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: 9298700
• 负责人: CYNTHIA L. BATTLE
• 金额: $ 54.02万
• 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/9298700
• 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; 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; Treatment outcome; 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; 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R 01重新提交的“产前瑜伽干预对产后抑郁症的疗效”是对NICHD PA-12-216，妊娠期和产后期妇女心理健康的回应。 产后抑郁症很常见，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着独特的担忧，并且通常不愿意服用抗抑郁药，这是最广泛的抑郁症治疗形式。产前瑜伽是一个很好的抑郁症干预的候选人，可能是有效的，以及可接受的和安全的怀孕期间。有证据支持瑜伽对一般人群抑郁症的疗效，以及合理的生物学和心理学机制（例如，炎症减少，对内部经历的不判断增加），瑜伽可能会对抑郁症产生影响。此外，产前瑜伽与非抑郁孕妇的健康益处有关（减少疼痛，更佳的妊娠结果）。然而，到目前为止，还没有严格设计的随机对照试验研究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点测试产前瑜伽计划（PYP）。我们开发了一个广泛的手册和教师培训计划，并进行了一个开放的试点试验（N=34），随后试点随机对照试验（N=20），比较PYP围产期为重点的健康教育计划，控制时间和注意力，即妈妈和婴儿健康研讨会（MBWW）。我们的试点研究的结果提供了强有力的支持PYP的可接受性，可行性和初步疗效。我们现在建议进行一项完全有效的随机对照试验，其中178名处于妊娠中期的抑郁症孕妇被随机分配到PYP或MBWW组，进行为期9周的干预。除了测试PYP的疗效外，本试验还将检查可能介导治疗组与结局之间关系的生物学和心理学因素的变化。所采用的方法将包括行为干预RCT的最佳实践，包括使用每种研究条件的详细手册，记录指导者忠诚度的方法，盲法结局评估和计划的意向治疗分析。具体目标包括：（1）比较PYP与MBWW从基线到干预终点（即，随机化后9周）;（2）比较PYP与MBWW的次要结局（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）;和（3）通过检查炎症水平降低和内部经验非判断性增加是否介导治疗组与主要结局之间的关联来测试生物学和心理学机制。这项研究将是第一个严格设计的产前瑜伽随机对照试验，作为产前抑郁症的干预措施，这是一种高度流行和有害的疾病，对母亲和孩子有已知的风险。