认知行为自助疗法和唑吡坦治疗慢性失眠的对照研究

Comparative study of effectiveness of cognitive behavioral self-help therapy and zolpidem on patients with chronic insomnia

目的比较电话指导下的认知行为自助疗法（CBTI-SH）和酒石酸唑吡坦对慢性失眠的疗效。方法选择自2011年7月至2012年10月中山大学附属三院精神心理科门诊慢性失眠患者60例，按奇偶数法分为研究组和对照组各30例。对照组给予睡眠卫生教育＋剂量递减的酒石酸唑吡坦治疗：药物起始剂量为10mg／d，每周递减1／4剂量，疗程4周：研究组给予睡眠卫生教育＋CBTI—SH治疗：疗程4周，内容包括认知重建、睡眠限制、刺激控制、放松训练，将CBTI．SH的内容制成文字材料，由患者自助实施，第1、3周末分别给予15min的电话指导。在基线时及第2、4、6周末应用匹茨堡睡眠质量指数量表（PSQI）、Epworth嗜睡量表（ESS）对睡眠情况进行评价：要求患者每天记录睡眠曰志，评价指标包括入睡潜伏期、入睡后觉醒时间、睡眠时间、卧床时间、睡眠效率；要求患者进行依从性评价，即过去1周内有多少天按照要求执行了CBTI—SH或睡眠卫生教育的6种主要成分。结果重复测量的方差分析显示，研究组和对照组PSQI量表、ESS量表评分及入睡潜伏期、睡眠效率、睡眠时间、卧床时间、入睡后觉醒时间在治疗前后不同时间之间的差异均有统计学意义（p〈0．05），且研究组的改善明显优于对照组，效应量分别为1．93、0．04、1．00、0．98、0．11、0．57、0．43。研究组对“不在床上做其他事”和“不在床上担忧”的依从性高于对照组，而对“限制卧床时间”、“不能睡则离开床”的依从性低于对照组，差异均有统计学意义（p〈0．05）。结论和应用剂量递减的酒石酸唑吡坦治疗策略相比，CBTI．SH治疗慢性失眠及伴随的日间思睡的疗效更优．但部分依从性有待提高。

Objective To test the efficacy of cognitive behavioral self-help therapy （CBTI-SH） on patients with chronic insomnia vs. a zolpidem control condition. Methods A total of 60 adults with chronic insomnia and common comorbidities were recruited from our hospital from July 2011 to October 2012. Participants were randomly assigned to either intervention group （n=30）, consisting of sleep hygiene plus four-week CBTI-SH with printed material and 2 telephone instruction-calls, or control group （n=30）, consisting of sleep hygiene plus a four-week supervised zolpidem tapering therapy. The CBTI-SH included cognitive restruction, stimulus control therapy, sleep restriction therapy and relaxation therapy. The primary outcome was self-report symptom, based on sleep diaries （including Sleep Latency-SL, Total Sleep Time-TST, Time In Bed-TIB, Sleep Efficiency-SE ,Wake after Sleep Onset-WASO）, Pittsburgh Sleep Quality Index （PSQI） and Epworth Sleeping Scale （ESS） which were evaluated at baseline and at the end of the 2th, 4th, 6th week treatment. Continuous variables were evaluated by repeated-measures multivariate analyses of variance （MANOVA）. At the end of every two weeks, each participant was asked to assess treatment adherence to the six core recommendations of CBTI-SH or sleep hygiene. Results The multivariate analysis of variance showed a significant treatment group plus time interaction, and timemain effects for PSQI, ESS, SL, SE, TST, TIB and WASO in the two groups （P〈0.05）. The patients in the intervention group had significantly better outcomes than those in control group. Effect sizes （Cohen d） were 1.93, 0.04, 1.00, 0.98, 0.11, 0.57 and 0.43, respectively. The intervention group reported higher average adherence scores in ＂use of the bed only for sleeping, not worrying in bed＂, and lower average scores in ＂adherence to TIB prescription, getting out of bed when unable to sleep＂, compared with those in the control group. Conclusion CBTI-SH is effective for treating chronic insomnia and daytime sleepiness as compared with supervised zolpidem tapering therapy, but the treatment adherence needs to be improved.