Efficacy of Digital CBT-I Utilizing Embodied Artificial Intelligence Agent in Virtual Reality
2026年7月15日 更新者：Tim M. H. Li、Chinese University of Hong Kong
Efficacy of Digital Cognitive Behavioral Therapy for Insomnia (CBT-I) Utilizing Embodied Artificial Intelligence Agent in Virtual Reality: A Randomized Controlled Trial
The goal of this clinical trial is to evaluate whether a virtually embodied artificial intelligence (AI) agent delivered via VR-enhanced digital cognitive behavioral therapy for insomnia (dCBT-I) can improve insomnia outcomes and treatment adherence in adults with insomnia.
The main questions it aims to answer are:
- Does VR-enhanced dCBT-I with an embodied AI agent lead to greater improvements in insomnia symptoms compared to app-based dCBT-I with an AI chatbot at post-intervention and 3-month follow-up?
Researchers will compare VR-enhanced dCBT-I with an embodied AI agent to app-based dCBT-I with an AI chatbot to see if the VR-enhanced intervention results in significantly improved clinical outcomes and adherence.
Participants will:
- Be randomly assigned to either the VR-enhanced AI agent intervention group or the app-based AI chatbot control group
- Complete a digital cognitive behavioral therapy for insomnia (dCBT-I) program with either a virtually embodied AI agent (VR-based) or a chatbot-based application
- Undergo assessments at baseline, post-intervention, and 3-month follow-up
研究概览
地位
尚未招聘
条件
研究类型
介入性
注册 (估计的)
168
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：Dr. Tim MH LI
- 电话号码：+852 61150322
- 邮箱：manholi@cuhk.edu.hk
研究联系人备份
- 姓名：Ms. Phoebe K.Y. Chan
- 电话号码：+852 53202853
- 邮箱：mastersleep@cuhk.edu.hk
学习地点
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Hong Kong、香港
- 7/F, Sleep Assessment Unit, Shatin Hospital, 33 A Kung Kok Street, Ma On Shan, New Territories
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接触：
- Dr. Tim MH LI
- 电话号码：+852 61150322
- 邮箱：manholi@cuhk.edu.hk
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-
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:
- Adults of Chinese ethnicity, aged between 18 and 65 years.
- Presence of insomnia, as indicated by a score of 10 or higher on the ISI.
- Meeting the DSM-IV-TR diagnostic criteria for insomnia disorder. The 1-month duration criterion in DSM-IV-TR rather than the 3-month criterion in DSM-V is adopted to broaden the clinical relevance of the study findings.
- Willing to provide online informed consent to participate in the study.
- Willing to comply with the requirements outlined in the study protocol.
- Possession of a smartphone and consistent internet access for smartphone use.
- Acceptance of the terms of service and privacy policies of the mobile apps used for intervention delivery.
Exclusion Criteria:
- A current or history of any sleep disorders other than insomnia disorder, such as narcolepsy, obstructive sleep apnea, and restless legs syndrome.
- A current or history of mental retardation or neuropsychiatric disorders other than depression or anxiety or stress disorders (as they are considered treatment outcomes), including bipolar disorder, schizophrenia, and substance use disorder.
- Presence of serious suicidality, demonstrated by ideation with a plan or a previous suicide attempt.
- Currently receiving long-term pharmacological treatment, including sleep-promoting agents.
- Currently undergoing structured psychotherapy.
- A current or history of significant visual, auditory, or balance impairment.
- A current or history of epilepsy
- Subject who is preparing for pregnancy or pregnant
- A current or history of any voice, speech, language disorders and learning difficulties.
- A current or history of severe health conditions (e.g., stroke, heart attack)
- Engaged in shiftwork or trans-meridian travel within the past 3 months or during the study.
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：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：App-based dCBT-I with AI chatbot
Participants will receive digital cognitive behavioral therapy for insomnia through a mobile application featuring a text-based artificial intelligence chatbot, which capable of two-way interactive communication.
The chatbot will provide psychoeducation, behavioral strategies, cognitive techniques, and relaxation sessions throughout the intervention period.
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Digital cognitive behavioral therapy for insomnia with two-way interactive, intelligent, and text-based conversational agents
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有源比较器：VR-enhanced dCBT-I with embodied AI agent
Participants will receive digital cognitive behavioral therapy for insomnia in a virtual reality environment.
The intervention will be delivered by a virtually embodied artificial intelligence agent capable of two-way interactive communication.
The embodied AI agent will provide the same therapeutic content as the app-based intervention, including psychoeducation, behavioral strategies, cognitive techniques, and relaxation sessions, while leveraging immersive virtual reality features to enhance user engagement and therapeutic interaction.
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Digital cognitive behavioral therapy for insomnia delivered in virtual reality with a two-way interactive, virtually embodied, and intelligent AI agent.
