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Brief Treatment for Posttraumatic Stress Disorder

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ClinicalTrials.gov Identifier: NCT03033602
Recruitment Status : Recruiting
First Posted : January 27, 2017
Last Update Posted : January 10, 2019
Sponsor:
Collaborators:
University of Texas
United States Department of Defense
Information provided by (Responsible Party):
Boston VA Research Institute, Inc.

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
PTSD Behavioral: written exposure therapy Behavioral: CPT, cognitive only Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 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 : July 20, 2015
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

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 Name: 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 Name: CPT-C




Primary Outcome Measures :
  1. Clinician Administered PTSD Scale, 5 [ Time Frame: Change from baseline to 10-, 20-, 30-weeks post first treatment session ]
    PTSD symptom scale



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03033602


Contacts
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Contact: Alan Peterson, Ph.D. (210) 562-6744 petersona3@uthscsa.edu

Locations
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United States, Texas
Ft. Hood Recruiting
Killeen, Texas, United States
Contact: Paul Fowler, B.A.       fowlerP@uthscsa.edu   
University of Texas Health Science Center, San Antonio Recruiting
San Antonio, Texas, United States, 78229
Contact: Amanda Flores, BA       floresa13@uthscsa.edu   
Sponsors and Collaborators
Boston VA Research Institute, Inc.
University of Texas
United States Department of Defense
Investigators
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Principal Investigator: Denise Sloan, Ph.D. Boston VA Research Institute, Inc.

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Responsible Party: Boston VA Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT03033602     History of Changes
Other Study ID Numbers: W81WH-15-1-0391
First Posted: January 27, 2017    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019