[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"social-isolation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:social-isolation":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,20,0,[8,45,75,111,136,161,187,211,240,262,285,322,352,374,397,422,451,477,506,539],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100551986","increasing-veterans-social-engagement-and-connectedness-100551986",false,"NCT06467214","Increasing Veterans' Social Engagement and Connectedness","CONNECTED","Inclusion Criteria:\n\nEligible participants for Aim 1 \\& Aim 2\n\n1. Must be Veterans at the Roudebush Veterans Affairs Medical Center or its Community-Based Outpatient Clinics who had a primary care encounter in the prior 6 months and\n2. Veteran obtained a score 12, indicating social isolation, on the Lubben Social Isolation Scale (LSNS-6), a validated, 6-item social isolation measure, at the time of screening in Aim 1.\n\nExclusion Criteria:\n\nFor Aim 1 and Aim 2, the investigators will exclude Veterans with\n\n1. Active suicidal ideation needing immediate mental health treatment\n2. severe cognitive, hearing or speech impairment,\n3. current exacerbation of severe psychiatric symptoms (e.g., active psychosis), or\n4. severe illness that makes study participation not feasible.","ALL","18 Years",{"count":19,"type":20},264,"ESTIMATED","INTERVENTIONAL",[23],"NA","Social isolation is a negative social determinant of health that affects 1-in-5 adults in the U.S. and 43% of Veterans. Social isolation is estimated to cost the nation $6.7 billion annually in federal healthcare spending. Yet, social isolation has rarely been the direct focus of healthcare interventions. The proposed project is a randomized controlled trial that seeks to test the effectiveness of the Increasing Veterans' Social Engagement and Connectedness (CONNECTED) intervention on social isolation among diverse Veteran groups in primary care clinics. Increasing Veterans' Social Engagement and Connectedness involves three key services delivered by peers via telehealth through individual and group sessions over 8 weeks: 1) peer support, which includes person-centered assessment for social isolation, 2) psychosocial interventions to address social isolation, and 3) navigation (i.e., connecting Veterans to social resources). Findings from this study will contribute to the VA's efforts to address social determinants of health among Veterans and to provide high quality, person-centered, and equitable care to all Veterans.",[26],"Social Isolation",[28,29,30,31],"Veterans","Peer specialists","Loneliness","Navigation","RECRUITING","2026-06-24",{"date":35,"type":36},"2026-06-29","ACTUAL",{"date":38,"type":36},"2024-10-04",{"date":40,"type":20},"2028-06-30",{"name":42,"class":43},"VA Office of Research and Development","FED",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":44},"100644029","social-prescribing-for-a-mindful-lifestyle-100644029","NCT07669805","Social Prescribing for a Mindful Lifestyle","Inclusion Criteria:\n\n* People aged 55 years or older.\n* People with a Geriatric Depression Scale (GDS-15) score of 7-10 or a UCLA Loneliness Scale Version 3 score of 35-64.\n* People can understand the research process, meet the requirements of the research, and can sign the informed consent and participate in the project.\n\nExclusion Criteria:\n\n* People that are unable to cooperate with the project or follow-up.\n* According to the PI's judgment, people with severe or poorly controlled conditions include ongoing acute diseases, severe infections, severe abnormal laboratory tests, or serious medical conditions with the following systems: cardiovascular, pulmonary, hepatic, nervous, mental, metabolic, renal, musculoskeletal, gastrointestinal, etc.\n* People with severe depression, risk of self-harm, severe cognitive impairment (dementia), visual or hearing impairment, and disabilities that prevent the completion of the project and assessment.\n* People are currently or expected to join any other physical training courses or nutrition intervention plans during the project period.\n* Others are based on the judgment of the PI that participating in this project may adversely affect the safety of the subjects, hinder the progress of the experiment, or interfere with the evaluation of the outcomes of the project.","55 Years",{"count":53,"type":20},50,[23],"The goal of this clinical trial is to evaluate the effectiveness of an 8-week mindfulness lifestyle social prescribing program in community-dwelling older adults aged 55 and older. The main questions it aims to answer are:\n\nTo establish a mindfulness lifestyle social prescribing model applied to the psychological and social health promotion of middle-aged and older populations.\n\nTo evaluate the effectiveness of the intervention on improving depressive symptoms, loneliness, and quality of life in this population.\n\nParticipants will receive an 8-week group intervention program, with each weekly session lasting approximately 3 hours. The structured curriculum integrates mindfulness awareness, body scanning, mindfulness stretching, breathing training, healthy dietary education, and art practices (such as herbal therapy and leaf printing). Researchers will collect and evaluate data from pre- and post-intervention assessments to measure changes in depressive symptoms, loneliness risk, and overall quality of life.",[57,30,26],"Depression and\u002For Anxiety in the Mild-to-moderate Range",[59,60,61,62,63],"Mindfulness","Older Adults","Lifestyle Medicine","Quality of Life","Social Prescribing","NOT_YET_RECRUITING","2026-06-21",{"date":67,"type":36},"2026-06-25",{"date":69,"type":20},"2026-07-01",{"date":71,"type":20},"2028-12-31",{"name":73,"class":74},"Buddhist Tzu Chi General Hospital","OTHER",{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":81,"sex":82,"minAge":17,"maxAge":83,"enrollmentInfo":84,"targetDuration":4,"studyType":21,"phases":86,"briefSummary":87,"conditions":88,"keywords":95,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":44},"100601479","sisters-for-heart-health-a-community-health-worker-initiative-for-improving-heart-health-in-farmworker-women-100601479","NCT07111026","Sisters for Heart Health: A Community Health Worker Initiative for Improving Heart Health in Farmworker Women","Inclusion Criteria:\n\n* Self-identified female employed as a farmworker;\n* Fluent in Spanish or English verbal literacy\n* Planning to be in the geographic area for a minimum of 6 months.\n\nExclusion Criteria:\n\n* Cognitive or psychological impairment precluding informed consent and\u002For active participation in the study due to substance use, neurologic, or other disorder\n* Pregnant or breastfeeding.",true,"FEMALE","50 Years",{"count":85,"type":20},269,[23],"The goal of this hybrid Type 1 effectiveness-implementation trial is to test the extent to which a peer support and community resource navigation intervention improves psychological well-being, addresses non-biologic drivers of health (access to healthcare, supportive services, nutrition, housing stability, transportation, chronic stress, social support), and thus reduces cardiometabolic risk among rural, low-income farmworker women aged 18-50 years. The main questions it aims to answer are:\n\n* If and to what extent does the intervention reduce stress, social isolation, and psychological distress by improving social support and access to needed resources?\n* If and to what extent does the intervention improve cardiometabolic health, measured by the American Heart Association's Life's Essential 8 (LE8) score?