Yoga Versus CBT-I for Insomnia in Cancer Survivors and Biobehavioral Mechanisms

瑜伽与 CBT-I 治疗癌症幸存者失眠及生物行为机制

• 批准号: 8719865
• 负责人: KAREN M. MUSTIAN
• 金额: $ 63.7万
• 依托单位: UNIVERSITY OF ROCHESTER
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-07-25 至 2019-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8719865
• 关键词: Adherence; Adjuvant; Adverse effects; Adverse event; Aftercare; Am 80; Attention; Biological; Blinded; Cancer Survivor; Cardiopulmonary; Circadian Rhythms; Clinical; Clinical Trials Design; Cognitive Therapy; Community Clinical Oncology Program; DSM-IV; Diagnosis; Distress; Effectiveness; Exercise; Gold; Health education; Hour; IL8 gene; Impairment; Inferior; Inflammation; Inflammatory Response; Interferon Type II; Interleukin-10; Interleukin-6; Intervention; Malignant Neoplasms; Matched Group; Measures; Mediating; Mediator of activation protein; Middle Insomnia; Morbidity - disease rate; Muscle; Napping; Participant; Patients; Pharmaceutical Preparations; Phase; Physical Function; Placebo Control; Quality of life; Randomized Controlled Trials; Reporting; Research Priority; Role; Severities; Sleep; Sleep Disorders; Sleeplessness; Supportive care; Survivors; Symptoms; TNFRSF1A gene; Techniques; Testing; Time; Walking; Yoga; actigraphy; arm; base; biobehavior; cytokine; evidence base; experience; falls; improved; indexing; innovation; meetings; mortality; post intervention; programs; public health relevance; response; sleep onset; standard care; trial comparing

ABSTRACT: Up to 90% of cancer survivors report insomnia or some form of sleep quality impairment (SQI) post-treatment which co-occurs with dysregulated circadian rhythm, impaired physical function, chronically up-regulated inflammatory responses, and, when severe, increased cancer morbidity and mortality. Despite the ubiquity of insomnia and SQI, they are under-diagnosed and under-treated in cancer survivors. Yoga is a well-tolerated exercise intervention with promising preliminary evidence for its efficacy in improving insomnia and SQI. Our previous multicenter, phase III, randomized, controlled, trial (RCT) in 410 cancer survivors from 12 community oncology practices in the U.S., showed that our standardized yoga intervention (YOCAS(c)(R): 4 wks, 2x/wk, 75 min/sess) produced moderate to large improvements in insomnia and SQI while also improving circadian activity rhythms. Yoga participants also decreased, while control participants increased, sleep medication use. Adherence to YOCAS(c)(R) was good (80%) with no study-related adverse events, and 100% of participants found YOCAS(c)(R) useful and would recommend it to other survivors. The next logical empirical steps, in line with NCI research priorities to develop effective, evidence-based, supportive care interventions for survivors, are to compare the YOCAS(c)(R) intervention to a gold-standard treatment (i.e., Cognitive Behavioral Therapy for Insomnia [CBT-I]) and a time and attention placebo control. Therefore, we propose to conduct a multicenter, 3-arm, blinded, phase III RCT comparing the effect of Arm 1) our YOCAS(c)(R) program, Arm 2) CBT-I, and Arm 3) a health education control on insomnia in 630 cancer survivors 6-12 months following adjuvant treatment using valid measures and analytical techniques. YOCAS(c)(R) and CBT-I will be delivered in groups using standard effective clinical formats (i.e., YOCAS(c)(R) = 2x/wk in 75-minute sessions over 4 weeks; CBT-I 1x/wk in 90-minute sessions over 8 weeks). Health education will also be delivered in groups and matched for equal time and attention to YOCAS(c)(R). We will require participants to meet DSM-IV insomnia criteria and the clinical cut off score for insomnia of >10 on the Insomnia Severity Index (ISI), assess the 3- and 6-month sustainability of insomnia benefits, and examine possible conceptually based biological mechanisms (circadian activity rhythms, physical function, and inflammation) that may influence insomnia via YOCAS(c)(R). We hypothesize YOCAS(c)(R) will be as effective as CBT-I and more effective than health education for improving insomnia, SQI, circadian activity rhythms, physical function, and inflammation; insomnia improvements will be sustained 3 and 6 months later in the YOCAS(c)(R) and CBT-I groups but not in the health education group; and changes in circadian activity rhythms, physical function, and inflammation will mediate the effects of YOCAS(c)(R) on insomnia. This is the first phase III, blinded RCT to test: 1) the effectiveness of YOCAS(c)(R) compared to CBT-I and a health education control for improving insomnia and SQI, 2) the 3- and 6-month sustainability of insomnia benefits from YOCAS(c)(R), and 3) the role of specific biological mediators in the efficacy of YOCAS . (c)(R)

