[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100054267":3},{"organization":4,"outcomesModule":7,"designInfo":78,"detailedDescription":77,"studyPopulation":77,"armGroups":86,"interventions":97,"overallOfficials":77,"centralContacts":105,"locations":111,"responsibleParty":125,"collaborators":77,"id":129,"slug":77,"hasResults":130,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":77,"eligibilityCriteria":134,"healthyVolunteers":130,"sex":135,"minAge":136,"maxAge":137,"enrollmentInfo":138,"targetDuration":77,"studyType":141,"phases":142,"briefSummary":144,"conditions":145,"keywords":77,"overallStatus":147,"whyStopped":77,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":157},{"fullName":5,"class":6},"Chinese University of Hong Kong","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":15,"otherOutcomes":77},[9,13],{"measure":10,"description":11,"timeFrame":12},"Insomnia Severity Index","the severity of insomnia symptoms","a) baseline; b) post-intervention (1-month after baseline); c) 3-month after intervention (4-month after baseline)",{"measure":14,"description":11,"timeFrame":12},"Insomnia Module in the Diagnostic Interview for Sleep Disorder (DISP)",[16,19,21,23,25,28,31,34,37,40,43,46,49,52,55,58,61,64,68,71,74],{"measure":17,"description":18,"timeFrame":12},"Sleep onset latency (SOL)","7-day sleep diary",{"measure":20,"description":18,"timeFrame":12},"Wake after sleep onset (WASO)",{"measure":22,"description":18,"timeFrame":12},"Sleep efficiency (SE)",{"measure":24,"description":18,"timeFrame":12},"Total sleep time (TST)",{"measure":26,"description":27,"timeFrame":12},"The Pre-Sleep Arousal Scale","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.",{"measure":29,"description":30,"timeFrame":12},"Ford Insomnia Response to Stress Test","personal vulnerability to stress-related insomnia Total score ranges from 9 to 36. Higher scores suggest a greater likelihood of stress-induced insomnia.",{"measure":32,"description":33,"timeFrame":12},"Reduced Morningness and Eveningness Questionnaire","Chronotype preference. Total score ranges from 4 to 25. Higher scores suggest a morning chronotype, while lower scores indicate an evening chronotype.",{"measure":35,"description":36,"timeFrame":12},"The Dysfunctional Beliefs and Attitudes about Sleep Scale","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.",{"measure":38,"description":39,"timeFrame":12},"Depression, Anxiety and Stress Scale - 21 Items","The DASS-21 contains 21 items in three subscales, which assess symptoms of depression, anxiety, and stress",{"measure":41,"description":42,"timeFrame":12},"Patient Health Questionnaire-9","The severity of depressive symptoms. Total score range of 0 to 27, where higher scores signify higher levels of depressive symptoms.",{"measure":44,"description":45,"timeFrame":12},"General Anxiety Disorder-7","The severity of anxiety symptoms. Total score range of 0 to 21, with higher scores reflecting higher levels of anxiety symptoms",{"measure":47,"description":48,"timeFrame":12},"The Sleep Hygiene Index","The practice of sleep hygiene behaviors. Total score ranges from 0 to 52. Higher scores reflect poorer sleep hygiene practices.",{"measure":50,"description":51,"timeFrame":12},"The Multidimensional Fatigue Inventory","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.",{"measure":53,"description":54,"timeFrame":12},"Sleep Self-Efficiency Scale","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.",{"measure":56,"description":57,"timeFrame":12},"Revised Attitudes Toward Internet Questionnaire","evaluates users' psychological, behavioral, and emotional responses to being online.",{"measure":59,"description":60,"timeFrame":12},"Credibility and expectancy questionnaire","measure a participant's treatment credibility and outcome expectancy in therapy.",{"measure":62,"description":63,"timeFrame":12},"Motivation to Change Sleep Behaviors questionnaire","Assess the level of motivation to change sleep behaviors.",{"measure":65,"description":66,"timeFrame":67},"Acceptability E-scale questionnaire","evaluate patients' impressions of computerized or e-health programs.","post-intervention (1-month after baseline)",{"measure":69,"description":70,"timeFrame":67},"The Embodied Conversational Agents Trust Questionnaire","measure a user's trust in a virtual agent or avatar. It evaluates trust across two dimensions: perceived credibility and perceived benevolence.",{"measure":72,"description":73,"timeFrame":67},"Adherence questionnaire","Assess the frequency of engagement in, and adherence to, the behavioral strategies and sleep-related recommendations taught during the