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Search / Trial NCT06640907

Feasibility Study and Pilot Hybrid Effectiveness-Implementation Trial for the Universal Prevention of Maternal Perinatal Mental Disorders as Normalized Routine Practice (e-Perinatal Pilot)

Launched by UNIVERSITY OF SEVILLE · Oct 11, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Depression Anxiety Perinatal Well Being Prevention M Health

ClinConnect Summary

The e-Perinatal Pilot study is researching a new mobile health program aimed at preventing mental health issues like depression and anxiety in mothers during pregnancy and shortly after giving birth. This study will help us understand how well this program works and how we can make it a regular part of care for new mothers. It’s a starting point for a larger trial that will look more deeply into how effective this program can be for improving mental health in new mothers.

To participate, mothers need to be invited by a healthcare professional and must be either pregnant (less than 28 weeks) or have given birth within the last five months. They should be at least 18 years old, have a mobile phone and internet access, be able to read and write in Spanish, and have a personal email. Partners or significant others can also join if their mother is participating, but they do not have any specific exclusion criteria. This study is not yet recruiting participants, but it aims to provide valuable insights into improving mental health care for mothers during a critical time.

Gender

ALL

Eligibility criteria

  • Inclusion criteria for mothers:
  • Must receive an invitation to participate from a healthcare professional at one of the participating primary healthcare centers
  • Must be pregnant for at least 16 weeks or have given birth within the last 5 months at the time of enrollment
  • Must be at least 18 years old
  • Must have access to a mobile phone and internet connection
  • Must be able to read, write, and understand Spanish
  • Must have a personal email account
  • Inclusion criteria for partners (or significant others):
  • Must receive an invitation to participate from a woman already enrolled in the study
  • Must be at least 18 years old
  • Must have access to a mobile phone and internet connection
  • Must be able to read, write, and understand Spanish
  • Must have a personal email account
  • Exclusion criteria for mothers:
  • Meet diagnostic criteria for anxiety or depression, as determined by a structured clinical interview
  • Be on a waiting list or currently receiving psychological or pharmacological treatment for any mental health or substance use condition
  • Exclusion criteria for partners (or significant others):
  • There are no exclusion criteria for partners

About University Of Seville

The University of Seville is a prestigious academic institution dedicated to advancing knowledge through innovative research and exceptional education. With a strong emphasis on interdisciplinary collaboration, the university actively engages in clinical trials aimed at enhancing patient care and medical outcomes. Its commitment to rigorous scientific inquiry and ethical standards positions it as a leading sponsor in the field of clinical research, fostering partnerships with healthcare professionals and institutions to drive advancements in medical science and improve public health.

Locations

Mairena Del Aljarafe, Seville, Spain

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported