Nurse-led Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) in University Students With Mild to Moderate Mental Health Problems: a Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Self-reported insomnia severity
研究概览
简要总结
This study aims to evaluate the feasibility, acceptability, and potential effectiveness of a nurse-led digital cognitive behavioral therapy for insomnia (dCBT-I) via large language model based-chatbot among university students with mental health problems.
详细描述
This is a two-arm, parallel pilot randomized controlled trial recruiting 100 university students in Hong Kong with mild to moderate symptoms of depression or anxiety who also screen positive for insomnia symptoms. All participants will receive brief sleep health advice and a booklet providing behavioral guidance on lifestyle and environmental factors related to sleep and insomnia. Participants in the intervention group will additionally receive 12 weeks of chatbot-delivered insomnia management intervention, including 2 weeks of daily sleep diary monitoring and 10 weeks of nurse-led instant messaging support grounded in cognitive behavioral therapy for insomnia (CBT-I). The primary outcome is self-reported insomnia severity at 6-month follow-up. Secondary outcomes include health-related quality of life, sleep related quality of life, sleep effort, pre-sleep arousal, anxiety and depression assessed at 3 and 6 months. Analyses will be conducted on intention-to-treat basis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
盲法说明
Blinding of the participants and treatment providers will not be possible because the behavior nature of the intervention, but the outcome assessors and statistical analysts will be blinded to group allocation.
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
- •Students aged ≥ 18 years from 22 local higher education institutions (University or Colleges) listed in Education Bureau.
- •Screening score indicating mild to moderate anxiety or depression, defined as a GAD-7 score of 5-14 and/or a PHQ-9 score of 5-14 at baseline.
- •Screened positive for insomnia symptoms using the Sleep Condition Indicator (SCI) and meeting DSM-5 diagnostic criteria for insomnia disorder.
- •Reporting a self-reported sleep efficiency of less than 85% over the past month.
- •Able to communicate in Chinese.
排除标准
- •Participants who self-reported diagnosis of epilepsy, schizophrenia, or bipolar disorder
- •Participants who self-reported current suicidal ideation with intent or a suicide attempt within the past 2 months
- •Participants who self-reported current receipt of psychological or behavioral treatment for insomnia from a health professional
- •Participants who self-reported participation in an online or digital insomnia treatment programme at the time of enrolment.
研究组 & 干预措施
Intervention group
干预措施: 2 weeks of chatbot-based daily sleep diary (Behavioral)
Intervention group
干预措施: 10 weeks chatbot-based IM support (Behavioral)
Intervention group
干预措施: Brief sleep health advice (Behavioral)
Control group
干预措施: Brief sleep health advice (Behavioral)
结局指标
主要结局
Self-reported insomnia severity
时间窗: 6-month follow-up
Assessed using the Insomnia Severity Index (ISI). The ISI is a 7-item self-report instrument that evaluates both nocturnal and daytime symptoms of insomnia, with total scores ranging from 0 to 28, higher scores indicate greater insomnia severity.
次要结局
- Health-related quality of life(3- and 6-month follow-ups)
- Sleep-related quality of life(3- and 6-month follow-ups)
- Depressive symptoms(3- and 6-month follow-ups)
- Anxiety symptoms(3- and 6-month follow-ups)
- Sleep effort(3- and 6-month follow-ups)
- Pre-sleep arousal(3- and 6-month follow-ups)
研究者
Shengzhi Zhao
Research Assistant Professor
The University of Hong Kong