The Efficacy of Masked Tapering on Discontinuation of Hypnotics in Older Veterans

蒙面减量对老年退伍军人停止催眠药的疗效

• 批准号: 9495636
• 负责人: Constance Fung
• 金额: --
• 依托单位: VA GREATER LOS ANGELES HEALTHCARE SYSTEM
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-01 至 2021-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9495636
• 关键词: Address; Affect; Aftercare; Agonist; Alcohols; Ambulatory Care Facilities; Appointment; Attenuated; Attitude; Belief; Benzodiazepine Receptor; Benzodiazepines; Chronic; Chronic Insomnia; Clinical; Cognition; Cognitive; Cognitive Therapy; Combined Modality Therapy; Consent; Coupled; Dose; Elderly; Encapsulated; Equilibrium; Exercise; Exercise Therapy; Expectancy; Goals; Guidelines; Health; Health Personnel; Healthcare; High Prevalence; Hip Fractures; Intervention; Lead; Letters; Masks; Measures; Medical Records; Mental Health; Methods; Monitor; Outcome; Participant; Patients; Persons; Pharmaceutical Preparations; Pharmacotherapy; Pharmacy facility; Placebo Effect; Placebos; Population; Process; Quality of life; Randomized; Randomized Clinical Trials; Relaxation; Risk; Schedule; Severities; Site; Sleep; Sleeplessness; Stimulus; Supervision; Symptoms; Telephone; Testing; Veterans; Withdrawal; arm; base; capsule; database query; design; diaries; disorder later incidence prevention; eligible participant; expectation; fall risk; follow-up; hypnotic; improved; indexing; innovation; novel; programs; psychosocial; randomized trial; recruit; safe patient; screening; skills; sleep quality; targeted treatment; tool

Hypnotics such as benzodiazepines and benzodiazepine receptor agonists are often prescribed for insomnia. Among Veterans attending outpatient clinics, approximately one-quarter use hypnotics (or bedtime alcohol). Hypnotics use is associated with an increased risk of falls and worse cognition in older adults. Discontinuing hypnotics often attenuates or reverses these negative effects, and the Department of Veterans Affairs (VA) has initiatives to reduce hypnotic use among older adults. Current discontinuation strategies focus on tapering off the hypnotic and/or treating insomnia symptoms. Common strategies include supervised gradual taper (SGT), cognitive behavioral therapy targeting hypnotic withdrawal (CBT-HW), cognitive behavioral therapy for insomnia (CBTI), and combination therapy (SGT+CBTI). Yet up to 40% of patients eventually resume use of hypnotics with these strategies, suggesting that other mechanisms need to be targeted to achieve and sustain high rates of non-use. Another mechanism that may be a viable target for achieving hypnotic discontinuation and sustaining long- term non-use is the placebo effect, which is characterized by real improvements in sleep arising from psychosocial aspects of treatment rather than drug effects alone. We recently developed and tested the feasibility of an intervention that targets the placebo effect. Our intervention retains core components tested in prior studies for achieving hypnotic discontinuation (i.e., SGT+CBTI), but adds a novel feature—“masked” tapering. Masking is achieved by encapsulating hypnotics (prepared by a compounding pharmacy) so the patient, 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 patient. Towards the end of the taper, placebo capsules are used. Through novel cognitive exercises, the therapist uses masking as a tool to challenge expectancies about hypnotics, which may be contributing to chronic use, and to augment CBT-HW (e.g., preparing for withdrawal). Coupled with CBTI (i.e., stimulus control, sleep restriction, cognitive therapy for insomnia, and relaxation), the intervention targets the placebo effect and the factors contributing to insomnia symptoms and helps patients safely taper off their hypnotic. Objectives: 1) To assess the efficacy of Masked Taper plus cognitive behavioral therapy-augmented program (MTcap) on hypnotic discontinuation among older Veterans, 2) to determine the impact of the MTcap intervention on insomnia severity, 3) to assess the impact of the MTcap intervention on participants' beliefs and expectancies for using hypnotics to improve sleep quality and daytime function, and 4) to assess the efficacy of MTcap on balance and cognition. To achieve these objectives, we propose to conduct a randomized clinical trial in older Veterans recruited from a single VA site. Veterans will undergo a 3-step screening process (letter with opt-out card, telephone screen, and in-person screen). Eligible participants (N = 132) will be randomized to 8 weeks of MTcap arm or SGT+CBTI. The MTcap arm will include gradual withdrawal plus CBTI & CBT-HW augmented with masking/placebo pharmacotherapy and novel CBT exercises addressing expectancies for hypnotics. The SGT+CBTI arm will use conventional medication packaging (bottle). Key outcomes will include hypnotic discontinuation and use (measured objectively through lab testing and medical record review/state prescription monitoring database query, and subjectively through sleep diary), insomnia severity, beliefs and expectations about hypnotics, balance, and cognition. Using quantitative methods, we will measure the effect of the MTcap intervention on hypnotic use, insomnia severity, beliefs/expectations for using hypnotics, balance, and cognition. This hypnotic discontinuation program could be an important tool to help older Veterans who want to discontinue hypnotics to achieve this goal.

