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

February 5, 2026 updated by: VA Office of Research and Development

Adapting a Brief Dyadic Intervention for Co-occurring Post-Traumatic Stress Disorder and Alcohol Use Disorder

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29401-5703
        • Ralph H. Johnson VA Medical Center, Charleston, SC
        • Principal Investigator:
          • Sarah T Giff, PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: COPE + BFIT
In this single arm study, participants will be assigned only to the pilot intervention of COPE + B-FIT.
Behavioral: COPE + BFIT
Veterans will engage in 12 sessions of COPE individually, and Veterans and their significant others will participate in in 3-4 sessions of the adapted B-FIT intervention specifically for Veterans with PTSD + AUD and their partners. COPE will be delivered concurrently with the adapted B-FIT.
Other Names:
  • Concurrent Treatment of PTSD and Substance Use Disorder with Prolonged Exposure and Brief Family Involved Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of Intervention (Number of Sessions Attended)
Time Frame: Baseline to 12 weeks
Feasibility of the adapted B-FIT intervention will be measured by number of sessions attended by each participant.
Baseline to 12 weeks
Acceptability of Intervention to Participants (Customer Satisfaction Questionnaire)
Time Frame: at 12 weeks
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.
at 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Drinks per Drinking Day (Alcohol Timeline Followback (TLFB))
Time Frame: Baseline to 12 weeks
Change in drinks per drinking day, as measured by the Alcohol Timeline Followback (TLFB).
Baseline to 12 weeks
PTSD Symptoms (PTSD Checklist (PCL-5)
Time Frame: Baseline to 12 weeks
Change in PTSD symptoms as measured by the PTSD Checklist (PCL-5). Scores range from 0-80 and higher scores are indicative of greater symptom severity.
Baseline to 12 weeks
Alcohol Problem Severity (Alcohol Use Disorders Identification Test (AUDIT))
Time Frame: Baseline to 12 weeks
Change in Alcohol problem severity as measured by the Alcohol Use Disorders Identification Test (AUDIT). Scores range from 0-40 with higher scores indicative of greater alcohol problem severity.
Baseline to 12 weeks
Relationship Satisfaction (Dyadic Adjustment Scales -7 (DAS-7))
Time Frame: Baseline to 12 weeks
Change in relationship satisfaction as measured by the brief Dyadic Adjustment Scales -7 (DAS-7). Scores range from 0-36, with higher scores indicating more positive relationship quality.
Baseline to 12 weeks
Quality of Life (Quality of Life Enjoyment and Satisfaction Scale (Q-LES-Q-SF))
Time Frame: Baseline to 12 weeks
Change in quality of life as measured by the Quality of Life Enjoyment and Satisfaction Scale (Q-LES-Q-SF). Scores range from 14-70 with higher scores indicating greater quality of life.
Baseline to 12 weeks
Interpersonal Functioning (Brief Inventory of Psychosocial Functioning (B-IPF))
Time Frame: Baseline to 12 weeks
Change in psychosocial functioning in relation to PTSD as measured by the Brief Inventory of Psychosocial Functioning (B-IPF). Scores range from 0-600 with higher scores indicating greater difficulty in psychosocial functioning.
Baseline to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Investigators

  • Principal Investigator: Sarah T Giff, PhD, Ralph H. Johnson VA Medical Center, Charleston, SC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2027

Primary Completion (Estimated)

September 30, 2030

Study Completion (Estimated)

February 3, 2031

Study Registration Dates

First Submitted

January 28, 2026

First Submitted That Met QC Criteria

January 28, 2026

First Posted (Actual)

February 5, 2026

Study Record Updates

Last Update Posted (Actual)

February 10, 2026

Last Update Submitted That Met QC Criteria

February 5, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RRD9-003-24W
  • IK2RD000536 (Other Grant/Funding Number: RRDT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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