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NCT07388654 · ClinicalTrials.gov registry record · Early Phase 1
PTSD and Alcohol Couples Treatment for Veterans
A Early Phase 1 study, sponsored by VA Office of Research and Development.
- Not yet
- Registry status
- Early Phase 1
- Development phase
- 80
- Enrollment target
NCT07388654: Clinical Trial Early Phase 1 study, sponsored by VA Office of Research and Development.
NCT07388654 is a Early Phase 1 study that has not yet begun recruiting, run by VA Office of Research and Development. The registered enrollment target is 80 participants, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (51% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07388654, a Early Phase 1 study, has not yet begun recruiting, sponsored by VA Office of Research and Development.
- NOT YET RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 80 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Veterans and Significant Others will report on their satisfaction with the adapted B-FIT intervention using the Customer Satisfaction Questionnaire (CSQ). Scores range from 1-4 and higher scores are indicative of greater satisfaction.
Interventions
- BEHAVIORAL COPE + BFIT
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2027-03-01 |
| Est. Completion | 2031-02-03 |
| Phase | Early Phase 1 |
What is known before NCT07388654 opens enrollment
NCT07388654 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (51% higher).
The record links to 0 conditions, and to 1 intervention - of which COPE + BFIT is the first listed.
NCT07388654 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07388654 about?
NCT07388654 is a clinical study titled "PTSD and Alcohol Couples Treatment for Veterans". 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 r...
What is the current status of trial NCT07388654?
This trial is currently not yet recruiting. It is a Early Phase 1 study. The enrollment target is 80 participants. The study started on 2027-03-01. Estimated completion is 2031-02-03.
What interventions are being tested in trial NCT07388654?
The interventions under investigation include: COPE + BFIT (BEHAVIORAL).
Who is sponsoring clinical trial NCT07388654?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07388654's enrollment target sits among peer trials
80 271st of 2000 higher than 1,703 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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