催眠药，如苯二氮卓类和苯二氮卓受体激动剂，通常用于 失眠在参加门诊的退伍军人中，大约四分之一的人使用催眠药（或睡前服用）。 酒精）。催眠药的使用与老年人跌倒的风险增加和认知能力下降有关。福尔斯。 停用催眠药通常会减弱或逆转这些负面影响，退伍军人部 事务部（VA）采取措施减少老年人使用催眠药。当前终止策略的重点 逐渐减少催眠和/或治疗失眠症状。常见的策略包括监督 逐步减量（SGT），以催眠戒断为靶点的认知行为疗法（CBT-HW），认知 失眠行为疗法（CBTI）和联合疗法（SGT+CBTI）。然而，高达40%的患者 最终恢复使用催眠药与这些策略，这表明其他机制需要 目标是实现和维持高的不使用率。 另一种机制可能是一个可行的目标，实现催眠中断和维持长期- 术语“不使用”是安慰剂效应，其特征是睡眠的真实的改善， 心理社会方面的治疗，而不仅仅是药物的影响。我们最近开发并测试了 针对安慰剂效应的干预措施的可行性。我们的干预措施保留了经过测试的核心组件， 先前用于实现催眠药中止的研究（即，SGT+CBTI），但增加了一个新颖的功能--“蒙面” 逐渐变细掩蔽是通过封装催眠药（由复合药房制备）， 已同意逐渐减量的患者，在治疗结束前不知道每粒胶囊的实际剂量。 当逐渐减少的时间表向患者透露时，逐渐减少。逐渐减量结束时，安慰剂 使用胶囊。通过新颖的认知练习，治疗师使用掩蔽作为挑战的工具， 对催眠药的期望，这可能有助于长期使用，并增加CBT-HW（例如， 准备撤退）。再加上CBTI（即，刺激控制，睡眠限制，认知疗法 失眠和放松），干预的目标是安慰剂效应和失眠的因素 帮助患者安全地逐渐减少催眠药。 目的：1）评价Masked Taper加认知行为疗法的疗效 计划（MTcap）在老年退伍军人中停用催眠药，2）确定MTcap的影响 3）评估MTcap干预对参与者信念的影响， 对使用催眠药改善睡眠质量和日间功能的期望，以及4）评估 平衡和认知的MTcap。 为了实现这些目标，我们建议在招募的老年退伍军人中进行随机临床试验 从一个退伍军人管理局的网站。退伍军人将经历3步筛选过程（带选择退出卡的信件，电话 屏幕和个人屏幕）。合格受试者（N = 132）将随机分配至8周MTcap组或 SGT+CBTI。MTcap组将包括逐渐退出加上CBTI和CBT-HW， 掩蔽/安慰剂药物治疗和新的CBT练习解决催眠药的预期。的 SGT+CBTI组将使用传统药物包装（瓶）。关键结果将包括催眠 停药和使用（通过实验室检测和病历审查/状态处方客观测量 监测数据库查询，并通过睡眠日记主观），失眠的严重程度，信念和期望 关于催眠平衡和认知使用定量方法，我们将衡量MTcap的效果 对催眠药使用、失眠严重程度、使用催眠药的信念/期望、平衡和 认知.这种催眠中止计划可能是一个重要的工具，以帮助老年退伍军人谁想要 停止使用催眠药来达到这个目的。