Behavioral Activation + Cognitive Processing Therapy for PTSD and Comorbid MDD

Sponsor

United States Naval Medical Center, San Diego (U.S. Fed)

Overall Status

Active, not recruiting

CT.gov ID

NCT02874131

Collaborator

Naval Health Research Center (U.S. Fed)

100

Enrollment

Location

Arms

83.4

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Posttraumatic Stress Disorder Major Depressive Disorder	Behavioral: Behavioral Activation Behavioral: Cognitive Processing Therapy	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

100 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 :

Oct 20, 2015

Actual Primary Completion Date :

Mar 18, 2022

Anticipated Study Completion Date :

Sep 30, 2022

Arms and Interventions

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 Names: BA Behavioral: Cognitive Processing Therapy Cognitive processing therapy Other Names: 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 Names: CPT

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 Names:

Behavioral: Cognitive Processing Therapy

Cognitive processing therapy

Other Names:

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 Names:

CPT

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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