抽象的： 多达90％的癌症幸存者报告失眠或某种形式的睡眠质量障碍（SQI）治疗后 它与昼夜节律失调，身体机能受损，长期上调 炎症反应，并且在严重时会增加癌症的发病率和死亡率。尽管无处不在 失眠和SQI，它们在癌症幸存者中被诊断不远，没有治疗。瑜伽是一个富裕的 运动干预措施具有有希望的初步证据，证明了其在改善失眠和SQI方面的功效。我们的 从12个社区的410个癌症幸存者中的以前的多中心，III期，随机，受控，试验（RCT） 美国的肿瘤学实践表明，我们的标准化瑜伽干预（Yocas（c）（r）：4周，2x/wk，75 Min/Sess）在失眠和SQI方面产生了中等至大的改进，同时也改善了昼夜节律 活动节奏。瑜伽参与者也有所减少，而对照参与者增加了睡眠药物的使用。 遵守Yocas（c）（r）是好的（80％），没有与研究相关的不良事件，100％的参与者 发现Yocas（C）（R）有用，并将其推荐给其他幸存者。下一个逻辑经验步骤，排队 有了NCI研究的优先级，可以为幸存者开发有效的，基于证据的支持护理干预措施， 将Yocas（c）（r）干预与金标准治疗进行比较（即认知行为疗法 失眠[CBT-I]）和时间和注意力安慰剂控制。因此，我们建议进行 多中心，3臂，盲目的第三阶段RCT比较了ARM的效果1）我们的Yocas（C）（R）程序，ARM 2） CBT-I和ARM 3）630个癌症幸存者的健康教育控制6-12个月后 使用有效措施和分析技术的辅助治疗。 yocas（c）（r）和cbt-i将交付 使用标准有效临床格式的组（即Yocas（c）（r）= 2x/wk在4周内的75分钟课程中； CBT-I 1x/wk在90分钟内进行了8周的时间。健康教育也将分组进行 匹配相等的时间，并与Yocas（c）（r）匹配。我们将要求参与者满足DSM-IV失眠症 在失眠严重程度指数（ISI）上失眠的标准和临床切断评分> 10 失眠益处的6个月可持续性，并检查可能基于概念的生物学机制 （昼夜节律节奏，身体功能和炎症）可能会通过yocas（c）（r）影响失眠症。 我们假设Yocas（c）（r）将与CBT-1一样有效，并且比健康教育更有效 失眠，SQI，昼夜节律节奏，身体功能和炎症；失眠的改善将是 3和6个月后，在Yocas（C）（R）和CBT-I组中持续，但在健康教育小组中持续下去；和 昼夜节律节奏，身体机能和炎症的变化将介导yocas（c）（r）的影响 关于失眠。这是第一阶段III，盲目的RCT测试：1）与yocas（c）（r）相比的有效性 CBT-I和改善失眠和SQI的健康教育控制，2）3个月和6个月的可持续性 失眠受益于Yocas（C）（R）和3）特定生物学介质在YOCAS功效中的作用。 （c）（r）