Behavioral Activation for Veterans with Alcohol and PTSD Issues

Adapting and Piloting Behavioral Activation for Veterans With Co-Occurring AUD and Posttraumatic Stress Disorder

This study is testing a new approach called Behavioral Activation to see if it helps veterans with alcohol problems and PTSD feel better compared to a standard treatment called Relapse Prevention.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 46 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: RTI International (other)
• Locations: 1 site (Durham, North Carolina)
• Trial ID: NCT06249386 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to compare an adapted version of Behavioral Activation (BA) with Relapse Prevention (RP) treatment for U.S. military veterans suffering from co-occurring alcohol use disorder (AUD) and posttraumatic stress disorder (PTSD). The study will evaluate the feasibility, acceptability, and preliminary effects of BA, which focuses on increasing participation in rewarding activities to improve functioning. Participants will undergo assessments before and after treatment, including passive geospatial analysis to measure recovery. The trial involves 8 sessions of either BA or RP, with a focus on addressing avoidance behaviors that maintain AUD/PTSD.

Who should consider this trial

Good fit: Ideal candidates for this study are U.S. veterans aged 18 to 65 who meet the criteria for both alcohol use disorder and posttraumatic stress disorder.

Not a fit: Patients with severe drug use disorders or those experiencing current psychosis or mania may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide veterans with more effective treatment options for managing both alcohol use disorder and posttraumatic stress disorder.

How similar studies have performed: Previous studies have shown that Behavioral Activation is effective for treating alcohol and drug use disorders, but its application for co-occurring AUD and PTSD is novel.

Eligibility criteria

Inclusion Criteria:

1. Be a U.S. veteran,
2. Be 18 to 65 years old,
3. Meet Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for current AUD,
4. Report 3+ heavy drinking days (5+ drinks for men/4+ drinks for women) and 1+ heavy drinking week (15+ drinks men/8+ drinks women) in the past 30 days,
5. Meet DSM-5 criteria for current PTSD,
6. Endorse at least moderate difficulties with psychosocial functioning, defined as a score of 31+ on the Brief Inventory of Psychosocial Functioning (BIPF),
7. Be fluent and literate in English, and
8. Be able to provide voluntary, informed consent to participate.

Exclusion Criteria:

1. Lifetime mania/hypomania or current psychosis,
2. Lifetime alcohol withdrawal-related seizures, delirium, or hallucinations,
3. Prior inpatient alcohol withdrawal management,
4. Current DSM-5 severe drug use disorder (DUD) except for severe tobacco use disorder (which is not exclusionary) or past-30-day heroin or non-prescription opioid use,
5. Psychotropic (including alcohol abstinence) medication changes within 90 days of study enrollment or plans to change medications during the study,
6. Current/planned non-study BA for any disorder during the study, or
7. Current/planned evidence-based psychotherapy for AUD, PTSD, or DUD during the study.

Where this trial is running

Durham, North Carolina

• Duke University School of Medicine — Durham, North Carolina, United States (RECRUITING)

Study contacts

• Principal investigator: Shannon M Blakey, PhD — RTI International
• Study coordinator: Shannon M Blakey, PhD

Conditions: Alcohol Use Disorder, Posttraumatic Stress Disorder