Behavioral Activation + Cognitive Processing Therapy for PTSD and Comorbid MDD

Not Applicable

Completed

• Conditions: Posttraumatic Stress Disorder; Major Depressive Disorder
• Interventions: Behavioral: Behavioral Activation; Behavioral: Cognitive Processing Therapy

• Registration Number: NCT02874131
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2015-10-20
• Study First Submitted: 2016-08-02
• Study First Submitted QC: 2016-08-16
• Study First Posted: 2016-08-22
• Primary Completion: 2022-03-18
• Study Completion: 2022-03-18
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-13
• Last Update Posted: 2024-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Behavioral Activation + CPT	Behavioral Activation	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 Activation + CPT	Cognitive Processing Therapy	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.
Cognitive Processing Therapy	Cognitive Processing Therapy	CPT is an evidence-based treatment for PTSD that has also been shown to reduce depression symptoms.

Primary Outcome Measures

Name	Time	Method
Montgomery-Asberg Depression Rating Scale (MADRS)	Prior to beginning treatment through three months following treatment completion (approximately 10 months)	Assessor-administered measure of depression symptoms

Secondary Outcome Measures

Name	Time	Method
Patient Health Questionnaire (PHQ-9)	Prior to beginning treatment through three months following treatment completion (approximately 10 months)	Self-report measure of depression symptoms
Clinician-Administered PTSD Scale for the DSM-5 (CAPS-5)	Prior to beginning treatment through three months following treatment completion (approximately 10 months)	Assessor-administered measure of PTSD symptoms

Trial Locations

Locations (1)

Naval Medical Center San Diego; 🇺🇸 San Diego, California, United States