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

No phase Interventional Insomnia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: App-based dCBT-I with AI chatbot, VR-enhanced dCBT-I with embodied AI agent.
Who it may be relevant to
Registry conditions: Insomnia. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

Interventions

  • Behavioral App-based dCBT-I with AI chatbot
    Digital cognitive behavioral therapy for insomnia with two-way interactive, intelligent, and text-based conversational agents
  • 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.

Primary outcome measures

  • Insomnia Severity Index [Time frame: 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)]
Secondary outcome measures (12)
  • 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)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

Hong Kong · 1 center
  • 7/F, Sleep Assessment Unit, Shatin Hospital, 33 A Kung Kok Street, Ma On Shan, New Territo — Hong Kong

Identifiers

NCT: NCT07699042 · 2025.771 · 23242231

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