Brief Treatment for Posttraumatic Stress Disorder

PTSD Clinical Trial

Official title:

Brief Treatment for PTSD: Enhancing Retention and Engagement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03033602
• Other study ID #: W81WH-15-1-0391
• Status: Completed
• Phase: N/A
• Start date: July 20, 2015
• Est. completion date: March 31, 2021

Study information

• Verified date: July 2022
• Source: Boston VA Research Institute, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 169
• Est. completion date: March 31, 2021
• Est. primary completion date: December 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• PTSD

Intervention

Behavioral:
• written exposure therapy
five sessions of writing about traumatic experience.
• CPT, cognitive only
12 sessions of cognitive therapy related to traumatic experience.

Locations

Country	Name	City	State
United States	Ft. Hood	Killeen	Texas
United States	University of Texas Health Science Center, San Antonio	San Antonio	Texas

Sponsors (3)

Lead Sponsor	Collaborator
Boston VA Research Institute, Inc.	United States Department of Defense, University of Texas

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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