Written Exposure Therapy for Posttraumatic Stress Disorder

Study Overview
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Brief Summary
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Although evidence-based treatments for PTSD exist, a significant minority of individuals do not benefit from these treatments and many individuals to not seek treatment, citing barriers such as time commitment and expense of treatment. The goal of the proposed study is to establish an alternative PTSD treatment that is efficacious and efficient.

Detailed Description
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Prior research has demonstrated that written exposure therapy (WET), is an efficient, well-tolerated, and efficacious treatment for PTSD. The proposed project takes the next step in establishing WET as an intervention for PTSD by examining whether WET is equally efficacious to an evidence-based treatment for PTSD. Using a randomized noninferiority controlled trial, 126 adults diagnosed with PTSD will be assigned to either WET or Cognitive Processing Therapy (CPT). Outcome data will be collected at baseline and 6-, 12-, 24-, 36- and 60-weeks post-first treatment session. The primary aim is to examine whether PTSD participants assigned to WET demonstrate PTSD symptom severity outcome that is noninferior to PTSD participants assigned to CPT. Secondary aims include examining whether expected treatment gains are sustained for both treatments and whether WET has a lower treatment dropout rate relative to CPT. Exploratory aims include examining moderators and mediators of WET and CPT. If the hypothesis that WET is noninferior to CPT is confirmed then a brief treatment option for PTSD will be established.

Official Title
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Written Exposure Therapy for Post Traumatic Stress Disorder: A Randomized Noninferiority Trial

Conditions
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Posttraumatic Stress Disorder

Intervention / Treatment
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* Behavioral: Written Exposure Therapy
* Behavioral: Cognitive Processing Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: PTSD diagnosis if taking psychotropic medication, on stable dose for 2 months Ability to read and write in English Exclusion Criteria: not currently engaged in active PTSD treatment no current diagnosis of substance dependence no current diagnosis of psychosis

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Written Exposure Therapy<br>Written exposure treatment is a 5 session treatment in which participants write about their trauma event in a specified manner. | Behavioral: Written Exposure Therapy<br>* Written exposure therapy is a 5 session, weekly treatment in which individuals write about their trauma event in a specified manner.<br>|
| Active Comparator: Cognitive Processing Therapy<br>cognitive processing therapy will be included as the evidence-based treatment for PTSD in this study. | Behavioral: Cognitive Processing Therapy<br>* Cognitive Processing Therapy (CPT) is an evidence-based treatment for PTSD. CPT consists of 12, weekly sessions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinician Administered PTSD Scale (CAPS) | Total score on the CAPS will be used to assess change in PTSD symptom severity from baseline (pre-treatment) until 36- weeks post first treatment session. | change from baseline PTSD symptom severity at 36 weeks post first treatment session | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| treatment dropout | Treatment condition differences in treatment drop out rate at post-treatment (treatment duration is 5 weeks for WET condition and 12 weeks for CPT condition). | course of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exposure treatment, clinical trial, trauma, PTSD