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Clinical Trials/NCT02313818
NCT02313818
Completed
N/A

Variable-length Cognitive Processing Therapy for Combat-Related PTSD

Duke University1 site in 1 country130 target enrollmentJune 2015

Overview

Phase
N/A
Intervention
Not specified
Conditions
Posttraumatic Stress Disorder
Sponsor
Duke University
Enrollment
130
Locations
1
Primary Endpoint
Change from baseline in PTSD symptoms as measured by thePosttraumatic Stress Disorder Checklist-5 (PCL-5)
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

The primary goal of this study is to improve the overall efficacy of cognitive processing therapy-cognitive-only version (CPT-C) in a sample of 130 active-duty service members through a variable length treatment.

Detailed Description

The primary goal of this study is to improve the overall efficacy of cognitive processing therapy-cognitive-only version (CPT-C) in a sample of 130 active-duty service members through a variable length treatment. The study seeks to determine if some service members would benefit from a longer or shorter dose of treatment (4-24 sessions), and to identify which individuals are likely to require more, less, or the standard number of treatment sessions to reach good end-state functioning. Predictors of length of therapy and treatment outcome will be examined. Specifically, we will evaluate factors related to internalizing/externalizing traits, cognitive flexibility, inability to inhibit dysfunctional cognitions, and readiness to change as they are related to the number of treatment sessions required to treat patients to the point of good end-state functioning. Additional outcomes including alcohol use, psychosocial functioning, physical health, and sleep also will be evaluated.

Registry
clinicaltrials.gov
Start Date
June 2015
End Date
December 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Adult male and female combat veterans who deployed in support of combat operations following 9/11
  • Diagnosis of PTSD determined by a Clinician-Administered Posttraumatic Stress Scale (CAPS-5)
  • Speak and read English

Exclusion Criteria

  • Current suicide or homicide risk meriting crisis intervention.
  • Active psychosis.
  • Moderate to severe brain damage (as determined by the inability to comprehend the baseline screening questionnaires).
  • Local availability of fewer than 5 months
  • Late-phase Med Board status, awaiting percentages
  • Undergoing a chapter

Outcomes

Primary Outcomes

Change from baseline in PTSD symptoms as measured by thePosttraumatic Stress Disorder Checklist-5 (PCL-5)

Time Frame: Pretreatment, weekly during treatment, 4 weeks, 12 weeks, and 24 weeks posttreatment

PCL-5 measures symptoms of posttraumatic stress disorder in response to a specific stressor.

Change from baseline in PTSD symptoms as measured by the Clinician Administered PTSD Scale (CAPS-5)

Time Frame: Pretreatment, weekly during treatment, 4 weeks, 12 weeks, and 24 weeks posttreatment

is an updated version of the gold standard CAPS designed to assess the criteria for PTSD as defined by the DSM-5

Secondary Outcomes

  • Change from baseline in depressive symptoms as measured by the Patient Health Questionnaire-9(Pretreatment, weekly during treatment, 4 weeks, 12 weeks, and 24 weeks posttreatment)

Study Sites (1)

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