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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

基本信息

批准号：
9341745
负责人：
Michael Lloyd Perlis
金额：
$ 80.53万
依托单位：
UNIVERSITY OF PENNSYLVANIA
依托单位国家：
美国
项目类别：
财政年份：
2016
资助国家：
美国
起止时间：
2016-09-30 至 2020-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9341745
关键词：
Accounting Address Adverse effects Adverse event Age Agonist Behavioral Benzodiazepine Receptor Benzodiazepines Case Management Chronic Disease Chronic Insomnia Clinical Cognitive Therapy Conditioned Stimulus Data Dependence Diagnostic and Statistical Manual of Mental Disorders Disease Dose Elderly Exhibits Expectancy Frequencies General Population Half-Life Health 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 Relapse Risk Risk Factors Safety Severities Sleep Sleeplessness Symptoms Temazepam Therapeutic Time Treatment Cost base capsule clinical effect conditioning cost habituation hazard hypnotic improved interest pill primary outcome sleeping pill targeted treatment treatment choice treatment responders treatment response zolpidem

项目摘要

DESCRIPTION (provided by applicant): Insomnia is nearly twice as common among older adults as it is in 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 potential 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. 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 over the course of years or decades. In the case of intermittent dosing (IDS), the reduced usage strategy is thought to extend the efficacy and safety "half-life" of pharmacotherapy, but at a cost: little or no clinical effects on non-medication nights. In order to address this issue, we propose to evaluate an alternative approach that is based on the behavioral principles of conditioning and reinforcement. Specifically, we propose to garner treatment responses with full dose treatment (1 month) and then conduct maintenance therapy using intermittent dosing with placebos on non-medication nights. This approach, by expectancy alone, should provide for better clinical outcomes than standard intermittent dosing. What makes the study theoretically interesting is the underlying concept: that the initial treatment response allows for the medication vehicle (the capsule) to become a conditioned stimulus for the therapeutic response (sleepiness and sleep) and that this can be maintained over time (if not indefinitely) with partial reinforcement. Building upon the findings from our prior investigation with partial reinforcement, we propose to assess two low frequency approaches to maintenance therapy in a three phase study. In Phase 1, all subjects receive zolpidem nightly for one month and are assessed for treatment response. In Phase 2, responders are 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 with placebos on non-medication nights); and a low frequency IDS condition (1 to 3 active doses per week, without placebos). 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, and number and severity of medical symptoms 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.