An interventional study of App-based dCBT-I with AI chatbot and VR-enhanced dCBT-I with embodied AI agent in Insomnia, sponsored by Chinese University of Hong Kong. Not yet recruiting at 1 site in Hong Kong. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-07-16.
Sponsored by Chinese University of Hong Kong · Not applicable, Interventional, and Supportive care
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:
1,856 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 594 are open to participants now.
This study's planned enrollment of 168 is above the median of 73 across 1,631 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
Browse Sleep Initiation and Maintenance Disorders studies →Chinese University of Hong Kong is the lead sponsor of 1,419 studies on the registry; 487 are open to participants now.
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Exclusion Criteria:
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.
Behavioral: App-based dCBT-I with AI chatbot
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.
Behavioral: VR-enhanced dCBT-I with embodied AI agent
Digital cognitive behavioral therapy for insomnia with two-way interactive, intelligent, and text-based conversational agents
Digital cognitive behavioral therapy for insomnia delivered in virtual reality with a two-way interactive, virtually embodied, and intelligent AI agent.
Insomnia Severity Index
the severity of insomnia symptoms
Time frame: a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
Insomnia Module in the Diagnostic Interview for Sleep Disorder (DISP)
the severity of insomnia symptoms
Time frame: a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
Sleep onset latency (SOL)
7-day sleep diary
Time frame: a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
Wake after sleep onset (WASO)
7-day sleep diary
Time frame: a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
Sleep efficiency (SE)
7-day sleep diary
Time frame: a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
Total sleep time (TST)
7-day sleep diary
Time frame: a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
The Pre-Sleep Arousal Scale
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.
Time frame: a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
Ford Insomnia Response to Stress Test
personal vulnerability to stress-related insomnia Total score ranges from 9 to 36. Higher scores suggest a greater likelihood of stress-induced insomnia.
Time frame: a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
Reduced Morningness and Eveningness Questionnaire
Chronotype preference. Total score ranges from 4 to 25. Higher scores suggest a morning chronotype, while lower scores indicate an evening chronotype.
Time frame: a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
The Dysfunctional Beliefs and Attitudes about Sleep Scale
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.
Time frame: a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
Depression, Anxiety and Stress Scale - 21 Items
The DASS-21 contains 21 items in three subscales, which assess symptoms of depression, anxiety, and stress
Time frame: a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
Patient Health Questionnaire-9
The severity of depressive symptoms. Total score range of 0 to 27, where higher scores signify higher levels of depressive symptoms.
Time frame: a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
General Anxiety Disorder-7
The severity of anxiety symptoms. Total score range of 0 to 21, with higher scores reflecting higher levels of anxiety symptoms
Time frame: a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
The Sleep Hygiene Index
The practice of sleep hygiene behaviors. Total score ranges from 0 to 52. Higher scores reflect poorer sleep hygiene practices.
Time frame: a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
The Multidimensional Fatigue Inventory
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.
Time frame: a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
Sleep Self-Efficiency Scale
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.
Time frame: a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
Revised Attitudes Toward Internet Questionnaire
evaluates users' psychological, behavioral, and emotional responses to being online.
Time frame: a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
Credibility and expectancy questionnaire
measure a participant's treatment credibility and outcome expectancy in therapy.
Time frame: a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
Motivation to Change Sleep Behaviors questionnaire
Assess the level of motivation to change sleep behaviors.
Time frame: a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
Acceptability E-scale questionnaire
evaluate patients' impressions of computerized or e-health programs.
Time frame: post-intervention (1-month after baseline)
The Embodied Conversational Agents Trust Questionnaire
measure a user's trust in a virtual agent or avatar. It evaluates trust across two dimensions: perceived credibility and perceived benevolence.
Time frame: post-intervention (1-month after baseline)
Adherence questionnaire
Assess the frequency of engagement in, and adherence to, the behavioral strategies and sleep-related recommendations taught during the program.
Time frame: post-intervention (1-month after baseline)
User survey
Measure perceived system usability, safety, interactivity, personalization, and overall user experience.
Time frame: post-intervention (1-month after baseline)
Plan to share: No — 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.
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This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Sleep Initiation and Maintenance Disorders→
Chinese University of Hong Kong