Online Self-Help Intervention for Insomnia: With or Without Feedback
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 262
- 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 whether feedback added to a self-help protocol for insomnia enhances the treatment effect. In this study all participants receive an online self-help cognitive behavioral therapy (CBT) intervention 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. Half of the participants will received by e-mail from a therapist, the other half of the participants will do the intervention without feedback. 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
- 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
- •Access to internet
- •Dutch citizen
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
CBT for insomnia with feedback
In this arm participants received internet based self-help CBT for insomnia with e-mail feedback form a therapist.
干预措施: CBT for insomnia (Behavioral)
CBT for insomnia without feedback
In this arm participants receive internet based self-help CBT for insomnia without feedback from a therapist.
干预措施: CBT for insomnia (Behavioral)
结局指标
主要结局
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 Sleep Quality.
Diary
时间窗: 6 month follow-up
Daily self-observation used to calculate Total Sleep Time, Wake After Sleep Onset, Sleep Onset Latency, Sleep Efficiency, and Sleep Quality.
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 Sleep Quality.
次要结局
- Insomnia Severity(6 month follow-up)
- Insomnia severity(4-week follow-up)
- Anxiety(6-month follow-up)
- Depression(6-month follow-up)
- Insomnia Severity(baseline)
- Anxiety(baseline)
- Anxiety(4-week follow-up)
- Depression(baseline)
- Depression(4-week follow-up)