Cognitive Behavior Therapy for Insomnia Delivered by a Therapist or on the Internet: a Randomized Controlled Noninferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- insomnia severity
研究概览
简要总结
Background: Insomnia is a highly prevalent and disabling disorder where Cognitive Behavior Therapy for Insomnia (CBT-I) is established as the best available treatment. Still, only a negligible number of patients with insomnia receive this treatment. One potential way of improving the dissemination of CBT-I is by using online adaptations of CBT-I. This is a new method for delivering CBT-I and it is not known how effective online treatment is compared to face-to-face CBT-I. This trial's purpose is to compare face-to-face CBT-I with online CBT-I. Because of the great advantage of online treatment in both availability and cost, the trial is designed as a noninferiority trial.
Aim: To test if online CBT-I is noninferior in reducing insomnia complaints compared with CBT-I as delivered face-to-face by a therapist.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •meeting the Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 diagnostic criteria for insomnia disorder
排除标准
- •a condition that renders the patient incapable of understanding the treatment (e.g. actively psychotic, mental retardation, dementia or others
- •an ongoing substance abuse problem
- •other organic sleep disturbances or circadian sleep disturbance
- •an ongoing medical condition where treatment of insomnia is not indicated (e.g. an attack phase of multiple sclerosis)
- •working night shifts and being unable to discontinue this work pattern
- •not being sufficiently fluent in Norwegian to understand the assessments or treatment
- •not having the necessary computer skills needed to log on to the web based program
研究组 & 干预措施
Internet CBT-i
Participants will be instructed on the use of the internet CBT-i (SHUTi) intervention site, then use the program for six weeks.
干预措施: Internet CBT-i SHUTi (Behavioral)
face-to-face CBT-i
4 to 8 sessions of face-to-face CBT-i treatment with one of three clinicians (experienced CBT-i psychiatrists)
干预措施: face-to-face CBT-i (Behavioral)
结局指标
主要结局
insomnia severity
时间窗: 8 weeks
as assessed by Insomnia Severity Index (Morin ea 2011 Sleep 34(5):601-8)
insomnia severity
时间窗: 6 months
as assessed by Insomnia Severity Index (Morin ea 2011 Sleep 34(5):601-8)
次要结局
未报告次要终点