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

NCT07699042 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2026-07-16

No results posted yet for this study

Summary

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

Conditions

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.

Sponsors & Collaborators

  • Chinese University of Hong Kong

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-23
Primary Completion
2028-09-30
Completion
2029-04-22

Countries

  • Hong Kong

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07699042 on ClinicalTrials.gov