Use of blinded tapering for hypnotic discontinuation

使用盲法逐渐减量来停止催眠

• 批准号: 10609458
• 负责人: JACK D EDINGER
• 金额: $ 36.6万
• 依托单位: NATIONAL JEWISH HEALTH
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-07-01 至 2025-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10609458
• 关键词: Abstinence; Acute; Adult; Aftercare; Agonist; Anxiety; Behavioral; Belief; Benzodiazepine Receptor; Benzodiazepines; Binding; Blinded; Chronic; Clinical; Clinical Trials Design; Cognitive; Data; Dependence; Diazepam; Dimensions; Disease remission; Dose; Drug Addiction; Elderly; Enrollment; Equipment and supply inventories; Face; Fatigue; Guidelines; Individual; Intervention; Measures; Mediator; Medicine; Methods; Morbidity - disease rate; Observational Study; Outcome; Outcome Measure; Outcome Study; Patients; Performance; Pharmaceutical Preparations; Pharmacotherapy; Phase; Physicians; Population; Primary Care; Protocols documentation; Psychological Factors; Quality of life; Randomized; Research; Risk; SF-36; Sampling; Self Efficacy; Self Management; Severities; Sleep; Sleeplessness; Symptoms; Testing; Time; Treatment outcome; Withdrawal; blind; cognitive training; cost; cost effective; demographics; design; dosage; experience; follow-up; hypnotic; improved; indexing; non-drug; nondrug therapy; open label; optimal treatments; outcome prediction; person centered; randomized, clinical trials; secondary analysis; secondary outcome; sedative; sleep quality; treatment group

PROJECT SUMMARY/ABSTRACT Treatment-seeking insomnia sufferers most often present in primary care venues where the first and usually only treatment is a prescription for a sedative hypnotic, typically a benzodiazepine (BZD) or newer benzodiazepine receptor agonist (BzRA). For some patients, short-term or intermittent hypnotic use provides satisfactory insomnia relief. However, more than 65% of individuals who are prescribed hypnotics use them for more than a year, and > 30% remain on these agents for more than five years. Whereas some patients may appreciate partial or full relief of insomnia symptoms with ongoing hypnotic use, continuous long-term use of these agents may not represent optimal therapy. Many insomnia patients who participate in non-drug insomnia therapy such as cognitive behavioral insomnia therapy (CBT-I) achieve sustained insomnia remission long after a time-limited course of treatment. However, it is difficult for most long-term hypnotic users to convert from use of medications to a self-management approach. Interventions that combine CBT-I with supervised medication tapering (SMT) have shown the greatest promise for achieving this outcome, but almost 50% of patients who receive this assistance either fail to discontinue their hypnotics or return to them even if they do achieve short-term abstinence. Our clinical and research observations suggest that psychological factors including sleep-related performance anxiety, low sleep-related self-efficacy and beliefs about needs for medications interact to lead to difficulties abstaining from hypnotic use. Moreover, our highly promising pilot data suggest that such factors may be mitigated by use of a blinded SMT protocol which appears to increase rates of medication abstinence. The current project will use a 2 x 4 randomized longitudinal clinical trial design to test the relative efficacy of our highly promising blinded tapering protocol, vis a vis open-label tapering, when combined with therapist delivered CBT-I. A sample of 260 will be enrolled, complete pre-intervention baseline measures and then be randomly assigned to: (1) a blinded hypnotic SMT + therapist delivered CBT-I; or (2) open-label tapering + CBT-I. During treatment all enrollees will first receive one on one treatment sessions with a trained CBT-I therapist over a 6 week period while maintaining baseline doses of their respective hypnotics. They then will begin a 10 week SMT during which they are provided a blinded or open-label tapering SMT protocol. During this phase they will have their hypnotic medication doses reduced by 25% every two weeks. Immediately after completing the SMT and again at 3- and 6-month follow-ups they will complete study outcome measures. The primary study outcome will be hypnotic discontinuance rates of the two treatment groups. Secondary outcomes include nights of hypnotic use per week, nightly average dosage of hypnotic used in diazepam equivalents as well as scores on sleep quality, daytime fatigue and quality of life. This study will lead to refining guidelines for tapering methods and providing a better understanding of treatment outcome predictors so as to provide more successful, person- centered interventions.

项目总结/摘要 寻求治疗的失眠症患者最常出现在初级保健场所， 治疗是镇静催眠药的处方，通常是苯二氮卓类（BZD）或更新的苯二氮卓类 受体激动剂（BzRA）。对某些病人来说，短期或间歇性使用催眠药可提供满意的失眠效果 救灾然而，超过65%的处方催眠药使用者使用时间超过一年， 超过30%的人使用这些药物超过五年。而有些病人可能会欣赏部分或全部 持续使用催眠药可以缓解失眠症状，但持续长期使用这些药物可能不会 代表最佳疗法许多参与非药物失眠治疗的失眠患者， 认知行为失眠疗法（CBT-I）在经过一段时间的限制后， 疗程然而，对于大多数长期使用催眠药的人来说， 自我管理的方法。将联合收割机CBT-I与监督药物减量（SMT）相结合的干预措施 已经显示出实现这一结果的最大希望，但几乎50%的接受这种治疗的患者 援助要么未能停止他们的催眠药或返回他们，即使他们实现短期 禁欲我们的临床和研究观察表明，包括睡眠相关的心理因素 表现焦虑，低睡眠相关的自我效能感和对药物需求的信念相互作用，导致 避免使用催眠药的困难。此外，我们非常有希望的试点数据表明，这些因素 可通过使用盲态SMT方案来缓解，该方案似乎可增加药物戒断率。 目前的项目将使用2x 4随机纵向临床试验设计来测试我们的相对疗效。 与开放标签逐渐减量相比，当与治疗师联合使用时， CBT-I将招募260名样本，完成干预前基线测量，然后随机 分配给：（1）盲法催眠SMT +治疗师给予CBT-I;或（2）开放标签减量+ CBT-I。期间 治疗所有参加者将首先接受一对一的治疗会议与训练有素的CBT-I治疗师超过6 周期间，同时维持各自催眠药的基线剂量。然后，他们将开始为期10周的SMT 在此期间，向他们提供盲法或开放标签逐渐减少SMT方案。在这个阶段，他们将拥有 催眠药物剂量每两周减少25%。完成SMT后， 再次在3个月和6个月随访时，他们将完成研究结果测量。主要研究结果将 两个治疗组的催眠药停药率。次要结果包括催眠药物的夜晚 每周使用，每晚平均使用的催眠药剂量（相当于地西泮）以及睡眠评分 质量、日间疲劳和生活质量。这项研究将导致细化准则，逐渐减少的方法， 更好地了解治疗结果预测因素，以便提供更成功的，个人- 集中干预。