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Written Exposure Therapy for Posttraumatic Stress Disorder (WET)

Primary Purpose

Posttraumatic Stress Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Written Exposure Therapy
Cognitive Processing Therapy
Sponsored by
Boston University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder focused on measuring PTSD, exposure treatment, clinical trial, trauma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • National Center for PTSD at VA Boston Healthcare System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Written Exposure Therapy

Cognitive Processing Therapy

Arm Description

Written exposure treatment is a 5 session treatment in which participants write about their trauma event in a specified manner.

cognitive processing therapy will be included as the evidence-based treatment for PTSD in this study.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).

Full Information

First Posted
February 15, 2013
Last Updated
January 14, 2019
Sponsor
Boston University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT01800773
Brief Title
Written Exposure Therapy for Posttraumatic Stress Disorder
Acronym
WET
Official Title
Written Exposure Therapy for Post Traumatic Stress Disorder: A Randomized Noninferiority Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
March 9, 2013 (Actual)
Primary Completion Date
January 10, 2018 (Actual)
Study Completion Date
April 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder
Keywords
PTSD, exposure treatment, clinical trial, trauma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
192 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Written Exposure Therapy
Arm Type
Experimental
Arm Description
Written exposure treatment is a 5 session treatment in which participants write about their trauma event in a specified manner.
Arm Title
Cognitive Processing Therapy
Arm Type
Active Comparator
Arm Description
cognitive processing therapy will be included as the evidence-based treatment for PTSD in this study.
Intervention Type
Behavioral
Intervention Name(s)
Written Exposure Therapy
Intervention Description
Written exposure therapy is a 5 session, weekly treatment in which individuals write about their trauma event in a specified manner.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Processing Therapy
Intervention Description
Cognitive Processing Therapy (CPT) is an evidence-based treatment for PTSD. CPT consists of 12, weekly sessions.
Primary Outcome Measure Information:
Title
Clinician Administered PTSD Scale (CAPS)
Description
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.
Time Frame
change from baseline PTSD symptom severity at 36 weeks post first treatment session
Secondary Outcome Measure Information:
Title
treatment dropout
Description
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).
Time Frame
course of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Denise M. Sloan, Ph.D.
Organizational Affiliation
Boston University
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Center for PTSD at VA Boston Healthcare System
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02130
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29344631
Citation
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.
Results Reference
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Written Exposure Therapy for Posttraumatic Stress Disorder

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