Efficacy of Digital Cognitive Behavioral Therapy for Insomnia (CBT-I) Utilizing Embodied Artificial Intelligence Agent in Virtual Reality: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- Insomnia Severity Index
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: App-based dCBT-I with AI chatbot (Behavioral)
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.
干预措施: VR-enhanced dCBT-I with embodied AI agent (Behavioral)
结局指标
主要结局
Insomnia Severity Index
时间窗: a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
the severity of insomnia symptoms
Insomnia Module in the Diagnostic Interview for Sleep Disorder (DISP)
时间窗: a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
the severity of insomnia symptoms
次要结局
- 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))
- Ford Insomnia Response to Stress Test(a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline))
- Reduced Morningness and Eveningness Questionnaire(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(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(a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline))
- Patient Health Questionnaire-9(a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline))
- General Anxiety Disorder-7(a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline))
- The Sleep Hygiene Index(a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline))
- The Multidimensional Fatigue Inventory(a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline))
- Sleep Self-Efficiency Scale(a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline))
- Revised Attitudes Toward Internet Questionnaire(a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline))
- Credibility and expectancy questionnaire(a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline))
- Motivation to Change Sleep Behaviors questionnaire(a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline))
- Acceptability E-scale questionnaire(post-intervention (1-month after baseline))
- The Embodied Conversational Agents Trust Questionnaire(post-intervention (1-month after baseline))
- Adherence questionnaire(post-intervention (1-month after baseline))
- User survey(post-intervention (1-month after baseline))
研究者
Tim M. H. Li
Assistant Professor
Chinese University of Hong Kong