COMPLETED

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

Conditions

Alcohol Use Disorder Posttraumatic Stress Disorder

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-01-17

Study Completion:2025-10-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06249386

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Principal Investigator

Shannon M Blakey, PhD

PRINCIPAL_INVESTIGATOR

RTI International

Eric B Elbogen, PhD

PRINCIPAL_INVESTIGATOR

Duke University

Study Locations (Sites)

Duke University School of Medicine

Durham, North Carolina, 27710

United States

Collaborators and Investigators

Sponsor: RTI International

Shannon M Blakey, PhD, PRINCIPAL_INVESTIGATOR, RTI International
Eric B Elbogen, PhD, PRINCIPAL_INVESTIGATOR, Duke University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-17

Study Completion Date2025-10-06

Study Record Updates

Study Start Date2025-01-17

Study Completion Date2025-10-06

Terms related to this study

Additional Relevant MeSH Terms

Alcohol Use Disorder
Posttraumatic Stress Disorder