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Efficacy of Digital CBT-I Utilizing Embodied Artificial Intelligence Agent in Virtual Reality

Key facts

Who runs it
Chinese University of Hong Kong
Where
Hong Kong, Hong KongSee the site
Trial code
Status
Not yet recruiting
People taking part
168 people, planned
Started
23 Oct 2026
Expected to end
22 Apr 2029
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • App-based dCBT-I with AI chatbot
  • VR-enhanced dCBT-I with embodied AI agent
Record updated
16 July 2026

Who can take part

Age
18 years to 65 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 18 criteriaShow less

Who can take part

  • 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 take part

  • 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
  • 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
  • A current or history of significant visual, auditory, or balance impairment
  • A current or history of epilepsy
  • 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)
  • Currently undergoing structured psychotherapy
  • Subject who is preparing for pregnancy or pregnant
  • Engaged in shiftwork or trans-meridian travel within the past 3 months or during the study

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 65 years old?

Where in Hong Kong

  • 7/F, Sleep Assessment Unit, Shatin Hospital, 33 A Kung Kok Street, Ma On Shan, New TerritoriesHong Kong, Hong KongContact: Dr. Tim MH LINo longer taking part

About the trial

What the trial wants to find out

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 full original descriptionShow less

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

The 2 groups in the trial

  • App-based dCBT-I with AI chatbotTreatment being tested

    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.

  • VR-enhanced dCBT-I with embodied AI agentExisting treatment, for comparison

    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.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Efficacy of Digital Cognitive Behavioral Therapy for Insomnia (CBT-I) Utilizing Embodied Artificial Intelligence Agent in Virtual Reality: A Randomized Controlled Trial
Fit questions
Built from NCT07699042, who can take part
Record updated
16 July 2026