The Role of Tapering Pace and Selected Traits on Hypnotic Discontinuation

 描述（由申请人提供）：寻求治疗的失眠患者最常出现在初级保健场所，其中第一种且通常唯一的治疗是镇静催眠药处方，通常是苯二氮卓类（BZD）或新型苯二氮卓类受体激动剂（BzRA）。对于某些患者，短期或间歇性使用可提供令人满意的失眠缓解。然而，超过65%的处方催眠药使用超过一年，超过30%的人使用这些药物超过五年。虽然有些患者可能会欣赏部分或完全缓解失眠症状与持续使用催眠药，连续长期使用这些药物可能并不代表最佳治疗。参与非药物失眠治疗（如认知行为失眠治疗（CBT-I））的相当大比例的失眠患者在有限时间的治疗过程后很长时间内实现了持续的失眠缓解。然而，对于大多数长期使用催眠药物的人来说，从使用药物转换到自我管理的方法是困难的。将联合收割机CBT-I与监督药物减量（SMT）相结合的干预措施显示出实现这一结果的最大希望，但几乎50%接受这种援助的患者要么未能停止使用催眠药，要么即使他们确实实现了短期禁欲，也会重新使用催眠药。以前的研究只提供了一个初步的了解，如何帮助长期催眠用户停止他们的睡眠援助，并成功地管理他们的失眠与CBT-I技术。现有研究的局限性包括未能考虑：（1）催眠戒断的速度如何影响结果;（2）患者特征，如对睡眠药物需求的信念，以及焦虑敏感性中度结果;（3）催眠戒断症状和睡眠质量的变化介导结果。该R34项目将收集关键的试点数据来解决这些限制。具体而言，本项目将比较目前推荐的逐渐减量（每两周减少25%剂量）与较慢的逐渐减量（每两周减少10%剂量）和无逐渐减量条件，以确定逐渐减量对结局的影响。该研究还将检查参与者对催眠药需求的信念，焦虑敏感性，以及催眠剂量，半衰期和时间作为结果的调节因素。催眠戒断症状和戒断期间睡眠障碍水平的影响，我们被测试作为中介的结果。入组者（N=75）将首先完成CBT-I，然后随机分配至逐渐递减起搏（每个SMT起搏n=25）。将对目标调节者和中介者进行检查，以评估其对结果的影响。主要结局将包括每个SMT起搏观察到的脱落率和催眠药停用率。我们将统计在SMT期间达到催眠药物剂量减少的患者的比率和在3个月随访时恢复使用催眠药物的患者的比率作为次要终点。结果将为未来的R 01级临床试验提供信息，该试验重点关注逐渐减少的起搏、缓和逐渐减少的起搏效果的患者特征以及介导逐渐减少的起搏效果的心理生理过程。这一系列的研究将通过帮助完善逐渐减量的指导方针来指导临床实践，从而提供更成功的、以人为本的干预措施。

 DESCRIPTION (provided by applicant): 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 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. A sizable proportion of 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. Previous research provides only a rudimentary understanding of how to help long-term hypnotic users discontinue their sleep aids and successfully manage their insomnia with CBT-I techniques. Limitations of existing research include failure to consider how: (1) the pace of hypnotic withdrawal influences outcomes; (2) patient characteristics such as belief in the need for sleep medications, and anxiety sensitivity moderate outcomes; and (3) hypnotic withdrawal symptoms and changes in sleep quality mediate outcomes. This R34 project will gather key pilot data to address these limitations. Specifically, this project will compare the currently recommended tapering pace (25% dose reduction every two weeks) to a slower tapering pace (10% dose reduction every two weeks) and a no tapering condition to determine the influence of tapering pace on outcomes. The study also will examine participants' beliefs about their need for hypnotics, anxiety sensitivity, and hypnotic dose, half-life and time used as moderators of outcomes. The influence of hypnotic withdrawal symptoms and level of sleep disturbance during withdrawal we be tested as mediators of outcomes. Enrollees (N=75) will first complete CBT-I and then will be randomized to a tapering pace (n=25 per SMT pace). Target moderators and mediators will be examined to assess their influence on outcomes. Primary outcomes will include drop-out rates and hypnotic discontinuation rates observed for each SMT pace. We will tally rates of those who achieve hypnotic dose reductions during SMT and those who return to hypnotic use by a 3-month follow-up as secondary endpoints. Results will inform a future R01-level clinical trial focusing on tapering pace, patient characteristics that moderate the effect of tapering pace, and psychophysiological processes that mediate the effect of tapering pace. This line of research will inform clinical practice by helping to refine guidelines for tapering pace so as to provide more successful, person-centered interventions.