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 |