InsomniaNCT07699042
Efficacy of Digital CBT-I Utilizing Embodied Artificial Intelligence Agent in Virtual Reality
A study testing App-based dCBT-I with AI chatbot and VR-enhanced dCBT-I with embodied AI agent in people with Insomnia, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Insomnia
- What is being tested?
- App-based dCBT-I with AI chatbot and VR-enhanced dCBT-I with embodied AI agent
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteHong Kong
- Study dates
- 23 Oct 2026to 22 Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site
7/F, Sleep Assessment Unit, Shatin Hospital, 33 A Kung Kok Street, Ma On Shan, New Territories
Hong Kong
Dr. Tim MH LI, +852 61150322, manholi@cuhk.edu.hk
About this study
Official title: 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:
Read more
- 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
- Conditions
- Insomnia
- Being tested
- App-based dCBT-I with AI chatbot, VR-enhanced dCBT-I with embodied AI agent
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
App-based dCBT-I with AI chatbotBehavioural
Digital cognitive behavioral therapy for insomnia with two-way interactive, intelligent, and text-based conversational agents
VR-enhanced dCBT-I with embodied AI agentBehavioural
Digital cognitive behavioral therapy for insomnia delivered in virtual reality with a two-way interactive, virtually embodied, and intelligent AI agent.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: App-based dCBT-I with AI chatbot |
| 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. Receives: Behavioral: VR-enhanced dCBT-I with embodied AI agent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia Severity Index
the severity of insomnia symptoms
Measured: 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
Measured: a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
Secondary outcomes (21)
Sleep onset latency (SOL)
7-day sleep diary
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: post-intervention (1-month after baseline)
User survey
Measure perceived system usability, safety, interactivity, personalization, and overall user experience.
Measured: post-intervention (1-month after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start23 Oct 2026 (estimated)
- Primary completion30 Sep 2028 (estimated)
- Study completion22 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tim M. H. Li, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07699042
- Sponsor's protocol ID
- 2025.771
- Other IDs
- 23242231
- Status last verified
- Jun 2026
- First submitted
- 8 Jul 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Digital Cognitive Behavioral Therapy for Insomnia (CBT-I) Utilizing Embodied Artificial Intelligence Agent in Virtual Reality: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07699042
- Acronym / sponsor ID
- 2025.771
- Conditions
- Insomnia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 23 Oct 2026 (estimated)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 22 Apr 2029 (estimated)
- First posted
- 13 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| App-based dCBT-I with AI chatbot | Experimental | Behavioral: App-based dCBT-I with AI chatbotParticipants 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. |
| VR-enhanced dCBT-I with embodied AI agent | Active comparator | Behavioral: VR-enhanced dCBT-I with embodied AI agentParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| App-based dCBT-I with AI chatbotDigital cognitive behavioral therapy for insomnia with two-way interactive, intelligent, and text-based conversational agents | Behavioural | App-based dCBT-I with AI chatbot |
| VR-enhanced dCBT-I with embodied AI agentDigital cognitive behavioral therapy for insomnia delivered in virtual reality with a two-way interactive, virtually embodied, and intelligent AI agent. | Behavioural | VR-enhanced dCBT-I with embodied AI agent |
Primary outcome
Insomnia Severity Index
Time frame: a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
the severity of insomnia symptoms
Insomnia Module in the Diagnostic Interview for Sleep Disorder (DISP)
Time frame: a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
the severity of insomnia symptoms
21 secondary outcomes
Sleep onset latency (SOL)
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)
Time frame: a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
Sleep efficiency (SE)
Time frame: a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
Total sleep time (TST)
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
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
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
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
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
Time frame: a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
Patient Health Questionnaire-9
Time frame: a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
General Anxiety Disorder-7
Time frame: a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
The Sleep Hygiene Index
Time frame: a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
The Multidimensional Fatigue Inventory
Time frame: a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
Sleep Self-Efficiency Scale
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
Time frame: a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
Credibility and expectancy questionnaire
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
Time frame: a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
Acceptability E-scale questionnaire
Time frame: post-intervention (1-month after baseline)
The Embodied Conversational Agents Trust Questionnaire
Time frame: post-intervention (1-month after baseline)
Adherence questionnaire
Time frame: post-intervention (1-month after baseline)
User survey
Time frame: post-intervention (1-month after baseline)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing App-based dCBT-I with AI chatbot and VR-enhanced dCBT-I with embodied AI agent in people with Insomnia, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Tim MH Li (+852 61150322, manholi@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia Severity Index (time frame: a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026; AzTrials last refreshed its copy on 3 Nov 2026.