\n\nResearchers will compare the CHW-led Sisters for Heart Health intervention to a Basic intervention (LE8 assessment and resource information) to assess the effect of peer support and community resource navigation on heart health outcomes.",[89,90,26,91,92,93,94],"Occupational Stress","Gender Related Stress","Hypertension","Pre Diabetes","Diabetes","Obesity",[96,97,98,99,100,101],"occupational stress","gender related stress","social isolation","psychological stress","cardiometabolic health","non biological drivers of health","2026-06-04",{"date":104,"type":36},"2026-06-08",{"date":106,"type":36},"2025-09-16",{"date":108,"type":20},"2028-12",{"name":110,"class":74},"Emory University",{"id":112,"slug":113,"hasResults":11,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":4,"eligibilityCriteria":117,"healthyVolunteers":81,"sex":16,"minAge":83,"maxAge":4,"enrollmentInfo":118,"targetDuration":4,"studyType":21,"phases":120,"briefSummary":121,"conditions":122,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":44},"100602422","capable-care--connect-100602422","NCT07123298","CAPABLE Care + Connect","CAPABLE Care + Connect: Pilot Feasibility of Implementing CAPABLE Into Homebased Primary Care","Inclusion Criteria:\n\n* Any patient currently in JHOME\n* At risk for or experiencing social isolation as defined by the Lubben Social Network Scale 6 item score less than or equal 12 points or loneliness as defined by the UCLA Loneliness Scale 3 item score of 6 to 9 points\n* Cognitive inclusion criteria Montreal Cognitive Assessment (MOCA) \\>23 as determined by referring JHOME study team member provider\n* English speaking (measures are standardized in English)\n* Ability to participate in an approximately 45-60 min virtual or in person meeting\n* Eligible for CAPABLE\n* 50 years or older\n* Not hospitalized over night more than 4 times in the last 12 months\n* Have some difficulty with any ADL\n* Cognitively intact\n* Live in Baltimore County or Baltimore City\n* Not receiving active cancer treatment\n* Interested in participating in CAPABLE Care partners will be included if the care partners provide \\> 10 hours of care\u002Fweek\n\nExclusion Criteria:\n\n* Terminally ill\n* live in long term care setting\n* receiving active cancer treatment\n\nStandard of Care\u002FComparison group Inclusion Criteria:\n\n• Any patient currently in JHOME who did not receive the CAPABLE intervention",{"count":119,"type":20},450,[23],"In this evaluation scale-up research project, the investigators seek to test an implementation of CAPABLE on the infrastructure of home-based primary care for individuals who may experience social isolation and\u002For loneliness. These two home-based care programs may improve each other and provide opportunity to further improve quality of life for people living with disabilities and the caregivers. The purpose of this mixed methods study is to adapt and test CAPABLE, an existing evidence-based program, to a new target population with the scalable infrastructure of home-based primary care.",[123,124,26,62,125,126],"Social Isolation in Older Adults","Social Isolation or Loneliness","Disability Physical","Homebound Persons","2026-06-01",{"date":129,"type":36},"2026-06-02",{"date":131,"type":36},"2025-08-14",{"date":133,"type":20},"2027-05",{"name":135,"class":74},"Johns Hopkins University",{"id":137,"slug":138,"hasResults":11,"nctId":139,"briefTitle":140,"officialTitle":140,"acronym":4,"eligibilityCriteria":141,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":142,"enrollmentInfo":143,"targetDuration":4,"studyType":21,"phases":145,"briefSummary":146,"conditions":147,"keywords":151,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":44},"100627886","aya-peerconnect-a-communication-coaching-intervention-for-adolescentyoung-adult-cancer-survivors-ayacs-100627886","NCT07454460","AYA-PeerConnect: A Communication Coaching Intervention for Adolescent\u002FYoung Adult Cancer Survivors (AYACS)","Inclusion Criteria:\n\n* Participant is currently ≥18-35 years old\n* Participant is receiving cancer-directed care at Penn State Cancer Institute or Penn State Children's Hospital\n* Participant has completed all cancer-directed therapy and is at least 1 year from end of cancer treatment (based on date of last cancer-directed treatment)\n* Participant has access to a computer with internet capability\n* Participant is fluent in written and spoken English\n\nExclusion Criteria:\n\n* Participant is not fluent in written and spoken English\n* Participant with cognitive inability to participant in the study as determined by the study team\n* Participants with history of relapsed cancer","35 Years",{"count":144,"type":20},10,[23],"This research is being done to test a communication coaching intervention pilot designed to improve communication quality between adolescent\u002Fyoung adult cancer survivors (AYACS) and their friends\u002Fpeers. The results of the study will help to understand how to best support adolescent\u002Fyoung adult cancer survivors, and may inform the development or future implementation of similar programs for cancer survivor populations.",[148,149,150,26],"Communication","Anxiety","Depression",[148,149,150,26],"2026-05-20",{"date":154,"type":36},"2026-05-22",{"date":156,"type":36},"2026-04-14",{"date":158,"type":20},"2026-07-30",{"name":160,"class":74},"Milton S. Hershey Medical Center",{"id":162,"slug":163,"hasResults":11,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":167,"eligibilityCriteria":168,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":169,"targetDuration":4,"studyType":21,"phases":171,"briefSummary":172,"conditions":173,"keywords":176,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":186},"100635637","testing-a-peer-support-group-for-veterans-who-hear-voices-100635637","NCT07555275","Testing a Peer-Support Group for Veterans Who Hear Voices","A Multisited Efficacy Trial of Veteran Voices and Visions","VVV RCT","Inclusion Criteria:\n\n* Has been experiencing auditory hallucinations at least weekly within the past 6 months that are not exclusively due to substance use\n* English fluency sufficient for participating in groups\n* Able to provide consent\n\nExclusion Criteria:\n\n* Psychosis exclusively due to substance use\n* Clinically significant seizure disorder, traumatic brain injury, dementia, developmental disorder\u002Fintellectual disability\n* Inability to provide informed consent for any reason, including due to acute psychosis, mania, or dementia, or active guardianship or durable power of attorney\n* Plan to transfer or terminate care in the next 3 months\n* Has previously attended a VVV group",{"count":170,"type":20},160,[23],"Veterans with schizophrenia spectrum disorders who experience psychosis struggle with social integration- e.g., participation in work, housing, and citizenship-due to symptoms, stigma, and psychosocial functioning deficits. Veteran Voices and Visions (VVV) is a psychosocial, peer-led group intervention for Veterans with psychosis based that reduces distress related to psychosis and fosters a sense of belonging for Veterans living with psychosis. VVV destigmatizes psychosis; reframes symptoms; and introduces personalized, meaningful coping strategies enabling social interaction. The investigators will assess VVV's efficacy in a trial comparing recipients of VVV to another peer-led group, Wellness Recovery Action Planning (WRAP), on outcomes of distress from psychosis, sense of belonging, and social functioning while identifying contextual factors regarding implementation at two sites. The investigators hypothesize that proximal reduction in distress and increased sense of belonging results in improvements in social functioning.",[174,175,26],"Psychotic