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Behavioral Intervention

Prolonged Exposure for Post-Traumatic Stress Disorder (PEP Trial)

N/A
Waitlist Available
Led By Wendy Muzzy, MRA, MLIS
Research Sponsored by Medical University of South Carolina
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 36 weeks
Awards & highlights

PEP Trial Summary

This trial will test whether or not having a peer support 'workout buddy' for in vivo exposure therapy helps veterans with PTSD who have prematurely dropped out of treatment to return and complete their therapy.

Eligible Conditions
  • Post-Traumatic Stress Disorder
  • Anxiety Disorders
  • Psychiatric Disorder

PEP Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Post-Traumatic Stress Disorder
Secondary outcome measures
Barriers to Therapeutic Exposure Scale (BTES)
Combat Exposure Scale (CES)
Deployment Risk and Resilience Inventory-2 (DRRI-2)
+7 more

Side effects data

From 2015 Phase 2 trial • 142 Patients • NCT00937235
89%
Miscellaneous
4%
Suicidal Ideation
3%
Respiratory issue
1%
Broken ankle + hospitalization
1%
Hospitalization secondary to drug or alcohol relapse
100%
80%
60%
40%
20%
0%
Study treatment Arm
Integrated Treatment
Varenicline

PEP Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: PE+Exposure Workout BuddyExperimental Treatment1 Intervention
Prolonged Exposure with assistance of Veteran who has successfully completed treatment to meet patients at exposure sites in the community to offer support during exposure.
Group II: PE+Peer General SupportActive Control1 Intervention
Prolonged Exposure with assistance of Veteran who has successfully completed treatment to call and talk to patients once per week, informally meet at patient appointments, encourage session attendance and check in about progress.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Prolonged Exposure
2010
Completed Phase 3
~1440

Find a Location

Who is running the clinical trial?

Charleston Research InstituteOTHER
3 Previous Clinical Trials
473 Total Patients Enrolled
Medical University of South CarolinaLead Sponsor
932 Previous Clinical Trials
7,394,120 Total Patients Enrolled
Wendy Muzzy, MRA, MLISPrincipal InvestigatorMedical University of South Carolina
1 Previous Clinical Trials
27 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any opportunities for volunteers to join this research project?

"The clinical trial that was originally posted on May 1, 2018 and edited last month is no longer recruiting participants. Nevertheless, there are currently 1732 other active trials in need of patients."

Answered by AI
~20 spots leftby Apr 2025