This study is part of the ERC-funded e-Perinatal project and represents a large-scale hybrid type 1 effectiveness-implementation cluster randomized controlled trial. The primary aim is to evaluate the effectiveness of a personalized and complex mobile health (mHealth) intervention (e-Perinatal) in the universal prevention of maternal perinatal depression and anxiety disorders. Secondary aims include evaluating the impact on paternal mental health and child development, as well as examining implementation outcomes in real-world primary healthcare settings.
None
Exclusion Criteria (Women)
Parallel
The e-Perinatal intervention is a personalized mobile health (mHealth) program
BehavioralThe 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.
Standard routine maternal care
Other interventionParticipants will receive standard maternal care as provided by the public healthcare system, including routine antenatal and postnatal visits and access to maternal education programs.
Cumulative incidence of maternal perinatal depression and anxiety disorders
Assessment method: Composite Internacional Diagnosis Interview (CIDI), based on DSM-5 criteria
Maternal depressive symptoms (mothers)
Changes in depressive symptoms. Assessment method: The Edinburgh Postnatal Depression Scale (EPDS), a 10-item self-report measure. Each item is scored from 0 to 3, with higher scores indicating more severe depressive symptoms.
Maternal anxiety symptoms (mothers)
Changes in anxiety symptoms. Assessment method: The General Anxiety Questionnaire (GAD-7), a 7-item self-report measure. Each item is scored from 0 to 3, with higher scores indicating more severe anxiety symptoms.
Paternal depressive symptoms (partner)
Changes in depressive symptoms. Assessment method: The Edinburgh Postnatal Depression Scale (EPDS), a 10-item self-report measure. Each item is scored from 0 to 3, with higher scores indicating more severe depressive symptoms.
Paternal anxiety symptoms (partner)
Changes in anxiety symptoms. Assessment method: The General Anxiety Questionnaire (GAD-7), a 7-item self-report measure. Each item is scored from 0 to 3, with higher scores indicating more severe anxiety symptoms.
Organizational readiness for implementing change
Organization's readiness for implementing changes in usual care. Assessment method: The Organizational Readiness Implementing Change (ORIC), a 12-item self-report measure. Each item is scored from 1 to 5, with higher scores indicating greater readiness for implementing change.
App quality (mothers, partners)
Objective and subjective quality, and the perceived impact of the application. Assessment method: The User Version of the Mobile Application Rating Scale (u-MARS), a 26-item self-report measure. Each item is scored from 1 to 5, with higher scores indicating better app quality.
Implementation process
App implementation process from the perspective of healthcare professionals involved in implementing complex interventions. Assessment method: The Normalization Measure Development Questionnaire (NoMAD), a 20-item self-report measure. Each item is scored from 1 to 5, with higher scores indicating more effective implementation processes.
Barriers and facilitators
Identifies barriers and facilitators impacting the integration of the intervention into routine healthcare, drawing from the experiences of users and healthcare professionals. Assessment method: Semi-structured interviews following the Normalization Process Theory (NPT) framework
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University of Seville
Lead sponsor
Junta de Andalucia
Collaborator
Health Service of Andalucia
Collaborator