Disorders","Hallucinations, Auditory",[174,177,98,28],"hallucinations, auditory","2026-04-21",{"date":180,"type":36},"2026-04-29",{"date":182,"type":20},"2027-04-01",{"date":184,"type":20},"2030-09-30",{"name":42,"class":43},2,{"id":188,"slug":189,"hasResults":11,"nctId":190,"briefTitle":191,"officialTitle":192,"acronym":193,"eligibilityCriteria":194,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":195,"targetDuration":4,"studyType":21,"phases":197,"briefSummary":198,"conditions":199,"keywords":201,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":205,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":210,"locationsCount":44},"100577825","qnnections-refinement-and-pilot-trial-of-a-suicide-prevention-intervention-to-increase-social-connection-100577825","NCT06803329","Qnnections: Refinement and Pilot Trial of a Suicide Prevention Intervention to Increase Social Connection","Qnnections: A Novel Suicide Prevention Intervention for Increasing Social Connection Among LGBTQ+ Veterans","Qnnections","Inclusion Criteria:\n\n* Veterans who report past-month active suicidal ideation (C-SSRS \\[Columbia-Suicide Severity Rating Scale\\]\n\n  \\-- or past-3-month suicidal behavior;\n* LGBTQ+ or other minoritized gender or sexual identity;\n* Have a mental health point-of-contact (e.g., Suicide Prevention Coordinator, Mental Health Treatment Coordinator);\n* Willing to complete or update safety plan.\n\nExclusion Criteria:\n\n* cannot provide informed consent;\n* imminent psychiatric hospitalization;\n* current or planned participation in residential\u002Fintensive outpatient program that would interfere study participation;\n* in a conservatorship; and\n* has participated in any previous parts of the study.",{"count":196,"type":20},66,[23],"Despite the high risk of suicide among LGBTQ+ Veterans, there is currently no suicide-focused intervention for this population. This study will refine and pilot Qnnections, a novel group-based suicide prevention intervention that aims to increase social connection and functioning in this population. The project will involve Veterans with lived experience in further refining Qnnections, and then will examine feasibility and acceptability of Qnnections and of study procedures in a pilot randomized clinical trial.",[200,26],"Suicidal Thoughts and Behaviors",[202,203],"Suicide","Social isolation","2026-03-10",{"date":206,"type":36},"2026-03-12",{"date":208,"type":36},"2026-03-01",{"date":184,"type":20},{"name":42,"class":43},{"id":212,"slug":213,"hasResults":11,"nctId":214,"briefTitle":215,"officialTitle":216,"acronym":217,"eligibilityCriteria":218,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":219,"enrollmentInfo":220,"targetDuration":4,"studyType":21,"phases":222,"briefSummary":223,"conditions":224,"keywords":225,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":232,"startDateStruct":234,"completionDateStruct":236,"leadSponsor":238,"locationsCount":44},"100555311","need-to-be-needed-n2bn-intervention-100555311","NCT06510439","Need to be Needed (N2BN) Intervention","Randomized, Controlled Trial of Need to be Needed (N2BN) Intervention to Improve Social Connection, Reduce Social Isolation and Loneliness","N2BN RCT","Inclusion Criteria:\n\n1. A research diagnosis of Major Depression, Bipolar I, II, or Schizophrenia Spectrum disorder.\n\n   Participants will be screened by research staff using sections of the Mini-International Neuropsychiatric Interview (MINI; Sheehan et al., 1998) that will identify research diagnoses of: Major Depression, Bipolar I, II, or Schizophrenia Spectrum disorder.\n2. Ages 18 years old and older\n3. Living in the community\n4. Able to communicate in written and oral English\n5. UCLA-Loneliness Scale score of 6 or higher\n\nExclusion Criteria:\n\n1. Having a legal guardian\n2. Unable to give informed consent.\n3. Living situation which restricts their ability to move freely\n\nPotential participants failing to meet screening criteria will be informed at the time that we are not able to enroll them in the study at this time. Any interview notes, or information recorded on the MINI will be destroyed or securely deleted.\n\nThe study will not enroll any vulnerable populations.","99 Years",{"count":221,"type":20},120,[23],"The proposed study is a randomized, controlled trial (RCT) that will examine the effectiveness of an intervention designed to reduce social isolation and loneliness of adults with serious mental illness (SMI). The intervention will focus on improving their sense of mattering by using acts of kindness and experiencing gratitude through volunteering. 120 participants will be randomly assigned to the intervention group or the attention control group. Over the course of the 6-month intervention, participants in the intervention arm, will receive weekly support from the interventionist. The interventionist and the participant will collaboratively set goals and develop an initial intervention plan, which is informed by the participants interests, values and goals. The attention control group will receive non-directive listening support through research assistants.\n\nData collection for all participants will occur at baseline, at the mid-point of the intervention at 3 months, and at the end of the 6-month intervention. Participants will be asked questions about quality of experience, social context and satisfaction, mattering components, kindness, gratitude, and loneliness. We will gather data on demographic background, life transitions, social network characteristics, internalized stigma, neighborhood climate, depression, and trait measures of mattering and loneliness during intake and exit interviews. Additionally, participants of the intervention arm will be asked to provide feedback about the intervention.",[30,26],[226,227,98,228,229,230],"mattering","loneliness","need to be needed","neededness","volunteering","2026-01-16",{"date":233,"type":36},"2026-01-21",{"date":235,"type":36},"2024-10-07",{"date":237,"type":20},"2035-05-31",{"name":239,"class":74},"Temple University",{"id":241,"slug":242,"hasResults":11,"nctId":243,"briefTitle":244,"officialTitle":245,"acronym":4,"eligibilityCriteria":246,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":247,"targetDuration":4,"studyType":21,"phases":249,"briefSummary":250,"conditions":251,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":253,"lastUpdatePostDateStruct":254,"startDateStruct":256,"completionDateStruct":258,"leadSponsor":260,"locationsCount":44},"100551303","intervening-on-opioid-use-and-loneliness-100551303","NCT06458335","Intervening on Opioid Use and Loneliness","Addressing Loneliness as a Therapy Target Among Individuals Using Opioids","Inclusion Criteria:\n\n* Must be 18+\n* understand English -have internet access-\n* screen positive for an opioid use disorder\n* screen positive for elevated loneliness\n\nExclusion Criteria:\n\n* does not understand consent\n* does not have consistent access to a phone and internet",{"count":248,"type":20},300,[23],"This study aims to enroll 300 participants who will be assigned to one of three 3 groups. Each group will receive an intervention lasting 6, weekly sessions of 40-60 minutes. Eligibility include having an opioid use disorder and reporting loneliness or feeling alone or disconnected.",[252,30,26],"Opioid Use Disorder","2025-12-08",{"date":255,"type":36},"2025-12-09",{"date":257,"type":36},"2024-09-19",{"date":259,"type":20},"2029-06-30",{"name":261,"class":74},"University of