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NCT Number: NCT07388654

PTSD and Alcohol Couples Treatment for Veterans

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Ralph H. Johnson VA Medical Center, Charleston, SC

Charleston, South Carolina, 29401-5703, United States

Location contact

Sarah T Giff, PhD

CONTACT

[email protected]

(843) 789-7311

Sarah T Giff, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

COPE + BFIT

Behavioral

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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).

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sarah T Giff, PhD

CONTACT

[email protected]

(843) 789-7311

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

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

Acronym: PACT-V

Important dates

Study start
2027
Primary completion
2030
Study completion
2031
First posted
Feb 5, 2026
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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