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Behavioral Intervention
Prolonged Exposure Therapy for PTSD and Substance Use Disorder (PREVAIL Trial)
N/A
Waitlist Available
Led By Shannon Kehle-Forbes, PhD
Research Sponsored by Veterans Medical Research Foundation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 4-, 16-, 28-, and 40-weeks post-first therapy session
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to see if having multiple sessions of Prolonged Exposure Therapy for PTSD in a week is as effective as having one session per week for veterans with PTSD and substance use disorder in intensive
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Prolonged Exposure Therapy may cause temporary increases in distress due to recalling traumatic events, but it's designed to help reduce PTSD symptoms over time. It does not involve medication, so drug-related side effects are not expected.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 4-, 16-, 28-, and 40-weeks post-first therapy session
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 4-, 16-, 28-, and 40-weeks post-first therapy session
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 (CAPS-5)
Psychotherapy Completion Rates
Time Line Follow back (TLFB)
Secondary study objectives
Brief Psychosocial Functioning Inventory (B-IPF)
Client Satisfaction Questionnaire-8 (CSQ-8)
Patient Health Questionnaire-9 (PHQ-9)
Side effects data
From 2017 Phase 4 trial • 223 Patients • NCT0152413349%
Gastrointestinal
35%
Psychological
32%
Neurological
25%
Genitourinary
14%
Respiratory
13%
Muskuloskeletal
4%
Increased Suicidal Ideation
3%
Cardiovascular
1%
dyspepsia
1%
Endocrine
1%
Dermatological
1%
Increased Irritability
100%
80%
60%
40%
20%
0%
Study treatment Arm
Prolonged Exposure + Sertraline (PE/SERT)
Sertraline + Enhanced Medication Management (SERT/EMM)
Prolonged Exposure + Placebo (PE/PLB)
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: 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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Prolonged Exposure Therapy
2008
Completed Phase 4
~1290
Find a Location
Who is running the clinical trial?
Veterans Medical Research FoundationLead Sponsor
44 Previous Clinical Trials
4,817 Total Patients Enrolled
University of MinnesotaOTHER
1,439 Previous Clinical Trials
1,621,758 Total Patients Enrolled
Center for Veterans Research and EducationOTHER
12 Previous Clinical Trials
1,456 Total Patients Enrolled
Shannon Kehle-Forbes, PhDPrincipal InvestigatorUniversity of Minnesota
2 Previous Clinical Trials
584 Total Patients Enrolled