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 在克罗恩病（CD）的患者中，睡眠不佳是常见的，并且预测症状耀斑的可能性更大， 手术，住院和生活质量降低。失眠障碍 - 持续启动或 保持睡眠 - 是该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。尽管该人群中的失眠最初可能由于CD耀斑而发展，但 我们的初步数据表明患有CD和失眠的人报告了与失眠有关的行为，并且是 对他们的睡眠问题有兴趣。 失眠的认知行为疗法（CBT-I）是建议的失眠的一线治疗 紊乱。它不仅对治疗失眠，而且对于改善疼痛和炎症非常有效。 但是，尽管在其他人群中证明了CBT-I的有效性，但夜间肠 由于担心粪便尿失禁而导致的动作和过度维护是克罗恩的独有的， 强调投资在该人群中的重要性。 在这个K23项目中，申请人将对适用于CD VS的CBT-I进行飞行员随机对照试验 在60名患有CD和失眠的成年人中对照。使用混合方法方法，她将调查：1） CD-I在CD中的可行性和可接受性； 2）CBT-I对失眠，睡眠模式，CD符号的影响 和炎症； 3）治疗反应子组，障碍以及对干预的促进者 订婚。这项研究有望提高我们对睡眠/CD关系的理解和 影响该人群的重大问题的可能治疗选择。 为了支持申请人的职业发展，培训目标和拟议的研究项目，她有 组建了一个杰出的训练团队，该团队带来了CD病理生理学，评估和 管理（Corey Siegel博士），客观睡眠评估和CBT-I（Michael Smith博士），混合方法 研究（Kelly Aschbrenner博士），IBD的行为临床试验（Laurie Keefer博士）和纵向方法 和数据分析（Tor Tosteson博士）。申请人的培训将涉及教学和 达特茅斯支持的优秀研究基础设施的实践经验，会议和使用 达特茅斯的希区柯克健康和盖斯尔医学院。这个全面的培训计划 研究将使她准备竞争NIH R01资金，以评估CBT-I的有效性 在较大，全功率的随机对照试验中控制。