[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656364":3},{"organization":4,"outcomesModule":7,"designInfo":30,"detailedDescription":39,"studyPopulation":13,"armGroups":40,"interventions":53,"overallOfficials":13,"centralContacts":61,"locations":70,"responsibleParty":87,"collaborators":13,"id":89,"slug":90,"hasResults":91,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":13,"eligibilityCriteria":95,"healthyVolunteers":91,"sex":96,"minAge":97,"maxAge":13,"enrollmentInfo":98,"targetDuration":13,"studyType":101,"phases":102,"briefSummary":104,"conditions":105,"keywords":108,"overallStatus":72,"whyStopped":13,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"The Hong Kong Polytechnic University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":14},[9],{"measure":10,"description":11,"timeFrame":12},"Sleep Quality","Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). Higher scores indicate poorer sleep quality.","Baseline, immediately post-intervention (8 weeks), and 3 months post-intervention",null,[15,18,21,24,27],{"measure":16,"description":17,"timeFrame":12},"Caregiving Appraisal","The Chinese version of the Caregiving Appraisal Scale will be used. This is a 5-point Likert scale with 26 items and four subscales (caregiving satisfaction, caregiving mastery, subjective caregiving burden, and caregiving impact).",{"measure":19,"description":20,"timeFrame":12},"Dysfunctional beliefs and attitudes about sleep","It will be measured using the Chinse version of 16-item Dysfunctional Beliefs and Attitudes about Sleep scale (DBAS-16). DBAS-16 is a 16-item scale.",{"measure":22,"description":23,"timeFrame":12},"Emotional distress","It will be measured with the stress, anxiety, and depression scales (DASS-21).",{"measure":25,"description":26,"timeFrame":12},"Patient neuropsychiatric symptoms","The Neuropsychiatric Inventory (NPI) will be used to measure neuropsychiatric symptoms. NPI evaluates 12 common neuropsychiatric disturbances in dementia.",{"measure":28,"description":29,"timeFrame":12},"Dyadic quality of life","It will be measured with the Quality of Life-Alzheimer's Disease Scale (QOL-AD), which will be separately rated by caregivers and care recipients. It is a 13-item, 4-point Likert scale that measures the quality of life for adults w",{"allocation":31,"interventionModel":32,"interventionModelDescription":13,"primaryPurpose":33,"observationalModel":13,"timePerspective":13,"maskingInfo":34},"RANDOMIZED","PARALLEL","SUPPORTIVE_CARE",{"masking":35,"maskingDescription":36,"whoMasked":37},"SINGLE","Outcome assessors will be blinded to group allocation throughout the study. Participants and intervention providers cannot be blinded due to the nature of the behavioral intervention.",[38],"OUTCOMES_ASSESSOR","This study is a two-arm randomized controlled trial designed to evaluate the effectiveness of telephone-coached sleep bibliotherapy for informal caregivers of people with dementia.\n\nA total of 120 eligible caregivers will be recruited and randomly assigned to either the intervention group or the control group. The intervention group will receive an 8-week telephone-coached sleep bibliotherapy program.\n\nThe control group will receive an educational booklet containing general health information and weekly check-in calls. Both groups will continue receiving usual community services.\n\nData will be collected at baseline, immediately after the intervention, and 3 months after the intervention. The primary outcome is sleep quality measured using the Pittsburgh Sleep Quality Index (PSQI). Secondary outcomes include caregiving appraisal, dysfunctional beliefs and attitudes about sleep, emotional distress, neuropsyatric symptoms of care recipients, and quality of life.