Etude Pilote d'évaluation de l'efficacité de l'ETP Sur l'Insomnie Chronique
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Improvement in chronic insomnia between groups
研究概览
简要总结
20 to 30% of the general population suffers from chronic insomnia. Cognitive behavioral therapy (CBT) is the first-line treatment, but unfortunately its implementation is complex. Long waiting times for a consultation / exploration, too short a consultation period, non-reimbursement of specialists and a lack of trained staff make the current care of insomniac patients difficult. Patients are thus treated late, often with heavy drug treatment, dependence on sleeping pills, difficult withdrawal and / or reactive mood disorders. The treatment is therefore limited to advice on sleep hygiene and a restriction of time spent in bed without ultimately intervening in the cognitive domain. Therapeutic education consists of empowering the patient in the management of chronic insomnia through group education workshops. The patient learns the principles of normal sleep, the way in which sleep evolves with aging, the dangers of treatments as well as the rules of sleep hygiene and the behaviors to modify to sleep well. In addition to benefiting from sharing of experience with other patients, therapeutic education makes the care pathway smoother and considerably reduces the long waiting times of the traditional care pathway in consultation.
The study investigators hypothesize that therapeutic education is more effective as a treatment for chronic insomnia than traditional management in individualized consultation (IC). Thus, therapeutic education could constitute an effective alternative to CBT.
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
- •The patient must have given their free and informed consent
- •The patient must be a member or beneficiary of a health insurance plan
- •Patient must understand and read French
- •Patient with ICSD-3 diagnostic criteria for chronic insomnia: ISI score > 14/28.
排除标准
- •Patient with cognitive impairment as assessed by the investigator
- •Patient with shift work
- •Patients scoring > 10/24 on the Epworth sleepiness scale
- •Patient suffering from medical or psychiatric illnesses which may, in the opinion of the investigator, compromise the subject's state of health or ability to participate in the study.
- •Patient with chronic alcohol consumption or drug abuse
- •Patient unable to express consent.
- •Pregnant, parturient or breastfeeding patient.
- •The subject is participating in a category 1 interventional study, or is in a period of exclusion determined by a previous study
- •It is impossible to give the subject informed information
- •The patient is under safeguard of justice or state guardianship
结局指标
主要结局
Improvement in chronic insomnia between groups
时间窗: Day 28
Change in Insomnia Severity Index (ISI) score (Score between 0 - 28) from inclusion
次要结局
- Change in total sleeping time between groups(Day 28)
- Change in time in bed between groups(Day 28)
- Change in effective sleep(Day 28)
- Change in sleep latency(Day 28)
- Change in intra-sleep time(Day 28)
- Change in anxiety since baseline between groups(Month 4)
- Change in depression since baseline between groups(Month 4)
- Change in quality of life since baseline(Month 4)
- Use of hypnotic drugs between groups(Day 28)
- Use of anxiolytic drugs between groups(Day 28)
- Dose of any hypnotic drugs taken between groups(Day 28)
- Dose of any anxiolytic drugs taken between groups(Day 28)
- Completion of therapeutic education sessions of patients in the therapeutic education group(Day 28)
- Length of workshops in the therapeutic education group(Day 28)
- Problems encountered during workshops of patients in the therapeutic education group(Day 28)
- Patient-reported reason for refusal to participate in the therapeutic education group(Day 28)
- Improvement in chronic insomnia between groups(Month 4)