NCT05307640: CG-Well

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

Recruiting now NA Last updated 26 March 2025

What this trial tests

NA trial testing CG-Well in Trauma, Brain in 100 participants. Currently enrolling.

Timeline

16 August 2021

Primary endpoint
1 October 2025

1 October 2025

Quick facts

Lead sponsor	Natalie Kreitzer
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	health services research
Enrollment	100
Start date	16 August 2021
Primary completion	1 October 2025
Estimated completion	1 October 2025
Sites	1 location across United States

Drugs / interventions tested

• CG-Well
• Information Support & Referral (ISR)

Conditions studied

• Trauma, Brain — all drugs for Trauma, Brain →

Sponsor

Natalie Kreitzer

Who can join

18 and older, any sex, with Trauma, Brain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Caregiver Wellness after Traumatic Brain Injury (CG-Well): Protocol for a randomized clinical trial.
   Kreitzer N, Fink S, Adeoye O, Kurowski G B, et al · · 2024 · cited 3× · PMID 39280784 · DOI 10.1016/j.conctc.2024.101356