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

8. juli 2026 opdateret af: 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

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

168

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Hong Kong
      • Hong Kong, Hong Kong
        • 7/F, Sleep Assessment Unit, Shatin Hospital, 33 A Kung Kok Street, Ma On Shan, New Territories
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: App-based dCBT-I with AI chatbot
Adfærdsmæssigt: App-based dCBT-I with AI chatbot
Digital cognitive behavioral therapy for insomnia with two-way interactive, intelligent, and text-based conversational agents
Aktiv komparator: VR-enhanced dCBT-I with embodied AI agent
Adfærdsmæssigt: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Insomnia Severity Index
Tidsramme: a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
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)
Tidsramme: a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
the severity of insomnia symptoms
a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Sleep onset latency (SOL)
Tidsramme: a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
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)
Tidsramme: a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
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)
Tidsramme: a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
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)
Tidsramme: a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
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
Tidsramme: 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.
a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
Ford Insomnia Response to Stress Test
Tidsramme: a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
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
Tidsramme: a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
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
Tidsramme: a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
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
Tidsramme: a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
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
Tidsramme: 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.
a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
General Anxiety Disorder-7
Tidsramme: 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
a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
The Sleep Hygiene Index
Tidsramme: a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
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
Tidsramme: 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.
a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
Sleep Self-Efficiency Scale
Tidsramme: 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.
a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
Revised Attitudes Toward Internet Questionnaire
Tidsramme: 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)
Credibility and expectancy questionnaire
Tidsramme: 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.
a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)
Motivation to Change Sleep Behaviors questionnaire
Tidsramme: 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)
Acceptability E-scale questionnaire
Tidsramme: post-intervention (1-month after baseline)
evaluate patients' impressions of computerized or e-health programs.
post-intervention (1-month after baseline)
The Embodied Conversational Agents Trust Questionnaire
Tidsramme: post-intervention (1-month after baseline)
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
Tidsramme: post-intervention (1-month after baseline)
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
Tidsramme: post-intervention (1-month after baseline)
Measure perceived system usability, safety, interactivity, personalization, and overall user experience.
post-intervention (1-month after baseline)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Chinese University of Hong Kong

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

23. oktober 2026

Primær færdiggørelse (Anslået)

30. september 2028

Studieafslutning (Anslået)

22. april 2029

Datoer for studieregistrering

Først indsendt

8. juli 2026

Først indsendt, der opfyldte QC-kriterier

8. juli 2026

Først opslået (Faktiske)

13. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. juli 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2025.771
  • 23242231 (Andet bevillings-/finansieringsnummer: Health and Medical Research Fund - Health Bureau)

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