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 range18 Years

SexALL

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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…

What they're measuring

Acceptability of Intervention to Participants (Customer Satisfaction Questionnaire)

Timeframe: at 12 weeks

Feasibility of Intervention (Number of Sessions Attended)

Timeframe: Baseline to 12 weeks

Trial details

NCT IDNCT07388654

SponsorVA Office of Research and Development

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2030-09-30

Contact for this trial

Sarah T Giff, PhD

(843) 789-7311 Sarah.Giff@va.gov