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
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Emma Motrico, PhD
- Telefoonnummer: 0034636995778
- E-mail: eperinatal@us.es
Studie Locaties
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Sevilla
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Mairena del Aljarafe, Sevilla, Spanje, 41927
- Werving
- Primary Health Care Center Mairena del Aljarafe - Ciudad Expo
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Contact:
- Ana Belén Naranjo Saucedo,, MSc
- Telefoonnummer: +34 676426430
- E-mail: ana.naranjo@juntadeandalucia.es
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Interventie groep
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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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Actieve vergelijker: Controlegroep
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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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Feasibility of referral strategy
Tijdsspanne: 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
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Identification of at-risk participants
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Follow-up period
Tijdsspanne: 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
Tijdsspanne: 12 months
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Assessment method: semi-structured interviews
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12 months
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Emma Motrico, PhD, University of Seville
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- EP-WP3-2025_R
- 101042139 (Ander subsidie-/financieringsnummer: European Research Council (ERC))
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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