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

Sponsor
Chinese University of Hong Kong
Study ID
NCT07699042
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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

Key Dates

First listed
Jul 13, 2026
Start date
Oct 23, 2026
Status verified
Jun 2026
Primary completion
Sep 30, 2028
Completion
Apr 22, 2029

Study Design

Enrollment
168 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • 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.
  • 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.

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) ]

Central Contacts

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