Clinical trial Recruiting at 1 site Interventional Ages 18 and up

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 typeInterventional
Ages18 Years and up
SexAll
Enrollment100 (estimated)
SponsorUniversity of Cincinnati
Academic / other
Locations1 site (Cincinnati, Ohio)
StatusRecruiting
StartedAugust 16, 2021
Main results expectedOctober 1, 2025
Study endsOctober 1, 2025
Registry record updatedMarch 26, 2025
Trial IDNCT05307640 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.