Objectives The primary objective was to compare the effect of cognitive behavioural therapy for insomnia (CBT-I) to usual care on sleep efficiency, measured by polysomnography (PSG) immediately after the intervention at week 7. Secondary objectives included comparing the longer-term effect on sleep- and RA-related outcomes at week 26. Methods In a randomised controlled trial using a parallel group design, the experimental intervention was six weeks’ nurse-led group-based CBT-I; the comparator was usual care. Analyses were based on the intention-to-treat (ITT) principle; missing data were statistically modelled using repeated-measures linear mixed effects models adjusted for the level at baseline. Results The ITT population consisted of 62 patients (89% women), with an average age of 58 years and an average sleep efficiency of 83.1%. At primary end point, sleep efficiency was 88.7% in the CBT-I group, compared with 83.7% in the control group (difference: 5.03 [95% CI -0.37–10.43]; p = 0.068) measured by PSG at week 7. Key secondary outcomes measured with PSG had not improved at week 26. However, for all the patient-reported key secondary sleep- and RA-related outcomes, there were statistically highly significant differences between CBT-I and usual care (p < 0.0001), e.g. insomnia (Insomnia Severity Index: -9.85 [95% CI -11.77 to -7.92]), and the RA impact of disease (RAID: -1.36 [95% CI-1.92 to -0.80]) at week 26. Conclusion Nurse-led group-based CBT-I did not lead to an effect on sleep efficiency objectively measured with PSG. However, CBT-I showed improvement on all patient-reported key secondary sleep- and RA-related outcomes measured at week 26. Trial registration ClinicalTrials.gov, https://clinicaltrials.gov, NCT03766100.

中文翻译：

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基于群体的认知行为疗法对类风湿性关节炎患者失眠的影响：一项随机对照试验

目标 主要目标是比较失眠认知行为疗法 (CBT-I) 与常规护理对睡眠效率的影响，在第 7 周干预后立即通过多导睡眠图 (PSG) 测量。次要目标包括比较长期效果关于第 26 周睡眠和 RA 相关结果的影响。比较对象是常规护理。分析基于意向性治疗 (ITT) 原则；使用针对基线水平调整的重复测量线性混合效应模型对缺失数据进行统计建模。结果 ITT 人群由 62 名患者（89% 为女性）组成，平均年龄为 58 岁，平均睡眠效率为 83.1%。在主要终点，CBT-I 组的睡眠效率为 88.7%，而对照组为 83.7%（差异：5.03 [95% CI -0.37–10.43]；p = 0.068），在第 7 周通过 PSG 测量。使用 PSG 测量的关键次要结果在第 26 周没有改善。然而，对于所有患者报告的关键次要睡眠和 RA 相关结果，CBT-I 与常规护理之间存在统计学上的高度显着差异（p <0.0001） ，例如失眠（失眠严重程度指数：-9.85 [95% CI -11.77 至 -7.92]），以及第 26 周时疾病对 RA 的影响（RAID：-1.36 [95% CI-1.92 至 -0.80]）。 结论 护士基于小组的 CBT-I 并未对使用 PSG 客观测量的睡眠效率产生影响。然而，CBT-I 显示在第 26 周测量的所有患者报告的关键次要睡眠和 RA 相关结果都有改善。