A five-year, $2.5 million grant from the National Institutes of Health (NIH) will fund a clinical trial testing a digital wellness program for caregivers of people with moderate-to-severe traumatic brain injury (TBI). The funding, awarded to the University of Cincinnati College of Medicine, supports the development of CG-Well 2, a web- and telephone-based intervention designed to reduce anxiety, depression, and burnout among family caregivers during the critical first six months after a TBI.
TBI disrupts normal brain function and often results from collisions, assaults, falls, or penetrating injuries. Caregivers frequently face unmet needs during recovery, including stress management, handling medical leave policies, and preparing homes for a loved one’s return. The program addresses these challenges through structured online modules and phone coaching.
The trial builds on earlier research by Natalie Kreitzer, MD, an associate professor of clinical medicine and vice chair of research in the Department of Emergency Medicine. Her prior study, CG-Well 1, enrolled 100 caregivers and found that participants reported lower psychological stress and greater satisfaction than those in a control group. The new trial will expand the scope, testing the intervention’s effectiveness as a scalable solution across multiple sites.
Unlike many caregiver support programs, CG-Well 2 begins within two weeks of a TBI diagnosis and continues through the transition from hospital to home. It will evaluate not only caregiver well-being but also patient outcomes, cost-effectiveness, and how caregivers perceive their roles. The trial will compare two groups: one receiving tailored coaching and modules, the other accessing only standard public information with minimal support.
Caregivers often experience heightened stress during the first six months after TBI, as they adjust to behavioral changes in their loved ones while managing medical decisions and daily care demands. The intervention aims to mitigate these effects by providing structured guidance on coping strategies, legal protections like the Family and Medical Leave Act, and practical preparations for discharge.
While earlier interventions have shown promise, scaling them requires rigorous testing. CG-Well 2 will enroll up to 354 patient-caregiver pairs at four U.S. medical centers: the University of Cincinnati, Ohio State University, Washington University in St. Louis, and the University of Washington. Enrollment is set to begin in early 2027, with results expected to inform broader adoption of digital support for TBI caregivers.