Prolonged Exposure Therapy for PTSD and Substance Use Disorder

(PREVAIL Trial)

Recruiting at 3 trial locations

Overseen by Shannon 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.

Research Team

Shannon Kehle-Forbes, PhD

Principal Investigator

University of Minnesota

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

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

Treatment Details

Interventions

• Prolonged Exposure Therapy (Behavioral Intervention)

Trial Overview 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.

Participant Groups

Group I: Massed PE Experimental Treatment 1 Intervention

Prolonged Exposure delivered in a massed format - sessions multiple times per week

Group II: Weekly PE Active Control 1 Intervention

Prolonged Exposure delivered with weekly sessions

Who Is Running the Clinical Trial?

Veterans Medical Research Foundation

Lead Sponsor

Trials

46

Recruited

5,100+

University of Minnesota

Collaborator

Trials

1,459

Recruited

1,623,000+

Center for Veterans Research and Education

Collaborator

Trials

13

Recruited

1,700+