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Perinatal Mental Health Screening and Early Community Intervention Using Digital Clinical Pathways (MATTER Project) (MATTER)

15 giugno 2026 aggiornato da: Universidade Nova de Lisboa

MATTER Project: Implementation and Evaluation of a Cross-Sector Digital Screening and Early Intervention Program for Perinatal Mental Health in Primary Care and Community Settings

The MATTER project is a digital, community-based perinatal mental health screening and early intervention program implemented in primary care and hospital settings in the Alentejo region, Portugal. The project integrates automated digital screening pathways within the national electronic health record system, allowing healthcare professionals to identify pregnant women and postpartum mothers at risk of depression and other mental health conditions using validated screening tools. Participants receive automated questionnaires via SMS, and results are stratified into risk levels that guide clinical decision-making and referral. The study evaluates feasibility, implementation outcomes, and the effectiveness of early screening and intervention pathways in improving perinatal mental health care delivery.

Panoramica dello studio

Stato

Attivo, non reclutante

Descrizione dettagliata

INTRODUCTION The perinatal period (understood as the time from conception to one year after childbirth) constitutes a unique individual and family experience, marked by multifaceted transformations and adaptations at the physical, psychological, social, and emotional levels. It is common for parents to experience a spiraling process of psychological distress during pregnancy and/or the postpartum period, which is often neglected not only by close support figures but also by healthcare professionals. This gap in attention to maternal mental well-being and to the newly (re)constructed family unit is partly due to the predominant focus on obstetric well-being, fetal health, and, subsequently, infant health.

From a holistic perspective aimed at maximizing intervention impact, perinatal mental health should be considered a key determinant to be actively safeguarded throughout pregnancy and the postpartum period. It is essential for the viability of a healthy parenting process and fundamental for child development. Families undertaking their parenting journey should be supported within a network of primary and secondary relational systems that may help mitigate or overcome vulnerabilities.

Over the past decade, growing evidence has highlighted the significant impact of perinatal mental health disorders. These conditions are currently considered the leading undiagnosed obstetric complication (1). The perinatal period has also been identified as the life stage during which women are at greatest risk of developing mental illness (1).

A study conducted in the United States involving more than 10,000 women reported a 21.9% prevalence of depression during the first year postpartum. Among these cases, 26.5% began before pregnancy, 33.4% during pregnancy, and 40.1% after childbirth (2).

Compared to other life stages, mental illness during the perinatal period tends to show more rapid symptom progression. This underscores the need for mental healthcare interventions that ensure both continuity of care and timely response. It is crucial to prevent or reduce the harms associated with untreated mental illness, given the risks to the mother (including obstetric complications or psychiatric hospitalization) and to the infant (including difficulties in secure attachment formation, emotional regulation, and cognitive development).

International guidelines emphasize early identification of mental health problems during pregnancy and postpartum, as well as relapse risk in women with previously known severe mental illness. For example, the United Kingdom's National Institute for Health and Care Excellence (NICE) recommends early referral for psychiatric assessment in the presence of severe mental health history (3). In Portugal, the Directorate-General of Health (DGS) guidelines clearly identify early intervention in perinatal mental health as a priority (4).

Epidemiological data demonstrate the substantial global prevalence of perinatal mental health disorders-further exacerbated by the stressors associated with the COVID-19 pandemic-highlighting the urgent need for structured intervention in this field.

Although Portuguese primary care guidelines emphasize the importance of assessing mental health during this life stage, the absence of a structured support and intervention plan during pregnancy and postpartum contributes to the exacerbation of vulnerabilities associated with the demands of parenthood, particularly when compounded by mental health disorders.

Given the high prevalence of perinatal mental health problems and the evidence supporting targeted intervention, the implementation of a cross-sector training, screening, and early community-based intervention project aims to improve access to and delivery of care for pregnant and postpartum women. It also seeks to strengthen professional capacity and foster sustainable interdisciplinary networks to support the management of clinically and socially vulnerable situations.

Methodology Package 1 1.1 Participant Selection Participants will be identified through the automatic detection of scheduled consultations corresponding to each screening time point. Invitations to participate will be sent via SMS one week prior to the scheduled appointment.

The invitation will be directed to women receiving follow-up care at Family Health Units (USFs) and Personalized Healthcare Units (UCSPs) within ACES Alentejo Central at key stages of pregnancy and the postpartum period.

1.2 Recruitment Modality Completion of the screening questionnaire and collection of sociodemographic data will be preceded by reading and acceptance of informed consent. The consent process includes information about the objectives of the program, the relevance of data collection, and authorization for the use of results within a structured monitoring pathway.

This digital pathway enables real-time communication of relevant information to healthcare professionals, supporting clinical decision-making, coordination of care, and multidisciplinary follow-up.

1.3 Implementation Methodology An automated system will send SMS, email, or voice call reminders prior to scheduled prenatal and postpartum consultations. Data may also be collected through in-person self-administered questionnaires when applicable.

Screening will be conducted at multiple time points throughout pregnancy and the postpartum period. Participants will access questionnaires via a secure digital platform and complete instruments assessing sociodemographic characteristics, mental health status, quality of life, and healthcare resource utilization.

Following a successful pilot study (approved under Opinion 19/CE/2022), which demonstrated feasibility, the program is currently being expanded across all primary healthcare units of ULSAC through the digitalization of the patient care pathway.

