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OpenTrials
Completed

NCT Number: NCT01800773

Written Exposure Therapy for Posttraumatic Stress Disorder

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Center for PTSD at VA Boston Healthcare System

Boston, Massachusetts, 02130, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Written Exposure Therapy

Behavioral

Written exposure therapy is a 5 session, weekly treatment in which individuals write about their trauma event in a specified manner.

cognitive processing therapy

Behavioral

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

Primary outcomes

  1. Clinician Administered PTSD Scale (CAPS)

    Time frame: 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 outcomes

  1. treatment dropout

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Boston University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Acronym: WET

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Feb 28, 2013
Registry last updated
Jan 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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