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.
Gestational age between 12-14 weeks of gestation.
The first obstetric ultrasound has been performed.
Women who know how to read and understand Spanish.
Women who have access to a mobile phone with an internet connection (data or wifi)
Termination of pregnancy, or early miscarriage
Perinatal loss at any time during pregnancy.
Severe mental pathology or moderate unstable mental pathology.
Consumption of toxic substances.
Parallel
Mobile application
Other interventionThe intervention that has been developed is a digital tool of a biopsychosocial nature based on the main cognitive-behavioral strategies: psychoeducation, reflection, self-observation, guided visualizations, mindfulness and progressive muscle relaxation. The intervention consists of 3 main areas of work: * Programs: Biopsychosocial programs in text and audio format. * Community: Forum with directed questions and space to share experiences between mothers. * Diary: Space to record mood and emotional record. The entire tool works transversally in 4 dimensions: self-care, relationship with perinatal changes, relationship with the baby, social relationship. The tool itself includes 3 mental health and well-being screening questionnaires: Whooley Questionnaire and the Edinburgh Postnatal Depression Scale (EPDS).
Monitoring via wearable
Other interventionParticipants that own a wearable will connect it to monitor variables related to sleeping patterns, activity and stress (see variables section).
Maternal well-being
Assessed using the World Health Organization-5 Well-Being Index (WHO-5). The WHO-5 is a brief 5-item self-report instrument designed to measure current mental well-being. It has adequate validity for screening depression and measuring clinical trial outcomes, with good properties when used in pregnant women (Mortazavi et al., 2021). Min value: 0 Max value: 25 Higher scores: Indicate better well-being. Scores below 13 suggest poor well-being, indicative of depression.
Depression
Using the Edinburgh Postpartum Depression Scale (EPDS), a 10-item questionnaire for detecting postpartum depression symptoms, validated for pregnancy and in Spanish women (Levis et al., 2020; Vázquez \& Míguez, 2019). Min value: 0 Max value: 30 Higher scores: Indicate worse symptoms. Scores ≥10 suggest possible depression; scores ≥13 or positive for question 10 indicate a high likelihood.
Anxiety
Using the State-Trait Anxiety Inventory (STAI), a 40-item tool for assessing state and trait anxiety (Brunton et al., 2015). Min value: 20 per subscale (STAI-S and STAI-T) Max value: 80 per subscale Higher scores: Indicate worse anxiety outcomes.
Birth Fear
Using the Wijma Delivery Expectancy/Experience Questionnaire (W-DEQ A-B), a 33-item tool to quantify fear of childbirth. Min value: 0 Max value: 165 Higher scores: Indicate higher levels of fear; scores \>85 suggest high fear levels.
Sleep
Using the Pittsburgh Sleep Quality Index (PSQI), a 19-item tool to assess sleep quality over the past 30 days. Min value: 0 Max value: 21 Higher scores: Indicate worse sleep quality; scores \>5 suggest poor sleep.
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A Thousand Colibris, S.L
Lead sponsor
Hospital Universitari Vall d'Hebron Research Institute
Collaborator
Universitat Rovira i Virgili (URV)
Collaborator
Hospital del Mar Research Institute (IMIM)
Collaborator
