The Coma Family Program (COMA-F): A multi-site clinical trial of a resilience program for caregivers of patients with severe acute brain injury

We aim to test the efficacy of a multi-site resilience intervention for emotional distress in caregivers of patients with severe acute brain injury (SABI) “The Coma Family Program (COMA-F).” Background: Roughly 258 for every 100,000 Americans are admitted to an intensive care unit (ICU) for SABI that causes coma, many of whom survive but remain functionally dependent. Up to 50% of caregivers of such patients experience chronic emotional distress, which drives poor quality of life, caregiver burden, and adverse health events. To address this need we developed COMA-F to promote resilience in SABI caregivers. Innovation: COMA-F fills the increasingly high demand for psychosocial services for SABI caregivers. This population is historically excluded from clinical trials and is without evidence-based psychosocial treatment options. COMA-F begins early to prevent development of chronic distress; specifically, caregivers learn coping skills in vivo to manage stressors related to both acute and long-term caregiving. COMA-F is fully remote (over video call) to increase access and reach, and is low burden (six, 30–45-minute weekly sessions) to account for caregivers’ feelings of overwhelm and competing time demands. COMA-F is innovative and necessary, as the alternative caregiver treatment routinely provided is nothing. Intervention characteristics: We developed COMA-F following the NIH Stage Model. Specifically, we took an efficacious stage 2 intervention (Recovering Together – program among cognitively-intact patients admitted to the Neuro-ICU and their caregivers) and returned to Stage 1 for tailoring for SABI caregivers (we maintained 2 of 3 core mechanisms: mindfulness and coping). We then interviewed 30 SABI caregivers from 14 different Neuro-ICUs, refined content based on their feedback, then conducted a successful multi-site open pilot trial (exceeded feasibility and acceptability benchmarks). COMA-F builds caregivers’ mindfulness and adaptive coping skills to enable them to approach and manage distress, rather than avoid it. Skills are transdiagnostic (address emotional distress broadly) and are rooted in experiential avoidance theory and theories of resilience as a process. Specific aims: We will recruit N=150 SABI caregivers from 3 geographically diverse intensive care units (Massachusetts General Hospital/Harvard Medical School [MGH/HMS], University of North Carolina School of Medicine [UNC], and University of Maryland School of Medicine [UMB]) to 1) determine the efficacy of COMA-F vs health education control in improving emotional distress, 2) evaluate whether effects of COMA-F are maintained through 3-months, 3) determine the degree to which COMA-F-dependent improvements in emotional distress are mediated by improvements in treatment mechanisms (mindfulness, coping) and modified by demographic and clinical variables. Team: Our team is led by Dr. Alexander Presciutti, clinical health psychologist at MGH/HMS, Dr. David Hwang, chief of the Neuro-ICU at UNC, and Dr. Melissa Motta neurointensivist at UMB, all experts in supporting families of SABI patients. We are supported by the robust recruitment infrastructure we built during our multi- site open pilot. Our proposal aligns with the NIA’s Strategic Direction Goal C-6 of “promoting positive caregiving outcomes and supports.” Impact: Our project can drastically improve emotional distress in SABI caregivers a population in high need of evidence-based psychosocial treatments and whose alternative is nothing. Project Number: 1R01AG098476-01 | Fiscal Year: 2026 | NIH Institute/Center: National Institute on Aging (NIA) | Principal Investigator: Alexander Presciutti | Institution: MASSACHUSETTS GENERAL HOSPITAL, BOSTON, MA | Award Amount: $722,746 | Activity Code: R01 | Study Section: Clinical Management in General Care Settings Study Section[CMGC] View on NIH RePORTER: https://reporter.nih.gov/project-details/11276859