Written Exposure Therapy for Posttraumatic Stress Disorder (WET)

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

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.

Study Overview

• Status: Completed
• Conditions: Posttraumatic Stress Disorder
• Intervention / Treatment: Behavioral: Written Exposure Therapy; Behavioral: Cognitive Processing Therapy

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 Type: Interventional
• Enrollment (Actual): 192
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02130
      • National Center for PTSD at VA Boston Healthcare System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Boston University
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Denise M. Sloan, Ph.D., Boston University

Publications and helpful links

General Publications

• Sloan DM, Marx BP, Lee DJ, Resick PA. A Brief Exposure-Based Treatment vs Cognitive Processing Therapy for Posttraumatic Stress Disorder: A Randomized Noninferiority Clinical Trial. JAMA Psychiatry. 2018 Mar 1;75(3):233-239. doi: 10.1001/jamapsychiatry.2017.4249.

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2013
• Primary Completion (Actual): January 10, 2018
• Study Completion (Actual): April 30, 2018

Study Registration Dates

• First Submitted: February 15, 2013
• First Submitted That Met QC Criteria: February 26, 2013
• First Posted (Estimate): February 28, 2013

Study Record Updates

• Last Update Posted (Actual): January 15, 2019
• Last Update Submitted That Met QC Criteria: January 14, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: PTSD; trauma; clinical trial; exposure treatment
• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: H-31806; 1R01MH095737-01A1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No