基于网络的癌症幸存者失眠认知行为疗法：OncoSleep随机试验。

Web-based cognitive-behavioral therapy for insomnia in cancer survivors: The OncoSleep randomized trial.

作者信息

Clara Maria I, van Straten Annemieke, Savard Josée, Canavarro Maria C, Allen Gomes Ana

机构信息

Center for Research in Neuropsychology and Cognitive Behavioral Intervention (CINEICC), University of Coimbra, Coimbra, Portugal; Laboratory of Chronopsychology and Cognitive Systems (ChronCog), University of Coimbra, Coimbra, Portugal; Faculty of Psychology and Educational Sciences, University of Coimbra, Coimbra, Portugal.

Department of Clinical Psychology & Amsterdam Public Health Research Institute, VU University, Amsterdam, the Netherlands.

出版信息

Sleep Med. 2025 May;129:67-74. doi: 10.1016/j.sleep.2025.02.021. Epub 2025 Feb 18.

DOI:10.1016/j.sleep.2025.02.021

PMID:39987779

Abstract

PURPOSE

Insomnia is highly prevalent among cancer survivors and can have serious implications if inadequately treated. Cognitive-behavioral therapy for Insomnia (CBT-I) is recommended as the first-line treatment for insomnia but is rarely available to cancer survivors. We tested the effectiveness of a web-based CBT-I program, OncoSleep, in cancer survivors.

METHODS

Cancer survivors with insomnia (n = 154) were randomly assigned (1:1) to digital CBT-I (6 weekly self-guided modules plus online clinician support) or a waitlist control group. Patient-reported outcome measures of insomnia severity (primary outcome), daytime functioning, and sleep diaries were administered online at baseline and post-treatment (8 weeks). Intention-to-treat analyses were performed using mixed-effects models. Statistical tests were two-sided.

RESULTS

The treatment group reported an average 11.0-point reduction in the Insomnia Severity index (ISI), compared to a 1.4-point reduction in the control group (p<.001). Statistically significant group-by-time interactions were observed: web-based CBT-I produced significant, large effects for improvements in insomnia severity (d = -2.56), cognitive functioning (d = 0.95), physical (d = 1.24) and psychological quality of life (d = 0.80), and fatigue (d = -1.35). Small-to-large effect sizes were found for reductions in anxiety (d = -0.77), depression (d = -0.71), and pain (d = -0.40). Change in insomnia severity mediated the effect of digital CBT-I on daytime outcomes.

CONCLUSIONS

Web-based CBT-I with clinician support appears to be an effective treatment for insomnia in cancer survivors, offering meaningful benefits for comorbid symptoms and quality of life. Further studies with active comparisons and longer follow-up periods are needed to confirm these findings. Digital CBT-I could be integrated into cancer rehabilitation programs to reduce the burden of insomnia. [ClinicalTrials.gov: NCT04898855].

摘要

目的

失眠在癌症幸存者中极为普遍，若治疗不当可能会产生严重影响。认知行为疗法治疗失眠（CBT-I）被推荐为失眠的一线治疗方法，但癌症幸存者很少能获得这种治疗。我们测试了一个基于网络的CBT-I项目OncoSleep对癌症幸存者的有效性。

方法

患有失眠的癌症幸存者（n = 154）被随机分配（1:1）到数字CBT-I组（6个每周一次的自我引导模块加在线临床医生支持）或等待列表对照组。在基线和治疗后（8周）通过在线方式进行患者报告的失眠严重程度（主要结局）、日间功能和睡眠日记等结局指标的测量。使用混合效应模型进行意向性分析。统计检验为双侧检验。

结果

治疗组报告失眠严重程度指数（ISI）平均降低11.0分，而对照组降低1.4分（p<0.001）。观察到具有统计学意义的组×时间交互作用：基于网络的CBT-I对改善失眠严重程度（d = -2.56）、认知功能（d = 0.95）、身体（d = 1.24）和心理生活质量（d = 0.80）以及疲劳（d = -1.35）产生了显著的、较大的效果。在降低焦虑（d = -0.77）、抑郁（d = -0.71）和疼痛（d = -0.40）方面发现了小到中等的效应量。失眠严重程度的变化介导了数字CBT-I对日间结局的影响。