Use of blinded tapering for hypnotic discontinuation

使用盲法逐渐减量来停止催眠

基本信息

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
项目类别：
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

项目摘要

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.

项目概要/摘要寻求治疗的失眠症患者最常出现在初级保健场所，在那里他们是第一个也是通常唯一的治疗是开出镇静催眠药的处方，通常是苯二氮卓类 (BZD) 或更新的苯二氮卓类药物受体激动剂（BzRA）。对于某些患者来说，短期或间歇性催眠可以提供令人满意的失眠效果宽慰。然而，超过 65% 的服用安眠药的人使用时间超过一年，并且 > 30% 的人继续使用这些药物超过五年。而有些患者可能会欣赏部分或全部通过持续使用催眠药来缓解失眠症状，连续长期使用这些药物可能不会代表最佳治疗。许多失眠患者参加非药物失眠治疗，例如认知行为失眠疗法（CBT-I）在限时后很长时间内实现持续的失眠缓解疗程。然而，大多数长期使用催眠药的人很难从药物的使用中转变过来采取自我管理的方法。将 CBT-I 与监督药物逐渐减少 (SMT) 相结合的干预措施已显示出实现这一结果的最大希望，但接受此治疗的患者中几乎有 50% 即使他们确实达到了短期效果，援助要么无法停止他们的催眠药，要么返回他们节制。我们的临床和研究观察表明，包括睡眠相关在内的心理因素表现焦虑、与睡眠相关的低自我效能和对药物需求的信念相互作用，导致戒除催眠药的困难。此外，我们非常有希望的试点数据表明，这些因素可以通过使用盲法 SMT 方案来缓解，该方案似乎会增加药物戒断率。当前的项目将使用 2 x 4 随机纵向临床试验设计来测试我们的相对功效与开放标签减量方案相比，与治疗师结合使用时，非常有前途的盲法减量方案 CBT-I。将招募 260 名样本，完成干预前基线测量，然后随机抽取分配给：（1）由盲法催眠 SMT + 治疗师实施 CBT-I；或 (2) 开放标签逐渐减量 + CBT-I。期间治疗所有参与者将首先接受由训练有素的 CBT-I 治疗师进行的一对一治疗，治疗时间超过 6 年一周期间，同时维持各自安眠药的基线剂量。然后他们将开始为期 10 周的 SMT 在此期间，他们将获得盲法或开放标签逐渐缩小的 SMT 协议。在此阶段他们将有他们的催眠药物剂量每两周减少 25%。完成 SMT 后立即在 3 个月和 6 个月的随访中，他们将再次完成研究结果测量。主要研究结果将是两个治疗组的催眠中断率。次要结果包括夜间催眠每周使用、每晚使用地西泮等量安眠药的平均剂量以及睡眠评分质量、白天疲劳和生活质量。这项研究将导致细化渐缩方法和提供对治疗结果预测因素的更好理解，以便提供更成功、更个人化的治疗集中干预。