Clinical Trial

Adaptation and Randomized Controlled Trial of Written Exposure Therapy for Adolescents

Active, Not Recruiting
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Summary
Written Exposure Therapy (WET) is a five-session mental health therapy for posttraumatic stress disorder (PTSD). Research shows that it works as well as longer treatments for PTSD among people over 18, even though it requires fewer sessions than other PTSD therapies. However, WET has not been adapted and formally tested in individual therapy with people aged 12 to 18. The present study aims to see how WET can be adapted to meet the needs of people aged 12 to 18 who have experienced trauma and currently have PTSD symptoms. To adapt WET for this age group, interviews will be conducted with PTSD experts and people aged 12 to 18 to learn what changes would help to make WET more suitable for young people. Next, WET will be delivered to five people aged 12 to 18 (using the WET manual as it is written for people over the age of 18) to obtain feedback about what changes should be made to better meet the needs of this age group. In the next part of the study, 48 adolescents aged 12 to 18 who have symptoms of PTSD will be recruited from an integrated pediatric primary clinic (PPC). Youth and caregivers who agree to participate will be randomized (like the flip of a coin) to either receive the adapted version of WET or to receive our current, gold-standard PTSD treatment: Trauma-Focused Cognitive Behavior Therapy (TF-CBT). Participants assigned to receive adapted WET will take part in five to seven weekly therapy sessions. Participants assigned to receive TF-CBT will take part in 12 to 16 weekly therapy sessions. Participants assigned to both groups will complete five study visits: one before therapy and four follow up assessments at 6-weeks, 10-weeks, 20-weeks, and 30-weeks after starting therapy. The purpose of the study visits occurring over a 30-week time period is to better understand how mental health symptoms and diagnoses may change over time following therapy engagement. All therapy and study visits can be completed remotely or in person, per the participant's preference. Individuals who are 18 can participate without caregiver permission; individuals aged 12 to 17 can only participate with caregiver permission. Ultimately, it is hoped that the results of the study will help inform efforts to increase access to treatment for posttraumatic stress disorder among young people.
Protocol Amendment History 2 changes
critical Trial status changed: Not Yet Recruiting → Active, Not Recruiting 2026-05-09
critical Primary endpoint(s) modified 2026-04-02
Trial Details
NCT Number NCT07498257
Lead Sponsor Medical University of South Carolina
Collaborators: National Institute of Mental Health (NIMH)
Conditions Posttraumatic Stress Disorder (PTSD)
Enrollment 48 participants
Start Date 2026-05-06
Primary Completion 2031-02-28 (estimated)
Study Completion 2031-02-28 (estimated)
Updated on ClinicalTrials.gov 2026-05-08