Brief Treatment for Posttraumatic Stress Disorder

Brief Treatment for PTSD: Enhancing Retention and Engagement

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.

Study Overview

• Status: Completed
• Conditions: PTSD
• Intervention / Treatment: Behavioral: written exposure therapy; Behavioral: CPT, cognitive only

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 Type: Interventional
• Enrollment (Actual): 169
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Killeen, Texas, United States
      • Ft. Hood
    • San Antonio, Texas, United States, 78229
      • University of Texas Health Science Center, San Antonio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Boston VA Research Institute, Inc.
• Collaborators: United States Department of Defense; University of Texas
• Investigators: Principal Investigator: Denise Sloan, Ph.D., Boston VA Research Institute, Inc.

Publications and helpful links

General Publications

• Sloan DM, Marx BP, Resick PA, Young-McCaughan S, Dondanville KA, Straud CL, Mintz J, Litz BT, Peterson AL; STRONG STAR Consortium. Effect of Written Exposure Therapy vs Cognitive Processing Therapy on Increasing Treatment Efficiency Among Military Service Members With Posttraumatic Stress Disorder: A Randomized Noninferiority Trial. JAMA Netw Open. 2022 Jan 4;5(1):e2140911. doi: 10.1001/jamanetworkopen.2021.40911.
• Sloan DM, Marx BP, Resick PA, Young-McCaughan S, Dondanville KA, Mintz J, Litz BT, Peterson AL; STRONG STAR Consortium. Study design comparing written exposure therapy to cognitive processing therapy for PTSD among military service members: A noninferiority trial. Contemp Clin Trials Commun. 2019 Dec 10;17:100507. doi: 10.1016/j.conctc.2019.100507. eCollection 2020 Mar.

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2015
• Primary Completion (Actual): December 15, 2020
• Study Completion (Actual): March 31, 2021

Study Registration Dates

• First Submitted: December 2, 2016
• First Submitted That Met QC Criteria: January 25, 2017
• First Posted (Estimate): January 27, 2017

Study Record Updates

• Last Update Posted (Actual): May 24, 2023
• Last Update Submitted That Met QC Criteria: July 22, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: W81WH-15-1-0391

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be made available upon written request to the PI.
• IPD Sharing Time Frame: 12 months after publication of the primary outcomes.
• IPD Sharing Access Criteria: Written request to the PI describing rationale for why data is needed and what will be done with data.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No