Actively Recruiting
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
Led by Natalie Kreitzer · Updated on 2025-03-26
100
Participants Needed
1
Research Sites
215 weeks
Total Duration
On this page
Sponsors
N
Natalie Kreitzer
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
After injury, survivors of msTBI depend on informal family caregivers. Upwards of 77% of family caregivers experience poor outcomes, such as adverse life changes, poor health related quality of life, and increased depressive symptoms. Caregivers frequently report minimal support or training to prepare them for their new role. Periods of care transitions, such as ICU discharge, are most difficult. The majority (93%) of previously developed caregiver and caregiver/survivor dyad interventions after msTBI focus on providing information or practical skills to either survivors, or to long-term caregivers (\>6 months post injury), rather than education, support, and skill-building that the new caregiver may use proactively that will benefit the dyad acutely after injury. The Aims of this proposal are to: (1) Determine feasibility, satisfaction, and data trends of CG-Well; and (2) Understand how baseline psychosocial risk factors affect response to CG-Well compared to an Information, Support, and Referral control group. To accomplish this, I will first enroll 6-10 caregivers and tailor CG-well until each finds the intervention acceptable, appropriate, and feasible. I will then enroll 100 (50/group) dyads and determine satisfaction ratings, recruitment, retention, and treatment fidelity of CG-Well. Additionally, I will determine if caregivers report reductions in depressive symptoms and improvements in life changes as a result of improvements in task difficulty and threat appraisal in CG-Well compared to ISR at six months. Information obtained in Aims 1 and 2 will be used to plan a larger Phase III trial of CG-Well. Completing these Aims and the training plan will improve outcomes of caregivers and downstream outcomes of survivors of msTBI, and provide me with the skillset necessary to become an independent researcher who can develop and test high-impact, high-fidelity, sustainable interventions.
CONDITIONS
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Survivor and caregiver 18 years or older
- Survivor Glasgow Coma Scale (GCS) score between 3 and 12 after resuscitation
- Survivor less than 2 weeks post injury
- Both survivor and caregiver speak English
You will not qualify if you...
- Patient not expected to survive
- Survivor or caregiver currently pregnant
- Survivor or caregiver is a prisoner
- History of pre-existing condition interfering with follow-up in survivor or caregiver (e.g., substance abuse, alcoholism, end-stage cancers)
- Major prior debilitating neurological or mental health disorder in survivor or caregiver (e.g., schizophrenia, bipolar disorder, stroke, dementia)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Cincinnati
Cincinnati, Ohio, United States, 45267
Actively Recruiting
Research Team
E
Emily Werff
CONTACT
S
Stephanie Thomas
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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