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Perinatal DepressionMATTERNCT07659977

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

An observational study of Perinatal Depression, run by Universidade Nova de Lisboa at 1 site in Portugal.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 16 to 46 years, women only
Conditions the study is for
Perinatal Depression
How many people
1,500 participants
Where
1 sitePortugal
Study dates
11 Sep 2023to 30 Aug 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 46 years
  • Women only
  • No healthy volunteers
  • Child, Adult

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

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Portugal1 site
  • Hospital Espírito Santo

    Evora, 7000

Other trials in Portugal

About this study

Official 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

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.

Read the detailed description

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.

Keywords
Perinatal mental health, Depression screening, Digital health, Clinical pathways, Primary care, Implementation science

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07659977
Study groupRoleWhat they receive
Pregnant and postpartum women undergoing digital perinatal mental health screeningWomen receiving routine prenatal and postnatal care who are invited to participate in automated digital mental health screening integrated into clinical care pathways

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Detection of perinatal depression risk

    Identification of participants classified into low, moderate, or high risk categories based on EPDS screening scores and digital clinical pathway alerts.

    Measured: Baseline and throughout pregnancy and postpartum period (up to 12 months postpartum)

Secondary outcomes (11)
  1. Screening questionnaire response rate

    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.

    Measured: 1 year

  2. Time to screening questionnaire completion

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

    Measured: 1 year

  3. Partial screening questionnaire completion rate

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

    Measured: 1 year

  4. Repeat screening adherence rate

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

    Measured: 1 year

  5. Referral to mental health services

    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.

    Measured: 1 year

  6. Follow-up appointment scheduling rate

    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.

    Measured: 1 year

  7. Initiation of specialized perinatal mental health care

    Proportion of participants classified as moderate or high risk based on EPDS score thresholds who initiate specialized psychological or psychiatric care following referral.

    Measured: 1 year

  8. Healthcare professionals trained

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

    Measured: 1 year

  9. Attendance rate at multidisciplinary implementation meetings

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

    Measured: 1 year

  10. Screening activation rate within the electronic health record system

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

    Measured: 1 year

  11. Clinical alert review rate

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

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2026
  2. Study start11 Sep 2023
  3. Primary completion31 Dec 2025
  4. Study completion30 Aug 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07659977
Sponsor's protocol ID
MATTER-UEVORA-2023
Acronym
MATTER
Status last verified
Jun 2026
First submitted
24 Mar 2026
Last updated
22 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: The data is still being organized and processed

Publications

  • Monteiro F, Pereira M, Canavarro MC, Fonseca A. Be a Mom's Efficacy in Enhancing Positive Mental Health among Postpartum Women Presenting Low Risk for Postpartum Depression: Results from a Pilot Randomized Trial. Int J Environ Res Public Health. 2020 Jun 29;17(13):4679. doi: 10.3390/ijerph17134679.

    PubMed 32610640
  • Carona C, Pereira M, Araujo-Pedrosa A, Canavarro MC, Fonseca A. The Efficacy of Be a Mom, a Web-Based Intervention to Prevent Postpartum Depression: Examining Mechanisms of Change in a Randomized Controlled Trial. JMIR Ment Health. 2023 Mar 17;10:e39253. doi: 10.2196/39253.

    PubMed 36930182
  • Ferreira PL, Pereira LN, Antunes P, Ferreira LN. EQ-5D-5L Portuguese population norms. Eur J Health Econ. 2023 Dec;24(9):1411-1420. doi: 10.1007/s10198-022-01552-9. Epub 2023 Jan 11.

    PubMed 36630005
  • Stolk E, Ludwig K, Rand K, van Hout B, Ramos-Goni JM. Overview, Update, and Lessons Learned From the International EQ-5D-5L Valuation Work: Version 2 of the EQ-5D-5L Valuation Protocol. Value Health. 2019 Jan;22(1):23-30. doi: 10.1016/j.jval.2018.05.010. Epub 2019 Jan 2.

    PubMed 30661630
  • Program BCRMH, Williams J. Best practice guidelines for mental health disorders in the perinatal period. BC Reproductive Mental Health Program; 2014.

  • Pereira AT, Bos S, Marques M, Maia BR, Soares MJ, Valente J, Gomes AA, Macedo A, Azevedo MH. The Portuguese version of the postpartum depression screening scale. J Psychosom Obstet Gynaecol. 2010 Jun;31(2):90-100. doi: 10.3109/0167482X.2010.481736.

    PubMed 20443658
  • Cepêda T, Brito I, Heitor MJ. Promoção da saúde mental na gravidez e primeira infância: manual de orientação para profissionais de saúde. Lisboa Direcção-Geral da Saúde, Ministério da Saúde. 2006.

  • Antenatal and postnatal mental health: clinical management and service guidance. London: National Institute for Health and Care Excellence (NICE); 2018 Apr. Available from http://www.ncbi.nlm.nih.gov/books/NBK553127/

    PubMed 31990493
  • Cox JL, Holden JM, Sagovsky R. Detection of postnatal depression. Development of the 10-item Edinburgh Postnatal Depression Scale. Br J Psychiatry. 1987 Jun;150:782-6. doi: 10.1192/bjp.150.6.782.

    PubMed 3651732
  • Wisner KL, Sit DK, McShea MC, Rizzo DM, Zoretich RA, Hughes CL, Eng HF, Luther JF, Wisniewski SR, Costantino ML, Confer AL, Moses-Kolko EL, Famy CS, Hanusa BH. Onset timing, thoughts of self-harm, and diagnoses in postpartum women with screen-positive depression findings. JAMA Psychiatry. 2013 May;70(5):490-8. doi: 10.1001/jamapsychiatry.2013.87.

    PubMed 23487258
  • Earls MF; Committee on Psychosocial Aspects of Child and Family Health American Academy of Pediatrics. Incorporating recognition and management of perinatal and postpartum depression into pediatric practice. Pediatrics. 2010 Nov;126(5):1032-9. doi: 10.1542/peds.2010-2348. Epub 2010 Oct 25.

    PubMed 20974776

Questions about this trial

What is this clinical trial studying?

An observational study of Perinatal Depression, run by Universidade Nova de Lisboa at 1 site in Portugal.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Detection of perinatal depression risk (time frame: Baseline and throughout pregnancy and postpartum period (up to 12 months postpartum)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07659977, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.

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