[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643231":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":33,"locations":39,"responsibleParty":54,"collaborators":58,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":9,"eligibilityCriteria":75,"healthyVolunteers":71,"sex":76,"minAge":77,"maxAge":32,"enrollmentInfo":78,"targetDuration":32,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":90,"overallStatus":105,"whyStopped":32,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"University of Washington","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"VOCALE LBD","EXPERIMENTAL","Participants in this arm receive the VOCALE LBD intervention: an 8-week, fully asynchronous, text-based online group program delivered via the Discourse platform. Groups of 10-15 participants are moderated by a licensed nurse or social worker who logs in daily. Weekly discussion topics address LBD-specific caregiving challenges (self-care, sleep problems, hallucinations and delusions) and problem-solving skills training using the ADAPT method. Participants are asked to post at least twice weekly.",[13],"Behavioral: VOCALE LBD: Virtual Online Communities for Aging Life Experiences: Lewy Body Dementia",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard of Care","ACTIVE_COMPARATOR","NIA and LBDA psychoeducational materials on LBD and caregiving; LBDA resource list; problem-solving principles handout. Materials delivered via email or mail per participant preference.",[19],"Other: Standard of Care Educational Materials",[21,29],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","VOCALE LBD: Virtual Online Communities for Aging Life Experiences: Lewy Body Dementia","The 8-week VOCALE LBD intervention is delivered asynchronously via the Discourse online platform. The weekly curriculum includes: Pre-intervention (icebreakers, self-introductions); Week 1 (self-care); Week 2 (sleep problems); Week 3 (hallucinations and delusions); Week 4 (problem-solving inventory, SPSI-R); Week 5 (ADAPT - Positive Attitude); Week 6 (ADAPT - Define the Problem); Week 7 (ADAPT - Alternative Solutions); Week 8 (ADAPT - Plan and Try).",[9],[9,27,28],"Virtual Online Community","Asynchronous Online Group Intervention",{"type":6,"name":30,"description":17,"armGroupLabels":31,"otherNames":32},"Standard of Care Educational Materials",[15],null,[34],{"name":35,"role":36,"phone":37,"phoneExt":32,"email":38},"Oleg Zaslavsky, PhD, RN","CONTACT","(206) 849-3301","zaslav@uw.edu",[40],{"facility":5,"status":32,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Seattle","Washington","98195","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-122.33207,47.60621,{"lat":50,"lon":49},[53],{"name":35,"role":36,"phone":37,"phoneExt":32,"email":38},{"type":55,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"PRINCIPAL_INVESTIGATOR","Oleg Zaslavsky","Associate Professor, University of Washington School of Nursing",[59,62,65,67],{"name":60,"class":61},"National Institute of Mental Health (NIMH)","NIH",{"name":63,"class":64},"The Lewy Body Dementia Association (LBDA)","UNKNOWN",{"name":66,"class":61},"National Institute on Aging (NIA)",{"name":68,"class":61},"National Institutes of Health (NIH)","100643231","vocale-lbd-online-peer-support-for-caregivers-of-people-with-lewy-body-dementia-100643231",false,"NCT07637097","VOCALE LBD: Online Peer Support for Caregivers of People With Lewy Body Dementia","Reducing Depression in Family Caregivers of Persons Living With Lewy Body Dementia Through Tailored Asynchronous Online Intervention.","Inclusion Criteria:\n\n* Current family member or informal (unpaid) caregiver of a person with a confirmed diagnosis of Lewy Body Dementia (LBD) or LBD mixed pathology\n* Experiences depressive symptoms as defined by a score of 5 or higher on the Patient Health Questionnaire-9 (PHQ-9)\n* Able to read, write, and speak English\n* Has access to a device (computer, tablet, or smartphone) that can connect to the internet and be used for videoconferencing or phone calls, OR is interested in using a loaner device\n\nExclusion Criteria:\n\n* Active suicidal ideation as indicated by endorsement of PHQ-9 Item 9 (thoughts that you would be better off dead, or thoughts of hurting yourself)\n* Paid or professional caregiver (must be unpaid family\u002Finformal caregiver)\n* Unable to read, write, or speak English","ALL","18 Years",{"count":79,"type":80},220,"ESTIMATED","INTERVENTIONAL",[83],"NA","This study tests whether a tailored, fully asynchronous online group intervention (VOCALE LBD) reduces depression in family caregivers of people with Lewy Body Dementia (LBD), compared to standard educational materials. LBD is the second most common form of degenerative dementia and causes distinct challenges, including visual hallucinations, REM sleep disorder, and severe motor symptoms, that are not addressed by generic caregiver interventions. Depression rates in LBD caregivers reach 40-50%, double the rate seen in Alzheimer's disease caregivers, yet no rigorous digital interventions exist specifically for this population. VOCALE LBD is a text-based, low-bandwidth platform (Discourse) that brings groups of 10-15 caregivers together in an 8-week moderated online community. Weekly topics address LBD-specific challenges (sleep problems, hallucinations, self-care) and problem-solving skills using the ADAPT method. A pilot study (n=54) showed strong effects on depressive symptoms (Cohen's d=0.54 at 1-month follow-up), near-perfect engagement, and high participant satisfaction. This RCT (N=220) will test efficacy, examine mechanisms of action (self-efficacy and problem-solving), and explore analytics approaches for pragmatic monitoring, laying groundwork for future implementation in clinics and community organizations.",[86,87,88,89],"Lewy Bodies Disease","Depression Disorder","Caregiver Burden","Caregivers",[91,92,93,94,95,96,97,98,99,100,101,102,103,104],"Lewy body disease","LBD","Family caregivers","Caregiver Depression","Online Intervention","Asynchronous","Digital Health","Peer Support","Problem-solving therapy","VOCALE","Telehealth","Dementia caregiver","ADAPT method","Discourse Platform","NOT_YET_RECRUITING","2026-06-03",{"date":108,"type":109},"2026-06-09","ACTUAL",{"date":111,"type":80},"2026-12-01",{"date":113,"type":80},"2030-11-30",{"name":5,"class":6},1]