Use of blinded tapering for hypnotic discontinuation

项目摘要/摘要 寻求治疗的失眠症患者最常出现在初级保健场所，在那里第一次也通常只有 治疗是对镇静催眠药的处方，通常是苯二氮卓类(BZD)或较新的苯二氮卓类 受体激动剂(BzRA)。对一些患者来说，短期或间歇性使用催眠药可以产生令人满意的失眠。 如释重负。然而，超过65%的被处方催眠药的个人使用时间超过一年，并且 &gt；30%的人将在这些代理上留任五年以上。而一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，但持续长期使用这些药物可能不会 代表最佳治疗方法。许多失眠患者参与非药物失眠治疗，如 认知行为失眠疗法(CBT-I)在有时间限制的很长一段时间内实现持续的失眠缓解 疗程。然而，对于大多数长期使用催眠药的人来说，很难从药物使用中转换过来 一种自我管理的方法。将CBT-I与监督药物缩减(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%接受这种治疗的患者 援助要么无法停止他们的催眠，要么回到他们身边，即使他们确实实现了短期的 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、低睡眠自我效能感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 可以通过使用盲目SMT方案来缓解，这种方案似乎增加了用药禁欲率。 目前的项目将使用2x4随机纵向临床试验设计来测试我们的 与VIS开放标签锥化相比，当与治疗师提供的治疗相结合时，非常有希望的盲目逐渐减少方案 CBT-I。将登记260个样本，完成干预前基线测量，然后随机 分配给：(1)盲目催眠SMT+治疗师提供CBT-I；或(2)开放标签逐渐减少+CBT-I；在.期间 治疗所有参与者将首先接受一对一的治疗课程，由训练有素的CBT-I治疗师在6 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，向他们提供盲法或开放标记法逐渐变细的SMT方案。在这一阶段，他们将拥有 他们的催眠药物剂量每两周减少25%。在完成SMT后立即和 同样，在3个月和6个月的随访中，他们将完成研究结果测量。初步研究结果将会是 观察两组催眠停药率。次要结果包括夜间催眠 每周使用安眠药，每晚平均安眠药用量，以及睡眠评分 质量、日间疲劳感和生活质量。这项研究将导致对缩减方法和 提供对治疗结果预测因素的更好理解，从而提供更成功、更人性化的 以干预为中心。

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.