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Clinical Trials/NCT02874131
NCT02874131
Completed
Not Applicable

Behavioral Activation + Cognitive Processing Therapy for Posttraumatic Stress Disorder and Comorbid Major Depressive Disorder

United States Naval Medical Center, San Diego1 site in 1 country100 target enrollmentOctober 20, 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Posttraumatic Stress Disorder
Sponsor
United States Naval Medical Center, San Diego
Enrollment
100
Locations
1
Primary Endpoint
Montgomery-Asberg Depression Rating Scale (MADRS)
Status
Completed
Last Updated
last year

Overview

Brief Summary

This study is a randomized controlled trial comparing an integrated treatment, Behavioral Activation + Cognitive Processing Therapy (BA + CPT), to CPT alone among active-duty service members with posttraumatic stress disorder (PTSD) and comorbid major depressive disorder (MDD). Participants will complete assessor-administered and self-report measures at pre- and post-treatment assessments, as well as a 3-month follow-up. Additionally, participants will complete self-report measures of PTSD and MDD symptoms at each therapy session.

Detailed Description

Major depressive disorder (MDD) is the psychological condition most commonly comorbid with posttraumatic stress disorder (PTSD). PTSD and MDD comorbidity is associated with greater symptom severity, lower levels of functioning, greater disability, and increased suicide potential relative to PTSD or MDD alone. Unfortunately, no psychological treatment intervention specifically addresses this comorbidity. Individuals with comorbid PTSD and MDD often receive evidence-based treatments for PTSD, such as cognitive processing therapy (CPT); although such treatments typically reduce both PTSD and depression symptoms, few studies have specifically examined these outcomes in individuals with PTSD and comorbid MDD. The primary goal of this randomized controlled trial is to evaluate whether greater improvement in depression symptoms can be achieved by augmenting CPT with behavioral activation (BA), a standard depression treatment, for active-duty service members with PTSD and comorbid MDD. Participants will be evaluated at three assessment time-points (pre-treatment, post-treatment, and three-month follow-up), as well as complete self-report measures of PTSD and MDD symptoms at each therapy session.

Registry
clinicaltrials.gov
Start Date
October 20, 2015
End Date
March 18, 2022
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
United States Naval Medical Center, San Diego
Responsible Party
Principal Investigator
Principal Investigator

Kristen Walter

Clinical Research Psychologist

United States Naval Medical Center, San Diego

Eligibility Criteria

Inclusion Criteria

  • Active-duty service member seeking mental health treatment at Naval Medical Center San Diego (NMCSD), branch clinics, or Naval Hospital Camp Pendleton (NHCP)
  • Meet current diagnostic criteria for PTSD based on the DSM-5 as a consequence of any index traumatic event (e.g., combat, military sexual trauma, child abuse, accidents, etc.)
  • Meet current diagnostic criteria for MDD based on DSM-5 criteria.

Exclusion Criteria

  • Unmanaged psychosis or manic episode in the past year
  • Substance use disorder warranting primary substance use treatment or detoxification
  • Participation in concurrent psychotherapies directly targeting PTSD
  • Participation in concurrent psychotherapies directly targeting depression

Outcomes

Primary Outcomes

Montgomery-Asberg Depression Rating Scale (MADRS)

Time Frame: Prior to beginning treatment through three months following treatment completion (approximately 10 months)

Assessor-administered measure of depression symptoms

Secondary Outcomes

  • Patient Health Questionnaire (PHQ-9)(Prior to beginning treatment through three months following treatment completion (approximately 10 months))
  • Clinician-Administered PTSD Scale for the DSM-5 (CAPS-5)(Prior to beginning treatment through three months following treatment completion (approximately 10 months))

Study Sites (1)

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