Treatment of Depression with Massage in End of Life AIDS

按摩治疗临终艾滋病患者的抑郁症

• 批准号: 6447252
• 负责人: RUSSELL Elliott POLAND
• 金额: $ 19.13万
• 依托单位: CEDARS-SINAI MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-09-27 至 2003-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6447252
• 关键词: AIDS therapy; alternative medicine; behavioral /social science research tag; clinical research; comorbidity; cortisol; depression; human subject; human therapy evaluation; massage therapy; patient oriented research; physical therapy; quality of life; terminal patient care

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.

描述（由申请人提供）：这是一个探索性/开发性的 向国家补充和研究中心申请研究（R21）拨款 替代医学响应 RFA AT-O1-002 评估其有用性 按摩疗法治疗抑郁症和改善生活质量 艾滋病临终患者的生活。 这项研究将定义按摩疗法的临床和生物学反应 临床稳定且处于固定状态的艾滋病和抑郁症患者 医疗方案。抑郁症是患有以下疾病的人的一种共病 晚期艾滋病毒疾病并对生活质量产生负面影响。沮丧 HIV感染者的依从性下降也与此相关 药物治疗和临床疾病的进展。药物治疗的同时 因为抑郁症在解决这个问题方面取得了不同程度的成功， 与这些患者服用的药物数量的增加有关 需要采取，额外的药物相互作用的潜力，以及许多 不良事件。对于晚期艾滋病毒患者，姑息治疗是 通常是一个优先事项，并确定不需要的新治疗方式 额外的药物，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 在艾滋病毒感染者和未感染者中进行。这些研究表明 未感染艾滋病毒的受试者的抑郁评分降低。在艾滋病毒感染者中 对于患者来说，按摩疗法已被证明可以改善生活质量 并降低血浆皮质醇水平。该提案的具体目标是 1) 确定按摩疗法对患有抑郁症的受试者的效果 晚期艾滋病毒疾病，2) 研究按摩疗法对 患有晚期 HIV 疾病的受试者的生活质量，以及 3) 进行调查 按摩疗法对患有以下疾病的受试者血浆皮质醇水平的影响 晚期艾滋病毒疾病。这项研究将对晚期艾滋病毒感染者进行随机分组 抑郁症受试者以1：1：1的方式进行按摩治疗，“假按摩” 或者没有物理干预。按摩组和“假按摩”组将 治疗一小时，每周两次，持续 8 周。所有注册科目将 在基线、第 1、2 周测量抑郁症（汉密尔顿抑郁量表） 4、6 和 8，以及生活质量 (SF-36) 和疼痛评估 (Gracely Pain 量表）在基线、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 HIV RNA 测量将在基线时进行评估， 第 4 周和第 8 周。这将是一项严格对照的临床试验，使用 评估临床（抑郁和生活质量）的有效措施，以及 按摩疗法对晚期受试者的生物（皮质醇水平）影响 HIV 疾病阶段和临床抑郁症。