Rochester",{"id":263,"slug":264,"hasResults":11,"nctId":265,"briefTitle":266,"officialTitle":267,"acronym":268,"eligibilityCriteria":269,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":270,"targetDuration":4,"studyType":21,"phases":272,"briefSummary":273,"conditions":274,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":276,"lastUpdatePostDateStruct":277,"startDateStruct":279,"completionDateStruct":281,"leadSponsor":283,"locationsCount":44},"100609775","fostering-agricultural-relationships-and-meaning---thriving-on-kinship-100609775","NCT07218965","Fostering Agricultural Relationships and Meaning - Thriving on Kinship","Fostering Agricultural Relationships and Meaning - Thriving on Kinship (FARM-TOK)","(FARM-TOK)","Inclusion Criteria:\n\n* 18 years of age or older\n* able to provide informed consent\n* understand English\n* have internet access\n* reside in an agricultural area\n* screen positive for loneliness by scoring at least 44 on the 20-item UCLA Loneliness Scale\n\nExclusion Criteria:\n\n* unable to give informed consent\n* non-English speaking\n* does not have consistent access to a phone and\u002For internet\n* reports being diagnosed with a neurological disorder or a current psychotic or bipolar 1 diagnosis\n* current suicidal or homicidal intent indicating a need for immediate hospitalization or treatment as determined by clinical interviewer",{"count":271,"type":20},65,[23],"This study aims to enroll 65 participants who will be assigned to one of two groups. Each group will receive an intervention consisting of six weekly sessions of 40-60 minutes each. Eligibility includes residing in an agricultural area and reporting loneliness or feeling alone or disconnected.",[30,26,275],"Rural Health","2025-10-17",{"date":278,"type":36},"2025-10-21",{"date":280,"type":36},"2025-07-26",{"date":282,"type":20},"2026-07",{"name":284,"class":74},"Ohio State University",{"id":286,"slug":287,"hasResults":11,"nctId":288,"briefTitle":289,"officialTitle":290,"acronym":4,"eligibilityCriteria":291,"healthyVolunteers":81,"sex":16,"minAge":51,"maxAge":4,"enrollmentInfo":292,"targetDuration":4,"studyType":21,"phases":294,"briefSummary":295,"conditions":296,"keywords":298,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":313,"lastUpdatePostDateStruct":314,"startDateStruct":316,"completionDateStruct":318,"leadSponsor":320,"locationsCount":44},"100601239","evaluating-and-implementing-the-connect-program---a-group-based-telehealth-intervention-to-reduce-social-isolation-loneliness-and-mental-health-symptoms-in-adults-ages-55-compared-to-routine-community-based-programming-100601239","NCT07107906","Evaluating and Implementing The CONNECT Program - a Group-Based Telehealth Intervention to Reduce Social Isolation, Loneliness, and Mental Health Symptoms in Adults Ages 55+, Compared to Routine Community-Based Programming","The CONNECT Program: Engaging Community Organizations in the Implementation and Evaluation of a Group Telehealth Mental Health Program for Older Canadians","Inclusion Criteria:\n\n* Adults aged 55 years or older\n* Able to speak, read, and understand English\n* Can manage hearing or vision changes well enough to participate in group conversations\n* Self-reported experiences of loneliness, social isolation, and\u002For mental health challenges (e.g., anxiety or depressive symptoms)\n\nExclusion Criteria:\n\n* Cannot communicate in English (verbal or written)",{"count":293,"type":20},128,[23],"Older adults in Canada are experiencing increasing levels of social isolation, loneliness, and mental health challenges, including anxiety and depression - trends that have worsened during and following the COVID-19 pandemic. Research consistently shows that loneliness and social isolation are associated with poorer mental and physical health outcomes, increased risk of dementia, and increased mortality. At the same time, social connection has a strong protective impact on health and well-being. Community-based programs that promote both social engagement and psychological support are urgently needed, particularly since older adults are less likely to access formal mental health services.\n\nApproximately 3-11% of older adults meet diagnostic criteria for mood or anxiety disorders each year, with even more experiencing elevated symptoms that greatly influence quality of life. Subsyndromal depression in late life is estimated to occur two to three times more often than major depressive disorder. Despite these needs, up to 70% of older adults with anxiety or mood disorders do not access psychological services, often due to low mental health literacy or practical barriers to care. At the same time, participation in community activities is associated with improved emotional well-being, greater social support, and lower rates of depression and anxiety.\n\nTo bridge this need for support, our team developed and pilot-tested The CONNECT Program - a group-based mental health intervention for adults 55 years and older, delivered via telephone or virtually. The CONNECT Program is grounded in Acceptance and Commitment Therapy (ACT), self-compassion, and theories of successful aging, and aims to improve psychological flexibility; reduce loneliness, social isolation, and co-occurring symptoms of depression and anxiety. A Manitoba pilot study (N = 34) demonstrated promising outcomes in terms of feasibility, acceptability, and preliminary effectiveness with the telephone-based group intervention.\n\nThe current trial will evaluate the implementation and effectiveness of The CONNECT Program in four Canadian provinces (British Columbia, Manitoba, New Brunswick, Saskatchewan), using an implementation-effectiveness hybrid design and a crossover randomized controlled trial. This study compares The CONNECT Program, delivered via telephone or virtually, to routine community programming (i.e., community participation as usual), which may occur in telephone, virtual, or in-person formats. The primary outcome is psychological flexibility; secondary outcomes include loneliness, social isolation, anxiety, depression, emotional support, mental health literacy. Implementation outcomes will be evaluated following the Proctor et al. framework.\n\nThis trial will contribute evidence on the mental health needs of adults 55+ and the value of low-barrier, community-based programs delivered remotely. Findings will guide further national and international implementation of The CONNECT Program and similar initiatives aimed at addressing the challenges of loneliness, social isolation, and mental health problems in late life.",[30,26,297,149],"Depression Disorders",[299,30,26,149,150,300,301,302,303,304,305,306,307,308,309,310,311,312],"Psychological Flexibility","Older adult","Aged","Psychotherapy, Group","Acceptance and Commitment Therapy","Mental Health","Telemedicine","Mental Health Teletherapy","Community Mental Health Services","Community-Based Participatory Research","Program Evaluation","Randomized Controlled Trial","Implementation Effectiveness Hybrid Design","Cross-Over Studies","2025-09-17",{"date":315,"type":36},"2025-09-19",{"date":317,"type":36},"2025-09-08",{"date":319,"type":20},"2026-12-31",{"name":321,"class":74},"University of Manitoba",{"id":323,"slug":324,"hasResults":11,"nctId":325,"briefTitle":326,"officialTitle":327,"acronym":328,"eligibilityCriteria":329,"healthyVolunteers":81,"sex":16,"minAge":330,"maxAge":331,"enrollmentInfo":332,"targetDuration":4,"studyType":21,"phases":334,"briefSummary":335,"conditions":336,"keywords":339,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":343,"lastUpdatePostDateStruct":344,"startDateStruct":346,"completionDateStruct":348,"leadSponsor":350,"locationsCount":44},"100420552","the-vespa-pilot-study-100420552","NCT04756245","The VESPA Pilot Study","The Virtually Engaging Socially With Physical Activity (VESPA) Pilot Study","VESPA","Inclusion Criteria:\n\n* Age of 45-80 years\n* Body mass index between 30-45 kg\u002Fm2\n* Low-active (30 or more minutes of moderate intensity physical activity on 2 or fewer days per week)\n* Have access to home Wi-Fi\n* Have regular access to a computer, tablet, or smartphone to receive teleconferencing calls\n* Have a clear \"VR space\" (7'x7' object-free space)\n* Have an \"Activity buddy\" (spouse, child, caregiver, etc.)