A Randomized Controlled Trial of Digital Cognitive Behavioral Therapy for Insomnia (dCBTi) for Adults With Attention Deficit Hyperactivity Disorder (ADHD)
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Changes in Insomnia Severity Index (ISI)
研究概览
简要总结
The current study aims to evaluate the efficacy and feasibility of a digital application-based CBTi treatment devised for adults with ADHD and insomnia compared to self-monitoring and sleep hygiene control condition.
详细描述
Participants would be randomly assigned to the experimental or sleep diary self-monitoring (control) group. Participants in the experimental group would use a digital application for seven weeks, whereas participants in the control group would watch psychoeducation videos on sleep hygiene and enter sleep diary measures using the application for seven weeks.
Question 1:
Does dCBTi work better than the active control?
Hypothesis 1:
Improvement in insomnia (immediately after treatment and at 1-month follow-up) would be greater for the experimental group than the active control group.
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 (Outcomes Assessor)
盲法说明
All outcome measures will be administered via online surveys
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(a) Hong Kong resident,
- •(b) Aged between 18-60,
- •(c) Diagnosed with ADHD,
- •(d) Able to read and write Chinese,
- •(e) Has regular access to a smart phone and internet,
- •(f) Insomnia severity index ⩾10
排除标准
- •(a) Having comorbid bipolar disorder, psychosis, suicidality, moderately severe to severe depression, narcolepsy, and/or hypersomnolence disorder,
- •(b) Having medical conditions that might affect sleep (e.g., serious physical concerns necessitating surgery, risk of falls, epilepsy),
- •(c) Having night shift schedules at work,
- •(d) Currently receiving psychological intervention for insomnia
研究组 & 干预措施
Digital Sleep Hygiene and Self-Monitoring Control
Participants assigned to this condition will receive an app to track sleep and offers sleep hygiene recommendations
干预措施: Sleep Hygiene and Self-Monitoring Control (Behavioral)
dCBTi-ADHD
Participants assigned to this condition will receive a 7-module digital cognitive behavioral therapy for insomnia (dCBTi) tailored for adults with ADHD
干预措施: dCBTi-ADHD (Behavioral)
结局指标
主要结局
Changes in Insomnia Severity Index (ISI)
时间窗: 13 weeks from baseline
Insomnia symptoms measured by the Insomnia Severity Index (ISI). The score ranges from 0 to 24. Higher scores indicate greater levels of insomnia symptoms
次要结局
- Changes in depressive symptoms(13 weeks from baseline)
- Changes in fatigue(13 weeks from baseline)
- Changes in total sleep time (TST)(13 weeks from baseline)
- Changes in sleep efficiency (SE)(13 weeks from baseline)
- Changes in sleep onset latency (SOL)(13 weeks from baseline)
- Changes in midsleep time (MST)(13 weeks from baseline)
- Changes in anxiety symptoms(13 weeks from baseline)
- Changes in mental wellbeing(13 weeks from baseline)
- Changes in ADHD symptoms(13 weeks from baseline)
- Changes in functional impairment due to ADHD symptoms(13 weeks from baseline)
- Changes in executive skills(13 weeks from baseline)
研究者
Dr. Chan Wai Sze
Assistant Professor
The University of Hong Kong