[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100618415":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":29,"locations":35,"responsibleParty":79,"collaborators":25,"id":83,"slug":25,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":84,"sex":90,"minAge":91,"maxAge":25,"enrollmentInfo":92,"targetDuration":25,"studyType":95,"phases":96,"briefSummary":98,"conditions":99,"keywords":106,"overallStatus":114,"whyStopped":25,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"Massachusetts General Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Coma Family Program 1","EXPERIMENTAL","This arm provides skills training to manage distress, uncertainty, and long-term caregiving challenges.",[13],"Behavioral: Coma Family Program 1",{"label":15,"type":16,"description":17,"interventionNames":18},"Coma Family Program 2","PLACEBO_COMPARATOR","This arm involves providing education about managing caregiving distress, uncertainty, and long-term challenges.",[19],"Behavioral: Coma Family Program 2",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","This intervention provides skills training to manage distress, uncertainty, and long-term caregiving challenges.",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"This involves education (but no skills training) about managing caregiving distress, uncertainty, and long-term challenges.",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},"Alexander M Presciutti, PhD","CONTACT","617 726 7913","apresciutti@mgh.harvard.edu",[36,53,64],{"facility":37,"status":25,"city":38,"state":39,"zip":40,"country":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"University of Maryland School of Medicine","Baltimore","Maryland","21201","United States",{"type":43,"coordinates":44},"Point",[45,46],-76.61219,39.29038,{"lat":46,"lon":45},[49],{"name":50,"role":32,"phone":51,"phoneExt":25,"email":52},"Melissa Motta, MD","410-328-4515","MMotta@som.umaryland.edu",{"facility":5,"status":25,"city":54,"state":55,"zip":56,"country":41,"cosmosGeoPoint":57,"geoPoint":61,"contacts":62},"Boston","Massachusetts","02114",{"type":43,"coordinates":58},[59,60],-71.05977,42.35843,{"lat":60,"lon":59},[63],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},{"facility":65,"status":25,"city":66,"state":67,"zip":68,"country":41,"cosmosGeoPoint":69,"geoPoint":73,"contacts":74},"University of North Carolina School of Medicine","Chapel Hill","North Carolina","27599",{"type":43,"coordinates":70},[71,72],-79.05584,35.9132,{"lat":72,"lon":71},[75],{"name":76,"role":32,"phone":77,"phoneExt":25,"email":78},"David Hwang","(919) 966-8178","David_Hwang@med.unc.edu",{"type":80,"investigatorFullName":81,"investigatorTitle":82,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Alexander Presciutti","Member of the Faculty","100618415",false,"NCT07331324","The Coma Family Program (COMA-F): A Resilience Program for Caregivers of Patients With Severe Acute Brain Injury","The Coma Family Program (COMA-F): A Multi-site Clinical Trial of a Resilience Program for Caregivers of Patients With Severe Acute Brain Injury","COMA-F","Inclusion Criteria:\n\n1. 18 years or older - study population\n2. English fluency and literacy - measures and intervention are in English\n3. Screens positive for emotional distress on either depression or anxiety subscales (\\>7) of the Hospital Anxiety and Depression scale - study population (caregivers must be at-risk for chronic distress via heightened acute distress)\n4. Confirmed by the clinical team as the primary caregiver of a patient who has been admitted to an intensive care unit (ICU) with a severe acute brain injury with the following characteristics:\n\n   1. 18 years or older - study population\n   2. Admitted with ischemic stroke, intracerebral hemorrhage, subarachnoid hemorrhage, traumatic brain injury, or hypoxic-ischemic encephalopathy - study population\n   3. Glasgow Coma Scale score below 9 (in judgement of the clinical team) while not intubated or an inability to follow meaningful commands while intubated at any point during the hospitalization for \\> 24 consecutive hours due to the brain injury itself and not a confounding factor (e.g., sedation or seizures) - study population\n   4. Still alive in ICU at the time the clinical team approaches the caregiver about possible recruitment - excludes caregivers of those that passed away as would require a different intervention (e.g., grieving intervention)\n   5. Has been committed to or has already received long-term life-sustaining treatments including tracheostomy and\u002For percutaneous endoscopic or surgical gastrostomy tube placement (trach or PEG) - study population; at time of enrollment patients can be in various early stages of cognitive\u002Ffunctional recovery from initial coma, but all were severe enough to require trach and\u002For PEG\n   6. Has a prognosis for survival of greater than 3 months and does not have a concurrent diagnosis of a terminal illness or injury as judged by the clinical team - as in \"d\"; such caregivers would require different intervention\n   7. Is still in ICU or has been transferred to a lower level of care (e.g., stepdown) for \\\u003C7 days at the time of consent - study population; we aim to begin the intervention when caregivers are acutely distressed in the context of the patient's ICU stay or shortly after the ICU stay (i.e., within 7 days of leaving)\n\nExclusion Criteria:\n\n* 1\\. Serious mental illness, substance misuse, or active suicidal intent or plan - requires higher level of care","ALL","18 Years",{"count":93,"type":94},150,"ESTIMATED","INTERVENTIONAL",[97],"NA","The purpose of this research study is to determine whether COMA-F is more efficacious at reducing emotional distress in caregivers of patients with severe acute brain injuries, compared to health education control.",[100,101,102,103,104,105],"Caregiver Distress","Emotional Distress","Caregivers","Resilience","Coma","Brain Injury",[107,108,109,110,111,112,113],"caregivers","emotional distress","caregiver burden","resilience","coma","severe acute brain injury","mindfulness","NOT_YET_RECRUITING","2026-02-18",{"date":117,"type":118},"2026-02-20","ACTUAL",{"date":120,"type":94},"2026-05",{"date":122,"type":94},"2030-12",{"name":5,"class":6},3]