Treatment of Depression with Massage in End of Life AIDS

描述（由申请人提供）：这是一项探索性/开发性研究 研究（R21）补助金申请国家中心的补充和 替代医学对RFA AT-O 1 -002的响应，以评估 按摩疗法治疗抑郁症和提高质量 艾滋病晚期患者的生命。 这项研究将确定按摩疗法的临床和生物反应， 患有艾滋病和抑郁症的患者，临床稳定， 医学养生抑郁症是一种并发症的个人与 艾滋病毒感染是一种晚期疾病，对生活质量有负面影响。抑郁 在HIV感染患者中， 药物和临床疾病的进展。虽然药物治疗 对于抑郁症导致了不同的成功管理这个问题，它 与这些患者服用的药物数量增加有关， 需要服用，可能发生额外的药物相互作用，许多 不良事件。在晚期艾滋病患者中，姑息治疗是 通常是优先事项，并确定新的治疗方式， 同时改善临床症状和整体质量 生命是最重要的按摩疗法的试点研究已经 在HIV感染者和未感染者中进行。这些研究表明 未感染艾滋病病毒的受试者的抑郁评分降低。hiv感染 按摩疗法已被证明可以改善患者的生活质量 降低血浆皮质醇水平本建议的具体目标是：1） 确定按摩疗法对抑郁症患者的影响， 艾滋病晚期，2）调查按摩疗法对 晚期HIV患者的生活质量，以及3）调查 按摩疗法对冠心病患者血浆皮质醇水平的影响 晚期艾滋病这项研究将随机选择晚期艾滋病毒感染者， 受试者以1：1：1的方式对抑郁症患者进行按摩治疗，即“假按摩” 或者没有物理干预。按摩组和“假按摩”组将 每周2次，每次1小时，共8周。所有入组受试者将 在基线、第1、2周， 4、6和8，生活质量（SF-36）和疼痛评估（Gracely Pain 基线、第4周和第8周时的量表）。此外，24小时尿游离皮质醇， 将在基线时评估淋巴细胞亚群和HIV RNA测量值， 第4周和第8周。这将是一个严格控制的临床试验， 评估临床（抑郁和生活质量）的有效措施，以及 按摩疗法对晚期乳腺癌患者的生物学（皮质醇水平）影响 艾滋病分期和临床抑郁症。

DESCRIPTION (provided by applicant): This is an Exploratory/Developmental Research (R21) grant application to the National Center for Complementary and Alternative Medicine in response to RFA AT-O1-002 to assess the usefulness of massage therapy for treatment of depression and improvement in the quality of life in patients with end of life AIDS. This study will define the clinical and biologic response to massage therapy in patients with AIDS and depression who are clinically stable and on a fixed medical regimen. Depression is a co-morbid condition in individuals with advanced HIV disease and has a negative impact on quality of life. Depression in HIV-infected patients also has been associated with a decrease in adherence to medications and progression of clinical disease. While pharmacologic therapy for depression have resulted in variable success in managing this problem, it is associated with an increase in the number of medications that these patients are required to take, potential for additional drug-drug interactions, and many adverse events. In patients with advanced stage HIV disease, palliative care is often a priority and identifying new treatment modalities that do not require additional medications while improve clinical symptoms and overall quality of life is of the utmost importance. Pilot studies with massage therapy have been performed in HIV-infected and uninfected individuals. These studies have shown a reduction in depression scores in HIV-uninfected subjects. In HIV-infected patients, massage therapy has been shown to improve quality of life measures and decrease plasma cortisol levels. The specific aims of this proposal are 1) to determine the effect of massage therapy on depression in subjects with advanced HIV disease, 2) to investigate the effect of massage therapy on quality of life in subjects with advanced HIV disease, and 3) to investigate the effect of massage therapy on plasma cortisol levels in subjects with advanced HIV disease. This study will randomize advanced stage HIV-infected subjects with depression in a 1:1:1 manner to massage therapy, "sham massage" or no physical intervention. The massage and "sham massage" groups will be treated for one hour, twice per week, for 8 weeks. All enrolled subjects will have depression measured (Hamilton Depression Scale) at baseline, weeks 1, 2, 4, 6 and 8, and quality of life (SF-36), and pain assessments (Gracely Pain Scale) at baseline, weeks 4 and 8. In addition, 24-hour urine free cortisol, lymphocyte subsets and HIV RNA measurements will be assessed at baseline and weeks 4 and 8. This will be a rigorously controlled clinical trial using validated measures to assess the clinical (depression and quality of life), and biologic (cortisol levels) effect of massage therapy on subjects with advanced stage HIV disease and clinical depression.