\n* Modified Telephone Interview for Cognitive Status (TICS-M) score of 32 or greater\n* Consent from a physician for study participation\n* Proficient in the English language\n* Willingness to create or use existing personal Facebook account for virtual reality activities.\n\nExclusion Criteria:\n\n* Current involvement in other physical activity research studies\n* Hearing or sight impairments (significant visual or hearing impairment that cannot be corrected and results in the inability to use the telephone or hear normal conversation, colorblindness)\n* Dependence on a cane or walker\n* More than 1 fall in the past year\n* Contraindication to exercise\n* Current or recent history within the last 6 months of: symptomatic coronary heart disease, cancer, liver or renal disease, severe pulmonary disease, gross physical impairment, or uncontrolled hypertension; myocardial infarction or cardiovascular procedure within the last 3 months\n* History of or diagnosis of photosensitive epilepsy\n* Score of \"severe\" on any question in the Virtual Reality Sickness Questionnaire;\n* Unwillingness to use a head-mounted virtual reality system\n* Current severe or untreated depression","45 Years","80 Years",{"count":333,"type":20},30,[23],"Physical activity has been described by the US federal government as a 'best buy' for public health. Unfortunately, most adults in the United States are not sufficiently active, and this worsens with age. Low levels of participation are driven by many challenging barriers, including lack of access, few opportunities for enjoyable activity, and few supportive social relationships, which is especially important given the central role of social connection for lasting behavior change.\n\nA half-century of research in behavioral sciences has generated effective group-based physical activity programs, but these are inaccessible to most as they are often delivered in a few select research centers. Recent advances in telehealth have offered media for extending these interventions more broadly, but the experience of such programs is often hampered by technology that does not allow for a sense of physical and social presence. Fortunately, uptake of virtual reality (VR) is increasing rapidly, and the medium has a high level of potential for advancing the delivery of immersive evidence-based group interventions to those that most need it. Thus our specific aims are:\n\nSpecific aim 1: To test the feasibility and acceptability of a group-mediated physical activity intervention delivered fully via modern VR to older adults.\n\nSpecific aim 2: To examine the impact of this program on overall physical activity among older adults compared to the current standard-of-care for telehealth: the video conference meeting platform.",[337,338,30,26],"Exercise","Behavior",[340,341,342],"Telehealth","Virtual Reality","Physical Activity","2025-07-14",{"date":345,"type":36},"2025-07-16",{"date":347,"type":36},"2020-12-17",{"date":349,"type":20},"2026-12-30",{"name":351,"class":74},"Wake Forest University",{"id":353,"slug":354,"hasResults":11,"nctId":355,"briefTitle":356,"officialTitle":357,"acronym":4,"eligibilityCriteria":358,"healthyVolunteers":81,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":359,"targetDuration":4,"studyType":21,"phases":361,"briefSummary":362,"conditions":363,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":365,"lastUpdatePostDateStruct":366,"startDateStruct":368,"completionDateStruct":370,"leadSponsor":372,"locationsCount":44},"100571896","walk-and-talk-connecting-people-with-psoriasis-100571896","NCT06726213","Walk and Talk: Connecting People With Psoriasis","'Walk and Talk - Connecting People With Psoriasis'. A Mixed-methods Exploratory Study to Determine Representativeness of Recruitment, Acceptability, and Feasibility of a Walk and Talk Intervention for People With Psoriasis","Inclusion Criteria:\n\n* Aged 18 years or over\n* Diagnosed with psoriasis\n* Currently attending psoriasis services in secondary care\n* Must be able to walk for 30 minutes at a slow pace (approx 2km). Or be a wheelchair user with a carer who can push up hills if necessary\n\nExclusion Criteria:\n\n* Participants who are not capable of understanding the information leaflet or consent form and thus are unable to give informed consent.\n* Participants who do not understand verbal explanations or written information given in English will be excluded, as a number of questionnaires need to be completed. The translation service provided to the hospital is usually telephone operated.\n* Participants not able to walk at a slow pace for 30 minutes will be excluded or wheelchair users who do not have a carer who can help to push up hills.\n* Children will be excluded from study as this study involves making social interactions and contact with adults. This would not be appropriate, as child protection screens will not be performed on participants",{"count":360,"type":20},170,[23],"The main aim of this study is to determine the acceptability, representativeness (e.g. age, sex, ethnicity and body mass index) and ideal format of a Walk and Talk intervention for people with psoriasis.\n\nSecondary aims are determining outcome measures of the intervention (patient related outcome measures, social connectedness, physical activity, cardiovascular risk)\n\nOther objectives are to determine relevant outcome measures and sample size needed to statistically evaluate a future, larger study. There have been no similar studies evaluating social interventions in people with psoriasis, so an exploratory study is needed to calculate how many people are needed to participate. Measures will include social connectedness (loneliness), physical activity, cardiovascular risk, psychological wellbeing, quality of life and psoriasis severity.\n\nPsoriasis is a systemic disease with multiple co-existent health issues. People with psoriasis are more socially isolated and inactive than the general population.\n\nThe health implications of social isolation are now recognised and thought to be equivalent to smoking. Consequently social prescribing is increasingly used for people living with long-term conditions. Specifically group walking activities are effective at increasing physical activity and improving mood. Additionally, disease specific walking groups provide peer psychosocial support.