Efficacy of a Prenatal Yoga Intervention for Antenatal Depression

产前瑜伽干预对产前抑郁症的疗效

• 批准号: 8963748
• 负责人: CYNTHIA L. BATTLE
• 金额: $ 57.43万
• 依托单位: BUTLER HOSPITAL (PROVIDENCE, RI)
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-09-01 至 2020-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8963748
• 关键词: Accounting; Affect; Antidepressive Agents; Anxiety; Attention; Behavior Therapy; Behavioral; Biological; Biological Factors; Biological Markers; Biological Testing; Birth; Birth Weight; Blinded; Breathing; Caring; Child; Clinical; Control Groups; Depressed mood; Developmental Delay Disorders; Distress; Educational workshop; Funding; Future; General Population; Health; Health Benefit; Health education; Healthcare; Infant; Inflammation; Inflammatory; Injury; Intervention; Interviewer; Lead; Literature; Low Birth Weight Infant; Manuals; Mediating; Mediator of activation protein; Meditation; Mental Depression; Mental Health; Methodology; Methods; Modification; Monitor; Mothers; National Institute of Child Health and Human Development; Outcome; Outcome Assessment; Pain; Participant; Patient Self-Report; Perinatal; Phase; Physical Function; Pilot Projects; Population; Positioning Attribute; Postpartum Depression; Postpartum Period; Posture; Pre-Eclampsia; Pregnancy; Pregnancy Outcome; Pregnant Women; Premature Birth; Prenatal care; Provider; Psychological Factors; Public Health; Publishing; Randomized; Randomized Controlled Trials; Research; Risk; Safety; Series; Severities; Sleep; Sleep disturbances; Spontaneous abortion; Teacher Professional Development; Test Result; Testing; Time; Training Programs; United States National Institutes of Health; Woman; Work; Yoga; adverse outcome; antepartum depression; cognitive skill; control trial; cost; delivery complications; depressive symptoms; design; efficacy testing; experience; improved; instructor; lifetime risk; neurobehavioral; novel; offspring; peripartum depression; pilot trial; prenatal; prenatal testing; primary outcome; programs; psychologic; public health relevance; randomized trial; response; secondary outcome; teacher; trial design

 DESCRIPTION DESCRIPTION (provided by applicant): This R01 resubmission "Efficacy of a Prenatal Yoga Intervention for Antenatal Depression" is in response to NICHD PA-12-216, Women's Mental Health During Pregnancy and the Postpartum Period. Antenatal depression is common and associated with adverse outcomes for mother and child, yet the majority of affected women do not receive any mental health treatment. Pregnant women have unique concerns about treatment acceptability and are often reluctant to take antidepressants, the most widely available form of depression care. Prenatal yoga is an excellent candidate for a depression intervention that might be efficacious as well as acceptable and safe during pregnancy. There is evidence to support the efficacy of yoga for depression in the general population, as well as plausible biological and psychological mechanisms (e.g., decreased inflammation, increased non-judgment of internal experiences) by which yoga might have an impact on depression. Moreover, prenatal yoga has been associated with health benefits in non- depressed pregnant women (decreased pain, more optimal pregnancy outcomes). Yet, to date, no rigorously designed RCTs have examined the efficacy of prenatal yoga for antenatal depression. Our interdisciplinary team was funded by NIH to develop and pilot test the Prenatal Yoga Program (PYP) for depressed pregnant women. We developed an extensive manual and teacher training program and conducted an open pilot trial (N=34), followed by a pilot RCT (N=20), which compared PYP to a perinatal-focused health education program that controlled for time and attention, namely, the Mom & Baby Wellness Workshop (MBWW). Results of our pilot studies provide strong support for the acceptability, feasibility, and preliminary efficacy of PYP. We now propose to conduct a fully-powered RCT in which 178 depressed pregnant women in their 2nd trimester are randomly assigned to either PYP or MBWW for a 9 week intervention period. In addition to testing the efficacy of PYP, this trial will examine change in biological and psychological factors that may mediate the relationship between treatment group and outcome. Methodology employed will include best practices for a RCT of behavioral intervention, including use of detailed manuals for each study condition, methods for documenting instructor fidelity, blinded outcome assessment, and planned intent-to-treat analysis. The specific aims include: (1) comparing PYP to MBWW in terms of level of depression severity from baseline to intervention endpoint (i.e., 9 weeks after randomization); (2) comparing PYP to MBWW on secondary outcomes (self-reported antenatal depression, anxiety, physical functioning, and sleep disturbance; and rates of preterm birth); and (3) testing biological and psychological mechanisms by examining whether lowered inflammation levels and increased non-judgment of internal experiences mediate the association between treatment group and primary outcome. This study would be the first rigorously-designed RCT of prenatal yoga as an intervention for antenatal depression, a highly prevalent and impairing condition with known risks to mother and child.

 描述 描述(由申请人提供)：这份R01重新提交的《产前瑜伽干预对产前抑郁的疗效》是对NICHD PA-12-216，妇女在怀孕和产后期间的心理健康的回应。产前抑郁很常见，并与母亲和孩子的不良后果有关，但大多数受影响的妇女没有接受任何心理健康治疗。孕妇对治疗的可接受性有独特的担忧，通常不愿服用抗抑郁药，这是最广泛获得的抑郁症护理形式。产前瑜伽是孕期抑郁症干预的一个很好的选择，它可能是有效的，也是可接受的和安全的。有证据表明瑜伽在普通人群中对抑郁症有疗效，以及瑜伽可能对抑郁症产生影响的看似合理的生物和心理机制(例如，减少炎症，增加对内在经验的非评判)。此外，产前瑜伽一直与非抑郁孕妇的健康益处有关(减少疼痛，更理想的妊娠结局)。然而，到目前为止，还没有经过严格设计的随机对照试验来检验产前瑜伽对产前抑郁症的疗效。我们的跨学科团队由美国国立卫生研究院资助，为抑郁的孕妇开发和试行产前瑜伽计划(PYP)。我们制定了广泛的手册和教师培训计划，并进行了开放的试点试验(N=34)，随后进行了试点RCT(N=20)，将PYP与控制时间和注意力的围产期健康教育计划，即母亲和婴儿健康研讨会(MBWW)进行了比较。我们的初步研究结果为PYP的可接受性、可行性和初步效果提供了强有力的支持。我们现在建议进行一项全功率随机对照试验，178名怀孕中期的抑郁孕妇被随机分配到PYP或MBWW，为期9周的干预期。除了测试PYP的疗效外，这项试验还将检查生物和心理因素的变化，这些因素可能调节治疗组和结果之间的关系。所采用的方法将包括行为干预RCT的最佳实践，包括使用针对每个研究条件的详细手册、记录教师忠诚度的方法、盲目结果评估和计划的治疗意图分析。具体目标包括：(1)比较PYP和MBWW在从基线到干预终点(即随机试验9周后)的抑郁严重程度；(2)比较PYP和MBWW在次要结果(自我报告的产前抑郁、焦虑、身体功能和睡眠障碍；以及早产率)方面的差异；以及(3)通过检查炎症水平的降低和对内部经验的增加的不可判断性是否在治疗组和主要结果之间的关联中测试生物和心理机制。这项研究将是第一个严格设计的产前瑜伽随机对照试验，作为对产前抑郁症的干预，产前抑郁症是一种高度普遍和有害的疾病，对母婴有已知的风险。