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.

项目摘要/摘要 寻求治疗的失眠症患者最常在初级保健中出现 治疗是处方催眠药。超过65％的处方催眠药将其用于 超过一年的时间，超过30％的人保留了五年多。这样的代理可能对 急性失眠和某些患有慢性睡眠困难的病例，但长时间的催眠使用可能导致 依赖性和发病率提高（例如，跌倒，认知/驾驶障碍）。减少或中断 对于开处方医生和使用的患者而言，长期使用后的催眠药是一项具有挑战性的任务 他们。尽管基于证据的医师监督药物逐渐减少（SMT）方案已显示 功效，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）愿意将其失眠症患者推荐给替代性循证非药物治疗，例如 认知行为失眠治疗（CBTI），但是这种治疗通常很难在专业之外获得 睡眠中心。鉴于研究与临床实践之间的差距，需要发展和 验证具有成本效益的干预措施，以促进主要的失眠和催眠锥 关心。为了响应Par-20-183，该应用程序经过精心设计以解决这些问题。我们 将进行大型随机试验，以比较合并的数字CBT（DCBTI）/SMT干预措施 单独提供的SMT干预措施可用于产生催眠终止和失眠症状的改善。 在基于实践的研究中，从8-10个初级保健诊所得出的430名催眠型患者样本 科罗拉多州奥罗拉科罗拉多大学科罗拉多大学医学院的网络将作为研究 参与者。该项目的主要目的是将DCBTI+SMT的性能与使用的SMT进行比较 单独实现催眠减少/停药和失眠症状的改善。另外，我们 将在RCT中纳入有效性实施评估，以识别患者 - 提供者和 可能影响采用，实施和维护干预类型的系统级因素 测试。有效性/实施的发现应有助于设计未来的实施试验 本文确定的策略以促进将DCBTI和SMT干预措施传播到初级保健中 这些治疗在当前试验中证明有效。我们还将收集探索性数据以确定谁 对DCBTI/SMT的反应最佳。这项研究将提供有关可行性，临床的新有用信息 这些干预措施管理失眠和 减少/消除初级保健中的催眠疗法。该项目应作为迈向的必要第一步 最终传播可访问的，具有成本效益的策略，以管理重大的公共卫生问题和 改善受控替代睡眠辅助工具的数百万长期使用者的生活质量。