An Investigation Into the Efficacy of Online Cognitive Behavioural Therapy for Insomnia ("Sleepio") to Improve Sleep After Stroke.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- Sleep Condition Indicator Score at Post-intervention, Adjusted for Baseline Score and Sex
研究概览
简要总结
This study evaluates the efficacy of digital cognitive behavioural therapy for insomnia (Sleepio) in chronic stroke survivors. Half of the participants will receive access to the digital (online) programme, half will receive a leaflet with sleep hygiene information. The primary outcome will be changes in sleep quality, assessed as the score on the Sleep Condition Indicator.
详细描述
Stroke is one of the leading causes of adult disability. Many stroke survivors report difficulties with sleep and our current research confirms this, indicating that chronic community dwelling stroke survivors experience poorer self-reported and objective sleep quality than age matched healthy controls.
"Sleepio" is an online Cognitive Behavioural Therapy for Insomnia (CBT-I) programme. The efficacy of this intervention has been demonstrated in people with chronic insomnia but has not yet been tested in people with stroke. The study therefore aims to determine whether digital CBT-I is effective for improving sleep quality in chronic stroke survivors. Participants will be randomised to receive either digital (online) CBT-I or a leaflet with sleep hygiene information. The primary outcome is the change in self-reported sleep quality, assessed using the Sleep Condition Indicator. Secondary outcomes include changes in sleep fragmentation and wake after sleep onset assessed with actigraphy, self-reported sleep onset latency from the sleep diaries, anxiety and depression using the PHQ9 and GAD7, quality of life using the SIS-8 and EQ-5D-5L as well as changes in healthcare costs during the 8 week follow up.
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
- Single (Participant)
盲法说明
Participants will be told that they will be assigned to one of two groups but will not be told whether one is hypothesised to be superior over another
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
- •Participant is willing and able to give informed consent for participation in the study.
- •At least 18 years of age
- •At least 3 months post stroke
- •Interest in improving sleep
- •Can understand verbal and written English well enough to engage with the programme and study procedures (with assistance from carer if needed).
- •Reliable access to internet
- •Currently living in the United Kingdom
- •Current stable health
排除标准
- •Serious physical health concerns with surgery scheduled in the next 5 months
- •Undergoing a psychological treatment programme for insomnia (with a health professional or online)
- •Pregnancy
- •Uncontrolled seizures
- •Untreated diagnosed obstructive sleep apnoea
- •Habitual night shift, evening or rotating shift-workers
- •Other serious clinical condition that may affect participation in the study
结局指标
主要结局
Sleep Condition Indicator Score at Post-intervention, Adjusted for Baseline Score and Sex
时间窗: 8 weeks
Self-reported sleep quality questionnaire, range 0-32, higher numbers indicate better sleep quality Assessed at baseline and post-intervention. Outcome is post-intervention score after adjustment for baseline score and sex using Analysis of Covariance
次要结局
- Sleep Condition Indicator Score at 8 Week Follow up Adjusted for Baseline Score(16 weeks)
- Sleep Fragmentation, Assessed at Post-intervention Adjusted for Baseline(8 weeks)
- Sleep Fragmentation at 8 Week Follow up Adjusted for Baseline(16 weeks)
- Wake After Sleep Onset at Post-intervention Adjusted for Baseline(8 weeks)
- Wake After Sleep Onset at 8 Week Follow up Adjusted for Baseline(16 weeks)
- Change in Sleep Onset Latency(8 weeks)
- Self-reported Depression Post-intervention, Assessed as PHQ9 Score at Post-intervention Adjusted for Baseline(8 weeks)
- Self-reported Depression at 8 Week Follow up, Assessed as PHQ9 Score at 8 Week Follow up Adjusted for Baseline(16 weeks)
- Self-reported Anxiety at Post-intervention, Assessed as GAD7 Score Post-intervention Adjusted for Baseline(8 weeks)
- Self-reported Anxiety at 8 Week Follow up, Assessed as GAD7 Score at 8 Week Follow up Adjusted for Baseline(16 weeks)
- Stroke Specific Quality of Life, Assessed as SIS Index Post-intervention Adjusted for Baseline(8 weeks)
- Stroke Specific Quality of Life at 8 Week Follow up, Assessed as SIS Index at 8 Week Follow up Adjusted for Baseline(16 weeks)