CG-Well Intervention for Caregivers of Traumatic Brain Injury Patients
(CG-Well Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Natalie Kreitzer
Disqualifiers: Substance abuse, Schizophrenia, Bipolar, others
Approved in 1 Jurisdiction
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.
12345Is 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.
12678What 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.
12479Eligibility 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.
+1 more
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.
+2 more
Trial 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
Participant Groups
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.
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.
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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of CincinnatiCincinnati, OH
Loading ...
Who Is Running the Clinical Trial?
Natalie KreitzerLead Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Collaborator
References
Iterative Development of the Caregiver Wellness After Traumatic Brain Injury Program (CG-Well). [2023](1) To iteratively design a web/phone-based intervention to support caregivers of adults acutely following traumatic brain injury (TBI), Caregiver Wellness (CG-Well), and (2) to obtain qualitative and quantitative feedback on CG-Well from experts and caregivers to refine the intervention.
Systematic Review of Caregiver and Dyad Interventions After Adult Traumatic Brain Injury. [2022]To describe and synthesize the literature on adult traumatic brain injury (TBI) family caregiver and dyad intervention. TBI is a common injury that has a significant long-term impact, and is sometimes even characterized as a chronic condition. Informal (ie, unpaid) family caregivers of adults with TBI experience high rates of burnout, depression, fatigue, anxiety, lower subjective well-being, and poorer levels of physical health compared to noncaregivers. This study addresses the critical gap in the understanding of interventions designed to address the impact of TBI on adult patients and their family caregivers.
Counselor-assisted problem solving improves caregiver efficacy following adolescent brain injury. [2021]The purpose of the current study is to examine the efficacy of Counselor-Assisted Problem Solving (CAPS) in improving caregiver adaptation following traumatic brain injury (TBI).
Efficacy of the Brain Injury Family Intervention: Impact on Family Members. [2015]Examine the effectiveness of an intervention (Brain Injury Family Intervention) for family caregivers after acquired brain injury.
A Randomized Controlled Pilot Study of a Manualized Intervention for Caregivers of Patients With Traumatic Brain Injury in Inpatient Rehabilitation. [2020]Investigate effectiveness of a 5-session manualized intervention for addressing needs of caregivers of persons in acute traumatic brain injury (TBI) rehabilitation.
Health, wellness, and safety concerns of persons with moderate-to-severe traumatic brain injury and their family caregivers: a qualitative content analysis. [2021]Persons with moderate-to-severe traumatic brain injury (TBI) face issues with health, wellness, and safety that affect their ability to independently manage their care, even for individuals who are ≥75% independent in activities of daily living. These issues often lead to increased family involvement in managing the person's condition after discharge home.
Caregiver's Burden of the Patients With Traumatic Brain Injury. [2020]Insufficient attention towards caregivers has resulted in the emergence of psychological and health complaints. Affliction tethers more towards spouses as compared to parents and females as compared to males. The role of sibling care givers was found to be no different from parents or spouses. Marital relationships were found to suffer the most, with the caregiver leaving the traumatic brain injury (TBI) patient in his time of need. The Brief Symptom Inventory (BSI) and family assessment device (FAD) predicted a correlation between patient variables and caregiver discontent. The Blacks/Hispanics proved to cope better with stress and their caregiver roles as compared to Whites. Time elapsed since the injury was found to relieve distress, while the surprising severity of the injury has no recorded impact. Social support or rather a lack of it has been seen to have an impact on family homeostasis, which can further be deteriorated by substance abuse by the patient. The therapeutic intervention found to be most advantageous was the D'Zurilla and Nezu social problem-solving model. Current evidence suggests that emphasis should be given on proper education and encouragement of caregivers before discharge of TBI patients from hospital to reduce the incidence of stressors. Additionally, counseling sessions should be led by professionally led support groups for dealing with psychological symptoms and peer-led group to eliminate social insecurities of caregivers.
Reliability and validity data to support the clinical utility of the Traumatic Brain Injury Caregiver Quality of Life (TBI-CareQOL). [2021]The Traumatic Brain Injury Caregiver Quality of Life (TBI-CareQOL) is a patient-reported outcome measurement system that is specific to caregivers of civilians and service members/veterans (SMVs) with traumatic brain injury (TBI). This measurement system includes 26 item banks that represent both generic (i.e., borrowed from existing measurement systems) and caregiver-specific components of health-related quality of life (HRQOL). This report provides reliability and validity data for measures within the TBI-CareQOL that have not previously been reported (i.e., 4 caregiver-specific and 7 generic measures of HRQOL).
Family stressors in traumatic brain injury: a two-year follow-up. [2022]A review of the literature suggests that psychosocial disability in traumatic brain-injured (TBI) individuals and distress in families continues long after the initial injury. In this study the relationship of family stress to a number of factors was studied longitudinally. Caregivers of 51 TBI inpatients were interviewed at rehabilitation admission and by phone at 6, 12, and 24 months postinjury. Caregivers' most common complaints about their relatives were a lack of involvement in leisure activities, fatigue, slowness, and forgetfulness. Increasingly severe temper outbursts, anxiety, and self-centeredness were reported over time. Aggressiveness was reported by caregivers as moderate or severe in 31% of cases by 2 years postinjury. Of all complaints, only reports of inappropriate social behavior decreased over time. Despite caregivers' increasing complaints about their relatives, there were no trends toward greater self-reported stress over time. At the 2-year assessment, stress was significantly higher for caregivers of those with an at risk psychosocial history, and for those without sufficient funds for services. Caregivers reporting financial strain increased 22% from rehabilitation admission. Forty-seven percent of caregivers had altered or given up their jobs at 1 year postinjury, and 33% at 2 years postinjury. Although self-perceived measurements of stress did not increase over time, caregivers reported notable increases in medication use and substance use, and decreases in employment and financial status over the 2-year time period. When spouse and parent caregiver responses were compared, spouses reported a consistently greater number of behavioral problems, which increased in severity over time. Those behaviors associated with mood disturbances predominated.(ABSTRACT TRUNCATED AT 250 WORDS)