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 催眠药（例如苯二氮卓类药物和苯二氮卓受体激动剂）的使用与对手有关 老年人的健康结果。对催眠停止计划的回应率通常不足， 许多患者最终恢复使用催眠药，这表明需要针对其他机制 实现和维持高的不使用率。当前的计划着重于催眠药和/或 治疗失眠症状。这些计划采用策略，例如监督级锥度， 靶向催眠戒断的认知行为疗法和/或失眠的认知行为疗法。 证据表明，涉及“安慰剂”效应的另一种机制可能是实现的可行目标 并维持较高的中断率。认知期望在产生安慰剂方面起着关键作用 效果是由治疗的社会心理方面引起的睡眠的真正改善的特征 而不是仅凭药物影响。这项研究的长期目标是改善老年人的健康 使用催眠药并患有失眠。该项目的目标是确定一个新程序是否有资格 结合新型的蒙面锥度加认知行为疗法调查计划（MTCAP） 与未面积的监督等级相比 磁带加上失眠的认知行为疗法（Sgt+CBTI），减少了对催眠药的期望， 提高催眠停药率，并改善失眠符号。中心假设是 产生安慰剂效应的认知期望是可修改的，催眠的停用和 当认知期望减少时，失眠的严重程度会提高。这个假设有 是根据我们广泛的初步数据制定的，其中包括“蒙版”锥度的结果 干预旨在改变产生安慰剂影响的认知期望。掩蔽是通过 封装催眠药，因此同意逐渐锥的参与者不知道实际 在每个胶囊的结尾处，逐渐变细的时间表向参与者揭示。这 治疗师使用蒙版作为一种工具来挑战有关催眠药的预期，这可能有助于慢性 使用并增加靶向催眠戒断的认知行为疗法（例如，准备戒断）。 中心假设将通过在进行的5年随机试验中追求三个特定目标来检验 在从两个站点招募的188名参与者中，确定MTCAP是否有所改善1）对 催眠药比中士+CBTI，2）催眠停药比中士+CBTI多，3）失眠严重程度 随访中的SGT+CBTI多。这种创新的方法针对以前未解决的机制 - 安慰剂效应 - 可能有助于慢性催眠。这项非常重要的研究将改善 了解与催眠相关的安慰剂作用，并最终改善暂停催眠和的努力 其他潜在的不当药物。