[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"care-giving-burden\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:care-giving-burden":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,50,95],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":32,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100605831","caring-for-the-carer-100605831",false,"NCT07167641","Caring for the Carer","CFC","Inclusion Criteria:\n\n* The participants must be a parent, caregiver, or supporter of a young person who has been referred to a CSC program for First Episode Psychosis (FEP) in the past 3 years. A parent or supporter is considered eligible for the study if their young person was referred to the program but chose not or was unable to engage in CSC or is currently on the waitlist for FEP treatment.\n* Parent, caregiver, or supporter must be at least 18 years of age\n* Participants recruited from UNC CSC programs\n* Parent, caregiver, or supporter must be able to engage in research assessments and consent to audio recording sessions for fidelity ratings\n\nExclusion Criteria:\n\n* Parent, caregiver, or supporter is currently engaged in legal action against the loved one receiving services\u002Fexperiencing psychosis\n* Parent, caregiver, or supporter's loved one has never experienced psychosis\n* Parent, caregiver, or supporter does not speak English",true,"ALL","18 Years","99 Years",{"count":21,"type":22},60,"ESTIMATED","INTERVENTIONAL",[25],"NA","The purpose of the present study is to investigate the acceptability and feasibility of implementing a novel, Cognitive Behavioral Therapy (CBT) intervention to caregivers and supporters of individuals who have experienced psychosis, regardless of their relative's engagement in treatment specific to psychosis (i.e., coordinated specialty care (CSC) services). Additionally, the investigators will assess the secondary aim of impact on well-being as a result of the intervention.",[28,29,30,31],"Care Burden","Care Giving Burden","Caregiver Burnout","Caregiver Wellbeing",[33,34,35,36],"Cognitive Behavioral Therapy","Supporters","Caregiving","Caregiver Support","RECRUITING","2026-05-26",{"date":40,"type":41},"2026-05-27","ACTUAL",{"date":43,"type":41},"2025-09-11",{"date":45,"type":22},"2027-01-31",{"name":47,"class":48},"University of North Carolina, Chapel Hill","OTHER",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":17,"minAge":58,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":23,"phases":61,"briefSummary":63,"conditions":64,"keywords":69,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":94},"100481029","phase-2-clinical-trial-on-agitation-in-alzheimers-dementia-100481029","NCT05543681","Clinical Trial on Agitation in Alzheimer's Dementia","A Phase 2, Multicenter, Double-Blind, Randomized, Placebo-Controlled, Trial of the Safety and Efficacy of IGC-AD1 on Agitation in Participants With Dementia Due to Alzheimer's Disease","CALMA","To be eligible to participate in this study, the participant must meet all the following criteria:\n\nInclusion Criteria\n\n1. Participant and\u002For Caregiver must provide a signed and dated ICF prior to any study procedures.\n2. Must have a Caregiver who is able and willing to comply with all required study procedures.\n3. The Caregiver must be known to the Participant and must be able to use electronic devices such as a cell phone, video conference over a laptop or cell phone, weighing scale, and be able to learn to take blood pressure, among others.\n4. Based on local practice, Participants that cannot consent may have Caregiver's consent provided the Caregiver has among others a) Power of Attorney, b) is a spouse, or c) a sibling or d) a child or e) a close relation. The practice of accepting consent must be consistent with established practice at the site and jurisdiction.\n5. Participants must consent to CYP450 and apolipoprotein E (ApoE) genotyping, and pharmacokinetics.\n6. Diagnosis of AD by NIA-AA criteria\n7. Clinically significant Agitation assessed by:\n\n   1. NPI (Agitation) ≥ 4\n   2. The presence of clinically significant, persistent Agitation based on the IPA definition (Appendix C) rather than those with recent onset and occasional symptoms, and\n   3. Agitation not attributable to another psychiatric disorder, suboptimal care conditions, other underlining medical condition, or the physiological effects of a substance.\n8. Negative drug screen, except for benzodiazepines if Participant has been using them in stable doses for at least 3 months before screening.\n9. All medications used for behavioral symptoms should be consistent for at least 6 weeks before screening, with allowance for dose changes up to 25%.\n10. Women must be of no childbearing potential (postmenopausal, defined as cessation of menses for at least 12 months, without an alternative medical cause for amenorrhea) or surgically sterile (hysterectomy, bilateral oophorectomy, or bilateral tubal ligation)).\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\nExclusion Criteria\n\n1. Prior adverse reaction to cannabinoids or to any component of Study Drug (IGC-AD1 and placebo).