[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659775":3},{"organization":4,"outcomesModule":7,"designInfo":39,"detailedDescription":46,"studyPopulation":42,"armGroups":47,"interventions":59,"overallOfficials":71,"centralContacts":77,"locations":83,"responsibleParty":97,"collaborators":100,"id":109,"slug":110,"hasResults":111,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":115,"eligibilityCriteria":116,"healthyVolunteers":111,"sex":117,"minAge":118,"maxAge":42,"enrollmentInfo":119,"targetDuration":42,"studyType":122,"phases":123,"briefSummary":125,"conditions":126,"keywords":130,"overallStatus":136,"whyStopped":42,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":141,"completionDateStruct":142,"leadSponsor":144,"locationsCount":145},{"fullName":5,"class":6},"Massachusetts General Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":26},[9],{"measure":10,"description":11,"timeFrame":12},"Zarit Burden Interview (ZBI-22)","22-item self-report of caregiver strain. Higher scores (min = 0, max = 88) indicate higher burden related to caregiving.","Baseline (Week 0), post-intervention (Week 7), 6-month post-intervention",[14,17,20,23],{"measure":15,"description":16,"timeFrame":12},"Patient Health Questionnaire-9 (PHQ-9)","9-item self-report assessing symptoms of depression. Higher total scores (min=0, max=27) indicate greater severity of depressive symptoms.",{"measure":18,"description":19,"timeFrame":12},"General Anxiety Disorder-7 (GAD-7)","7-item self-report measure of general anxiety symptoms. Higher total scores (min=0, max=21) indicate greater anxiety severity.",{"measure":21,"description":22,"timeFrame":12},"PROMIS Global Physical Health 4a (PROMIS-GPH)","4-item self-report of overall physical health, physical function, pain, and fatigue. Higher T scores (mean=50, SD =10) indicate greater perceived general physical wellbeing.",{"measure":24,"description":25,"timeFrame":12},"Neuropsychiatric Inventory Questionnaire (NPI-Q)","12-item self-report assessing behavioral and psychological symptoms in persons with memory loss. Study team will assess symptom severity (min=0, max=36, higher scores indicate greater neuropsychiatric symptom burden) and distress (min=0, max=60, higher scores indicate greater caregiver distress due to symptomology).",[27,30,33,36],{"measure":28,"description":29,"timeFrame":12},"Caregiver Self-Efficacy Scale-8","8-item self-report assessing caregiver confidence and self-efficacy. Higher total scores (min=8, max=80) indicate greater confidence in maintaining personal activities along with the caregiver role.",{"measure":31,"description":32,"timeFrame":12},"Leisure Time Satisfaction (LTS)","7-item self-report assessing satisfaction with the amount of time participants have for leisure activities. Higher total scores (min=0, max=14) indicate greater fulfilment and satisfaction with one's ability to engage in their everyday enjoyable activities while caregiving.",{"measure":34,"description":35,"timeFrame":12},"Dysfunctional Thoughts about Caregiving Questionnaire (DTCQ)","16-item self-report assessing negative or rigid thoughts and beliefs common among caregivers. Higher scores (min=0, max=64) indicate a more maladaptive approach to caregiving.",{"measure":37,"description":38,"timeFrame":12},"Brief-COPE Dysfunctional Coping Subscale","12-item self-report assessing effective and ineffective ways of coping with stress, using dysfunctional coping strategies. Higher scores (min = 12, max = 48) indicate greater utilization of different dysfunctional coping methods.",{"allocation":40,"interventionModel":41,"interventionModelDescription":42,"primaryPurpose":43,"observationalModel":42,"timePerspective":42,"maskingInfo":44},"RANDOMIZED","PARALLEL",null,"TREATMENT",{"masking":45,"maskingDescription":42,"whoMasked":42},"NONE","The aim of this clinical trial is to conduct a randomized, comparative effectiveness trial (N=450) of two group-based, telehealth programs for caregivers of persons with memory loss. The central goal is to test which of the evidence-based behavioral intervention comparators - Caring Together or Savvy Caregiver - should be implemented in real-world clinical practice to reduce elevated caregiver strain. Investigators will evaluate:\n\nAim 1: Whether group-delivered telehealth Caring Together is superior to group-delivered telehealth Savvy Caregiver in reducing elevated caregiver strain (primary outcome; as measured by the ZBI) as well as secondary outcomes of caregiver depression, caregiver anxiety, caregiver physical health, and behavioral and psychiatric symptoms of memory loss, at post-treatment.\n\nAim 2: Whether improvements in both Caring Together and Savvy Caregiver will be maintained over a 6-month follow-up.\n\nAim 3: Heterogeneity of treatment effects (HTE) analyses to examine treatment preference as the primary potential source of HTE. The investigators will explore additional potential sources of HTE, including relationship type (i.e., spouse versus other), service utilization (e.g., respite, case management), caregiver gender (i.e., woman versus other), and caregiver network size.\n\nThe investigators will recruit caregivers of persons with memory loss who are reporting caregiver strain from partner dementia care clinics at Mass General Brigham, the University of Rochester, the University of Colorado, and Tufts Medical Center. Participants will also be recruited through social media and community-based organizations.\n\nEnrolled participants will be randomized to one of two programs (Savvy Caregiver or Caring Together) and will complete 6 weekly 120-minute sessions via Zoom delivered by a clinical psychologist or trainee. Participants will complete self-reported assessments at 3 timepoints: before the intervention, after the intervention, and 6-months after completing the intervention.