School of Nursing, Virginia Commonwealth University, Richmond, VA, USA; Virginia Institute for Psychiatric and Behavioral Genetics, Virginia Commonwealth University, Richmond, VA, USA.
Department of Sociology, Virginia Commonwealth University, Richmond, VA, USA.
Contemp Clin Trials. 2023 Sep;132:107302. doi: 10.1016/j.cct.2023.107302. Epub 2023 Jul 25.
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.
超过五分之一的美国孕妇会出现抑郁症状。尽管有治疗方法，但由于担心耻辱感、副作用以及药物或心理治疗的成本，许多人仍未接受治疗或治疗不足，尤其是那些被边缘化的人（定义为少数民族、低收入或低教育程度的人）。此外，标准的抑郁症治疗方法并不能解决社交联系问题，而社交联系是与抑郁症状病因相关的一个潜在可改变的因素。本方案介绍了一项两臂纵向平行组随机对照试验——正念妈妈研究的基本原理、设计和现状，该研究旨在评估基于小组的正念身体活动（瑜伽）干预对有抑郁症状的边缘化孕妇（n=200）的效果和机制，与产前教育对照组相比。主要目的是评估组间分配对抑郁症状严重程度、焦虑和感知压力的影响，从基线到产后六周。次要目标包括了解社会联系作为影响的调节剂的作用，并确定与产后抑郁症状和感知社会联系相关的全基因组 DNA 甲基化模式。关注通过非药物、可及的治疗方法来充分管理症状，这些治疗方法在怀孕期间针对社交联系，这是一个紧迫的临床和研究重点。这项研究的成功完成将为社交联系作为一种降低在很大程度上被低估的人群中抑郁症状的机制提供重要的见解。试验注册：NCT04886856。
