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Table 2 World Health Organization Trial Registration Data Set

From: A smartphone-assisted brief online cognitive-behavioral intervention for pregnant women with depression: a study protocol of a randomized controlled trial

Data category

Information

Primary registry and trial identifying number

ClinicalTrials.gov

NCT04495166

Date of registration in primary registry

29/07/2020

Secondary identifying numbers

SB-POC-1810-20573

Source(s) of monetary or material support

Grand Challenges Canada

Fundação Maria Cecilia Souto Vidigal

Primary sponsor

University of Sao Paulo

Secondary sponsor(s)

Grand Challenges Canada

Fundação Maria Cecilia Souto Vidigal

Contact for public queries

Daniel Fatori, PhD (daniel.fatori@gmail.com)

Contact for scientific queries

Daniel Fatori, PhD, University of Sao Paulo Medical School

Public title

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

Scientific title

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

Countries of recruitment

Brazil

Health condition(s) or problem(s) studied

Perinatal depression

Intervention(s)

Treatment: Motherly app + brief psychotherapy

Active control: Educational app + brief psychotherapy

Key inclusion and exclusion criteria

Ages eligible for study: 16 to 40 years

Sexes eligible for study: female

Gender based: no

Accepts healthy volunteers: no

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

Exclusion criteria: 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).

Study type

Interventional

Allocation: randomized

Intervention model: parallel assignment

Masking: Double (Investigator, Outcomes Assessor)

Primary purpose: Treatment

Phase III

Date of first enrolment

August 2020

Target sample size

70

Recruitment status

Recruitment ended

Primary outcome(s)

Change in maternal prenatal depression from baseline to posttreatment (8 weeks)

Key secondary outcome(s)

Change in maternal prenatal anxiety from baseline to posttreatment

Change in maternal prenatal quality of life from baseline to posttreatment

Change in maternal prenatal psychological well-being from baseline to posttreatment

Change in maternal physical activity levels from baseline to posttreatment

Change in maternal prenatal perceived stress from baseline to posttreatment

Change in maternal prenatal depression severity from baseline to posttreatment

Change in maternal prenatal sleep quality from baseline to posttreatment

Infant developmental milestones at 2 months of age