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- Ensaio Clínico NCT01045655
MOMCare: Culturally Relevant Treatment Services for Perinatal Depression (MOMCare)
For Moms: Culturally Relevant Treatment Services for Perinatal Depression
Visão geral do estudo
Descrição detalhada
The randomized control trial will evaluate the effects of a culturally relevant, multi-component intervention for antenatal depression. MOMCare has the potential to overcome patient, provider, and system-level barriers to care and engage depressed, low-income women in evidence-based treatments to reduce antenatal depressive symptoms, improve maternal psychosocial functioning, and ameliorate postpartum depression. Specific Aim 1: To evaluate the impact of MOMCare on treatment engagement and retention. Specific Aim 2: To evaluate the impact of MOMCare on maternal clinical symptoms and functional outcomes. Specific Aim 3: To conduct an incremental cost-effectiveness analysis for a health care and welfare agency perspective that includes a) tracking the medical costs of health service use in MOMCare and usual care patients; b) monitoring the use of infant preventative health services in both groups; and c) tracking the percentage of women on Medicaid and the percentage working in both groups.
The intervention will be assessed through a practical randomized controlled trial in which we have recruited 168 pregnant women with major depression and/or dysthymia who were on Medicaid and/or received Maternal Support Services (MSS) in selected public health centers in Seattle - King County (PHSKC). Patients who were eligible and consented to study enrollment were randomly assigned to either usual care (UC) or MOMCare. Baseline and four follow-up assessments (3 - 18 months post-baseline) are scheduled for study participants in both groups. The MOMCare intervention includes a choice of brief interpersonal psychotherapy or collaborative management of antidepressant medication. Treatment response will be monitored, and the treatment will be adjusted as necessary (adding treatments, increasing dosages).
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Washington
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Seattle, Washington, Estados Unidos, 98105
- University of Washington
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- 18 or older
- pregnant: 12-32 weeks gestation
- able to speak English
- telephone access
- major depressive disorder or dysthymia
- on Medicaid
- receiving health care in King County, Washington
Exclusion Criteria:
- currently in psychotherapy
- currently receiving pharmacotherapy from a psychiatrist
- high suicide risk
- history of bipolar disorder
- history of schizophrenia
- substance use or dependence in previous 3 months
- currently in a relationship with severe interpersonal violence
- history of repetitive self-harm behavior
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Experimental: MOMCare intervention
Depression care treatment with study depression care specialist (brief interpersonal psychotherapy or pharmacotherapy)
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8 sessions of brief interpersonal psychotherapy or medication management; maintenance sessions through 12 months postpartum.
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Sem intervenção: Care Plus
Usual care group; referral to community mental health treatment
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
---|---|
SCL-20 depression
Prazo: baseline, 3, 6 12, 18 month follow-ups
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baseline, 3, 6 12, 18 month follow-ups
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Medidas de resultados secundários
Medida de resultado |
Prazo |
---|---|
Maternal health services utilization use and estimated costs
Prazo: baseline, 3, 6 12, 18 month follow-ups
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baseline, 3, 6 12, 18 month follow-ups
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Pregnancy, delivery, birth outcomes
Prazo: 6 month follow-up
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6 month follow-up
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Child services & outcomes (immunizations, well-child visits)
Prazo: 6, 12, 18 month follow-ups
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6, 12, 18 month follow-ups
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Depression free days & Quality Adjusted Life Years (EuroQol)
Prazo: 3, 6, 12, 18 month follow-ups
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3, 6, 12, 18 month follow-ups
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Quality of depression care process
Prazo: 3, 6, 12, 18 month follow-ups
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3, 6, 12, 18 month follow-ups
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Number of depression treatment sessions attended
Prazo: 3, 6, 12, 18 month follow-ups
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3, 6, 12, 18 month follow-ups
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PHQ-9 depression
Prazo: screening, baseline, 3, 6, 12, 18 month follow-ups
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screening, baseline, 3, 6, 12, 18 month follow-ups
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Edinburgh Postnatal Depression Scale
Prazo: baseline, 3, 6, 12, 18 month follow-ups
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baseline, 3, 6, 12, 18 month follow-ups
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Social Functioning (Work & Social Adjustment, Social & Leisure, Social Support)
Prazo: baseline, 3, 6, 12, 18 month follow-ups
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baseline, 3, 6, 12, 18 month follow-ups
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Inventory of Functional Status After Childbirth (IFSAC)
Prazo: 6, 12, 18 month follow-ups
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6, 12, 18 month follow-ups
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Nancy K Grote, PhD, University of Washington
Publicações e links úteis
Publicações Gerais
- Grote NK, Katon WJ, Russo JE, Lohr MJ, Curran M, Galvin E, Carson K. COLLABORATIVE CARE FOR PERINATAL DEPRESSION IN SOCIOECONOMICALLY DISADVANTAGED WOMEN: A RANDOMIZED TRIAL. Depress Anxiety. 2015 Nov;32(11):821-34. doi: 10.1002/da.22405. Epub 2015 Sep 8.
- Grote NK, Katon WJ, Russo JE, Lohr MJ, Curran M, Galvin E, Carson K. A Randomized Trial of Collaborative Care for Perinatal Depression in Socioeconomically Disadvantaged Women: The Impact of Comorbid Posttraumatic Stress Disorder. J Clin Psychiatry. 2016 Nov;77(11):1527-1537. doi: 10.4088/JCP.15m10477.
- Grote NK, Katon WJ, Lohr MJ, Carson K, Curran M, Galvin E, Russo JE, Gregory M. Culturally relevant treatment services for perinatal depression in socio-economically disadvantaged women: the design of the MOMCare study. Contemp Clin Trials. 2014 Sep;39(1):34-49. doi: 10.1016/j.cct.2014.07.001. Epub 2014 Jul 10.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
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
- R01MH084897 (Concessão/Contrato do NIH dos EUA)
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