RCT of hatha yoga for persistent depression

严重抑郁症是相当普遍的：最近的数据表明，大约7%的美国居民在前一年经历过严重抑郁症。抑郁症治疗的目标是帮助个人实现症状缓解和正常的社会和角色功能。即使患者对治疗有一些反应，他们也往往达不到这一目标。相对于对治疗完全有反应的患者，对治疗的部分反应与复发、自杀和心理社会功能较差的风险增加相关。当个体对抗抑郁药治疗有部分反应时，一个关键的治疗选择是增强。传统上，另一种药物或心理治疗将被用来增加最初的药物。然而，患者可能对多种药物有顾虑，并报告心理治疗的实际或其他障碍。哈他瑜伽专注于促进良好的身心健康，而不是缓解问题，可能是应对抑郁症的一种可行且有吸引力的选择。此外，哈他瑜伽可能有其他重要的好处，如改善身体功能。 哈他瑜伽专注于训练身体，最终目标是促进身体和情感的健康。瑜伽包括呼吸控制（调息），身体姿势（体式）和冥想（禅）。瑜伽可能很有吸引力，相对便宜，而且容易获得许多抑郁症患者。有初步证据表明瑜伽的功效以及瑜伽可能对抑郁症产生影响的合理机制。这些机制包括：增加正念，增加身体活动，减少反刍，减少应激反应（通过HPA轴），降低炎症生物标志物水平。然而，目前还没有设计良好、对照充分、有充分把握的随机临床试验来评估瑜伽作为抑郁症的连续或独立治疗的疗效。 本提案的首要目标是进行这样一项审判。主要目的是招募150名尽管接受了至少8周的抗抑郁药物治疗但仍有持续性MDD症状的个体，进行一项为期8周的瑜伽计划加持续抗抑郁药物治疗与对照组（即，每周一次的教育计划，题为整体方法抑郁症，或HAD）加上持续的抗抑郁治疗。我们的目标是测试瑜伽是否上级HAD：a）改善抑郁症状; B）改善工作/角色和家庭功能; c）在终点（8周）和随访时改善身体功能，疼痛和身体健康。我们假设，相对于对照组，瑜伽组的参与者将在以下方面表现出更多的改善：a）主要结果，即，抑郁症状;和B）次要结果，包括：心理社会（工作/角色和家庭）功能、自我报告的健康、身体功能、疼痛和身体健康。我们还将研究瑜伽可能对抑郁症产生影响的潜在生物学和心理学机制。

DESCRIPTION (provided by applicant): Project Summary Major depression is quite prevalent: recent data suggest that approximately 7 percent of U.S. residents have experienced major depression in the previous year. The goal of depression treatment is to help individuals achieve symptomatic remission and normal social and role functioning. Even when patients do have some response to treatment, they often do not reach that goal. A partial response to treatment is associated with increased risk for relapse, for suicide, and for poorer psychosocial functioning relative to those who fully respond to treatment. When individuals have a partial response to antidepressant treatments, a key treatment option is augmentation. Traditionally, another medication or psychotherapy would be used to augment the initial medication. However, patients may have concerns about multiple medications, and report practical or other barriers to psychotherapy. Hatha yoga, with its focus on promoting good mental and physical health rather than on alleviating problems, may be a viable and attractive alternative for coping with depression. Further, hatha yoga may have additional benefits that are important, such as improved physical functioning. Hatha yoga focuses on training the body with the ultimate goal of promoting physical and emotional well- being. Yoga involves breath control (pranayama), physical postures (asanas), and meditation (dhyana). Yoga may be appealing, relatively inexpensive, and easy to access for many depressed patients. There is preliminary evidence for its efficacy as well as plausible mechanisms by which yoga might have an impact on depression. These mechanisms include: increased mindfulness, increased physical activity, decreased rumination, decreased stress reactivity (via the HPA axis), and decreased levels of inflammatory biomarkers. However, there are no well-designed, adequately controlled, and adequately powered randomized clinical trials that have evaluated the efficacy of yoga as an adjunctive or stand-alone treatment for depression. The overarching goal of this proposal is to conduct such a trial. The primary aim is to enroll 150 individuals with persisting symptoms of MDD, despite at least 8 weeks of antidepressant medication treatment, in an adequately powered randomized trial of an 8-week yoga program plus continued antidepressant treatment vs. a control group (i.e., a weekly educational program entitled Holistic Approaches to Depression, or HAD) plus continued antidepressant treatment. We aim to test whether yoga is superior to HAD in a) improving depression symptoms; b) improving work / role and family functioning; and c) improving physical functioning, pain, and physical fitness at endpoint (8 weeks) and follow-up. We hypothesize that, relative to the control group, participants in the yoga group will show more improvement in: a) the primary outcome, i.e., depressive symptoms; and b) secondary outcomes, including: psychosocial (work/ role and family) functioning, self- reported health, physical functioning, pain, and physical fitness. We will also investigate potential biological and psychological mechanisms by which yoga might have an impact on depression.