[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100583783":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":11,"centralContacts":34,"locations":11,"responsibleParty":40,"collaborators":11,"id":44,"slug":45,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":11,"eligibilityCriteria":50,"healthyVolunteers":46,"sex":51,"minAge":52,"maxAge":11,"enrollmentInfo":53,"targetDuration":11,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":11,"overallStatus":62,"whyStopped":11,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":11},{"fullName":5,"class":6},"The Hong Kong Polytechnic University","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Closed-Loop and Neuroplasticity-Based Mindfulness Program","EXPERIMENTAL",null,[13],"Behavioral: Closed-Loop and Neuroplasticity-Based Mindfulness Program",{"label":15,"type":16,"description":11,"interventionNames":17},"Traditional Mindfulness Program (Without the Closed-Loop Approach)","ACTIVE_COMPARATOR",[18],"Behavioral: Traditional Mindfulness Program (Without the Closed-Loop Approach)",{"label":20,"type":16,"description":11,"interventionNames":21},"Psychoeducation",[22],"Behavioral: Psychoeducation",[24,28,31],{"type":25,"name":9,"description":26,"armGroupLabels":27,"otherNames":11},"BEHAVIORAL","The intervention includes three weekly 90-minute face-to-face mindfulness training sessions and daily guided self-practice using a closed-loop, neuroplasticity-based mobile app over 8 weeks. Training integrates mindfulness practices (e.g., mindful eating, body scanning) to help caregivers apply mindfulness in daily life. During self-practice, participants listen to a lesson, monitor distractions, and refocus on their breathing. Initial trials start at 20 seconds, adjusting by 10% if focused or decreasing by 20% if distracted, helping participants regulate attention. Progress is stored to continue in later sessions, with instant feedback during trials and delayed feedback on overall progress. Facilitators provide weekly follow-ups via the app to monitor caregivers' progress.",[9],{"type":25,"name":15,"description":29,"armGroupLabels":30,"otherNames":11},"Family caregivers in the traditional mindfulness group will participate in general mindfulness practices (e.g., mindful eating, body scanning, and mindful walking) without the closed-loop approach. These practices aim to help caregivers learn mindfulness skills and integrate them into their everyday life. Sessions will be delivered through a mobile approach with the same group size, duration, and frequency as the intervention groups.",[15],{"type":25,"name":20,"description":32,"armGroupLabels":33,"otherNames":11},"Family caregivers in the control group will receive self-directed e-learning on dementia care with support from a registered nurse experienced in dementia care or elderly care. This group will serve as a control for socialization and interaction aspects with peers and the interventionist (nurse). The self-directed learning will be delivered through a mobile approach, maintaining the same group size, duration, and frequency as the intervention groups. Educational content will include brief sessions on dementia care, caregiving skills, and group sharing of caregiving tasks.",[20],[35],{"name":36,"role":37,"phone":38,"phoneExt":11,"email":39},"Patrick Kor, PhD","CONTACT","27665622","patrick.kor@polyu.edu.hk",{"type":41,"investigatorFullName":42,"investigatorTitle":43,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Patrick KOR Pui Kin","Assistant Professor","100583783","closed-loop-and-neuroplasticity-based-mindfulness-program-for-family-caregivers-100583783",false,"NCT06880822","Closed-Loop and Neuroplasticity-Based Mindfulness Program for Family Caregivers","Effects of a Closed-Loop and Neuroplasticity-Based Mindfulness Program for Reducing Stress in Family Caregivers of People with Dementia: a Randomized Controlled Trial with a Process Evaluation","Inclusion Criteria:\n\n* Age 18 or above;\n* Family caregiver of an individual who has been living in the community with a confirmed medical diagnosis of any type of dementia (verified through NGO records or care recipient's medical records) for more than one year;\n* Living in the same household as the care recipient;\n* Providing care with daily contact of 4 hours or more.\n\nExclusion Criteria:\n\n* Has participated in any structured mind-body intervention or structured psychosocial intervention within 6 months prior to recruitment;\n* Has an acute psychiatric condition that is potentially life-threatening or would limit participation in the study (indicated by answering \"yes\" to any of the six questions on the Columbia Suicide Severity Rating Scale).","ALL","18 Years",{"count":54,"type":55},189,"ESTIMATED","INTERVENTIONAL",[58],"NA","The aim of this study is to evaluate the effectiveness of a closed-loop and neuroplasticity-based mindfulness program for reducing stress among family caregivers of people with dementia. Participants will be randomly assigned to one of three groups: the closed-loop and neuroplasticity-based mindfulness program, a traditional mindfulness program, or brief education on dementia care. The closed-loop and neuroplasticity-based mindfulness program will include three weekly face-to-face training sessions (90 minutes each) and daily guided self-practice over 8 weeks via a mobile application. The traditional mindfulness program will not include the closed-loop approach but will feature general mindfulness practices with the same group size, duration, and frequency as the closed-loop program. The family caregivers in the control group will receive self-directed e-learning on dementia care with support from a registered nurse experienced in dementia care or elderly care, maintaining the same group size, duration, and frequency as the intervention groups. Evaluations will be conducted at baseline (0 weeks), immediately post-intervention (8 weeks), and during a follow-up assessment (6 months). All groups will complete the same assessments at the same time points.",[61],"Caregiving Stress","NOT_YET_RECRUITING","2025-03-18",{"date":65,"type":66},"2025-03-20","ACTUAL",{"date":68,"type":55},"2025-04-01",{"date":70,"type":55},"2027-04",{"name":5,"class":6}]