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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

Awards & highlights

CG-Well Trial 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.Check my eligibility

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.See study design

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.

CG-Well Trial 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.

CG-Well Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 36 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Intervention Satisfaction

Secondary outcome measures

Appraisal of Caregiving Scale Threat Subscale

Bakas Caregiver Outcomes Scale (BCOS)

Brief Symptom Inventory-18 (BSI-18)

+7 more

CG-Well 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.

0 / 1Eligibility criteria met

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

1,965 Previous Clinical Trials

2,672,697 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there opportunities for new enrollees in this trial?

"That is accurate. According to the information on clinicaltrials.gov, this research project was initially posted on August 16th 2021 and has been updated as recently as April 13th 2022. The study necessitates 100 volunteers at a single medical site."

Answered by AI

How many participants can be accepted into this research endeavor?

"Affirmative. Per the information on clinicaltrials.gov, this medical trial which was first published in August 2021 is presently searching for participants to take part. It requires 100 individuals from across 1 location and has been updated as recently as April 13th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Natalie Kreitzer 2021. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05307640.

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