\n2. Serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic, or hematologic disease, which might confound assessment of safety outcomes.\n3. History of seizures, schizophrenia, or bipolar disorder.\n4. Has participated in an investigational drug or device study within 30 days prior to study start.\n5. Urine drug screen positive for drug use, except for benzodiazepines if Participant was using them previously and their dose had remained stable for at least six weeks before screening.\n6. History of Alcohol and Drug use disorder, within one year prior to enrollment.\n7. Hypertension: Participants with a history of uncontrolled hypertension as determined by the PI and Participants with a hypertensive crisis in the six months prior to enrollment.\n8. Falls: Participants with a history of recurrent falls defined as more than two falls in the six-month period prior to enrollment and a history of falls resulting in injuries or associated with a new acute illness, loss of consciousness, fever, or abnormal blood pressure (Fuller et al., 2000).","60 Years",{"count":60,"type":22},164,[62],"PHASE2","The purpose of this study is to assess the efficacy of the oral medication IGC-AD1, a THC-based (Delta-9-Tetrahydrocannabinol) formulation administered twice a day on Agitation in patients with mild to severe dementia from Alzheimer's.",[65,66,29,67,68],"Alzheimer Disease","Agitation,Psychomotor","NPS","Aggression",[70,71,72,73,74,75,76,77,78,79,80,81,82,83],"Cannabis","Tetrahydrocannabinol","THC","Melatonin","Alzheimer's","Marijuana","Hemp","Agitation","Dementia","Depression","Anxiety","NPI","CMAI","Dronabinol","2026-05-18",{"date":86,"type":41},"2026-05-20",{"date":88,"type":41},"2022-10-11",{"date":90,"type":22},"2026-08",{"name":92,"class":93},"IGC Pharma, LLC","INDUSTRY",31,{"id":96,"slug":97,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":101,"eligibilityCriteria":102,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":103,"enrollmentInfo":104,"targetDuration":4,"studyType":23,"phases":105,"briefSummary":106,"conditions":107,"keywords":111,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":49},"100595430","e-tailored-pain-management-support-for-dementia-family-caregivers-feasibility-of-the-pace-app-100595430","NCT07032350","E-Tailored Pain Management Support for Dementia Family Caregivers: Feasibility of the PACE-app","E-Tailored Pain Management Support for Dementia Family Caregivers","PACE-app","Inclusion Criteria:\n\n* Be a primary caregiver - (a family member, relative, or friend) of a person with dementia (or cognitive impairment) and chronic pain (lasting \\>3 months)'\n* Be responsible for managing the care recipient's pain and pain treatments (including interpreting verbal or non-verbal pain communication).\n* Be age 18 - 100.\n* Be able to read and speak English.\n* Have regular access to an electronic device (tablet, laptop, or computer) with internet connectivity (for using the app and participating in data collection).\n* Be accessible by phone or email to schedule meetings.\n* Be willing to commit to the full study duration and protocol.\n\nExclusion Criteria:\n\n* Currently participating in another research study that could interfere with this intervention.","100 Years",{"count":21,"type":22},[25],"The goal of this clinical trial is to test whether a web-based application called the Pain Control Enhancement App (PACE-app) can support family caregivers in managing pain for their care recipients with dementia. The main questions it aims to answer are:\n\nIs it feasible and acceptable for family caregivers to use the PACE-app?\n\nDoes using the PACE-app improve caregiver self-efficacy in pain management, adherence to pain treatments, communication with care providers, well-being, and their care recipient's pain conditions?\n\nResearchers will compare caregivers who use the PACE-app to those who continue with their usual care practices to see if the app leads to better outcomes for both caregivers and care recipients.\n\nParticipants will:\n\nBe randomly assigned to either the PACE-app group or a usual-care control group\n\nComplete online surveys at baseline, 1 month, and 2 months\n\nIf assigned to the PACE-app group:\n\nUse the PACE-app for 1 month to receive tailored pain management strategies and tools, and record their care recipient's pain in a digital diary\n\nParticipate in an interview about their experience with the app\n\nAll participation activities can be done remotely or in person.",[29,78,108,109,110],"Chronic Pain","Pain Management","Palliative Care",[78,65,108,109,112,113,114,115,116,110,117,118,119,120,121,122,123,124,125,126,127],"Caregivers","Family Caregivers","Digital Health Intervention","eHealth","Web-based Intervention","Home Care","Self-efficacy","Caregiver Stress","Caregiver Depression","Communication with Providers","Health Literacy","Rural Caregivers","Geriatrics","Aging","Cognitive Impairment","Pain Diary","2025-06-25",{"date":130,"type":41},"2025-06-29",{"date":132,"type":41},"2025-05-22",{"date":134,"type":22},"2026-05",{"name":136,"class":48},"University of Iowa"]