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Behavioral Activation + Cognitive Processing Therapy for PTSD and Comorbid MDD

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ClinicalTrials.gov Identifier: NCT02874131
Recruitment Status : Recruiting
First Posted : August 22, 2016
Last Update Posted : March 13, 2019
Sponsor:
Collaborator:
Naval Health Research Center
Information provided by (Responsible Party):
United States Naval Medical Center, San Diego

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.

Condition or disease Intervention/treatment Phase
Posttraumatic Stress Disorder Major Depressive Disorder Behavioral: Behavioral Activation Behavioral: Cognitive Processing Therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Behavioral Activation + Cognitive Processing Therapy for Posttraumatic Stress Disorder and Comorbid Major Depressive Disorder
Actual Study Start Date : April 1, 2015
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Behavioral Activation + CPT
Behavioral Activation, an evidence-based treatment for depression, is combined with Cognitive Processing Therapy (CPT), an evidence-based treatment for PTSD, to address symptoms of PTSD and comorbid MDD.
Behavioral: Behavioral Activation
Behavioral activation
Other Name: BA

Behavioral: Cognitive Processing Therapy
Cognitive processing therapy
Other Name: CPT

Active Comparator: Cognitive Processing Therapy
CPT is an evidence-based treatment for PTSD that has also been shown to reduce depression symptoms.
Behavioral: Cognitive Processing Therapy
Cognitive processing therapy
Other Name: CPT




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Clinician-Administered PTSD Scale for the DSM-5 (CAPS-5) [ Time Frame: Prior to beginning treatment through three months following treatment completion (approximately 10 months) ]
    Assessor-administered measure of PTSD symptoms

  2. Patient Health Questionnaire (PHQ-9) [ Time Frame: Prior to beginning treatment through three months following treatment completion (approximately 10 months) ]
    Self-report measure of depression symptoms



Information from the National Library of Medicine

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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:

  • 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

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): NCT02874131


Contacts
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Contact: William M. Hunt, Ph.D. 619-532-5761 william.m.hunt.civ@mail.mil
Contact: Kristen H Walter, Ph.D. 619.540.4108 kristen.h.walter.ctr@mail.mil

Locations
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United States, California
Naval Medical Center San Diego Recruiting
San Diego, California, United States, 92134
Contact: William M. Hunt, Ph.D.    619-532-5761    william.m.hunt.civ@mail.mil   
Contact: Kristen H. Walter, Ph.D.    619.540.4108    kristen.h.walter.ctr@mail.mil   
Principal Investigator: William M. Hunt, Ph.D.         
Sub-Investigator: Kristen H. Walter, Ph.D.         
Sub-Investigator: Cynthia J. Thomsen, Ph.D.         
Sub-Investigator: Lisa H. Glassman, Ph.D.         
Sponsors and Collaborators
United States Naval Medical Center, San Diego
Naval Health Research Center
Investigators
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Principal Investigator: William M. Hunt, Ph.D. United States Naval Medical Center, San Diego

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Responsible Party: United States Naval Medical Center, San Diego
ClinicalTrials.gov Identifier: NCT02874131     History of Changes
Other Study ID Numbers: NMCSD.2015.0039
First Posted: August 22, 2016    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data will be available only in aggregate

Keywords provided by United States Naval Medical Center, San Diego:
Posttraumatic Stress Disorder
Major Depressive Disorder
Behavioral Activation
Cognitive Processing Therapy
Comorbidity
Military

Additional relevant MeSH terms:
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Depressive Disorder
Depression
Depressive Disorder, Major
Behavioral Symptoms
Disease
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Pathologic Processes
Mood Disorders
Mental Disorders
Trauma and Stressor Related Disorders