[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100646079":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":33,"centralContacts":48,"locations":58,"responsibleParty":76,"collaborators":79,"id":82,"slug":83,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":84,"sex":90,"minAge":91,"maxAge":33,"enrollmentInfo":92,"targetDuration":33,"studyType":95,"phases":96,"briefSummary":98,"conditions":99,"keywords":103,"overallStatus":61,"whyStopped":33,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},{"fullName":5,"class":6},"The University of Hong Kong","OTHER",[8,15,21],{"label":9,"type":10,"description":11,"interventionNames":12},"CBT-I + Melatonin","EXPERIMENTAL","Four weekly group-based CBT-I sessions (120-min, 6-8 participants) plus oral melatonin 3 mg immediate-release taken 30 min before habitual bedtime for 4 weeks.",[13,14],"Behavioral: Cognitive behavioural therapy for insomnia","Dietary Supplement: Melatonin 3 mg immediate-release",{"label":16,"type":17,"description":18,"interventionNames":19},"CBT-I + Placebo","ACTIVE_COMPARATOR","Identical four weekly group-based CBT-I sessions plus placebo capsule (identical appearance) taken 30 min before habitual bedtime for 4 weeks.",[13,20],"Drug: Placebo Oral Tablet",{"label":22,"type":23,"description":24,"interventionNames":25},"Psychoeducation + Placebo","PLACEBO_COMPARATOR","Four weekly group-based sleep psychoeducation sessions (sleep hygiene, healthy diet, and exercise for older adults; no active CBT-I components) plus placebo capsule for 4 weeks.",[26,20],"Behavioral: Psychoeducation",[28,34,39,43],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"BEHAVIORAL","Cognitive behavioural therapy for insomnia","CBT-I is a multi-component, non-pharmacologic intervention that targets behavioural, cognitive, and physiological perpetuating factors of insomnia.\n\nFour group-based weekly sessions (120-min; 6-8 participants) will be delivered. Components: sleep psychoeducation, sleep hygiene, stimulus control, sleep restriction, relaxation training, cognitive restructuring (addressing dysfunctional beliefs about sleep), and relapse prevention. Delivered in-person by trained therapists supervised weekly by the PI.",[9,16],null,{"type":35,"name":36,"description":37,"armGroupLabels":38,"otherNames":33},"DIETARY_SUPPLEMENT","Melatonin 3 mg immediate-release","Melatonin is a safe and accessible sleep-promoting supplement. The tablet will be taken once daily, 30 minutes before habitual bedtime for 4 weeks, concurrent with CBT-I.",[9],{"type":29,"name":40,"description":41,"armGroupLabels":42,"otherNames":33},"Psychoeducation","Four group-based weekly sessions covering sleep hygiene, healthy diet, and exercise habits for older adults. This arm will not include any active therapeutic CBT-I components. It serves as the active control, controlling for attention and non-specific expectancy effects.",[22],{"type":44,"name":45,"description":46,"armGroupLabels":47,"otherNames":33},"DRUG","Placebo Oral Tablet","Placebo capsule identical in appearance to the melatonin capsule, taken once daily, 30 minutes before habitual bedtime for 4 weeks. Used in CBT-I + Placebo and Psychoeducation + Placebo arms.",[16,22],[49,54],{"name":50,"role":51,"phone":52,"phoneExt":33,"email":53},"Shirley Xin LI, DClinPsy, PhD","CONTACT","852 39177035","shirleyx@hku.hk",{"name":55,"role":51,"phone":56,"phoneExt":33,"email":57},"Zihan Chen, MS","852 93675825","zihan.chen@connect.hku.hk",[59],{"facility":60,"status":61,"city":62,"state":33,"zip":33,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"Sleep Research Clinic and Laboratory, Department of Psychology, The University of Hong Kong","RECRUITING","Hong Kong","HK",{"type":65,"coordinates":66},"Point",[67,68],114.17469,22.27832,{"lat":68,"lon":67},[71,73],{"name":72,"role":51,"phone":56,"phoneExt":33,"email":57},"Zihan Chen",{"name":74,"role":75,"phone":33,"phoneExt":33,"email":33},"Shirley X. Li, PhD, DClinPsy","PRINCIPAL_INVESTIGATOR",{"type":75,"investigatorFullName":77,"investigatorTitle":78,"investigatorAffiliation":5,"oldNameTitle":33,"oldOrganization":33},"Dr. Shirley Xin Li","Associate Professor",[80],{"name":81,"class":6},"Chinese University of Hong Kong","100646079","efficacy-of-cbt-i-with-adjuvant-melatonin-in-older-adults-chronic-insomnia-100646079",false,"NCT07695246","Efficacy of CBT-I With Adjuvant Melatonin in Older Adults Chronic Insomnia","Efficacy of Cognitive Behavioural Therapy for Insomnia With Adjuvant Melatonin Treatment in Older Adults With Chronic Insomnia: A Randomised Controlled Trial","SOAM","Inclusion Criteria:\n\n1. Chinese aged ≥ 60.\n2. Provision of written informed consent.\n3. Having a DSM-5 diagnosis of insomnia disorder (i.e., having difficulty initiating sleep, maintaining sleep, or early morning awakening at least three times a week for at least three months, with clinically significant impairment or distress).\n4. Having a score of \\> 14 on the ISI, indicating clinical insomnia.\n\nExclusion Criteria:\n\n1. Having a current diagnosis or a history of manic or hypomanic episodes, schizophrenia spectrum disorders, neurodevelopmental disorders, neurocognitive disorders, organic mental disorders, intellectual disabilities, or substance abuse or dependence.\n2. Having a progressive medical condition directly related to the onset and course of insomnia (e.g., cancer, chronic pain).\n3. Undergoing treatment for diseases known to affect sleep (e.g., chemotherapy).\n4. Having an untreated sleep disorder that may disrupt sleep continuity and quality (e.g., sleep-disordered breathing) except for insomnia disorder.\n5. Having mild to significant cognitive impairment, defined by having a score of \\\u003C 22 on MOCA.\n6. Concurrent and regular use of extraneous melatonin or melatonin agonist (e.g., ramelteon).\n7. Receiving concurrent psychological treatment for insomnia.\n8. Meeting potential contraindications for melatonin (e.g., undergoing dialysis) or concurrently using medications that have a potential drug interaction with melatonin (e.g., anticoagulant and anti-platelet).\n9. Being a night shift worker.","ALL","60 Years",{"count":93,"type":94},183,"ESTIMATED","INTERVENTIONAL",[97],"NA","This study tests the efficacy of cognitive behavioural therapy for insomnia (CBT-I) with or without adjunct melatonin in older adults with insomnia. Adults aged 60 or above with chronic insomnia will be randomly assigned to one of three groups: (1) CBT-I plus nightly melatonin, (2) CBT-I plus nightly placebo tablet, or (3) sleep health psychoeducation plus nightly placebo tablet. All group sessions occur weekly for four weeks.",[100,101,102],"Insomnia","Aging","Sleep Disorders",[100,104,105,106,107,108,109,110],"Elderly","CBT","Melatonin","Circadian Rhythm","Sleep","Randomised controlled trial","Older adults","2026-08-20",{"date":113,"type":114},"2026-08-21","ACTUAL",{"date":116,"type":114},"2026-08-01",{"date":118,"type":94},"2029-08-01",{"name":5,"class":6},1]