Brief sleep health advice 和 2 weeks of chatbot-based daily sleep diary 和 10 weeks chatbot-based IM support 在精神健康-临床试验注册中心-ICH GCP

研究概览

地位

尚未招聘

条件

精神健康

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

100

阶段

不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

姓名：Shengzhi Zhao
电话号码：+852 6561 4500
邮箱：lubabezz@connect.hku.hk

研究联系人备份

姓名：Tsz Kiu Chan
电话号码：+852 5506 4711
邮箱：natctk1@hku.hk

学习地点

香港
- - Hong Kong、香港
    - School of Public Health, The University of Hong Kong, 18/F, Metro South Tower 1, 39 Wong Chuk Hang Road, Wong Chuk Hang, Hong Kong
    - 接触：
      
      Shengzhi Zhao
      
      电话号码：+852 6561 4500
      
      邮箱：lubabezz@connect.hku.hk
    - 首席研究员：
      
      Shengzhi Zhao
    - 接触：
      
      Tsz Kiu Chan
      
      电话号码：+852 5506 4711
      
      邮箱：natctk1@hku.hk

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

成人
年长者

接受健康志愿者

不

描述

Inclusion Criteria:

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.

Exclusion Criteria:

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

主要用途：卫生服务研究
分配：随机化
介入模型：并行分配
屏蔽：单身的

手臂数量

2

武器和干预

参与者组/臂	干预/治疗
实验性的：干预组	行为的：Brief sleep health advice At baseline, both groups will receive a 1-on-1 brief sleep health advice developed using guidelines by U.S. Centers for Diseases Control and Prevention and a booklet providing behavioral guidance on lifestyle and environmental factors related to sleep and insomnia. 行为的：2 weeks of chatbot-based daily sleep diary Following randomization, participants in the intervention group will complete a 2-week chatbot-based daily sleep diary. Each morning (e.g., 8:00 am), participants will be prompted via Whatsapp message delivered by chatbot to report key sleep parameters from the previous night, including bedtime, wake time, sleep onset latency, number and duration of nocturnal awakenings, total sleep time, and perceived sleep quality. The collected sleep diary data will be processed by the chatbot to generate tailored and personalized feedback, supporting individualized sleep recommendations and behavioral adjustments. At the initiation of the intervention, participants will also complete a brief baseline questionnaire to establish personalized treatment goals related to sleep improvement. Throughout the intervention period, participants will have continuous access to chatbot-delivered support, including adaptive guidance based on diary inputs, reinforcement of recommended sleep strategies, and progress 行为的：10 weeks chatbot-based IM support Participants in the intervention group will also receive cognitive behavioral therapy for insomnia (CBT-I) delivered via an LLM-based chatbot through WhatsApp over a 10-week period. The intervention is fully automated and available 24/7, with underlying algorithms enabling the delivery of information, therapeutic support, and advice in a personalized and adaptive manner, informed by participants' ongoing inputs and interaction patterns. The intervention will be structured into 20 chatbot-delivered instant messaging (2 pieces per week). The therapeutic content is adapted from established CBT-I manuals and led by research nurse, incorporating evidence-based behavioral, cognitive, and educational components. Behavioral strategies include sleep restriction, stimulus control, and relaxation techniques. Cognitive components comprise paradoxical intention, cognitive restructuring, mindfulness-based techniques, positive imagery, and strategies for "putting the day to rest." Educational compone
有源比较器：控制组	行为的：Brief sleep health advice At baseline, both groups will receive a 1-on-1 brief sleep health advice developed using guidelines by U.S. Centers for Diseases Control and Prevention and a booklet providing behavioral guidance on lifestyle and environmental factors related to sleep and insomnia.

参与者组/臂

干预/治疗

实验性的：干预组

行为的：Brief sleep health advice

At baseline, both groups will receive a 1-on-1 brief sleep health advice developed using guidelines by U.S. Centers for Diseases Control and Prevention and a booklet providing behavioral guidance on lifestyle and environmental factors related to sleep and insomnia.

行为的：2 weeks of chatbot-based daily sleep diary

Following randomization, participants in the intervention group will complete a 2-week chatbot-based daily sleep diary. Each morning (e.g., 8:00 am), participants will be prompted via Whatsapp message delivered by chatbot to report key sleep parameters from the previous night, including bedtime, wake time, sleep onset latency, number and duration of nocturnal awakenings, total sleep time, and perceived sleep quality. The collected sleep diary data will be processed by the chatbot to generate tailored and personalized feedback, supporting individualized sleep recommendations and behavioral adjustments. At the initiation of the intervention, participants will also complete a brief baseline questionnaire to establish personalized treatment goals related to sleep improvement. Throughout the intervention period, participants will have continuous access to chatbot-delivered support, including adaptive guidance based on diary inputs, reinforcement of recommended sleep strategies, and progress

行为的：10 weeks chatbot-based IM support

Participants in the intervention group will also receive cognitive behavioral therapy for insomnia (CBT-I) delivered via an LLM-based chatbot through WhatsApp over a 10-week period. The intervention is fully automated and available 24/7, with underlying algorithms enabling the delivery of information, therapeutic support, and advice in a personalized and adaptive manner, informed by participants' ongoing inputs and interaction patterns. The intervention will be structured into 20 chatbot-delivered instant messaging (2 pieces per week). The therapeutic content is adapted from established CBT-I manuals and led by research nurse, incorporating evidence-based behavioral, cognitive, and educational components. Behavioral strategies include sleep restriction, stimulus control, and relaxation techniques. Cognitive components comprise paradoxical intention, cognitive restructuring, mindfulness-based techniques, positive imagery, and strategies for "putting the day to rest." Educational compone

有源比较器：控制组

行为的：Brief sleep health advice

At baseline, both groups will receive a 1-on-1 brief sleep health advice developed using guidelines by U.S. Centers for Diseases Control and Prevention and a booklet providing behavioral guidance on lifestyle and environmental factors related to sleep and insomnia.