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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 |
|---|---|---|
|
Insomnia Severity Index
大体时间：a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
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the severity of insomnia symptoms
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a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
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Insomnia Module in the Diagnostic Interview for Sleep Disorder (DISP)
大体时间：a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
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the severity of insomnia symptoms
|
a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Sleep onset latency (SOL)
大体时间：a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
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7-day sleep diary
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a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
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Wake after sleep onset (WASO)
大体时间：a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
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7-day sleep diary
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a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
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Sleep efficiency (SE)
大体时间：a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
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7-day sleep diary
|
a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
|
|
Total sleep time (TST)
大体时间：a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
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7-day sleep diary
|
a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
|
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The Pre-Sleep Arousal Scale
大体时间：a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
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cognitive and somatic manifestations of arousal near bedtime Total score ranges from 8 to 40.
Higher scores suggest increased cognitive and somatic arousal before sleep.
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a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
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Ford Insomnia Response to Stress Test
大体时间：a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
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personal vulnerability to stress-related insomnia Total score ranges from 9 to 36.
Higher scores suggest a greater likelihood of stress-induced insomnia.
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a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
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Reduced Morningness and Eveningness Questionnaire
大体时间：a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
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Chronotype preference.
Total score ranges from 4 to 25.
Higher scores suggest a morning chronotype, while lower scores indicate an evening chronotype.
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a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
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The Dysfunctional Beliefs and Attitudes about Sleep Scale
大体时间：a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
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Faulty sleep-related beliefs and cognitions, which are cognitive aspects typically involved in the maintenance of insomnia.
Total score range of 0 to 160, with higher scores indicating stronger dysfunctional beliefs about sleep.
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a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
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Depression, Anxiety and Stress Scale - 21 Items
大体时间：a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
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The DASS-21 contains 21 items in three subscales, which assess symptoms of depression, anxiety, and stress
|
a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
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Patient Health Questionnaire-9
大体时间：a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
|
The severity of depressive symptoms.
Total score range of 0 to 27, where higher scores signify higher levels of depressive symptoms.
|
a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
|
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General Anxiety Disorder-7
大体时间：a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
|
The severity of anxiety symptoms.
Total score range of 0 to 21, with higher scores reflecting higher levels of anxiety symptoms
|
a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
|
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The Sleep Hygiene Index
大体时间：a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
|
The practice of sleep hygiene behaviors.
Total score ranges from 0 to 52.
Higher scores reflect poorer sleep hygiene practices.
|
a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
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The Multidimensional Fatigue Inventory
大体时间：a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
|
Five dimensions of fatigue (general fatigue, physical fatigues, mental fatigue, decreased motivation, and decreased activities).
Total score ranges from 20 to 100.
Higher scores indicate greater fatigue levels.
|
a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
|
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Sleep Self-Efficiency Scale
大体时间：a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
|
A 9-item scale evaluating abilities such as falling asleep quickly, returning to sleep after waking, and preventing a poor night's sleep from disrupting daily activities.
|
a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
|
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Revised Attitudes Toward Internet Questionnaire
大体时间：a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
|
evaluates users' psychological, behavioral, and emotional responses to being online.
|
a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
|
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Credibility and expectancy questionnaire
大体时间：a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
|
measure a participant's treatment credibility and outcome expectancy in therapy.
|
a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
|
|
Motivation to Change Sleep Behaviors questionnaire
大体时间：a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
|
Assess the level of motivation to change sleep behaviors.
|
a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
|
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Acceptability E-scale questionnaire
大体时间：post-intervention (1-month after baseline)
|
evaluate patients' impressions of computerized or e-health programs.
|
post-intervention (1-month after baseline)
|
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The Embodied Conversational Agents Trust Questionnaire
大体时间：post-intervention (1-month after baseline)
|
measure a user's trust in a virtual agent or avatar.
It evaluates trust across two dimensions: perceived credibility and perceived benevolence.
|
post-intervention (1-month after baseline)
|
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Adherence questionnaire
大体时间：post-intervention (1-month after baseline)
|
Assess the frequency of engagement in, and adherence to, the behavioral strategies and sleep-related recommendations taught during the program.
|
post-intervention (1-month after baseline)
|
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User survey
大体时间：post-intervention (1-month after baseline)
|
Measure perceived system usability, safety, interactivity, personalization, and overall user experience.
|
post-intervention (1-month after baseline)
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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。
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10月23日
初级完成 (估计的)
2028年9月30日
研究完成 (估计的)
2029年4月22日
研究注册日期
首次提交
2026年7月8日
首先提交符合 QC 标准的
2026年7月8日
首次发布 (实际的)
2026年7月13日
研究记录更新
最后更新发布 (实际的)
2026年7月16日
上次提交的符合 QC 标准的更新
2026年7月15日
最后验证
2026年6月1日
更多信息
与本研究相关的术语
其他研究编号
- 2025.771
- 23242231 (其他赠款/资助编号：Health and Medical Research Fund - Health Bureau)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
Individual participant data collected during this study will not be made publicly available because participant consent does not include permission for data sharing outside the study team and because of considerations related to participant privacy and confidentiality.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.