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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment CG-Well for caregivers of traumatic brain injury patients?

The CG-Well program is designed to support caregivers of traumatic brain injury patients, and its development involved feedback from experts and caregivers to improve its effectiveness. Additionally, similar interventions, like Counselor-Assisted Problem Solving, have shown to improve caregiver adaptation after brain injury, suggesting that structured support programs can be beneficial. ^{1 2 3 4 5}

Is the CG-Well Intervention safe for caregivers of traumatic brain injury patients?

The available research does not provide specific safety data for the CG-Well Intervention, but it focuses on supporting caregivers of traumatic brain injury patients, which suggests it is designed to be safe and supportive. ^{1 2 6 7 8}

What makes the CG-Well treatment unique for caregivers of traumatic brain injury patients?

The CG-Well treatment is unique because it is a web/phone-based intervention specifically designed to support caregivers of adults with traumatic brain injury, focusing on their wellness and mental health, which is often overlooked in other treatments. ^{1 2 4 7 9}

Eligibility Criteria

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

Both my caregiver and I can speak English.

You have survived less than 2 weeks since your injury.

I am 18 years or older.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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 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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Iterative Development of the Caregiver Wellness After Traumatic Brain Injury Program (CG-Well). [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Systematic Review of Caregiver and Dyad Interventions After Adult Traumatic Brain Injury. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Counselor-assisted problem solving improves caregiver efficacy following adolescent brain injury. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Efficacy of the Brain Injury Family Intervention: Impact on Family Members. [2015]

5. United States 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. [2020]

6. England 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. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Caregiver's Burden of the Patients With Traumatic Brain Injury. [2020]

8. United States 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). [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Family stressors in traumatic brain injury: a two-year follow-up. [2022]