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.

项目概要 睡眠不佳在克罗恩病 (CD) 患者中很常见，并且预示着症状发作的可能性更大， 手术、住院和生活质量下降。 失眠症——长期难以入睡或失眠。 维持睡眠——是该人群中最常见的睡眠障碍，它也与睡眠增加有关。 虽然该人群的失眠最初可能是由于 CD 发作引起的， 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，并且 对治疗睡眠问题感兴趣。 失眠认知行为疗法（CBT-I）是推荐的失眠一线治疗方法 它不仅对治疗失眠，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，但夜间排便 由于害怕大便失禁而导致的运动和高度警惕是克罗恩病所独有的， 强调了对该人群进行调查的重要性。 在这个K23项目中，申请人将进行一项针对CD与CD的CBT-I试点随机对照试验 她将使用混合方法对 60 名患有 CD 和失眠症的成年人进行控制。 CBT-I 在 CD 中的可行性和可接受性；2) CBT-I 对失眠、睡眠模式、CD 症状的影响， 和炎症；3) 治疗反应亚组以及干预的障碍和促进因素 这项研究预计将增进我们对睡眠/CD 关系的理解。 针对影响该人群的重大问题的可能治疗方案。 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 组建了一支出色的指导团队，提供 CD 病理生理学、评估和治疗方面的专业知识 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 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数据分析的结合。 实践经验、会议以及达特茅斯支持的优秀研究基础设施的使用- 希区柯克健康中心和达特茅斯盖泽尔医学院提供这一综合培训计划。 研究将为她竞争 NIH R01 资助做好准备，以评估 CBT-I 的有效性 在更大规模、更有力的随机对照试验中进行控制。