Kessler Foundation
East Hanover, New Jersey, 07936, United States
Location status: Recruiting
NCT Number: NCT05048966
Approximately 5.3 million people live with a long-term disability resulting from a traumatic brain injury (TBI) and between 5-8% of those older than 60 suffer from Alzheimer's disease or other forms of dementia (ADRD). Consequences of these conditions can result in dramatic and persistent changes in functioning, impacting not only the patients, but also loved ones who become informal support persons. Many existing services help the family in the moment, but do not address long-term wellness. Thus, the purpose of this research study is to compare the effect of two different types of group wellness treatments for individuals with chronic mild TBI, moderate to severe TBI, and ADRD and their support persons.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
East Hanover, New Jersey, 07936, United States
Location status: Recruiting
The study will involve three sites, with a different clinical population targeted at each site. Kessler Foundation will serve as the Coordinating Center and will enroll individuals with moderate/severe TBI. Indiana University and University of Michigan will serve as partnering sites and will enroll individuals with chronic mild TBI and ADRD respectively. The research protocols at each site will be unique to the patient population, but harmonized through unified project goals: 1) to evaluate the efficacy of two different online group wellness treatments designed to improve self-efficacy and quality of life, and 2) to determine whether patient neurobehavioral functioning moderates the relationship between treatment outcomes and burden in caregivers, and 3) to determine the neural, behavioral, and blood biomarkers that best predict treatment efficacy. It is expected that findings generated from this study will lead to improved holistic approaches for brain injury and dementia systems of care.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
For individuals with moderate/severe TBI:
Inclusion criteria
Exclusion criteria
For individuals with chronic mild TBI:
Inclusion criteria
Exclusion criteria
For Individuals with Alzheimer's Disease Related Dementias (ADRD)
Inclusion criteria
Exclusion criteria
For Support Persons:
Inclusion criteria
Exclusion criteria
Twelve weekly online group wellness sessions for individuals with the disability and their support person. Each class will last for approximately 2 hours.
Twelve weekly online group wellness sessions for individuals with the disability and their support person. Each class will last for approximately 2 hours.
Time frame: 12 weeks (between pre- and post-testing) and 6 months (between post-testing and 6 month follow-up)
self-report instrument that assesses an individual's and support person's self-efficacy as it relates to their ability to manage the effects of the neurologic conditions on their daily functioning
Time frame: 12 weeks (between pre- and post-testing) and 6 months (between post-testing and 6 month follow-up)
self-report measure that examines life satisfaction component of subjective well-being and quality of life
Contact information is provided by the study sponsor or research team.
Kessler Foundation
Other
Comparison of Two Group Wellness Interventions for Individuals With Neurologic Conditions and Their Support Persons: A Randomized Clinical Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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