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Behavioral Intervention
Written Exposure Therapy for PTSD
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change in pcl-5 scores will be assessed up to 14 weeks 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
Awards & highlights
Study Summary
This trial will evaluate the feasibility and acceptability of a cognitive-behavioral treatment (WET-I) for people with co-occurring PTSD and opioid use disorder (OUD) receiving medications for OUD (MOUD). It will examine if WET-I can reduce PTSD, anxiety/depression symptoms, and decrease substance use behaviors/cravings.
Who is the study for?
This trial is for adults over 18 who have experienced trauma, are diagnosed with PTSD and opioid use disorder (OUD), can read and write in English, and are currently enrolled in a methadone or buprenorphine program in Kentucky. They must not be undergoing other trauma-focused treatments and should maintain stable doses of any psychotropic or OUD medications.Check my eligibility
What is being tested?
The study tests Written Exposure Therapy-Integrated (WET-I) combined with harm reduction skills among patients receiving medication for OUD. It aims to see if this five-session treatment can reduce PTSD symptoms without increasing substance cravings or use, using weekly sessions over a one-month follow-up period.See study design
What are the potential side effects?
While specific side effects aren't listed for WET-I, participants may experience emotional discomfort recalling traumatic events during therapy sessions. The study will monitor any negative impacts on mental health like increased anxiety, depression, or drug cravings.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change in pcl-5 scores will be assessed up to 14 weeks 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 pcl-5 scores will be assessed up to 14 weeks 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
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 - Integrated (WET-I) followed by a 4-week follow-up phase with repeated weekly assessments.
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 - Integrated (WET-I) followed by a 4-week follow-up phase with repeated weekly assessments.
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Who is running the clinical trial?
Jesse McCannLead Sponsor
1 Previous Clinical Trials
20 Total Patients Enrolled
Christal Badour, PhDStudy DirectorUniversity of Kentucky
1 Previous Clinical Trials
21 Total Patients Enrolled
Jesse McCann, MSPrincipal InvestigatorUniversity of Kentucky
1 Previous Clinical Trials
20 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am enrolled in a methadone or buprenorphine program in Kentucky.I am 18 or older and speak English fluently.I've been on a stable dose of my mental health or opioid use meds for 4 weeks.I agree not to start any new trauma-focused therapy during the study.You have experienced trauma within the last month which meets PTSD criteria, and you meet diagnostic status for OUD either presently or in the past.I have a psychological condition that might need different treatment.
Research Study Groups:
This trial has the following groups:- Group 1: 5-Week Baseline
- Group 2: 3-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.
Does this research accept elderly participants?
"The age range for eligibility in this trial is between 18 and 100."
Answered by AI
What are the eligibility requirements for joining this clinical experiment?
"Participants interested in joining this trial must have a diagnosis of post-traumatic stress disorder and lie between 18 to 100 years old. Currently, 20 participants are being accepted for the study."
Answered by AI
Are there still openings for individuals who wish to partake in this investigation?
"The trial's information page on clinicaltrials.gov indicates that this study is not presently enrolling patients. Although the project was initially published on April 1st 2023, it has since been updated for the last time on April 4th of 2023 and does not appear to be actively seeking participants at present. Fortunately, there are still 1426 other trials in search of volunteers right now."
Answered by AI
Who else is applying?
What site did they apply to?
University of Kentucky Clinic for Emotional Health (CEH)
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
Why did patients apply to this trial?
I was diagnosed with C-PTSD in 2016 and would like to help research move forward for this condition.
PatientReceived 2+ prior treatments
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