[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638871":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":28,"centralContacts":35,"locations":40,"responsibleParty":55,"collaborators":24,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":24,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":24,"enrollmentInfo":67,"targetDuration":24,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":76,"overallStatus":80,"whyStopped":24,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"Case Western Reserve University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"REFRAME","EXPERIMENTAL","Tablet-Based Emotion Regulation Tool",[13],"Behavioral: REFRAME",{"label":15,"type":6,"description":16,"interventionNames":17},"Informational Support","Video-Based Psychoeducational Attention Control",[18],"Behavioral: Informational Support",[20,25],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"BEHAVIORAL","consists of three self-guided, tablet-based modules that align with the process model of emotion regulation. Each module lasts approximately 10-20 minutes and is delivered sequentially over three sessions, spaced 24-48 hours apart after enrollment.",[9],null,{"type":21,"name":15,"description":26,"armGroupLabels":27,"otherNames":24},"The informational support (IS) condition functions as an attention-matched psychoeducational control, featuring three sequential video-based modules delivered every 24-48 hours.",[15],[29,32],{"name":30,"affiliation":5,"role":31},"Grant Pignatiello, PhD","PRINCIPAL_INVESTIGATOR",{"name":33,"affiliation":34,"role":31},"S. Alan Hoffer, MD","University Hospitals Cleveland Medical Center",[36],{"name":30,"role":37,"phone":38,"phoneExt":24,"email":39},"CONTACT","216-368-4480","gap54@case.edu",[41],{"facility":34,"status":24,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Cleveland","Ohio","44106","United States","US",{"type":48,"coordinates":49},"Point",[50,51],-81.69541,41.4995,{"lat":51,"lon":50},[54],{"name":30,"role":37,"phone":38,"phoneExt":24,"email":39},{"type":31,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Grant Pignatiello","Assistant Professor","100638871","reframe-an-emotion-regulation-intervention-to-improve-psychological-outcomes-in-surrogate-decision-makers-of-the-critically-ill-100638871",false,"NCT07630844","REFRAME: an Emotion Regulation Intervention to Improve Psychological Outcomes in Surrogate Decision-Makers of the Critically Ill","A Randomized Trial of REFRAME: an Emotion Regulation Intervention to Improve Psychological Outcomes in Surrogate Decision-Makers of the Critically Ill","Patient Inclusion Criteria:\n\n* 1\\. Age ≥ 35 years\n* 2\\. Lacks decision-making capacity\n* 3\\. Not expected to be discharged from the ICU in 24 hours (including death)\n\nLegally Authorized Representative Inclusion Criteria (Primary Participant)\n\n* 1\\. Age ≥ 18 years\n* 2\\. Identified as LAR by ICU team\n* 3\\. Able to speak and understand English\n* 4\\. Able to visualize content on a tablet device\n\nPatient Exclusion Criteria:\n\n* 1\\. Age \\\u003C 35 years\n* 2\\. Possesses decision-making capacity\n* 3\\. Anticipated discharge from ICU within next 24 hours.\n\nLegally Authorized Representative Exclusion Criteria:\n\n* 1\\. Age \\\u003C 18 years\n* 2\\. Not recognized as LAR by ICU team\n* 3\\. Unable to speak and understand English\n* 4\\. Unable to visualize content on a tablet device","ALL","18 Years",{"count":68,"type":69},387,"ESTIMATED","INTERVENTIONAL",[72],"NA","Every year in the United States, millions of adults make crucial medical decisions for loved ones in the intensive care unit while facing extreme emotional stress. This project will assess REFRAME, a brief tablet-based program designed to help decision-makers manage their emotions in these situations. Results from this study may lead to the creation of a widely accessible tool that alleviates emotional suffering and enhances the quality of medical decision-making for families in crisis.",[75],"Critical Illness",[77,78,79],"Emotion Regulation","Psychological Distress","Surrogate Decision-Makers","NOT_YET_RECRUITING","2026-06-23",{"date":83,"type":84},"2026-06-25","ACTUAL",{"date":86,"type":69},"2027-01-04",{"date":88,"type":69},"2031-04-04",{"name":5,"class":6},1]