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Supported Online Self-Help for Veterans With Depression in Primary Care

Supported Online Self-Help for Veterans With Depression in Primary Care (SOS-Depression)

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07781228
Acronym
SOS-Depression
Enrollment
400
Registered
2026-08-24
Start date
2026-09-01
Completion date
2029-08-01
Last updated
2026-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Keywords

Cognitive Behavioral Therapy, Depression, Veterans Health, Telehealth, mHealth, Peer Group, Primary Health Care, Chronic Care Management

Brief 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. 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.

Interventions

BEHAVIORALEnhanced 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.

BEHAVIORALSupported 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.

Sponsors

University of California, Los Angeles
Lead SponsorOTHER
San Diego Veterans Healthcare System
CollaboratorFED
VA Greater Los Angeles Healthcare System
CollaboratorFED
Congressionally Directed Medical Research Programs
CollaboratorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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)

Design outcomes

Primary

MeasureTime frameDescription
Patient Health Questionnaire (PHQ-9)3- and 6-month follow upThe 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).

Secondary

MeasureTime frameDescription
Behavioral Activation for Depression Scale (BADS-SF)3- and 6-month follow upThe 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).
Generalized Anxiety Disorder (GAD-7)3- and 6-month follow upThe 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.
World Health Organization Disability Assessment Schedule (WHODAS 2.0)3- and 6-month follow upThe 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.

Countries

United States

Contacts

CONTACTLucinda B Leung, MD, PhD, MPH
sos.depression@mednet.ucla.edu310-267-7780

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 25, 2026