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Written Exposure Therapy for Posttraumatic Stress Disorder

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01800773
Acronym
WET
Enrollment
192
Registered
2013-02-28
Start date
2013-03-09
Completion date
2018-04-30
Last updated
2019-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Posttraumatic Stress Disorder

Keywords

PTSD, exposure treatment, clinical trial, trauma

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.

Interventions

BEHAVIORALWritten Exposure Therapy

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

BEHAVIORALCognitive Processing Therapy

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

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
Boston University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Clinician Administered PTSD Scale (CAPS)change from baseline PTSD symptom severity at 36 weeks post first treatment sessionTotal 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

MeasureTime frameDescription
treatment dropoutcourse of treatmentTreatment condition differences in treatment drop out rate at post-treatment (treatment duration is 5 weeks for WET condition and 12 weeks for CPT condition).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026