PTSD and Alcohol Couples Treatment for Veterans (PACT-V)

VA Office of Research and Development

Status and phase

Begins enrollment in a year or more

Phase 1

Conditions

PTSD, AUD

Treatments

Behavioral: COPE + BFIT

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT07388654

RRD9-003-24W

IK2RD000536 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full description

Co-occurring PTSD-AUD is a complex and urgent public health crisis. COPE is a highly efficacious integrated intervention that has strong positive effects on reducing PTSD symptoms, but has substantial room for improvement regarding AUD outcomes. Adapting a brief dyadic intervention designed to target AUD to be delivered alongside COPE (COPE + B-FIT) is a promising way to bolster AUD outcomes and increase relationship functioning to promote recovery for Veteran and their families. The present study will test a modified version of B-FIT that is specifically designed to be delivered to Veterans with PTSD-AUD and their romantic partners. The goals of B-FIT are to: 1. increase reinforcement for AUD treatment engagement, 2. increase positive rewards from drinking reductions, and 3. decrease drinking cues by decreasing negative communication and increasing positive communication. This trial will recruit Veterans and their romantic partners (N=40 couples/80 individuals). This Stage 1a/1b trial will look at primary outcomes of feasibility and acceptability of the adapted B-FIT intervention, and secondary outcomes of PTSD symptoms, AUD symptoms, and psychosocial functioning.

Enrollment

80 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 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