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:8547800
- 负责人:
- 金额:$ 24.36万
- 依托单位:
- 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:
- 关键词:AcuteAddressAdverse effectsAdverse eventAgonistAlgorithmsBehavior TherapyBehavioralBenzodiazepine ReceptorBiological MarkersChronic InsomniaClinicalClinical assessmentsCognitiveCognitive TherapyComorbidityDataDevelopmentDiseaseDisease remissionDoseDropoutEnrollmentGoalsGuidelinesHealthHealth Care CostsInterventionMaintenance TherapyMajor Depressive DisorderMeasuresMental disordersModalityMoodsOutcomeOutcome MeasureParticipantPatient Self-ReportPatientsPatternPharmaceutical PreparationsPharmacotherapyPrimary InsomniaProtocols documentationProviderRandomizedRelianceResearch DesignRiskSWI1Sample SizeSamplingSampling StudiesSeveritiesSiteSleepSleeplessnessStagingSymptomsTestingTherapeuticTimeTrainingTrazodoneTreatment EfficacyTreatment outcomeclinical practiceclinically relevantcohortcomparative efficacydiariesevidence baseflexibilityfollow-upimprovedindexinginnovationmeetingsprimary outcomepsychologicresponsesecondary outcometherapy designtraitzolpidem
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):慢性失眠是一种普遍存在的疾病,与医疗费用增加、功能受损以及发生严重精神疾病的风险增加有关。认知行为疗法(CBT)和苯二氮卓受体激动剂(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 药物治疗失眠的效果。以前的失眠治疗研究也受到小规模、高度筛选的研究样本、不代表通常的可调整剂量实践的固定剂量和固定药物治疗策略、相对较短的随访间隔以及依赖自我报告或多导睡眠图的限制。 PSG)将睡眠参数作为结果进行评估,而不是根据与临床实践更相关的失眠缓解指标。最后,研究尚未测试各种治疗顺序策略对于那些对最初的失眠疗法没有反应的人的好处。这个双站点项目将解决这些限制。这两个研究中心将总共招募 320 名符合慢性失眠症广泛标准的参与者。参与者将接受临床评估和 PSG 评估,然后随机分配接受 CBT 或唑吡坦(最广泛使用的 BzRA)第一阶段治疗。集中培训的治疗师将根据灵活的手动治疗算法进行 CBT 和唑吡坦治疗。初步结果将在 6 周后评估,治疗转介者将在接下来的 12 个月内接受维持治疗的跟踪。那些未能通过一线治疗实现失眠缓解的患者将被鼓励接受随机分配,接受第二次为期 6 周的药物治疗(唑吡坦或曲唑酮)或行为治疗(标准或定制 CBT)治疗。所有参与者将在方案开始后 12 周以及在继续最终治疗的同时进行 3、6、9 和 12 个月的随访时重新评估。失眠缓解,明确定义为失眠严重程度指数得分 < 8,将作为治疗比较的主要结果。次要结果包括睡眠日记和 PSG 睡眠测量;睡眠和日间功能的主观评分;不良事件;辍学率;和治疗的可接受性。研究目的包括:(1) 比较 CBT 和唑吡坦作为一线疗法用于持续缓解失眠的功效; (2) 比较治疗转换和强化策略对一线治疗未能缓解的患者的疗效; (3) 比较患有和不患有精神合并症的患者对一线和二线治疗的反应; (4) 探索选定的生物标志物和特征测量作为治疗结果预测因子的有用性。我们的首要目标是获取有助于制定 PI 和 CMI 管理临床指南的新信息。
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
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JACK D EDINGER其他文献
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{{ truncateString('JACK D EDINGER', 18)}}的其他基金
Enhancing Hypnotic Medication Discontinuation in Primary Care through Supervised Medication Tapering and Digital Cognitive Behavioral Insomnia Therapy
通过监督药物逐渐减量和数字认知行为失眠治疗,加强初级保健中催眠药物的停药
- 批准号:
10736443 - 财政年份:2023
- 资助金额:
$ 24.36万 - 项目类别:
Use of blinded tapering for hypnotic discontinuation
使用盲法逐渐减量来停止催眠
- 批准号:
10385850 - 财政年份:2019
- 资助金额:
$ 24.36万 - 项目类别:
Use of blinded tapering for hypnotic discontinuation
使用盲法逐渐减量来停止催眠
- 批准号:
9816837 - 财政年份:2019
- 资助金额:
$ 24.36万 - 项目类别:
Use of blinded tapering for hypnotic discontinuation
使用盲法逐渐减量来停止催眠
- 批准号:
10609458 - 财政年份:2019
- 资助金额:
$ 24.36万 - 项目类别:
Stepped-care management of insomnia co-occurring with sleep apnea
失眠合并睡眠呼吸暂停的分级护理管理
- 批准号:
9339721 - 财政年份:2016
- 资助金额:
$ 24.36万 - 项目类别:
The Role of Tapering Pace and Selected Traits on Hypnotic Discontinuation
逐渐减量的速度和选定的特征对催眠中断的作用
- 批准号:
8970476 - 财政年份:2015
- 资助金额:
$ 24.36万 - 项目类别:
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:
8636041 - 财政年份:2011
- 资助金额:
$ 24.36万 - 项目类别:
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:
8817322 - 财政年份:2011
- 资助金额:
$ 24.36万 - 项目类别:
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 - 财政年份:2011
- 资助金额:
$ 24.36万 - 项目类别:
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:
8108288 - 财政年份:2011
- 资助金额:
$ 24.36万 - 项目类别:
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