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PTSD, AUDEarly Phase 1PACT-VNCT07388654

PTSD and Alcohol Couples Treatment for Veterans

A Early Phase 1 study testing COPE + BFIT in people with PTSD, AUD, run by VA Office of Research and Development at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
PTSD, AUD
What is being tested?
COPE + BFIT
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteUnited States
Study dates
1 Mar 2027to 3 Feb 2031
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 11Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Sarah T Giff, PhD contact

(843) 789-7311

Sarah.Giff@va.gov

United States1 site

  • Ralph H. Johnson VA Medical Center, Charleston, SC

    Charleston, South Carolina, 29401-5703

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

    Sarah T Giff, PhD

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions
PTSD, AUD
Being tested
COPE + BFIT
Keywords
Stress Disorders, Post-Traumatic, Alcohol Use Disorder, Veterans
Medical subject headings
Stress Disorders, Post-Traumatic, Alcoholism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • COPE + BFITBehavioural

    Also called Concurrent Treatment of PTSD and Substance Use Disorder with Prolonged Exposure and Brief Family Involved Treatment

    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.

Study groups in NCT07388654
Study groupRoleWhat they receive
COPE + BFITExperimentalIn this single arm study, participants will be assigned only to the pilot intervention of COPE + B-FIT.
Receives: Behavioral: COPE + BFIT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Acceptability of Intervention to Participants (Customer Satisfaction Questionnaire)

    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.

    Measured: at 12 weeks

  2. Feasibility of Intervention (Number of Sessions Attended)

    Feasibility of the adapted B-FIT intervention will be measured by number of sessions attended by each participant.

    Measured: Baseline to 12 weeks

Secondary outcomes (6)

  1. Drinks per Drinking Day (Alcohol Timeline Followback (TLFB))

    Change in drinks per drinking day, as measured by the Alcohol Timeline Followback (TLFB).

    Measured: Baseline to 12 weeks

  2. PTSD Symptoms (PTSD Checklist (PCL-5)

    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.

    Measured: Baseline to 12 weeks

  3. Alcohol Problem Severity (Alcohol Use Disorders Identification Test (AUDIT))

    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.

    Measured: Baseline to 12 weeks

  4. Relationship Satisfaction (Dyadic Adjustment Scales -7 (DAS-7))

    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.

    Measured: Baseline to 12 weeks

  5. Quality of Life (Quality of Life Enjoyment and Satisfaction Scale (Q-LES-Q-SF))

    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.

    Measured: Baseline to 12 weeks

  6. Interpersonal Functioning (Brief Inventory of Psychosocial Functioning (B-IPF))

    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.

    Measured: Baseline to 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2026
  2. Study start1 Mar 2027 (estimated)
  3. Primary completion30 Sep 2030 (estimated)
  4. Study completion3 Feb 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
This is a stage 1a/1b one-armed non-randomized pilot trial.
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07388654
Sponsor's protocol ID
RRD9-003-24W
Other IDs
IK2RD000536
Acronym
PACT-V
Status last verified
Feb 2026
First submitted
28 Jan 2026
Last updated
10 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing COPE + BFIT in people with PTSD, AUD, run by VA Office of Research and Development at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sarah T Giff, PhD ((843) 789-7311, Sarah.Giff@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acceptability of Intervention to Participants (Customer Satisfaction Questionnaire) (time frame: at 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07388654.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.

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