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Active, Not Recruiting

NCT Number: NCT07659977

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

16 year–46 year

Sex eligibility

Female

Study type

Observational

Primary location

Hospital Espírito Santo

Evora, 7000, Portugal

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Detection of perinatal depression risk

    Time frame: 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.

Secondary outcomes

  1. Screening questionnaire response rate

    Time frame: 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.

  2. Time to screening questionnaire completion

    Time frame: 1 year

    Time elapsed between the automated SMS invitation and completion of the digital perinatal mental health screening questionnaire.

  3. Partial screening questionnaire completion rate

    Time frame: 1 year

    Proportion of participants who initiate but do not complete the digital perinatal mental health screening questionnaire after receiving an automated SMS invitation.

  4. Repeat screening adherence rate

    Time frame: 1 year

    Proportion of participants who complete follow-up or repeated perinatal mental health screening questionnaires according to the scheduled screening protocol.

  5. Referral to mental health services

    Time frame: 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.

  6. Follow-up appointment scheduling rate

    Time frame: 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.

  7. Initiation of specialized perinatal mental health care

    Time frame: 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.

  8. Healthcare professionals trained

    Time frame: 1 year

    Number of healthcare professionals onboarded and trained in the implementation of the digital perinatal mental health screening pathway.

  9. Attendance rate at multidisciplinary implementation meetings

    Time frame: 1 year

    Proportion of invited healthcare professionals attending multidisciplinary implementation meetings related to the project.

  10. Screening activation rate within the electronic health record system

    Time frame: 1 year

    Proportion of eligible clinical encounters in which the digital perinatal mental health screening pathway is activated through the electronic health record system.

  11. Clinical alert review rate

    Time frame: 1 year

    Proportion of automatically generated clinical alerts reviewed by healthcare professionals within the electronic health record system.

Sponsors and collaborators

Lead sponsor

Universidade Nova de Lisboa

Other

Collaborators

  • Comprehensive Health Research Center
  • University of Évora

Registry information

Official study title

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

Acronym: MATTER

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Jun 22, 2026
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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