N/A N=10 Randomized Single-blind Treatment

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

Alcohol Use Disorder · Posttraumatic Stress Disorder

Bottom Line

View on ClinicalTrials.gov: NCT06249386 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2026

Primary outcome: Primary: Timeline Follow-Back (Alcohol Use) — 4.36; 3.90; 1.82; 3.31 Drinks per day — p=0.4174

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Behavioral Activation (BA) (Behavioral); Relapse Prevention (RP) (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: RTI International
Primary completion: Oct 2025

Outcome Measures

Outcome	Result	p-value
PRIMARY Timeline Follow-Back (Alcohol Use)	4.36; 3.90; 1.82; 3.31	0.4174
PRIMARY Clinician-Administered PTSD Scale for DSM-5 (PTSD Severity)	36.60; 38.20; 15.67; 20.00	0.4787
SECONDARY Brief Inventory of Psychosocial Functioning (Psychosocial Functioning)	70.95; 50.74; 26.19; 29.37	0.4586
SECONDARY Geospatial Activity	426.5; 23.8; 1277.44; 4.29	0.5024
SECONDARY PTSD Checklist for DSM-5 (PCL-5)	42.20; 36.40; 41.50; 33.50; 23.00; 22.33	0.6728
SECONDARY Generalized Anxiety Disorder-7 (GAD-7)	12.60; 9.40; 6.67; 5.33	0.0801
SECONDARY Patient Health Questionnaire-9 (PHQ-9)	13.80; 12.80; 6.67; 6.00	0.2304
SECONDARY Insomnia Severity Index	20.00; 17.80; 13.00; 12.00	0.4711

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. Adapt Behavioral Activation to treat veterans with AUD/PTSD, 2. Evaluate the feasibility, acceptability, and preliminary effects of Behavioral Activation for AUD/PTSD, and 3. Explore geospatial analysis as a new method for measuring AUD/PTSD recovery. Participants will complete self-report and interview measures immediately before and immediately after treatment. Participants will also be asked to participate in passive geospatial assessment for 14-day periods immediately before and immediately after treatment. Participants will be randomized to treatment condition, which involves 8 sessions of either Behavioral Activation or Relapse Prevention, delivered individually by a trained study therapist.

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT06249386). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.