Study protocol for the Mindful Moms Study: A randomized controlled trial evaluating a mindful movement intervention for marginalized pregnant people experiencing depression.

Autor: Kinser PA; School of Nursing, Virginia Commonwealth University, Richmond, VA, USA; Virginia Institute for Psychiatric and Behavioral Genetics, Virginia Commonwealth University, Richmond, VA, USA. Electronic address: kinserpa@vcu.edu., Bodnar-Deren S; Department of Sociology, Virginia Commonwealth University, Richmond, VA, USA., Amstadter AB; Virginia Institute for Psychiatric and Behavioral Genetics, Virginia Commonwealth University, Richmond, VA, USA; Department of Psychiatry, Virginia Commonwealth University, Richmond, VA, USA., Lapato DM; Virginia Institute for Psychiatric and Behavioral Genetics, Virginia Commonwealth University, Richmond, VA, USA; Department of Human and Molecular Genetics, Virginia Commonwealth University, Richmond, VA, USA., Thacker LR; Department of Biostatistics, Virginia Commonwealth University, Richmond, VA, USA., Johnson JA; Department of Sociology, Virginia Polytechnic Institute and State University, Blacksburg, VA, USA., Aubry C; School of Nursing, Virginia Commonwealth University, Richmond, VA, USA., Johnson A; School of Nursing, Virginia Commonwealth University, Richmond, VA, USA., Gault C; School of Nursing, Virginia Commonwealth University, Richmond, VA, USA., Hill-Thomas A; School of Nursing, Virginia Commonwealth University, Richmond, VA, USA., Russell S; School of Nursing, Virginia Commonwealth University, Richmond, VA, USA., Lanni S; School of Medicine, Virginia Commonwealth University, Richmond, VA, USA., Freeman A; Healthy Hearts Plus II, Richmond, VA, USA.
Jazyk: angličtina
Zdroj: Contemporary clinical trials [Contemp Clin Trials] 2023 Sep; Vol. 132, pp. 107302. Date of Electronic Publication: 2023 Jul 25.
DOI: 10.1016/j.cct.2023.107302
Abstrakt: More than 1 in 5 pregnant people in the United States experience depressive symptoms. Although treatments exist, many people remain under- or un-treated due to concerns about stigma, side effects, and costs of medications or psychotherapy, particularly those who are marginalized (defined as those who are minoritized, low-income, or with low-educational attainment). Further, the standard depression treatments do not address social connectedness, which is a potentially modifiable factor involved in depressive symptom etiology. This protocol presents the rationale, design, and status of the two-arm longitudinal parallel group randomized controlled trial - the Mindful Moms Study - which aims to evaluate the effects and mechanisms of a group-based mindful physical activity (yoga) intervention in marginalized pregnant people with depressive symptoms (n = 200) compared to a prenatal education control group. The primary aim is to evaluate effects of group assignment on depressive symptom severity, anxiety, and perceived stress over time from baseline to six weeks postpartum. Secondary aims include understanding the role of social connectedness as a moderator of the effects and to identify genome-wide DNA methylation patterns associated with depressive symptoms and perceived social connectedness at postpartum. A focus on adequate symptom management through non-pharmacologic, accessible therapies that address social connectedness during pregnancy in marginalized women is an urgent clinical and research priority. The successful completion of this study will provide important insights into social connectedness as a mechanism to decrease depressive symptoms in a largely understudied population. Trial registration: NCT04886856.
Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
(Copyright © 2023 Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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