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

NCT07699042 | Not Yet Recruiting DMC

• 2 other identifiers: 2025.77123242231
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

Brief 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

Insomnia

Outcome Measures

Primary Outcomes (2)

• Insomnia Severity Index

  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)

  the severity of insomnia symptoms

  a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)

Secondary Outcomes (21)

• Sleep onset latency (SOL)

  a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)

• Wake after sleep onset (WASO)

  a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)

• Sleep efficiency (SE)

  a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)

• Total sleep time (TST)

  a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)

• The Pre-Sleep Arousal Scale

  a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)

Study Arms (2)

App-based dCBT-I with AI chatbot

EXPERIMENTAL

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

VR-enhanced dCBT-I with embodied AI agent

ACTIVE COMPARATOR

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

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

App-based dCBT-I with AI chatbot

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.

VR-enhanced dCBT-I with embodied AI agent

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

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

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Central Study Contacts

Dr. Tim MH Li

CONTACT

+852 61150322; manholi@cuhk.edu.hk

Ms. Phoebe K.Y. Chan

CONTACT

+852 53202853; mastersleep@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 8, 2026
• First Posted: July 13, 2026
• Study Start (Estimated): October 23, 2026
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): April 22, 2029
• Last Updated: July 16, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)