ISRCTN13983243已完成未知
Physiological and emotional hyperarousal in chronic insomnia, and their relationships with insomnia treatment: a randomized controlled trial of cognitive-behavioural therapy for insomnia versus waitlist in participants with chronic insomnia
Concordia University0 个研究点目标入组 60 人开始时间: 2018年8月13日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 60
研究概览
简要总结
2022 Results article in https://doi.org/10.1016/j.sleep.2022.05.010 (added 27/09/2022)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Meeting diagnostic criteria for chronic insomnia for at least 6 months
- •2. Aged 18 years or older
排除标准
- •1. Current neurological disorder
- •2. Past history of brain lesion
- •3. Major surgery requiring general anaesthesia in the past 3 months
- •4. Untreated thyroid disorder
- •5. Chronic pain syndrome self-reported as interfering with sleep
- •6. Recent and severe infection in the past 3 months (e.g. pneumonia, kidney infection)
- •7. Active cancer or treated cancer with post-cancer treatment for less than 2 years
- •9. Myocardial infarction
- •10. Arterial bypass or angioplasty (e.g. coronary, carotid, femoral)
- •11. Pacemaker
- •12. Heart failure causing limitation of ordinary physical activity
- •13. Renal insufficiency
- •14. Sleep apnea with an apnea-hypopnea index greater than 15/h
- •15. Restless legs syndrome with symptoms occurring on 3 or more days per week (based on Restless Legs Syndrome Rating Scale)
- •16. Periodic limb movements during sleep with index greater than 15/h during polysomnography
- •17. REM sleep behaviour disorder with more than 1 episode per month (based on polysomnography)
- •18. Narcolepsy with cataplexy (based on Ullanlinna Narcolepsy Scale)
- •19. Sleepwalking more than once per month
- •20. Having worked on night shifts or rotating shifts for more than 2 weeks in the last 3 months, or expecting to do so during the study period
- •21. Poor cognitive function (diagnosed with dementia and/or Montreal Cognitive Assessment (MoCA) less than 26)
- •22. Severe mental disorders:
- •22.1. Type I bipolar disorder
- •22.2. Schizophrenia
- •22.3. Anxiety disorders other than generalised anxiety disorder, except if associated with major depressive disorder (MDD)
- •22.4. Current substance use disorder
- •22.5. Current post-traumatic stress disorder
- •23. Current suicidality
- •24. Frequency alcohol consumption (more than 10 glasses per week)
- •25. Use of illicit drugs (more than once per month)
- •26. Pregnant or breastfeeding
- •27. Current psychotherapy or past cognitive behavioural therapy for insomnia
- •28. Unable to stop hypnosedative medications for at least 2 weeks prior to the first assessment
研究者
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