Perinatal Depression Treatment in a Pediatric Setting- Pilot Phase (MITT)
Adapting Collaborative Care Perinatal Depression Treatment to a Pediatric Setting - Pilot Phase
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This research project consists of two phases that are designed, in sequence, to adapt standard collaborative care depression treatment to the unique needs of low-income depressed postpartum women and to the pediatric setting where women will receive the treatment. These adaptations, in turn, are designed to improve maternal engagement in and adherence to depression treatment, the primary outcomes at this early stage of intervention development. Phase I is the initial pilot project in which the model will be developed. We will 1) adapt standard collaborative care depression models into the Mother-Infant Treatment Team (MITT) intervention and develop a procedure manual based on maternal and provider input, 2) pilot the MITT intervention with 10 depressed mothers to test the feasibility of implementing the model, and 3) evaluate the experiences of participating mothers and providers to revise and finalize MITT processes and procedures.
Phase II will be an open label trial of MITT to determine whether MITT is associated with improved maternal engagement and adherence to depression treatment.
We will pilot MITT with 10 mothers to determine the feasibility of implementing MITT. We will collect recruitment and logistical feasibility measures. We will also determine engagement and adherence rates to treatment as well as the effort required to engage women in treatment.
We will determine mothers' and providers' perceptions of their experiences with MITT and will use all of this information to revise the MITT protocol in preparation for Phase II.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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New York
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Rochester, New York, Estados Unidos, 14642
- University of Rochester
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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:
- Mothers of infants 12 months of age or younger who present to the Pediatric Practice at Golisano Children's Hospital
- Women who are 18 years of age or older
- Mothers who understand and speak English sufficiently to participate in therapy with an English speaking provider
- Have a current score of > 10 on the EPDS
- Provide written informed consent
- Meet criteria for unipolar major depressive disorder.
Exclusion Criteria:
Women who:
- do not speak or understand English well enough to participate in the therapy with an English speaking provider
- are under 18 years of age
- children are not cared for at the Pediatric Practice at the Golisano Children's Hospital
- are actively psychotic, suicidal or homicidal,
- require treatment (including additional psychotropic medications) not provided by MITT,
- in the judgment of the MITT psychiatric provider require a higher level of psychiatric care (i.e. partial hospitalization, hospitalization, intensive case management),
- are in active counseling or psychotherapy,
- are under the care of a psychiatric provider and/or are receiving active treatment for depression including light therapy, ECT, or antidepressants
- are receiving psychotropic medications not allowed in this study,
- previously participated in and/or were terminated from the study,
- have a diagnosis of bipolar disorder, schizophrenia, other psychotic disorder or alcohol/substance use disorder, and/or
- have a medical condition or are taking medications that are contraindicated for sertraline
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: MITT
Mothers will be assigned to the Mother-Infant Treatment Team (MITT)and will receive either psychotherapy or sertraline or both as well as outreach.
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This is a treatment team approach that allows for outreach.
The clinical team will be a nurse practitioner of psychiatry and a social worker.
The nurse practitioner will provide either interpersonal psychotherapy, sertraline or both as indicated.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Treatment Engagement
Periodo de tiempo: 6 weeks
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6 weeks
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Treatment Adherence
Periodo de tiempo: 18 weeks
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18 weeks
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Treatment Response
Periodo de tiempo: 12 weeks
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12 weeks
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Treatment Remission
Periodo de tiempo: 12 weeks
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12 weeks
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Maternal functional assessment
Periodo de tiempo: 12 weeks
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12 weeks
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Maternal healthcare utilization
Periodo de tiempo: 18 weeks
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18 weeks
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Infant healthcare utilization
Periodo de tiempo: 18 weeks
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18 weeks
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Linda H Chaudron, MD, MS, University of Rochester
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
- 1R34MH082141-01 (Subvención/contrato del NIH de EE. UU.)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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