A Fully Remote Pilot Randomized Controlled Trial to Investigate the Impact of Insomnia Treatment on Crohn’s disease

项目总结 睡眠不佳在克罗恩病(CD)患者中很常见，并预示着症状发作的可能性更大， 手术、住院和生活质量下降。失眠障碍--慢性入睡困难或 维持睡眠--是这一人群中最常见的睡眠障碍。它也与增长联系在一起 在慢性疼痛和炎症方面。虽然这一人群的失眠最初可能是由于CD闪光而发展起来的， 我们的初步数据表明，患有CD和失眠的人报告了与失眠相关的行为，并 对治疗他们的睡眠问题感兴趣。 失眠认知行为疗法(CBT-I)是推荐的失眠一线治疗方法 无序。它不仅对治疗失眠非常有效，而且对缓解疼痛和炎症也很有效。 然而，尽管CBT-I已经在其他人群中证明了有效性，但夜间肠道 由于害怕大便失禁而导致的运动和高度警惕是克罗恩所特有的， 突显了调查在这一人群中的重要性。 在这个K23项目中，申请者将进行一项针对CD和VS的CBT-I的试点随机对照试验 60例成人CD伴失眠对照研究。使用混合方法，她将调查：1) CBT-I用于CD的可行性和可接受性；2)CBT-I对失眠、睡眠模式、CD症状、 和炎症；以及3)治疗反应亚群和干预的障碍和促进者 订婚。这项研究有望促进我们对睡眠/CD关系的理解，并 对于影响这一人群的重大问题，可能的治疗方案。 为了支持申请者的职业发展、培训目标和建议的研究项目，她有 组建了一支出色的指导团队，提供CD病理生理学、评估和 管理(科里·西格尔博士)，客观睡眠评估和CBT-I(迈克尔·史密斯博士)，混合方法 研究(Kelly Aschbrenner博士)、IBD行为临床试验(Laurie Keefer博士)和纵向方法 和数据分析(托尔·托斯特森博士)。申请者的培训将包括教学和培训相结合 实践经验、会议和达特茅斯支持的卓越研究基础设施的使用- 希区柯克健康和达特茅斯的盖泽尔医学院。这一全面的培训计划 而研究将为她竞争NIH R01的资金做准备，以评估CBT-I的效果对比 在一项更大的、完全有效的随机对照试验中进行对照。

PROJECT SUMMARY Poor sleep is common in people with Crohn’s disease (CD) and predicts greater likelihood of symptom flares, surgery, hospitalization, and reduced quality of life. Insomnia disorder – chronic difficulty with initiating or maintaining sleep – is the most common sleep disorder in this population. It is also associated with increases in both chronic pain and inflammation. While insomnia in this population may initially develop due to CD flares, our preliminary data indicate that people with CD and insomnia report insomnia-related behaviors and are interested in treatment for their sleep problems. Cognitive Behavioral Therapy for Insomnia (CBT-I) is the recommended first-line treatment for insomnia disorder. It is highly effective not only for treating insomnia, but also for improving pain and inflammation. However, while effectiveness of CBT-I has been demonstrated in other populations, nighttime bowel movements and the hypervigilance that results from fear of fecal incontinence are unique to Crohn’s, highlighting the importance of investigation in this population. In this K23 project, the applicant will conduct a pilot randomized controlled trial of CBT-I adapted for CD vs control in 60 adults with CD and insomnia. Using a mixed-methods approach, she will investigate: 1) the feasibility and acceptability of CBT-I in CD; 2) the impact of CBT-I on insomnia, sleep patterns, CD symptoms, and inflammation; and 3) treatment response subgroups and barriers and facilitators to intervention engagement. This research is expected to advance our understanding of the sleep/CD relationship and possible treatment options for a significant problem affecting this population. To support the applicant’s career development, training goals, and proposed research project, she has assembled an exceptional mentorship team that brings expertise in CD pathophysiology, assessment, and management (Dr. Corey Siegel), objective sleep assessment and CBT-I (Dr. Michael Smith), mixed-methods research (Dr. Kelly Aschbrenner), behavioral clinical trials in IBD (Dr. Laurie Keefer), and longitudinal methods and data analysis (Dr. Tor Tosteson). The applicant’s training will involve a combination of didactic and practical experiences, conferences, and use of the excellent research infrastructure supported by Dartmouth- Hitchcock Health and the Geisel School of Medicine at Dartmouth. This comprehensive program of training and research will prepare her to compete for NIH R01 funding to evaluate the effectiveness of CBT-I compared to control in a larger, fully powered randomized controlled trial.