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

July 15, 2026 updated by: 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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
168

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • 7/F, Sleep Assessment Unit, Shatin Hospital, 33 A Kung Kok Street, Ma On Shan, New Territories
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Behavioral: App-based dCBT-I with AI chatbot
Digital cognitive behavioral therapy for insomnia with two-way interactive, intelligent, and text-based conversational agents
Active Comparator: 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.
Behavioral: VR-enhanced dCBT-I with embodied AI agent
Digital cognitive behavioral therapy for insomnia delivered in virtual reality with a two-way interactive, virtually embodied, and intelligent AI agent.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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)
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
a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Sleep onset latency (SOL)
Time Frame: a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
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)
Time Frame: a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
7-day sleep diary
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)
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)
Time Frame: a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
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
Time Frame: a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
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
Time Frame: a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
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
Time Frame: a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
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
Time Frame: a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
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
Time Frame: a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
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
Time Frame: 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)
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 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
Time Frame: 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)
The Multidimensional Fatigue Inventory
Time Frame: 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)
Sleep Self-Efficiency Scale
Time Frame: 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)
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)
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
Time Frame: 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
Time Frame: 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)
Acceptability E-scale questionnaire
Time Frame: post-intervention (1-month after baseline)
evaluate patients' impressions of computerized or e-health programs.
post-intervention (1-month after baseline)
The Embodied Conversational Agents Trust Questionnaire
Time Frame: 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)
Adherence questionnaire
Time Frame: 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)
User survey
Time Frame: post-intervention (1-month after baseline)
Measure perceived system usability, safety, interactivity, personalization, and overall user experience.
post-intervention (1-month after baseline)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chinese University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 23, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 22, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 8, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 8, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 13, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2025.771
  • 23242231 (Other Grant/Funding Number: Health and Medical Research Fund - Health Bureau)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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