\n\nIt seems likely that a group walking intervention for people with psoriasis could promote social connectedness, increase physical activity and provide peer psychosocial support. However, as people with psoriasis avoid social contact, have low levels of physical activity and difficulty in discussing feelings, it is possible a Walk and Talk activity may not be taken up by many, or only by specific sub-groups such as young, slim, white people. Hence the need for an exploratory study before committing to a larger adequately powered study. Ultimately the investigators anticipate a format for Walk and Talk groups that is specifically tailored for people with psoriasis may enable groups to be rolled out at centres nationwide",[364,26],"Psoriasis","2024-12-04",{"date":367,"type":36},"2024-12-10",{"date":369,"type":36},"2024-07-07",{"date":371,"type":20},"2026-01",{"name":373,"class":74},"Royal Free Hospital NHS Foundation Trust",{"id":375,"slug":376,"hasResults":11,"nctId":377,"briefTitle":378,"officialTitle":379,"acronym":4,"eligibilityCriteria":380,"healthyVolunteers":11,"sex":16,"minAge":381,"maxAge":4,"enrollmentInfo":382,"targetDuration":4,"studyType":21,"phases":384,"briefSummary":385,"conditions":386,"keywords":387,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":389,"lastUpdatePostDateStruct":390,"startDateStruct":391,"completionDateStruct":393,"leadSponsor":395,"locationsCount":4},"100562472","adaptation-and-implementation-of-an-intensive-geriatric-service-worker-igsw-model-of-care-for-socially-isolated-older-adults-100562472","NCT06603610","Adaptation and Implementation of an Intensive Geriatric Service Worker (IGSW) Model of Care for Socially Isolated Older Adults","Adaptation and Implementation of an Intensive Geriatric Service Worker (IGSW) Model of Care for Socially Isolated Older Adults: a Pilot Randomized Trial","Inclusion Criteria:\n\n(i) adults aged ≥65 years old (ii) socially isolated, defined as living alone (iii) identified by the multidisciplinary Acute Care of the Elderly team, Internal Consultation Team, or Elders' Clinic as having one or more instrumental activity of daily living (IADL) impairments (defined as per the Lawton IADL scale) that could be supported by the intensive geriatric service worker (iv) capable of consenting to study participation or have a substitute decision-maker who can provide consent on their behalf (v) able to understand and communicate in English (e.g., if a participant is hearing impaired, but they can lip read or hear sufficiently with a hearing aid, they will be included) or know someone who can help with translation (vi) living in a private dwelling (e.g., apartment, house, condominium) within a geographical catchment area (i.e., boundaries will be Bloor St, Don Valley Parkway, Lakeshore Blvd, and Yonge St) (vii) a patient of a family physician or nurse practitioner (or be willing to become a patient of a family physician or nurse practitioner).\n\nExclusion Criteria:\n\n(i) live in a retirement home, long-term care home or shelter (because there is varying availability of resources to support patients' activities of daily living (ADLs) and IADLs in these settings and we want to implement the IGSW care model where we hypothesize that it will have the greatest impact (ii) do not have a fixed address (iii) are participating in another study (iv) are being transferred to a rehabilitation facility other than Providence Healthcare prior to discharge home (Providence Healthcare is a collaborating study site; our team has an ongoing research collaboration with the medical rehabilitation unit at Providence Healthcare \\[where ACE and ICT medical consultation patients are transferred\\]","65 Years",{"count":383,"type":20},60,[23],"In this study, participants will be randomly assigned to receive either the intervention or control treatment for up to 6 months. Participants in the intervention group will receive care from an intensive geriatric service worker (IGSW), who will help the participant:\n\n(i) Coordinate community resources and actively support participants' instrumental activities of daily living (IADLs) (e.g., linking participants with Meals-on-Wheels, taking participants to appointments) (ii) Advocate for support from home care for completing activities of daily living (ADLs) (iii) Implement patients' prioritized treatment recommendations made by healthcare professionals (e.g., supporting patients to purchase and install home safety equipment because this aligns with their values and preferences).\n\nParticipants in the control group will receive their usual care, along with a booklet containing information about locally available resources, such as those related to meal preparation, grocery delivery, housekeeping, pharmacies that deliver medicines, home care, and Wheel-Trans.\n\nWe are interested in learning about the number and demographic characteristics of participants we will be able to recruit to the study, who will remain in the study and who will be adherent to their prioritized treatment recommendations. We are also interested in learning about changes in participants' quality of life, proportion of IADLs being completed independently or with support, emergency department visit rate, and hospitalization rate at 3 and 6 months.",[60,26],[388,98],"older adults","2024-09-16",{"date":257,"type":36},{"date":392,"type":20},"2024-10",{"date":394,"type":20},"2026-03",{"name":396,"class":74},"Unity Health Toronto",{"id":398,"slug":399,"hasResults":11,"nctId":400,"briefTitle":401,"officialTitle":402,"acronym":403,"eligibilityCriteria":404,"healthyVolunteers":81,"sex":16,"minAge":17,"maxAge":219,"enrollmentInfo":405,"targetDuration":4,"studyType":21,"phases":407,"briefSummary":408,"conditions":409,"keywords":411,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":415,"lastUpdatePostDateStruct":416,"startDateStruct":417,"completionDateStruct":419,"leadSponsor":421,"locationsCount":4},"100561735","community-navigators-100561735","NCT06594029","Community Navigators","Community Participation Navigators: Testing a Peer Intervention for Adults With Serious Mental Illnesses","Navigators","Inclusion Criteria:\n\n1. meet the criteria for an SMI diagnosis of schizophrenia, schizoaffective, bipolar, or major depression diagnosis based on the MINI,\n2. are over the age of 18-years-old\n3. are fluent in English: As current intervention materials and research and intervention personnel are only fluent in English, only participants who can communicate in written and spoken English are eligible for enrollment.\n4. have a permanent residence without constraints on participation (free to come and go from residence without restrictions) 2\n5. have the ability to provide informed consent.\n\nExclusion Criteria:\n\n* inability to provide consent (legal guardian)\n* unable to speak and understand English",{"count":406,"type":20},96,[23],"The Temple University Collaborative on Community Inclusion (TU Collaborative) is testing a community navigation intervention study based upon effective health navigation models by conducting a randomized controlled trial of the intervention to establish feasibility, efficacy, and outcomes among adults with serious mental illness (SMI).",[30,26,410],"Mental Health Issue",[412,413,414],"peer support","community participation","Serious Mental Illness","2024-09-10",{"date":257,"type":36},{"date":418,"type":20},"2024-09",{"date":420,"type":20},"2032-06",{"name":239,"class":74},{"id":423,"slug":424,"hasResults":11,"nctId":425,"briefTitle":426,"officialTitle":427,"acronym":428,"eligibilityCriteria":429,"healthyVolunteers":81,"sex":16,"minAge":430,"maxAge":4,"enrollmentInfo":431,"targetDuration":4,"studyType":21,"phases":433,"briefSummary":434,"conditions":435,"keywords":438,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":443,"lastUpdatePostDateStruct":444,"startDateStruct":446,"completionDateStruct":447,"leadSponsor":449,"locationsCount":4},"100558857","e-intervention-enhancing-mental-health-in-adolescents-100558857","NCT06556576","e-Intervention Enhancing Mental Health in Adolescents","e-Intervention Enhancing Mental Health in Adolescents (IMPROVA)","IMPROVA","Inclusion Criteria:\n\n* Adolescents enrolled in the selected secondary schools will be eligible.\n* Parents of adolescents enrolled in the selected schools will be eligible\n* Teachers and school staff: All teachers and school staff working in the selected schools will be eligible.\n* Participants can be of any gender.\n* Teachers and school staff will have to be older than 18 years.