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OpenTrials
Completed

NCT Number: NCT03033602

Brief Treatment for Posttraumatic Stress Disorder

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.

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Key information

Conditions

PTSD Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ft. Hood, Killeen, Texas, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Written Exposure Therapy

Behavioral

five sessions of writing about traumatic experience.

Other names: WET

CPT, cognitive only

Behavioral

12 sessions of cognitive therapy related to traumatic experience.

Other names: CPT-C

Primary outcomes

  1. Clinician Administered PTSD Scale, 5 (CAPS-5)

    Time frame: Change from baseline to 10-, 20-, 30-weeks post first treatment session

    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.

Sponsors and collaborators

Lead sponsor

Boston VA Research Institute, Inc.

Other

Collaborators

  • United States Department of Defense
  • University of Texas

Registry information

Official study title

Brief Treatment for PTSD: Enhancing Retention and Engagement

Important dates

Study start
2015
Primary completion
2020
Study completion
2021
First posted
Jan 27, 2017
Registry last updated
May 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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