\n\nParticipants will participate in weekly 120-minute virtual group sessions in small groups (6-8 participants) over the course of 6 weeks delivered by trained behavioral clinicians. The investigators will run groups in English and Spanish.\n\nAfter completing the intervention, participants will be administered post-intervention assessments, and a follow-up survey at 6 months.",[48,54],{"label":49,"type":50,"description":51,"interventionNames":52},"Caring Together","ACTIVE_COMPARATOR","Caring Together is a cognitive-behavioral therapy utilized for patients experiencing elevated caregiver strain. This program is designed to help caregivers of persons living with memory problems diagnosis build coping skills, reduce stress, find more moments of joy, and feel less alone in their role. The small group-based structure focuses on practical tools for managing difficult emotions, responding to dementia-related challenges, and strengthening resilience and self-care. The program focuses on coping with stress and learning how to modify negative thoughts, feelings, and behaviors that caregivers often experience.",[53],"Behavioral: Caring Together",{"label":55,"type":50,"description":56,"interventionNames":57},"Savvy Caregiver","Savvy Caregiver is a structured, multi-component behavioral intervention for elevated caregiver strain. This program is designed to help caregivers of persons living with memory problems feel more confident, less overwhelmed, and better prepared to respond to day-to-day challenges. The small group-based program structure focuses on understanding dementia symptoms, structuring daily routines, and responding to challenges that arise, while also considering your own well-being. This program focuses on understanding dementia and practical problem-solving strategies for common challenges caregivers experience.",[58],"Behavioral: Savvy Caregiver",[60,66],{"type":61,"name":49,"description":62,"armGroupLabels":63,"otherNames":64},"BEHAVIORAL","Caring Together is the standard treatment for elevated caregiver strain. Caring Together follows the Stress-Process Model and teaches basic illness knowledge, and problem-solving frameworks to increase self-efficacy and psychological coping skills of cognitive reframing and behavioral activation for self care.",[49],[65],"CT",{"type":61,"name":55,"description":67,"armGroupLabels":68,"otherNames":69},"Savvy Caregiver is a widely structured multi-component behavioral interventions for elevated caregiver strain. Savvy Caregiver is also rooted in the Stress-Process Model, rooted in providing illness education, problem-solving frameworks, and psychological coping skills.",[55],[70],"SC",[72,75],{"name":73,"affiliation":5,"role":74},"Evan Plys, PhD","PRINCIPAL_INVESTIGATOR",{"name":76,"affiliation":5,"role":74},"Ana-Maria Vranceanu, PhD",[78],{"name":79,"role":80,"phone":81,"phoneExt":42,"email":82},"LIGHTEN Study Coordinator","CONTACT","617-724-1279","mghlightenstudy@mgb.org",[84],{"facility":85,"status":42,"city":86,"state":87,"zip":88,"country":89,"countryCode":90,"cosmosGeoPoint":91,"geoPoint":96,"contacts":42},"Mass General Hospital","Boston","Massachusetts","02114","United States","US",{"type":92,"coordinates":93},"Point",[94,95],-71.05977,42.35843,{"lat":95,"lon":94},{"type":74,"investigatorFullName":98,"investigatorTitle":99,"investigatorAffiliation":5,"oldNameTitle":42,"oldOrganization":42},"Evan Plys","Assistant Professor",[101,103,105,107],{"name":102,"class":6},"Patient-Centered Outcomes Research Institute",{"name":104,"class":6},"University of Colorado, Denver",{"name":106,"class":6},"Tufts Medical Center",{"name":108,"class":6},"University of Rochester","100659775","leveraging-interventions-for-caregiver-growth-health-training-empowerment-and-navigation-comparing-group-behavioral-interventions-to-improve-dementia-caregiver-strain-100659775",false,"NCT07868588","Leveraging Interventions for Caregiver Growth, Health, Training, Empowerment and Navigation: Comparing Group Behavioral Interventions to Improve Dementia Caregiver Strain","Comparing Group Behavioral Interventions to Improve Dementia Caregiver Strain","LIGHTEN","While the below criteria reference both the caregiver and care recipient, only caregivers will be enrolled in this study.\n\nInclusion Criteria:\n\n* Caregiver of a person with memory loss currently\n* Care recipient currently living in community\n* Caregiver at least 18 years of age\n* Caregiver Zarit Burden Interview-6 (ZBI-6) greater than or equal to 9\n* English or Spanish fluency\u002Fliteracy\n* Able and willing to participate\n\nExclusion Criteria:\n\n* Care recipient enrolled or planning to enroll in hospice\n* Severe, untreated mental illness or substance use (self or clinician report)\n* Active suicide risk\n* Residence outside the U.S. during study procedures","ALL","18 Years",{"count":120,"type":121},450,"ESTIMATED","INTERVENTIONAL",[124],"NA","The goal of this clinical trial is to compare two group-based interventions for caregivers of persons with memory loss (N=450) delivered via telehealth. The aim is to evaluate which program is most effective for different types of caregivers in reducing stress, improving coping, and increasing confidence related to caregiving.\n\nParticipants will be randomly assigned to one of the two programs, as well as be asked to complete study assessments at baseline (week 0), post-intervention (week 7), and 6-month follow-up.",[127,128,129],"Elevated Caregiver Strain","Dementia Caregiver","Caregiver Stress",[131,132,133,134,49,55,129,135],"Caregiving","Cognitive Behavioral Therapy","Zarit Burden Interview","Dementia caregiving","Alzheimer's Caregiver","NOT_YET_RECRUITING","2026-10-05",{"date":139,"type":140},"2026-10-09","ACTUAL",{"date":137,"type":121},{"date":143,"type":121},"2031-07-01",{"name":5,"class":6},1]