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
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Emma Motrico, PhD
- Numéro de téléphone: 0034636995778
- E-mail: eperinatal@us.es
Lieux d'étude
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Sevilla
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Mairena del Aljarafe, Sevilla, Espagne, 41927
- Recrutement
- Primary Health Care Center Mairena del Aljarafe - Ciudad Expo
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Contact:
- Ana Belén Naranjo Saucedo,, MSc
- Numéro de téléphone: +34 676426430
- E-mail: ana.naranjo@juntadeandalucia.es
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Groupe d'intervention
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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. |
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Comparateur actif: Groupe de contrôle
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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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Feasibility of referral strategy
Délai: Baseline, 12 months postpartum
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Assessment method: Recruitment rates, retention rates
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Baseline, 12 months postpartum
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Acceptability of the referral
Délai: through study completion, an average of 18 months
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Acceptability of referral will be assessed using an ad hoc self-report assessment.
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through study completion, an average of 18 months
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Identification of at-risk participants
Délai: through study completion, an average of 18 months
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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.
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through study completion, an average of 18 months
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Referral to specialized mental health services
Délai: through study completion, an average of 18 months
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Number of referral to specialized mental health services, as recorded in clinical records.
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through study completion, an average of 18 months
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Time to referral
Délai: through study completion, an average of 18 months
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Assessment method: Time between identification and referral
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through study completion, an average of 18 months
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Engagement with mental health services
Délai: through study completion, an average of 18 months
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Number of accesses to specialized mental health services, as recorded in clinical records.
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through study completion, an average of 18 months
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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Follow-up period
Délai: 12 months
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Assessment method: Semi-structured interviews (Normalization Process Theory)
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12 months
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Healthcare professional engagement
Délai: 12 months
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Assessment method: semi-structured interviews
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12 months
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Emma Motrico, PhD, University of Seville
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- EP-WP3-2025_R
- 101042139 (Autre subvention/numéro de financement: European Research Council (ERC))
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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