Feasibility and Implementation of Early Referral in Perinatal Mental Health (e-Perinatal-Re)
Feasibility, Acceptability, and Preliminary Effectiveness of Early Referral Strategy to Specialized Mental Health Services: An Embedded Implementation Study
Descripción general del estudio
Estado
Condiciones
Descripción detallada
This embedded study evaluates the implementation of the e-Perinatal app as a screening tool to facilitate early referral to specialized mental health services within routine primary healthcare settings.
The study will be conducted within the context of the main e-Perinatal trial in primary healthcare centers in Andalusia, Spain. Participants will include pregnant and postpartum women enrolled in the main study who are at risk of presenting maternal perinatal depression and/or anxiety disorders, based on a structured clinical interview.
The primary objective is to assess the feasibility and acceptability of an early referral in routine care. The secondary aim is to validate and implement an Artificial Intelligence-based algorithm for the early screening of mental health disorders in routine services.
Data will be collected using questionnaires, clinical records, and semi-structured interviews with participants and healthcare professionals.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Emma Motrico, PhD
- Número de teléfono: 0034636995778
- Correo electrónico: eperinatal@us.es
Ubicaciones de estudio
-
-
Sevilla
-
Mairena del Aljarafe, Sevilla, España, 41927
- Reclutamiento
- Primary Health Care Center Mairena del Aljarafe - Ciudad Expo
-
Contacto:
- Ana Belén Naranjo Saucedo,, MSc
- Número de teléfono: +34 676426430
- Correo electrónico: ana.naranjo@juntadeandalucia.es
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Pregnant and postpartum women enrolled in the main e-Perinatal trial, indicating the presence of a depressive or anxiety disorder with CIDI.
- Access to smartphone and internet
- Able to write and read in Spanish
Exclusion Criteria:
- None beyond those defined in the main trial
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Grupo de intervención
|
The e-Perinatal intervention is a personalized mobile health (mHealth) program that includes: 1) Digital micro-interventions focused on psychological, physical activity, and healthy lifestyle domains; 2) a personalized recommendation engine; 3) a social support section; 4) mental health monitoring; 5) an 'SOS' button for assistance; and 6) an appointment reminder tool. The intervention is delivered through a mobile application and is integrated into routine maternal care. Participants will use the app from recruitment (pregnancy) until 12 months of postpartum. |
|
Comparador activo: Grupo de control
|
Participants will receive standard maternal care as provided by the public healthcare system, including routine antenatal and postnatal visits and access to maternal education programs.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Feasibility of referral strategy
Periodo de tiempo: Baseline, 12 months postpartum
|
Assessment method: Recruitment rates, retention rates
|
Baseline, 12 months postpartum
|
|
Acceptability of the referral
Periodo de tiempo: through study completion, an average of 18 months
|
Acceptability of referral will be assessed using an ad hoc self-report assessment.
|
through study completion, an average of 18 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Identification of at-risk participants
Periodo de tiempo: through study completion, an average of 18 months
|
Measure of the number of at-risk participants.
Participants will be considered at risk if they score above the clinical cutoff on at least one of the two scales (Edinburgh Postnatal Depression Scale (EPDS) ≥ 12 and/or Generalized Anxiety Disorder-7 (GAD-7) ≥ 10), measuring the severity of the depression and anxiety symptoms, respectively.
EPDS and GAD-7 will be collected within the e-Perinatal app.
|
through study completion, an average of 18 months
|
|
Referral to specialized mental health services
Periodo de tiempo: through study completion, an average of 18 months
|
Number of referral to specialized mental health services, as recorded in clinical records.
|
through study completion, an average of 18 months
|
|
Time to referral
Periodo de tiempo: through study completion, an average of 18 months
|
Assessment method: Time between identification and referral
|
through study completion, an average of 18 months
|
|
Engagement with mental health services
Periodo de tiempo: through study completion, an average of 18 months
|
Number of accesses to specialized mental health services, as recorded in clinical records.
|
through study completion, an average of 18 months
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Follow-up period
Periodo de tiempo: 12 months
|
Assessment method: Semi-structured interviews (Normalization Process Theory)
|
12 months
|
|
Healthcare professional engagement
Periodo de tiempo: 12 months
|
Assessment method: semi-structured interviews
|
12 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Emma Motrico, PhD, University of Seville
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- EP-WP3-2025_R
- 101042139 (Otro número de subvención/financiamiento: European Research Council (ERC))
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .