Effectiveness and Implementation of a Personalized mHealth Intervention for the Universal Prevention of Maternal Perinatal Mental Disorders (ePerinatal-RCT)
25 maja 2026 zaktualizowane przez: Emma Motrico, University of Seville
Universal Prevention of Maternal Perinatal Mental Disorders and Its Implementation as Normalized Routine Practice (e-Perinatal): A Cluster Randomized Hybrid Effectiveness-Implementation Trial
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.
Przegląd badań
Status
Jeszcze nie rekrutacja
Szczegółowy opis
This clinical trial evaluates the effectiveness and implementation of the e-Perinatal intervention, a personalized mobile health (mHealth) psychological program designed for the universal prevention of maternal perinatal depression and anxiety disorders. The study will be conducted as a two-arm, cluster-randomized, hybrid type 1 effectiveness-implementation trial in routine maternal care settings within primary healthcare centers.
Primary healthcare centers will be randomized to either the intervention or control arm. Participants will include pregnant women and their partners.
The primary objective is to evaluate the effectiveness of the e-Perinatal intervention in reducing the cumulative incidence of maternal perinatal depression and anxiety disorders, assessed via structured diagnostic interviews. Secondary objectives include assessing maternal and paternal mental health outcomes, child development outcomes, and identifying moderators and mediators of intervention effectiveness.
In addition, the study will evaluate implementation outcomes, including acceptability, feasibility, adoption, fidelity, and barriers and facilitators to implementation in real-world healthcare settings.
Participants in the intervention group will receive access to the e-Perinatal app alongside usual maternal care. The e-Perinatal app 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. Participants in the control group will receive usual maternal care.
Typ studiów
Interwencyjne
Zapisy (Szacowany)
3000
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Kontakt w sprawie studiów
- Nazwa: Emma Motrico, PhD Psychology
- Numer telefonu: 0034636995778
- E-mail: eperinatal@us.es
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Tak
Opis
Inclusion Criteria:
- Inclusion Criteria (Women)
Must receive an invitation to participate from a healthcare professional at one of the participating primary healthcare centers
Must be pregnant for at least 11 weeks at the time of enrollment
Must be at least 18 years old
Must have access to a mobile phone and internet connection
Must be able to read, write, and understand Spanish
Must have a personal email account
No diagnosis of depression or anxiety disorder at baseline Forma
- Inclusion Criteria (Partners or significant others)
Must receive an invitation to participate from a woman already enrolled in the study
Must be at least 18 years old
Must have access to a mobile phone and internet connection
Must be able to read, write, and understand Spanish
Must have a personal email account
Exclusion Criteria:
- Exclusion Criteria (Women)
Current diagnosis of depression or anxiety disorder
Receiving psychological or pharmacological treatment for mental health or substance use conditions
- Exclusion criteria for partners (or significant others):
There are no exclusion criteria for partners
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Zapobieganie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: Grupa interwencyjna
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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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Aktywny komparator: Grupa kontrolna
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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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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Cumulative incidence of maternal perinatal depression and anxiety disorders
Ramy czasowe: Baseline and 12 months postpartum
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Assessment method: Composite Internacional Diagnosis Interview (CIDI), based on DSM-5 criteria
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Baseline and 12 months postpartum
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Maternal depressive symptoms (mothers)
Ramy czasowe: Baseline, 34-36 weeks of gestation (for participants enrolled before 31 weeks), 6 weeks postpartum, and 6, 12, and 18 months postpartum
|
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.
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Baseline, 34-36 weeks of gestation (for participants enrolled before 31 weeks), 6 weeks postpartum, and 6, 12, and 18 months postpartum
|
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Maternal anxiety symptoms (mothers)
Ramy czasowe: Baseline, 34-36 weeks of gestation (for participants enrolled before 31 weeks), 6 weeks postpartum, and 6, 12, and 18 months postpartum
|
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.
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Baseline, 34-36 weeks of gestation (for participants enrolled before 31 weeks), 6 weeks postpartum, and 6, 12, and 18 months postpartum
|
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Paternal depressive symptoms (partner)
Ramy czasowe: Baseline, 34-36 weeks of gestation (for participants enrolled before 31 weeks), 6 weeks postpartum, and 6, 12, and 18 months postpartum
|
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.
|
Baseline, 34-36 weeks of gestation (for participants enrolled before 31 weeks), 6 weeks postpartum, and 6, 12, and 18 months postpartum
|
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Paternal anxiety symptoms (partner)
Ramy czasowe: Baseline, 34-36 weeks of gestation (for participants enrolled before 31 weeks), 6 weeks postpartum, and 6, 12, and 18 months postpartum
|
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.
|
Baseline, 34-36 weeks of gestation (for participants enrolled before 31 weeks), 6 weeks postpartum, and 6, 12, and 18 months postpartum
|
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Psychological well-being (mothers, partners)
Ramy czasowe: Baseline, 34-36 weeks of gestation (for participants enrolled before 31 weeks), 6 weeks postpartum, and 6, 12, and 18 months postpartum
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Changes in subjective well-being.
Assessment method: The Well-Being Index (WHO-5), a 5-item self-report measure.
Each item is scored from 0 to 5, with higher scores indicating better subjective well-being.
|
Baseline, 34-36 weeks of gestation (for participants enrolled before 31 weeks), 6 weeks postpartum, and 6, 12, and 18 months postpartum
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Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Gotowość organizacyjna do wdrożenia zmian
Ramy czasowe: Mierzone przed rekrutacją
|
Gotowość organizacji do wprowadzenia zmian w zwykłej opiece.
Metoda oceny: Gotowość organizacyjna wdrażająca zmianę (ORIC), składająca się z 12 elementów samoopisowa miara.
Każda pozycja jest oceniana w skali od 1 do 5, przy czym wyższa ocena oznacza większą gotowość do wdrożenia zmiany.
|
Mierzone przed rekrutacją
|
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Charakterystyka PHC
Ramy czasowe: Mierzone przed rekrutacją
|
Wielkość populacji, w której znajduje się POZ i liczba specjalistów POZ.
Metoda oceny: Kwestionariusz opracowany przez zespół badawczy
|
Mierzone przed rekrutacją
|
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App quality (mothers, partners)
Ramy czasowe: 12 months postpartum
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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.
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12 months postpartum
|
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Implementation process
Ramy czasowe: 12 months postpartum
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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.
|
12 months postpartum
|
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Barriers and facilitators
Ramy czasowe: 12 months postpartum
|
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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12 months postpartum
|
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Reasons for dropout (mothers, partners)
Ramy czasowe: 12 months postpartum
|
Number and reasons (e.g., experienced miscarriage or stillbirth, lack of engagement with the app) for dropout among women and their partners.
Assessment method: Records and semi structured interviews.
|
12 months postpartum
|
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Antenatal and postnatal risks (mothers, partners)
Ramy czasowe: Baseline, 6 weeks postpartum
|
Measures both antenatal and postnatal risk factors.
Assessment method: The Antenatal Risk Questionnaire (ANRQ-R), a 11-item self-report measure.
Some items are scored from 1 to 5 and others are scored on categorical scale, with higher scores indicating greater risk.
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Baseline, 6 weeks postpartum
|
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Basic psychological needs (mothers, partners)
Ramy czasowe: Baseline, 34-36 weeks of gestation (for participants enrolled before 31 weeks)
|
Measures the satisfaction and frustration of basic psychological needs.
Assessment method: The Basic Psychological Need Satisfaction and Frustration Scale - Short Form (BPNSFS), a 12-item self-report measure.
Each item is scored from 1 to 5, with higher scores indicating a higher need satisfaction (i.e., need satisfaction subscale) or a higher need frustration (i.e., need frustration subscale).
|
Baseline, 34-36 weeks of gestation (for participants enrolled before 31 weeks)
|
|
Maternal post-traumatic stress symptoms (mothers)
Ramy czasowe: 6 weeks postpartum
|
Presence of post-traumatic stress symptoms after childbirth.
Assessment method: City Birth Trauma Scale (City-BiTS), a 5-item self-report measure.
A total of 4 items are scored from 0 to 3 and one item is scored from 0 to 1, with higher scores indicating greater severity of postnatal post-traumatic stress.
|
6 weeks postpartum
|
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Maternal perceptions of childbirth (mothers)
Ramy czasowe: 6 weeks postpartum
|
Measure of the perceived quality of the childbirth experience.
Assessment method: Childbirth Experience Questionnaire (CEQ-E), a 22-items self-report scale.
A total of 19 items range from 1 to 4. A total of 2 items range from 0 to 10. Higher scores indicate a more positive experience of childbirth.
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6 weeks postpartum
|
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Maternal breastfeeding experience (mothers)
Ramy czasowe: 6 weeks postpartum; 6 months postpartum
|
Assessment method: Ad hoc instrument.
The instrument assesses infant feeding practices (2 items) and maternal satisfaction with breastfeeding (1 item), yielding a score ranging from 0 to 100.
Higher scores indicate greater satisfaction with breastfeeding.
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6 weeks postpartum; 6 months postpartum
|
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Maternal antenatal attachment (mothers)
Ramy czasowe: 34-36 weeks of gestation (for participants enrolled before 31 weeks)
|
Measures the level of maternal antenatal attachment to the baby.
Assessment method: The Maternal Antenatal Attachment Scale (MAAS), a 19-item self-report measure.
Each item is scored from 1 to 5, with higher scores indicating stronger maternal antenatal attachment.
|
34-36 weeks of gestation (for participants enrolled before 31 weeks)
|
|
Paternal antenatal attachment (partners)
Ramy czasowe: 34-36 weeks of gestation (for participants enrolled before 31 weeks)
|
Measures the level of paternal antenatal attachment to the baby.
Assessment method: The Paternal Antenatal Attachment Scale (PAAS), a 16-item self-report measure.
Each item is scored from 1 to 5, with higher scores indicating stronger paternal antenatal attachment.
|
34-36 weeks of gestation (for participants enrolled before 31 weeks)
|
|
Maternal postnatal attachment (mothers)
Ramy czasowe: 6 weeks postpartum
|
Measures the level of maternal postnatal attachment to the baby.
Assessment method: The Maternal Postnatal Attachment Scale (MPAS), a 19-item self-report measure.
Each item is scored from 1 to 5, with higher scores indicating stronger maternal postnatal attachment.
|
6 weeks postpartum
|
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Paternal postnatal attachment (fathers)
Ramy czasowe: 6 weeks postpartum
|
Measures the level of postnatal attachment to the baby in both mothers and fathers.
Assessment method: The Paternal Postnatal Attachment Scale (PPAS), a 19-item self-report measure.
Each item is scored from 1 to 5, with higher scores indicating stronger paternal postnatal attachment.
|
6 weeks postpartum
|
|
Psychological flexibility (mothers, partner)
Ramy czasowe: Baseline, 34-36 weeks of gestation (for participants enrolled before 31 weeks)
|
Measure of psychological flexibility.
Assessment method: Comprehensive assessment of Acceptance and Commitment Therapy processes (CompACT), a 10-item self-report scale.
Each item is scored from 1 to 7, with higher scores indicating greater psychological flexibilityTime
|
Baseline, 34-36 weeks of gestation (for participants enrolled before 31 weeks)
|
|
Partnership quality (mothers, partners)
Ramy czasowe: Baseline, 34-36 weeks of gestation (for participants enrolled before 31 weeks)
|
Measures the quality of the marital or partnership relationship.
Assessment method: The Quality of Marriage Index (QMI), a 6-item self-report measure.
Some items are scored from 1 to 7 and others from 1 to 10, with higher scores indicating better relationship quality.
|
Baseline, 34-36 weeks of gestation (for participants enrolled before 31 weeks)
|
|
Parental role perception (mothers)
Ramy czasowe: 6 months postpartum
|
Measures parents' perception of their competence in the parental role.
Assessment method: The Parental Sense of Competence scale (PSOC), a 21-item self-report measure.
Each item is scored from 1 to 6, with higher scores indicating a stronger sense of parental competence.
|
6 months postpartum
|
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Coparenting dynamics (mothers, partners)
Ramy czasowe: 6 months postpartum
|
Measures the dynamics of coparenting relationships.
Assessment method: The Coparenting Relationship Scale (CRS), a 14-item self-report measure.
Each item is scored from 0 to 6, with higher scores indicating more positive coparenting dynamics.
|
6 months postpartum
|
|
Mediterranean diet adherence (mothers, partners)
Ramy czasowe: Baseline, 34-36 weeks of gestation (for participants enrolled before 31 weeks)
|
Measure of adherence to the mediterranean diet.
Assessment method: Mediterranean Diet Adherence Screener (MEDAS), a 14-items self-report instrument.
Each item score from 0 to 1. Higher scores indicate greater adherence to the mediterranean diet.
|
Baseline, 34-36 weeks of gestation (for participants enrolled before 31 weeks)
|
|
Maternal physical activity levels (mothers)
Ramy czasowe: Baseline, 6 months postpartum
|
Measures physical activity levels in pregnant women and mothers.
Assessment method: The Pregnancy Physical Activity Questionnaire (PPAQ), a 33-item self-report measure.
Each item is scored from 0 to 5, with higher scores indicating higher levels of physical activity.
|
Baseline, 6 months postpartum
|
|
Physical condition (mothers)
Ramy czasowe: Baseline, 6 months postpartum
|
Measures overall physical condition and the main components (i.e., cardiorespiratory fitness, muscular strength, speed-agility, and flexibility) in pregnant women and mothers.
Assessment method: The International FItness Scale (IFIS), a 5-item self-report measure.
Each item is scored from 1 to 5, with higher scores indicating better physical condition.
|
Baseline, 6 months postpartum
|
|
Child temperament (mothers)
Ramy czasowe: 6 months postpartum
|
Measures various aspect of infant temperament.
Assessment method: The Infant Behavior Questionnaire-Revised Short Form (IBQ-R SF), a 37-item self-report measure.
Each item is scored from 1 to 7, with higher scores indicating a higher frequency of the specified temperament behavior.
|
6 months postpartum
|
|
Child development (mothers)
Ramy czasowe: 6 months postpartum
|
Measures of various domains of infant development. Assessment method: Ages & Stages Questionnaires (ASQ-3), a self-report measure. Each milestone question is answered using one of three frequency options, which are converted into point values:
|
6 months postpartum
|
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Life quality (mothers, partners)
Ramy czasowe: 12 months postpartum
|
Measures the overall quality of life.
Assessment method: The European Quality of Life-5 Dimensions-5 Levels (EuroQol-5D-5L), a 5-item self-report measure.
Each item is scored from 1 to 5, with higher scores indicating worse quality of life
|
12 months postpartum
|
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Identity (mothers, partners)
Ramy czasowe: Baseline, 6 months postpartum
|
Measure of various domains of identity development.
Assessment method: Dimensions of Identity Development Scale (DIDS)., a 25-items self-report measure.
Each item is scored from 1 to 5, with higher scores indicating greater endorsement of the corresponding identity development dimension.
|
Baseline, 6 months postpartum
|
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Economic data
Ramy czasowe: 12 months postpartum
|
Measures healthcare service utilization and sick leave days over the previous year among participating women.
Assessment method: a post hoc semi-structured interview that collects information on emergency visits, hospital admissions, primary care visits (e.g., nurse, midwife, social worker), secondary care visits, and consultations with specialists.
|
12 months postpartum
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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Śledczy
- Główny śledczy: Emma Motrico, PhD, University of Seville
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
30 maja 2026
Zakończenie podstawowe (Szacowany)
30 grudnia 2027
Ukończenie studiów (Szacowany)
30 marca 2028
Daty rejestracji na studia
Pierwszy przesłany
6 maja 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
25 maja 2026
Pierwszy wysłany (Rzeczywisty)
29 maja 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
29 maja 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
25 maja 2026
Ostatnia weryfikacja
1 maja 2026
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- EP-WP3-2025
- 101042139 (Inny identyfikator: European Research Council (ERC))
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
NIE
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
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