DepressionSOS-DepressionNCT07781228
Supported Online Self-Help for Veterans With Depression in Primary Care
A study testing Supported Online Self-help for Depression (SOS-Depression) in people with Depression, run by University of California, Los Angeles at 2 sites in United States.
Trial summary
Depression is disabling and affects one in five Veterans. VA's Primary Care-Mental health Integration (PCMHI) enables specialists to support medication treatment in primary care, but timely and sufficient access to psychotherapy is unattainable despite Veteran preference for psychotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Supported Online Self-help for Depression (SOS-Depression)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2026to Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be enrolled in the VHA and currently receiving primary care services at VA Los Angeles or San Diego
- Have access to computer (mobile or desktop), internet, telephone, and email
- Able to read English text on a computer screen
- Score 10 or higher on the PHQ-9
Who cannot join
- Have moderate-high suicide risk (e.g. suicide flag) or active suicidality
- Have other serious mental illness (e.g. bipolar disorder, psychosis)
- Have medical disorder that would prevent/ interfere with participation (e.g. dementia/cognitive impairment, terminal illness)
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
VA San Diego Healthcare System
San Diego, California, 92161
VA Greater Los Angeles Healthcare System
West Los Angeles, California, 90073-1003
About this study
Official title: Supported Online Self-Help for Veterans With Depression in Primary Care (SOS-Depression)
Depression is disabling and affects one in five Veterans. VA's Primary Care-Mental health Integration (PCMHI) enables specialists to support medication treatment in primary care, but timely and sufficient access to psychotherapy is unattainable despite Veteran preference for psychotherapy. This study aims to close the gap in psychotherapy access for VA primary care patients with depression by adapting PCMHI collaborative care models to improve uptake of peer-supported computerized cognitive behavioral therapy (cCBT).
Read the detailed description
Background: VA's Primary Care-Mental Health Integration (PCMHI) is rooted in evidence-based collaborative care models, where care managers, mental health specialists, and primary care providers jointly treat depression in primary care. While PCMHI enabled specialists to support medication treatment in primary care, access to psychotherapy is not timely and sufficient. Alternative therapy modalities are needed. Peer-supported cCBT for depression has been shown to be effective but is not yet widely used within VA.
Significance/Impact: Depression is disabling and affects one in five Veterans. Psychotherapy is preferred by Veterans, but fraught with multilevel barriers (e.g., staff availability, patient travel to clinic, limited clinic hours). Without enhancing existing PCMHI models to enable better primary care patient access to effective psychotherapies, Veteran engagement in depression treatment is unlikely to improve.
Innovation: This study aims to close the gap in psychotherapy access for VA primary care patients with depression by adapting PCMHI collaborative care models to improve uptake of peer-supported computerized cognitive behavioral therapy (cCBT). cCBT is accessible 24/7 via the internet and has effectively treated depression in more than 30 trials. With peer specialist support, it is comparable to face-to-face psychotherapy. Peer support specialists and PCMHI teams can facilitate Veteran uptake of cCBT, using an evidence-based collaborative care model to provide the follow-up care management and mental health specialist back-up that characterizes the most effective cCBT trials.
Specific Aims/Methodology: This study involves 400 recent military service members and Veterans in VA Greater Los Angeles and San Diego. VA providers help service members undergoing discharge at military treatment facilities transition to the VA for care. Once at the VA, providers screen patients every year for depression. This randomized clinical trial will study the implementation and effectiveness of online therapy for depression. First, to help providers deliver and monitor online treatment, we will use three tested strategies for implementation: facilitators/coaches, quality improvement, and data monitoring/dashboards. Second, we will randomly assign patients who are newly diagnosed with depression to receive either: 1) online therapy supported by Veterans peers and VA PCMHI clinical teams (SOS-D intervention), or 2) online therapy supported by VA PCMHI clinical teams alone (enhanced usual care). Our research team will measure and compare depressive symptoms at the study start then at 3 months and 6 months across both groups. We will measure how much online therapy is used by each group. Third, through interviews we will compare the experiences of women Veterans and patients with TBI using online therapy to men Veterans and those without TBI.
