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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 April 23, 2025

Not yet recruiting

Keywords

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

ClinConnect Summary

BACKGROUND Pregnancy represents a significant developmental transition, presenting both opportunities and challenges for maternal mental health. While it can be a time of joy and fulfillment, it also involves profound physiological and psychological changes, often accompanied by stress and uncertainty regarding pregnancy, childbirth, and motherhood. Epidemiological studies indicate that pregnant women are at a higher risk of emotional disorders compared to non-pregnant women. The prevalence of subthreshold anxiety symptoms ranges from 10% to 39%, while 11.4% to 30% of pregnant women meet di...

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.

Trial Officials

Carmen Hernández Martínez, Doctor

Principal Investigator

University Rovira i Virgili

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

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported