- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07659977
Perinatal Mental Health Screening and Early Community Intervention Using Digital Clinical Pathways (MATTER Project) (MATTER)
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
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Geschätzt)
Kontakte und Standorte
Studienorte
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Evora, Portugal, 7000
- Hospital Espírito Santo
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Kind
- Erwachsene
Akzeptiert gesunde Freiwillige
Probenahmeverfahren
Studienpopulation
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
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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
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Detection of perinatal depression risk
Zeitfenster: Baseline and throughout pregnancy and postpartum period (up to 12 months postpartum)
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Identification of participants classified into low, moderate, or high risk categories based on EPDS screening scores and digital clinical pathway alerts.
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Baseline and throughout pregnancy and postpartum period (up to 12 months postpartum)
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Screening questionnaire response rate
Zeitfenster: 1 year
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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
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Time to screening questionnaire completion
Zeitfenster: 1 year
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Time elapsed between the automated SMS invitation and completion of the digital perinatal mental health screening questionnaire.
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1 year
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Partial screening questionnaire completion rate
Zeitfenster: 1 year
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Proportion of participants who initiate but do not complete the digital perinatal mental health screening questionnaire after receiving an automated SMS invitation.
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1 year
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Repeat screening adherence rate
Zeitfenster: 1 year
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Proportion of participants who complete follow-up or repeated perinatal mental health screening questionnaires according to the scheduled screening protocol.
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1 year
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Referral to mental health services
Zeitfenster: 1 year
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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.
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1 year
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Follow-up appointment scheduling rate
Zeitfenster: 1 year
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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.
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1 year
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Initiation of specialized perinatal mental health care
Zeitfenster: 1 year
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Proportion of participants classified as moderate or high risk based on EPDS score thresholds who initiate specialized psychological or psychiatric care following referral.
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1 year
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Healthcare professionals trained
Zeitfenster: 1 year
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Number of healthcare professionals onboarded and trained in the implementation of the digital perinatal mental health screening pathway.
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1 year
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Attendance rate at multidisciplinary implementation meetings
Zeitfenster: 1 year
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Proportion of invited healthcare professionals attending multidisciplinary implementation meetings related to the project.
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1 year
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Screening activation rate within the electronic health record system
Zeitfenster: 1 year
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Proportion of eligible clinical encounters in which the digital perinatal mental health screening pathway is activated through the electronic health record system.
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1 year
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Clinical alert review rate
Zeitfenster: 1 year
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Proportion of automatically generated clinical alerts reviewed by healthcare professionals within the electronic health record system.
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1 year
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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Teresa Reis, PhD, University of Évora
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- 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/
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- MATTER-UEVORA-2023
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