CG-Well Intervention for Caregivers of Traumatic Brain Injury Patients

(CG-Well Trial)

Overseen By Emily Werff

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Natalie Kreitzer

Disqualifiers: Substance abuse, Schizophrenia, Bipolar, others

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new program called CG-Well, designed to support caregivers of individuals who have recently experienced a moderate to severe traumatic brain injury (msTBI). The goal is to determine if this program helps caregivers feel better prepared, less stressed, and healthier overall by providing tools and support immediately after the injury. Participants will either use the CG-Well program or receive standard support from the Brain Injury Association of America. Ideal participants are English-speaking caregivers of msTBI survivors who are less than two weeks post-injury and are encountering challenges in their new caregiving role. As an unphased trial, this study offers caregivers a unique opportunity to access potentially beneficial support tools early in their caregiving journey.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the CG-Well intervention is safe for caregivers of traumatic brain injury patients?

Research shows that the CG-Well program is a web and phone-based support system for family caregivers of individuals with traumatic brain injuries. This program emphasizes emotional and social support, avoiding medication or medical procedures, which typically reduces the risk of physical side effects. The main goal is to teach caregivers how to find information, gain education, and receive support.

As this trial is in an early stage, no previous trial data confirms its safety regarding side effects. However, because it involves no physical procedures, it is generally considered safe. Participants might experience improvements in quality of life and reduced stress or depression.

Prospective participants should know that the program aims to help caregivers feel more supported and prepared, potentially benefiting both the caregiver and the person they care for. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CG-Well intervention because it offers a fresh approach to supporting caregivers of traumatic brain injury (TBI) patients. Unlike standard care options that may focus primarily on the TBI patients themselves, CG-Well is a web and phone-based psychosocial program designed specifically for caregivers. It teaches them how to access information, education, and support, which can be crucial in managing stress and improving their quality of life. This unique focus on caregivers is what sets CG-Well apart and could lead to better overall outcomes for both caregivers and patients.

What evidence suggests that the CG-Well intervention is effective for caregivers of traumatic brain injury patients?

Research shows that the CG-Well program, one of the interventions in this trial, is designed to improve the overall well-being of caregivers for people with traumatic brain injuries (TBI). Caregivers often face high stress and poor health. Early studies suggest that providing specific education and support can help them manage these challenges more effectively. CG-Well aims to teach caregivers how to cope with stress soon after the injury, potentially reducing depression and enhancing their quality of life. Although data collection on CG-Well's effectiveness is ongoing, the program appears promising by offering proactive support during critical care transitions. Another group in this trial will receive Information Support and Referral, serving as an attention control group, with phone calls and modules from the Brain Injury Association of America. ^{1 4 5 6 7}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

You have survived less than 2 weeks since your injury.

I was in a severe condition but have been stabilized.

Exclusion Criteria

You are pregnant or a caregiver for someone who is pregnant.

The caregiver or survivor has a serious neurological or mental health disorder that has caused major difficulties in the past.

You are currently in prison, or have been in prison and are now a survivor, or you are a caregiver for someone who is in prison.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Caregivers participate in the CG-Well intervention, which includes web and phone-based psychosocial support and education

6 months

Monthly phone calls and online module participation

Follow-up

Participants are monitored for satisfaction, retention, and changes in depressive symptoms and life changes

up to 36 months

Regular study visit calls

What Are the Treatments Tested in This Trial?

Interventions

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

Trial Overview 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.

How Is the Trial Designed?

Group I: CG-Well Experimental Treatment 1 Intervention

CG-Well is a web \& phone based psychosocial intervention that teaches caregivers how to obtain information, education \& support

Group II: Information Support and Referral Placebo Group 1 Intervention

Attention control group that receives phone calls and modules from the Brain Injury Association of America.

CG-Well is already approved in United States for the following indications:

Approved in United States as CG-WELL for:

• Support for caregivers of acute moderate to severe traumatic brain injuries

Who Is Running the Clinical Trial?

Natalie Kreitzer

Lead Sponsor

Trials

1

Recruited

100+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Published Research Related to This Trial

Interventions specifically targeting family caregivers of adults with traumatic brain injury (TBI) are more effective in reducing caregiver burnout and improving well-being than those aimed at both caregivers and survivors or just the survivors themselves.

The review included 14 studies, primarily randomized clinical trials, but highlighted limitations such as small sample sizes and high risk of bias, suggesting that future research should focus on larger, more rigorously designed studies to better assess the effectiveness of these interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic Review of Caregiver and Dyad Interventions After Adult Traumatic Brain Injury. Kreitzer, N., Kurowski, BG., Bakas, T.[2022]

The Brain Injury Family Intervention significantly improved caregiver outcomes, including increased satisfaction with services and reduced caregiver burden, after five 2-hour sessions with 108 families participating in the study.

The benefits of the intervention were observed up to 3 months post-treatment, indicating its effectiveness in addressing the needs of family caregivers after acquired brain injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of the Brain Injury Family Intervention: Impact on Family Members. Kreutzer, JS., Marwitz, JH., Sima, AP., et al.[2015]

The Caregiver Wellness (CG-Well) program, designed to support caregivers of adults after traumatic brain injury, received high ratings for relevance, clarity, accuracy, and utility, indicating strong initial acceptability among users.

