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Written Exposure Therapy for Post-Traumatic Stress Disorder
N/A
Recruiting
Led By Jesse McCann, MS
Research Sponsored by Jesse McCann
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
18 years of age or older
Fluent in English (including being able to read and write in English)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change in prior week symptom severity assessed with self-report scale from 3 or 5 weeks prior to beginning treatment, compared to weekly during treatment, and compared weekly to 4 weeks after completing treatment
Awards & highlights
Study Summary
This trial will use Single Case Experimental Design to study the effects of WET in reducing both PTSD symptoms and trauma-related mental contamination among individuals with PTSD resulting from sexual trauma.
Who is the study for?
This trial is for adults who have experienced sexual trauma, can read and write in English, and are currently dealing with PTSD symptoms and mental contamination. They must not be starting new trauma-related treatments or changing their stable psychotropic medication doses during the study.Check my eligibility
What is being tested?
The trial tests Written Exposure Therapy (WET), a brief treatment involving writing about one's traumatic experience over five sessions. The goal is to see if WET reduces PTSD symptoms and feelings of internal 'dirtiness' without physical contact, known as mental contamination.See study design
What are the potential side effects?
While not explicitly listed, potential side effects may include temporary increases in distress due to recalling traumatic events during therapy sessions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I can speak, read, and write in English fluently.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change in prior week symptom severity assessed with self-report checklist from 3 or 5 weeks prior to beginning treatment, compared to weekly during treatment, and compared weekly to 4 weeks after completing treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change in prior week symptom severity assessed with self-report checklist from 3 or 5 weeks prior to beginning treatment, compared to weekly during treatment, and compared weekly to 4 weeks after completing treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
PTSD Checklist for DSM-5 (PCL-5)
Posttraumatic Experience of Mental Contamination Scale (PEMC)
Trial Design
2Treatment groups
Experimental Treatment
Group I: 5-Week BaselineExperimental Treatment1 Intervention
Participants in this arm are randomized to a 5-week baseline period with repeated weekly assessment after the initial intake. Following the 5-week baseline, participants receive 5 weekly sessions of Written Exposure Therapy (WET) followed by a 4-week follow-up phase with repeated weekly assessments, including a post-study evaluation one week after ending WET.
Group II: 3-Week BaselineExperimental Treatment1 Intervention
Participants in this arm are randomized to a 3-week baseline period with repeated weekly assessment after the initial intake. Following the 3-week baseline, participants receive 5 weekly sessions of Written Exposure Therapy (WET) followed by a 4-week follow-up phase with repeated weekly assessments, including a post-study evaluation one week after ending WET.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Written Exposure Therapy
2021
Completed Phase 2
~370
Find a Location
Who is running the clinical trial?
Jesse McCannLead Sponsor
1 Previous Clinical Trials
20 Total Patients Enrolled
Christal L Badour, PhDStudy DirectorUniversity of Kentucky
1 Previous Clinical Trials
12 Total Patients Enrolled
Jesse McCann, MSPrincipal InvestigatorUniversity of Kentucky
1 Previous Clinical Trials
20 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You cannot receive any other treatments for trauma while participating in the study.I have been on a stable dose of my mental health medication for at least 4 weeks.I am 18 years old or older.I can speak, read, and write in English fluently.You are currently experiencing mental contamination due to trauma, and scored 20 or higher on the PEMC assessment.I can speak, read, and write in English fluently.I do not have severe psychological conditions that require different treatments.I have been on a stable dose of my mental health medication for at least 4 weeks.You have experienced sexual trauma in the past and are currently experiencing symptoms of PTSD, which will be determined by answering some questions and scoring a certain number on a test called PCL-5.
Research Study Groups:
This trial has the following groups:- Group 1: 3-Week Baseline
- Group 2: 5-Week Baseline
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.
Are there any opportunities for people to participate in this experiment currently?
"Yes, according to clinicaltrials.gov's records, this medical trial is currently recruiting for 20 participants from a single site. The study was first uploaded on March 31st 2022 and the information has been revised as recently as August 12th 2022."
Answered by AI
What is the highest capacity for participants in this clinical experiment?
"Affirmative. The clinical trial data hosted on clinicaltrials.gov shows that the study is currently recruiting participants, which commenced from March 31st 2022 and was recently revised on August 12th 2022. This medical test requires 20 volunteers to be recruited at a single site."
Answered by AI
Who is eligible to be part of this research endeavor?
"This clinical trial is currently recruiting a cohort of 20 adults aged between 18 and 100 years old suffering from moral injury. All participants must be able to read, write and fluently speak English as well as have an endorsement score of at least 20 on the PEMC scale. Additionally, it is essential that applicants meet the criteria for PTSD diagnosis according to both DIAMOND testing and PCL-5 scoring greater than 33 points; they should also remain on their psychotropic medications throughout the study period without any dose changes. Lastly, all particpants are expected to abstain from further trauma treatment during this research project's duration."
Answered by AI
Is this medical trial open to seniors aged 85 and above?
"This trial is open to participants between the ages of 18 and 100, in accordance with the specified eligibility criteria."
Answered by AI
Who else is applying?
What state do they live in?
Ohio
West Virginia
Kentucky
How old are they?
18 - 65
What site did they apply to?
University of Kentucky Clinic for Emotional Health (CEH)
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How responsive is this trial?
Typically responds via
Email
Average response time
- < 1 Day
Most responsive sites:
- University of Kentucky Clinic for Emotional Health (CEH): < 24 hours
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