Prenatal Yoga to Prevent Postpartum Depression (PRY-D)

产前瑜伽预防产后抑郁症 (PRY-D)

• 批准号: 10723544
• 负责人: Amy Michele Loree
• 金额: $ 68.3万
• 依托单位: HENRY FORD HEALTH SYSTEM
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-07-03 至 2026-07-02
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10723544
• 关键词: Administrator; Affect; Behavior; Black race; Body Image; Child; Childhood; Cost Savings; Data; Development; Disease; Effectiveness of Interventions; Emotional; Enrollment; Evidence based practice; Exclusion; Fatigue; Focus Groups; Foundations; Future; Health; Health Services Accessibility; Health system; Healthcare Systems; High Risk Woman; Hybrids; Infant; Infant Health; Intervention; Knowledge; Logistics; Measures; Mediating; Mediator; Mental Depression; Mental Health; Mental Health Services; Mental disorders; Methodology; Minority Women; Morbidity - disease rate; Not Hispanic or Latino; Participant; Patients; Phase; Physical activity; Postpartum Depression; Postpartum Period; Pregnancy; Pregnant Women; Prenatal care; Prevention; Preventive; Provider; Public Health; Randomized; Randomized, Controlled Trials; Recording of previous events; Research; Risk; Risk Factors; Services; Stress; Surveys; Target Populations; Techniques; Time; Use Effectiveness; Vaginal delivery procedure; Woman; Women' s Health; Work; Yoga; acceptability and feasibility; adverse outcome; antepartum depression; associated symptom; depressive symptoms; effectiveness evaluation; effectiveness research; effectiveness testing; effectiveness trial; effectiveness/implementation trial; ethnic diversity; ethnic minority; evidence base; exercise intervention; experience; fetal; follow-up; group intervention; high risk population; implementation barriers; implementation facilitators; implementation intervention; improved; individual patient; intervention delivery; intervention refinement; metropolitan; mindfulness; patient oriented; perinatal mental health; phenomenological models; pilot test; post intervention; pregnant; prenatal; prevent; preventive intervention; primary outcome; psychologic; racial diversity; racial minority; racial minority population; recruit; risk prediction; satisfaction; systematic review; treatment as usual; virtual; virtual delivery

PROJECT ABSTRACT Postpartum depression (PPD) affects 13% of women and is associated with maternal, fetal/infant, and childhood morbidity. Though risk factors are multifactorial, a history of depression strongly predicts risk of PPD, and women of racial/ethnic minority status are especially vulnerable. Although psychological interventions exist for the prevention of PPD, a yoga-based intervention to prevent PPD among at-risk women utilizes a similar theoretical foundation (i.e., mindfulness), may be more acceptable to women of minority status, and may confer additional physical activity benefits. Yoga interventions in pregnancy have been shown to be efficacious for depression, although pragmatic research is needed to evaluate these types of interventions in a way that facilitates external validity. The purpose of this R34 Pilot Effectiveness Trial is to determine the effectiveness of using a virtually delivered prenatal yoga intervention for the prevention of PPD among at-risk women in a diverse health care system and explore preliminary factors which influence implementation of the intervention. To this end, we have gathered a research team with content, intervention, statistical, and methodological expertise who will collaboratively execute the proposed project. In the proposed study, Phase 1 will evaluate facilitators and barriers to intervention implementation among patient, clinician, and health system stakeholders, followed by an open trial, and Phase 2 will include conducting an 8-session pilot randomized controlled trial to assess the feasibility and acceptability of the proposed prenatal yoga intervention among women with a history of depression, as well as the onset and course of PPD and mediating factors. The specific aims are to: 1) Optimize delivery of a yoga intervention within a healthcare system to prevent PPD through examining facilitators and barriers of implementation, 2) Examine feasibility, acceptability and satisfaction of the intervention within a health care system, and 3) Evaluate preliminary effectiveness of the intervention on PPD and proposed mechanisms. For Phase 1, separate focus groups with patient stakeholders and clinician and administrative stakeholders from Henry Ford Health will inform intervention implementation, and an open trial to refine and optimize the intervention. For Phase 2, women with a history of depression who are 8-28 weeks pregnant will be randomized to the intervention group (n=24) or treatment-as-usual (n=24) and will complete survey measures at baseline, post-intervention, and 1 and 3 months postpartum. It is hypothesized that the intervention will be feasible and acceptable, engage women of racial/ethnic minority status, and contribute to lower rates of PPD onset. Embodiment and mindfulness are the proposed mediators. Findings from this study will provide preliminary data to inform a fully powered hybrid type 2 effectiveness- implementation trial. The potential knowledge gained from this study can facilitate prevention efforts for PPD and ameliorate the adverse public health impact of this disorder.

项目摘要 产后抑郁(PPD)影响13%的女性，与母亲、胎儿/婴儿和 儿童发病率。虽然风险因素是多因素的，但抑郁症病史强烈地预测了产后抑郁的风险， 具有种族/少数民族地位的妇女尤其容易受到伤害。尽管存在心理干预 对于PPD的预防，一种基于瑜伽的干预措施在高危女性中预防PPD，使用了类似的 理论基础(即正念)，可能更容易被少数群体地位的妇女接受，并可能 提供额外的体力活动好处。瑜伽在怀孕期间的干预已被证明是有效的 对于抑郁症，尽管需要务实的研究来评估这些类型的干预措施， 促进外部效度。R34试点有效性试验的目的是确定 使用虚拟交付的产前瑜伽干预在高危妇女中预防产后抑郁 探讨影响干预实施的初步因素。 为此，我们聚集了一支内容、干预、统计和方法方面的研究团队 将协作执行提议的项目的专业人员。在拟议的研究中，第一阶段将评估 患者、临床医生和卫生系统实施干预的促进者和障碍 利益相关者，随后是开放试验，第二阶段将包括进行8次随机试验 评估拟议中的产前瑜伽干预的可行性和可接受性的对照试验 有抑郁史的妇女，以及产后抑郁的发病和病程以及中介因素。这个 具体目标是：1)优化医疗保健系统内瑜伽干预的交付，以预防产后抑郁 通过审查促进者和实施障碍，2)审查可行性、可接受性和 卫生保健系统内干预的满意度，以及3)评估初步的有效性 对产后抑郁的干预和拟议的机制。对于第一阶段，将焦点小组与患者利益相关者分开 亨利·福特健康公司的临床医生和行政利益相关者将通知干预实施情况， 并进行公开试验，以完善和优化干预措施。对于第二阶段，有抑郁症病史的女性 怀孕8-28周的孕妇将被随机分为干预组(n=24)或照常治疗(n=24)。 将在基线、干预后、产后1个月和3个月完成调查。它是 假定干预将是可行和可接受的，吸引种族/少数民族妇女参与 状态，并有助于降低产后抑郁的发病率。化身和正念是被提议的中介者。 这项研究的发现将提供初步数据，以告知全动力混合动力2型的有效性- 实施试行。从这项研究中获得的潜在知识可以促进产后抑郁的预防工作 并改善这种疾病对公众健康的不利影响。