Clinical trial NCT01800773: Written Exposure Therapy for Posttraumatic Stress Disorder
Official title: Written Exposure Therapy for Post Traumatic Stress Disorder: A Randomized Noninferiority Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Stress Disorder
Keywords: PTSD
exposure treatment
clinical trial
trauma
Lead sponsor: Boston University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2013-02-28
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Clinician Administered PTSD Scale (CAPS)
timeFrame: change from baseline PTSD symptom severity at 36 weeks post first treatment session
Secondary outcomes:
measure: treatment dropout
timeFrame: course of treatment
Other outcomes:
Locations:
city: Boston
country: United States
facility: National Center for PTSD at VA Boston Healthcare System
state: Massachusetts
Study officials:
affiliation: Boston University
name: Denise M. Sloan, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.