Written Exposure Therapy for Posttraumatic Stress Disorder

Posttraumatic Stress Disorder Clinical Trial

— WET  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01800773
• Other study ID #: H-31806
• Secondary ID: 1R01MH095737-01A
• Status: Completed
• Phase: N/A
• Start date: March 9, 2013
• Est. completion date: April 30, 2018

Study information

• Verified date: January 2019
• Source: Boston University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: April 30, 2018
• Est. primary completion date: January 10, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

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.
• Cognitive Processing Therapy
Cognitive Processing Therapy (CPT) is an evidence-based treatment for PTSD. CPT consists of 12, weekly sessions.

Locations

Country	Name	City	State
United States	National Center for PTSD at VA Boston Healthcare System	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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.20 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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