数字认知行为疗法对合并失眠和睡眠呼吸暂停患者失眠的影响（COMISA）：一项初步随机对照试验。
The Effect of Digital Cognitive Behavioural Therapy for Insomnia in People With Co-Morbid Insomnia and Sleep Apnoea (COMISA): A Pilot Randomised Controlled Trial.
作者信息
Sweetman Alexander, Richardson Cele, Smith Allan, Reynolds Chelsea
机构信息
Adelaide Institute for Sleep Health and Flinders Health and Medical Research Institute: Sleep Health, College of Medicine and Public Health, Flinders University, Adelaide, Australia.
School of Psychological Science, University of Western Australia, Perth, Australia.
出版信息
J Sleep Res. 2025 Jun 25:e70114. doi: 10.1111/jsr.70114.
Co-morbid insomnia and sleep apnoea (COMISA) is a prevalent and debilitating condition. Cognitive behavioural therapy for insomnia (CBTi) is an effective but largely inaccessible treatment in patients with COMISA. We aimed to test a self-guided interactive digital CBTi program tailored for COMISA and insomnia alone. A pilot randomised controlled trial was conducted to investigate the effect of an interactive tailored digital CBTi program, versus digital sleep education (control) on symptoms of insomnia, depression, anxiety, sleepiness, fatigue, and maladaptive beliefs about sleep in people with COMISA. Online questionnaires were administered at baseline, 8 weeks, 16 weeks, and 24 weeks. Intent-to-treat mixed models and complete-case Fisher's exact analyses were used. Participants were 30 adults with COMISA (Age M[sd] = 61.0[10.3], 60% female, BMI = 33.5[6.5]). Compared to control, CBTi was associated with lower insomnia (M[95% CI] difference = 8.3[5.0-11.6], p < 0.001, d = 2.88), depression (3.7[1.0-6.5], p = 0.008, d = 1.66), anxiety (2.9[0.9-4.9], p = 0.005, d = 0.62), sleepiness (2.7[0.8-4.5], p = 0.007, d = 0.71), and maladaptive beliefs about sleep (13.9[5.7-22.2], p = 0.001, d = 1.16), but not fatigue (1.9[-1.2-4.9], p = 0.229, d = 0.68) at 8-week follow-up, controlling for baseline scores. The CBTi group experienced greater rates of insomnia remission (ISI < 8; 42%, vs. 0%, p = 0.012), and improvement (ISI reduction ≥ 6; 75% vs. 14%; p = 0.004) by 8-weeks. Improvements in the CBTi group were sustained by 24-weeks. This tailored digital CBTi program led to large and sustained improvements in insomnia, depression, anxiety, sleepiness, and maladaptive beliefs about sleep in people with COMISA. Trial Registration: This trial was prospectively registered on the Australian and New Zealand Clinical Trials Registry (ANZCTR, ACTRN12622001218785). https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=384648&isReview=true.
共病性失眠与睡眠呼吸暂停（COMISA）是一种常见且使人衰弱的病症。失眠的认知行为疗法（CBTi）是一种有效的治疗方法，但在患有COMISA的患者中，很大程度上难以获得。我们旨在测试一种专门为COMISA和单纯性失眠量身定制的自我引导交互式数字CBTi程序。进行了一项试点随机对照试验，以研究交互式定制数字CBTi程序与数字睡眠教育（对照）对COMISA患者失眠、抑郁、焦虑、嗜睡、疲劳以及对睡眠的适应不良信念症状的影响。在基线、8周、16周和24周时进行在线问卷调查。使用意向性治疗混合模型和完全病例费舍尔精确分析。参与者为30名患有COMISA的成年人（年龄M[标准差]=61.0[10.3]，60%为女性，BMI=33.5[6.5]）。与对照组相比，在控制基线分数的情况下，CBTi组在8周随访时失眠程度更低（M[95%CI]差异=8.3[5.0-11.6]，p<0.001，d=2.88）、抑郁程度更低（3.7[1.0-6.5]，p=0.008，d=1.66）、焦虑程度更低（2.9[0.9-4.9]，p=0.005，d=0.62）、嗜睡程度更低（2.7[0.8-4.5]，p=0.007，d=0.71）以及对睡眠的适应不良信念程度更低（13.9[5.7-22.2]，p=0.001！，d=1.16），但疲劳程度无差异（1.9[-1.2-4.9]，p=0.229，d=0.68）。到8周时，CBTi组失眠缓解率（失眠严重程度指数<8；42%，对照组为0%，p=0.012）和改善率（失眠严重程度指数降低≥6；75%对14%；p=0.004）更高。CBTi组的改善在24周时得以持续。这种量身定制的数字CBTi程序使COMISA患者的失眠症状、抑郁、焦虑、嗜睡以及对睡眠的适应不良信念得到了大幅且持续的改善。试验注册：本试验已在澳大利亚和新西兰临床试验注册中心（ANZCTR，ACTRN12622001218785）进行前瞻性注册。https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=384648&isReview=true 。
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