Prolonged Exposure Therapy for PTSD and Substance Use Disorder
(PREVAIL Trial)
Recruiting in Palo Alto (17 mi)
+3 other locations
Overseen byShannon Kehle-Forbes, PhD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Waitlist Available
Sponsor: Veterans Medical Research Foundation
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?The goal of this clinical trial is to learn if receiving Prolonged Exposure Therapy for PTSD in massed format (multiple sessions weekly) is as effective as receiving it with sessions once per week among veterans with PTSD and substance use disorder in intensive outpatient substance use treatment. The main questions it aims to answer are:
* Will the massed format help participants complete and benefit from Prolonged Exposure in terms of PTSD symptoms?
* Will it help participants reduce substance use? Participants who are in intensive substance use treatment will be asked to complete Prolonged Exposure with either weekly sessions or multiple sessions per week.
Eligibility Criteria
This trial is for veterans with PTSD and substance use disorder who are currently in intensive outpatient treatment. Participants will be asked to complete Prolonged Exposure Therapy, which requires attending either weekly sessions or multiple sessions per week.Inclusion Criteria
Report substance use at least 20 of the last 90 days
Meet DSM-5 criteria for PTSD
Are able to give informed consent
+2 more
Exclusion Criteria
I have significant memory or thinking problems.
I do not have thoughts of harming myself or others that need immediate attention.
Current unstable psychotic or manic symptoms not attributable to SUD
Participant Groups
The study is testing the effectiveness of Prolonged Exposure Therapy for PTSD when conducted in a massed format (multiple sessions weekly) compared to the standard once-a-week session schedule among veterans undergoing substance use treatment.
2Treatment groups
Experimental Treatment
Active Control
Group I: Massed PEExperimental Treatment1 Intervention
Prolonged Exposure delivered in a massed format - sessions multiple times per week
Group II: Weekly PEActive Control1 Intervention
Prolonged Exposure delivered with weekly sessions
Prolonged Exposure Therapy is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Prolonged Exposure Therapy for:
- Posttraumatic Stress Disorder (PTSD)
🇪🇺 Approved in European Union as Prolonged Exposure Therapy for:
- Posttraumatic Stress Disorder (PTSD)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Hines VA Healthcare SystemChicago, IL
VA Tampa Healthcare SystemTampa, FL
VA San Diego Healthcare SystemSan Diego, CA
VA Atlanta Healthcare SystemAtlanta, GA
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Who Is Running the Clinical Trial?
Veterans Medical Research FoundationLead Sponsor
University of MinnesotaCollaborator
Center for Veterans Research and EducationCollaborator