RCT of hatha yoga for persistent depression

哈他瑜伽治疗持续性抑郁症的随机对照试验

• 批准号: 8040283
• 负责人: Lisa A Uebelacker
• 金额: $ 39.65万
• 依托单位: BUTLER HOSPITAL (PROVIDENCE, RI)
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-02-02 至 2015-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8040283
• 关键词: Adherence; Antidepressive Agents; Area; Basic Science; Behavior Therapy; Biological; Biological Markers; Chronic; Clinical Research; Control Groups; Data; Depressed mood; Depressive disorder; Disease remission; Dose; Emotional; Enrollment; Exhibits; Family; Goals; Health; Hydrocortisone; Individual; Inflammation; Inflammatory; Intervention; Life; Major Depressive Disorder; Manuals; Measures; Mediating; Meditation; Mental Depression; Mental Health; Mission; Pain; Participant; Patient Self-Report; Patients; Personal Satisfaction; Pharmaceutical Preparations; Physical Fitness; Physical Function; Physical activity; Posture; Procedures; Psychotherapy; Quality of life; Randomized Clinical Trials; Relapse; Relative (related person); Reporting; Research; Risk; Role; Salivary; Self Management; Social Functioning; Stress; Suicide; Symptoms; Testing; Training; Work; Yoga; burden of illness; coping; depressive symptoms; design; experience; follow-up; health related quality of life; holistic approach; hypothalamic-pituitary-adrenal axis; improved; inflammatory marker; instructor; interest; mindfulness; partial response; physical conditioning; pranayama; primary outcome; programs; psychologic; psychosocial; randomized trial; response; secondary outcome; single episode major depressive disorder; symptom management; teacher; treatment strategy

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. PUBLIC HEALTH RELEVANCE: Project Narrative Major depression is a relatively common problem. Although there are efficacious treatments for depression, such as antidepressant medications, there are many depressed individuals who experience some improvement with antidepressants, but continue to experience symptoms and problems with psychosocial functioning. The purpose of this research is to evaluate hatha yoga as an adjunctive treatment for these individuals; if effective, hatha yoga may provide an alternative to psychotherapy or multiple medications that is attractive, inexpensive, widely available, and may have physical health benefits as well.

描述（由申请人提供）：项目总结重度抑郁症相当普遍：最近的数据表明，大约7%的美国居民在过去一年中经历过重度抑郁症。抑郁症治疗的目标是帮助个体达到症状缓解和正常的社会和角色功能。即使病人对治疗有一些反应，他们也常常达不到这个目标。与对治疗有完全反应的患者相比，对治疗有部分反应的患者复发、自杀和社会心理功能较差的风险增加。当个体对抗抑郁治疗有部分反应时，一个关键的治疗选择是增强治疗。传统上，另一种药物或心理治疗将用于增加初始药物。然而，患者可能会担心多种药物，并报告心理治疗的实际或其他障碍。哈他瑜伽的重点是促进良好的精神和身体健康，而不是减轻问题，可能是应对抑郁症的一种可行和有吸引力的选择。此外，哈他瑜伽可能还有其他重要的好处，比如改善身体机能。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（禅坐）。瑜伽可能很有吸引力，相对便宜，对许多抑郁症患者来说也很容易接触到。有初步证据表明瑜伽的有效性，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，增加体力活动，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，目前还没有经过精心设计、充分控制和充分支持的随机临床试验来评估瑜伽作为抑郁症辅助治疗或独立治疗的效果。这项提议的首要目标就是进行这样的试验。研究的主要目的是招募150名持续出现重度抑郁症症状的患者，尽管他们接受了至少8周的抗抑郁药物治疗，但在一个足够有力的随机试验中，他们接受了8周的瑜伽课程加持续的抗抑郁治疗，而对照组（即每周接受名为“整体治疗抑郁症”（HAD）的教育课程）加持续的抗抑郁治疗。我们的目的是测试瑜伽是否优于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大的改善：a)主要结果，即抑郁症状；b)次要结果，包括：社会心理（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。