App-delivered Sleep ThERapy for Older Individuals With Insomnia (ASTEROID Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 270
- 试验地点
- 2
- 主要终点
- Change in insomnia symptom severity
研究概览
简要总结
This randomised, open, parallel controlled trial aims to compare the efficacy of a digital brief behavioural therapy for insomnia (dBBTi) against online sleep health education on insomnia symptom severity in older adults aged 60 years and over. The trial will be totally online with participants recruited from the community across Australia.
详细描述
Insomnia is a highly prevalent sleep disorder affecting up to 10% of the adult population and reports of over 40% in the older population. Current insomnia treatments focus heavily on symptom management with cognitive behavioural therapy for insomnia (CBTi), in both digital and face-to-face form as the recommended first-line treatment. Despite the strong evidence for digital CBTi, there are a lack of data related to older people and whether digital brief behavioural therapy is efficacious in this population.
The investigators will conduct a fully online study comparing 6-weeks of digital brief behavioural therapy for insomnia (dBBTi) against online sleep health education. Participants will be recruited, screened and determined eligibility and consent will be conducted online. Thereafter, participants will be randomly allocated to either dBBTi delivered via a mobile application called SleepFix or wait-listed control. The SleepFix app delivers sleep restriction therapy using a 4 stage approach to improve sleep efficiency. The control will consist of 3 online sleep health education modules provided bi-weekly with information about sleep and sleep hygiene without any specific insomnia therapy. Participants will be recruited using social media and directed to a website to determine eligibility and then provided access to either the dBBTi (SleepFix) or the control with a link to the first online module.
At baseline, all participants will complete self-reported measures of insomnia, sleep, fatigue, sleepiness , anxiety, depression, quality of life, cognition and digital health literacy. These will be repeated at follow-up at weeks 8, 16 and 26.
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 (Investigator)
盲法说明
Participants will not be blinded as they will know what treatment they receive. This is typical of behavioural interventions.
Note: the study project coordinator will not be blinded as they will be managing the study such as sending sleep-tracking wearable devices to the intervention arm and communicating with participants. All investigators and data analysts will be blinded.
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Older adults aged ≥ 60 years
- •Able to give informed online consent
- •Insomnia Severity Index ≥ 10, including a score of 3 in at least one of the first three items (nocturnal symptoms).
- •English fluency
- •Access to a smartphone and willingness/proficiency to use a mobile app
排除标准
- •Shift-workers
- •Travel to a destination with >2 hours time-difference (within 30-days)
- •Serious medical and/or psychiatric illnesses/disorders or self-harm risk (Patient Health Questionnaire-9, item 9, 1+ score of risk of suicidal ideation)
- •Diagnosed sleep disorders other than insomnia
- •Regular sleep medications or sleep devices (>2 times a week over last 6 months)
- •Currently receiving or previously received (within the last 12 months) psychotherapy for insomnia including Cognitive Behavioural Therapy (CBT).
- •Drive for work/operate heavy machinery
结局指标
主要结局
Change in insomnia symptom severity
时间窗: Change score from baseline at 8 weeks
Insomnia Severity Index (ISI) is a 7-item questionnaire used to examine overall insomnia severity. It consists of a five-point Likert type scale for each item (ranging from "no problem" = 0 to "severe problem" = 4) regarding symptoms over the past 2 weeks. Scores range from 0-28 with higher scores indicating greater insomnia symptom severity.
次要结局
- Change in subjective sleep quality(Change score from baseline at 8 weeks)
- Change in sleep onset latency(Change score from baseline at 8 weeks)
- Change in fatigue(Change score from baseline at 8 weeks)
- Change in daytime sleepiness(Change score from baseline at 8 weeks)
- Change in quality of Life(Change score from baseline at 8 weeks)
- Change in self-reported cognition(Change score from baseline at 8 weeks)
- The effect of baseline digital health literacy on therapy efficacy(Baseline, week 8)
- Change in wake after sleep onset(Change score from baseline at 8 weeks)
- Change in total sleep time(Change score from baseline at 8 weeks)
- Change in depressive symptoms(Change score from baseline at 8 weeks)
- Change in anxiety(Change score from baseline at 8 weeks)
- Engagement(Baseline, week 8)