Development of a Yoga Intervention for Antenatal Depression

描述(申请人提供)：虽然怀孕曾被认为是女性免受精神痛苦的时期，但实际上，产前严重抑郁的终生风险估计为10%-25%。产前抑郁与许多不良后果有关，包括自然流产、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里程碑延迟等。尽管有这些风险，大多数抑郁的孕妇并不寻求任何心理健康治疗。特别是，孕妇对使用抗抑郁药物有顾虑。由于围产期患者对抑郁症的治疗有独特的担忧，因此有必要开发专门的方法来治疗围产期抑郁症，这些方法不仅有效，而且被认为是可接受的、安全的，特别是为孕妇量身定做的。NIH PA-06-376《妇女在孕期和产后的心理健康》进一步强调了这一点，强调为围产期抑郁症开发更广泛的创新非药物干预措施是目前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。瑜伽侧重于训练身体，最终目标是身体和情感上的自我转变。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(禅定)。医疗保健提供者和女性都认为产前瑜伽在怀孕期间是安全的，许多孕妇已经参加了产前瑜伽课。有一些初步证据表明瑜伽在治疗抑郁症方面的效果，以及瑜伽可能对抑郁症产生影响的看似合理的机制(例如，促进正念和锻炼)。孕妇可能还会欣赏瑜伽的其他好处，比如减少焦虑和改善下腰痛。这一治疗开发应用的总体目标是：1)开发一种安全、可接受和可行的针对产前抑郁症的瑜伽干预措施，以及2)准备一种足够强大的RCT，使我们能够测试这种干预措施对产前抑郁症的疗效。我们将进行三项小型临床试验。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)，主要目标是开发和改进瑜伽疗法。我们还为抑郁的孕妇进行了一项小型开放试验(n=10)，目的是将这种治疗作为一种独立的治疗方法来改进。随后，我们将进行一项先导性随机临床试验(n=30)，将产前抑郁患者随机分配到：1)产前瑜伽治疗抑郁症；2)认知治疗；或3)支持性自助。试验性随机对照试验的主要目标将是完善研究程序，并证明研究设计和对照治疗的可行性和可接受性。然后，我们将申请一台R01，以进行具有足够动力的随机对照试验，其研究设计与本拨款中建议的小型随机对照试验相同。 公共卫生相关性：妊娠期抑郁是一个常见的问题。然而，孕妇往往对现有抑郁症治疗(特别是抗抑郁药)的风险有特别的担忧，而且大多数抑郁症孕妇不寻求任何形式的心理健康治疗。这项研究的目的是评估瑜伽作为一种潜在的治疗孕期抑郁症的方法。如果被证明是有效的，瑜伽可以为抑郁症女性提供一种可能比现有疗法更容易接受的治疗选择。

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.