ISRCTN70652461已完成未知
Sleep and COgnition following Therapy for Insomnia: A randomized controlled trial of digital cognitive behavioral therapy for insomnia (CBTi)
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Participant is willing and able to give informed consent for participation in the study
- •2. Male or Female, aged 25-65 years
- •3. Screening positive for persistent insomnia disorder as indicated on the Sleep Condition Indicator
- •4. Average (over 7 nights) sleep onset latency of >30min and/or wake after sleep onset >30min (determined by actigraphy)
- •5. Typical sleep period takes place within the hours of 10pm – 9am
- •6. Can read and understand English
- •7. Regular access to the internet with a tablet, laptop or desktop computer
- •8. Normal or corrected to normal vision
排除标准
- •Current exclusion criteria as of 10/03/2020:
- •1. Unstable physical or mental health problems that may explain sleep disturbance
- •2. Additional sleep disorders (e.g. sleep disordered breathing or periodic leg movements during sleep)
- •3. Habitual night shift, evening, or rotating shift-workers
- •4. Undergoing a psychological treatment programme for insomnia with a health professional
- •5. Central nervous system medications (including hypnotics)
- •6. Substance misuse
- •7. Pregnancy
- •8. Psychosis or epilepsies
- •9. A score within the clinical range for depression (>14) or anxiety (>14) on the Hospital Anxiety and Depression Questionnaire (HADS)
- •10. Learning disability
- •11. Skin allergies or very sensitive skin
- •12. Diagnosis of a neurological condition (e.g. epilepsy, stroke, multiple sclerosis)
- •13. Previously accessing a digital CBT sleep improvement programme
- •Previous exclusion criteria as of 09/12/2019:
- •1. Unstable physical or mental health problems that may explain sleep disturbance
- •2. Additional sleep disorders (e.g. sleep disordered breathing or periodic leg movements during sleep)
- •3. Habitual night shift, evening, or rotating shift-workers
- •4. Undergoing a psychological treatment programme for insomnia with a health professional
- •5. Central nervous system medications (including hypnotics)
- •6. Substance misuse
- •7. Pregnancy
- •8. Psychosis or epilepsies
- •9. A score within the clinical range for depression (>10) or anxiety (>10) on the Hospital Anxiety and Depression Questionnaire (HADS)
- •10. Learning disability
- •11. Skin allergies or very sensitive skin
- •12. Diagnosis of a neurological condition (e.g. epilepsy, stroke, multiple sclerosis)
- •13. Previously accessing a digital CBT sleep improvement programme
- •Previous exclusion criteria:
- •1. Unstable physical or mental health problems that may explain sleep disturbance
- •2. Additional sleep disorders (e.g. sleep disordered breathing or periodic leg movements during sleep)
- •3. Habitual night shift, evening, or rotating shift-workers
- •4. Undergoing a psychological treatment programme for insomnia with a health professional
- •5. Central nervous system medications (including hypnotics)
- •6. Substance misuse
- •7. Pregnancy
- •8. Psychosis or epilepsies
- •9. A score within the clinical range for depression (>7) or anxiety (>10) on the Hospital Anxiety and Depression Questionnaire (HADS)
- •10. Learning disability
- •11. Skin allergies or very sensitive skin
- •12. Diagnosis of a neurological condition (e.g. epilepsy, stroke, multiple sclerosis)
- •Added 21/08/2019:
- •13. Previously accessing a digital CBT sleep improvement programme
研究者
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