Clinical trial NCT03033602: Brief Treatment for Posttraumatic Stress Disorder
Official title: Brief Treatment for PTSD: Enhancing Retention and Engagement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PTSD
Lead sponsor: Boston VA Research Institute, Inc.
Sponsor class: OTHER
Collaborators: name: University of Texas
name: United States Department of Defense
First posted: 2017-01-27
Enrollment: 169
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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinician Administered PTSD Scale, 5 (CAPS-5)
timeFrame: Change from baseline to 10-, 20-, 30-weeks post first treatment session
Secondary outcomes:
Other outcomes:
Locations:
city: Killeen
country: United States
facility: Ft. Hood
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Science Center, San Antonio
state: Texas
Study officials:
affiliation: Boston VA Research Institute, Inc.
name: Denise Sloan, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.