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

基本信息

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
项目类别：
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

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

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项目摘要

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.

诸如苯二氮卓类和苯二氮卓受体激动剂之类的催眠药经常被处方失眠。在参加门诊诊所的退伍军人中，大约四分之一使用催眠药（或就寝时间酒精）。使用催眠药与老年人跌倒风险增加和认知较差有关。中止催眠药通常会削弱或逆转这些负面影响，而退伍军人部事务（VA）采取了减少老年人催眠使用的举措。当前的停用策略重点减少催眠和/或治疗失眠症状时。常见策略包括监督逐渐锥度（SGT），靶向催眠戒断的认知行为疗法（CBT-HW），认知失眠（CBTI）和联合疗法（SGT+CBTI）的行为疗法。但多达40％的患者甚至在这些策略中恢复催眠药的使用，这表明其他机制需要是目标是实现和维持高率的非使用率。另一种可能是实现催眠停药和维持长期持续的可行目标的机制术语不使用是安慰剂效应，其特征是由治疗的心理社会方面，而不是单独的药物作用。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。我们的干预保留了测试的核心组件实现催眠停药的先前研究（即中士+CBTI），但增加了一种新颖的特征 - “掩盖” 锥度。通过封装催眠药（由复合药房制备）来实现掩饰同意逐渐锥的患者不知道每个胶囊中的实际剂量直到结束锥度，当逐渐变细的时间表向患者揭示时。在锥度末端，安慰剂使用胶囊。通过新颖的认知练习，治疗师使用蒙版作为挑战的工具关于催眠药的期望，这可能导致长期使用和增加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摆脱催眠。目标：1）评估蒙面锥度和认知行为疗法的效率关于老年退伍军人的催眠停药的计划（MTCAP），2）确定MTCAP的影响干预失眠严重程度，3）评估MTCAP干预对参与者信念的影响期望使用催眠药改善睡眠质量和白天功能，以及4）评估效率 MTCAP平衡和认知。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一项随机临床试验来自一个VA网站。退伍军人将进行三步筛选过程（带有退出卡的字母，电话屏幕和面对面的屏幕）。合格的参与者（n = 132）将被随机分为MTCAP组8周或中士+CBTI。 MTCAP臂将包括Gustal Plus CBTI＆CBT-HW增强掩盖/安慰剂药物治疗和新型CBT练习解决了催眠药的期望。这中士+CBTI手臂将使用常规药物包装（瓶）。关键结果将包括催眠停用和使用（通过实验室测试和病历审查/州处方客观地衡量监视数据库查询，以及主观通过睡眠日记），失眠严重性，信念和期望关于催眠术，平衡和认知。使用定量方法，我们将测量MTCAP的效果干预催眠使用，失眠的严重程度，信念/期望使用催眠药，平衡和认识。这个催眠中断计划可能是帮助想要的老年退伍军人停止实现这一目标的催眠药。