Written Exposure Therapy for Posttraumatic Stress Disorder

Not Applicable

Completed

• Conditions: Posttraumatic Stress Disorder
• Interventions: Behavioral: Written Exposure Therapy; Behavioral: Cognitive Processing Therapy

• Registration Number: NCT01800773
• Lead Sponsor: Boston University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2013-02-15
• Study First Submitted QC: 2013-02-26
• Study First Posted: 2013-02-28
• Study Start: 2013-03-09
• Primary Completion: 2018-01-10
• Study Completion: 2018-04-30
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-14
• Last Update Posted: 2019-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 192

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Written Exposure Therapy	Written Exposure Therapy	Written exposure treatment is a 5 session treatment in which participants write about their trauma event in a specified manner.
Cognitive Processing Therapy	Cognitive Processing Therapy	cognitive processing therapy will be included as the evidence-based treatment for PTSD in this study.

Primary Outcome Measures

Name	Time	Method
Clinician Administered PTSD Scale (CAPS)	change from baseline PTSD symptom severity at 36 weeks post first treatment session	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.

Secondary Outcome Measures

Name	Time	Method
treatment dropout	course of treatment	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).

Trial Locations

Locations (1)

National Center for PTSD at VA Boston Healthcare System; 🇺🇸 Boston, Massachusetts, United States