The iterative design process, which involved feedback from both caregivers and experts, has led to a refined intervention that is now being tested in an early-stage randomized controlled trial to evaluate its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Iterative Development of the Caregiver Wellness After Traumatic Brain Injury Program (CG-Well). Kreitzer, N., Adeoye, O., Wade, SL., et al.[2023]

Caregivers of individuals with traumatic brain injury (TBI) reported increasing behavioral issues, such as temper outbursts and anxiety, over a 2-year period, with 31% noting moderate to severe aggressiveness by the end of the study.

Despite the rising complaints about their relatives' behaviors, caregivers did not report increased self-perceived stress over time, but many experienced financial strain and job changes, indicating a complex relationship between caregiver stress and the challenges of managing TBI-related disabilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family stressors in traumatic brain injury: a two-year follow-up. Hall, KM., Karzmark, P., Stevens, M., et al.[2022]

Counselor-Assisted Problem Solving (CAPS) significantly improved caregiver self-efficacy and reduced depression among parents of adolescents with traumatic brain injury (TBI), especially for those with limited prior computer experience.

Parents who engaged in 5 or more CAPS sessions experienced greater benefits compared to those using an information-based Internet Resource Comparison (IRC), highlighting the effectiveness of structured online support in caregiver adaptation post-TBI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Counselor-assisted problem solving improves caregiver efficacy following adolescent brain injury. Wade, SL., Karver, CL., Taylor, HG., et al.[2021]

The TBI-CareQOL measurement system, which includes 26 item banks for assessing health-related quality of life in caregivers of individuals with traumatic brain injury, has demonstrated strong reliability and validity based on a study of 385 caregivers.

The measures within TBI-CareQOL showed excellent internal consistency and stability, making them suitable for standardized assessments of caregiver quality of life in both civilian and service member populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reliability and validity data to support the clinical utility of the Traumatic Brain Injury Caregiver Quality of Life (TBI-CareQOL). Carlozzi, NE., Boileau, NR., Kallen, MA., et al.[2021]

Caregivers of traumatic brain injury (TBI) patients, especially spouses and females, experience significant psychological and health issues, highlighting the need for better support and education for these caregivers before patient discharge.

The D'Zurilla and Nezu social problem-solving model was identified as the most beneficial therapeutic intervention for caregivers, suggesting that structured support and counseling can help alleviate caregiver stress and improve family dynamics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Caregiver's Burden of the Patients With Traumatic Brain Injury. Qadeer, A., Khalid, U., Amin, M., et al.[2020]

Individuals with moderate-to-severe traumatic brain injury (TBI) face significant health, wellness, and safety challenges even when they are largely independent in daily activities, highlighting the need for ongoing support after discharge from rehabilitation.

Interviews with 27 TBI patients and their caregivers revealed key concerns such as medication management, mental health issues, mobility challenges, and social relationship adjustments, indicating that tailored resources and tools are essential for improving post-discharge care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health, wellness, and safety concerns of persons with moderate-to-severe traumatic brain injury and their family caregivers: a qualitative content analysis. Oyesanya, TO., Arulselvam, K., Thompson, N., et al.[2021]

Caregivers of patients with moderate-to-severe traumatic brain injury (TBI) showed significant improvements in meeting their emotional support needs and knowledge about brain injury after a 5-session intervention, compared to a control group.

However, the benefits of the intervention did not last at the 3-month follow-up, suggesting that caregivers may need ongoing support to maintain these improvements.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Controlled Pilot Study of a Manualized Intervention for Caregivers of Patients With Traumatic Brain Injury in Inpatient Rehabilitation. Niemeier, JP., Kreutzer, JS., Marwitz, JH., et al.[2020]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39280784/

Caregiver Wellness after Traumatic Brain Injury (CG-Well) Upwards of 77 % of family caregivers experience poor outcomes, such as adverse life changes, poor health-related quality of life, and increased ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2451865424001030

Caregiver Wellness after Traumatic Brain Injury (CG-Well) Upwards of 77 % of family caregivers experience poor outcomes, such as adverse life changes, poor health-related quality of life, and increased depressive ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05307640?term=AREA%5BBasicSearch%5D(Traumatic%20brain%20injury%20AND%20NICHD)&rank=8

Caregiver Wellness After Traumatic Brain Injury (CG ... A general description of the clinical trial arm. It identifies the role of the intervention that participants receive. Types of arms include experimental arm, ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10517076/

Iterative Development of the Caregiver Wellness after ... This study described the unmet needs of caregivers of patients with a TBI beginning at 72 hours post injury, characterized the changing timeline of caregiver ...

5. researchgate.net researchgate.net/publication/384078203_Caregiver_Wellness_after_Traumatic_Brain_Injury_CG-Well_Protocol_for_a_randomized_clinical_trial

Caregiver Wellness after Traumatic Brain Injury (CG-Well) Upwards of 77 % of family caregivers experience poor outcomes, such as adverse life changes, poor health-related quality of life, and increased ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05307640?aggFilters=funderType:nih,status:rec%20not%20ava&cond=trauma&rank=5

Caregiver Wellness After Traumatic Brain Injury (CG ... Upwards of 77% of family caregivers experience poor outcomes, such as adverse life changes, poor health related quality of life, and increased depressive ...

7. trialx.com trialx.com/clinical-trials/listings/221976/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/

Caregiver Wellness After Traumatic Brain Injury (CG ... Upwards of 77% of family caregivers experience poor outcomes, such as adverse life changes, poor health related quality of life, and increased ...