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Behavioral Activation + Cognitive Processing Therapy for PTSD and Comorbid MDD

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02874131
Enrollment
100
Registered
2016-08-22
Start date
2015-10-20
Completion date
2022-03-18
Last updated
2024-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder, Posttraumatic Stress Disorder

Keywords

Posttraumatic Stress Disorder, Major Depressive Disorder, Behavioral Activation, Cognitive Processing Therapy, Comorbidity, Military

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.

Interventions

BEHAVIORALBehavioral Activation

Behavioral activation

BEHAVIORALCognitive Processing Therapy

Cognitive processing therapy

Sponsors

Naval Health Research Center
CollaboratorFED
United States Naval Medical Center, San Diego
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
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

MeasureTime frameDescription
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 10, 2026