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NCT Number: NCT07699042

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

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

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Key information

Conditions

Insomnia Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

7/F, Sleep Assessment Unit, Shatin Hospital, 33 A Kung Kok Street, Ma On Shan, New Territories

Hong Kong

Location contact

Dr. Tim MH LI

CONTACT

[email protected]

+852 61150322

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

App-based dCBT-I with AI chatbot

Behavioral

Digital cognitive behavioral therapy for insomnia with two-way interactive, intelligent, and text-based conversational agents

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.

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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

  10. 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.

  11. 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

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. Acceptability E-scale questionnaire

    Time frame: post-intervention (1-month after baseline)

    evaluate patients' impressions of computerized or e-health programs.

  19. 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.

  20. 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.

  21. User survey

    Time frame: post-intervention (1-month after baseline)

    Measure perceived system usability, safety, interactivity, personalization, and overall user experience.

Study contacts

Contact information is provided by the study sponsor or research team.

Dr. Tim MH Li

CONTACT

[email protected]

+852 61150322

Ms. Phoebe K.Y. Chan

CONTACT

[email protected]

+852 53202853

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

Efficacy of Digital Cognitive Behavioral Therapy for Insomnia (CBT-I) Utilizing Embodied Artificial Intelligence Agent in Virtual Reality: A Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Jul 13, 2026
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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