[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100618415":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":29,"locations":35,"responsibleParty":80,"collaborators":25,"id":84,"slug":85,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":86,"sex":92,"minAge":93,"maxAge":25,"enrollmentInfo":94,"targetDuration":25,"studyType":97,"phases":98,"briefSummary":100,"conditions":101,"keywords":108,"overallStatus":116,"whyStopped":25,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},{"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",[36,54,65],{"facility":37,"status":25,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"University of Maryland School of Medicine","Baltimore","Maryland","21201","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-76.61219,39.29038,{"lat":47,"lon":46},[50],{"name":51,"role":32,"phone":52,"phoneExt":25,"email":53},"Melissa Motta, MD","410-328-4515","MMotta@som.umaryland.edu",{"facility":5,"status":25,"city":55,"state":56,"zip":57,"country":41,"countryCode":42,"cosmosGeoPoint":58,"geoPoint":62,"contacts":63},"Boston","Massachusetts","02114",{"type":44,"coordinates":59},[60,61],-71.05977,42.35843,{"lat":61,"lon":60},[64],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},{"facility":66,"status":25,"city":67,"state":68,"zip":69,"country":41,"countryCode":42,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"University of North Carolina School of Medicine","Chapel Hill","North Carolina","27599",{"type":44,"coordinates":71},[72,73],-79.05584,35.9132,{"lat":73,"lon":72},[76],{"name":77,"role":32,"phone":78,"phoneExt":25,"email":79},"David Hwang","(919) 966-8178","David_Hwang@med.unc.edu",{"type":81,"investigatorFullName":82,"investigatorTitle":83,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Alexander Presciutti","Member of the Faculty","100618415","the-coma-family-program-coma-f-a-resilience-program-for-caregivers-of-patients-with-severe-acute-brain-injury-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":95,"type":96},150,"ESTIMATED","INTERVENTIONAL",[99],"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.",[102,103,104,105,106,107],"Caregiver Distress","Emotional Distress","Caregivers","Resilience","Coma","Brain Injury",[109,110,111,112,113,114,115],"caregivers","emotional distress","caregiver burden","resilience","coma","severe acute brain injury","mindfulness","NOT_YET_RECRUITING","2026-02-18",{"date":119,"type":120},"2026-02-20","ACTUAL",{"date":122,"type":96},"2026-05",{"date":124,"type":96},"2030-12",{"name":5,"class":6},3]