PTSD and Alcohol Couples Treatment for Veterans

Starting soon · Early Phase 1

Conditions studied: PTSD, AUD

In brief

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 facts

Study ID: NCT07388654
Run by: VA Office of Research and Development
People needed: 80
Starts: 2027-03-01
Expected to finish: 2031-02-03
Last updated by the study team: 2026-02-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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 use disorder, or concerns about alcohol withdrawal as demonstrated by a score >8 on the CIWA-Ar)
Either partner reports current suicidal or homicidal ideation and intent or prior intent or attempt in the past 6 months as assessed by the CSSRS and PHQ-9 item 9
The Veteran's SO cannot have substance use problems as indicated by a score < 8 on the AUDIT and QuickSCID

Where it is running

Ralph H. Johnson VA Medical Center, Charleston, SC — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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