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: 10406305
• 负责人: Constance Fung
• 金额: $ 49.94万
• 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 2024-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10406305
• 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 使用催眠药如苯二氮卓类和苯二氮卓类受体激动剂与不良反应相关。 老年人的健康状况。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催眠药，这表明需要针对其他机制 以实现和维持高的不使用率。目前的项目集中在催眠药的逐渐减少和/或 治疗失眠症状。这些计划采用的策略，如监督逐步减少， 针对催眠戒断的认知行为疗法和/或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 并保持较高的停药率。认知预期在产生安慰剂中起着关键作用 效果，其特征为治疗的心理社会方面引起的睡眠真实的改善 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， 使用催眠药和失眠。该项目的目标是确定是否有一个新的方案，题为 Masked Taper加上认知行为治疗增强计划（MTcap），结合了新颖的 认知练习和掩蔽渐减（如下所述），与未掩蔽的监督渐进相比， 减量加认知行为疗法治疗失眠（SGT+CBTI），减少对催眠药的期望， 提高催眠药的停药率，改善失眠症状。核心假设是， 产生安慰剂效应的认知预期是可以改变的， 当对催眠药认知预期降低时，失眠的严重程度会改善。这一假设 根据我们广泛的初步数据制定，其中包括“掩蔽”锥形的结果 干预旨在改变认知预期，产生安慰剂效应。掩蔽通过以下方式实现： 封装催眠药，使参与者，谁同意逐步减量，是不知道的实际 剂量在每个胶囊中，直到逐渐减量结束，当逐渐减量时间表向受试者透露时。的 治疗师使用掩蔽作为一种工具来挑战对催眠药的期望，这可能有助于慢性 使用和增强以催眠戒断为目标的认知行为疗法（例如，准备撤退）。 中心假设将在一项为期5年的随机试验中通过追求三个特定目标进行检验， 在从2个研究中心招募的188名参与者中：确定MTcap是否改善了1）关于 催眠药多于SGT+CBTI，2）催眠停药多于SGT+CBTI，3）失眠严重程度 随访时SGT+CBTI。这一创新方法针对的是一种以前未涉及的机制- 安慰剂效应-这可能导致长期使用催眠药。这项意义重大的研究将改善 了解催眠相关的安慰剂效应，并最终改善停用催眠药的努力， 其他可能不适当的药物。