Brief Treatment for Posttraumatic Stress Disorder

NCT03033602 | Completed Results DMC

• 1 other identifier: W81WH-15-1-0391
• Study Type: interventional
• Target: 169
• Locations: 1 country
• Sites: 2

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.

Conditions

PTSD

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Written exposure therapy

EXPERIMENTAL

5 sessions of imaginal exposure therapy.

Behavioral: written exposure therapy

CPT, cognitive only

ACTIVE COMPARATOR

12 sessions of cognitive therapy.

Behavioral: CPT, cognitive only

Interventions

written exposure therapy BEHAVIORAL

five sessions of writing about traumatic experience.

Also known as: WET

Written exposure therapy

CPT, cognitive only BEHAVIORAL

12 sessions of cognitive therapy related to traumatic experience.

Also known as: CPT-C

CPT, cognitive only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Current suicide or homicide risk meriting crisis intervention
• Active psychosis
• Moderate to severe brain damage

Sponsors & Collaborators

• Boston VA Research Institute, Inc.: lead
• University of Texas: collaborator
• United States Department of Defense: collaborator

Study Sites (2)

Ft. Hood

Killeen, Texas, United States

Location

University of Texas Health Science Center, San Antonio

San Antonio, Texas, 78229, United States

Location

Related Publications (2)

• 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.

  PMID: 35015065 BACKGROUND

• 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.

  PMID: 31890987 BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

2-cyclohexylidenhydrazo-4-phenyl-thiazole

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Limitations and Caveats

Participants who dropped out prematurely of treatment were less likely to return for subsequent assessments.

Results Point of Contact

• Title: Dr. Denise Sloan, Professor of Psychiatry
• Organization: VA Boston Healthcare System & Boston University School of Medicine

dsloan@bu.edu

857-364-6333

Study Officials

• Denise Sloan, Ph.D.

  Boston VA Research Institute, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2016
• First Posted: January 27, 2017
• Study Start: July 20, 2015
• Primary Completion: December 15, 2020
• Study Completion: March 31, 2021
• Last Updated: May 24, 2023
• Results First Posted: May 24, 2023

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: 12 months after publication of the primary outcomes.
• Access Criteria: Written request to the PI describing rationale for why data is needed and what will be done with data.

Locations

US (2)