NIH Backs $2.5 Million Trial of Web-Based Wellness Program for Traumatic Brain Injury Caregivers

Family caregivers of people with traumatic brain injury often shoulder an enormous and largely invisible burden, and a new federally funded clinical trial at the University of Cincinnati aims to give them structured, evidence-based support at exactly the moment they need it most. Natalie Kreitzer, MD, an associate professor of clinical medicine and vice chair of research in the Department of Emergency Medicine, has received a five-year, $2.5 million R01 grant from the Eunice Kennedy Shriver National Institute of Child Health and Human Development at the National Institutes of Health. The award will fund a multisite, randomized clinical trial of CG-Well 2, a web- and telephone-based wellness intervention designed to reduce psychological distress and improve coping among family caregivers of individuals with moderate-to-severe traumatic brain injury.

Traumatic brain injury, or TBI, is a disruption in normal brain function caused by a forceful bump, blow, jolt or penetrating object to the head. The mechanisms are disturbingly ordinary: motor vehicle collisions, assaults, gunshot wounds and falls, with falls posing a particular risk among older adults. What follows the initial injury is often a long and disorienting recovery that extends far beyond the hospital walls. Survivors may face lasting changes in cognition, mood and behavior, and the people who absorb most of those changes day to day are frequently spouses, parents, adult children and siblings who receive little formal preparation for the role they are about to assume.

Kreitzer’s interest in this population grew directly out of her clinical work. She completed a neurocritical care fellowship at UC and is a member of the UC Stroke Team, and she has spent substantial time in the neuro intensive care unit treating patients with severe brain injuries. From my experience in the neuro ICU, I’ve developed a deep interest in working with patients who have suffered traumatic brain injuries and with their family members, who often become their caregivers, she said. That bedside perspective shaped her research trajectory, pushing her to think about the recovery period as a family-wide event rather than a purely patient-centered one.

The intervention at the heart of the new trial, CG-Well, short for CareGiver Well, was developed on the basis of earlier studies and delivers structured wellness content through web modules and phone coaching. The program includes 43 modules, available online and in print, tailored to address families’ unmet needs during recovery. The topics focus on common issues likely to arise for families in the first six months after a TBI, including coping with stress, navigating the Family and Medical Leave Act, transitioning from the ICU to a rehabilitation facility or long-term acute care, and preparing the home for a loved one’s return, Kreitzer explained. In other words, the curriculum targets the practical and emotional chokepoints that caregivers reliably encounter, from employment protections to the logistics of moving a medically fragile relative between care settings.

The new grant builds on Kreitzer’s earlier project, CG-Well 1, which enrolled 100 family caregivers and was funded by a five-year NIH K23 career development award. That pilot produced encouraging signals. It was a positive trial, Kreitzer said. Caregivers enrolled in CG-Well reported greater satisfaction and fewer symptoms of psychological stress than those who received the control intervention. Caregivers in this population face high rates of anxiety, depression and burnout, and the pilot results suggested that a structured, remotely delivered program could meaningfully move the needle on those outcomes without requiring families to travel to a clinic they may have neither the time nor the transportation to reach.

CG-Well 2 is designed to test the intervention with far greater rigor and at a scale that speaks to real-world implementation. The trial will evaluate the program as a scalable offering, beginning within the first two weeks after a patient’s injury and continuing through the transition from hospital to home. That timing is deliberate. The first six months after a TBI can be especially intense for caregivers, who may experience changes in a loved one’s behavior while managing caregiving demands and making decisions about treatment and rehabilitation. The trial will also examine effects on caregiver health and well-being, as well as caregiving appraisal, the term researchers use for how a caregiver perceives their situation, along with patient outcomes and the intervention’s feasibility, acceptability and cost.

The study design follows the classic randomized controlled trial architecture that regulators and health systems look for before adopting a program widely. Participants will be randomly assigned to one of two groups. One group will receive regular phone calls from a trained interventionist with a social work or nursing background who will check in and guide caregivers through the tailored modules. The comparison group will not receive the modules; those caregivers will have access only to publicly available information, and their phone calls will involve active listening but no tailored intervention or advice. This active-control structure is important because it separates the specific effect of the CG-Well content from the general benefit of simply having someone attentive on the phone, a distinction that has tripped up many psychosocial intervention studies in the past.

To reach a sample capable of detecting reliable effects, the trial will enroll up to 354 patient-caregiver pairs across four U.S. sites: the University of Cincinnati, Ohio State University in Columbus, Washington University in St. Louis and the University of Washington in Seattle. Enrollment is expected to begin in early 2027. Kreitzer’s co-investigators at UC include Stephanie Fink, lead coordinator and clinical research project manager in the Department of Emergency Medicine; Heidi Sucharew, PhD, research professor in the Department of Emergency Medicine; Brad Kurowski, MD, professor-affiliate in the Department of Pediatrics and Cincinnati Children’s Division of Rehabilitation Medicine; Shari Wade, PhD, professor-affiliate in the Department of Pediatrics and director of research at Cincinnati Children’s Division of Rehabilitation Medicine; and Tamilyn Bakas, PhD, professor and endowed chair in the College of Nursing. The spread of expertise, spanning emergency medicine, biostatistics, pediatric rehabilitation medicine and nursing science, reflects the reality that caregiver support cuts across nearly every specialty involved in brain injury care.

The stakes extend well beyond the families enrolled in the study. Informal family caregivers provide billions of dollars’ worth of unpaid care in the United States each year, and when they burn out, the consequences cascade: patients are readmitted to hospitals, placed in institutional care earlier than necessary, or left without consistent supervision during a recovery window when structured support matters most. An intervention that is web-based and telephone-delivered is inherently scalable, which is precisely why the trial is measuring cost and acceptability alongside clinical outcomes. If CG-Well 2 confirms the pilot findings, hospitals and rehabilitation systems could have a low-cost, evidence-based template for supporting caregivers nationally, delivered through channels that already exist in nearly every American household.

For Kreitzer, the R01 represents a major career milestone, the transition from mentored career development funding to independent investigator status at the NIH. But the milestone is also a signal of where the field is heading. Neurocritical care has traditionally measured success in survival and discharge disposition, while the long shadow cast by moderate-to-severe TBI on families went largely unmeasured. A rigorously designed, multisite trial that treats caregiver psychological health as a primary target, and that begins support within two weeks of injury rather than after a crisis, reflects a growing recognition that the unit of recovery after brain injury is not the patient alone but the household around them. Whether CG-Well 2 can convert a promising pilot into a scalable standard of care will become clear as enrollment opens in early 2027 and results accumulate over the five-year award period.

Subject of Research: A randomized clinical trial of a web- and telephone-based wellness intervention for family caregivers of traumatic brain injury patients

Article Title: University of Cincinnati physician-researcher earns $2.5 million NIH grant for caregiver wellness trial

Article References: University of Cincinnati physician-researcher earns $2.5 million NIH grant for caregiver wellness trial. (n.d.). Original publication

Image Credits: AI Generated

DOI: Not provided

Keywords: traumatic brain injury, family caregivers, NIH R01 grant, CG-Well, randomized clinical trial, University of Cincinnati, caregiver burnout, neurocritical care, psychological distress, emergency medicine, rehabilitation, telehealth intervention