Tai Chi Chih Compared With Cognitive Behavioral Therapy for the Treatment of Insomnia in Survivors of Breast Cancer: A Randomized, Partially Blinded, Noninferiority Trial
Tai Chi Chih Compared With Cognitive Behavioral Therapy for the Treatment of Insomnia in Survivors of Breast Cancer: A Randomized, Partially Blinded, Noninferiority Trial
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DOI：
10.1200/jco.2016.71.0285
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发表时间：
2017-08-10
影响因子：
45.3
通讯作者：
Bower, Julienne E.
中科院分区：
文献类型：
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作者：
Irwin, Michael R.;Olmstead, Richard;Bower, Julienne E.
目的失眠认知行为疗法(CBT-I)和太极拳运动冥想(TCC)可改善失眠症状。在这里，我们评估了TCC在治疗乳腺癌幸存者失眠方面是否不逊于CBT-I。患者和方法这是一项随机、部分盲、非劣势试验，研究对象为2008年4月至2012年7月从洛杉矶社区招募的乳腺癌失眠幸存者。在重复基线评估的2个月分阶段后，参与者被随机分配到CBT-I或TCC治疗3个月，并在2、3(治疗后)、6和15个月(随访)进行评估。主要结果是15个月时失眠治疗的反应-即匹兹堡睡眠质量指数显示症状的临床显著改善。次要结果是临床医生评估的失眠缓解；睡眠质量；总睡眠时间、入睡潜伏期、睡眠效率和入睡后觉醒，来自睡眠日记；多导睡眠图；以及疲劳、嗜睡和抑郁症状。结果在145名筛选的参与者中，90人被随机分配(CBT-I：n=45；TCC：n=45)。在CBT-I和TCC中，15个月时出现失眠治疗反应的参与者比例分别为43.7%和46.7%。非劣性检验显示TCC在15个月(P=0.02)、3个月(P=0.02)和6个月(P=0.02)时均不逊于CBT-I。
PurposeCognitive behavioral therapy for insomnia (CBT-I) and Tai Chi Chih (TCC), a movement meditation, improve insomnia symptoms. Here, we evaluated whether TCC is noninferior to CBT-I for the treatment of insomnia in survivors of breast cancer.Patients and MethodsThis was a randomized, partially blinded, noninferiority trial that involved survivors of breast cancer with insomnia who were recruited from the Los Angeles community from April 2008 to July 2012. After a 2-month phase-in period with repeated baseline assessment, participants were randomly assigned to 3 months of CBT-I or TCC and evaluated at months 2, 3 (post-treatment), 6, and 15 (follow-up). Primary outcome was insomnia treatment response-that is, marked clinical improvement of symptoms by the Pittsburgh Sleep Quality Index-at 15 months. Secondary outcomes were clinician-assessed remission of insomnia; sleep quality; total sleep time, sleep onset latency, sleep efficiency, and awake after sleep onset, derived from sleep diaries; polysomnography; and symptoms of fatigue, sleepiness, and depression.ResultsOf 145 participants who were screened, 90 were randomly assigned (CBT-I: n = 45; TCC: n = 45). The proportion of participants who showed insomnia treatment response at 15 months was 43.7% and 46.7% in CBT-I and TCC, respectively. Tests of noninferiority showed that TCC was noninferior to CBT-I at 15 months (P =.02) and at months 3 (P =.02) and 6 (P