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

Alcohol Use Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06249386
• Other study ID #: 0219135
• Secondary ID: R34AA030820Pro00
• Status: Recruiting
• Phase: N/A
• Start date: May 30, 2024
• Est. completion date: November 2025

Study information

• Verified date: May 2024
• Source: RTI International
• Contact: Shannon M Blakey, PhD
• Phone: 919-485-5427
• Email: sblakey[@]rti.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. completion date: November 2025
• Est. primary completion date: November 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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 history of seizures,

3. Lifetime alcohol withdrawal-related delirium or hallucinations,

4. Prior inpatient alcohol withdrawal management,

5. A score of 10+ on the Clinical Institute Withdrawal Assessment of Alcohol Scale, Revised (CIWA-Ar),

6. 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,

7. Psychotropic (including alcohol abstinence) medication changes within 90 days of study enrollment or plans to change medications during the study,

8. Current/planned non-study BA for any disorder during the study, or

9. Current/planned evidence-based psychotherapy for AUD, PTSD, or DUD during the study.

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder
• Alcoholism
• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Duke University School of Medicine	Durham	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
RTI International	Duke University, National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Timeline Follow-Back (alcohol use)	Changes in past-30-day alcohol consumption from baseline to immediately post-treatment	Through study completion, an average of 3 months
Primary	Clinician-Administered PTSD Scale for DSM-5 (PTSD severity)	Changes in past-month PTSD severity from baseline to immediately post-treatment	Through study completion, an average of 3 months
Secondary	Brief Inventory of Psychosocial Functioning (psychosocial functioning)	Changes in past-30-day psychosocial functioning from baseline to immediately post-treatment	Through study completion, an average of 3 months
Secondary	Geospatial activity	Changes in past-14-day geospatial activity metrics (e.g., activity space) from baseline to immediately post-treatment	Through study completion, an average of 3 months
Secondary	PTSD Checklist for DSM-5 (PCL-5)	Changes in past-month PTSD severity from baseline to immediately post-treatment	Through study completion, an average of 3 months
Secondary	Generalized Anxiety Disorder-7 (GAD-7)	Changes in past-2-week anxiety severity from baseline to immediately post-treatment	Through study completion, an average of 3 months
Secondary	Patient Health Questionnaire-9 (PHQ-9)	Changes in past-2-week depressive symptom severity from baseline to immediately posttreatment	Through study completion, an average of 3 months
Secondary	Insomnia Severity Index	Changes in past-2-week sleep disturbance from baseline to immediately post-treatment	Through study completion, an average of 3 months