1/2-Sequenced Therapies for Comorbid and Primary Insomnias

共病和原发性失眠的 1/2 序列疗法

• 批准号: 8277187
• 负责人: JACK D EDINGER
• 金额: $ 26.84万
• 依托单位: NATIONAL JEWISH HEALTH
• 依托单位国家: 美国
• 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/8277187
• 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

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(申请人提供)：慢性失眠是一种流行的疾病，与医疗保健费用增加，功能受损，以及发展为严重精神障碍的风险增加有关。认知行为疗法(CBT)和苯二氮卓类受体激动剂(BzRA)药物是最广泛支持的失眠治疗方法。不幸的是，很少有研究比较CBT和BzRA治疗失眠的药物。以前的失眠治疗研究也受到以下因素的限制：小样本、高筛选研究、固定剂量和固定药物治疗策略，这些策略不代表通常的可调整剂量做法，相对较短的随访间隔，以及依赖自我报告或多导睡眠图(PSG)评估的睡眠参数作为结果，而不是依赖与临床实践更相关的失眠缓解指标。最后，研究还没有测试各种治疗排序策略对那些对最初的失眠治疗没有反应的人的好处。这个双站点项目将解决这些限制。这两个研究地点将招募总共320名符合慢性失眠障碍广泛标准的参与者。参与者将接受临床评估和PSG评估，然后随机分配到CBT或唑吡坦(最广泛使用的BzRA)的第一阶段治疗。集中培训的治疗师将根据尽管灵活但手动的治疗算法来实施CBT和唑吡坦。初步结果将在6周后进行评估，治疗汇款者将在接下来的12个月内接受维持治疗。那些未能通过一线治疗缓解失眠的人将被鼓励接受随机分配到第二个为期6周的药物治疗(唑吡坦或曲唑酮)或行为治疗(标准或定制的CBT)。所有参与者将在方案开始后12周以及在3、6、9和12个月的随访中进行重新评估，同时继续他们的最终治疗。失眠缓解被明确定义为失眠严重指数的8分，将作为治疗比较的主要结果。次要结果将包括睡眠日记和PSG睡眠测量；睡眠和日间功能的主观评级；不良事件；辍学率；以及治疗的可接受性。研究的目的包括：(1)比较CBT和唑吡坦作为一线治疗时产生持续失眠缓解的疗效；(2)比较一线治疗未能缓解的患者的治疗转换和强化策略的有效性；(3)比较有和没有精神合并症的患者对一线和二线治疗的反应；以及(4)探索选定的生物标记物和特征测量作为治疗结果预测因素的有用性。我们的总体目标是获得有助于发展PI和CMI管理的临床指南的新信息。