[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100524487":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":39,"responsibleParty":55,"collaborators":18,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":18,"eligibilityCriteria":64,"healthyVolunteers":65,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":18,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":79,"overallStatus":41,"whyStopped":18,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Chinese University of Hong Kong","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Stepped-care CBT-I group","EXPERIMENTAL","A total of 3 steps of CBT-I intervention will be provided, with the objectives to increase the awareness of sleep health, increase sleep literacy, establish good sleep hygiene and treat insomnia.\n\nStep 1: self-help digital CBT-I program; Step 2: guided CBT-I program; Step 3: individualized consultation.",[13],"Behavioral: Cognitive behavioral therapy for insomnia (CBT-I)",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group","NO_INTERVENTION","Participants in the control group remain unexposed to the stepped-care CBT-I intervention.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"BEHAVIORAL","Cognitive behavioral therapy for insomnia (CBT-I)","CBT-I intervention will be provided to participants once their districts are exposed.",[9],[26],{"name":27,"affiliation":28,"role":29},"Yun Kwok Wing, FRCPsych","Department of Psychiatry, the Chinese University of Hong Kong","PRINCIPAL_INVESTIGATOR",[31,36],{"name":32,"role":33,"phone":34,"phoneExt":18,"email":35},"Rachel Ngan Yin Chan, PhD","CONTACT","39710548","rachel.chan@cuhk.edu.hk",{"name":37,"role":33,"phone":34,"phoneExt":18,"email":38},"Jucheng Yu, PhD","juchengyu@cuhk.edu.hk",[40],{"facility":28,"status":41,"city":42,"state":43,"zip":18,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"RECRUITING","Shatin","New Territories","Hong Kong","HK",{"type":47,"coordinates":48},"Point",[49,50],114.18333,22.38333,{"lat":50,"lon":49},[53,54],{"name":32,"role":33,"phone":34,"phoneExt":18,"email":35},{"name":37,"role":33,"phone":34,"phoneExt":18,"email":38},{"type":29,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Professor Wing Yun Kwok","Professor, Department of Psychiatry","100524487","a-stepped-care-model-to-deliver-cbt-i-in-community-100524487",false,"NCT06109363","A Stepped Care Model to Deliver CBT-I in Community","Effectiveness of a Stepped Care Model to Deliver Cognitive-behaviour Therapy for Insomnia in Adults, a Pragmatic Stepped-wedge Cluster Randomized Trial","Inclusion Criteria:\n\n1. Chinese adults aged 18-70 years old,\n2. The score of Insomnia Severity Index ≥ 10.\n\nExclusion Criteria:\n\n1. present with psychotic disorders such as bipolar disorder and schizophrenia,\n2. present with severe depression or suicidal ideation,\n3. present with neurodegenerative diseases that prevent participant from completing the intervention (e.g., dementia and Parkinson's disease).\n4. unable to provide consent",true,"ALL","18 Years","70 Years",{"count":70,"type":71},1100,"ESTIMATED","INTERVENTIONAL",[74],"NA","Insomnia is one of the most common sleep disorders and affects approximately 10 - 40% of the population across different age groups in Hong Kong. Cognitive behavioral therapy for insomnia (CBT-I) is the first line treatment for adult insomnia due to its comparable effect to medication in short term but is more sustainable in the long run. However, only a few sufferers have received CBT-I, due to limited accessibility, lack of trained sleep therapists, time costing and geographical limitations. To increase CBT-I accessibility, different formats of CBT-I have been proposed. Empirical evidence including ours consistently suggested that self-help digital CBT-I is effective in improving sleep while its augmentation with a guided approach could further enhance the treatment gain. Previous evidence has suggested that although self-help CBT-I could lead to positive outcomes, the drop out rate is quite high and maybe less effective for patients with comorbidity or high level of distress.\n\nThus, a stepped-care approach to CBT-I that utilizes online self help and therapist-guided modes of delivery might be a potential way to facilitate efficient dissemination of effective insomnia treatment resources. The effectiveness of the stepped care model will be evaluated in a real world setting using stepped-wedge cluster randomized controlled design. The program will be rolled out to different districts in Hong Kong sequentially in 18 districts over 4 steps with a eqaully spaced time periods.",[77,78],"Insomnia","Sleep Disturbance",[77,80,81],"Stepped care model","Stepped wedge cluster randomized trial","2026-06-19",{"date":84,"type":85},"2026-06-24","ACTUAL",{"date":87,"type":85},"2023-10-23",{"date":89,"type":71},"2027-04-22",{"name":5,"class":6},1]