[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100566080":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":45,"centralContacts":53,"locations":61,"responsibleParty":101,"collaborators":104,"id":108,"slug":109,"hasResults":110,"nctId":111,"briefTitle":112,"officialTitle":112,"acronym":27,"eligibilityCriteria":113,"healthyVolunteers":114,"sex":115,"minAge":116,"maxAge":27,"enrollmentInfo":117,"targetDuration":27,"studyType":120,"phases":121,"briefSummary":123,"conditions":124,"keywords":127,"overallStatus":64,"whyStopped":27,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":140},{"fullName":5,"class":6},"Emory University","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Group 1: Empathy Training","EXPERIMENTAL","Participants will be randomly assigned to the empathy training or control condition for 6 months. During the first phase of the study, participants in Group 1 will receive the photo captioning intervention.\n\nAt the 6-month time point, participants in Group 1 will crossover to control.\n\nAssessments will be collected at baseline, 10-day (immediate post-training), 6-month (crossover), 6-month and 10-day (immediate post-crossover) and 12-month (completion)",[13,14,15],"Behavioral: Cognitive Empathy Training","Procedure: Pre and post intervention blood spot collection","Procedure: Pre and post intervention MRI session",{"label":17,"type":6,"description":18,"interventionNames":19},"Group 2: Control Condition","During the first phase of the study, participants in Group 2 are controls. At the 6-month time point, participants in Group 2 will crossover and initiate the intervention.\n\nAssessments will be collected at baseline, 10-day (immediate post-training), 6-month (crossover), 6-month and 10-day (immediate post-crossover), and 12-month (completion)",[20,14,15],"Behavioral: Control Condition",[22,28,32,39],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"BEHAVIORAL","Cognitive Empathy Training","Participants will engage in a mentalization activity by captioning photos of their care recipients, reflecting on what the care recipient might be thinking or feeling. Over 10 days, caregivers will take 3-5 daily pictures of their care recipient and caption each with descriptive text representing the recipient's inner voice. This task encourages caregivers to consider the care recipient's perspective and motivations behind their behavior or emotional experiences. Photos will be shared securely via encrypted email. Utilizing accessible smartphone technology, the study allows caregivers to capture and reflect on meaningful moments with their care recipients",[9],null,{"type":23,"name":29,"description":30,"armGroupLabels":31,"otherNames":27},"Control Condition","In the control condition, participants will be asked to take 3-5 daily photographs of nature over 10 days. They will be asked to caption each photo with a description of what they see. This exercise will involve many of the same activities as the cognitive empathy training, except that participants will not be mentalizing or taking the the perspective of their PLWD or anyone else.",[17],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"PROCEDURE","Pre and post intervention blood spot collection","At their initial study visit, participants will provide a blood spot sample for measurement of C-reactive protein, pro-inflammatory cytokines and Epstein-Barr virus antibody titers.",[9,17],[38],"Labs",{"type":33,"name":40,"description":41,"armGroupLabels":42,"otherNames":43},"Pre and post intervention MRI session","In this study, caregivers will be positioned in a Siemens Trio 3T MRI scanner for functional imaging. They will view images of their care recipient care recipient, other similar care recipients care recipient, and photographs of friends or family members, pressing a button each time they see their care recipient care recipient's photo to monitor attention. The task involves viewing eight photos of four individuals with happy and neutral expressions, followed by rest periods. This