A novel mechanism for helping older adults discontinue use of sleeping pills

帮助老年人停止使用安眠药的新机制

• 批准号: 9927969
• 负责人: Constance Fung
• 金额: $ 46.52万
• 依托单位: UNIVERSITY OF CALIFORNIA LOS ANGELES
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-15 至 2023-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9927969
• 关键词: Affect; Aftercare; Agonist; Attenuated; Attitude; Belief; Benzodiazepine Receptor; Chronic; Clinical; Cognition; Cognitive; Cognitive Therapy; Combined Modality Therapy; Consent; Coupled; Data; Disease; Dose; Elderly; Encapsulated; Exercise; Exercise Therapy; Expectancy; Geriatrics; Goals; Health; Intervention; Knowledge; Life; Masks; Measures; Mission; National Institute on Aging; Outcome; Outpatients; Participant; Patient Recruitments; Patients; Pharmaceutical Preparations; Pharmacy facility; Physical Performance; Placebo Effect; Placebos; Play; Positioning Attribute; Psychiatry; Psychology; Public Health; Relaxation; Research; Research Personnel; Role; Schedule; Severities; Site; Sleep; Sleeplessness; Stimulus; Supervision; Symptoms; Testing; United States; Visit; Withdrawal; Work; capsule; disorder later incidence prevention; fall risk; follow-up; hypnotic; improved; indexing; innovation; novel; programs; psychosocial; public health relevance; randomized trial; response; safe patient; skills; sleeping pill; targeted treatment; tool

Project Summary Use of hypnotics such as benzodiazepines and benzodiazepine receptor agonists is associated with adverse health outcomes in older adults. Response rates to hypnotic discontinuation programs are often inadequate, and many patients eventually resume use of hypnotics, suggesting that other mechanisms need to be targeted to achieve and sustain high rates of non-use. Current programs focus on the tapering of hypnotics and/or the treatment of insomnia symptoms. These programs employ strategies such as supervised gradual taper, cognitive behavioral therapy targeting hypnotic withdrawal, and/or cognitive behavioral therapy for insomnia. Evidence suggests that another mechanism involving “placebo” effects may be a viable target for achieving and sustaining higher discontinuation rates. Cognitive expectancies play a key role in producing placebo effects, which are characterized as real improvements in sleep arising from psychosocial aspects of treatment rather than drug effects alone. The long-term goal of this research is to improve the health of older adults who use hypnotics and have insomnia. This project's objectives are to determine whether a new program, entitled Masked Taper plus cognitive behavioral therapy-augmented program (MTcap), which combines novel cognitive exercises and masked tapering (described below), compared to an unmasked supervised gradual taper plus cognitive behavioral therapy for insomnia (SGT+CBTI), reduces expectancies for hypnotics, improves hypnotic discontinuation rates, and improves insomnia symptoms. The central hypothesis is that cognitive expectancies that produce placebo effects are modifiable and that hypnotic discontinuation and insomnia severity improve when cognitive expectancies for hypnotics are diminished. This hypothesis has been formulated on our extensive preliminary data, which includes results from a “masked” tapering intervention aimed at altering cognitive expectancies that produce placebo effects. Masking is achieved by encapsulating hypnotics so the participant, who has consented to a gradual taper, is unaware of the actual dose in each capsule until the end of the taper, when the tapering schedule is revealed to the participant. The therapist uses masking as a tool to challenge expectancies about hypnotics that may be contributing to chronic use and to augment cognitive behavioral therapy targeting hypnotic withdrawal (e.g., preparing for withdrawal). The central hypothesis will be tested by pursing three specific aims in a 5-year randomized trial conducted among 188 participants recruited from 2 sites: Determine whether MTcap improves 1) expectancies about hypnotics more than SGT+CBTI, 2) hypnotic discontinuation more than SGT+CBTI, and 3) insomnia severity more than SGT+CBTI at follow-up. This innovative approach targets a previously unaddressed mechanism— the placebo effect—that may contribute to chronic hypnotic use. This highly significant research will improve understanding of hypnotic-related placebo effects and ultimately, improve efforts to discontinue hypnotics and other potentially inappropriate medications.

项目概要 使用苯二氮卓类药物和苯二氮卓受体激动剂等安眠药与不良反应有关。 老年人的健康结果。对催眠停药计划的反应率往往不足， 许多患者最终恢复使用安眠药，这表明需要针对其他机制 实现并维持高不使用率。目前的计划重点是逐渐减少催眠药和/或 治疗失眠症状。这些计划采用了监督逐步减量等策略， 针对催眠戒断的认知行为疗法和/或针对失眠的认知行为疗法。 有证据表明，另一种涉及“安慰剂”效应的机制可能是实现这一目标的可行目标 并维持较高的停药率。认知预期在安慰剂的产生中发挥着关键作用 效果，其特征是治疗的心理社会方面带来的睡眠的真正改善 而不仅仅是药物作用。这项研究的长期目标是改善老年人的健康 使用安眠药并失眠。该项目的目标是确定一个新计划是否名为 Masked Taper 加上认知行为治疗增强计划 (MTcap)，结合了新颖的 认知练习和掩蔽逐渐减量（如下所述），与非掩蔽监督渐进训练相比 逐渐减少失眠认知行为疗法（SGT+CBTI），降低对催眠药的期望， 提高催眠中断率，改善失眠症状。中心假设是 产生安慰剂效应的认知预期是可以改变的，并且催眠终止和 当对催眠药的认知预期降低时，失眠的严重程度就会改善。这个假设有 是根据我们广泛的初步数据制定的，其中包括“掩盖”逐渐减少的结果 旨在改变产生安慰剂效应的认知预期的干预措施。掩蔽是通过以下方式实现的 封装催眠药，以便同意逐渐减量的参与者不知道实际的情况 每个胶囊中的剂量直至减量结束，此时减量时间表会向参与者透露。这 治疗师使用掩蔽作为一种工具来挑战对可能导致慢性催眠药的期望 使用并增强针对催眠戒断的认知行为疗法（例如，准备戒断）。 中心假设将通过在为期 5 年的随机试验中追求三个具体目标来检验 在从 2 个地点招募的 188 名参与者中：确定 MTcap 是否改善了 1) 的预期 催眠药使用次数多于 SGT+CBTI，2) 催眠停药次数多于 SGT+CBTI，以及 3) 失眠严重程度 随访时超过SGT+CBTI。这种创新方法针对的是一个以前未解决的机制—— 安慰剂效应——可能会导致长期使用催眠药。这项非常重要的研究将改善 了解催眠相关的安慰剂效应，并最终改进停止催眠药物的努力 其他可能不合适的药物。