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临床试验/NCT03313466
NCT03313466已完成不适用

Trial of Internet-Based Cognitive Behavioral Therapy for Insomnia in Patients Prescribed Insomnia Medications

Kaiser Permanente1 个研究点 分布在 1 个国家目标入组 136,630 人开始时间: 2018年3月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
136,630
试验地点
1
主要终点
Days supply of dispensed insomnia medications

研究概览

简要总结

The investigators will conduct a randomized, controlled trial of internet-based cognitive behavioral therapy (iCBT) vs usual care for insomnia. The target population is patients prescribed medications for insomnia who have not had a dispensation of these medications in the preceding six months. The primary outcomes is dispensed days supply over the subsequent one year. Secondary outcomes include all types of health system clinical encounters. The investigators hypothesize that the group randomized into iCBT will have less insomnia medications dispensed than usual care controls, and less clinical encounters..

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •A prescription for any of a set of selected insomnia medications.
  • •Age >18 years at the time of the prescription.
  • •A recent (<30 days before the prescription date) diagnosis of insomnia as determined by a set of selected International Classification of Disease (ICD) codes, to be used for medications that are not prescribed just for insomnia.
  • •Membership for >365 days prior to the prescription date.
  • •No evidence of a dispensed insomnia medication within six months (183 days) of the current prescription.

排除标准

  • •Contained in inclusion criteria.

研究组 & 干预措施

iCBTI

Experimental

Intervention: An internet-based cognitive behavioral therapy program for insomnia (iCBTI) that is tailored to the individual's needs based on responses to questions.

干预措施: Internet cognitive behavioral therapy for insomnia (iCBTI) (Behavioral)

Usual care

Active Comparator

Intervention: A group class on insomnia provided at each Kaiser Permanente Southern California medical center.

干预措施: Class in sleeping well and improving insomnia (Behavioral)

结局指标

主要结局

Days supply of dispensed insomnia medications

时间窗: One year

Days supply of dispensed insomnia medications up to one year after randomization.

次要结局

  • Health care inpatient and outpatient encounters(One year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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