Development of a Yoga Intervention for Antenatal Depression

瑜伽干预产前抑郁症的开发

• 批准号: 7788256
• 负责人: CYNTHIA L. BATTLE
• 金额: $ 19.09万
• 依托单位: BUTLER HOSPITAL (PROVIDENCE, RI)
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-04-01 至 2013-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7788256
• 关键词: Achievement; Adherence; Antidepressive Agents; Anxiety; Child; Clinical Trials; Cognitive Therapy; Competence; Consent; Depressed mood; Development; Developmental Delay Disorders; Distress; Emotional; Exercise; Goals; Grant; Growth; Health Personnel; Home environment; Hydrocortisone; Intervention; Link; Low Back Pain; Low Birth Weight Infant; Major Depressive Disorder; Manuals; Measures; Meditation; Mental Depression; Mental Health; Methods; Mothers; Muscle; National Institute of Mental Health; Neonatal; Participant; Patients; Perinatal; Pharmaceutical Preparations; Population; Postpartum Depression; Postpartum Period; Posture; Pre-Eclampsia; Pregnancy; Pregnant Women; Procedures; Process; Process Assessment; Randomized; Randomized Clinical Trials; Reporting; Research; Research Design; Risk; Safety; Spontaneous abortion; Supervision; Testing; Time; Training; Treatment Efficacy; United States National Institutes of Health; Woman; Yoga; adverse outcome; design; efficacy testing; experience; improved; innovation; lifetime risk; meetings; mindfulness; offspring; perinatal intervention; pranayama; pregnant; prenatal; primary outcome; public health relevance; self help; skeletal; teacher; therapy development

DESCRIPTION (provided by applicant): Although pregnancy was once believed to be a time when women were protected from psychiatric distress, the lifetime risk for antenatal major depression is actually estimated to be 10-25%. Antenatal depression is linked to many adverse outcomes, including higher rates of spontaneous abortion, pre-eclampsia, operative delivery, postpartum depression, neonatal growth retardation, pre-term delivery, low birth weight, and delayed developmental milestones for the child. Despite these risks, the majority of depressed pregnant women do not pursue any mental health treatment. In particular, pregnant women have concerns about using antidepressant medications. Because perinatal patients have unique concerns about depression treatment, there is a need to develop specialized approaches for perinatal depression that are not only efficacious, but are also viewed as acceptable, safe, and especially-tailored for pregnant women. This has been further highlighted in NIH PA-06- 376 "Women's Mental Health in Pregnancy and the Postpartum Period," which emphasized that developing a wider range of innovative non-pharmacological interventions for perinatal depression is a current NIMH priority. Prenatal yoga is a good candidate for a treatment that might be efficacious as well as acceptable and safe to pregnant women. Yoga focuses on training the body with the ultimate goal of physical and emotional self transformation. Like other forms of hatha yoga, prenatal yoga involves breath control (pranayama), physical postures (asanas), and meditation (dhyana). Both health-care providers and women view prenatal yoga as safe during pregnancy, and many pregnant women already participate in prenatal yoga classes. There is some preliminary evidence for the efficacy of yoga in treating depression, as well as plausible mechanisms (e.g., promotion of mindfulness and exercise) by which yoga might have an impact on depression. Pregnant women may also appreciate other benefits of yoga, such as decreasing anxiety and improving lower back pain. The overall goals of this treatment development application are: 1) to develop a safe, acceptable, and feasible yoga intervention for antenatal depression and 2) to prepare for an adequately-powered RCT that will enable us to test the efficacy of this intervention in antenatal depression. We will conduct three small clinical trials. First, we will conduct an open trial of prenatal yoga for depression (n = 30), with the primary goal being developing and refining the yoga treatment. We all also conduct a small open trial (n = 10) of supported self- help for depressed pregnant women, with the primary goal being refining this treatment as a stand-alone treatment. Subsequently, we will conduct a pilot randomized clinical trial (n = 30), in which prenatal depressed patients will be randomly assigned to:1) prenatal yoga for depression; 2) cognitive therapy; or 3) supported self-help. The primary goal of the pilot RCT will be to refine research procedures and demonstrate feasibility and acceptability of the research design and control treatments. We will then apply for an R01 to conduct an adequately powered RCT with the same research design as the small RCT proposed in this grant. PUBLIC HEALTH RELEVANCE: Depression during pregnancy is a common problem. However, pregnant women often have special concerns about the risks of existing depression treatments (particularly antidepressants) and the majority of depressed pregnant women do not pursue any form of mental health treatment. The purpose of this study is to evaluate yoga as a potential treatment for depression during pregnancy. If shown to be effective, yoga could provide depressed women with an option for treatment that may be more acceptable than existing treatments.

描述（由申请人提供）：虽然怀孕曾经被认为是妇女免受精神困扰的时期，但产前重度抑郁症的终生风险实际上估计为10-25%。产前抑郁与许多不良后果有关，包括较高的自然流产率、先兆子痫、手术分娩、产后抑郁、新生儿生长迟缓、早产、低出生体重和儿童发育迟缓。尽管存在这些风险，大多数抑郁孕妇并不寻求任何精神健康治疗。孕妇尤其担心使用抗抑郁药物。由于围产期患者对抑郁症治疗有独特的关注，因此有必要开发专门的围产期抑郁症治疗方法，这种方法不仅有效，而且被认为是可接受的、安全的，并特别为孕妇量身定制。这在NIH PA-06- 376“怀孕和产后妇女的心理健康”中得到了进一步强调，该报告强调，开发更广泛的创新的非药物干预围产期抑郁症是目前NIMH的优先事项。产前瑜伽是一种很好的治疗方法，对孕妇来说可能是有效的、可接受的和安全的。瑜伽专注于身体的训练，最终目标是身体和情感的自我转化。和其他形式的哈他瑜伽一样，产前瑜伽包括呼吸控制（调息）、身体姿势（体式）和冥想（禅坐）。医疗保健提供者和妇女都认为孕期瑜伽是安全的，许多孕妇已经参加了孕期瑜伽课程。有一些初步证据表明瑜伽在治疗抑郁症方面的有效性，以及瑜伽可能对抑郁症产生影响的合理机制（例如，促进正念和锻炼）。孕妇可能也会欣赏瑜伽的其他好处，比如减少焦虑和改善腰痛。这项治疗开发应用的总体目标是：1)为产前抑郁症开发一种安全、可接受、可行的瑜伽干预措施；2)为一项足够有力的随机对照试验做准备，使我们能够测试这种干预措施对产前抑郁症的疗效。我们将进行三个小型临床试验。首先，我们将进行一项产前瑜伽治疗抑郁症的公开试验（n = 30），主要目标是发展和完善瑜伽治疗。我们还为抑郁的孕妇进行了一个小型的公开试验（n = 10），支持自助，主要目标是将这种治疗方法完善为独立的治疗方法。随后，我们将进行一项随机临床试验（n = 30），其中产前抑郁症患者将被随机分配到：1)产前瑜伽治疗抑郁症；2)认知疗法；或者3)支持自助。试验RCT的主要目标是完善研究程序，并证明研究设计和对照治疗的可行性和可接受性。然后，我们将申请一个R01来进行一个足够动力的RCT，其研究设计与本拨款中提议的小型RCT相同。