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: 10290894
• 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/10290894
• 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.

安眠药，如苯二氮卓类和苯二氮卓类受体激动剂，经常被开给 失眠。在门诊就诊的退伍军人中，大约四分之一的人使用催眠药(或就寝时间 酒精)。在老年人中，使用催眠药与摔倒和认知障碍的风险增加有关。 停用催眠药通常会减弱或逆转这些负面影响，退伍军人事务部 事务(VA)有减少老年人使用催眠药的举措。当前的戒毒战略重点 关于逐渐减少催眠药和/或治疗失眠症状。常见策略包括受监督 逐渐减少(SGT)，以催眠戒断为目标的认知行为疗法(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，这表明其他机制需要 有针对性地实现并维持较高的不使用率。 另一种机制可能是实现催眠停用并长期维持的可行目标- 术语不使用是安慰剂效应，其特征是由以下因素引起的睡眠真正改善 治疗的心理社会方面，而不仅仅是药物效应。我们最近开发并测试了 针对安慰剂效应的干预的可行性。我们的干预保留了经过测试的核心组件 以前关于实现催眠停用的研究(即SGT+CBTI)，但增加了一个新的功能-“蒙面” 逐渐减少。掩饰是通过封装催眠药(由复方药房配制)来实现的，因此 患者已经同意逐步减少，直到结束时才知道每个胶囊的实际剂量。 锥度，当锥度时间表向患者透露时。在接近结束的时候，服用安慰剂 使用胶囊。通过新的认知练习，治疗师将掩饰作为一种工具来挑战 关于催眠药的预期，这可能有助于长期使用，并增加CBT-HW(例如， 为撤军做准备)。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导致失眠的因素 症状，并帮助患者安全地逐渐停止使用催眠药。 目的：1)评估面罩锥体疗法加认知行为疗法的疗效 老年退伍军人催眠停药计划(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 使用催眠药改善睡眠质量和白天功能的预期，以及4)评估 关于平衡和认知的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 来自单一的退伍军人事务部。退伍军人将经历3个步骤的筛选过程(带选择退出卡的信件、电话 屏幕和面对面屏幕)。符合条件的参与者(N=132)将被随机分配到8周的MTCap ARM或 SGT+CBTI。MTCAP ARM将包括逐步退出以及CBTI和CBT-HW 掩蔽/安慰剂药物治疗和新的CBT练习解决了催眠药的预期。这个 SGT+CBTI ARM将使用常规药物包装(瓶)。关键结果将包括催眠药 停用和使用(通过实验室测试和病历审查/国家处方进行客观衡量 监控数据库查询，并主观地通过睡眠日记)、失眠严重程度、信念和期望 关于催眠、平衡和认知。我们将使用定量的方法来衡量MTCap的效果 对催眠药的使用、失眠严重程度、对使用催眠药的信念/期望、平衡和 认知力。这个催眠停药计划可能是一个重要的工具，帮助那些想要 停止使用催眠药以达到这一目标。