Brief Treatment for Posttraumatic Stress Disorder

Study Overview
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Brief Summary
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The primary goal of this study is to examine whether a brief treatment approach for PTSD is equally efficacious in the treatment of active duty service members relative to a first line treatment approach that requires much greater treatment dose.

Detailed Description
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The goal of this randomized clinical trial is to investigate if a brief, written intervention for posttraumatic stress disorder (PTSD), Written Exposure Therapy (WET), is non-inferior compared to an evidenced-based behavioral therapy, Cognitive Processing Therapy-Cognition only (CPT-C), in the treatment of PTSD in active duty military men and women with a diagnosis of PTSD who have deployed in support of a post-9/11. The primary study outcome is change in symptom severity as assessed by the Clinician Administered PTSD Scale for Diagnostic and Statistical Manual-5 edition (CAPS-5). Independent assessors evaluated participants using the CAPS-5 at baseline, 10-, 20-, and 30-week after the first treatment session.

Official Title
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Brief Treatment for PTSD: Enhancing Retention and Engagement

Conditions
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PTSD

Intervention / Treatment
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* Behavioral: written exposure therapy
* Behavioral: CPT, cognitive only


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female active duty military personnel who have deployed in support of a post-9/11 conflict seeking treatment for PTSD Diagnosis of PTSD Ability to speak, read and write English Not currently engaged in psychosocial treatment for PTSD Individuals taking psychotropic medications agree to work with their prescriber to remain on stable doses of any prescribed psychotropic medications for the duration of the intervention and through the first follow-up assessment as much as possible and as medically indicated. Exclusion Criteria: Current suicide or homicide risk meriting crisis intervention Active psychosis Moderate to severe brain damage

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Written exposure therapy<br>5 sessions of imaginal exposure therapy. | Behavioral: written exposure therapy<br>* five sessions of writing about traumatic experience.<br>* Other names: WET;|
| Active Comparator: CPT, cognitive only<br>12 sessions of cognitive therapy. | Behavioral: CPT, cognitive only<br>* 12 sessions of cognitive therapy related to traumatic experience.<br>* Other names: CPT-C;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinician Administered PTSD Scale, 5 (CAPS-5) | The CAPS-5 is a semi-structured interview for assessment of PTSD according to DSM-5 diagnostic criteria. The measure assesses PTSD according to the 20 symptoms of DSM-5, as well as impairment. A total score is calculated as well as whether PTSD diagnosis is met. Scores can range from 0-80, with higher scores representing greater symptom severity. For this study, the CAPS-5 total score was used as the primary outcome measure. | Change from baseline to 10-, 20-, 30-weeks post first treatment session |