The Coma Family Program (COMA-F): A Multi-site Clinical Trial of a Resilience Program for Caregivers of Patients With Severe Acute Brain Injury
| Registry | NCT07331324, acronym COMA-F |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, treatment |
| Enrollment | 150 (Estimated) |
| Sponsor | Massachusetts General Hospital (Other) |
| Conditions | Caregiver Distress, Emotional Distress, Caregivers, Resilience, Coma, Brain Injury |
| Interventions | Coma Family Program 1, Coma Family Program 2 (Behavioral) |
| Dates | start 2026-05-01 (estimated), primary completion 2030-08-01 (estimated), completion 2030-12-01 (estimated), first posted 2026-01-09, last updated 2026-02-20 |
| Locations | 3 sites in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Caregiver Distress All trials for Emotional Distress All trials of Coma Family Program 1 All trials of Coma Family Program 2
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Coma Family Program 1 | Experimental | Behavioral: Coma Family Program 1 | This arm provides skills training to manage distress, uncertainty, and long-term caregiving challenges. |
| Coma Family Program 2 | Placebo comparator | Behavioral: Coma Family Program 2 | This arm involves providing education about managing caregiving distress, uncertainty, and long-term challenges. |
Sex: All, ages: 18 Years to any
Inclusion Criteria: 1. 18 years or older - study population 2. English fluency and literacy - measures and intervention are in English 3. 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) 4. 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: 1. 18 years or older - study population 2. Admitted with ischemic stroke, intracerebral hemorrhage, subarachnoid hemorrhage, traumatic brain injury, or hypoxic-ischemic encephalopathy - study population 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 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) 5. 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 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 7. 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: * 1\. Serious mental illness, substance misuse, or active suicidal intent or plan - requires higher level of care
| Facility | City | Country | Status |
|---|---|---|---|
| University of Maryland School of Medicine | Baltimore, Maryland | United States | |
| Massachusetts General Hospital | Boston, Massachusetts | United States | |
| University of North Carolina School of Medicine | Chapel Hill, North Carolina | United States |