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Study protocol for a multisite randomized controlled trial of an internet and mobile‐based intervention for preventing and reducing perinatal depressive symptoms
Author(s) -
Kinser Patricia,
Jallo Nancy,
Huberty Jennifer,
Jones Evelyn,
Thacker Leroy,
Moyer Sara,
Laird Breanne,
Rider Amy,
Lanni Susan,
Drozd Filip,
Haga Silje
Publication year - 2021
Publication title -
research in nursing and health
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.836
H-Index - 85
eISSN - 1098-240X
pISSN - 0160-6891
DOI - 10.1002/nur.22092
Subject(s) - randomized controlled trial , psychological intervention , medicine , intervention (counseling) , anxiety , pregnancy , clinical psychology , self management , postpartum period , social support , protocol (science) , edinburgh postnatal depression scale , depressive symptoms , physical therapy , psychology , psychiatry , psychotherapist , alternative medicine , pathology , genetics , surgery , machine learning , computer science , biology
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.