在初级保健中，谁能从失眠认知行为疗法（CBT）中获益？来自生活方式试验纵向结果的重要患者选择和试验设计经验教训。
Who benefits from CBT for insomnia in primary care? Important patient selection and trial design lessons from longitudinal results of the Lifestyles trial.
作者信息
McCurry Susan M, Shortreed Susan M, Von Korff Michael, Balderson Benjamin H, Baker Laura D, Rybarczyk Bruce D, Vitiello Michael V
机构信息
Department of Psychosocial and Community Health, University of Washington School of Nursing, Seattle, WA.
Group Health Research Institute, Seattle, WA.
出版信息
Sleep. 2014 Feb 1;37(2):299-308. doi: 10.5665/sleep.3402.
STUDY OBJECTIVES
Evaluate long-term effects of group interventions on sleep and pain outcomes in a primary care population of older adults with osteoarthritis pain and sleep disturbance.
DESIGN
Double-blind, cluster-randomized controlled trial with 18-mo follow-up.
SETTING
Group Health and University of Washington, Seattle, WA, from 2009 to 2011.
PARTICIPANTS
Three hundred sixty-seven adults age 60 y and older, with osteoarthritis pain and insomnia symptoms.
INTERVENTIONS
Six weekly sessions of group cognitive behavioral therapy for insomnia and pain (CBT-PI), pain alone (CBT-P), and education-only control (EOC) delivered in patients' primary care clinics.
MEASUREMENTS AND RESULTS
There were no significant differences between treatment groups in sleep outcomes at 18 mo. This is a change from published significant 9-mo follow-up results for insomnia severity (Insomnia Severity Index) and sleep efficiency. There were no significant treatment differences in pain at either follow-up. Post hoc analyses of participants with greater insomnia and pain severity at baseline (n = 98) showed significant (P = 0.01) 18-mo reductions in pain comparing CBT-PI versus CBT-P (adjusted mean difference [AMD] = -1.29 [95% confidence interval (CI): -2.24,-0.33]). Moderate, albeit nonsignificant, CBT-PI versus EOC treatment effects for insomnia severity (AMD = -1.43 [95% CI: -4.71, 1.86]) and sleep efficiency (AMD = 2.50 [95% CI: -5.04, 10.05]) were also observed. Possible trial design and methodological considerations that may have affected results are discussed.
CONCLUSIONS
Results suggest patients with higher levels of comorbid pain and insomnia may be most likely to experience sustained benefit from cognitive behavioral therapy interventions over time, and inclusion of insomnia treatment may yield more clinically meaningful improvements than cognitive behavioral therapy for pain alone.
TRIAL REGISTRATION
clinicaltrials.gov identifier: NCT01142349.
研究目的
评估团体干预对患有骨关节炎疼痛和睡眠障碍的老年初级保健人群睡眠和疼痛结局的长期影响。
设计
双盲、整群随机对照试验，随访18个月。
地点
2009年至2011年，华盛顿州西雅图市的Group Health和华盛顿大学。
参与者
367名60岁及以上患有骨关节炎疼痛和失眠症状的成年人。
干预措施
在患者的初级保健诊所进行为期六周的团体认知行为疗法，分别针对失眠和疼痛（CBT-PI）、仅针对疼痛（CBT-P）以及仅进行教育的对照（EOC）。
测量与结果
18个月时，各治疗组在睡眠结局方面无显著差异。这与已发表的9个月随访时失眠严重程度（失眠严重程度指数）和睡眠效率的显著结果有所不同。两次随访时在疼痛方面均无显著的治疗差异。对基线时失眠和疼痛严重程度更高的参与者（n = 98）进行的事后分析显示，比较CBT-PI与CBT-P时，18个月时疼痛有显著降低（P = 0.01）（调整后平均差异[AMD] = -1.29 [95%置信区间(CI)：-2.24，-0.33]）。还观察到CBT-PI与EOC在失眠严重程度（AMD = -1.43 [95% CI：-4.71，1.86]）和睡眠效率（AMD = 2.50 [95% CI：-5.04，10.05]）方面有中等程度（尽管不显著）的治疗效果。讨论了可能影响结果的试验设计和方法学考虑因素。
结论
结果表明，随着时间推移，合并疼痛和失眠程度较高的患者可能最有可能从认知行为疗法干预中持续获益，并且与仅针对疼痛的认知行为疗法相比，纳入失眠治疗可能会产生更具临床意义的改善。
试验注册
clinicaltrials.gov标识符：NCT01142349。
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