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

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

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.

Study Overview

• Status: Completed
• Conditions: Posttraumatic Stress Disorder; Alcohol Use Disorder
• Intervention / Treatment: Behavioral: Behavioral Activation (BA); Behavioral: Relapse Prevention (RP)

Detailed Description

Alcohol use disorder (AUD) frequently co-occurs with posttraumatic stress disorder (PTSD) among U.S. military veterans. Compared to veterans with AUD only, veterans with AUD/PTSD have greater symptom severity, more psychosocial functioning difficulties, and higher risk of suicide. Many people with AUD/PTSD perform behaviors aimed at avoiding unpleasant emotions (e.g., drinking to avoid trauma-related nightmares, skipping social events to avoid anxiety-provoking crowds). These "avoidance behaviors" provide temporary relief from unpleasant emotions, but they maintain AUD/PTSD and interfere with long-term functioning. Although treatments for AUD/PTSD exist, they emphasize symptom reduction (not functional improvement) and have dropout rates as high as 50%. Originally developed to treat depression, Behavioral Activation (BA) is an intervention that increases daily participation in rewarding, alcohol-free activities relevant to patients' social, vocational, and health-related values. Randomized controlled trials (RCTs) adapting BA for other disorders have shown that BA is efficacious for adults with alcohol/drug use disorders and acceptable to veterans with PTSD, but BA has not been used to treat co-occurring AUD/PTSD. Additionally, because RCTs of AUD/PTSD treatments typically emphasize significant mean group differences in AUD/PTSD outcomes, less is known about the degree to which these treatments yield clinically significant improvements at the individual level. Individual-level improvements in AUD/PTSD should be evident not only in subjective clinical assessments, but also in objective measures of geospatial activity. Specifically, patients' daily geospatial activity is likely to change as they decrease their avoidance behaviors and increase their engagement in various social, vocational, and health-promoting activities. Advances in geospatial methods, coupled with discreet and portable global positioning system (GPS) trackers, have made it possible to objectively measure people's spatial movement within their communities. Yet although geospatial methods have been used to identify social determinants of alcohol use, they have not been used to measure response to AUD or AUD/PTSD treatment. As the long-term objectives of this work are to identify a more acceptable AUD/PTSD treatment option and improve the measurement of AUD/PTSD recovery, this R34 project will address the following specific aims: (1) adapt BA for use with veterans with AUD/PTSD; (2) evaluate the feasibility, acceptability, and preliminary effects of BA, relative to Relapse Prevention, for veterans with AUD/PTSD in a pilot RCT; and (3) explore geospatial analysis of GPS-collected data as a new approach to measuring AUD/PTSD treatment response. This study will advance research and practice by piloting a novel application of BA and a novel measure of AUD/PTSD recovery. This project aligns with the National Institute on Alcohol Abuse and Alcoholism's special interest in investigating treatments for patients with AUD and co-occurring disorders, dimensions of functioning and well-being associated with recovery, and innovative methods for evaluating AUD treatment and recovery.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Be a U.S. veteran,
2. Be at least 18 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) or 1+ heavy drinking week (15+ drinks men/8+ drinks women) in the past 30 days,
5. 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),
6. Be fluent and literate in English, and
7. Be able to provide voluntary, informed consent to participate.

Exclusion Criteria:

1. Current 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,
5. Psychotropic (including alcohol abstinence) medication changes within 30 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Behavioral Activation (BA); Individual psychotherapy	Behavioral: Behavioral Activation (BA); BA reduces alcohol use and posttraumatic stress symptoms and increases psychosocial functioning via psychoeducation, activity monitoring, values clarification, and activity scheduling.
Active Comparator: Relapse Prevention (RP); Individual psychotherapy	Behavioral: Relapse Prevention (RP); RP reduces alcohol use via increasing awareness and avoidance of high-risk situations, enhancing drink refusal skills, improving assertiveness, and other strategies.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brief Inventory of Psychosocial Functioning (Psychosocial Functioning)	Changes in past-30-day psychosocial functioning from baseline to immediately post-treatment. The percentage measurement scale has a minimum value of 0 and a maximum value of 100, where higher values reflect greater functioning difficulties (worse functioning).	Through study completion, an average of 3 months
PTSD Checklist for DSM-5 (PCL-5)	Changes in past-month PTSD severity from baseline through mid-treatment (an average of 1.5 months) to immediately post-treatment (an average of 3 months). Total scores on this measure range 0 to 80, with higher scores reflecting more severe PTSD symptoms.	Through study completion, an average of 1.5 months (mid-treatment) and 3 months (post-treatment)
Generalized Anxiety Disorder-7 (GAD-7)	Changes in past-2-week anxiety severity from baseline to immediately post-treatment. Total scores on this measure range 0 to 21, with higher scores reflecting more severe anxiety symptoms.	Through study completion, an average of 3 months
Patient Health Questionnaire-9 (PHQ-9)	Changes in past-2-week depressive symptom severity from baseline to immediately posttreatment. Total scores on this measure range 0 to 27, with higher scores reflecting more severe depressive symptoms.	Through study completion, an average of 3 months
Insomnia Severity Index	Changes in past-2-week sleep disturbance from baseline to immediately post-treatment. Total scores on this measure range 0 to 28, with higher scores reflecting more severe insomnia symptoms.	Through study completion, an average of 3 months
Geospatial Activity	Changes in past-14-day geospatial activity metrics (e.g., activity space) from baseline to immediately post-treatment. This outcome is measured in square kilometers (km2). The 14-day period began on the date of the baseline or post-treatment assessment at which all other outcome data were collected. Reported values represent the average activity space per day.	Through study completion, an average of 3 months

Collaborators and Investigators

• Sponsor: RTI International
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA); Duke University
• Investigators: Principal Investigator: Eric B Elbogen, PhD, Duke University; Principal Investigator: Shannon M Blakey, PhD, RTI International

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2025
• Primary Completion (Actual): October 6, 2025
• Study Completion (Actual): October 6, 2025

Study Registration Dates

• First Submitted: January 30, 2024
• First Submitted That Met QC Criteria: February 7, 2024
• First Posted (Actual): February 8, 2024

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Stress Disorders, Traumatic; Alcoholism; Stress Disorders, Post-Traumatic; Therapeutics; Public Health; Environment and Public Health; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Public Health Practice; Secondary Prevention
• Other Study ID Numbers: 0219135; R34AA030820 (U.S. NIH Grant/Contract); Pro00113641 (Other Identifier: Duke University School of Medicine); STUDY00022679 (Other Identifier: RTI International)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data from consenting participants will be submitted to the National Institute on Alcohol Abuse and Alcoholism Data Archive.
• IPD Sharing 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).
• IPD Sharing 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No