Clinical trial NCT04495166: A Smartphone-Assisted Brief Behavioral Intervention for Pregnant Women With Depression
Official title: Smartphone-Assisted Brief Behavioral Intervention for Pregnant Women With Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perinatal Depression
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Grand Challenges Canada
name: Fundação Maria Cecilia Souto Vidigal
First posted: 2020-07-31
Enrollment: 81
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 efficacy of Motherly in conjunction with brief cognitive-behavioral therapy. 70 pregnant women between 16-40 years old will be recruited. Since all interventions will be conducted online, participants will be recruited from any Brazilian state or municipality. Participants will be randomly assigned to either receive intervention via app consisting of behavioral activation and psychoeducation to promote changes in sleep, nutrition, and physical activity habits, as well as to engage in prenatal care, breastfeeding, and social support, and to stimulate child development, in addition to brief cognitive-behavioral therapy (CBT) (n=35); or to a comparison group receiving an psychoeducational app (active control) with psychoeducational content about gestation, maternal health and mental health, and child development in addition to brief CBT (n=35). Duration of treatment will be eight weeks, during which participants in both groups will be assessed at the beginning (baseline; T0), weeks 3-4 (midpoint; T1), and week 8 (endpoint; T2) in order to evaluate treatment effects. A follow-up postnatal assessment will also be conducted when the child is three months of age (T3).


Eligibility criteria: Inclusion Criteria:

* 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 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, etc).

Primary outcomes:
measure: Change in Maternal Prenatal Depression at Baseline, Midpoint, and Posttreatment (8 Weeks)
timeFrame: Baseline (T0), Weeks 3-4 (Midpoint, T1), Week 8 (Posttreatment, T2).
Secondary outcomes:
measure: Change in Maternal Prenatal Anxiety From Baseline to Posttreatment (8 Weeks)
timeFrame: Baseline (T0), Weeks 3-4 (Midpoint, T1), Week 8 (Posttreatment, T2).
measure: Change in Maternal Prenatal Quality of Life From Baseline to Posttreatment (8 Weeks)
timeFrame: Baseline (T0), Weeks 3-4 (Midpoint, T1), Week 8 (Posttreatment, T2).
measure: Change in Maternal Prenatal Psychological Well-Being From Baseline to Posttreatment (8 Weeks).
timeFrame: Baseline (T0), Week 8 (Posttreatment, T2).
measure: Change in Maternal Physical Activity Levels From Baseline to Posttreatment (8 Weeks).
timeFrame: Baseline (T0), Week 8 (Posttreatment, T2).
measure: Change in Maternal Prenatal Perceived Stress From Baseline to Posttreatment (8 Weeks).
timeFrame: Baseline (T0), Weeks 3-4 (Midpoint, T1), Week 8 (Posttreatment, T2).
measure: Change in Maternal Prenatal Depression Severity From Baseline to Posttreatment (8 Weeks).
timeFrame: Weeks 3-4 (Midpoint, T1), Week 8 (Posttreatment, T2).
measure: Change in Maternal Prenatal Sleep Quality From Baseline to Posttreatment (8 Weeks).
timeFrame: Baseline (T0), Weeks 3-4 (Midpoint, T1), Week 8 (Posttreatment, T2).
measure: Infant Developmental Milestones at 2 Months of Age.
timeFrame: When the infant is two months of age (Follow-up, T3).
measure: Infant Social/Emotional Problems at 2 Months of Age.
timeFrame: When the infant is two months of age (Follow-up, T3).
measure: Change in Maternal Prenatal Depression From Baseline to Follow-up.
timeFrame: Baseline (T0), when the infant is two months of age (Follow-up, T3).
measure: Change in Maternal Prenatal Anxiety From Baseline to to Follow-up.
timeFrame: Baseline (T0), when the infant is two months of age (Follow-up, T3).
measure: Change in Maternal Prenatal Quality of Life From Baseline to to Follow-up.
timeFrame: Baseline (T0), when the infant is two months of age (Follow-up, T3).
measure: Change in Maternal Prenatal Psychological Well-Being From Baseline to Follow-up.
timeFrame: Baseline (T0), when the infant is two months of age (Follow-up, T3).
measure: Change in Maternal Prenatal Perceived Stress From Baseline to Follow-up.
timeFrame: Baseline (T0), when the infant is two months of age (Follow-up, T3).
measure: Change in Maternal Prenatal Depression Severity From Baseline to Follow-up.
timeFrame: Baseline (T0), when the infant is two months of age (Follow-up, T3).
measure: Change in Maternal Prenatal Sleep Quality From Baseline to Follow-up.
timeFrame: Baseline (T0), when the infant is two months of age (Follow-up, T3).
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Daniel Fatori
Study officials:
affiliation: Medical School, University of Sao Paulo
name: Daniel Fatori, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sockol LE, Epperson CN, Barber JP. A meta-analysis of treatments for perinatal depression. Clin Psychol Rev. 2011 Jul;31(5):839-49. doi: 10.1016/j.cpr.2011.03.009. Epub 2011 Mar 27.
citation: Graham JW, Olchowski AE, Gilreath TD. How many imputations are really needed? Some practical clarifications of multiple imputation theory. Prev Sci. 2007 Sep;8(3):206-13. doi: 10.1007/s11121-007-0070-9. Epub 2007 Jun 5.
citation: Zuccolo PF, Xavier MO, Matijasevich A, Polanczyk G, Fatori D. A smartphone-assisted brief online cognitive-behavioral intervention for pregnant women with depression: a study protocol of a randomized controlled trial. Trials. 2021 Mar 23;22(1):227. doi: 10.1186/s13063-021-05179-8.