\n\nExclusion Criteria:\n\n• Apart from not signing the informed consent, no exclusion criteria will be applied.","10 Years",{"count":432,"type":20},6000,[23],"The e-Intervention Enhancing Mental Health in Adolescents (IMPROVA) study will co-design, test, evaluate, and facilitate the upscaling of a modular eHealth intervention platform that aims to improve mental health and wellbeing, early detect mental health problems and prevent common mental problems in adolescents. IMPROVA will be implemented in school settings and will include components for adolescents, parents, teachers, and other school staff in complementary and synergistic modules based on materials designed and tested in \\>20 projects carried out by the consortium members. After alpha, beta and pilot testing of the platform, the IMPROVA program will be implemented via a randomised controlled trial in secondary education schools in France, Germany, Romania and Spain, including approximately 6,000 adolescents. A 360º evaluation of IMPROVA will include Effectiveness, Implementation, Economic, and Social Return on Investment analysis. The primary outcome to assess the effectiveness of the IMPROVA program is the overall mental health of adolescents. A series of secondary outcomes will also evaluate the potential impact of the platform on other health-related outcomes (e.g., wellbeing, social isolation, anxiety, life satisfaction). Using implementation science methodology, IMPROVA will co-design transferable evidence-based guidance for scaling up the platform with users and policymakers. IMPROVA aims to provide an evidence-based, innovative, large-scale, comprehensive intervention, and a scale-up plan to promote mental health and prevent mental disorders in adolescents; empower adolescents and families to make better decisions regarding their mental health; and provide schools and the community with tools to achieve a society with better mental health and lower stigma.",[436,437,26],"Well-Being, Psychological","Depressive Symptoms",[439,440,441,442],"Adolescents","School-based interventions","Health promotion","Mental health","2024-08-21",{"date":445,"type":36},"2024-08-23",{"date":418,"type":20},{"date":448,"type":20},"2025-12-31",{"name":450,"class":74},"Fundació Sant Joan de Déu",{"id":452,"slug":453,"hasResults":11,"nctId":454,"briefTitle":455,"officialTitle":456,"acronym":457,"eligibilityCriteria":458,"healthyVolunteers":81,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":459,"targetDuration":4,"studyType":21,"phases":461,"briefSummary":462,"conditions":463,"keywords":465,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":443,"lastUpdatePostDateStruct":469,"startDateStruct":471,"completionDateStruct":473,"leadSponsor":475,"locationsCount":44},"100503147","leaptogether-an-intergenerational-intervention-to-address-loneliness-and-social-isolation-100503147","NCT05831475","LEAPTogether: An Intergenerational Intervention to Address Loneliness and Social Isolation","Leveraging Exercise to Age in Place (LEAP) Together: An Intergenerational Intervention to Address Loneliness and Social Isolation","LEAPTogether","Inclusion Criteria:\n\n* Verbal informed consent obtained from subject and ability for subject to comply with the requirements of the study\n* Age 18-30 years for younger adults\n* Age greater than or equal to 65 years for older adults\n* Has access to a tablet, laptop, or desktop computer with video capabilities connected to the internet with a screen at least 13 inches across\n* Able to read, write, and understand English\n* Has a 5 x 6 foot space at home in which to exercise\n\nExclusion Criteria:\n\n* Current diagnosis of dementia",{"count":460,"type":20},80,[23],"Older adult participants will engage in exercise videos twice a week for 8 weeks either while paired with a peer (same age group) or paired with a younger adult with the ability to simultaneously video chat while exercising.",[26,30,464],"Intergenerational Relations",[466,388,467,98,227,468],"physical activity","intergenerational","virtual exercise",{"date":470,"type":36},"2024-08-22",{"date":472,"type":36},"2023-09-07",{"date":474,"type":20},"2025-10",{"name":476,"class":74},"Cedars-Sinai Medical Center",{"id":478,"slug":479,"hasResults":11,"nctId":480,"briefTitle":481,"officialTitle":482,"acronym":483,"eligibilityCriteria":484,"healthyVolunteers":81,"sex":16,"minAge":485,"maxAge":331,"enrollmentInfo":486,"targetDuration":4,"studyType":21,"phases":487,"briefSummary":488,"conditions":489,"keywords":491,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":497,"lastUpdatePostDateStruct":498,"startDateStruct":500,"completionDateStruct":502,"leadSponsor":504,"locationsCount":186},"100526711","telepsychiatry-for-social-isolation-in-youths-100526711","NCT06138301","Telepsychiatry for Social Isolation in Youths","Digital Interventions for Social isOLation In youThs And theIR familiEs","SOLITAIRE","Inclusion Criteria:\n\nPatients with SI:\n\n* age11-17 years (adolescents) 18-45 years (adults)\n* moderate-to-high levels of SI as detected by clinical evaluation and confirmed by the HQ-25 score\n* stable pharmacotherapy and symptomatology in the last 3 months\n* not being in psychotherapy or being willing to interrupt it during the study\n* have an internet connection\n\nCaregivers:\n\n* Age ≤ 80\n* no history of psychotic spectrum disorders\n* have a first-degree relative with moderate-to-severe SI\n* have an internet connection\n\nExclusion Criteria:\n\nAll participants:\n\n* primary medical conditions or vision\u002Fhearing deficits that interfere with the ability to participate in the project\n* suicidal Ideation\n* IQ \\\u003C 70","11 Years",{"count":460,"type":20},[23],"This clinical trial aims to implement multimodal digital interventions for adolescents and young adults with social isolation (SI) and their family members. Furthermore, the neurobiological basis of SI will be explored by analyzing blood neuroinflammation biomarkers in socially isolated participants.\n\nThe main questions that this project aims to answer are:\n\n* What is the general feasibility and applicability of the proposed digital interventions?\n* What is the effect of the proposed digital interventions on the SI-related clinical symptoms and the cognitive and global functioning of participants with SI?\n\nParticipants will be asked to undergo:\n\n* A detailed clinical and neuropsychological evaluation (pre-post treatment)\n* A blood sample (pre-post treatment)\n* A telepsychiatry intervention (cognitive behavioural therapy (CBT) and\u002For cognitive remediation (CR) for SI participants and psychoeducation (PE) for family members)\n\nThe researchers will compare SI participants treated with CBT+CR (experimental group) with SI patients treated only with CBT (control group) to see if the combined intervention of the experimental group leads to more durable and generalizable effects.