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Behavioral Intervention

Behavioral Activation vs Relapse Prevention for Veterans with Alcoholism and PTSD

N/A
Recruiting
Led By Eric B Elbogen, PhD
Research Sponsored by RTI International
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be 18 to 65 years old
Be older than 18 years old
Must not have
Lifetime mania/hypomania or current psychosis
Lifetime history of seizures
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 3 months
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to compare two types of behavioral interventions, Behavioral Activation and Relapse Prevention, in U.S. military veterans with both alcohol use disorder (AUD) and posttraumatic stress disorder (PT

Who is the study for?
This trial is for U.S. military veterans who are dealing with both alcohol use disorder (AUD) and posttraumatic stress disorder (PTSD). Participants should be willing to undergo interviews, self-report measures, and geospatial assessments before and after the treatment.
What is being tested?
The study compares two treatments: Behavioral Activation (BA), adapted specifically for veterans with AUD/PTSD, against Relapse Prevention (RP). Each participant receives 8 sessions of one treatment type, decided randomly.
What are the potential side effects?
Since BA and RP are behavioral interventions rather than medications, they may not have typical 'side effects' but could include emotional discomfort or distress during therapy sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have never had mania or hypomania, and I am not currently experiencing psychosis.
Select...
I have had seizures at some point in my life.
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I am not using any non-study brain treatments during the trial.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Clinician-Administered PTSD Scale for DSM-5 (PTSD severity)
Timeline Follow-Back (alcohol use)
Secondary study objectives
Brief Inventory of Psychosocial Functioning (psychosocial functioning)
Generalized Anxiety Disorder-7 (GAD-7)
Geospatial activity
+3 more

Side effects data

From 2016 Phase 3 trial • 221 Patients • NCT01299766
4%
Stroke
4%
Blood clot
4%
Death NOS
3%
UTI
2%
Dehydration
2%
Knee replacement
2%
internal bleeding
2%
Prostate cancer
1%
Depression
1%
GI bleed
1%
Chrohn's Disease
1%
Neck pain
1%
Valve replacement
1%
Acid reflux
1%
pneumonia
1%
bronchitis
1%
Chest pain
1%
Heart attack
1%
Death
1%
Pacemaker implanted
1%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Supportive Therapy (ST)
Behavior Activation

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Behavioral Activation (BA)Experimental Treatment1 Intervention
Individual psychotherapy
Group II: Relapse Prevention (RP)Active Control1 Intervention
Individual psychotherapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Behavioral Activation (BA)
2014
Completed Phase 3
~350

Find a Location

Who is running the clinical trial?

National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
835 Previous Clinical Trials
1,082,724 Total Patients Enrolled
456 Trials studying Alcoholism
823,740 Patients Enrolled for Alcoholism
Duke UniversityOTHER
2,455 Previous Clinical Trials
2,971,506 Total Patients Enrolled
5 Trials studying Alcoholism
2,707 Patients Enrolled for Alcoholism
RTI InternationalLead Sponsor
196 Previous Clinical Trials
844,500 Total Patients Enrolled
7 Trials studying Alcoholism
1,929 Patients Enrolled for Alcoholism
~31 spots leftby Nov 2025
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