[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100555311":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":33,"locations":42,"responsibleParty":62,"collaborators":64,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":70,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":32,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":89,"overallStatus":45,"whyStopped":32,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Temple University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Need to be Needed Intervention","EXPERIMENTAL","Interventionists will meet with participants to discuss supported volunteering concepts and develop an initial plan. This plan will be flexible as it is likely that participants will need multiple opportunities to identify and explore options for voluntarism. Once the plan is developed, interventionist will make weekly contact to support participants in achieving goals. These weekly contacts (3x per month) are expected to be brief (30-40 minutes) and focused on information sharing and supported problem solving. Interventionists will also schedule monthly plan reviews (1x per month) with participants to review and revise supported volunteering individualized plans. Both clients who are achieving goals as well as those falling short of their goals may want to revise or change their plan.",[13],"Behavioral: Need to Be Needed Intervention",{"label":15,"type":16,"description":17,"interventionNames":18},"Active control group","ACTIVE_COMPARATOR","Participants assigned to the attention control condition will receive printed information on the importance and opportunities for volunteering and will be encouraged to review resources from the TU Collaborative website. They will receive weekly 10-minute non-directive supportive listening sessions via telephone\u002Fvideoconferencing with a Research assistant. Research assistants are full-time staff members with an undergraduate degree in psychology. Undergraduate students are not involved in performing the weekly check-ins with the control group. The control group will not receive weekly 1:1 support through a trained clinician.",[19],"Other: Active Control Group",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","Need to Be Needed Intervention","Interventionist-supported volunteering intervention that targets opportunities creating social connections that matter through focus on kindness and gratitude throughout the intervention.",[9],[27],"N2BN Intervention",{"type":6,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Active Control Group","Weekly non-directive listening support",[15],null,[34,39],{"name":35,"role":36,"phone":37,"phoneExt":32,"email":38},"Bryan Mccormick, PhD","CONTACT","1-215-204-6817","bryan.mccormick@temple.edu",{"name":40,"role":36,"phone":32,"phoneExt":32,"email":41},"Tabea Neumann, M.Sc","tabea.neumann@temple.edu",[43],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Hall Mercer","RECRUITING","Philadelphia","Pennsylvania","19106","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-75.16362,39.95238,{"lat":55,"lon":54},[58],{"name":59,"role":36,"phone":60,"phoneExt":32,"email":61},"Steven Niederriter, MBA","215.829.5575","steven.niederriter@pennmedicine.upenn.edu",{"type":63,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR",[65],{"name":66,"class":67},"National Institute on Disability, Independent Living, and Rehabilitation Research","FED","100555311","need-to-be-needed-n2bn-intervention-100555311",false,"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.","ALL","18 Years","99 Years",{"count":80,"type":81},120,"ESTIMATED","INTERVENTIONAL",[84],"NA","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.",[87,88],"Loneliness","Social Isolation",[90,91,92,93,94,95],"mattering","loneliness","social isolation","need to be needed","neededness","volunteering","2026-01-16",{"date":98,"type":99},"2026-01-21","ACTUAL",{"date":101,"type":99},"2024-10-07",{"date":103,"type":81},"2035-05-31",{"name":5,"class":6},1]