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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Insomnia
• Intervention / Treatment: Behavioral: App-based dCBT-I with AI chatbot; Behavioral: VR-enhanced dCBT-I with embodied AI agent

• Study Type: Interventional
• Enrollment (Estimated): 168
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dr. Tim MH LI; Phone Number: +852 61150322; Email: manholi@cuhk.edu.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • 7/F, Sleep Assessment Unit, Shatin Hospital, 33 A Kung Kok Street, Ma On Shan, New Territories
    • Contact: Dr. Tim MH LI; Phone Number: +852 61150322; Email: manholi@cuhk.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: App-based dCBT-I with AI chatbot	Behavioral: App-based dCBT-I with AI chatbot; Digital cognitive behavioral therapy for insomnia with two-way interactive, intelligent, and text-based conversational agents
Active Comparator: VR-enhanced dCBT-I with embodied AI agent	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep onset latency (SOL)	7-day sleep diary	a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
Wake after sleep onset (WASO)	7-day sleep diary	a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
Sleep efficiency (SE)	7-day sleep diary	a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
Total sleep time (TST)	7-day sleep diary	a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
The Pre-Sleep Arousal Scale	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.	a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
Ford Insomnia Response to Stress Test	personal vulnerability to stress-related insomnia Total score ranges from 9 to 36. Higher scores suggest a greater likelihood of stress-induced insomnia.	a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
Reduced Morningness and Eveningness Questionnaire	Chronotype preference. Total score ranges from 4 to 25. Higher scores suggest a morning chronotype, while lower scores indicate an evening chronotype.	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	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.	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	The DASS-21 contains 21 items in three subscales, which assess symptoms of depression, anxiety, and stress	a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
Patient Health Questionnaire-9	The severity of depressive symptoms. Total score range of 0 to 27, where higher scores signify higher levels of depressive symptoms.	a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
General Anxiety Disorder-7	The severity of anxiety symptoms. Total score range of 0 to 21, with higher scores reflecting higher levels of anxiety symptoms	a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
The Sleep Hygiene Index	The practice of sleep hygiene behaviors. Total score ranges from 0 to 52. Higher scores reflect poorer sleep hygiene practices.	a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
The Multidimensional Fatigue Inventory	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.	a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
Sleep Self-Efficiency Scale	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.	a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
Revised Attitudes Toward Internet Questionnaire	evaluates users' psychological, behavioral, and emotional responses to being online.	a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
Credibility and expectancy questionnaire	measure a participant's treatment credibility and outcome expectancy in therapy.	a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
Motivation to Change Sleep Behaviors questionnaire	Assess the level of motivation to change sleep behaviors.	a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
Acceptability E-scale questionnaire	evaluate patients' impressions of computerized or e-health programs.	post-intervention (1-month after baseline)
The Embodied Conversational Agents Trust Questionnaire	measure a user's trust in a virtual agent or avatar. It evaluates trust across two dimensions: perceived credibility and perceived benevolence.	post-intervention (1-month after baseline)
Adherence questionnaire	Assess the frequency of engagement in, and adherence to, the behavioral strategies and sleep-related recommendations taught during the program.	post-intervention (1-month after baseline)
User survey	Measure perceived system usability, safety, interactivity, personalization, and overall user experience.	post-intervention (1-month after baseline)

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Estimated): October 23, 2026
• Primary Completion (Estimated): September 30, 2028
• Study Completion (Estimated): April 22, 2029

Study Registration Dates

• First Submitted: July 8, 2026
• First Submitted That Met QC Criteria: July 8, 2026
• First Posted (Actual): July 13, 2026

Study Record Updates

• Last Update Posted (Actual): July 13, 2026
• Last Update Submitted That Met QC Criteria: July 8, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: 2025.771; 23242231 (Other Grant/Funding Number: Health and Medical Research Fund - Health Bureau)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No