Next Steps/Implementation: This research will demonstrate how online depression treatment can be given to military service members, Veterans, and civilians on a larger scale. Bringing Veteran peers onto VA clinical teams can enhance use of online therapy for depression and support Veteran recovery. Ensuring depression treatment is available immediately when needs are identified is important in preventing suicide.
- Conditions
- Depression
- Being tested
- Enhanced Usual Care (EUC), Supported Online Self-help for Depression (SOS-Depression)
- Keywords
- Cognitive Behavioral Therapy, Depression, Veterans Health, Telehealth, mHealth, Peer Group, Primary Health Care, Chronic Care Management
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Usual Care (EUC)Behavioural
Enhanced usual care includes all the usual depression care at the VA and access to an online therapy program with no peer support sessions. The online therapy program offered consists of several modules for depression care, specifically tailored for Veterans.
Supported Online Self-help for Depression (SOS-Depression)Behavioural
Supported Online Self-help for Depression (SOS-Depression) includes all the usual depression care at the VA and access to an online therapy program with support sessions with a peer. The online therapy program consists of several modules for depression care, specifically tailored for Veterans.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Usual Care (EUC) | Active comparator | Participants in the enhanced usual care arm will receive access to computerized cognitive behavioral therapy (cCBT) supported by a care manager in addition to the usual care provided. Receives: Behavioral: Enhanced Usual Care (EUC) |
| Supported Online Self-help for Depression (SOS-Depression) | Experimental | Participants in the intervention arm will receive computerized cognitive behavioral therapy (cCBT) supported by a care manager and a designated Peer support specialist in addition to the usual care provided. Receives: Behavioral: Supported Online Self-help for Depression (SOS-Depression) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Health Questionnaire (PHQ-9)
The Patient Health Questionnaire (PHQ-9) is a scale commonly used to measure and categorize depression symptoms. It is already administered as part of routine primary care at our study site. The minimum score is 0, the maximum is 27. A higher score indicates a worse outcome (i.e. more severe depression symptoms).
Measured: 3- and 6-month follow up
Secondary outcomes (3)
Behavioral Activation for Depression Scale (BADS-SF)
The 9-item Behavioral Activation for Depression Scale (BADS-SF) will also be used to examine behavioral activation as an intermediary to depression symptomatology outcomes. The minimum score is 0, the maximum is 54. Higher scores indicate a better outcome (i.e., higher activation).
Measured: 3- and 6-month follow up
Generalized Anxiety Disorder (GAD-7)
The 7-item Generalized Anxiety Disorder (GAD-7) is among the most commonly used and best validated anxiety measures in primary care settings. The minimum score is 0, the maximum is 21. Higher scores indicate a worse outcome (i.e., more severe anxiety). For reference: scores of 0-4=minimal anxiety, 5-9=mild anxiety, 10-14=moderate anxiety, and 15-21=severe anxiety.
Measured: 3- and 6-month follow up
World Health Organization Disability Assessment Schedule (WHODAS 2.0)
The World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) 12-item version is a brief self-report measure that will be used to assess functioning and disability across multiple domains of daily life. The minimum score is 0, and the maximum score is 48. Higher scores indicate greater disability.
