1/2-Sequenced Therapies for Comorbid and Primary Insomnias

共病和原发性失眠的 1/2 序列疗法

基本信息

批准号：
8636041
负责人：
JACK D EDINGER
金额：
$ 25.37万
依托单位：
NATIONAL JEWISH HEALTH
依托单位国家：
美国
项目类别：
财政年份：
2011
资助国家：
美国
起止时间：
2011-06-07 至 2016-02-29
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8636041
关键词：
Acute Address Adverse effects Adverse event Agonist Algorithms Behavior Therapy Behavioral Benzodiazepine Receptor Biological Markers Chronic Insomnia Clinical Clinical assessments Cognitive Cognitive Therapy Comorbidity Data Development Disease Disease remission Dose Dropout Enrollment Goals Guidelines Health Health Care Costs Intervention Maintenance Therapy Major Depressive Disorder Measures Mental disorders Modality Moods Outcome Outcome Measure Participant Patient Self-Report Patients Pattern Pharmaceutical Preparations Pharmacotherapy Primary Insomnia Protocols documentation Provider Randomized Reliance Research Design Risk SWI1 Sample Size Sampling Sampling Studies Severities Site Sleep Sleeplessness Staging Symptoms Testing Therapeutic Time Training Trazodone Treatment Efficacy Treatment outcome clinical practice clinically relevant cohort comparative efficacy diaries evidence base flexibility follow-up improved indexing innovation meetings primary outcome psychologic response secondary outcome therapy design trait zolpidem

项目摘要

DESCRIPTION (provided by applicant): Chronic insomnia is a prevalent disorder associated with increased health care costs, impaired functioning, and an increased risk for developing serious psychiatric disorders. Cognitive Behavioral Therapy (CBT) and benzodiazepine receptor agonist (BzRA) medications are the most widely supported approaches for insomnia management. Unfortunately, few studies have compared CBT and BzRA medications for insomnia treatment. Previous insomnia treatment studies also have been limited by small, highly screened study samples, fixed- dose and fixed-agent pharmacotherapy strategies that do not represent usual adjustable dosing practices, relatively short follow-up intervals, and reliance on self-reported or polysomnographically (PSG) assessed sleep parameters as outcomes, rather than on insomnia remission indicators that are more relevant to clinical practice. Finally, studies have yet to test the benefits of various treatment-sequencing strategies for those who do not respond to initial their insomnia therapies. This dual-site project will address these limitations. The two study sites will enroll a total of 320 participants who meet broad criteria for chronic insomnia disorder. Participants will be evaluated with clinical assessments and PSG, then randomly assigned to first-stage therapy with CBT or zolpidem (most widely-prescribed BzRA). Centrally trained therapists will administer CBT and zolpidem according to manualized, albeit flexible, treatment algorithms. Initial outcomes will be assessed after 6 weeks, and treatment remitters will be followed for the next 12 months on maintenance therapy. Those who fail to achieve insomnia remission with first-line therapy will be encouraged to accept random assignment to a second, 6-week, medication (zolpidem or trazodone) or behavioral (standard or tailored CBT) treatment. All participants will be re-evaluated 12 weeks after protocol initiation, and at 3-, 6-, 9-, and 12-month follow-ups while continuing their final treatment. Insomnia remission, defined categorically as a score < 8 on the Insomnia Severity Index, will serve as the primary outcome for treatment comparisons. Secondary outcomes will include sleep diary and PSG sleep measures; subjective ratings of sleep and daytime function; adverse events; dropout rates; and treatment acceptability. Study Aims include: (1) comparing the efficacy of CBT and Zolpidem for producing sustained insomnia remission when used as first line therapies; (2) comparing the efficacy of treatment switching and augmentation strategies for those who fail to remit with first line treatments; (3) comparing the responses of those with and without psychiatric comorbities to first and second line treatments; and (4) exploring the usefulness of selected biomarkers and trait measures as predictors of treatment outcomes. Our over-arching goal is to obtain new information that contributes to the development of clinical guidelines for PI and CMI management.

描述（由申请人提供）：慢性失眠是一种与医疗保健成本增加，功能受损以及患上严重精神疾病的风险增加有关的普遍疾病。认知行为疗法（CBT）和苯二氮卓受体激动剂（BZRA）药物是失眠管理最广泛支持的方法。不幸的是，很少有研究比较CBT和BZRA药物用于失眠治疗。先前的失眠治疗研究也受到小型，高度筛查的研究样本的限制，固定剂量和固定性药物疗法策略并不代表通常可调节的剂量实践，相对较短的后续间隔以及对自我报告的或多个术语（PSG）的依赖（PSG）评估的睡眠参数，而不是对INSOMNIA的练习，而不是对INSOMNIA的练习，而不是对INSOMNIA的练习。最后，研究尚未测试各种治疗序列策略的好处，为那些对初始失眠疗法做出反应的人。这个双站点项目将解决这些限制。这两个研究地点将招募320名符合慢性失眠症标准的参与者。参与者将通过临床评估和PSG进行评估，然后随机分配给CBT或Zolpidem（最广泛规定的BZRA）的第一阶段治疗。经过集中训练的治疗师将根据手动（尽管灵活，治疗算法）管理CBT和Zolpidem。 6周后将评估初始结果，并在接下来的12个月内进行维护治疗。那些未能通过一线治疗实现失眠的人将被鼓励接受第二次，6周的药物（Zolpidem或trazodone）或行为（标准或量身定制的CBT）治疗。所有参与者将在协议启动后12周重新评估，并在继续进行最终待遇的同时，在3日，6，9和12个月的随访中进行重新评估。在失眠严重程度指数上，已明确定义为<8的失眠症缓解将是治疗比较的主要结果。次要结果将包括睡眠日记和PSG睡眠度量；睡眠和白天功能的主观评分；不利事件；辍学率；和治疗可接受性。研究目的包括：（1）比较CBT和Zolpidem在用作第一线疗法时产生持续失眠的疗效；（2）将治疗转换和增强策略的功效与未能通过第一线治疗汇款的人进行比较；（3）比较有或没有精神病合并症的人的反应与第一线和第二行治疗；（4）探索所选生物标志物和性状措施的有用性，作为治疗结果的预测指标。我们的整理目标是获取有助于制定PI和CMI管理临床指南的新信息。