Prevalence of mood and anxiety disorders during pregnancy: A case-control study with a large sample size.
Faruk Uguz, Eda Yakut, Semra Aydogan...
https://pubmed.ncbi.nlm.nih.gov/30597383Actively Recruiting
Led by A Thousand Colibris, S.L · Updated on 2025-01-17
1200
Participants Needed
3
Research Sites
112 weeks
Total Duration
A
A Thousand Colibris, S.L
Lead Sponsor
H
Hospital Universitari Vall d'Hebron Research Institute
Collaborating Sponsor
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
MamaConecta: Digital Tool for Maternal Mental Health
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
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
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
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
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
V
Veronica Montesinos
R
Roser Palau-Costafreda, PhD
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
Have more questions? Get in touch with our team for quick support
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Faruk Uguz, Eda Yakut, Semra Aydogan...
https://pubmed.ncbi.nlm.nih.gov/30597383Vivette Glover
https://pubmed.ncbi.nlm.nih.gov/32081251Nichole Fairbrother, Allan H Young, Patricia Janssen...
https://pubmed.ncbi.nlm.nih.gov/26303960Kerry Evans, C Jane Morrell, Helen Spiby
https://pubmed.ncbi.nlm.nih.gov/28921612Loredana Cena, Antonella Gigantesco, Fiorino Mirabella...
https://pubmed.ncbi.nlm.nih.gov/34658970Amy E Beddoe, Kathryn A Lee
https://pubmed.ncbi.nlm.nih.gov/18336440Judith Alder, Nadine Fink, Johannes Bitzer...
https://pubmed.ncbi.nlm.nih.gov/17437220Wing Shan Yuen, Hiu Ching Lo, Wing Nga Wong...
https://pubmed.ncbi.nlm.nih.gov/34753018C A Woody, A J Ferrari, D J Siskind...
https://pubmed.ncbi.nlm.nih.gov/28531848Irena K Veringa, Esther I de Bruin, Nancy Bardacke...
https://pubmed.ncbi.nlm.nih.gov/27821151