Measured: 3- and 6-month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionMar 2029 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- San Diego Veterans Healthcare System, VA Greater Los Angeles Healthcare System, Congressionally Directed Medical Research Programs
- Responsible party
- Principal investigator, Lucinda B. Leung, MD, PhD, MPH, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07781228
- Sponsor's protocol ID
- IRB-25-0799
- Other IDs
- HT9425-25-1-0831
- Acronym
- SOS-Depression
- Status last verified
- Aug 2026
- First submitted
- 19 Aug 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data collected during this clinical trial will be made available to the research community by depositing de-identified data into the NIMH Data Archive (NDA). All of the NIMH Common Data Elements (CDEs) will be collected for this study, following the NIMH expectations. In addition to the CDEs required by the NDA, we will also submit data elements covering demographics and health outcomes, healthcare services use, and satisfaction. We will use NIH-endorsed CDEs when possible. * Sex * Marital status * Ethnicity * Race * Level of education * Work status * Housing status * Behavioral Activation for Depression Scale (BADS-SF) * Alcohol Use Disorders Identification Test (AUDIT-C) * Columbia-Suicide Severity Rating Scale (C-SSRS) * Posttraumatic Stress Disorder (PTSD) Checklist for DSM-5 * Client Satisfaction Questionnaire (CSQ-I) * System Usability Scale (SUS)
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supported Online Self-Help for Veterans With Depression in Primary Care (SOS-Depression)
- ClinicalTrials.gov ID
- NCT07781228
- Acronym / sponsor ID
- SOS-Depression / IRB-25-0799
- Conditions
- Depression
- Keywords
- Cognitive Behavioral Therapy, Depression, Veterans Health, Telehealth, mHealth, Peer Group, Primary Health Care, Chronic Care Management
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- San Diego Veterans Healthcare System, VA Greater Los Angeles Healthcare System, Congressionally Directed Medical Research Programs
- Study start
- Sep 2026 (estimated)
- Primary completion
- Mar 2029 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 24 Aug 2026 (actual)
- 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.
Depression is disabling and affects one in five Veterans. VA's Primary Care-Mental health Integration (PCMHI) enables specialists to support medication treatment in primary care, but timely and sufficient access to psychotherapy is unattainable despite Veteran preference for psychotherapy. This study aims to close the gap in psychotherapy access for VA primary care patients with depression by adapting PCMHI collaborative care models to improve uptake of peer-supported computerized cognitive behavioral therapy (cCBT).
Detailed description
Background: VA's Primary Care-Mental Health Integration (PCMHI) is rooted in evidence-based collaborative care models, where care managers, mental health specialists, and primary care providers jointly treat depression in primary care. While PCMHI enabled specialists to support medication treatment in primary care, access to psychotherapy is not timely and sufficient. Alternative therapy modalities are needed. Peer-supported cCBT for depression has been shown to be effective but is not yet widely used within VA.
Significance/Impact: Depression is disabling and affects one in five Veterans. Psychotherapy is preferred by Veterans, but fraught with multilevel barriers (e.g., staff availability, patient travel to clinic, limited clinic hours). Without enhancing existing PCMHI models to enable better primary care patient access to effective psychotherapies, Veteran engagement in depression treatment is unlikely to improve.
Innovation: This study aims to close the gap in psychotherapy access for VA primary care patients with depression by adapting PCMHI collaborative care models to improve uptake of peer-supported computerized cognitive behavioral therapy (cCBT). cCBT is accessible 24/7 via the internet and has effectively treated depression in more than 30 trials. With peer specialist support, it is comparable to face-to-face psychotherapy. Peer support specialists and PCMHI teams can facilitate Veteran uptake of cCBT, using an evidence-based collaborative care model to provide the follow-up care management and mental health specialist back-up that characterizes the most effective cCBT trials.
Specific Aims/Methodology: This study involves 400 recent military service members and Veterans in VA Greater Los Angeles and San Diego. VA providers help service members undergoing discharge at military treatment facilities transition to the VA for care. Once at the VA, providers screen patients every year for depression. This randomized clinical trial will study the implementation and effectiveness of online therapy for depression. First, to help providers deliver and monitor online treatment, we will use three tested strategies for implementation: facilitators/coaches, quality improvement, and data monitoring/dashboards. Second, we will randomly assign patients who are newly diagnosed with depression to receive either: 1) online therapy supported by Veterans peers and VA PCMHI clinical teams (SOS-D intervention), or 2) online therapy supported by VA PCMHI clinical teams alone (enhanced usual care). Our research team will measure and compare depressive symptoms at the study start then at 3 months and 6 months across both groups. We will measure how much online therapy is used by each group. Third, through interviews we will compare the experiences of women Veterans and patients with TBI using online therapy to men Veterans and those without TBI.