program.",{"measure":75,"description":76,"timeFrame":67},"User survey","Measure perceived system usability, safety, interactivity, personalization, and overall user experience.",null,{"allocation":79,"interventionModel":80,"interventionModelDescription":77,"primaryPurpose":81,"observationalModel":77,"timePerspective":77,"maskingInfo":82},"RANDOMIZED","PARALLEL","SUPPORTIVE_CARE",{"masking":83,"maskingDescription":77,"whoMasked":84},"SINGLE",[85],"OUTCOMES_ASSESSOR",[87,92],{"label":88,"type":89,"description":77,"interventionNames":90},"App-based dCBT-I with AI chatbot","EXPERIMENTAL",[91],"Behavioral: App-based dCBT-I with AI chatbot",{"label":93,"type":94,"description":77,"interventionNames":95},"VR-enhanced dCBT-I with embodied AI agent","ACTIVE_COMPARATOR",[96],"Behavioral: VR-enhanced dCBT-I with embodied AI agent",[98,102],{"type":99,"name":88,"description":100,"armGroupLabels":101,"otherNames":77},"BEHAVIORAL","Digital cognitive behavioral therapy for insomnia with two-way interactive, intelligent, and text-based conversational agents",[88],{"type":99,"name":93,"description":103,"armGroupLabels":104,"otherNames":77},"Digital cognitive behavioral therapy for insomnia delivered in virtual reality with a two-way interactive, virtually embodied, and intelligent AI agent.",[93],[106],{"name":107,"role":108,"phone":109,"phoneExt":77,"email":110},"Dr. Tim MH Li","CONTACT","+852 61150322","manholi@cuhk.edu.hk",[112],{"facility":113,"status":77,"city":114,"state":77,"zip":77,"country":114,"countryCode":115,"cosmosGeoPoint":116,"geoPoint":121,"contacts":122},"7\u002FF, Sleep Assessment Unit, Shatin Hospital, 33 A Kung Kok Street, Ma On Shan, New Territories","Hong Kong","HK",{"type":117,"coordinates":118},"Point",[119,120],114.17469,22.27832,{"lat":120,"lon":119},[123],{"name":124,"role":108,"phone":109,"phoneExt":77,"email":110},"Dr. Tim MH LI",{"type":126,"investigatorFullName":127,"investigatorTitle":128,"investigatorAffiliation":5,"oldNameTitle":77,"oldOrganization":77},"PRINCIPAL_INVESTIGATOR","Tim M. H. Li","Assistant Professor","100054267",false,"NCT07699042","Efficacy of Digital Cognitive Behavioral Therapy for Insomnia (CBT-I) Utilizing Embodied Artificial Intelligence Agent in Virtual Reality","Efficacy of Digital Cognitive Behavioral Therapy for Insomnia (CBT-I) Utilizing Embodied Artificial Intelligence Agent in Virtual Reality: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Adults of Chinese ethnicity, aged between 18 and 65 years.\n* Presence of insomnia, as indicated by a score of 10 or higher on the ISI.\n* 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.\n* Willing to provide online informed consent to participate in the study.\n* Willing to comply with the requirements outlined in the study protocol.\n* Possession of a smartphone and consistent internet access for smartphone use.\n* Acceptance of the terms of service and privacy policies of the mobile apps used for intervention delivery.\n\nExclusion Criteria:\n\n* A current or history of any sleep disorders other than insomnia disorder, such as narcolepsy, obstructive sleep apnea, and restless legs syndrome.\n* 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.\n* Presence of serious suicidality, demonstrated by ideation with a plan or a previous suicide attempt.\n* Currently receiving long-term pharmacological treatment, including sleep-promoting agents.\n* Currently undergoing structured psychotherapy.\n* A current or history of significant visual, auditory, or balance impairment.\n* A current or history of epilepsy\n* Subject who is preparing for pregnancy or pregnant\n* A current or history of any voice, speech, language disorders and learning difficulties.\n* A current or history of severe health conditions (e.g., stroke, heart attack)\n* Engaged in shiftwork or trans-meridian travel within the past 3 months or during the study.","ALL","18 Years","65 Years",{"count":139,"type":140},168,"ESTIMATED","INTERVENTIONAL",[143],"NA","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.\n\nThe main questions it aims to answer are:\n\n\\- 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?\n\nResearchers 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.\n\nParticipants will:\n\n* Be randomly assigned to either the VR-enhanced AI agent intervention group or the app-based AI chatbot control group\n* 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\n* Undergo assessments at baseline, post-intervention, and 3-month follow-up",[146],"Insomnia","NOT_YET_RECRUITING","2026-07-08",{"date":150,"type":151},"2026-07-13","ACTUAL",{"date":153,"type":140},"2026-10-23",{"date":155,"type":140},"2029-04-22",{"name":5,"class":6},1]