Efficacy of Digital Cognitive Behavioral Therapy for Insomnia (CBT-I) Utilizing Embodied Artificial Intelligence Agent in Virtual Reality
2026년 7월 8일 업데이트: Tim M. H. Li, Chinese University of Hong Kong
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
연구 개요
상태
아직 모집하지 않음
정황
연구 유형
중재적
등록 (추정된)
168
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Dr. Tim MH LI
- 전화번호: +852 61150322
- 이메일: manholi@cuhk.edu.hk
연구 장소
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Hong Kong, 홍콩
- 7/F, Sleep Assessment Unit, Shatin Hospital, 33 A Kung Kok Street, Ma On Shan, New Territories
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연락하다:
- Dr. Tim MH LI
- 전화번호: +852 61150322
- 이메일: manholi@cuhk.edu.hk
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: App-based dCBT-I with AI chatbot
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Digital cognitive behavioral therapy for insomnia with two-way interactive, intelligent, and text-based conversational agents
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활성 비교기: VR-enhanced dCBT-I with embodied AI agent
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Digital cognitive behavioral therapy for insomnia delivered in virtual reality with a two-way interactive, virtually embodied, and intelligent AI agent.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Insomnia Severity Index
기간: a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
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the severity of insomnia symptoms
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a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
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Insomnia Module in the Diagnostic Interview for Sleep Disorder (DISP)
기간: a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
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the severity of insomnia symptoms
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a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Sleep onset latency (SOL)
기간: a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
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7-day sleep diary
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a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
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Wake after sleep onset (WASO)
기간: a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
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7-day sleep diary
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a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
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Sleep efficiency (SE)
기간: a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
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7-day sleep diary
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a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
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Total sleep time (TST)
기간: a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
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7-day sleep diary
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a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
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The Pre-Sleep Arousal Scale
기간: a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
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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.
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a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
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Ford Insomnia Response to Stress Test
기간: a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
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personal vulnerability to stress-related insomnia Total score ranges from 9 to 36.
Higher scores suggest a greater likelihood of stress-induced insomnia.
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a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
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Reduced Morningness and Eveningness Questionnaire
기간: a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
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Chronotype preference.
Total score ranges from 4 to 25.
Higher scores suggest a morning chronotype, while lower scores indicate an evening chronotype.
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a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
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The Dysfunctional Beliefs and Attitudes about Sleep Scale
기간: a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
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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.
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a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
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Depression, Anxiety and Stress Scale - 21 Items
기간: a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
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The DASS-21 contains 21 items in three subscales, which assess symptoms of depression, anxiety, and stress
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a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
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Patient Health Questionnaire-9
기간: a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
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The severity of depressive symptoms.
Total score range of 0 to 27, where higher scores signify higher levels of depressive symptoms.
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a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
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General Anxiety Disorder-7
기간: a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
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The severity of anxiety symptoms.
Total score range of 0 to 21, with higher scores reflecting higher levels of anxiety symptoms
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a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
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The Sleep Hygiene Index
기간: a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
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The practice of sleep hygiene behaviors.
Total score ranges from 0 to 52.
Higher scores reflect poorer sleep hygiene practices.
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a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
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The Multidimensional Fatigue Inventory
기간: a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
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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.
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a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
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Sleep Self-Efficiency Scale
기간: a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
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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.
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a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
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Revised Attitudes Toward Internet Questionnaire
기간: a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
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evaluates users' psychological, behavioral, and emotional responses to being online.
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a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
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Credibility and expectancy questionnaire
기간: a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
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measure a participant's treatment credibility and outcome expectancy in therapy.
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a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
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Motivation to Change Sleep Behaviors questionnaire
기간: a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
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Assess the level of motivation to change sleep behaviors.
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a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
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Acceptability E-scale questionnaire
기간: post-intervention (1-month after baseline)
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evaluate patients' impressions of computerized or e-health programs.
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post-intervention (1-month after baseline)
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The Embodied Conversational Agents Trust Questionnaire
기간: post-intervention (1-month after baseline)
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measure a user's trust in a virtual agent or avatar.
It evaluates trust across two dimensions: perceived credibility and perceived benevolence.
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post-intervention (1-month after baseline)
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Adherence questionnaire
기간: post-intervention (1-month after baseline)
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Assess the frequency of engagement in, and adherence to, the behavioral strategies and sleep-related recommendations taught during the program.
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post-intervention (1-month after baseline)
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User survey
기간: post-intervention (1-month after baseline)
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Measure perceived system usability, safety, interactivity, personalization, and overall user experience.
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post-intervention (1-month after baseline)
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 10월 23일
기본 완료 (추정된)
2028년 9월 30일
연구 완료 (추정된)
2029년 4월 22일
연구 등록 날짜
최초 제출
2026년 7월 8일
QC 기준을 충족하는 최초 제출
2026년 7월 8일
처음 게시됨 (실제)
2026년 7월 13일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 7월 13일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 7월 8일
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .