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: 10197053
• 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 2023-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10197053
• 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; Process; Quality of life; Randomized; Randomized Clinical Trials; Relaxation; Risk; Schedule; Severities; Site; Sleep; Sleeplessness; Stimulus; Supervision; Symptoms; Telephone; Testing; United States Department of Veterans Affairs; Veterans; Withdrawal; arm; base; capsule; database query; design; diaries; disorder later incidence prevention; eligible participant; expectation; fall risk; feasibility testing; follow-up; hypnotic; improved; indexing; innovation; military veteran; 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.

苯二氮卓类药物和苯二氮卓受体激动剂等安眠药通常用于治疗 失眠。在门诊就诊的退伍军人中，大约四分之一使用安眠药（或睡前服用） 酒精）。使用安眠药与老年人跌倒风险增加和认知能力下降有关。 停用催眠药通常会减轻或逆转这些负面影响，退伍军人部 事务部 (VA) 采取了减少老年人使用安眠药的举措。当前停产策略的重点 逐渐减少催眠和/或治疗失眠症状。常见的策略包括监督 逐渐减量（SGT）、针对催眠戒断的认知行为疗法（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 最终通过这些策略恢复使用催眠药，这表明需要采取其他机制 旨在实现并维持高不使用率。 另一种机制可能是实现催眠停止和维持长期催眠的可行目标。 术语“不使用”是安慰剂效应，其特点是睡眠确实得到改善 治疗的心理社会方面，而不仅仅是药物作用。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 先前研究实现催眠中断（即SGT+CBTI），但增加了一个新功能——“掩蔽” 逐渐变细。掩蔽是通过封装安眠药（由复方药房配制）来实现的，因此 同意逐渐减量的患者直到疗程结束才知道每个胶囊中的实际剂量 当向患者透露逐渐减量计划时，逐渐减量。在逐渐减量结束时，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，这可能会导致长期使用，并增强 CBT-HW（例如， 准备退出）。结合 CBTI（即刺激控制、睡眠限制、认知疗法） 失眠和放松），干预措施针对安慰剂效应和导致失眠的因素 症状并帮助患者安全地逐渐减少催眠药。 目标：1) 评估 Masked Taper 联合认知行为疗法增强的疗效 关于老年退伍军人停止催眠的计划 (MTcap)，2) 确定 MTcap 的影响 对失眠严重程度的干预，3) 评估 MTcap 干预对参与者信念和认知的影响 使用催眠药改善睡眠质量和日间功能的期望，以及 4) 评估效果 MTcap 关于平衡和认知。 为了实现这些目标，我们建议对招募的老年退伍军人进行随机临床试验 来自单个 VA 站点。退伍军人将接受三步筛选流程（带有选择退出卡的信件、电话 屏幕和现场屏幕）。符合资格的参与者 (N = 132) 将被随机分配到 8 周的 MTcap 组或 SGT+CBTI。 MTcap 臂将包括逐步撤回以及 CBTI 和 CBT-HW 增强 掩蔽/安慰剂药物疗法和新颖的 CBT 练习解决了对催眠药的期望。这 SGT+CBTI手臂将使用传统的药物包装（瓶子）。主要成果将包括催眠 停用和使用（通过实验室测试和病历审查/说明处方客观衡量） 监测数据库查询，并主观地通过睡眠日记）了解失眠的严重程度、信念和期望 关于催眠、平衡和认知。我们将使用定量方法来衡量 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 认识。这种催眠停药计划可能是帮助那些想要的老年退伍军人的重要工具 停止使用催眠药来实现这一目标。