment information.
Where is the NCT05995678 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT05995678 clinical trial?
NCT05995678 is sponsored by VA Office of Research and Development. The principal investigator is Catherine B Fortier, PhD at VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA. The trial plans to enroll 120 participants.