[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100616423":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":28,"centralContacts":29,"locations":35,"responsibleParty":50,"collaborators":28,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":26,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":28,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":76,"overallStatus":38,"whyStopped":28,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"The University of Hong Kong","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"COPE Intervention Group","EXPERIMENTAL","COPE is a 6-week group-based programme comprising one face-to-face workshop (4 caregivers per group) and five online sessions (4 caregivers per group) delivered via Zoom. The COPE programme integrates the strategies from cognitive behavioral therapy (CBT), emotional-focused mindfulness therapy and social skill training to improve the expressed emotion (EE) of the caregivers, with the focus to ameliorate negative causal attrition of BPSD, increase emotional regulation and enhance social interaction skills with PwD. The group size of 4 is used to optimize the social interactions between the peer caregivers. The first session will adopt a face-to-face mode to better develop their rapport with each other, and to facilitate their self-reflection and disclosure on their social interaction with the care recipients in day-to-day caregiving.",[13],"Behavioral: Caregivers Of dementia Processing Emotions (COPE)",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group","ACTIVE_COMPARATOR","Structured education will function as the control intervention to mitigate potential confounding effects attributable to additional attention. The control condition will comprise one initial face-to-face session followed by five consecutive weekly online educational sessions focusing on dementia caregiving. These sessions will be administered by a research assistant (RA2) following a standardized PowerPoint presentation developed in accordance with established clinical practice guidelines. The implementation of an active control condition, rather than a passive or waitlist control, provides more robust evidence regarding the specific efficacy of the experimental intervention. Furthermore, this approach enhances both participant recruitment and retention rates by ensuring that all participants receive a credible and potentially beneficial intervention.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","Caregivers Of dementia Processing Emotions (COPE)","This is the first study to develop an easily accessible and feasible intervention programme, namely the Caregivers Of dementia Processing Emotions (COPE), to primarily reduce expressed emotion (EE) in family caregivers of PwD via processing one's attributional biases, dysregulated emotion, dysfunctional social dynamics using an integrative therapy. By displacing these negative thoughts and emotions, the integrative therapy has great potential to reduce the depressive symptoms in caregivers and thus mitigate their perceived stress from BPSD. In addition, the interactive social dynamics in the dementia caregiving context can be improved.",[9,15],[26,27],"COPE","Mindfulness and Cognitive Behavioral Therapy",null,[30],{"name":31,"role":32,"phone":33,"phoneExt":28,"email":34},"YU Sau Fung, RN, PhD, FHKAN, FAAN, FGSA","CONTACT","852 + 39176319","dyu1@hku.hk",[36],{"facility":37,"status":38,"city":39,"state":28,"zip":28,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"University of Hong Kong","RECRUITING","Hong Kong","HK",{"type":42,"coordinates":43},"Point",[44,45],114.17469,22.27832,{"lat":45,"lon":44},[48],{"name":49,"role":32,"phone":33,"phoneExt":28,"email":34},"YU Sau Fung",{"type":51,"investigatorFullName":52,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":28,"oldOrganization":28},"PRINCIPAL_INVESTIGATOR","Prof. Yu, Doris Sau Fung","Proferssor","100616423","integrative-therapeutic-programme-to-regulate-expressed-emotions-among-informal-caregivers-of-people-with-dementia-100616423",false,"NCT07305415","Integrative Therapeutic Programme to Regulate Expressed Emotions Among Informal Caregivers of People With Dementia","Integrative Therapeutic Programme to Regulate Expressed Emotions Among Informal Caregivers of People With Dementia: a Pilot Randomized Controlled Trial","Inclusion Criteria:\n\n* (1) With a high level of EE as indicated by a cut-off score of 35 or above on the Family Attitude Scale (Chinese version; FAS-C)\n* (2) Provides care at least 4 hours per day\n* (3) Consent to participate\n* (4) No acute psychiatric illness\n\nExclusion Criteria:\n\n* (1) With a score below 35 on the Family Attitude Scale (Chinese version; FAS-C)\n* (2) Provides care no more than 4 hours per day\n* (3) Does not consent to participate\n* (4) With acute psychiatric illness.","ALL","18 Years","100 Years",{"count":65,"type":66},56,"ESTIMATED","INTERVENTIONAL",[69],"NA","The dual-modal (face-to-face and online approaches), client-customized Caregivers Of dementia Processing Emotions (COPE) programme aims to\n\n1. reduce caregivers' Expressed Emotion (EE),\n2. reduce caregivers' depressive symptoms,\n3. reduce the behaviourally interactive social dynamic of maladaptation (i.e., dysfunctional dyadic relationship and quality of care), and\n4. improve caregivers' perceived stress from PwD's Behavioral and Psychological Symptoms of Dementia (BPSD).\n\nResearchers will compare COPE to a control group (standard therapy) to examine how effective the COPE programme is.\n\nParticipants will take part in:\n\nPretest prior to COPE implementation Post-test after COPE completion Follow up test in 3 months after COPE completion",[72,73,74,75],"BPSD (Behavioral and Psycological Symptoms of Dementia)","Expressed Emotion","Depressive Symptom","Caregiving Stress",[77,78,73,79,80,81,82,83,84,85],"BPSD","behavioral and psychological symptoms of dementia","Dementia caregivers","Dementia caregiving","preceived stress","caregiver depression","caregiving stress","caregiving relationship","dyadic care relationship","2026-03-25",{"date":88,"type":89},"2026-03-31","ACTUAL",{"date":91,"type":89},"2025-12-20",{"date":93,"type":66},"2027-03-30",{"name":5,"class":6},1]