\n\nThe same PE intervention will be offered to the family members of all recruited SI participants.",[26,490],"Psychosocial Problem",[26,492,493,494,495,496,30],"Telepsychiatry","Digital health","Cognitive remediation","CBT","Psychotherapy","2024-07-29",{"date":499,"type":36},"2024-07-30",{"date":501,"type":36},"2023-09-01",{"date":503,"type":20},"2025-05",{"name":505,"class":74},"Azienda Ospedaliera Universitaria Integrata Verona",{"id":507,"slug":508,"hasResults":11,"nctId":509,"briefTitle":510,"officialTitle":511,"acronym":512,"eligibilityCriteria":513,"healthyVolunteers":81,"sex":16,"minAge":51,"maxAge":4,"enrollmentInfo":514,"targetDuration":4,"studyType":21,"phases":515,"briefSummary":516,"conditions":517,"keywords":521,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":530,"lastUpdatePostDateStruct":531,"startDateStruct":533,"completionDateStruct":535,"leadSponsor":537,"locationsCount":186},"100449263","developing-and-assessing-an-innovative-exergaming-technology-for-older-adults-living-in-long-term-care-homes-100449263","NCT05130203","Developing and Assessing an Innovative Exergaming Technology for Older Adults Living in Long-term Care Homes","Developing and Assessing an Innovative Exergaming Technology for Older Adults Living in Long-term Care Homes With a User-centered Design Approach","MouvMat","Inclusion Criteria:\n\n* All residents at the participating long-term care homes are eligible if they are 55 years of age or older\n* Ability to communicate and speak English\n* Able to provide informed consent or have a substitute decision maker (SDM) who provides informed consent\n* A family member, friend, or personally-hired caregiver of an older adult residing in one of our participating LTC facilities are eligible to participate if they are 18 years of age or older, can communicate and speak English\n* The LTC resident does not need to be enrolled in or study in order for their family member\u002Ffriend\u002Fcaregiver to participate\n* LTC staff are eligible if they can communicate and speak English, are currently working in one of the participating LTC facilities, have at least 6 months experience working with older adults in LTC, providing or supervising physical or recreational activities, or involved with purchasing or directing these activities, and are a member of one of the following professions\u002Fpositions: physiotherapist, physiotherapy assistant, recreational therapist, or LTC administrator.\n\nExclusion Criteria:\n\n* Residents will be ineligible to participate in the study is they cannot communicate or speak English\n* Residents who typically do not participate in recreational activities\n* Residents who have a severe sensory (e.g., deaf, blind) or severe to moderate cognitive impairment AND\u002FOR scores less than 20 on the Mini- Mental Status Examination (MMSE)\n* Family Members who cannot communicate or speak English\n* Family Members who cannot interact with the MouvMat due to sensory limitations (i.e., severe visual or auditory impairment)\n* Family Members who cannot provide verbal feedback",{"count":383,"type":20},[23],"Residents living in long-term care (LTC) homes spend up to 75% of their day in sedentary, socially withdrawn situations which increases their risk for depression, dementia, decreased functional status and increased care costs. Physical activity is an accepted intervention to improve the physical health, cognition, and well-being of older adults. Moreover, systematic reviews have found that exergaming (i.e. physical activity gamified with technology) offers physical, cognitive, and social benefits by means of dual-task activities that engage both motor and cognitive abilities. The effect of exergaming for older adults in LTC is less clear, as this population has greater health needs related to physical health conditions, cognitive impairment, and functional dependence. Given the increased global demand for LTC, there is a need to develop and assess innovative exergaming technologies that can support the physical and cognitive health of LTC residents.\n\nMouvMat is an exergaming technology intervention with an interactive digital gaming surface designed for older adults (OA) in LTC settings. Participants can play familiar games, like Simon or Bingo, by stepping on or tapping the surface with an assistive pointing device. Games can be played individually or with multiple players. LED lights on the surface provide an adaptive digital display and embedded pressure sensors respond to players' input. The investigators collaboratively designed a preliminary prototype with OA aged 65 and older in a pilot project.\n\nThe overall objective of this proposal is to conduct a pilot RCT of the Mouvmat to evaluate the feasibility, acceptability and efficacy of the exergaming technology to improve the primary outcome of mobility, and the secondary outcomes of cognitive function and social isolation compared to a usual care control group receiving standard recreational programming by recreational therapists.",[518,519,520,26],"Physical Inactivity","Cognitive Decline","Aging",[522,523,524,525,526,527,528,529],"nursing homes","long-term care","exergaming","user-centered design","older adult","aging","depression","dementia","2024-06-11",{"date":532,"type":36},"2024-06-13",{"date":534,"type":36},"2022-10-01",{"date":536,"type":20},"2025-01",{"name":538,"class":74},"University of Toronto",{"id":540,"slug":541,"hasResults":11,"nctId":542,"briefTitle":543,"officialTitle":543,"acronym":4,"eligibilityCriteria":544,"healthyVolunteers":81,"sex":16,"minAge":330,"maxAge":545,"enrollmentInfo":546,"targetDuration":548,"studyType":549,"phases":4,"briefSummary":550,"conditions":551,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":558,"lastUpdatePostDateStruct":559,"startDateStruct":561,"completionDateStruct":563,"leadSponsor":565,"locationsCount":44},"100541897","the-effects-of-social-isolation-and-social-interaction-on-the-risk-of-dementia-progression-and-brain-function-in-scd-subjective-cognitive-decline-scd-100541897","NCT06335836","The Effects of Social Isolation and Social Interaction on the Risk of Dementia Progression and Brain Function in SCD (Subjective Cognitive Decline, SCD)","Inclusion Criteria:\n\n* SCD\n\n  1. Self-perceived continuous cognitive decline compared with the previous normal state, and is not related to acute events;\n  2. After adjustment for age, gender, and years of education, the standard cognitive test is normal, or the diagnostic criteria for MCI are not met;\n  3. Selected candidates can sign the informed consent form themselves.\n\nExclusion Criteria:\n\n* (a) Aged under 45 years or older than 85 years; (b) Vascular dementia or other central nervous system diseases; (c) Hachinski Ischemic Scale score \\> 4 points; (d); Unable to complete neuropsychological tests (e.g., blindness, deafness, severe language impairment); (e) Drug abuse or alcohol dependency within the last 6 months; (f) Current participation in other cognition studies; (g) Severe diabetes mellitus, or severe cardiovascular disease, cerebrovascular disease, liver diseases, kidney diseases, psychiatric disorders; (h) Contraindications to imaging techniques: claustrophobia, metallic implants (e.g., intracranial metal clips), electronic devices (e.g., cardiac pacemakers)","85 Years",{"count":547,"type":20},209,"5 Years","OBSERVATIONAL","The goal of this clinical trial is to learn about the effects of social isolation and social interaction on the risk of dementia progression and brain function in SCD\n\n1. To explore the association between social isolation and lonely SCD populations and the occurrence and progression of MCI and AD through cross-sectional studies, cohort studies and randomized controlled trials of SCD;\n2. To clarify the correlation between different carrier states, resting brain function connectivity characteristics, and dual-task walking ability of APOEε4 allele and the progression of SCD to MCI and AD during the cognitive progress of people with SCD affected by social isolation;\n3. Establish a predictive model of cognitive decline from SCD to MCI and AD, and apply it to the SCD population to carry out individualized interventions;\n4. Confirm the protective effect of social interaction on cognitive level and brain function in SCD patients.",[26,552,553,554,555,556,557],"SCD","Subjective Cognitive Decline","MCI","Mild Cognitive Impairment","AD","Alzheimer Disease","2024-03-21",{"date":560,"type":36},"2024-03-28",{"date":562,"type":36},"2024-03-01",{"date":564,"type":20},"2028-12-30",{"name":566,"class":74},"The First Affiliated Hospital with Nanjing Medical University"]