[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653165":3},{"organization":4,"outcomesModule":7,"designInfo":28,"detailedDescription":37,"studyPopulation":31,"armGroups":38,"interventions":51,"overallOfficials":31,"centralContacts":59,"locations":65,"responsibleParty":88,"collaborators":92,"id":99,"slug":100,"hasResults":101,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":101,"sex":107,"minAge":108,"maxAge":31,"enrollmentInfo":109,"targetDuration":31,"studyType":112,"phases":113,"briefSummary":115,"conditions":116,"keywords":118,"overallStatus":126,"whyStopped":31,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":136},{"fullName":5,"class":6},"University of California, Los Angeles","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":23},[9],{"measure":10,"description":11,"timeFrame":12},"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).","3- and 6-month follow up",[14,17,20],{"measure":15,"description":16,"timeFrame":12},"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).",{"measure":18,"description":19,"timeFrame":12},"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.",{"measure":21,"description":22,"timeFrame":12},"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.",[24],{"measure":25,"description":26,"timeFrame":27},"Treatment Engagement","Treatment engagement will be conceptualized as the number of cCBT sessions completed. A higher number indicates more cCBT sessions completed, but isn't indicative of a better or worse outcome.","6-months",{"allocation":29,"interventionModel":30,"interventionModelDescription":31,"primaryPurpose":32,"observationalModel":31,"timePerspective":31,"maskingInfo":33},"RANDOMIZED","PARALLEL",null,"HEALTH_SERVICES_RESEARCH",{"masking":34,"maskingDescription":31,"whoMasked":35},"SINGLE",[36],"OUTCOMES_ASSESSOR","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.\n\nSignificance\u002FImpact: 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.\n\nInnovation: 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\u002F7 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.\n\nSpecific Aims\u002FMethodology: 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\u002Fcoaches, quality improvement, and data monitoring\u002Fdashboards. 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.\n\nNext Steps\u002FImplementation: 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.",[39,45],{"label":40,"type":41,"description":42,"interventionNames":43},"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.",[44],"Behavioral: Enhanced Usual Care (EUC)",{"label":46,"type":47,"description":48,"interventionNames":49},"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.",[50],"Behavioral: Supported Online Self-help for Depression (SOS-Depression)",[52,56],{"type":53,"name":40,"description":54,"armGroupLabels":55,"otherNames":31},"BEHAVIORAL","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.",[40],{"type":53,"name":46,"description":57,"armGroupLabels":58,"otherNames":31},"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.",[46],[60],{"name":61,"role":62,"phone":63,"phoneExt":31,"email":64},"Lucinda B Leung, MD, PhD, MPH","CONTACT","310-267-7780","sos.depression@mednet.ucla.edu",[66,79],{"facility":67,"status":31,"city":68,"state":69,"zip":70,"country":71,"countryCode":72,"cosmosGeoPoint":73,"geoPoint":78,"contacts":31},"VA San Diego Healthcare System","San Diego","California","92161","United States","US",{"type":74,"coordinates":75},"Point",[76,77],-117.16472,32.71571,{"lat":77,"lon":76},{"facility":80,"status":31,"city":81,"state":69,"zip":82,"country":71,"countryCode":72,"cosmosGeoPoint":83,"geoPoint":87,"contacts":31},"VA Greater Los Angeles Healthcare System","West Los Angeles","90073-1003",{"type":74,"coordinates":84},[85,86],-118.43068,34.0462,{"lat":86,"lon":85},{"type":89,"investigatorFullName":90,"investigatorTitle":91,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"PRINCIPAL_INVESTIGATOR","Lucinda B. Leung, MD, PhD, MPH","Associate Professor of Medicine and Psychiatry",[93,96,97],{"name":94,"class":95},"San Diego Veterans Healthcare System","FED",{"name":80,"class":95},{"name":98,"class":95},"Congressionally Directed Medical Research Programs","100653165","supported-online-self-help-for-veterans-with-depression-in-primary-care-100653165",false,"NCT07781228","Supported Online Self-Help for Veterans With Depression in Primary Care","Supported Online Self-Help for Veterans With Depression in Primary Care (SOS-Depression)","SOS-Depression","Inclusion Criteria:\n\n* Must be enrolled in the VHA and currently receiving primary care services at VA Los Angeles or San Diego\n* Have access to computer (mobile or desktop), internet, telephone, and email\n* Able to read English text on a computer screen\n* Score 10 or higher on the PHQ-9\n\nExclusion Criteria:\n\n* Have moderate-high suicide risk (e.g. suicide flag) or active suicidality\n* Have other serious mental illness (e.g. bipolar disorder, psychosis)\n* Have medical disorder that would prevent\u002F interfere with participation (e.g. dementia\u002Fcognitive impairment, terminal illness)","ALL","18 Years",{"count":110,"type":111},400,"ESTIMATED","INTERVENTIONAL",[114],"NA","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).",[117],"Depression",[119,117,120,121,122,123,124,125],"Cognitive Behavioral Therapy","Veterans Health","Telehealth","mHealth","Peer Group","Primary Health Care","Chronic Care Management","NOT_YET_RECRUITING","2026-08-19",{"date":129,"type":130},"2026-08-24","ACTUAL",{"date":132,"type":111},"2026-09",{"date":134,"type":111},"2029-08",{"name":5,"class":6},2]