Better Sleep Without Medicine - a Cross-sectoral, Quantitative and Qualitative Study for Adult Patients With Mental Disorders and Sleep Problems
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- Change in sleep quality.
研究概览
简要总结
The aim of this study is to examine the effect of a non-pharmacological transdiagnostic sleep intervention as add on to standard treatment for bipolar disorder, depression and attention deficit disorder. Our hypothesis is that the intervention will reduce the severity of the sleep problem and increase sleep quality compared to a control group receiving sleep hygiene education.
详细描述
Sleep problems include insomnia, circadian rhythm disorders, hypersomnia, and inadequate sleep hygiene. Patients suffering from mental illness are more likely to suffer from sleep problems than the general population. Sleep problems can aggravate the underlying disorder, cause relapse and suicidal ideation. Sleep problems often persist after the mental disorder is successfully treated. Sleep medication is often used but not recommended for long term use. Non-pharmacological treatment of sleep problems is in demand by patients, but treatment options are few. The present intervention is based on a transdiagnostic manual combining Cognitive Behavioral Therapy for Insomnia with chronotherapy, but more research on the efficacy is warranted.
The aim of this study is to investigate whether the intervention reduces the severity of the sleep problem, increases sleep quality, leads to increased sleep efficiency, reduces sleep latency and awakenings, provides better quality of life, increases personal recovery, provides greater readiness to take on a job or reduces consumption of sleep medication.
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
- •Age ≥18 years
- •F31 Bipolar disorder, F32 unipolar depression or F90 attention deficit disorder
- •Insomnia Severity Index (ISI) ≥ 14 (exceeding the threshold for a sleep problem)
- •Sleep problems for 3 months: 3 times a week at least one of the following:
- •Sleep onset latency ≥ 30 minutes
- •Wake after sleep onset ≥ 30 minutes
- •Total sleep time ≥ 11 hours per day
- •Displaced circadian rhythm; sleeps earlier than 8 P.M. or later than 02 A.M.
- •Irregular circadian rhythm; bedtime varies ≥ 3 hours throughout the week
排除标准
- •Acutely increased suicide risk (Central Regions guideline for assessment of suicide risk)
- •Active substance abuse (F10-19)
- •The sleep problem can be significantly explained by insufficient treatment of physical
- •disease affecting sleep (documented in patients electronic journal)
- •Unstable social situation (does not have a permanent residence)
- •Shift work (≥ 2 times a week for the last 2 months)
- •Pregnancy and breast-feeding
结局指标
主要结局
Change in sleep quality.
时间窗: Is measured at inclusion (baseline/ week 0) and at week 6 (endpoint).
Measured by Pittsburgh Sleeping Quality Index (PSQI). The score is between 0 and 21, "0" indicating no difficulty and "21" indicating severe difficulties.
Change in the severity of the sleep problem
时间窗: Is measured at inclusion (baseline/ week 0), at week 2 and at week 6 (endpoint)
Is measured by Insomnia Severity Index. A self-report instrument measuring the patient's perception of insomnia. The scale ranges from 0 to 28. The higher the score the more severe the insomnia.
次要结局
- Change in well-being(Is measured at inclusion (baseline/ week 0), at week 2 and at week 6 (endpoint)
- Changes in sleep latency(Is measured daily during the 6 week study period)
- Changes in sleep nocturnal awakenings(Is measured daily during the 6 week study period.)
- Change in readiness to take on a job(Is measured at inclusion (baseline/ week 0), at week 2 and at week 6 (endpoint))
- Change in consumption of sleep medications(Is registered daily during the 6 week study period)
- Level of personal recovery(Is measured at inclusion (baseline/ week 0), at week 2 and at week 6 (endpoint).)
- Changes in health-related items.(Is measured at inclusion (baseline/ week 0), at week 2 and at week 6 (endpoint))
- Changes in sleep efficiency(Is measured daily during the 6 week study period.)