Three Approaches to Maintenance Therapy for Chronic Insomnia in Older Adults
Three Approaches to Maintenance Therapy for Chronic Insomnia in Older Adults
批准号:
10221560
负责人:
Michael Lloyd Perlis
金额:
$56.62万
依托单位国家:
美国
项目类别:
财政年份:
2018
资助国家:
美国
项目状态:
已结题
起止时间:
2018-09-30 至 2024-09-30
关键词:
AddressAdverse eventAgonistBehavioralBenzodiazepine ReceptorChronic InsomniaClinicalCognitive TherapyDSM-VDiseaseDoseElderlyExhibitsFrequenciesGeneral PopulationGoalsHalf-LifeIncidenceIndividualInvestigationMaintenanceMaintenance TherapyMeasuresMedicalMental disordersMorbidity - disease rateOutcomeOutcome StudyPatientsPharmaceutical PreparationsPharmacotherapyPhasePlacebosPrevalencePsychological DependencePsychological reinforcementRandomizedRecurrenceRegimenRelapseRestRisk FactorsSafetySeveritiesSleepSleeplessnessSymptomsTimeTreatment Protocolscomorbidityconditioningcostexperimental grouphabituationhazardhypnoticimprovedpillprimary outcomeside effecttargeted treatmenttreatment choicetreatment effecttreatment responderstreatment responsezolpidem
中文摘要
老年慢性失眠症维持治疗的三种方法
摘要
失眠在老年人中的普遍程度几乎是普通人群的两倍。这一点意义重大
临床关注,因为失眠是新发病和反复发作的精神和内科疾病的危险因素。已被占用
总而言之,失眠在老年人中的患病率和后果表明,失眠不应该
未经治疗。这一临床上的当务之急得到了进一步的强调:1)失眠症的重新定义
DSM-5和ICSD-3作为一种障碍(与其他障碍的症状相比)和2)靶向治疗的结果
睡眠连续性障碍可能会对发生的医学和精神障碍产生临床收益
与失眠并存。因此,目前的问题不是是否治疗,而是如何最好地治疗
在一般情况下,尤其是在老年人的情况下,精神障碍。虽然CBT-I是首选的治疗方法,但
对于那些没有接受CBT-I治疗的人来说,治疗失眠仍然是主要的选择,
更可取的,或有空的。在现有的药物治疗中,研究得最好的策略是苯二氮卓类药物。
和苯二氮类受体激动剂(BZRAs)。在这两种情况下,治疗通常是通过以下两种方法之一完成的
夜间或间歇给药。在夜间给药(QHS)的情况下,BZRA已被发现是安全的和
有效的周期长达一年。不太清楚的是,这种效力能否在以下背景下保持
维持治疗(历时数年或数十年)。在间歇给药(IDS)的情况下,
减少用药量的方法被认为可以延长药物治疗的有效性和安全性,但在
费用:在非药物治疗的夜晚,治疗效果很小或没有。为了解决这个问题,我们提出了
将行为学原理应用于药物治疗,以确定通过
标准疗法可以通过部分强化来维持(在一些药丸含有的情况下,夜间使用药丸
唑吡坦和一些安慰剂)。基于我们先前研究的结果,通过部分加固,
我们建议评估一种低频率的给药方法,将其与老年人夜间用药进行比较。
成年人。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 mg唑吡坦治疗
1个月后评估治疗反应。在第二阶段,治疗应答者将被随机分配到
为期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次有效剂量,其余为安慰剂);或低频率的入侵检测
情况(每周1至3次有效剂量)。第三阶段将是一个延长期,以评估超过9个月的
这些方法的长期耐用性。这项研究的结果将是:复发率,复发潜伏期,
治疗期间和白天的平均睡眠持续时间、医疗症状的数量和严重程度
治疗过程中的功能。这项研究的主要假设是,部分加固条件将
产生与夜间给药相似的结果,而优于入侵检测系统的情况。
英文摘要
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.
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