MamaConecta Study Using a Mobile App to Support Mental Health and Well-Being for Pregnant Women from Early Pregnancy to Two Years After Birth

What this Trial Is About

Researchers are evaluating a digital health tool called the Dana app designed to support mental health monitoring and improve well-being for women during the perinatal period. This randomized controlled trial aims to determine if the app can enhance maternal well-being, increase early detection of mental health disorders, assist healthcare professionals in diagnosis and monitoring, and improve obstetric outcomes and infant psychological and cognitive development. The study focuses on women transitioning into motherhood who are at risk of mood disorders, anxiety, depression, and other mental health issues during pregnancy and postpartum. The study involves two groups one using the Dana app regularly from 12-14 weeks of pregnancy until 24 months after birth, and a control group receiving usual care without app content. The app provides biopsychosocial programs, a community forum, and a diary for mood tracking, also incorporating mental health screening questionnaires. Participants who own wearable devices will connect them to monitor sleep, activity, and stress. Data is collected through questionnaires, monitoring, and infant development evaluations. Participants will undergo regular assessments of their emotional state, lifestyle, clinical and obstetric data, and their infants development from birth to two years old. Researchers will measure maternal well-being at multiple time points during pregnancy and postpartum, along with secondary outcomes like depression, anxiety, birth experience, breastfeeding, and infant neurodevelopment. The study includes data protection measures, and researchers remain blinded to group assignments. Total participation spans from early pregnancy through two years postpartum.

MamaConecta: Digital Tool for Maternal Mental Health