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| Name | Class |
|---|---|
| Naval Health Research Center | FED |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Cognitive Processing Therapy | Active Comparator | CPT is an evidence-based treatment for PTSD that has also been shown to reduce depression symptoms. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral Activation | Behavioral | Behavioral activation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Patient Health Questionnaire (PHQ-9) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William M. Hunt, Ph.D. | United States Naval Medical Center, San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Naval Medical Center San Diego | San Diego | California | 92134 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29107036 | Background | 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. | |
| 37418778 |
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Data will be available only in aggregate
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D003866 | Depressive Disorder |
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| ID | Term |
|---|---|
| C000708228 | 2-cyclohexylidenhydrazo-4-phenyl-thiazole |
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| Cognitive Processing Therapy | Behavioral | Cognitive processing therapy |
|
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Self-report measure of depression symptoms
| Prior to beginning treatment through three months following treatment completion (approximately 10 months) |
| 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. |
| 38497740 | 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. |
| 41620779 | Derived | 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;14(1):284. doi: 10.1186/s40359-025-03878-4. |
| 40288269 | 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. |
| D019964 | Mood Disorders |