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Brief Treatment for Posttraumatic Stress Disorder

Sponsor
Boston VA Research Institute, Inc. (Other)
Overall Status
Completed
CT.gov ID
NCT03033602
Collaborator
University of Texas (Other), United States Department of Defense (U.S. Fed)
170
Enrollment
2
Locations
2
Arms
85
Patients Per Site

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: written exposure therapy
  • Behavioral: CPT, cognitive only
 N/A

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 equally efficacious as 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 will be change in symptom severity as assessed by the Clinician Administered PTSD Scale for Diagnostic and Statistical Manual-5 edition (CAPS-5). Independent assessors will evaluate participants using the CAPS-5 at baseline, 10- (post-treatment), 20-, and 30-week intervals after the start of treatment.

Study Design

Study Type:
Interventional
Actual Enrollment :
170 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Brief Treatment for PTSD: Enhancing Retention and Engagement
Actual Study Start Date :
Jul 20, 2015
Actual Primary Completion Date :
Oct 15, 2020

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Clinician Administered PTSD Scale, 5 [Change from baseline to 10-, 20-, 30-weeks post first treatment session]

      PTSD symptom scale

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ft. Hood Killeen Texas United States
    2 University of Texas Health Science Center, San Antonio San Antonio Texas United States 78229

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Denise Sloan, Ph.D., Boston VA Research Institute, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Boston VA Research Institute, Inc.
    ClinicalTrials.gov Identifier:
    NCT03033602
    Other Study ID Numbers:
    • W81WH-15-1-0391
    First Posted:
    Jan 27, 2017
    Last Update Posted:
    Dec 17, 2020
    Last Verified:
    Dec 1, 2020

    Study Results

    No Results Posted as of Dec 17, 2020