Behavioral Activation + Cognitive Processing Therapy for PTSD and Comorbid MDD

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Posttraumatic Stress Disorder, Major Depressive Disorder

Intervention / Treatment
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* Behavioral: Behavioral Activation
* Behavioral: Cognitive Processing Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Behavioral Activation + CPT<br>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<br>* Behavioral activation<br>* Other names: BA;Behavioral: Cognitive Processing Therapy<br>* Cognitive processing therapy<br>* Other names: CPT;|
| Active Comparator: Cognitive Processing Therapy<br>CPT is an evidence-based treatment for PTSD that has also been shown to reduce depression symptoms. | Behavioral: Cognitive Processing Therapy<br>* Cognitive processing therapy<br>* Other names: CPT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Montgomery-Asberg Depression Rating Scale (MADRS) | Assessor-administered measure of depression symptoms | Prior to beginning treatment through three months following treatment completion (approximately 10 months) | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Posttraumatic Stress Disorder, Major Depressive Disorder, Behavioral Activation, Cognitive Processing Therapy, Comorbidity, Military