Behavioral Activation + Cognitive Processing Therapy for PTSD and Comorbid MDD

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02874131
• Other study ID #: NMCSD.2015.0039
• Status: Completed
• Phase: N/A
• Start date: October 20, 2015
• Est. completion date: March 18, 2022

Study information

• Verified date: March 2023
• Source: United States Naval Medical Center, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 18, 2022
• Est. primary completion date: March 18, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Major Depressive Disorder
• Posttraumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Behavioral Activation
Behavioral activation
• Cognitive Processing Therapy
Cognitive processing therapy

Locations

Country	Name	City	State
United States	Naval Medical Center San Diego	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
United States Naval Medical Center, San Diego	Naval Health Research Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

Walter KH, Glassman LH, Michael Hunt W, Otis NP, Thomsen CJ. Evaluation of an integrated treatment for active duty service members with comorbid posttraumatic stress disorder and major depressive disorder: Study protocol for a randomized controlled trial. Contemp Clin Trials. 2018 Jan;64:152-160. doi: 10.1016/j.cct.2017.10.010. Epub 2017 Nov 7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	Patient Health Questionnaire (PHQ-9)	Self-report measure of depression symptoms	Prior to beginning treatment through three months following treatment completion (approximately 10 months)