- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01045655
MOMCare: Culturally Relevant Treatment Services for Perinatal Depression (MOMCare)
For Moms: Culturally Relevant Treatment Services for Perinatal Depression
Descripción general del estudio
Descripción detallada
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 estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Washington
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Seattle, Washington, Estados Unidos, 98105
- University of Washington
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
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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Sin intervención: Care Plus
Usual care group; referral to community mental health treatment
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
SCL-20 depression
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
Maternal health services utilization use and estimated costs
Periodo de tiempo: 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
Periodo de tiempo: 6 month follow-up
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6 month follow-up
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Child services & outcomes (immunizations, well-child visits)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- R01MH084897 (Subvención/contrato del NIH de EE. UU.)
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