Mind-Body Approach to Improve Health- Related Quality of Life for People with Narcolepsy: A Feasibility Study

项目摘要 嗜睡症是一种严重和使人衰弱的疾病，涉及持续和过度的嗜睡，影响2000名美国人中的1人和全世界300万人。虽然唤醒促进药物治疗可以减少嗜睡，但没有治愈方法，嗜睡症患者的健康相关生活质量显着下降，特别是在精神和社会健康领域。新的初步数据显示，传统医疗保健系统的现行做法不足以满足嗜睡症患者的心理需求。因此，本研究的总体目标是测试基于正念的干预（MBI）改善健康相关生活质量的有效性，作为嗜睡症标准护理的补充实践。该项目建立在我们的初步工作，进行可行性试验，以确定适应和提供MBI的人与嗜睡症的最佳参数。具体目标是：1）确定使用视频会议提供MBI的可行性和可接受性，以改善嗜睡症患者的心理社会功能; 2）确定使用视频会议提供MBI的招募和评估方法的可行性。我们计划分两个阶段实现这些目标。第一阶段的特点是完成研究方案和培训MBI提供者与嗜睡症患者一起工作。第二阶段的特点是可行性试验，其中60名发作性睡病成人将随机接受4周（短），8周（标准）或12周（延长）MBI。每个MBI在内容上都是相似的，其中包括正念练习和小组讨论，以及对嗜睡症症状的适应。所有医疗保险都将使用现场视频会议平台以小组形式提供，以提高无障碍性。如果该项目的结果支持进一步测试的可行性，下一个项目将旨在提高严谨性和可重复性（例如，设计适当的控制，完善结果措施和资格标准），为大规模的务实试验做准备。我们拥有一支在正念、睡眠障碍和治疗开发方面经验丰富的团队，以及一个拥有基础设施和资源的丰富环境来开展这个项目。这项研究的总体意义是开发一种可扩展的身心干预，解决了改善嗜睡症患者心理社会功能的主要研究空白。

PROJECT SUMMARY Narcolepsy is a serious and debilitating condition involving persistent and excessive sleepiness that affects 1 in 2000 Americans and 3 million people worldwide. Although wake-promoting pharmacotherapy can reduce sleepiness there is no cure and people with narcolepsy experience significantly poor health-related quality of life, particularly in the domains of mental and social health. New preliminary data reveals that current practices within the traditional health care system are not adequate for addressing the psychosocial needs of people with narcolepsy. Therefore, the overarching goal of this research is to test the effectiveness of a mindfulness-based intervention (MBI) for improving health-related quality of life as a complementary practice to standard care for narcolepsy. This project builds upon our preliminary work by conducting a feasibility trial to determine the optimal parameters for adapting and delivering MBI to people with narcolepsy. The specific aims are to: 1) Determine the feasibility and acceptability of MBI delivered using videoconferencing for the purpose of improving psychosocial functioning in people with narcolepsy and 2) Determine the feasibility of recruitment and assessment methods for delivering MBI using videoconferencing. We plan to carry out these aims in two phases. Phase I features the completion of the study protocol and training of MBI providers to work with narcolepsy patients. Phase II features a feasibility trial in which 60 adults with narcolepsy will be randomized to receive either a 4-week (short), 8-week (standard), or 12-week (extended) MBI. Each MBI will be similar in content, which includes mindfulness practices and group discussions with adaptations for working with narcolepsy symptoms. All MBIs will be delivered in small groups using a live videoconferencing platform to enhance accessibility. If the findings of this project support the feasibility of further testing, the next project would be aimed at enhancing rigor and reproducibility (e.g., designing appropriate control, refining outcome measures and eligibility criteria) in preparation for a large-scale pragmatic trial. We have a team armed with experience in mindfulness, sleep disorders, and treatment development, and a rich environment with the infrastructure and resources to carry out this project. The overall significance of this research is to develop a scalable mind-body intervention that addresses a major research gap on improving psychosocial functioning in people with narcolepsy.