Clinical trial NCT06249386: Adapting and Piloting Behavioral Activation for Veterans With Alcohol Use Disorder and Posttraumatic Stress Disorder
Official title: Adapting and Piloting Behavioral Activation for Veterans With Co-Occurring AUD and Posttraumatic Stress Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alcohol Use Disorder
Posttraumatic Stress Disorder
Lead sponsor: RTI International
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
name: Duke University
First posted: 2024-02-08
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be block randomized to either Behavioral Activation treatment (n=23) or Relapse Prevention treatment (n=23).
Primary purpose: TREATMENT

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. 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Timeline Follow-Back (alcohol use)
timeFrame: Through study completion, an average of 3 months
measure: Clinician-Administered PTSD Scale for DSM-5 (PTSD severity)
timeFrame: Through study completion, an average of 3 months
Secondary outcomes:
measure: Brief Inventory of Psychosocial Functioning (psychosocial functioning)
timeFrame: Through study completion, an average of 3 months
measure: Geospatial activity
timeFrame: Through study completion, an average of 3 months
measure: PTSD Checklist for DSM-5 (PCL-5)
timeFrame: Through study completion, an average of 3 months
measure: Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: Through study completion, an average of 3 months
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Through study completion, an average of 3 months
measure: Insomnia Severity Index
timeFrame: Through study completion, an average of 3 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University School of Medicine
state: North Carolina
Study officials:
affiliation: RTI International
name: Shannon M Blakey, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Eric B Elbogen, PhD
role: PRINCIPAL_INVESTIGATOR
References: