Behavioral Activation + Cognitive Processing Therapy for PTSD and Comorbid MDD

NCT02874131 | Completed DMC

• 1 other identifier: NMCSD.2015.0039
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Posttraumatic Stress Disorder; Major Depressive Disorder

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

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

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

• Patient Health Questionnaire (PHQ-9)

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

Study Arms (2)

Behavioral Activation + CPT

EXPERIMENTAL

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; Behavioral: Cognitive Processing Therapy

Cognitive Processing Therapy

ACTIVE COMPARATOR

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

Behavioral: Cognitive Processing Therapy

Interventions

Behavioral Activation BEHAVIORAL

Behavioral activation

Also known as: BA

Behavioral Activation + CPT

Cognitive Processing Therapy BEHAVIORAL

Cognitive processing therapy

Also known as: CPT

Behavioral Activation + CPT; Cognitive Processing Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• United States Naval Medical Center, San Diego: lead
• Naval Health Research Center: collaborator

Study Sites (1)

Naval Medical Center San Diego

San Diego, California, 92134, United States

Location

Related Publications (5)

• 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.

  PMID: 29107036 BACKGROUND

• Walter KH, Hunt WM, Otis NP, Kline AC, Miggantz EL, Thomsen CJ, Glassman LH. Comparison of behavioral activation-enhanced cognitive processing therapy and cognitive processing therapy among U.S. service members: A randomized clinical trial. Psychiatry Res. 2023 Aug;326:115330. doi: 10.1016/j.psychres.2023.115330. Epub 2023 Jul 4.

  PMID: 37418778 RESULT

• Kline AC, Otis NP, Norman SB, Hunt WM, Walter KH. Dropout in a clinical trial for comorbid PTSD and MDD among US service members: Are pretreatment characteristics predictive? Psychother Res. 2025 Apr;35(4):614-626. doi: 10.1080/10503307.2024.2325519. Epub 2024 Mar 18.

  PMID: 38497740 RESULT

• Glassman LH, Otis NP, Kline AC, Hunt WM, Walter KH. Sex differences in treatment outcomes among U.S. service members with comorbid PTSD and MDD. BMC Psychol. 2026 Jan 31. doi: 10.1186/s40359-025-03878-4. Online ahead of print.

  PMID: 41620779 DERIVED

• Otis NP, Kline AC, Glassman LH, Michael Hunt W, Walter KH. Sudden gains in cognitive processing therapy with and without behavioral activation among service members with comorbid PTSD and MDD. Behav Res Ther. 2025 Jul;190:104753. doi: 10.1016/j.brat.2025.104753. Epub 2025 Apr 22.

  PMID: 40288269 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Depressive Disorder, Major

Interventions

2-cyclohexylidenhydrazo-4-phenyl-thiazole

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Depressive Disorder; Mood Disorders

Study Officials

• William M. Hunt, Ph.D.

  United States Naval Medical Center, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Research Psychologist

Study Record Dates

• First Submitted: August 2, 2016
• First Posted: August 22, 2016
• Study Start: October 20, 2015
• Primary Completion: March 18, 2022
• Study Completion: March 18, 2022
• Last Updated: November 15, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)