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

Abstract

Background Pregnancy is strongly associated with increased risk for depression. Approximately 25% of pregnant women develop depression. Treatment for depression during pregnancy has several complexities: the use of psychiatric medications during pregnancy might result in developmental problems in the child and must be used with caution. Psychosocial interventions are effective, but they require specialized professionals. Low- and middle-income countries (LMIC) such as Brazil do not have enough mental health professionals needed to meet this demand. In this context, smartphone-based interventions show immense potential. We developed Motherly, a smartphone application (app) designed to treat maternal depression. We aim to test the efficacy of Motherly 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 aged between 16 and 40 years with depression will be randomized to intervention or active control. The intervention group will have access to Motherly, a smartphone app based on three concepts: psychoeducation, behavior monitoring, and gaming elements. Motherly is composed of a package of interventions composed of modules: mental health, sleep, nutrition, physical activity, social support, prenatal/postnatal support, and educational content. The main focus of Motherly is delivering behavioral activation (BA), a brief and structured psychological treatment. The app allows participants to schedule and engage in, and monitor activities according to a plan to avoid acting exclusively according to their mood. The active control group will have access to a simplified version of the app consisting of educational content about various aspects of pregnancy, maternal physical and mental health, and infant development (BA, activity scheduling, sleep hygiene, among other functionalities, will not be present in this version). Both groups will receive four sessions of brief CBT in 8 weeks. Participants will be evaluated by assessors blind to randomization and allocation status. Assessments will occur at baseline (T0), midpoint (T1, week 4–5), posttreatment (T2, week 8), and follow-up (T3, when the child is 2 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 The potential of digital technology to deliver mental health interventions has been increasingly recognized worldwide. 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 promote maternal and child health and well-being. In particular, we aim to treat depression, for which the use of digital technologies is still scarce. Smartphone applications designed to treat maternal depression are especially relevant because of the potential to circumvent barriers that prevent pregnant women from accessing mental health care. Trial registration ClinicalTrials.gov NCT04495166. Prospectively registered on July 29, 2020.

The Efficacy of Digital Cognitive–Behavioral Interventions in Supporting the Psychological Adjustment and Sleep Quality of Pregnant Women with Sub-Clinical Symptoms: A Systematic Review and Meta-Analysis

“…Moreover, these studies were based either on specific intervention protocols (e.g., traditional CBTs) [ 41 , 42 ] or conversely included psychological interventions at large [ 50 , 51 ], despite their specific theoretical background. In addition, among the studies that placed attention on pregnancy, the involved women presented either clinically relevant psychological symptoms or mental disorders, such as major depression [ 52 , 53 ], or were instead recruited from the general population regardless of their symptomatology level [ 41 , 42 , 54 ]. The only available study that solely included women with sub-clinical symptoms and no prior mental disorder considered the broader perinatal period and investigated the efficacy of in-person MBIs [ 46 ].…”

Psychological Interventions for Prenatal Anxiety in Latinas and Black Women: A Scoping Review and Recommendations

“…Most protocols ( n = 6) were RCTs proposing to test the efficacy of CBT. These protocols involved delivery of CBT face-to-face ( 38 , 40 , 41 , 43 ), online ( 42 , 45 ), or in combination with a positive parenting intervention ( 43 ). One protocol compared an enhanced Prenatal Positive Parenting Program with Mellow Bumps , an intervention focused on promoting antenatal health and mother-infant attachment ( 44 ).…”

“…Six studies planned to deliver their interventions individually (38,41,42), and the other two planned to deliver them in a group setting (43,44). Three of the five protocols made explicit reference to techniques under consideration to improve cultural fit of their interventions with historically excluded groups of pregnant women (38)(39)(40)(43)(44)(45), and five planned to collect acceptability data from enrolled women (38)(39)(40)(41)44).…”

Obesity in pregnancy

“…The use of monitored home programs is becoming increasingly common and is used in a large number of pathologies (Block et al, 2016;Brouwers et al, 2020;Correia et al, 2018Correia et al, , 2019Gandolfi et al, 2017;Matheve et al, 2017;Vieira et al, 2017). Specifically in pregnant women, it has been used as a tool to change sedentary behavior (Sandborg et al, 2021), to promote healthy eating (Carolan-Olah et al, 2021), to control gestational diabetes (C. Kim et al, 2012;Nicklas et al, 2014), promote recommended gestational weight gain (Graham et al, 2014) and to improve mental health (Carissoli et al, 2019;Krusche et al, 2018;Zuccolo et al, 2021).…”