Adapting and Piloting Behavioral Activation for Veterans With Alcohol Use Disorder and Posttraumatic Stress Disorder

NCT06249386 | Completed Results

• 4 other identifiers: 0219135R34AA030820Pro00113641STUDY00022679
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to compare an adaptation of Behavioral Activation, a behavioral intervention, to Relapse Prevention treatment, another behavioral intervention, in a sample of U.S. military veterans with co-occurring alcohol use disorder (AUD) and posttraumatic stress disorder (PTSD). The primary aims of this study are to:

1. 1.Adapt Behavioral Activation to treat veterans with AUD/PTSD,
2. 2.Evaluate the feasibility, acceptability, and preliminary effects of Behavioral Activation for AUD/PTSD, and
3. 3.Explore geospatial analysis as a new method for measuring AUD/PTSD recovery.

Conditions

Alcohol Use Disorder; Posttraumatic Stress Disorder

Outcome Measures

Primary Outcomes (2)

• Timeline Follow-Back (Alcohol Use)

  Changes in past-30-day alcohol consumption from baseline to immediately post-treatment. One standard drink is defined in the United States as any beverage containing 0.6 fl oz or 14 grams. A drinking day refers to a day with any alcohol use. Higher values on this outcome reflect greater alcohol consumption.

  Through study completion, an average of 3 months

• Clinician-Administered PTSD Scale for DSM-5 (PTSD Severity)

  Changes in past-month PTSD severity from baseline to immediately post-treatment. Total scores on this measure range 0 to 80, with higher scores reflecting more severe PTSD symptoms.

  Through study completion, an average of 3 months

Secondary Outcomes (6)

• Brief Inventory of Psychosocial Functioning (Psychosocial Functioning)

  Through study completion, an average of 3 months

• Geospatial Activity

  Through study completion, an average of 3 months

• PTSD Checklist for DSM-5 (PCL-5)

  Through study completion, an average of 1.5 months (mid-treatment) and 3 months (post-treatment)

• Generalized Anxiety Disorder-7 (GAD-7)

  Through study completion, an average of 3 months

• Patient Health Questionnaire-9 (PHQ-9)

  Through study completion, an average of 3 months

Study Arms (2)

Behavioral Activation (BA)

EXPERIMENTAL

Individual psychotherapy

Behavioral: Behavioral Activation (BA)

Relapse Prevention (RP)

ACTIVE COMPARATOR

Individual psychotherapy

Behavioral: Relapse Prevention (RP)

Interventions

Behavioral Activation (BA) BEHAVIORAL

BA reduces alcohol use and posttraumatic stress symptoms and increases psychosocial functioning via psychoeducation, activity monitoring, values clarification, and activity scheduling.

Behavioral Activation (BA)

Relapse Prevention (RP) BEHAVIORAL

RP reduces alcohol use via increasing awareness and avoidance of high-risk situations, enhancing drink refusal skills, improving assertiveness, and other strategies.

Relapse Prevention (RP)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be a U.S. veteran,
• Be at least 18 years old,
• Meet Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for current AUD,
• Report 3+ heavy drinking days (5+ drinks for men/4+ drinks for women) or 1+ heavy drinking week (15+ drinks men/8+ drinks women) in the past 30 days,
• Meet DSM-5 criteria for current PTSD or satisfy the definition of current subthreshold PTSD (i.e., up to one of symptom clusters B-E may fall below diagnostic threshold),
• Be fluent and literate in English, and
• Be able to provide voluntary, informed consent to participate.

You may not qualify if:

• Current mania/hypomania or current psychosis,
• Lifetime alcohol withdrawal-related seizures, delirium, or hallucinations,
• Prior inpatient alcohol withdrawal management,
• Current DSM-5 severe drug use disorder (DUD) except for severe tobacco use disorder,
• Psychotropic (including alcohol abstinence) medication changes within 30 days of study enrollment or plans to change medications during the study,
• Current/planned non-study BA for any disorder during the study, or
• Current/planned evidence-based psychotherapy for AUD, PTSD, or DUD during the study.

Sponsors & Collaborators

• RTI International: lead
• Duke University: collaborator
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Duke University School of Medicine

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

• Blakey SM, Alsobrooks AK, Morgan-Lopez AA, Kruskamp N, Simpson TL, Daughters SB, DuBois CM, Huang JS, Evans J, Serrano BN, Calhoun PS, Beckham JC, Elbogen EB. Behavioral activation for veterans with co-occurring alcohol use disorder and posttraumatic stress disorder: Basis and methodology for a pilot randomized controlled trial. Contemp Clin Trials. 2024 Nov;146:107670. doi: 10.1016/j.cct.2024.107670. Epub 2024 Aug 24.

  PMID: 39186971 DERIVED

MeSH Terms

Conditions

Alcoholism; Stress Disorders, Post-Traumatic

Interventions

Secondary Prevention

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Intervention Hierarchy (Ancestors)

Therapeutics; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Public Health Practice; Public Health; Environment and Public Health

Results Point of Contact

• Title: Shannon Blakey, PhD
• Organization: RTI International

sblakey@rti.org

919-485-5427

Study Officials

• Shannon M Blakey, PhD

  RTI International

  PRINCIPAL INVESTIGATOR

• Eric B Elbogen, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessors will be blind to treatment condition. The participant, study therapist, and PI (providing clinical consultation and evaluating therapist fidelity to treatment protocol) will not be blinded to participants' assigned treatment condition.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Clinical Psychologist

Model Details: Participants will be block randomized to either Behavioral Activation treatment (n=23) or Relapse Prevention treatment (n=23).

Study Record Dates

• First Submitted: January 30, 2024
• First Posted: February 8, 2024
• Study Start: January 17, 2025
• Primary Completion: October 6, 2025
• Study Completion: October 6, 2025
• Last Updated: April 28, 2026
• Results First Posted: April 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Time Frame: All collection data are shared automatically two years after the grant end date specified on the first Notice of Award. PI requests for exceptions will be considered for only extreme and unusual circumstances (e.g., unanticipated life event \[death of family member\] or other force majeure).
• Access Criteria: Data access requires sponsorship by an Institution on behalf of Recipient(s) and satisfaction of any other criteria required by the National Institute on Alcohol Abuse and Alcoholism Data Archive.

Locations

US (1)