Digital Tool to Improve Maternal Mental Health: Enhancing Well-being, Early Detection, Diagnosis Support, and Monitoring of Mental Health Problems During the Perinatal Period

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: t
View:

• 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)

• Women who have knowledge of technology tools via app.

• Have signed the informed consent to participate in the study.

Locations
Other Locations
Spain
Hospital del Mar
RECRUITING
Barcelona
Hospital Vall d'Hebron
RECRUITING
Barcelona
ASSIR Tarragona
RECRUITING
Tarragona
Contact Information
Primary
Veronica Montesinos
veronica@athousandcolibris.com
+34622353245
Backup
Roser Palau-Costafreda, PhD
roser@dana.health
Time Frame
Start Date: 2024-12-28
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 1200
Treatments
Active_comparator: Control
Participants of this group will have care as usual from healthcare providers. Participants will have the study variables measured (by questionnaires and monitoring via wearable).
Experimental: Mobile application
Participants of this group will have access to the content of the application and will use it regularly from the start of the study until 4 months postpartum. Participants will have the study variables measured (by questionnaires and monitoring via wearable)
Related Therapeutic Areas
Sponsors
Collaborators: Hospital del Mar Research Institute (IMIM), Universitat Rovira i Virgili (URV), Hospital Universitari Vall d'Hebron Research Institute (VHIR)
Leads: A Thousand Colibris, S.L

This content was sourced from clinicaltrials.gov