PTSD and Alcohol Couples Treatment for Veterans (NCT07388654) | Clinical Trial Compass
Not Yet RecruitingEarly Phase 1
PTSD and Alcohol Couples Treatment for Veterans
United States80 participantsStarted 2027-03-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Inclusion criteria for Veterans and Significant Others:
* Any gender or sexual identity; any race or ethnicity
* Married, cohabiting for at least 6 months, or in a committed relationship for at least 6 months and both partners are willing to participate.
* The Veteran meets current or past-year DSM-5 diagnostic status for both PTSD (assessed via CAPS-5) and AUD (assessed via the Quick Structured Clinical Interview for DSM-5)
* Concurrent substance use disorders are acceptable provided that alcohol is the Veteran's primary substance of choice
* Must demonstrate cognitive functioning sufficient to provide informed consent and participate accurately (=\>26 on the Mini-Mental State Exam \[MMSE\])
* Participants taking psychotropic medications will be required to be maintained on a stable dose for at least 4 weeks before study initiation
* Not currently enrolled in couple therapy
Additional inclusion criteria for the Veteran patient:
* U.S. military Veteran
* Enrolled, or is willing to become enrolled, in VA healthcare
* Not attending trauma-focused therapy during the intervention period
Exclusion Criteria:
* History of moderate, severe, or unilateral violence in the relationship in the past year as measured by the CTS-2
* Either partner demonstrates a need for a higher level of care as assessed by the Quick Structured Clinical Interview for DSM-5 Disorders (QuickSCID)
* i.e., history of or current psychotic or bipolar disorders, current severe drug…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Acceptability of Intervention to Participants (Customer Satisfaction Questionnaire)
Timeframe: at 12 weeks
2
Feasibility of Intervention (Number of Sessions Attended)