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认知行为疗法与佐匹克隆治疗老年人慢性原发性失眠的随机对照试验

Cognitive behavioral therapy vs zopiclone for treatment of chronic primary insomnia in older adults: a randomized controlled trial.

作者信息

Sivertsen Børge, Omvik Siri, Pallesen Ståle, Bjorvatn Bjørn, Havik Odd E, Kvale Gerd, Nielsen Geir Høstmark, Nordhus Inger Hilde

机构信息

Department of Clinical Psychology, University of Bergen, Bergen, Norway.

出版信息

JAMA. 2006 Jun 28;295(24):2851-8. doi: 10.1001/jama.295.24.2851.

DOI:10.1001/jama.295.24.2851
PMID:16804151
Abstract

CONTEXT

Insomnia is a common condition in older adults and is associated with a number of adverse medical, social, and psychological consequences. Previous research has suggested beneficial outcomes of both psychological and pharmacological treatments, but blinded placebo-controlled trials comparing the effects of these treatments are lacking.

OBJECTIVE

To examine short- and long-term clinical efficacy of cognitive behavioral therapy (CBT) and pharmacological treatment in older adults experiencing chronic primary insomnia.

DESIGN, SETTING, AND PARTICIPANTS: A randomized, double-blinded, placebo-controlled trial of 46 adults (mean age, 60.8 y; 22 women) with chronic primary insomnia conducted between January 2004 and December 2005 in a single Norwegian university-based outpatient clinic for adults and elderly patients.

INTERVENTION

CBT (sleep hygiene, sleep restriction, stimulus control, cognitive therapy, and relaxation; n = 18), sleep medication (7.5-mg zopiclone each night; n = 16), or placebo medication (n = 12). All treatment duration was 6 weeks, and the 2 active treatments were followed up at 6 months.

MAIN OUTCOME MEASURES

Ambulant clinical polysomnographic data and sleep diaries were used to determine total wake time, total sleep time, sleep efficiency, and slow-wave sleep (only assessed using polysomnography) on all 3 assessment points.

RESULTS

CBT resulted in improved short- and long-term outcomes compared with zopiclone on 3 out of 4 outcome measures. For most outcomes, zopiclone did not differ from placebo. Participants receiving CBT improved their sleep efficiency from 81.4% at pretreatment to 90.1% at 6-month follow-up compared with a decrease from 82.3% to 81.9% in the zopiclone group. Participants in the CBT group spent much more time in slow-wave sleep (stages 3 and 4) compared with those in other groups, and spent less time awake during the night. Total sleep time was similar in all 3 groups; at 6 months, patients receiving CBT had better sleep efficiency using polysomnography than those taking zopiclone.

CONCLUSION

These results suggest that interventions based on CBT are superior to zopiclone treatment both in short- and long-term management of insomnia in older adults.

TRIAL REGISTRATION

clinicaltrials.gov Identifier: NCT00295386.

摘要

背景

失眠在老年人中是一种常见病症,与许多不良的医学、社会和心理后果相关。先前的研究表明心理治疗和药物治疗都有有益效果,但缺乏比较这些治疗效果的双盲安慰剂对照试验。

目的

研究认知行为疗法(CBT)和药物治疗对患有慢性原发性失眠的老年人的短期和长期临床疗效。

设计、地点和参与者:2004年1月至2005年12月在挪威一所大学的成人及老年患者门诊进行的一项随机、双盲、安慰剂对照试验,纳入46名患有慢性原发性失眠的成年人(平均年龄60.8岁;22名女性)。

干预措施

CBT(睡眠卫生、睡眠限制、刺激控制、认知疗法和放松;n = 18)、助眠药物(每晚服用7.5毫克佐匹克隆;n = 16)或安慰剂药物(n = 12)。所有治疗持续6周,两种积极治疗在6个月时进行随访。

主要观察指标

使用动态临床多导睡眠图数据和睡眠日记来确定所有3个评估点的总觉醒时间、总睡眠时间、睡眠效率和慢波睡眠(仅使用多导睡眠图评估)。

结果

在4项观察指标中的3项上,与佐匹克隆相比,CBT在短期和长期治疗效果上均有改善。对于大多数指标,佐匹克隆与安慰剂无差异。接受CBT的参与者的睡眠效率从治疗前的81.4%提高到6个月随访时的90.1%,而佐匹克隆组从82.3%降至81.9%。与其他组相比,CBT组参与者在慢波睡眠(3期和4期)中的时间更多,夜间清醒时间更少。所有3组的总睡眠时间相似;在6个月时,接受CBT的患者使用多导睡眠图测得的睡眠效率优于服用佐匹克隆的患者。

结论

这些结果表明,在老年人失眠的短期和长期管理中,基于CBT的干预措施优于佐匹克隆治疗。

试验注册

clinicaltrials.gov标识符:NCT00295386。

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