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

Smartphone-Assisted Brief Behavioral Intervention for Pregnant Women With Depression

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).

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).