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（由适用提供）：寻求治疗的失眠症患者最常出现在初级保健场所中，其中第一个也是唯一的治疗是镇静性催眠的处方，通常是苯并二氮卓（BZD）或较新的苯二氮卓受体受体激动剂（BZRA）。对于某些患者，短期或间歇性用途可减轻失眠。但是，有65％以上的处方催眠药使用它们超过一年，> 30％的人在这些代理商中保留了五年以上。尽管有些患者可能会随着催眠的持续使用而欣赏失眠症状的部分或完全缓解，但这些药物的持续长期使用可能并不代表最佳治疗。参与非药物失眠疗法（例如认知行为失眠症）（CBT-I）的失眠症患者相当相当长的比例很长，在时间限制的治疗过程中很长一段时间就可以持续缓解失眠。但是，大多数长期催眠用户很难从使用药物转换为自我管理方法。将CBT-1与监督药物锥度（SMT）结合使用的干预措施表现出了实现这一结果的最大前景，但是即使获得这种援助的患者中，几乎50％的患者也无法停止其催眠药，或者即使他们确实实现了短期戒酒。先前的研究仅提供了对如何帮助长期催眠使用者停止睡眠帮助并通过CBT-I技术成功管理其失眠的基本理解。现有研究的局限性包括未能考虑：（1）催眠戒断影响的速度； （2）患者特征，例如相信需要睡眠药物的需求和焦虑敏感性适度的结果； （3）催眠戒断症状和睡眠质量媒体结果的变化。该R34项目将收集关键的试点数据以解决这些限制。具体而言，该项目将比较当前推荐的锥形空间（每两周减少25％剂量）与较慢的锥形空间（每两周减少10％剂量），并且没有锥形条件来确定锥形空间对结果的影响。该研究还将检查参与者对催眠术，焦虑敏感性和催眠剂量，半衰期和时间用作结果的主持人的信念。催眠戒断症状和戒断期间睡眠灾难水平的影响，我们被作为结果的介体进行了测试。注册（n = 75）将首先完成CBT-I，然后将其随机化为锥形空间（n = 25 SMT空间）。将检查目标主持人和调解人，以评估其对结果的影响。主要结果将包括每个SMT空间观察到的辍学率和催眠终止率。在SMT期间，那些在SMT期间降低了催眠剂量的人，以及3个月随访作为次要终点的人的最高率。结果将为未来的R01级临床试验提供介绍，该试验的重点是缩小空间，适度锥形空间影响的患者特征以及介导锥形空间效果的心理生理过程。这项研究将通过帮助完善缩小空间的准则来为临床实践提供依据，从而提供更成功的以人为本的干预措施。