Brief Treatment for Posttraumatic Stress Disorder

Not Applicable

Completed

• Conditions: PTSD
• Interventions: Behavioral: written exposure therapy; Behavioral: CPT, cognitive only

• Registration Number: NCT03033602
• Lead Sponsor: Boston VA Research Institute, Inc.

Brief Summary

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

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.

Study Timeline

• Study Start: 2015-07-20
• Study First Submitted: 2016-12-02
• Study First Submitted QC: 2017-01-25
• Study First Posted: 2017-01-27
• Primary Completion: 2020-12-15
• Study Completion: 2021-03-31
• Results First Submitted: 2022-03-03
• Status Verified: 2022-07
• Results First Submitted QC: 2022-07-22
• Last Update Submitted: 2022-07-22
• Results First Posted: 2023-05-24
• Last Update Posted: 2023-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 169

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Written exposure therapy	written exposure therapy	5 sessions of imaginal exposure therapy.
CPT, cognitive only	CPT, cognitive only	12 sessions of cognitive therapy.

Primary Outcome Measures

Name	Time	Method
Clinician Administered PTSD Scale, 5 (CAPS-5)	Change from baseline to 10-, 20-, 30-weeks post first treatment session	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.

Trial Locations

Locations (2)

Ft. Hood; 🇺🇸 Killeen, Texas, United States

University of Texas Health Science Center, San Antonio; 🇺🇸 San Antonio, Texas, United States