The Sleepio After Cancer Study (SACS). Digital CBT for Insomnia in Women Cancer Patients - A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 308
- 试验地点
- 2
- 主要终点
- Proportion of women with SCI score >16 as measured by the Sleep Condition Indicator (SCI) Score
研究概览
简要总结
This study will recruit women over the age of 18 with a current or prior cancer diagnosis who have clinical insomnia. This study will examine the efficacy of digital cognitive behavioural therapy for insomnia (dCBT-I) compared to sleep hygiene education.
详细描述
Women who are eligible and provide informed consent will be enrolled into this 2-armed, parallel group open label randomised controlled trial. Participants will be randomised 1:1 to receive dCBT-I (intervention arm) or to sleep hygiene education (control arm). The primary outcome will be the mean continuous change in sleep condition indicator (SCI) score in the intervention arm compared to the control arm at 6 months. In addition to this, the proportion of women with an SCI > 16 at 6 months will be assessed. Secondary outcomes will include fatigue, sleep related quality of life, depression, anxiety, as well as hot flush interference in those experiencing vasomotor symptoms.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Aged 18 and over
- •Sleep Condition Indicator (SCI) score of 16 or less
- •Current or past diagnosis of cancer
- •Fluent in written and spoken English
- •Internet access and comfortable with its use
排除标准
- •Acute Illness
- •Life expectancy less than 6 months
- •Evidence of another sleep disorder
- •Untreated Psychiatric Disorder
- •Drug Misuse
- •Currently receiving CBT for insomnia from a health professional or taking part in an online treatment programme for insomnia
- •Any condition that may be exacerbated by sleep restriction therapy (Obstructive sleep apnoea, Bipolar disorder, psychosis, schizophrenia, epilepsy, current suicidal ideation, shift work, dementia, Parkinson's disease, Lewy body dementia)
- •Planned Major Surgery
- •Commencement or a change in sleep medication within the last 4 weeks
结局指标
主要结局
Proportion of women with SCI score >16 as measured by the Sleep Condition Indicator (SCI) Score
时间窗: 24 weeks
The co-primary outcome will be the proportion of women with an SCI score \> 16 at 24 weeks. Possible total score ranges from 0 to 32, with higher values indicative of better sleep. A score of 16 or less is indicative of insomnia.
Mean continuous change in the intervention group compared to the control arm as measured by the Sleep Condition Indicator Score
时间窗: 24 weeks
The primary outcome will be the mean continuous change in Sleep Condition Indicator score in the intervention arm compared to the control arm at 24 weeks. Possible total score ranges from 0 to 32, with higher values indicative of better sleep. The magnitude of change in SCI score that represents a reliable improvement on the Sleep Condition Indicator is 7 scale points
次要结局
- Fatigue as measured by the Fatigue Symptom inventory (FSI)(12, 24 and 33 weeks)
- Sleep related Quality of life as measured by Glasgow Sleep Impact Index (GSII)(12, 24 and 33 weeks)
- The impact of Hot Flushes as measured by the Hot Flash Related Daily Interference Scale (HFRDIS)(12, 24 and 33 weeks)
- Anxiety as measured by the Generalised Anxiety Disorder - 7 (GAD7) questionnaire(12, 24 and 33 weeks)
- Depression as measured by the Patient Health Questionnaire - 8 (PHQ8)(12, 24 and 33 weeks)