Treatment of Depression with Massage in End of Life AIDS

描述(由申请人提供)：这是一个试探性/发展性的 研究(R21)向国家补充和发展中心的拨款申请 替代医学对RFA AT-O1-002的响应，以评估 推拿疗法治疗抑郁症与改善患者生活质量 生命垂危的艾滋病患者。 这项研究将确定推拿治疗的临床和生物学反应 临床稳定并处于固定状态的艾滋病和抑郁症患者 医疗养生。抑郁症是一种合并疾病，在患有 并对生活质量产生负面影响。抑郁症 在感染艾滋病毒的患者中，依从性的下降也是相关的 与药物和临床疾病的进展有关。虽然药物治疗 因为抑郁症导致了在处理这个问题上的不同成功，它 与这些患者服用的药物数量的增加有关 需要服用，可能会有更多的药物-药物相互作用，以及许多 不良事件。在晚期艾滋病毒患者中，姑息治疗是 通常是优先事项，并确定不需要 在改善临床症状和整体质量的同时服用其他药物 生命是最重要的。按摩疗法的试点研究已经被 在感染艾滋病毒和未感染艾滋病毒的个人中进行。这些研究表明 未感染艾滋病毒的受试者抑郁评分降低。在感染艾滋病毒的人中 患者推拿疗法已被证明是提高生活质量的措施 并降低血浆皮质醇水平。这项建议的具体目标是1) 确定推拿疗法对抑郁症患者的影响 晚期HIV疾病，2)观察推拿疗法对患者的影响 晚期HIV疾病患者的生活质量，以及3)调查 推拿疗法对老年高血压患者血浆皮质醇水平的影响 晚期艾滋病。这项研究将对晚期艾滋病毒感染者进行随机化 抑郁症患者以1：1：1的方式进行推拿治疗，“假推拿” 或者没有身体干预。推拿组和“假推拿组”将 每周治疗两次，每次1小时，共治疗8周。所有已登记的科目将 在基线、1周、2周、 4、6和8以及生活质量(SF-36)和疼痛评估(Gracely Pain 基线、第4周和第8周)。此外，24小时尿游离皮质醇， 淋巴细胞亚群和艾滋病毒RNA测量将在基线和 第4周和第8周。这将是一项严格控制的临床试验，使用 评估临床(抑郁症和生活质量)的有效措施，以及 推拿疗法对晚期糖尿病患者生物学(皮质醇)水平的影响 艾滋病和临床抑郁症的分期。

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.