Behavioral Activation + Cognitive Processing Therapy for PTSD and Comorbid MDD

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-20

Study Completion Date

2022-03-18

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

DoD PTSD November 13 - Information Processing Modification in the Treatment of PTSD

NCT00604045

Stress Disorders, Post-Traumatic

COMPLETED NA

Comparing Individual Therapies for Veterans With Depression, PTSD, and Panic Disorder

NCT04293341

Major Depressive Disorder Posttraumatic Stress Disorder Panic Disorder and Agoraphobia

COMPLETED NA

Behavioral Activation for PTSD/Depression Treatment in OIF/OEF Veterans

NCT00805532

Posttraumatic Stress Disorder Depression

COMPLETED NA

Adaptive Disclosure: A Combat-Specific PTSD Treatment

NCT01628718

Posttraumatic Stress Disorder

COMPLETED NA

Facilitating Transition to Recommended PTSD Treatment

NCT05165940

PTSD

NOT_YET_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Posttraumatic Stress Disorder Major Depressive Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Behavioral Activation

Intervention Type BEHAVIORAL

Behavioral activation

Cognitive Processing Therapy

Intervention Type BEHAVIORAL

Cognitive processing therapy

Cognitive Processing Therapy

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

Group Type ACTIVE_COMPARATOR

Cognitive Processing Therapy

Intervention Type BEHAVIORAL

Cognitive processing therapy

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Behavioral Activation

Behavioral activation

Intervention Type BEHAVIORAL

Cognitive Processing Therapy

Cognitive processing therapy

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

BA CPT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes