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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

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.
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.
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 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
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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
2 Previous Clinical Trials
121 Total Patients Enrolled
Jesse McCann, MSPrincipal InvestigatorUniversity of Kentucky
1 Previous Clinical Trials
20 Total Patients Enrolled

Media Library

Written Exposure Therapy - Integrated (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05817344 — N/A
Post-Traumatic Stress Disorder Research Study Groups: 5-Week Baseline, 3-Week Baseline
Post-Traumatic Stress Disorder Clinical Trial 2023: Written Exposure Therapy - Integrated Highlights & Side Effects. Trial Name: NCT05817344 — N/A
Written Exposure Therapy - Integrated (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05817344 — N/A
~11 spots leftby Jun 2025
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