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MamaConecta: Digital Tool for Maternal Mental Health

Study acronym: DDT
StatusRecruiting
PhaseNot applicable
Started2024-12-28
View on ClinicalTrials.gov ↗
Record status
This record was last updated January 17, 2025 (before its estimated November 1, 2025 completion). Its status may not reflect the trial's current state.
The goal of this randomized controlled trial is to validate a digital health tool, Dana app, that enhances well-being and supports mental health monitoring for women during the perinatal period. The primary purpose is to improve maternal well-being, early detection of mental health issues, and aid in the diagnosis and monitoring by healthcare professionals in women transitioning into motherhood. The main questions it aims to answer are: * Does the app improve overall maternal well-being during the perinatal period? * Can the app increase the early detection rates of perinatal mental health disorders? * Can the app be an effective tool to support healthcare professionals to diagnose perinatal mental health problems? * How effective is the app in improving obstetric outcomes and the psychological and cognitive development of infants? Researchers will compare the group using the app with a control group not using the digital tool to see if Dana provides significant improvements in maternal and infant health outcomes. Participants will: * Use the mobile application from 12-14 weeks of gestation until 24 months postpartum. * Undergo regular assessments to monitor their emotional state, lifestyle, clinical, and obstetric data. * Participate in evaluations for their infants' psychological and cognitive development at various stages from birth to two years old. This trial is conducted at multiple centers, including Hospital Vall d'Hebron, the Sexual and Reproductive Health Care Services (ASSIR) in Tarragona and ASSIR Litoral (Barcelona), Hospital del Mar, following CONSORT standards. The study aligns with the Health and Culture priorities of the Spanish Government's Scientific, Technical, and Innovation Research Plan 2021-2023.

Amendment record

Amended once since 2024-05-28. Every amendment is listed below.

Dates here are the day the sponsor filed the amendment, not the day ClinicalTrials.gov published it. Version history last read from ClinicalTrials.gov on 2026-08-30.

2025-01-15
Amendment Not Yet RecruitingRecruiting Study Status, Sponsor/Collaborators, Contacts/Locations, References v1
2024-05-28
Original filing
Trial Details
NCT Number NCT06442774
Lead Sponsor A Thousand Colibris, S.L
Collaborators: Hospital Universitari Vall d'Hebron Research Institute, Universitat Rovira i Virgili (URV), Hospital del Mar Research Institute (IMIM)
Conditions Pregnancy Related, Mental Health Issue, Postpartum Depression, Postpartum Anxiety, Well-Being, Psychological
Enrollment 1,200 participants
Start Date 2024-12-28
Primary Completion 2025-11-01 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-01-17