PTSD and Alcohol Couples Treatment for Veterans
Part of paid clinical trials in Charleston, South Carolina.
- Sponsor
- VA Office of Research and Development
- Study ID
- NCT07388654
- Phase
- EARLY_PHASE1
- Status
- Not Yet Recruiting
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Conditions
- PTSD, AUD
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- COPE + BFIT — BEHAVIORALVeterans will engage in 12 sessions of COPE individually, and Veterans and their significant others will participate in in 3-4 sessions of the adapted B-FIT intervention specifically for Veterans with PTSD + AUD and their partners. COPE will be delivered concurrently with the adapted B-FIT.
Study Details
Treatment of post-traumatic stress disorder (PTSD) and alcohol use disorder (AUD) treatment for Veterans is challenging for Veterans. Veterans often benefit from social support from friends and loved ones while in treatment; however, the symptoms of PTSD and AUD often are associated with increased relationship conflict. It is essential to identify new ways to improve PTSD-AUD treatment, and involving loved ones in the process may be a way to improve treatment. The purpose of this study is to pilot test a brief couples intervention that is designed to be delivered while Veterans are in treatment for PTSD-AUD. Over the course of 12 weeks, Veterans will receive individual treatment through Concurrent Treatment of PTSD and Substance Use Disorders with Prolonged Exposure (COPE), and Veterans and their romantic partners will attend 3-4 sessions of Brief Family Involved Treatment (B-FIT) which has been modified specifically for Veterans with PTSD-AUD. Veterans and their romantic partners will complete a baseline visit, 12 weeks of weekly measures, and a 3-month follow-up visit. This is a stage 1a one-armed non-randomized pilot trial.
Key Dates
- Start date
- Mar 1, 2027
- Status verified
- Feb 2026
- Primary completion
- Sep 30, 2030
- Completion
- Feb 3, 2031
Study Design
- Enrollment
- 80 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: COPE + BFITIn this single arm study, participants will be assigned only to the pilot intervention of COPE + B-FIT.
Primary Outcome Measure
Acceptability of Intervention to Participants (Customer Satisfaction Questionnaire) [ Time Frame: at 12 weeks ]
Central Contacts
- Sarah T Giff, PhD(843) 789-7311
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Ralph H. Johnson VA Medical Center, Charleston, SC | Charleston | South Carolina | 29401-5703 | Sarah T Giff, PhD (PRINCIPAL_INVESTIGATOR) |