Department of Neurology, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
Center for Circadian and Sleep Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
Sleep. 2024 Oct 11;47(10). doi: 10.1093/sleep/zsae137.
Mindfulness-based interventions (MBI) have been shown to improve psychosocial functioning in medical populations but have not been studied in narcolepsy. This study examined the feasibility and acceptability of an MBI that was adapted for narcolepsy, including three variations in program length.
Adults with narcolepsy (N = 60) were randomized to MBI groups of varying durations: brief (4 weeks), standard (8 weeks), or extended (12 weeks). Participants completed assessments at baseline, 4, 8, and 12 weeks. To assess feasibility and acceptability, primary outcomes included attendance, meditation practice, and data completeness. Additionally, participants completed measures of mindfulness, self-compassion, mood, sleep, psychosocial functioning, and cognition. An effect size of Cohen's d ≥ 0.5 was used as the prespecified benchmark for a minimal clinically important difference (MCID).
The attendance, meditation, and data completeness benchmarks were met by 71.7%, 61.7%, and 78.3% of participants, respectively. Higher proportions of the brief and extended groups met these benchmarks compared to the standard group. All groups met the MCID for mindfulness, self-compassion, self-efficacy for managing emotions, positive psychosocial impact, global mental health, and fatigue. Standard and extended groups met the MCID for anxiety and depression, and extended groups met the MCID for additional measures including social and cognitive functioning, daytime sleepiness, hypersomnia symptoms, and hypersomnia-related functioning.
Results suggest that the remote delivery and data collection methods are feasible to employ in future clinical trials, and it appears that the extended MBI provides the most favorable clinical impact while maintaining attendance and engagement in meditation practice.
Awareness and Self-Compassion Enhancing Narcolepsy Treatment (ASCENT), NCT04306952, https://clinicaltrials.gov/ct2/show/NCT04306952.
基于正念的干预（MBI）已被证明可以改善医疗人群的社会心理功能，但尚未在嗜睡症中进行研究。本研究考察了一种适应嗜睡症的 MBI 的可行性和可接受性，包括方案长度的三种变化。
将 60 名嗜睡症成年人随机分配到 MBI 组，时长不同：简短（4 周）、标准（8 周）或延长（12 周）。参与者在基线、4、8 和 12 周时完成评估。为了评估可行性和可接受性，主要结果包括出勤率、冥想练习和数据完整性。此外，参与者完成了正念、自我同情、情绪、睡眠、社会心理功能和认知的测量。使用 Cohen's d≥0.5 的效应大小作为最小临床重要差异（MCID）的预定基准。
分别有 71.7%、61.7%和 78.3%的参与者达到了出勤率、冥想和数据完整性标准。与标准组相比，简短和延长组的比例更高。所有组都达到了正念、自我同情、管理情绪的自我效能、积极的社会心理影响、整体心理健康和疲劳的 MCID。标准组和延长组达到了焦虑和抑郁的 MCID，延长组达到了包括社会和认知功能、日间嗜睡、过度嗜睡症状和过度嗜睡相关功能在内的其他措施的 MCID。
结果表明，远程交付和数据收集方法在未来的临床试验中是可行的，并且延长的 MBI 似乎提供了最有利的临床影响，同时保持了出勤率和对冥想练习的参与度。
嗜睡症治疗的意识和自我同情增强（ASCENT），NCT04306952，https://clinicaltrials.gov/ct2/show/NCT04306952。
