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| ID | Type | Description | Link |
|---|---|---|---|
| 23242231 | Other Grant/Funding Number | Health and Medical Research Fund - Health Bureau |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| App-based dCBT-I with AI chatbot | Experimental | 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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| VR-enhanced dCBT-I with embodied AI agent | Active Comparator | 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| App-based dCBT-I with AI chatbot | Behavioral | Digital cognitive behavioral therapy for insomnia with two-way interactive, intelligent, and text-based conversational agents |
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| Measure | Description | Time Frame |
|---|---|---|
| Insomnia Severity Index | the severity of insomnia symptoms | 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 | a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline) |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep onset latency (SOL) | 7-day sleep diary | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr. Tim MH Li | Contact | +852 61150322 | manholi@cuhk.edu.hk | |
| Ms. Phoebe K.Y. Chan | Contact | +852 53202853 | mastersleep@cuhk.edu.hk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 7/F, Sleep Assessment Unit, Shatin Hospital, 33 A Kung Kok Street, Ma On Shan, New Territories | Hong Kong | Hong Kong |
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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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| VR-enhanced dCBT-I with embodied AI agent | Behavioral | Digital cognitive behavioral therapy for insomnia delivered in virtual reality with a two-way interactive, virtually embodied, and intelligent AI agent. |
|
| 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 | 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 | 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. | 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. | 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. | 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. | 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 | 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. | 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 | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | post-intervention (1-month after baseline) |
| User survey | Measure perceived system usability, safety, interactivity, personalization, and overall user experience. | post-intervention (1-month after baseline) |
| D001523 |
| Mental Disorders |