[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100647545":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":38,"locations":47,"responsibleParty":62,"collaborators":11,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":11,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":11,"enrollmentInfo":73,"targetDuration":11,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":88,"whyStopped":11,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"The University of Hong Kong","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention group","EXPERIMENTAL",null,[13,14,15],"Behavioral: Brief sleep health advice","Behavioral: 2 weeks of chatbot-based daily sleep diary","Behavioral: 10 weeks chatbot-based IM support",{"label":17,"type":18,"description":11,"interventionNames":19},"Control group","ACTIVE_COMPARATOR",[13],[21,26,30],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":11},"BEHAVIORAL","Brief sleep health advice","At baseline, both groups will receive a 1-on-1 brief sleep health advice developed using guidelines by U.S. Centers for Diseases Control and Prevention and a booklet providing behavioral guidance on lifestyle and environmental factors related to sleep and insomnia.",[17,9],{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":11},"2 weeks of chatbot-based daily sleep diary","Following randomization, participants in the intervention group will complete a 2-week chatbot-based daily sleep diary. Each morning (e.g., 8:00 am), participants will be prompted via Whatsapp message delivered by chatbot to report key sleep parameters from the previous night, including bedtime, wake time, sleep onset latency, number and duration of nocturnal awakenings, total sleep time, and perceived sleep quality. The collected sleep diary data will be processed by the chatbot to generate tailored and personalized feedback, supporting individualized sleep recommendations and behavioral adjustments. At the initiation of the intervention, participants will also complete a brief baseline questionnaire to establish personalized treatment goals related to sleep improvement. Throughout the intervention period, participants will have continuous access to chatbot-delivered support, including adaptive guidance based on diary inputs, reinforcement of recommended sleep strategies, and progress",[9],{"type":22,"name":31,"description":32,"armGroupLabels":33,"otherNames":11},"10 weeks chatbot-based IM support","Participants in the intervention group will also receive cognitive behavioral therapy for insomnia (CBT-I) delivered via an LLM-based chatbot through WhatsApp over a 10-week period. The intervention is fully automated and available 24\u002F7, with underlying algorithms enabling the delivery of information, therapeutic support, and advice in a personalized and adaptive manner, informed by participants' ongoing inputs and interaction patterns. The intervention will be structured into 20 chatbot-delivered instant messaging (2 pieces per week). The therapeutic content is adapted from established CBT-I manuals and led by research nurse, incorporating evidence-based behavioral, cognitive, and educational components. Behavioral strategies include sleep restriction, stimulus control, and relaxation techniques. Cognitive components comprise paradoxical intention, cognitive restructuring, mindfulness-based techniques, positive imagery, and strategies for \"putting the day to rest.\" Educational compone",[9],[35],{"name":36,"affiliation":5,"role":37},"Shengzhi Zhao","PRINCIPAL_INVESTIGATOR",[39,43],{"name":36,"role":40,"phone":41,"phoneExt":11,"email":42},"CONTACT","+852 6561 4500","lubabezz@connect.hku.hk",{"name":44,"role":40,"phone":45,"phoneExt":11,"email":46},"Tsz Kiu Chan","+852 5506 4711","natctk1@hku.hk",[48],{"facility":49,"status":11,"city":50,"state":11,"zip":11,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"School of Public Health, The University of Hong Kong, 18\u002FF, Metro South Tower 1, 39 Wong Chuk Hang Road, Wong Chuk Hang, Hong Kong","Hong Kong","HK",{"type":53,"coordinates":54},"Point",[55,56],114.17469,22.27832,{"lat":56,"lon":55},[59,60,61],{"name":36,"role":40,"phone":41,"phoneExt":11,"email":42},{"name":44,"role":40,"phone":45,"phoneExt":11,"email":46},{"name":36,"role":37,"phone":11,"phoneExt":11,"email":11},{"type":37,"investigatorFullName":36,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"Research Assistant Professor","100647545","nurse-led-digital-cognitive-behavioral-therapy-for-insomnia-dcbt-i-in-university-students-with-mild-to-moderate-mental-health-problems-100647545",false,"NCT07711769","Nurse-led Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) in University Students With Mild to Moderate Mental Health Problems","Nurse-led Digital Cognitive Behavioral Therapy for Insomnia (dCBT-I) in University Students With Mild to Moderate Mental Health Problems: a Pilot Randomized Controlled Trial","Inclusion Criteria:\n\n* Students aged ≥ 18 years from 22 local higher education institutions (University or Colleges) listed in Education Bureau.\n* Screening score indicating mild to moderate anxiety or depression, defined as a GAD-7 score of 5-14 and\u002For a PHQ-9 score of 5-14 at baseline.\n* Screened positive for insomnia symptoms using the Sleep Condition Indicator (SCI) and meeting DSM-5 diagnostic criteria for insomnia disorder.\n* Reporting a self-reported sleep efficiency of less than 85% over the past month.\n* Able to communicate in Chinese.\n\nExclusion Criteria:\n\n* Participants who self-reported diagnosis of epilepsy, schizophrenia, or bipolar disorder\n* Participants who self-reported current suicidal ideation with intent or a suicide attempt within the past 2 months\n* Participants who self-reported current receipt of psychological or behavioral treatment for insomnia from a health professional\n* Participants who self-reported participation in an online or digital insomnia treatment programme at the time of enrolment.","ALL","18 Years",{"count":74,"type":75},100,"ESTIMATED","INTERVENTIONAL",[78],"NA","This study aims to evaluate the feasibility, acceptability, and potential effectiveness of a nurse-led digital cognitive behavioral therapy for insomnia (dCBT-I) via large language model based-chatbot among university students with mental health problems.",[81],"Mental Health",[83,84,85,86,87],"Cognitive Behavioral Therapy for Insomnia","insomnia","large language model","chatbot","university student","NOT_YET_RECRUITING","2026-07-23",{"date":91,"type":92},"2026-07-24","ACTUAL",{"date":94,"type":75},"2026-09-01",{"date":96,"type":75},"2027-10-31",{"name":5,"class":6},1]