Posttraumatic Stress DisorderNCT02874131
Behavioral Activation + Cognitive Processing Therapy for PTSD and Comorbid MDD
A study testing Behavioral Activation and Cognitive Processing Therapy in people with Posttraumatic Stress Disorder and Major Depressive Disorder, run by United States Naval Medical Center, San Diego at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Posttraumatic Stress Disorder, Major Depressive Disorder
- What is being tested?
- Behavioral Activation and Cognitive Processing Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2015to 18 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Naval Medical Center San Diego
San Diego, California, 92134
About this study
Official title: Behavioral Activation + Cognitive Processing Therapy for Posttraumatic Stress Disorder and Comorbid Major Depressive Disorder
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.
Read the 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.
- Being tested
- Behavioral Activation, Cognitive Processing Therapy
- Keywords
- Posttraumatic Stress Disorder, Major Depressive Disorder, Behavioral Activation, Cognitive Processing Therapy, Comorbidity, Military
- Medical subject headings
- Stress Disorders, Post-Traumatic, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral ActivationBehavioural
Also called BA
Behavioral activation
Cognitive Processing TherapyBehavioural
Also called CPT
Cognitive processing therapy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Cognitive Processing Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montgomery-Asberg Depression Rating Scale (MADRS)
Assessor-administered measure of depression symptoms
Measured: 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)
Assessor-administered measure of PTSD symptoms
Measured: Prior to beginning treatment through three months following treatment completion (approximately 10 months)
Patient Health Questionnaire (PHQ-9)
Self-report measure of depression symptoms
Measured: Prior to beginning treatment through three months following treatment completion (approximately 10 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2016 (estimated)
- Study start20 Oct 2015
- Primary completion18 Mar 2022
- Study completion18 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- United States Naval Medical Center, San Diego
- Sponsor type
- US federal agency
- Collaborators
- Naval Health Research Center
- Responsible party
- Principal investigator, Kristen Walter, United States Naval Medical Center, San Diego
- Investigators
- William M. Hunt, Ph.D., Principal investigator, United States Naval Medical Center, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02874131
- Sponsor's protocol ID
- NMCSD.2015.0039
- Status last verified
- Nov 2024
- First submitted
- 2 Aug 2016
- Last updated
- 15 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: Data will be available only in aggregate
Publications
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.
PubMed 29107036Walter 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.
PubMed 37418778Kline 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.
PubMed 38497740Kline AC, Crocker LD, Otis NP, Vera JD, Myers HC, Glassman LH, Michael Hunt W, Walter KH. Treatment dose and reliable change in trauma-focused therapy for comorbid PTSD and MDD. Psychother Res. 2026 Sep 9:1-14. doi: 10.1080/10503307.2026.2724950. Online ahead of print.
PubMed 42714093Glassman 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.
PubMed 41620779Otis 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.
PubMed 40288269
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Activation + Cognitive Processing Therapy for Posttraumatic Stress Disorder and Comorbid Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT02874131
- Acronym / sponsor ID
- NMCSD.2015.0039
- Keywords
- Posttraumatic Stress Disorder, Major Depressive Disorder, Behavioral Activation, Cognitive Processing Therapy, Comorbidity, Military
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- United States Naval Medical Center, San DiegoUS federal agency
- Collaborators
- Naval Health Research Center
- Study start
- 20 Oct 2015 (actual)
- Primary completion
- 18 Mar 2022 (actual)
- Study completion
- 18 Mar 2022 (actual)
- First posted
- 22 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral Activation + CPT | Experimental | Behavioral: Behavioral Activation, Behavioral: Cognitive Processing TherapyBehavioral 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. |
| Cognitive Processing Therapy | Active comparator | Behavioral: Cognitive Processing TherapyCPT is an evidence-based treatment for PTSD that has also been shown to reduce depression symptoms. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral ActivationAlso: BABehavioral activation | Behavioural | Behavioral Activation + CPT |
| Cognitive Processing TherapyAlso: CPTCognitive processing therapy | Behavioural | Behavioral Activation + CPT, Cognitive Processing Therapy |
Primary outcome
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
2 secondary outcomes
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)
Patient Health Questionnaire (PHQ-9)
Time frame: Prior to beginning treatment through three months following treatment completion (approximately 10 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2024.
- Background: PubMed 29107036Walter 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.
- Results publication: PubMed 37418778Walter 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.
- Results publication: PubMed 38497740Kline 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.
- Derived from this study: PubMed 42714093Kline AC, Crocker LD, Otis NP, Vera JD, Myers HC, Glassman LH, Michael Hunt W, Walter KH. Treatment dose and reliable change in trauma-focused therapy for comorbid PTSD and MDD. Psychother Res. 2026 Sep 9:1-14. doi: 10.1080/10503307.2026.2724950. Online ahead of print.
- Derived from this study: PubMed 41620779Glassman 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.
- Derived from this study: PubMed 40288269Otis 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.
- Individual participant dataSharing planned: No. Data will be available only in aggregate
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William M. Hunt, Ph.D. principal investigator
United States Naval Medical Center, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Activation and Cognitive Processing Therapy in people with Posttraumatic Stress Disorder and Major Depressive Disorder, run by United States Naval Medical Center, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montgomery-Asberg Depression Rating Scale (MADRS) (time frame: Prior to beginning treatment through three months following treatment completion (approximately 10 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02874131, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2024.