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 产后抑郁症 (PPD) 影响 13% 的女性，并与母亲、胎儿/婴儿和 儿童期发病。尽管危险因素是多因素的，但抑郁症病史强烈预测产后抑郁症的风险， 少数种族/族裔妇女尤其容易受到伤害。尽管存在心理干预 为了预防产后抑郁症，一项以瑜伽为基础的干预措施可在高危女性中预防产后抑郁症，该干预措施采用了类似的方法 理论基础（即正念）可能更容易被少数民族妇女所接受，并且可能 带来额外的身体活动益处。瑜伽干预怀孕已被证明是有效的 对于抑郁症，尽管需要进行务实的研究来评估这些类型的干预措施 促进外部有效性。 R34 试点有效性试验的目的是确定 R34 试点有效性 使用虚拟产前瑜伽干预来预防高危女性产后抑郁症 多样化的医疗保健系统，并探索影响干预措施实施的初步因素。 为此，我们聚集了一个具有内容、干预、统计和方法论的研究团队 将协作执行拟议项目的专家。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措施的促进因素和障碍 利益相关者的参与，随后进行公开试验，第二阶段将包括进行 8 次随机试验 对照试验评估拟议的产前瑜伽干预的可行性和可接受性 有抑郁症病史的女性，以及 PPD 的发病和病程及中介因素。这 具体目标是： 1) 在医疗保健系统内优化瑜伽干预的实施，以预防产后抑郁症 通过检查实施的促进因素和障碍，2）检查可行性、可接受性和 对医疗保健系统内干预措施的满意度，以及 3) 评估干预措施的初步有效性 对 PPD 的干预和拟议的机制。对于第一阶段，与患者利益相关者分开焦点小组 亨利·福特健康中心的临床医生和行政利益相关者将告知干预措施的实施， 以及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 周将被随机分配到干预组 (n=24) 或照常治疗组 (n=24)，并且 将完成基线、干预后以及产后 1 个月和 3 个月的调查措施。这是 假设干预措施可行且可接受，让少数种族/族裔妇女参与 状态，并有助于降低 PPD 发病率。体现和正念是建议的调解者。 这项研究的结果将提供初步数据，以告知全动力混合动力 2 型的有效性 - 实施试点。从这项研究中获得的潜在知识可以促进产后抑郁症的预防工作 并改善这种疾病对公共健康的不利影响。