NCT07659977

Brief 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. 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
1mo left

Started Sep 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress97%
Sep 2023Aug 2026

Study Start

First participant enrolled

September 11, 2023

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 24, 2026

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 22, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2026

Expected
Last Updated

June 22, 2026

Status Verified

June 1, 2026

Enrollment Period

2.3 years

First QC Date

March 24, 2026

Last Update Submit

June 15, 2026

Conditions

Perinatal Depression

Keywords

Perinatal mental healthDepression screeningDigital healthClinical pathwaysPrimary careImplementation science

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (11)

  • Screening questionnaire response rate

    1 year

  • Time to screening questionnaire completion

    1 year

  • Partial screening questionnaire completion rate

    1 year

  • Repeat screening adherence rate

    1 year

  • Referral to mental health services

    1 year

  • +6 more secondary outcomes

Study Arms (1)

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

Eligibility Criteria

Age16 Years - 46 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Espírito Santo

Evora, 7000, Portugal

Location

Related Publications (11)

  • 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.

    PMID: 32610640RESULT

  • 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.

    PMID: 36930182RESULT

  • 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.

    PMID: 36630005RESULT

  • 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.

    PMID: 30661630RESULT

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

    RESULT

  • 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.

    PMID: 20443658RESULT

  • 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.

    RESULT

  • 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/

    PMID: 31990493RESULT

  • 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.

    PMID: 3651732RESULT

  • 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.

    PMID: 23487258RESULT

  • 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.

    PMID: 20974776RESULT

Study Officials

  • Teresa Reis, PhD

    University of Évora

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2026

First Posted

June 22, 2026

Study Start

September 11, 2023

Primary Completion

December 31, 2025

Study Completion (Estimated)

August 30, 2026

Last Updated

June 22, 2026

Record last verified: 2026-06

Locations

PT(1)