A Smartphone-Assisted Brief Behavioral Intervention for Pregnant Women with Depression: a Study Protocol of a Randomized Controlled Trial

• Published in: Trials 2021
• Main Authors: Pedro Fonseca Zuccolo, Xavier, Mariana O, Matijasevich, Alicia, Guilherme Vanoni Polanczyk, Fatori, Daniel
• Format: Text Resource
• Language: English
• Subjects: Anxiety; Behavior modification; Children; Intervention; Medical personnel; Mental depression; Mental health; Quality of life; Sleep; Smartphones; Women; Womens health
• DOI: 10.21203/rs.3.rs-67826/v1

Background: Pregnancy is strongly associated with increased risk for depression, but treating pregnant women is challenging. The use of psychiatric medications might result in developmental problems in the child, therefore must be used with caution. Psychosocial interventions require specialized professionals which are scarce, especially in low- and middle-income countries. In this context, smartphone-based interventions show immense potential. We created Motherly, a smartphone app designed to promote maternal mental health. The Motherly app delivers a package of interventions, including mental health, sleep, nutrition, physical activity, social support, prenatal/postnatal support, and psychoeducational content. With this study, we will test the effectiveness of the Motherly app in addition to brief cognitive-behavioral therapies (CBT) to treat maternal depression. Methods: We will conduct a 2-arm parallel randomized controlled clinical trial in which 70 pregnant women between 16-40 years with depression will be randomized to intervention or active control. The intervention group will have access to the Motherly app. The active control group will have access to a simplified version of the app consisting exclusively of psychoeducational content. Both groups will undergo four sessions of CBT in 8 weeks. Participants will be evaluated by assessors blind to randomization and allocation status at baseline (T0), midpoint (T1, week 4-5), posttreatment (T2, week 8), and follow-up (T3, when the child is two months-old). Maternal mental health (prenatal anxiety, psychological well-being, perceived stress, depression, depression severity, and sleep quality), quality of life, physical activity levels, and infant developmental milestones and social/emotional problems will be measured. Our primary outcome is the change in maternal prenatal depression from baseline to posttreatment (8 weeks). Discussion: There is a growing literature on interventions using smartphone applications to promote mental health, both with or without the intermediation of a mental health professional. Our study adds to the literature by testing whether an app providing an intervention package, including CBT, psychoeducation, nutrition, physical activity, and social support, can treat depression, a condition for which the use of digital technologies is still scarce. Smartphone applications designed to treat maternal depression have the potential to circumvent barriers that prevent pregnant women