Wellness program for caregivers of patients with traumatic brain injuries
Official title: Caregiver Wellness After Traumatic Brain Injury (CG-WELL): An Intervention Designed to Promote Well-being in Caregivers of Acute Moderate to Severe Traumatic Brain Injuries
Run by University of Cincinnati · NCT05307640 · Data updated 2026-11-12
This study tests a wellness program designed to help caregivers of patients with serious brain injuries feel better and manage their challenges more effectively compared to regular support services.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | University of Cincinnati Academic / other |
| Locations | 1 site (Cincinnati, Ohio) |
| Status | Recruiting |
| Started | August 16, 2021 |
| Main results expected | October 1, 2025 |
| Study ends | October 1, 2025 |
| Registry record updated | March 26, 2025 |
| Trial ID | NCT05307640 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include English-speaking caregivers and survivors aged 18 and older who are within two weeks post-injury and have a Glasgow Coma Scale score between 3 and 12.
✕Probably not a fit
Patients who are not expected to survive, pregnant, prisoners, or have significant pre-existing conditions that could interfere with follow-up will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This intervention focuses on enhancing the well-being of caregivers who support individuals with moderate to severe traumatic brain injuries (msTBI). It aims to provide education, support, and skill-building for caregivers during the critical period shortly after the injury, particularly during care transitions like ICU discharge. The study will assess the feasibility and satisfaction of the CG-Well program compared to standard information and support services. By addressing the unique challenges faced by new caregivers, the program seeks to improve their health-related quality of life and reduce depressive symptoms.
Why it matters
Potential benefit: If successful, this program could significantly improve the mental health and overall well-being of caregivers, leading to better care for patients with traumatic brain injuries.
How similar studies have gone: While previous interventions have focused on long-term caregivers, this approach is novel as it targets new caregivers immediately following the injury.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion criteria: * Survivor and caregiver ≥18 years old * Survivor GCS 3-12 after resuscitation * Survivor \< 2 weeks post injury * English Speaking - survivor and caregiver Exclusion criteria: * Patient not expected to survive. * Pregnant - survivor or caregiver * Prisoner - survivor or caregiver * History of pre-existing condition that would interfere with follow-up in caregiver or survivor (e.g., substance abuse, alcoholism, end-stage cancers) * Major prior debilitating neurological or mental health disorder in caregiver or survivor (e.g., schizophrenia, bipolar, stroke, dementia).
Where it's running
-
University of Cincinnati
Cincinnati, Ohio, United States Recruiting
Study contacts
- Study coordinator: Emily Werff
- Email: werffel@ucmail.uc.edu
- Phone: 513-307-2963
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.