Behavioral Intervention
Prolonged Exposure for Post-Traumatic Stress Disorder
Ralph H. Johnson VA Medical Center, Charleston, SC
Targeting 4 different conditionsProlonged ExposureN/AWaitlist AvailableLed by Wendy Muzzy, MRA, MLISResearch Sponsored by Medical University of South CarolinaEligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Successful competition of exposure therapy treatment in the past and willingness to act as peer in the program.
PCL-5 score of 32 or lower.
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up36 weeks
Awards & highlights
No Placebo-Only Group
Study 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
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You have completed exposure therapy before and are willing to share your experience with others in the program.
Select...
Your score on a PTSD symptoms test called PCL-5 is 32 or less.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 36 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 weeks
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 moreSide effects data
From 2015 Phase 2 trial • 142 Patients • NCT0093723589%
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
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: 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 site
Who is running the clinical trial?
Charleston Research InstituteOTHER
3 Previous Clinical Trials
473 Total Patients Enrolled
Medical University of South CarolinaLead Sponsor
900 Previous Clinical Trials
5,364,842 Total Patients Enrolled
Wendy Muzzy, MRA, MLISPrincipal Investigator
Medical University of South Carolina1 Previous Clinical Trials
15 Total Patients Enrolled
Wendy Muzzy, MRA,MLISPrincipal Investigator
Medical University of South CarolinaRon Acierno, PhDPrincipal Investigator
Ralph H. Johnson VA Medical CenterFrequently 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."
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