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CG-Well Intervention for Caregivers of Traumatic Brain Injury Patients (CG-Well Trial)

N/A
Recruiting
Research Sponsored by Natalie Kreitzer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Survivor GCS 3-12 after resuscitation
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 36 months

Summary

This trial is testing a new intervention for caregivers of people with msTBI. The intervention is designed to help the caregivers manage their depressive symptoms and improve their quality of life.

Who is the study for?
This trial is for adult caregivers of patients with moderate to severe traumatic brain injuries (msTBI) that occurred less than 2 weeks ago. Both the caregiver and patient must be over 18, speak English, and the patient should have a GCS score between 3-12 after resuscitation. Those not expected to survive, pregnant individuals, prisoners, or those with conditions like substance abuse or major neurological/mental health disorders cannot participate.
What is being tested?
The study tests CG-Well intervention aimed at improving well-being in new caregivers by providing education, support, and skill-building immediately following injury. It will be compared against an Information Support & Referral (ISR) control group to see if it reduces depressive symptoms and improves life changes due to task difficulty and threat appraisal.
What are the potential side effects?
Since this trial focuses on educational and supportive interventions rather than medical treatments or drugs, traditional side effects are not applicable. However, participants may experience varying levels of emotional discomfort or stress during the process.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I was in a severe condition but have been stabilized.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 36 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Intervention Satisfaction
Secondary study objectives
Appraisal of Caregiving Scale Threat Subscale
Bakas Caregiver Outcomes Scale (BCOS)
Brief Symptom Inventory-18 (BSI-18)
+7 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: CG-WellExperimental Treatment1 Intervention
CG-Well is a web \& phone based psychosocial intervention that teaches caregivers how to obtain information, education \& support
Group II: Information Support and ReferralPlacebo Group1 Intervention
Attention control group that receives phone calls and modules from the Brain Injury Association of America.

Find a Location

Who is running the clinical trial?

Natalie KreitzerLead Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
2,068 Previous Clinical Trials
2,747,444 Total Patients Enrolled

Media Library

CG-Well Clinical Trial Eligibility Overview. Trial Name: NCT05307640 — N/A
Traumatic Brain Injury Research Study Groups: CG-Well, Information Support and Referral
Traumatic Brain Injury Clinical Trial 2023: CG-Well Highlights & Side Effects. Trial Name: NCT05307640 — N/A
CG-Well 2023 Treatment Timeline for Medical Study. Trial Name: NCT05307640 — N/A
~9 spots leftby Apr 2025
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