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: 10160732
• 负责人: Constance Fung
• 金额: $ 46.41万
• 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/10160732
• 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; feasibility testing; 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.

项目摘要 使用安眠药，如苯二氮卓类和苯二氮卓类受体激动剂，与不良反应有关 老年人的健康结果。对催眠停药计划的应答率通常是不够的， 许多患者最终恢复使用催眠药，这表明需要针对其他机制 以实现并维持较高的不使用率。目前的方案侧重于逐渐减少催眠药和/或 治疗失眠症状。这些计划采用了诸如监督逐步缩减等战略， 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 并维持较高的停用率。认知预期在生产安慰剂中起着关键作用 效果，其特征是由于治疗的心理社会方面而引起的睡眠实际改善 而不仅仅是药物效应。这项研究的长期目标是改善老年人的健康 使用催眠药和失眠。该项目的目标是确定一项名为 蒙面缩减加认知行为治疗-增强计划(MTCAP)，它结合了新的 认知练习和戴面具逐渐减少(如下所述)，与无面具监督逐步减少相比较 锥体加认知行为疗法治疗失眠(SGT+CBTI)，降低催眠药的预期， 提高催眠药的停用率，改善失眠症状。中心假设是 产生安慰剂效果的认知预期是可以改变的，而且催眠停药和 当催眠药的认知期望值降低时，失眠的严重程度会得到改善。这一假设已经 是根据我们广泛的初步数据制定的，其中包括“掩饰”缩减的结果 干预旨在改变产生安慰剂效果的认知预期。掩码通过以下方式实现 封装催眠药，以便同意逐渐减少的参与者不会意识到实际的 在每个胶囊中给药，直到锥化结束，当参与者了解到锥化时间表时。这个 治疗师使用掩饰作为一种工具来挑战关于催眠药可能导致慢性疾病的预期 使用和加强针对催眠戒断的认知行为疗法(例如，准备戒断)。 在一项为期5年的随机试验中，将通过追求三个具体目标来检验中心假设 从2个站点招募的188名参与者中：确定MTCap是否提高了1)预期 催眠药多于SGT+CBTI，2)催眠停药多于SGT+CBTI，以及3)失眠严重 随访时超过SGT+CBTI。这一创新方法针对的是一种以前未解决的机制- 安慰剂效应--这可能会导致长期使用催眠药。这项非常有意义的研究将会改进 了解与催眠相关的安慰剂效应，并最终改进停用催眠药物和 其他可能不适当的药物。