Clinical trial NCT02874131: Behavioral Activation + Cognitive Processing Therapy for PTSD and Comorbid MDD
Official title: Behavioral Activation + Cognitive Processing Therapy for Posttraumatic Stress Disorder and Comorbid Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Stress Disorder
Major Depressive Disorder
Keywords: Posttraumatic Stress Disorder
Major Depressive Disorder
Behavioral Activation
Cognitive Processing Therapy
Comorbidity
Military
Lead sponsor: United States Naval Medical Center, San Diego
Sponsor class: FED
Collaborators: name: Naval Health Research Center
First posted: 2016-08-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Montgomery-Asberg Depression Rating Scale (MADRS)
timeFrame: Prior to beginning treatment through three months following treatment completion (approximately 10 months)
Secondary outcomes:
measure: Clinician-Administered PTSD Scale for the DSM-5 (CAPS-5)
timeFrame: Prior to beginning treatment through three months following treatment completion (approximately 10 months)
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Prior to beginning treatment through three months following treatment completion (approximately 10 months)
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Naval Medical Center San Diego
state: California
Study officials:
affiliation: United States Naval Medical Center, San Diego
name: William M. Hunt, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.