\n\nThe findings will provide evidence regarding the effectiveness of a low-cost and easily disseminated intervention for improving sleep and well-being among caregivers of people with dementia.",[41,47],{"label":42,"type":43,"description":44,"interventionNames":45},"Telephone-Coached Sleep Bibliotherapy","EXPERIMENTAL","Participants receive an 8-week sleep bibliotherapy program consisting of a sleep bibliotherapy manual, cartoon videos, and weekly telephone coaching. The intervention integrates dementia caregiving education with behavioral and cognitive strategies for improving sleep.",[46],"Behavioral: Telephone-Coached Sleep Bibliotherapy",{"label":48,"type":49,"description":50,"interventionNames":51},"Educational Booklet","ACTIVE_COMPARATOR","Participants receive an educational booklet containing general health information and weekly check-in telephone calls. The booklet does not include therapeutic sleep intervention components.",[52],"Behavioral: Educational Booklet",[54,58],{"type":55,"name":42,"description":56,"armGroupLabels":57,"otherNames":13},"BEHAVIORAL","An 8-week behavioral intervention consisting of a sleep bibliotherapy manual, cartoon videos, and weekly telephone coaching. The intervention integrates dementia caregiving education with behavioral and cognitive strategies to improve sleep among informal caregivers of people with dementia.",[42],{"type":55,"name":48,"description":59,"armGroupLabels":60,"otherNames":13},"Participants receive an educational booklet containing general health information and weekly check-in telephone calls.",[48],[62,67],{"name":63,"role":64,"phone":65,"phoneExt":13,"email":66},"Shanshan WANG, PhD","CONTACT","+852 2766 4696","shan-shan.wang@polyu.edu.hk",{"name":68,"role":64,"phone":69,"phoneExt":13,"email":13},"Mingyue HU, PhD","+852 54131253",[71],{"facility":5,"status":72,"city":73,"state":74,"zip":13,"country":75,"countryCode":76,"cosmosGeoPoint":77,"geoPoint":82,"contacts":83},"RECRUITING","Hung Hom","Kowloon","Hong Kong","HK",{"type":78,"coordinates":79},"Point",[80,81],114.18532,22.30715,{"lat":81,"lon":80},[84],{"name":85,"role":64,"phone":86,"phoneExt":13,"email":66},"Shanshan Wang","68421201",{"type":88,"investigatorFullName":13,"investigatorTitle":13,"investigatorAffiliation":13,"oldNameTitle":13,"oldOrganization":13},"SPONSOR","100656364","telephone-coached-sleep-bibliotherapy-for-dementia-caregivers-100656364",false,"NCT07826663","Telephone-Coached Sleep Bibliotherapy for Dementia Caregivers","Telephone-Coached Sleep Bibliotherapy for Informal Caregivers of People With Dementia: A Randomized Controlled Trial","Inclusion criteria: a) aged 18 years or older; b) provide unpaid care to a family member with dementia; c) living with the patient or actively involved in the patient's care daily for a minimum of 4 hours\u002Fday for at least 6 months; d) endorse one or more sleep problems; e) having the sleep problem with an average of 3 or more nights per week during the past month; d) taking no medication for sleep or stabilized on current medication for at least 6 weeks; e) could be contacted by phone.\n\nExclusion criteria: a) report a prior diagnosis of primary sleep disorder (e.g., sleep apnoea); b) have a severe chronic illness that could cause their sleep problems (e.g., emphysema); c) receive medical, psychological, or psychiatric treatment for sleep disturbance or depression; d) have cognitive impairment; e) be included in another interventional study.","ALL","18 Years",{"count":99,"type":100},120,"ESTIMATED","INTERVENTIONAL",[103],"NA","Sleep disturbances are common among informal caregivers of people with dementia and can negatively affect their physical and psychological well-being. This randomized controlled trial aims to evaluate the effectiveness of an 8-week telephone-coached sleep bibliotherapy program in improving sleep quality among informal caregivers of people with dementia. Participants will be randomly assigned to either a sleep bibliotherapy intervention group or an educational booklet control group. Outcomes including sleep quality, caregiving appraisal, dysfunctional beliefs about sleep, emotional distress, neuropsychiatric symptoms of care recipients, and quality of life will be assessed at baseline, immediately post-intervention, and 3 months post-intervention.",[106,107],"Sleep Disturbance","Dementia",[109,110,10,111,112,113,114],"Dementia Caregiver","Sleep Bibliotherapy","Caregiver","Insomnia","Telephone Coaching","Behavioral Intervention","2026-09-14",{"date":117,"type":118},"2026-09-17","ACTUAL",{"date":120,"type":118},"2026-08-01",{"date":122,"type":100},"2028-12",{"name":5,"class":6},1]