Development of a Yoga Intervention for Antenatal Depression

描述（由申请人提供）：虽然怀孕曾经被认为是保护妇女免受精神痛苦的时候，但产前重度抑郁症的终生风险实际上估计为10- 25%。产后抑郁症与许多不良后果有关，包括自发性流产、先兆子痫、手术分娩、产后抑郁症、新生儿生长迟缓、早产、低出生体重和儿童发育里程碑延迟的发生率较高。尽管存在这些风险，但大多数抑郁症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感到担忧。由于围产期患者对抑郁症的治疗有独特的关注，因此需要制定专门的方法来治疗围产期抑郁症，这些方法不仅有效，而且被视为可接受的，安全的，特别是为孕妇量身定制的。国家卫生研究院PA-06- 376“妇女在怀孕和产后期间的心理健康”进一步强调了这一点，其中强调，为围产期抑郁症制定更广泛的创新性非药物干预措施是国家卫生研究院目前的优先事项。 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。瑜伽专注于训练身体，最终目标是身体和情感的自我转化。像其他形式的哈他瑜伽，产前瑜伽涉及呼吸控制（调息），身体姿势（体式），冥想（禅）。卫生保健提供者和妇女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程。有一些初步的证据表明瑜伽在治疗抑郁症方面的疗效，以及合理的机制（例如，促进正念和锻炼），瑜伽可能会对抑郁症产生影响。孕妇也可以欣赏瑜伽的其他好处，例如减少焦虑和改善下背部疼痛。 这项治疗开发申请的总体目标是：1）为产前抑郁症开发一种安全，可接受和可行的瑜伽干预措施; 2）为一项充分有效的RCT做准备，使我们能够测试这种干预措施在产前抑郁症中的疗效。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开放试验（n = 30），主要目标是开发和完善瑜伽治疗。我们还进行了一项小型开放试验（n = 10），为抑郁的孕妇提供自助支持，主要目标是将这种治疗作为一种独立的治疗方法进行改进。随后，我们将进行一项试点随机临床试验（n = 30），其中产前抑郁症患者将被随机分配到：1）产前瑜伽抑郁症; 2）认知疗法;或3）支持自助。试点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R 01，以进行与本补助金中建议的小型RCT相同的研究设计的足够动力的RCT。 公共卫生相关性：怀孕期间的抑郁症是一个常见的问题。然而，孕妇通常对现有抑郁症治疗（特别是抗抑郁药）的风险有特别的担忧，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抑郁症在怀孕期间。如果瑜伽被证明是有效的，它可以为抑郁症女性提供一种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.