Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
Healthy Volunteers
ID06442774

Digital Tool to Improve Maternal Mental Health: Supporting Well-being and Early Detection During Pregnancy and Postpartum

Led by A Thousand Colibris, S.L · Updated on 2025-01-17

1200

Participants Needed

3

Research Sites

156 weeks

Total Duration

On this page

Sponsors

A

A Thousand Colibris, S.L

Lead Sponsor

H

Hospital Universitari Vall d'Hebron Research Institute

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating a digital health tool called Dana app designed to improve maternal well-being and support mental health monitoring during the perinatal period. This study focuses on women transitioning into motherhood, aiming to enhance early detection of mental health disorders, assist healthcare professionals in diagnosis and monitoring, and improve obstetric outcomes as well as infant psychological and cognitive development. The trial addresses the high prevalence of mood disorders in pregnant women and the challenges of underdiagnosis and inadequate treatment that affect both mother and child. Participants will use the Dana mobile application from 12-14 weeks of pregnancy until 24 months after giving birth. The app includes biopsychosocial programs based on cognitive-behavioral strategies such as psychoeducation, mindfulness, and relaxation exercises. It offers a community forum, a mood diary, and built-in mental health screening questionnaires. Participants who own wearables can connect them to monitor sleep, activity, and stress. The study compares an intervention group using the full app to a control group with an app containing no content. During the study, women will undergo regular assessments of their emotional state, lifestyle, clinical, and obstetric data at multiple time points including 12-14 and 33-34 weeks of pregnancy, and 6 weeks, 6, 12, and 24 months postpartum. Infant development will also be evaluated up to two years old. Data protection is ensured through pseudonymization. Researchers will measure maternal well-being, early detection of mental health issues, diagnostic support, obstetric and neonatal outcomes, and infant neurodevelopment. The total participation lasts from early pregnancy to two years postpartum.

CONDITIONS

Official Title

MamaConecta: Digital Tool for Maternal Mental Health

Who Can Participate

Age: 18Years +
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

Hospital Vall d'Hebron

Barcelona, Catalonia, Spain, 08550

Actively Recruiting

2

Hospital del Mar

Barcelona, Spain, 08003

Actively Recruiting

3

ASSIR Tarragona

Tarragona, Spain, 43007

Actively Recruiting

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Research Team

V

Veronica Montesinos

R

Roser Palau-Costafreda, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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Published Research Related To This Trial

Systematic review and meta-analysis of non-pharmacological interventions to reduce the symptoms of mild to moderate anxiety in pregnant women.

Kerry Evans, C Jane Morrell, Helen Spiby

https://pubmed.ncbi.nlm.nih.gov/28921612

Prevalence of Maternal Postnatal Anxiety and Its Association With Demographic and Socioeconomic Factors: A Multicentre Study in Italy.

Loredana Cena, Antonella Gigantesco, Fiorino Mirabella...

https://pubmed.ncbi.nlm.nih.gov/34658970

Depression and anxiety during pregnancy: a risk factor for obstetric, fetal and neonatal outcome? A critical review of the literature.

Judith Alder, Nadine Fink, Johannes Bitzer...

https://pubmed.ncbi.nlm.nih.gov/17437220

'I've Changed My Mind', Mindfulness-Based Childbirth and Parenting (MBCP) for pregnant women with a high level of fear of childbirth and their partners: study protocol of the quasi-experimental controlled trial.

Irena K Veringa, Esther I de Bruin, Nancy Bardacke...

https://pubmed.ncbi.nlm.nih.gov/27821151