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Self-reported insomnia severity 大体时间：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.	6-month follow-up

次要结果测量

结果测量	措施说明	大体时间
Health-related quality of life 大体时间：3- and 6-month follow-ups	Assessed using 36-Item Short Form Health Survey [SF-36]. The SF-36 is a 36-item self-reported instrument that measures both Physical Component Scores and Mental Component Scores, with scores ranging from 0 to 100; higher scores indicate better health-related quality of life.	3- and 6-month follow-ups
Sleep-related quality of life 大体时间：3- and 6-month follow-ups	Assessed using Glasgow Sleep Impact Index [GSII]. The GSII is a 7-item self-report instrument that evaluates the sleep-related quality of life, with total scores ranging from 0 to 28, higher scores indicate lower level of sleep-related quality of life.	3- and 6-month follow-ups
Depressive symptoms 大体时间：3- and 6-month follow-ups	Assessed using Patient Health Questionnaire-9 [PHQ-9]. The PHQ-9 is a 9-item self-report instrument that evaluates frequency and severity of depressive symptoms, with total scores ranging from 0 to 27, higher scores indicate higher level of depression.	3- and 6-month follow-ups
Anxiety symptoms 大体时间：3- and 6-month follow-ups	Assessed using Generalized Anxiety Disorder-7 [GAD-7]. The GAD-7 is a 7-item self-report instrument that evaluates the frequency and severity of anxious symptoms, with total scores ranging from 0 to 21, higher scores indicate higher level of anxiety.	3- and 6-month follow-ups
Sleep effort 大体时间：3- and 6-month follow-ups	Assessed using Glasgow Sleep Effort Scale [GSES]. The GSES is a 7-item self-reported instrument, with scores ranging from 0 to 14, higher scores indicate greater sleep effort.	3- and 6-month follow-ups
Pre-sleep arousal 大体时间：3- and 6-month follow-ups	Assessed using Pre-Sleep Arousal Scale [PSAS]. The PSAS is a 16-item self-reported instrument consists of two subscales (cognitive arousal and somatic arousal), with scores ranging from 8 to 40 on each subscale, higher scores indicate greater pre-sleep arousal.	3- and 6-month follow-ups

其他结果措施

结果测量	措施说明	大体时间
Recruitment rate 大体时间：Baseline	Defined as the number of participants divided by the number of eligible university students.	Baseline
Retention rate 大体时间：3- and 6-month follow-ups	Defined as the number of participants who completed the follow-up divided by the number of participants.	3- and 6-month follow-ups
Engagement rate of the interventions 大体时间：3- and 6-month follow-ups	Engagement rate will be determined by Instant message (IM) log. At least 2 times response will be considered as engaged.	3- and 6-month follow-ups
Usability for the development of a full-scale trial 大体时间：3- and 6-month follow-ups	We will use the 10-item System Usability Scale (SUS) to assess perceived effectiveness, efficiency, and satisfaction of the intervention. The score of SUS ranges from 0 to 100 and 68 is the threshold to determine the usability for the development of a full-scale trial.	3- and 6-month follow-ups
Usability of the chatbot 大体时间：3- and 6-month follow-ups	The usability of the chatbot (Cronbach's alpha: 0.90) is measured by the validated 15-item Bot Usability Scale (BUS).	3- and 6-month follow-ups

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

The University of Hong Kong

调查人员

首席研究员：Shengzhi Zhao、The University of Hong Kong

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年9月1日

初级完成 (估计的)

2027年9月30日

研究完成 (估计的)

2027年10月31日

研究注册日期

首次提交

2026年7月13日

首先提交符合 QC 标准的

2026年7月13日

首次发布 (实际的)

2026年7月17日

研究记录更新

最后更新发布 (实际的)

2026年7月24日

上次提交的符合 QC 标准的更新

2026年7月23日

最后验证

2026年7月1日

Nurse-led Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) in University Students With Mild to Moderate Mental Health Problems

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

研究概览

地位

条件

干预/治疗

详细说明

研究类型

注册 (估计的)

阶段

联系人和位置

学习联系方式

研究联系人备份

学习地点

参与标准

资格标准

适合学习的年龄

接受健康志愿者

描述

学习计划

研究是如何设计的？

设计细节

手臂数量

武器和干预

参与者组/臂

干预/治疗

研究衡量的是什么？

主要结果指标

结果测量

措施说明

大体时间

次要结果测量

结果测量

措施说明

大体时间

其他结果措施

结果测量

措施说明

大体时间

合作者和调查者

赞助

调查人员

研究记录日期

研究主要日期

学习开始 (估计的)

初级完成 (估计的)

研究完成 (估计的)

研究注册日期

首次提交

首先提交符合 QC 标准的

首次发布 (实际的)

研究记录更新

最后更新发布 (实际的)

上次提交的符合 QC 标准的更新

最后验证

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

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