Efficacy of Digital Cognitive Behavioral Therapy for Insomnia (CBT-I) Utilizing Embodied Artificial Intelligence Agent in Virtual Reality
2026年7月8日 更新者：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
調査の概要
状態
まだ募集していません
条件
研究の種類
介入
入学 (推定)
168
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Dr. Tim MH LI
- 電話番号：+852 61150322
- メール：manholi@cuhk.edu.hk
研究場所
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Hong Kong、香港
- 7/F, Sleep Assessment Unit, Shatin Hospital, 33 A Kung Kok Street, Ma On Shan, New Territories
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コンタクト：
- Dr. Tim MH LI
- 電話番号：+852 61150322
- メール：manholi@cuhk.edu.hk
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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アクティブコンパレータ：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Insomnia Severity Index
時間枠：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)
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Sleep onset latency (SOL)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
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
時間枠：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
時間枠：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
時間枠：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
時間枠：a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
|
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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：post-intervention (1-month after baseline)
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Measure perceived system usability, safety, interactivity, personalization, and overall user experience.
|
post-intervention (1-month after baseline)
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年10月23日
一次修了 (推定)
2028年9月30日
研究の完了 (推定)
2029年4月22日
試験登録日
最初に提出
2026年7月8日
QC基準を満たした最初の提出物
2026年7月8日
最初の投稿 (実際)
2026年7月13日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月13日
QC基準を満たした最後の更新が送信されました
2026年7月8日
最終確認日
2026年6月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。