Efficacy of Digital CBT-I Utilizing Embodied Artificial Intelligence Agent in Virtual Reality
15 de julho de 2026 atualizado por: 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
Visão geral do estudo
Status
Ainda não está recrutando
Condições
Tipo de estudo
Intervencional
Inscrição (Estimado)
168
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Dr. Tim MH LI
- Número de telefone: +852 61150322
- E-mail: manholi@cuhk.edu.hk
Estude backup de contato
- Nome: Ms. Phoebe K.Y. Chan
- Número de telefone: +852 53202853
- E-mail: mastersleep@cuhk.edu.hk
Locais de estudo
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Hong Kong, Hong Kong
- 7/F, Sleep Assessment Unit, Shatin Hospital, 33 A Kung Kok Street, Ma On Shan, New Territories
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Contato:
- Dr. Tim MH LI
- Número de telefone: +852 61150322
- E-mail: manholi@cuhk.edu.hk
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-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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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.
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Digital cognitive behavioral therapy for insomnia with two-way interactive, intelligent, and text-based conversational agents
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Comparador Ativo: 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.
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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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Insomnia Severity Index
Prazo: 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)
Prazo: 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)
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Sleep onset latency (SOL)
Prazo: 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)
Prazo: 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)
Prazo: a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
|
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)
|
|
Total sleep time (TST)
Prazo: a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
|
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
Prazo: a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
|
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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
|
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
Prazo: a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
|
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
Prazo: 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
Prazo: 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
Prazo: a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
|
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
Prazo: a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
|
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)
|
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Credibility and expectancy questionnaire
Prazo: a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
|
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
Prazo: a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
|
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)
|
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Acceptability E-scale questionnaire
Prazo: post-intervention (1-month after baseline)
|
evaluate patients' impressions of computerized or e-health programs.
|
post-intervention (1-month after baseline)
|
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The Embodied Conversational Agents Trust Questionnaire
Prazo: 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
Prazo: 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
Prazo: post-intervention (1-month after baseline)
|
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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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
23 de outubro de 2026
Conclusão Primária (Estimado)
30 de setembro de 2028
Conclusão do estudo (Estimado)
22 de abril de 2029
Datas de inscrição no estudo
Enviado pela primeira vez
8 de julho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
8 de julho de 2026
Primeira postagem (Real)
13 de julho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
16 de julho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
15 de julho de 2026
Última verificação
1 de junho de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2025.771
- 23242231 (Número de outro subsídio/financiamento: Health and Medical Research Fund - Health Bureau)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Descrição do plano IPD
Individual participant data collected during this study will not be made publicly available because participant consent does not include permission for data sharing outside the study team and because of considerations related to participant privacy and confidentiality.
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .