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

一项完全远程试点随机对照试验，研究失眠治疗对克罗恩病的影响

• 批准号: 10571042
• 负责人: Jessica K Salwen-Deremer
• 金额: $ 19万
• 依托单位: DARTMOUTH-HITCHCOCK CLINIC
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-02-15 至 2027-11-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10571042
• 关键词: Abdominal Pain; Address; Adult; Affect; Behavior; Behavior Therapy; Biological Markers; Body Weight decreased; C-reactive protein; Chronic; Clinical Trials; Cognitive Therapy; Crohn' s disease; Data; Data Analyses; Defecation; Development; Diarrhea; Disease; Disease remission; Effectiveness; Etiology; Eye; Fatigue; Fecal Incontinence; Feces; Flare; Frequencies; Fright; Functional disorder; Funding; Gastrointestinal tract structure; Generations; Goals; Health; Hospitalization; Immune; Individual; Inflammation; Inflammatory; Intervention; Interview; Intestines; Investigation; Joints; Lead; Leukocyte L1 Antigen Complex; Link; Mediating; Mentorship; Methodology; Methods; Moods; Operative Surgical Procedures; Outcome; Pain; Participant; Patient Care; Patient Self-Report; Pattern; Persons; Pharmacotherapy; Population; Procedures; Quality of life; Questionnaires; Randomized, Controlled Trials; Recommendation; Reporting; Research; Research Infrastructure; Research Methodology; Research Project Grants; Severities; Severity of illness; Skin; Sleep; Sleep Disorders; Sleeplessness; Structure; Subgroup; Symptoms; Testing; Time; Training; Training Programs; United States National Institutes of Health; Visit; acceptability and feasibility; active control; behavioral clinical trial; burden of illness; career development; chronic pain; comorbidity; comparison control; cost; effectiveness evaluation; experience; feasibility trial; gastrointestinal symptom; improved; improvement on sleep; indexing; interest; medical schools; physical conditioning; poor sleep; post intervention; primary outcome; prospective; recruit; secondary outcome; side effect; sleep onset; sleep pattern; social health determinants; symposium; telehealth; treatment response

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.

项目摘要 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。肌肉功能障碍-慢性启动困难或 维持睡眠-是这一人群中最常见的睡眠障碍。它也与增加有关 在慢性疼痛和炎症中的作用虽然这一人群的失眠最初可能是由于CD发作， 我们的初步数据表明，患有CD和失眠症的人报告失眠相关行为， 对治疗他们的睡眠问题感兴趣 失眠的认知行为疗法（CBT-I）是推荐的失眠一线治疗方法 disorder.它不仅对治疗失眠非常有效，而且对改善疼痛和炎症也非常有效。 然而，虽然CBT-I的有效性已在其他人群中得到证实， 由于害怕大便失禁而引起的运动和高度警惕是克罗恩病所特有的， 强调了在这一人群中进行调查的重要性。 在本K23项目中，申请人将进行一项适用于CD与 对照组60例CD伴失眠患者。使用混合方法的方法，她将调查：1） CBT-I治疗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;和3）治疗反应亚组和干预的障碍和促进因素 订婚这项研究有望促进我们对睡眠/CD关系的理解， 可能的治疗方案，为影响这一人口的重大问题。 为了支持申请人的职业发展，培训目标和拟议的研究项目，她已经 组建了一个出色的导师团队，带来了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的行为临床试验（劳里基弗博士）和纵向方法 数据分析（Dr. Tor Tosteson）申请人的培训将包括教学和 实践经验，会议，并使用由达特茅斯支持的优秀研究基础设施- 希区柯克健康和盖泽尔医学院在达特茅斯。这个全面的训练计划 研究将使她准备竞争NIH R 01基金，以评估CBT-I的有效性， 在一个更大的、完全有效的随机对照试验中进行控制。