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Behavioral Intervention
Prolonged Exposure Therapy + Emotion Regulation Training for PTSD (PE+ER Trial)
N/A
Waitlist Available
Led By Amanda Gilmore, PhD
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
Diagnosis of PTSD related to MST assigned on the basis of the Clinician Administered PTSD Scale (CAPS; Weathers et al., 2013)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 13 weeks
Awards & highlights
PE+ER Trial Summary
This trial is testing whether adding emotion regulation skills training to a scientifically validated PTSD treatment will help people with MST-related PTSD stick with the treatment and improve outcomes.
Who is the study for?
This trial is for Veterans who have PTSD due to military sexual trauma (MST) and struggle with managing their emotions. They must be diagnosed using specific scales for PTSD and emotion regulation issues. However, those with active psychosis, dementia, severe substance use disorder, suicidal intent or participating in other PTSD/depression trials cannot join.Check my eligibility
What is being tested?
The study tests a combined treatment called PE+ER which integrates Prolonged Exposure therapy for PTSD with emotion regulation skills training. The goal is to see if this approach helps veterans stay in treatment longer and improves their PTSD symptoms related to MST as well as their ability to regulate emotions.See study design
What are the potential side effects?
While the trial description does not specify side effects, treatments like Prolonged Exposure can sometimes cause temporary increases in distress due to recalling traumatic events or practicing new coping strategies.
PE+ER Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have PTSD from military sexual trauma, confirmed by a CAPS test.
PE+ER Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 13 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~13 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
PTSD Checklist, 5th Version (PCL-5)
PE+ER Trial Design
1Treatment groups
Experimental Treatment
Group I: Prolonged Exposure + Emotion Regulation Skills TrainingExperimental Treatment1 Intervention
Twelve, 90-minute sessions of Prolonged Exposure (PE) with Dialectical Behavior Therapy (DBT) Emotion Regulation Skills Training.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PE+ER
2021
N/A
~30
Find a Location
Who is running the clinical trial?
Medical University of South CarolinaLead Sponsor
933 Previous Clinical Trials
7,394,588 Total Patients Enrolled
14 Trials studying Anxiety Disorders
1,036 Patients Enrolled for Anxiety Disorders
Georgia State UniversityOTHER
57 Previous Clinical Trials
25,402 Total Patients Enrolled
2 Trials studying Anxiety Disorders
97 Patients Enrolled for Anxiety Disorders
Amanda Gilmore, PhDPrincipal InvestigatorGeorgia State University
1 Previous Clinical Trials
3,300 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have PTSD from military sexual trauma, confirmed by a CAPS test.You have trouble controlling your emotions as determined by a specific test called the Difficulties with Emotion Regulation Scale (DERS). If your score on this test is high, it could mean that you have greater difficulty managing your emotions than most women.You have a mental condition like dementia or active psychosis during the screening process.You have expressed a desire to harm yourself and have a detailed plan to do so.I am currently participating in a clinical trial for PTSD or depression.You have experienced a significant medical event related to MST (Mesenchymal Chondrosarcoma with Elevated LDH) condition.You are currently struggling with moderate to severe addiction to drugs or alcohol.
Research Study Groups:
This trial has the following groups:- Group 1: Prolonged Exposure + Emotion Regulation Skills Training
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there still availability for participants in this research study?
"Affirmative. Clinicaltrials.gov has noted that this medical research, which was initially posted on August 16th 2021 is currently looking for participants. Specifically 15 patients from one clinical trial centre are needed to take part in the study."
Answered by AI
What is the current enrolment rate for this clinical investigation?
"Affirmative. Per the documents on clinicaltrials.gov, this research is currently recruiting with a post date of August 16th 2021 and an update published on August 26th 2022. The study requires 15 individuals to enrol at one location."
Answered by AI
Who else is applying?
What state do they live in?
Pennsylvania
Kansas
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
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