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Search / Trial NCT06871397

Effectiveness of an Online Biopsychosocial Intervention to Improve Well-being and Mental Health During Pregnancy

Launched by UNIVERSITY ROVIRA I VIRGILI · Mar 6, 2025

Trial Information

Current as of May 09, 2025

Not yet recruiting

Keywords

Wellbeing Anxiety Depression E Health Maternal Mental Health Health Promotion Cognitive Behavioral Intervention Randomized Controlled Trial Pregnancy

ClinConnect Summary

This clinical trial is studying the effectiveness of a mobile app designed to help pregnant women manage their emotions and well-being during pregnancy. The app offers practical tools and activities that focus on relaxation, stress management, and preparing for motherhood. By using this app, women may feel more emotionally stable, better connected to their baby, and more prepared for childbirth, which could also reduce the risk of issues like postpartum depression.

To participate in the study, women need to be over 18 years old, currently pregnant (less than 15 weeks along), and able to understand Spanish. They should also have a smartphone and be comfortable using apps. Participants will be divided into two groups: one group will receive the usual medical care along with access to the app, while the other group will only receive standard care. Throughout the study, participants will answer questionnaires to help researchers understand how the app is impacting their emotional well-being and preparation for motherhood. This trial is not yet recruiting, but it aims to provide valuable support for pregnant women.

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • Pregnant women
  • Pregnancy of less than 15 weeks of gestation
  • More than 18 years old age
  • Able to read, write, and understand Spanish
  • In possession of a smartphone
  • Able to manage smartphone apps
  • Have signed a written informed consent document
  • Exclusion Criteria:
  • Having a high-risk pregnancy that entails transfer to another specialized health centre
  • Having diagnosis of disease that may affect the central nervous system, such as brain pathology or traumatic brain injury
  • Having other psychiatric diagnosis or acute psychiatric illness, such as substance dependence or abuse, a presence of schizophrenia or other psychotic disorders or risk for suicide
  • To be under psychopharmacological medication or under psychopharmacological treatment.

About University Rovira I Virgili

The University Rovira i Virgili (URV) is a prestigious academic institution located in Tarragona, Spain, renowned for its commitment to research and innovation in various fields, including health sciences. With a strong emphasis on interdisciplinary collaboration, URV actively engages in clinical trials aimed at advancing medical knowledge and improving patient care. The university's research initiatives are supported by state-of-the-art facilities and a network of experienced professionals dedicated to conducting high-quality studies that adhere to ethical standards and regulatory guidelines. Through its clinical research endeavors, URV seeks to contribute to the development of new treatments and therapies, ultimately enhancing the health outcomes of diverse populations.

Locations

Reus, Tarragona, Spain

Patients applied

0 patients applied

Trial Officials

Carmen Hernández Martínez, Doctor

Principal Investigator

University Rovira i Virgili

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported