[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100484398":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":38,"locations":47,"responsibleParty":93,"collaborators":95,"id":99,"slug":100,"hasResults":101,"nctId":102,"briefTitle":103,"officialTitle":103,"acronym":26,"eligibilityCriteria":104,"healthyVolunteers":105,"sex":106,"minAge":107,"maxAge":26,"enrollmentInfo":108,"targetDuration":26,"studyType":111,"phases":112,"briefSummary":114,"conditions":115,"keywords":26,"overallStatus":68,"whyStopped":26,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},{"fullName":5,"class":6},"Weill Medical College of Cornell University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"EMPOWER arm","EXPERIMENTAL","The EMPOWER arm includes six 15 minute modules delivered in a 1-on-1 format with the same interventionist, and 2 boosters (approximately 45 minutes each) conducted by phone.\n\nSubjects who meet eligibility criteria will receive up to 4 sequential assessments before and after the EMPOWER intervention within 3 months conducted in person and by phone.",[13],"Behavioral: EMPOWER",{"label":15,"type":16,"description":17,"interventionNames":18},"Supportive Conversation arm","PLACEBO_COMPARATOR","The Supportive Conversation (SC) arm includes a supportive, empathic encounter without specific skill-building for approximately the same amount of time as EMPOWER.\n\nSubjects who meet eligibility criteria will receive up to 4 sequential assessments before and after SC within 3 months conducted in person and by phone.",[19],"Other: Supportive Conversation",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","EMPOWER","EMPOWER is a manualized treatment delivered based in cognitive behavioral and acceptance and commitment therapies delivered by a trained mental health professional that utilizes breathing and grounding exercises, mindfulness meditation, psychoeducation, imaginal dialogue with the patient, and coping rehearsal techniques.\n\nThe total amount of time EMPOWER intervention is about 90 minutes, about 15 minutes each module. It can either be administered in one session or many sessions to accommodate the dynamic nature of ICU, and has two booster follow-up calls (roughly 45 minutes each) in the month following initial treatment.",[9],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Supportive Conversation","The Supportive Conversation will match the time and attention offered through EMPOWER, so will be about 1.5-2 hours and will have two additional follow-up calls.",[15],[32,35],{"name":33,"affiliation":5,"role":34},"Holly Prigerson, PhD","PRINCIPAL_INVESTIGATOR",{"name":36,"affiliation":37,"role":34},"Wendy Lichtenthal, PhD","University of Miami",[39,43],{"name":33,"role":40,"phone":41,"phoneExt":26,"email":42},"CONTACT","212-746-1374","hgp2001@med.cornell.edu",{"name":44,"role":40,"phone":45,"phoneExt":26,"email":46},"Hillary Winoker, B.A.","646-962-7143","hiw4002@med.cornell.edu",[48,66,82],{"facility":37,"status":49,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"NOT_YET_RECRUITING","Miami","Florida","33136","United States","US",{"type":56,"coordinates":57},"Point",[58,59],-80.19366,25.77427,{"lat":59,"lon":58},[62],{"name":63,"role":40,"phone":64,"phoneExt":26,"email":65},"Wendy Lichtenthal, Ph.D.","305-243-8983","wgl31@miami.edu",{"facility":67,"status":68,"city":69,"state":69,"zip":70,"country":53,"countryCode":54,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"Memorial Sloan Kettering Cancer Center","RECRUITING","New York","10021",{"type":56,"coordinates":72},[73,74],-74.00597,40.71427,{"lat":74,"lon":73},[77,80],{"name":78,"role":40,"phone":79,"phoneExt":26,"email":26},"Rosario Costas-Muñiz","646-888-8062",{"name":81,"role":34,"phone":26,"phoneExt":26,"email":26},"Rosario Costas-Muñiz, PhD",{"facility":83,"status":68,"city":69,"state":69,"zip":84,"country":53,"countryCode":54,"cosmosGeoPoint":85,"geoPoint":87,"contacts":88},"NewYork-Presbyterian Weill Cornell Medicine","10065",{"type":56,"coordinates":86},[73,74],{"lat":74,"lon":73},[89,90,92],{"name":44,"role":40,"phone":45,"phoneExt":26,"email":46},{"name":91,"role":40,"phone":41,"phoneExt":26,"email":42},"Holly G Prigerson, PhD",{"name":91,"role":34,"phone":26,"phoneExt":26,"email":26},{"type":94,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[96],{"name":97,"class":98},"National Institute of Nursing Research (NINR)","NIH","100484398","phase-2-a-clinical-trial-of-interventions-to-support-family-surrogates-of-critically-ill-patients-100484398",false,"NCT05587517","A Clinical Trial of Interventions to Support Family Surrogates of Critically Ill Patients","Inclusion Criteria:\n\n* Patients who, during their hospital stay, have been admitted to the ICU and are near EoL, as indicated by a modified \"surprise question\" whereby physicians are asked to identify patients whom they do not expect to survive the next 12 months.\n* Surrogate decision-makers of patients who were admitted to the ICU or step-down unit during their current admission\u002Fstay, or within 1 month of discharge from their last admission\u002Fstay.\n* Surrogate decision-makers are 18 years or older.\n* Surrogate decision-makers whom physicians or advance practice providers (i.e. physician assistants, nurse practitioners) indicate as the designated health care proxy or decision-making patient surrogates, or who are listed as such in the patient's medical charts or by self-report of the surrogate.\n* Surrogate decision-makers must speak English.\n* Surrogate decision-makers must report \"syndromal\" levels of pre-loss grief (PG-12 score ≥ 25) or peritraumatic distress (PDI ≥ 23).\n* Surrogate decision makers will need to reside in a state in which an interventionist is licensed or otherwise be able to comply with current telehealth regulations.\n* Surrogate decision-makers will need to be willing to utilize a device (computer, tablet, phone) with internet.\n* Surrogate decision-makers who are able and willing to provide an emergency contact.\n\nExclusion Criteria:\n\n* Patients and surrogate decision-makers who do not meet the eligibility criteria.\n* Surrogate decision-makers who indicate the presence of cognitive impairment based on responses to the Ultra-Brief Confusion Assessment Method and\u002For significant psychiatric or cognitive disturbance sufficient, in the investigator\u002Fstudy staff's judgment, to preclude completion of the assessment measures, interview or informed consent.\n* Surrogate-decision makers who endorse suicidal ideation in the past month based on responses to the Columbia Suicide Severity Rating Scale.\n* Surrogate-decision makers who are unable to access a functional device for videoconferencing and decline the offer to use a study loner device.",true,"ALL","18 Years",{"count":109,"type":110},172,"ESTIMATED","INTERVENTIONAL",[113],"PHASE2","Hypotheses 1a and 1b: Compared to Supportive Conversation arm, the EMPOWER intervention will significantly decrease surrogate decision makers' symptoms of grief and Post Traumatic Stress Disorder (PTSD) (primary outcomes); and H1b. experiential avoidance, depression, regrets, and increases in patients' value-concordant care (secondary outcomes) at T1-T4.\n\nHypothesis 2. Qualitative data will provide insights not captured by quantitative data.\n\nHypothesis 3. Reductions in experiential avoidance will mediate reductions in grief and Post Traumatic Stress Disorder (PTSD) symptoms, highlighting it as important to target in future implementation.",[116,117,118,119],"Grief","Trauma","Psychotherapy","Critical Care","2025-10-27",{"date":122,"type":123},"2025-10-29","ACTUAL",{"date":125,"type":123},"2022-10-11",{"date":127,"type":110},"2027-12-11",{"name":5,"class":6},3]