Supported Online Self-Help for Veterans With Depression in Primary Care (SOS-Depression)
Supported Online Self-Help for Veterans With Depression in Primary Care (SOS-Depression)
Visão geral do estudo
Status
Condições
Descrição detalhada
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.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Lucinda B Leung, MD, PhD, MPH
- Número de telefone: 310-267-7780
- E-mail: sos.depression@mednet.ucla.edu
Locais de estudo
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California
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San Diego, California, Estados Unidos, 92161
- VA San Diego Healthcare System
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West Los Angeles, California, Estados Unidos, 90073-1003
- VA Greater Los Angeles Healthcare System
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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)
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Pesquisa de serviços de saúde
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Comparador Ativo: 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.
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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.
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Experimental: 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.
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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.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Patient Health Questionnaire (PHQ-9)
Prazo: 3- and 6-month follow up
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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).
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3- and 6-month follow up
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Behavioral Activation for Depression Scale (BADS-SF)
Prazo: 3- and 6-month follow up
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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).
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3- and 6-month follow up
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Generalized Anxiety Disorder (GAD-7)
Prazo: 3- and 6-month follow up
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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.
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3- and 6-month follow up
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World Health Organization Disability Assessment Schedule (WHODAS 2.0)
Prazo: 3- and 6-month follow up
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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.
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3- and 6-month follow up
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Treatment Engagement
Prazo: 6-months
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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.
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6-months
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Colaboradores e Investigadores
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- IRB-25-0799
- HT9425-25-1-0831 (Número de outro subsídio/financiamento: Congressionally Directed Medical Research Programs (CDMRP))
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
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)
Prazo de Compartilhamento de IPD
Critérios de acesso de compartilhamento IPD
UCLA is committed to the ideals of collaborative research, and as such, will adhere to the sponsors Grant Policy on Sharing of Unique Research Resources. The data collected for this research represent a valuable resource to the scientific community, and we will undertake all reasonable procedures to make them accessible to others, while respecting the special needs for confidentiality. 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).
The NDA houses, harmonizes, and shares all human-subjects data collected as part of NIMH-funded projects with the goal of accelerating progress in the research of mental health. NDA is one database infrastructure that supports efforts to make data collected by different laboratories as consistent as possible and allow other researchers to access those data for secondary use. NDA stores and shares clinical/phenotypic, imaging, genomic, and othe
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