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
Studieoversikt
Status
Forhold
Detaljert beskrivelse
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
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Emma Motrico, PhD
- Telefonnummer: 0034636995778
- E-post: eperinatal@us.es
Studiesteder
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Sevilla
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Mairena del Aljarafe, Sevilla, Spania, 41927
- Rekruttering
- Primary Health Care Center Mairena del Aljarafe - Ciudad Expo
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Ta kontakt med:
- Ana Belén Naranjo Saucedo,, MSc
- Telefonnummer: +34 676426430
- E-post: ana.naranjo@juntadeandalucia.es
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Intervensjonsgruppe
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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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Aktiv komparator: Kontrollgruppe
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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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Feasibility of referral strategy
Tidsramme: 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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Identification of at-risk participants
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Follow-up period
Tidsramme: 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
Tidsramme: 12 months
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Assessment method: semi-structured interviews
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12 months
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Emma Motrico, PhD, University of Seville
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- EP-WP3-2025_R
- 101042139 (Annet stipend/finansieringsnummer: European Research Council (ERC))
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