The Role of Tapering Pace and Selected Traits on Hypnotic Discontinuation

逐渐减量的速度和选定的特征对催眠中断的作用

• 批准号: 8970476
• 负责人: JACK D EDINGER
• 金额: $ 27.12万
• 依托单位: NATIONAL JEWISH HEALTH
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-08-01 至 2018-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8970476
• 关键词: Abstinence; Address; Adult; Affect; Aftercare; Agonist; Anxiety; Behavioral; Belief; Benzodiazepine Receptor; Benzodiazepines; Characteristics; Chronic; Clinical Trials; Cognitive; Control Groups; Data; Dependence; Development; Disease remission; Dose; Double-Blind Method; Drops; Drug Addiction; Elderly; Face; Failure; Fright; Future; Guidelines; Half-Life; Individual; Intervention; Lead; Mediating; Mediator of activation protein; Medicine; Minor; Morbidity - disease rate; Outcome; Participant; Patients; Perception; Persons; Pharmaceutical Preparations; Pharmacotherapy; Population; Primary Health Care; Process; Protocols documentation; Psychophysiology; Randomized; Relapse; Research; Risk; Role; Self Efficacy; Self Management; Sleep; Sleep disturbances; Sleeplessness; Staging; Symptoms; Techniques; Testing; Time; Treatment outcome; Withdrawal; Withdrawal Symptom; anxiety sensitivity; clinical practice; cost effective; demographics; design; dosage; effective intervention; experience; follow-up; hypnotic; improved; non-drug; nondrug therapy; person centered; primary outcome; public health relevance; response; sedative; success; therapy design; time use; trait; treatment adherence

 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.

 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，其中第一个也是通常唯一的治疗方法是镇静催眠药的处方，通常是苯二氮卓类药物（BZD）或新型苯二氮卓类受体激动剂（BzRA）。对一些患者来说，短期或间歇性使用可以令人满意地缓解失眠，但是，超过 65% 的服用安眠药的人会更多地使用它们。超过一年，并且超过 30% 的患者继续使用这些药物超过五年，除非某些患者可能认为持续使用催眠药可部分或完全缓解失眠症状，但持续长期使用这些药物可能并不代表治疗 A 的最佳效果。相当一部分失眠患者在接受非药物失眠治疗如认知行为失眠治疗（CBT-I）后，在限时疗程后长期获得持续的失眠缓解，但对大多数人来说这是困难的。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，但接受这种治疗的患者中有近 50%。先前的研究仅对如何帮助长期使用催眠药的人停止使用催眠药并成功管理睡眠提供了初步的了解。现有研究的局限性包括未能考虑：（1）催眠撤药的速度如何影响结果；（2）患者特征，例如对睡眠药物的需求和焦虑敏感性对结果的影响； (3) 催眠戒断症状和睡眠质量的变化会影响结果。该 R34 项目将收集关键试点数据来解决这些局限性。具体而言，该项目将比较当前建议的逐渐减量速度（每两周减少 25% 剂量）。逐渐减慢步伐（每两周减少 10% 剂量）和不逐渐减量的条件，以确定减量速度对结果的影响。该研究还将检查参与者对催眠药需求、焦虑敏感性以及催眠剂量、半衰期和时间的信念。催眠戒断症状和戒断期间睡眠障碍水平的影响，我们将作为结果中介进行测试，参与者（N = 75）将首先完成 CBT-I，然后将被随机分配到逐渐减慢的速度。 （每个 SMT 速度 n=25）。我们将检查目标调节者和调解者对结果的影响，包括每个 SMT 速度观察到的退出率和催眠中断率。 SMT 期间的剂量减少以及 3 个月随访后恢复使用催眠药的患者作为次要终点，结果将为未来的 R01 级临床试验提供信息，该试验重点关注逐渐减量的速度、调节效果的患者特征。减配速的影响，以及介导减配速影响的心理生理过程，这一系列研究将通过帮助完善减配速指南来为临床实践提供信息，从而提供更成功、以人为本的干预措施。