Actively Recruiting

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

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

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

1200

Participants Needed

3

Research Sites

112 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 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.

CONDITIONS

Brief 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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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for eligibility assessment before 15 weeks of gestation

Treatment

Duration - From 12-14 weeks of pregnancy until 4 months postpartum

Participants use the digital tool or receive usual care during pregnancy and early postpartum to improve maternal mental health and well-being.

Participants use the mobile application regularly; monitoring via wearable device if owned

Long-term Monitoring

Duration - Up to 24 months postpartum

Participants are monitored for maternal mental health, child neurodevelopment, and related outcomes up to 24 months postpartum.

Follow-up assessments at 6 weeks, 6 months, 12 months, and 24 months postpartum

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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Frequently Asked Questions

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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