Next Steps/Implementation: This research will demonstrate how online depression treatment can be given to military service members, Veterans, and civilians on a larger scale. Bringing Veteran peers onto VA clinical teams can enhance use of online therapy for depression and support Veteran recovery. Ensuring depression treatment is available immediately when needs are identified is important in preventing suicide.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced Usual Care (EUC) | Active comparator | Behavioral: Enhanced Usual Care (EUC)Participants in the enhanced usual care arm will receive access to computerized cognitive behavioral therapy (cCBT) supported by a care manager in addition to the usual care provided. |
| Supported Online Self-help for Depression (SOS-Depression) | Experimental | Behavioral: Supported Online Self-help for Depression (SOS-Depression)Participants in the intervention arm will receive computerized cognitive behavioral therapy (cCBT) supported by a care manager and a designated Peer support specialist in addition to the usual care provided. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Must be enrolled in the VHA and currently receiving primary care services at VA Los Angeles or San Diego
- Have access to computer (mobile or desktop), internet, telephone, and email
- Able to read English text on a computer screen
- Score 10 or higher on the PHQ-9
Key exclusion criteria (3 listed)
- Have moderate-high suicide risk (e.g. suicide flag) or active suicidality
- Have other serious mental illness (e.g. bipolar disorder, psychosis)
- Have medical disorder that would prevent/ interfere with participation (e.g. dementia/cognitive impairment, terminal illness)
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 |
|---|---|---|
| Enhanced Usual Care (EUC)Enhanced usual care includes all the usual depression care at the VA and access to an online therapy program with no peer support sessions. The online therapy program offered consists of several modules for depression care, specifically tailored for Veterans. | Behavioural | Enhanced Usual Care (EUC) |
| Supported Online Self-help for Depression (SOS-Depression)Supported Online Self-help for Depression (SOS-Depression) includes all the usual depression care at the VA and access to an online therapy program with support sessions with a peer. The online therapy program consists of several modules for depression care, specifically tailored for Veterans. | Behavioural | Supported Online Self-help for Depression (SOS-Depression) |
Primary outcome
Patient Health Questionnaire (PHQ-9)
Time frame: 3- and 6-month follow up
The Patient Health Questionnaire (PHQ-9) is a scale commonly used to measure and categorize depression symptoms. It is already administered as part of routine primary care at our study site. The minimum score is 0, the maximum is 27. A higher score indicates a worse outcome (i.e. more severe depression symptoms).
3 secondary outcomes
Behavioral Activation for Depression Scale (BADS-SF)
Time frame: 3- and 6-month follow up
Generalized Anxiety Disorder (GAD-7)
Time frame: 3- and 6-month follow up
World Health Organization Disability Assessment Schedule (WHODAS 2.0)
Time frame: 3- and 6-month follow up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Individual participant dataSharing planned: Yes. The data collected during this clinical trial will be made available to the research community by depositing de-identified data into the NIMH Data Archive (NDA). All of the NIMH Common Data Elements (CDEs) will be collected for this study, following the NIMH expectations. In addition to the CDEs required by the NDA, we will also submit data elements covering demographics and health outcomes, healthcare services use, and satisfaction. We will use NIH-endorsed CDEs when possible. * Sex * Marital status * Ethnicity * Race * Level of education * Work status * Housing status * Behavioral Activation for Depression Scale (BADS-SF) * Alcohol Use Disorders Identification Test (AUDIT-C) * Columbia-Suicide Severity Rating Scale (C-SSRS) * Posttraumatic Stress Disorder (PTSD) Checklist for DSM-5 * Client Satisfaction Questionnaire (CSQ-I) * System Usability Scale (SUS)
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supported Online Self-help for Depression (SOS-Depression) in people with Depression, run by University of California, Los Angeles at 2 sites 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 4 inclusion and 3 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: opening soon, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lucinda B Leung, MD, PhD, MPH (310-267-7780, sos.depression@mednet.ucla.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Health Questionnaire (PHQ-9) (time frame: 3- and 6-month follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Aug 2026.