Status:

COMPLETED

A Smartphone-Assisted Brief Behavioral Intervention for Pregnant Women With Depression

Lead Sponsor:

University of Sao Paulo

Collaborating Sponsors:

Grand Challenges Canada

Fundação Maria Cecilia Souto Vidigal

Conditions:

Perinatal Depression

Eligibility:

FEMALE

16-40 years

Phase:

NA

Brief Summary

Investigators developed Motherly 1.0, a smartphone app designed to treat and promote maternal mental health. A 2-arm parallel-randomized controlled clinical trial (RCT) will be conducted to test the e...

Eligibility Criteria

Inclusion

  • women aged between 16-40 years;
  • having a score of \>7 on the Edinburgh Postnatal Depression Scale (EPDS);
  • gestational age between 17-26 weeks;
  • being literate;
  • owning a functional smartphone with Android for personal use.

Exclusion

  • pregnancies classified as being at risk, fetal malformation, or congenital disease;
  • visual, auditory or intellectual disabilities, or chronic diseases associated with fetal development alterations;
  • severe and/or chronic mental disorder (e.g., schizophrenia, bipolar disorder, etc).

Key Trial Info

Start Date :

August 3 2020

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 27 2021

Estimated Enrollment :

81 Patients enrolled

Trial Details

Trial ID

NCT04495166

Start Date

August 3 2020

End Date

April 27 2021

Last Update

January 11 2022

Active Locations (1)

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1

Daniel Fatori

São Paulo, Brazil