Study protocol for a multisite randomized controlled trial of an internet and mobile-based intervention for...

Nearly 20% of women in the United States experience clinically significant depressive symptoms during pregnancy or the postpartum period. These women may benefit from easily accessible, nonpharmacologic, and inexpensive self-management approaches, such as via internet and mobile-based interventions, to prevent development of symptoms and/or intervene with current symptoms. This paper summarizes the research protocol of a nationally-funded large-scale randomized controlled study to evaluate "Mamma Mia," a self-guided program with 44 modules that women use throughout pregnancy to 6 months postpartum. The program contains a novel combination of components designed to enable women to enhance self-efficacy, emotional self-regulation, and perceived social support. The overall goal of this three-arm longitudinal randomized controlled trial is to evaluate the effects and mechanisms of this self-management approach in diverse women in the U.S. (n = 1950). Enrolled pregnant women will be randomly assigned to one of three groups: (1) "Mamma Mia" alone, which is self-guided; (2) "Mamma Mia Plus" in which participants engage in the "Mamma Mia" modules plus receive brief guided support from a registered nurse; or (3) usual prenatal/postpartum care. The first specific aim is to evaluate effects by group on the primary outcome of interest, depressive symptoms, over time. The second aim is to evaluate effects by group on subjective well-being, anxiety, and stress. Using a conceptual framework based upon Individual and Family Self-Management Theory, the third aim is to evaluate possible mediators (self-efficacy, emotion self-regulation, perceived support) and possible moderators (e.g., race/ethnicity, type of healthcare clinician) of this self-management approach.