Enhancing Hypnotic Medication Discontinuation in Primary Care through Supervised Medication Tapering and Digital Cognitive Behavioral Insomnia Therapy

通过监督药物逐渐减量和数字认知行为失眠治疗，加强初级保健中催眠药物的停药

• 批准号: 10736443
• 负责人: JACK D EDINGER
• 金额: $ 53.55万
• 依托单位: NATIONAL JEWISH HEALTH
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-08-01 至 2028-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10736443
• 关键词: Abstinence; Achievement; Acute; Address; Adoption; Aftercare; Age; Anxiety; Behavioral; Belief; Chronic; Clinical; Cognitive; Colorado; Combined Modality Therapy; Complex; Dangerousness; Data; Dependence; Disease; Disease remission; Dose; Enrollment; Ethnic Origin; Fatigue; Frequencies; Future; Goals; Individual; Initial Insomnia; Intervention; Interview; Lead; Maintenance; Measures; Modeling; Monitor; Moods; Morbidity - disease rate; Participant; Patient Self-Report; Patients; Performance; Pharmaceutical Preparations; Physicians; Primary Care; Process; Protocols documentation; Provider; Public Health; Quality of life; Questionnaires; Reporting; Research; Risk; Sampling; Severities; Sleep; Sleeplessness; Structure; Symptoms; System; Testing; Therapeutic Intervention; Time; Training; Universities; Withdrawal Symptom; actigraphy; age group; clinical practice; comorbidity; cost effective; cost effective intervention; design; diaries; digital; efficacy testing; evidence base; experience; falls; follow-up; human old age (65+); hypnotic; impaired driving performance; implementation evaluation; implementation science; implementation strategy; implementation/effectiveness; improved; medical schools; medical specialties; nondrug therapy; open label; practice-based research network; primary care clinic; primary care patient; primary care provider; primary care setting; primary outcome; randomized trial; response; secondary outcome; sedative; sex; sleep behavior; sleep difficulty; symptomatic improvement; theories

PROJECT SUMMARY/ABSTRACT Treatment-seeking insomnia sufferers most often present in primary care where their first and usually only treatment is a prescription hypnotic medication. More than 65% of individuals prescribed hypnotics use them for more than a year, and more than 30% remain on them for more than five years. Such agents may be useful for acute insomnia and certain cases with chronic sleep difficulties, but prolonged hypnotic use can lead to dependency and increased morbidity (e.g., falls, cognitive/driving impairments). Reducing or discontinuing hypnotics after prolonged use is a challenging task for both prescribing physicians and the patients who use them. Although evidenced-based physician-supervised medication tapering (SMT) protocols have shown efficacy, such interventions have yet to be disseminated widely in primary care. Most primary care providers (PCPs) are willing to refer their insomnia patients to alternative evidence-based non-drug treatments such as cognitive behavioral insomnia therapy (CBTI), but such treatment is often difficult to access outside of specialty sleep centers. Given this gap between research and clinical practice, there is a pressing need to develop and validate cost-effective interventions to facilitate the management of insomnia and hypnotic tapering in primary care. In response to PAR-20-183, This application has been carefully designed to address these issues. We will conduct a large randomized trial to compare the combined digital CBT (dCBTI)/SMT intervention, to the SMT intervention delivered alone for producing hypnotic discontinuation and insomnia symptom improvement. A sample of 430 hypnotic-reliant patients drawn from 8-10 primary care clinics within a practice-based research network affiliated with the University of Colorado Medical School in Aurora, Colorado will serve as study participants. The main objective of the project is to compare the performance of dCBTI+SMT with SMT used alone for achieving hypnotic reduction/discontinuation and insomnia symptom improvement. In addition, we will incorporate an Effectiveness-Implementation assessment into the RCT to identify patient- provider- and system-level factors that may impact adoption, implementation and maintenance of the types of interventions tested. Findings from the effectiveness/implementation should help design future trials of implementation strategies identified herein to promote dissemination of dCBTI and SMT interventions into primary care should these treatments prove effective in the current trial. We also will gather exploratory data to determine who responds best to dCBTI/SMT. This study will provide new and useful information about the feasibility, clinical utility, and patient-, provider-, and system-level acceptability of these interventions to manage insomnia and reduce/eliminate hypnotic use in primary care. This project should serve as a necessary first step toward the eventual dissemination of accessible, cost-effective strategies to manage a significant public health problem and improve the quality of life of millions of chronic users of controlled-substance sleep aids.

项目概要/摘要 寻求治疗的失眠患者最常出现在初级保健机构，他们的第一个也是通常唯一的 治疗方法是处方催眠药物。超过 65% 的服用安眠药的人将其用于 超过一年，超过 30% 的人坚持使用五年以上。此类试剂可能适用于 急性失眠和某些慢性睡眠困难的病例，但长期使用催眠药可能会导致 依赖性和发病率增加（例如跌倒、认知/驾驶障碍）。减少或停止 长期使用催眠药对处方医生和使用者来说都是一项具有挑战性的任务 他们。尽管基于证据的医生监督药物逐渐减量 (SMT) 方案已表明 但此类干预措施尚未在初级保健中广泛传播。大多数初级保健提供者 （PCP）愿意将失眠患者转介给其他基于证据的非药物治疗，例如 认知行为失眠疗法（CBTI），但这种治疗通常很难在专业之外获得 睡眠中心。鉴于研究和临床实践之间的差距，迫切需要开发和 验证具有成本效益的干预措施，以促进初级儿童失眠和催眠逐渐减少的管理 关心。为了响应 PAR-20-183，此应用程序经过精心设计来解决这些问题。我们 将进行一项大型随机试验，以比较数字 CBT (dCBTI)/SMT 联合干预与 单独进行 SMT 干预可实现催眠停止和失眠症状改善。 在一项基于实践的研究中，从 8-10 个初级保健诊所抽取了 430 名依赖催眠的患者作为样本 科罗拉多州奥罗拉市科罗拉多大学医学院附属网络将作为研究 参与者。该项目的主要目标是比较 dCBTI+SMT 与所使用的 SMT 的性能 单独用于实现催眠减少/终止和失眠症状改善。此外，我们 将在 RCT 中纳入有效性实施评估，以确定患者、提供者和 可能影响干预措施类型的采用、实施和维护的系统级因素 已测试。有效性/实施的结果应有助于设计未来的实施试验 本文确定的促进将 dCBTI 和 SMT 干预措施传播到初级保健的策略应 这些治疗方法在当前的试验中证明是有效的。我们还将收集探索性数据以确定谁 对 DCBTI/SMT 反应最佳。这项研究将提供有关可行性、临床效果的新的有用信息 这些干预措施在管理失眠和失眠方面的效用以及患者、提供者和系统层面的可接受性 减少/消除初级保健中安眠药的使用。该项目应作为迈向 最终传播可利用的、具有成本效益的战略来管理重大公共卫生问题， 改善数百万长期使用管制药物助眠剂的人的生活质量。