1.4 Intervention Stratification Participants are stratified according to screening results, allowing for differentiated levels of follow-up and support. These include access to digital interventions, referral to primary care services, and specialized care when necessary.

The Be a Mom program is an online, self-guided cognitive-behavioral intervention designed to support emotional adjustment during the perinatal period. It addresses key domains such as emotional regulation, cognitive restructuring, social support, and recognition of warning signs.

Package 2 Healthcare professionals from participating institutions will be invited through direct institutional contact.

A microcredential training program, organized by the University of Évora, will address perinatal mental health and include contributions from psychiatric specialists. Continuous capacity building will be supported through an online platform hosting training materials and knowledge translation tools to promote behavioral change.

Package 3 Monthly online multidisciplinary sessions will be conducted with participating professionals. These sessions aim to support continuous training, review aggregated screening data, discuss anonymized cases, clarify operational procedures, and identify barriers and facilitators to implementation.

Qualitative methods, including focus groups conducted every four to six months, will be used to assess implementation processes.

Package 4 A digital partner will develop an online platform to support the digitalization of the patient pathway, including risk stratification, referral management, and multidisciplinary coordination.

Healthcare professionals who voluntarily adopt the digital tools will be included, with implementation supported through structured communication and coordination between research teams and primary care services.

Data Analysis Quantitative data will be analyzed using correlation analyses and uni- and multivariate regression models. Statistical significance will be set at p < 0.05.

Qualitative data will be analyzed using content analysis methods supported by qualitative data analysis software.

Tipo di studio

Osservativo

Iscrizione (Stimato)

1500

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

      • Evora, Portogallo, 7000
        • Hospital Espírito Santo

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

Pregnant and postpartum women receiving care in primary healthcare units and hospital maternity services in the Alentejo region, Portugal.

Descrizione

Inclusion Criteria:

  • Pregnant women receiving prenatal care
  • Postpartum women receiving healthcare services
  • Participants able to provide informed consent

Exclusion Criteria:

  • Unable to provide informed consent
  • Not receiving care in participating healthcare services

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Pregnant and postpartum women undergoing digital perinatal mental health screening
Women receiving routine prenatal and postnatal care who are invited to participate in automated digital mental health screening integrated into clinical care pathways

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Detection of perinatal depression risk
Lasso di tempo: Baseline and throughout pregnancy and postpartum period (up to 12 months postpartum)
Identification of participants classified into low, moderate, or high risk categories based on EPDS screening scores and digital clinical pathway alerts.
Baseline and throughout pregnancy and postpartum period (up to 12 months postpartum)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Screening questionnaire response rate
Lasso di tempo: 1 year

Proportion of eligible pregnant and postpartum women who complete the digital perinatal mental health screening questionnaires after receiving an automated SMS invitation through the electronic clinical system.

The response rate will be calculated as:

(number of completed screening questionnaires / total number of screening invitations sent) × 100.

1 year
Time to screening questionnaire completion
Lasso di tempo: 1 year
Time elapsed between the automated SMS invitation and completion of the digital perinatal mental health screening questionnaire.
1 year
Partial screening questionnaire completion rate
Lasso di tempo: 1 year
Proportion of participants who initiate but do not complete the digital perinatal mental health screening questionnaire after receiving an automated SMS invitation.
1 year
Repeat screening adherence rate
Lasso di tempo: 1 year
Proportion of participants who complete follow-up or repeated perinatal mental health screening questionnaires according to the scheduled screening protocol.
1 year
Referral to mental health services
Lasso di tempo: 1 year
Proportion of participants classified as moderate or high risk based on EPDS score thresholds who receive a documented referral to psychological or psychiatric services following screening.
1 year
Follow-up appointment scheduling rate
Lasso di tempo: 1 year
Proportion of participants classified as moderate or high risk based on EPDS score thresholds who receive a scheduled follow-up mental health appointment after screening.
1 year
Initiation of specialized perinatal mental health care
Lasso di tempo: 1 year
Proportion of participants classified as moderate or high risk based on EPDS score thresholds who initiate specialized psychological or psychiatric care following referral.
1 year
Healthcare professionals trained
Lasso di tempo: 1 year
Number of healthcare professionals onboarded and trained in the implementation of the digital perinatal mental health screening pathway.
1 year
Attendance rate at multidisciplinary implementation meetings
Lasso di tempo: 1 year
Proportion of invited healthcare professionals attending multidisciplinary implementation meetings related to the project.
1 year
Screening activation rate within the electronic health record system
Lasso di tempo: 1 year
Proportion of eligible clinical encounters in which the digital perinatal mental health screening pathway is activated through the electronic health record system.
1 year
Clinical alert review rate
Lasso di tempo: 1 year
Proportion of automatically generated clinical alerts reviewed by healthcare professionals within the electronic health record system.
1 year

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Teresa Reis, PhD, University of Évora

Pubblicazioni e link utili

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Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

11 settembre 2023

Completamento primario (Effettivo)

31 dicembre 2025

Completamento dello studio (Stimato)

30 agosto 2026

Date di iscrizione allo studio

Primo inviato

24 marzo 2026

Primo inviato che soddisfa i criteri di controllo qualità

15 giugno 2026

Primo Inserito (Effettivo)

22 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

22 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

15 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Descrizione del piano IPD

The data is still being organized and processed

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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