MamaConecta: Digital Tool for Maternal Mental Health

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.

Conditions

• Pregnancy Related
• Mental Health Issue
• Postpartum Depression
• Postpartum Anxiety
• Well-Being, Psychological

Interventions

OTHER

Mobile application

The 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).

OTHER

Monitoring via wearable

Participants that own a wearable will connect it to monitor variables related to sleeping patterns, activity and stress (see variables section).

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute (VHIR)

  collaborator UNKNOWN

• Universitat Rovira i Virgili (URV)

  collaborator UNKNOWN

• Hospital del Mar Research Institute (IMIM)

  collaborator OTHER

• A Thousand Colibris, S.L

  lead INDUSTRY

Principal Investigators

• Roser Palau-Costafreda, PhD · A Thousand Colibris, S.L

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-12-28

Primary Completion

2025-11-01

Completion

2027-12-31

Countries

• Spain

Study Locations