Three Approaches to Maintenance Therapy for Chronic Insomnia in Older Adults

老年人慢性失眠维持治疗的三种方法

• 批准号: 10221560
• 负责人: Michael Lloyd Perlis
• 金额: $ 56.62万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-30 至 2024-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10221560
• 关键词: Address; Adverse event; Agonist; Behavioral; Benzodiazepine Receptor; Chronic Insomnia; Clinical; Cognitive Therapy; DSM-V; Disease; Dose; Elderly; Exhibits; Frequencies; General Population; Goals; Half-Life; Incidence; Individual; Investigation; Maintenance; Maintenance Therapy; Measures; Medical; Mental disorders; Morbidity - disease rate; Outcome; Outcome Study; Patients; Pharmaceutical Preparations; Pharmacotherapy; Phase; Placebos; Prevalence; Psychological Dependence; Psychological reinforcement; Randomized; Recurrence; Regimen; Relapse; Rest; Risk Factors; Safety; Severities; Sleep; Sleeplessness; Symptoms; Time; Treatment Protocols; comorbidity; conditioning; cost; experimental group; habituation; hazard; hypnotic; improved; pill; primary outcome; side effect; targeted treatment; treatment choice; treatment effect; treatment responders; treatment response; zolpidem

Three Approaches to Maintenance Therapy for Chronic Insomnia in Older Adults ABSTRACT Insomnia is nearly twice as common among older adults as it is the general population. This is of significant clinical concern as insomnia is a risk factor for new onset and recurrent psychiatric and medical illness. Taken together, the prevalence and consequences of insomnia in older adults suggests that insomnia should not go untreated. This clinical imperative is further underscored by 1) the reconceptualization of Insomnia within the DSM-5 and ICSD-3 as a disorder (vs. a symptom of other disorders) and 2) the findings that targeted treatment of sleep continuity disturbance may produce clinical gains for medical and psychiatric disorders that occur comorbidly with insomnia. Thus, at present, the question is not whether to treat but how to best treat the disorder in general, and specifically in the context of older adults. While CBT-I is the treatment of choice, the medical treatment of insomnia remains the primary alternative for those for whom CBT-I is not indicated, preferable, or available. Of the available medical treatments, the best studied strategies are benzodiazepines and benzodiazepine receptor agonists (BZRAs). In both cases, treatment is typically accomplished with either nightly or intermittent dosing. In the case of nightly dosing (QHS), BZRAs have been found to be safe and efficacious for periods of up to a year. Less clear is whether such efficacy can be maintained in the context of maintenance therapy (over the course of years or decades). In the case of intermittent dosing (IDS), the reduced usage approach is thought to extend the efficacy and safety “half-life” of pharmacotherapy, but at a cost: little or no treatment effects on non-medication nights. In order to address this issue, we have proposed that behavioral principles be applied to pharmacotherapy to determine whether clinical gains obtained with standard therapy can be maintained with partial reinforcement (nightly pill use where some of the pills contain zolpidem and some are placebos). Building upon the findings from our prior study with partial reinforcement, we propose to assess a low frequency approach to dosing as compared to nightly medication use in older adults. The study will be conducted in three phases. In Phase 1, all subjects receive 5mg zolpidem nightly for one month and are assessed for treatment response. In Phase 2, treatment responders will be randomized to one of four maintenance conditions for three months: Nightly medication use (QHS); one of two low frequency partial reinforcement conditions (1 or 3 active doses per week and the rest placebos); or a low frequency IDS condition (1 to 3 active doses per week). Phase 3 will be an extension period to assess, over 9 months, the long-term durability of the approaches. The outcomes for the study will be: rate of relapse, latency to relapse, average sleep continuity, number and severity of medical symptoms function during treatment, and daytime function during treatment. The primary hypothesis for the study is that the partial reinforcement conditions will produce similar outcomes to nightly dosing and superior outcomes to the IDS condition.

老年人慢性失眠维持治疗的三种方法 抽象的 老年人失眠的发生率几乎是普通人群的两倍，这一点意义重大。 临床关注，因为失眠是新发和复发的精神和内科疾病的危险因素。 总之，老年人失眠的患病率和后果表明，失眠不应该消失 1）失眠的重新概念进一步强调了这一临床必要性。 DSM-5 和 ICSD-3 作为一种疾病（相对于其他疾病的症状）以及 2) 靶向治疗的发现 睡眠连续性障碍可能会对发生的医学和精神疾病产生临床收益 因此，目前的问题不是是否治疗，而是如何最好地治疗。 虽然 CBT-I 是一种治疗选择，但对于一般疾病，尤其是老年人而言。 对于那些不适合 CBT-I 的人来说，失眠的药物治疗仍然是主要选择， 在现有的治疗方法中，研究最好的策略是苯二氮卓类药物。 在这两种情况下，通常使用其中一种来完成治疗。 夜间或间歇给药（QHS）时，BZRA 被发现是安全且有效的。 尚不清楚的是，这种功效是否可以在长达一年的情况下维持。 维持治疗（数年或数十年）在间歇给药（IDS）的情况下， 减少使用方法被认为可以延长药物治疗的功效和安全性“半衰期”，但 成本：非药物夜晚的治疗效果很少或没有 为了解决这个问题，我们提出了建议。 将行为原则应用于药物治疗，以确定是否能获得临床获益 标准治疗可以通过部分强化来维持（每晚使用药丸，其中一些药丸含有 基于我们之前的研究结果并进行了部分强化， 我们建议评估老年人与夜间用药相比的低频给药方法 该研究将分三个阶段进行，在第一阶段，所有受试者每晚接受 5 毫克唑吡坦治疗。 一个月并评估治疗反应 在第 2 阶段，治疗反应者将被随机分组​​。 三个月的四种维持条件之一： 夜间用药 (QHS) 两种低频率之一； 部分强化条件（每周 1 或 3 次活性剂量，其余为安慰剂）或低频 IDS； 第 3 阶段将是一个延长期，用于在 9 个月内评估病情。 研究的结果将是：复发率、复发潜伏期、 治疗期间和白天的平均睡眠连续性、医学症状的数量和严重程度 该研究的主要假设是部分强化条件会影响治疗期间的功能。 产生与夜间给药相似的结果，并产生优于 IDS 条件的结果。