Non-deceptive Application of Placebos in Insomnia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Self-reported Total Sleep Time
研究概览
简要总结
The purpose of this study is to evaluate whether non-deceptive application of a placebo has an impact on subjective or objective sleep parameters in patients with primary insomnia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 18 years to 69 years
- •fluent in German language
- •provide written informed consent
- •ability to understand the explanations and instructions given by the study physician and the investigator
排除标准
- •evidence for sleep disorders caused by medical factors (e.g. sleep apnea, restless legs syndrome, narcolepsy, substance-induced insomnia)
- •allergies to ingredients of placebo
- •patients scoring below 8 or above 21 on the Insomnia Severity Index
- •patients suffering from a mental disorder as verified by the SCID
- •patients suffering from an acute physical illness
- •nicotine consumption > 10 cigarettes/day
- •unwillingness to refrain from alcohol consumption throughout the study
- •change in concomitant medication regime during the last 2 weeks prior to visit 1 or after randomization
- •intake of psychotropic drugs during the last 3 months prior to visit 1
- •currently pregnant (verified by urine pregnancy test) or lactating
研究组 & 干预措施
Non-deceptive placebo group (additional information)
Participants receive a placebo pill and are told that it is placebo. They receive additional information about the power of placebo effects via a film sequence before they take the placebo.
干预措施: Placebo (Drug)
Non-deceptive placebo group (additional information)
Participants receive a placebo pill and are told that it is placebo. They receive additional information about the power of placebo effects via a film sequence before they take the placebo.
干预措施: Film sequence (Other)
Non-deceptive placebo group (no additional information)
Participants receive a placebo pill and are told that it is placebo. They do not receive additional information about placebo effects. Instead, they watch a neutral film sequence about sleep.
干预措施: Placebo (Drug)
Non-deceptive placebo group (no additional information)
Participants receive a placebo pill and are told that it is placebo. They do not receive additional information about placebo effects. Instead, they watch a neutral film sequence about sleep.
干预措施: Film sequence (Other)
结局指标
主要结局
Self-reported Total Sleep Time
时间窗: change from baseline to 1 night after placebo intake
assessed by sleep diary
次要结局
- Objective Sleep Onset Latency(change from baseline to 1 night after placebo intake)
- Objective Total Sleep Time(change from baseline to 1 night after placebo intake)
- Objective Sleep Efficiency(change from baseline to 1 night after placebo intake)
- Self-reported Sleep Onset Latency(change from baseline to 1 night after placebo intake)
研究者
Winfried Rief
Professor Dr.
Philipps University Marburg Medical Center