Phase 3 Study of Internet-based Self-help for Insomnia: Factors That Are Associated With Success of the Intervention
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 479
- 试验地点
- 1
- 主要终点
- Sleep diary
研究概览
简要总结
The object of this study is to determine variables associated with therapy-success of a cognitive behavioral self help intervention for insomnia. In this study all participants receive an online self-help CBT manual consisting of information (psycho-education) about sleep and cognitive-behavioural exercises. Adult persons with insomnia will be invited via a popular scientific website to fill out online questionnaires. Participants will be measured 4, 16, and 40 weeks after intervention with the same questionnaires.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 是
入选标准
- •Access to the internet
排除标准
- •Alcohol or substance abuse
- •Being suicidal
- •Sleep apnea
- •Schizophrenic or having a psychosis disorder
研究组 & 干预措施
Internet Deliviered CBT for Insomnia
Cognitive behavioral self-help method for insomnia via the Internet
干预措施: Cognitive Behavioral Treatment (Behavioral)
结局指标
主要结局
Sleep diary
时间窗: 48-week follow-up
Daily self-observation used to calculate Total Sleep Time, Wake After Sleep Onset, Sleep Onset Latency, Sleep Efficiency, and Day ratings.
Sleep diary
时间窗: baseline
Daily self-observation used to calculate Total Sleep Time, Wake After Sleep Onset, Sleep Onset Latency, Sleep Efficiency, and Day ratings.
Sleep diary
时间窗: 4-week follow-up
Daily self-observation used to calculate Total Sleep Time, Wake After Sleep Onset, Sleep Onset Latency, Sleep Efficiency, and Day ratings.
Sleep diary
时间窗: 18-week follow-up
Daily self-observation used to calculate Total Sleep Time, Wake After Sleep Onset, Sleep Onset Latency, Sleep Efficiency, and Day ratings.
次要结局
- Anxiety(48-week follow-up)
- Depression(48-week follow-up)
- Sleep medication(48-week follow-up)
- Insomnia Severity(Baseline)
- Insomnia severity(48-week follow-up)
- Depression(18-week follow-up)
- Sleep medication(Baseline)
- Anxiety(Baseline)
- Anxiety(4-week follow-up)
- Anxiety(18-week follow-up)
- Depression(Baseline)
- Depression(4 week follow-up)
- Sleep medication(4-week follow-up)
- Sleep medication(18-week follow-up)
- Insomnia severity(four-week follow-up)
- Insomnia severity(18-week follow-up)