CG-well 2: a multisite trial of a caregiver wellness intervention for moderate-to-severe traumatic brain injury

The National Institute of Child Health and Human Development awarded the University of Cincinnati $721,286 on September 1, 2026, for a multisite trial of CG-WELL 2, a web and phone-based caregiver wellness intervention for family members supporting adults with moderate-to-severe traumatic brain injury. The award is funded under the Child Health and Human Development Extramural Research program (CFDA 93.865).

CG-WELL 2 expands a previously tested single-site intervention by scaling to multiple research centers and enhancing delivery flexibility. The intervention comprises 43 modules addressing caregiver needs during the first six months post-injury, coupled with structured phone sessions delivered by trained coordinators. Enhanced delivery modes include website access, printed guides, phone support, videoconferencing, and text or email notifications, with a coaching-oriented protocol emphasizing individualized goal-setting. A prior feasibility trial demonstrated that CG-WELL significantly improved caregiver satisfaction and reduced psychological distress compared to an information, support, and referral control condition.

Performance occurs at Cincinnati, Ohio with a period of performance running from September 1, 2026, through August 31, 2031. The University of Cincinnati's Sponsored Research Services Division serves as the prime recipient.

Abstract

Traumatic brain injury (TBI) is a leading cause of long-term disability, with over 300,000 americans sustaining moderate-to-severe TBI annually. Survivors often require intensive caregiving from family members, yet few caregivers receive adequate training or support in the acute or subacute phases of recovery. These unmet needs place caregivers at risk for anxiety, depression, and poor quality of life, which in turn negatively impact survivor outcomes. National guidelines highlight the need for early, structured caregiver education, but existing interventions are limited, largely delivered late after injury, and lack a tailored approach. To address this GAP, we designed caregiver wellness after TBI (CG-WELL), a web and phone based intervention that offers support, skill-building, and education for family caregivers of adults who have sustained an mstbi. CG-WELL was developed through qualitative research, expert consensus, and iterative refinement with caregivers. IT includes 43 modules addressing issues commonly faced by caregivers during the first six months after TBI, as WELL as structured phone sessions with trained coordinators. In our single-site randomized feasibility trial (N=100 dyads), CG-WELL significantly improved caregiver satisfaction (primary outcome), and reduced caregiver psychological distress (secondary outcome) when compared to an information, support, and referral (ISR) control group (K23HD102555). The next logical step in development of CG-WELL is to test the intervention in a larger, multicenter cohort. Building on these promising results, CG-WELL 2 expands access and scalability. Enhancements include flexible delivery modes (website, printed guide, phone, videoconferencing, text/email notifications), interactive features to support engagement, and a coaching-oriented phone protocol emphasizing individualized goal-setting. Content aligns with family systems theory, the lazarus stress and coping model, and uncertainty in illness theory, emphasizing threat appraisal, coping, and caregiver empowerment. We propose a multi-site (four sites), randomized controlled efficacy trial to test CG-WELL 2 (N=320 caregiver/survivor dyads), randomizing participants within two weeks of ICU admission to either CG-WELL 2 or ISR control, and following them for six months. The primary outcome is caregiver psychological distress (BSI-18). Secondary outcomes include task difficulty, threat appraisal, and caregiver burden. Early implementation outcomes such as acceptability, adoption, feasibility, fidelity, and cost will also be evaluated. This project directly addresses national priorities in digital health, caregiver empowerment, and implementation of evidence-based interventions. By targeting the critical early caregiving period, CG-WELL 2 is uniquely positioned to prevent psychological deterioration, promote caregiver resilience, and improve survivor recovery trajectories. If efficacious, CG-WELL 2 may be integrated into trauma systems of care and adapted for caregivers across other neurologic and chronic conditions.