The Coma Family Program (COMA-F): A Resilience Program for Caregivers of Patients With Severe Acute Brain Injury
Recruiting
The Coma Family Program (COMA-F): A Multi-site Clinical Trial of a Resilience Program for Caregivers of Patients With Severe Acute Brain Injury
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
Inclusion Criteria: * 18 years or older - study population * English fluency and literacy - measures and intervention are in English * 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) * 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: * 18 years or older - study population * Admitted with ischemic stroke, intracerebral hemorrhage, subarachnoid hemorrhage, traumatic brain injury, or hypoxic-ischemic encephalopathy - study population * 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 * 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) * Has been committed to or has already received long-term life-sustaining treatments including tracheostomy and/or 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/functional recovery from initial coma, but all were severe enough to require trach and/or PEG * 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 * Is still in ICU or has been transferred to a lower level of care (e.g., stepdown) for \<7 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) Exclusion Criteria: • Serious mental illness, substance misuse, or active suicidal intent or plan - requires higher level of care
About the study
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.
What is being tested
- Coma Family Program 1 (behavioral)
- Coma Family Program 2 (behavioral)
Sponsor: Icahn School of Medicine at Mount Sinai · Participants: 150 · Started: Sep 28, 2026
Contact the study team
- Alexander M Presciutti, PhD · Phone: 332-877-281
- Georgia Cosola, MA · Phone: 332-877-2814
Official record on ClinicalTrials.gov — NCT07331324
Locations in the U.S.
| Maryland | University of Maryland School of Medicine, Baltimore |
| New York | Mount Sinai Health System, New York |
| North Carolina | University of North Carolina School of Medicine, Chapel Hill |
Conditions
From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.