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Behavioral Activation + Cognitive Processing Therapy for PTSD and Comorbid MDD

Primary Purpose

Posttraumatic Stress Disorder, Major Depressive Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral Activation
Cognitive Processing Therapy
Sponsored by
United States Naval Medical Center, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder focused on measuring Posttraumatic Stress Disorder, Major Depressive Disorder, Behavioral Activation, Cognitive Processing Therapy, Comorbidity, Military

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Naval Medical Center San Diego

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Behavioral Activation + CPT

Cognitive Processing Therapy

Arm Description

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.

CPT is an evidence-based treatment for PTSD that has also been shown to reduce depression symptoms.

Outcomes

Primary Outcome Measures

Montgomery-Asberg Depression Rating Scale (MADRS)
Assessor-administered measure of depression symptoms

Secondary Outcome Measures

Clinician-Administered PTSD Scale for the DSM-5 (CAPS-5)
Assessor-administered measure of PTSD symptoms
Patient Health Questionnaire (PHQ-9)
Self-report measure of depression symptoms

Full Information

First Posted
August 2, 2016
Last Updated
March 10, 2023
Sponsor
United States Naval Medical Center, San Diego
Collaborators
Naval Health Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT02874131
Brief Title
Behavioral Activation + Cognitive Processing Therapy for PTSD and Comorbid MDD
Official Title
Behavioral Activation + Cognitive Processing Therapy for Posttraumatic Stress Disorder and Comorbid Major Depressive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
October 20, 2015 (Actual)
Primary Completion Date
March 18, 2022 (Actual)
Study Completion Date
March 18, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
United States Naval Medical Center, San Diego
Collaborators
Naval Health Research Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder, Major Depressive Disorder
Keywords
Posttraumatic Stress Disorder, Major Depressive Disorder, Behavioral Activation, Cognitive Processing Therapy, Comorbidity, Military

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Behavioral Activation + CPT
Arm Type
Experimental
Arm Description
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.
Arm Title
Cognitive Processing Therapy
Arm Type
Active Comparator
Arm Description
CPT is an evidence-based treatment for PTSD that has also been shown to reduce depression symptoms.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Activation
Other Intervention Name(s)
BA
Intervention Description
Behavioral activation
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Processing Therapy
Other Intervention Name(s)
CPT
Intervention Description
Cognitive processing therapy
Primary Outcome Measure Information:
Title
Montgomery-Asberg Depression Rating Scale (MADRS)
Description
Assessor-administered measure of depression symptoms
Time Frame
Prior to beginning treatment through three months following treatment completion (approximately 10 months)
Secondary Outcome Measure Information:
Title
Clinician-Administered PTSD Scale for the DSM-5 (CAPS-5)
Description
Assessor-administered measure of PTSD symptoms
Time Frame
Prior to beginning treatment through three months following treatment completion (approximately 10 months)
Title
Patient Health Questionnaire (PHQ-9)
Description
Self-report measure of depression symptoms
Time Frame
Prior to beginning treatment through three months following treatment completion (approximately 10 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William M. Hunt, Ph.D.
Organizational Affiliation
United States Naval Medical Center, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
Naval Medical Center San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92134
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data will be available only in aggregate
Citations:
PubMed Identifier
29107036
Citation
Walter KH, Glassman LH, Michael Hunt W, Otis NP, Thomsen CJ. Evaluation of an integrated treatment for active duty service members with comorbid posttraumatic stress disorder and major depressive disorder: Study protocol for a randomized controlled trial. Contemp Clin Trials. 2018 Jan;64:152-160. doi: 10.1016/j.cct.2017.10.010. Epub 2017 Nov 7.
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Behavioral Activation + Cognitive Processing Therapy for PTSD and Comorbid MDD

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