Nearly 20% of women in the United States experience clinically significant depressive symptoms during pregnancy or the postpartum period. Pregnant and postpartum women would benefit from easily accessible, non-pharmacologic, and inexpensive self-management approaches, such as via the internet, to prevent development of symptoms and/or intervene with current symptoms. At present, no systematic internet-based self-management approaches designed to prevent or treat perinatal depressive symptoms exist in the U.S. Our proposed study will address this gap by evaluating an internet-based self-management program to prevent and intervene with perinatal depressive symptoms? ?Mamma Mia?? in a large scale randomized controlled study. ?Mamma Mia? is a self-guided program that women will begin during the ?teachable moment? of pregnancy, when intrinsic motivation for self-management is high, and will complete by six 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. With our Norwegian colleagues, we recently established the feasibility and efficacy of ?Mamma Mia? for perinatal depressive symptoms in 1342 women in Norway and we piloted a demonstration version in the U.S. The proposed study builds upon our findings by adapting the intervention for a diverse U.S. audience; by using national and hub-based (local) strategies for recruiting women of diverse racial/ethnic and socioeconomic status; and, by adding a small amount of guided support (?Mamma Mia Plus?). The overall goal of this three-arm longitudinal randomized controlled trial is to evaluate the effects and mechanisms of this internet-based 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? in which they engage in 44 modules throughout their pregnancy and the first six months postpartum; (2) ?Mamma Mia Plus? in which they 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 symptom severity, over time.
The second aim i s 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 tertiary 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, which may differ from those in the Norwegian RCT. We seek to shift the clinical paradigm regarding prevention of perinatal depressive symptoms by using an internet-based self-management approach that allows for wide-ranging accessibility and large reach to individuals across all geographical regions of the U.S. If proven efficacious, ?Mamma Mia? may be a low-cost, sustainable, and translatable option for prevention of and intervention in perinatal depressive symptoms.

Public Health Relevance

/ RELEVANCE TO PUBLIC HEALTH Nearly 20% of women in the U.S. (1 million women per year) experience clinically significant depressive symptoms during pregnancy or postpartum, and the majority of these women suffer ?in silence? due to various barriers to care. A promising internet-based approach for preventing perinatal depressive symptoms, ?Mamma Mia?, has been developed and tested in Norway; we propose to build upon this work by evaluating an adapted version through a multi-site randomized controlled trial in a large group of diverse women in the U.S. If successful, the proposed project has high potential to change self-management of perinatal depressive symptoms because it is practical, internet-based, and low-cost.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Research Project (R01)
Project #
1R01HD100395-01
Application #
9858485
Study Section
Clinical Management of Patients in Community-based Settings Study Section (CMPC)
Program Officer
Davis, Maurice
Project Start
2020-04-06
Project End
2025-03-31
Budget Start
2020-04-06
Budget End
2021-03-31
Support Year
1
Fiscal Year
2020
Total Cost
Indirect Cost
Name
Virginia Commonwealth University
Department
Other Health Professions
Type
Schools of Nursing
DUNS #
105300446
City
Richmond
State
VA
Country
United States
Zip Code
23298