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Completed

NCT Number: NCT02874131

Behavioral Activation + Cognitive Processing Therapy for PTSD and Comorbid MDD

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Naval Medical Center San Diego

San Diego, California, 92134, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Behavioral Activation

Behavioral

Behavioral activation

Other names: BA

cognitive processing therapy

Behavioral

Cognitive processing therapy

Other names: CPT

Primary outcomes

  1. Montgomery-Asberg Depression Rating Scale (MADRS)

    Time frame: Prior to beginning treatment through three months following treatment completion (approximately 10 months)

    Assessor-administered measure of depression symptoms

Secondary outcomes

  1. Clinician-Administered PTSD Scale for the DSM-5 (CAPS-5)

    Time frame: Prior to beginning treatment through three months following treatment completion (approximately 10 months)

    Assessor-administered measure of PTSD symptoms

  2. Patient Health Questionnaire (PHQ-9)

    Time frame: Prior to beginning treatment through three months following treatment completion (approximately 10 months)

    Self-report measure of depression symptoms

Sponsors and collaborators

Lead sponsor

United States Naval Medical Center, San Diego

Fed

Collaborators

  • Naval Health Research Center

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2022
Study completion
2022
First posted
Aug 22, 2016
Registry last updated
Nov 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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