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: 9728008
• 负责人: CYNTHIA L. BATTLE
• 金额: $ 51.01万
• 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 2023-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9728008
• 关键词: 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; Impairment; 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; Psychological Factors; Public Health; Publishing; Randomized; Randomized Controlled Trials; Research; Risk; Safety; Second Pregnancy Trimester; Series; Severities; Sleep; Sleep disturbances; Spontaneous abortion; Teacher Professional Development; Test Result; Testing; Time; Training Programs; Treatment outcome; United States National Institutes of Health; Woman; Work; Yoga; adverse outcome; antepartum depression; care providers; cognitive skill; cost; delivery complications; depressive symptoms; design; efficacy testing; experience; improved; instructor; lifetime risk; maternal outcome; neurobehavioral; novel; offspring; perinatal intervention; perinatal mental health; peripartum depression; pilot trial; prenatal; prenatal testing; primary outcome; programs; psychologic; public health relevance; randomized trial; response; secondary outcome; teacher; treatment group; 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）：此 R01 重新提交的“产前瑜伽干预对产前抑郁症的功效”是针对 NICHD PA-12-216，《妊娠期和产后时期妇女的心理健康很常见并与不良产前抑郁症相关》的回应。然而，大多数受影响的妇女没有接受任何心理健康治疗，她们对治疗的可接受性有独特的担忧，并且往往不愿意接受。抗抑郁药是最广泛使用的抑郁症护理形式，是抑郁症干预的绝佳选择，在怀孕期间可能是有效且可接受且安全的，有证据支持瑜伽对普通人群的抑郁症的功效。以及瑜伽可能对抑郁症产生影响的合理的生物和心理机制（例如减少炎症、增加对内部体验的不评判）此外，产前瑜伽与非抑郁症孕妇的健康益处相关（减少）。然而，迄今为止，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功效。我们的跨学科团队由 NIH 资助，为抑郁症孕妇开发和试点测试产前瑜伽计划 (PYP)。教师培训计划，并进行了一项开放试点试验（N=34），随后进行了一项试点随机对照试验（N=20），将 PYP 与控制时间和时间的围产期健康教育计划进行了比较。我们的试点研究结果为 PYP 的可接受性、可行性和初步疗效提供了强有力的支持，其中包括 178 名抑郁孕妇。在妊娠第二个月，她们被随机分配到 PYP 或 MBWW，为期 9 周的干预期。除了测试 PYP 的功效外，该试验还将检查可能介导治疗组之间关系的生物和心理因素的变化。所采用的方法将包括行为干预的随机对照试验的最佳实践，包括针对每种研究条件使用详细的手册、记录指导员忠诚度的方法、盲法结果评估和计划的意向治疗分析。 (1) 在从基线到干预终点（即随机化后 9 周）的抑郁严重程度方面比较 PYP 与 MBWW；(2) 在次要结局（产前自我报告）方面比较 PYP 与 MBWW；抑郁、焦虑、身体机能和早产率）；以及（3）通过检查炎症水平降低和内部体验非判断力增加是否介导治疗组与主要结局之间的关联来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作为产前抑郁症干预措施的随机对照试验，产前抑郁症是一种非常普遍且有害的疾病，已知对母亲和儿童存在风险。