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.
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.
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.
- Conditions
- Perinatal Depression
- 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 group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
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
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
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
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
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
Healthcare professionals trained
Number of healthcare professionals onboarded and trained in the implementation of the digital perinatal mental health screening pathway.
Measured: 1 year
Attendance rate at multidisciplinary implementation meetings
Proportion of invited healthcare professionals attending multidisciplinary implementation meetings related to the project.
Measured: 1 year
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
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.
- First posted22 Jun 2026
- Study start11 Sep 2023
- Primary completion31 Dec 2025
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Perinatal DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Universidade Nova de Lisboa
- Sponsor type
- University, hospital or other
- Collaborators
- University of Évora, Comprehensive Health Research Center
- Responsible party
- Sponsor
- Investigators
- Teresa Reis, PhD, Principal investigator, University of Évora
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 32610640Carona 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 36930182Ferreira 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 36630005Stolk 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 30661630Program 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 20443658Cepêda 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 31990493Cox 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 3651732Wisner 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 23487258Earls 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
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07659977
- Acronym / sponsor ID
- MATTER / MATTER-UEVORA-2023
- Conditions
- Perinatal Depression
- Keywords
- Perinatal mental health, Depression screening, Digital health, Clinical pathways, Primary care, Implementation science
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Universidade Nova de LisboaUniversity, hospital or other
- Collaborators
- University of Évora, Comprehensive Health Research Center
- Study start
- 11 Sep 2023 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 22 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 16 to 46 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pregnant and postpartum women receiving care in primary healthcare units and hospital maternity services in the Alentejo region, Portugal.
Key inclusion criteria (3 listed)
- Pregnant women receiving prenatal care
- Postpartum women receiving healthcare services
- Participants able to provide informed consent
Key exclusion criteria (2 listed)
- Unable to provide informed consent
- Not receiving care in participating healthcare services
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
11 secondary outcomes
Screening questionnaire response rate
Time frame: 1 year
Time to screening questionnaire completion
Time frame: 1 year
Partial screening questionnaire completion rate
Time frame: 1 year
Repeat screening adherence rate
Time frame: 1 year
Referral to mental health services
Time frame: 1 year
Follow-up appointment scheduling rate
Time frame: 1 year
Initiation of specialized perinatal mental health care
Time frame: 1 year
Healthcare professionals trained
Time frame: 1 year
Attendance rate at multidisciplinary implementation meetings
Time frame: 1 year
Screening activation rate within the electronic health record system
Time frame: 1 year
Clinical alert review rate
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Results publication: PubMed 32610640Monteiro 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.
- Results publication: PubMed 36930182Carona 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.
- Results publication: PubMed 36630005Ferreira 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.
- Results publication: PubMed 30661630Stolk 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.
- Results publicationProgram BCRMH, Williams J. Best practice guidelines for mental health disorders in the perinatal period. BC Reproductive Mental Health Program; 2014.
- Results publication: PubMed 20443658Pereira 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.
- Results publicationCepêda 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.
- Results publication: PubMed 31990493Antenatal 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/
- Results publication: PubMed 3651732Cox 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.
- Results publication: PubMed 23487258Wisner 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.
- Results publication: PubMed 20974776Earls 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.
- Individual participant dataSharing planned: Undecided. The data is still being organized and processed
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Teresa Reis, PhD principal investigator
University of Évora
1 site in 1 country: see every site and its status.
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.