sequence repeats five times, with each stimulus presented for 5 seconds and inter-trial intervals of 2, 3, or 4 seconds, totaling 11 minutes and 15 seconds. A subsequent 10-minute diffusion-weighted scan will assess brain white matter integrity, using 60 diffusion directions. All scans will be completed within 40 minutes.",[9,17],[44],"MRI scan",[46,50],{"name":47,"affiliation":48,"role":49},"James Rilling, PhD","Emory College of Arts & Sciences","PRINCIPAL_INVESTIGATOR",{"name":51,"affiliation":52,"role":49},"Kenneth Hepburn, PhD","Emory School of Nursing",[54,58],{"name":47,"role":55,"phone":56,"phoneExt":27,"email":57},"CONTACT","404-727-3062","jrillin@emory.edu",{"name":51,"role":55,"phone":59,"phoneExt":27,"email":60},"404-712-9286","khepbur@emory.edu",[62,81,92],{"facility":63,"status":64,"city":65,"state":66,"zip":67,"country":68,"countryCode":69,"cosmosGeoPoint":70,"geoPoint":75,"contacts":76},"Alter","RECRUITING","Atlanta","Georgia","30302","United States","US",{"type":71,"coordinates":72},"Point",[73,74],-84.38798,33.749,{"lat":74,"lon":73},[77],{"name":78,"role":55,"phone":79,"phoneExt":27,"email":80},"Fayron Epps, PhD,RN","770-686-7730","outreach@alterdementia.com",{"facility":82,"status":64,"city":65,"state":66,"zip":83,"country":68,"countryCode":69,"cosmosGeoPoint":84,"geoPoint":86,"contacts":87},"Emory Integrated Memory Care","30329",{"type":71,"coordinates":85},[73,74],{"lat":74,"lon":73},[88],{"name":89,"role":55,"phone":90,"phoneExt":27,"email":91},"Carolyn Clevenger, PhD","404-712-2394","carolyn.clevenger@emory.edu",{"facility":93,"status":64,"city":65,"state":66,"zip":83,"country":68,"countryCode":69,"cosmosGeoPoint":94,"geoPoint":96,"contacts":97},"NIA Goizueta Alzheimer's Disease Research Center",{"type":71,"coordinates":95},[73,74],{"lat":74,"lon":73},[98],{"name":99,"role":55,"phone":100,"phoneExt":27,"email":27},"Allen Levey, MD, PhD","404-727-6050",{"type":49,"investigatorFullName":102,"investigatorTitle":103,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"James K. Rilling","Professor",[105],{"name":106,"class":107},"National Institute on Aging (NIA)","NIH","100566080","effect-of-cognitive-empathy-training-on-dementia-caregivers-100566080",false,"NCT06650527","Effect of Cognitive Empathy Training on Dementia Caregivers","Inclusion Criteria:\n\n* Caregivers must live with their care recipient\n* Caregivers must have a Zarit Burden Scale score of 19 or higher\n* Caregivers must have no plans to move their care recipient to an institutional setting within the next year\n* Caregivers must be able to read and write English\n* Care recipient not in hospice\n* Access to a mobile phone that can take and email photographs\n\nExclusion Criteria:\n\n* Subjects with a history of seizures or other neurological disorders, alcoholism, or any other substance abuse\n* Subjects with a history of psychiatric illness (excluding depression and anxiety disorders) will also be excluded\n* Subjects with a history of head trauma based on Survey\n* Subjects with MRI contra-indications",true,"ALL","50 Years",{"count":118,"type":119},118,"ESTIMATED","INTERVENTIONAL",[122],"NA","The goal of this project is to investigate the effect of cognitive empathy training on mental health, inflammation, and immune function in caregivers of people living with dementia (PLWD), and to examine the underlying psychological and neurobiological mechanisms.\n\nThe primary aim is to establish the effectiveness of cognitive empathy training in improving caregiver mental health and immune function, and in decreasing caregiver inflammation\n\nThe secondary aim is to investigate the psychological and neurobiological mechanism by which cognitive empathy training improves caregiver well-being",[125,126],"Caregivers of People Living With Dementia","Dementia",[128,129,130],"Cognitive empathy","People Living With Dementia","Caregivers","2026-08-16",{"date":133,"type":134},"2026-08-18","ACTUAL",{"date":136,"type":134},"2025-02-13",{"date":138,"type":119},"2028-11-01",{"name":5,"class":6},3]