NCT05048966

Comparison of Two Group Wellness Interventions for Individuals With Neurologic Conditions and Their Support Persons

Comparison of Two Group Wellness Interventions for Individuals With Neurologic Conditions and Their Support Persons: A Randomized Clinical Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 360 (estimated)
• Sponsor: Kessler Foundation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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. Franciscan Health in Indiana 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.

Conditions

• Traumatic Brain Injury
• Mild Traumatic Brain Injury
• Alzheimer's Disease
• Brain Injury Traumatic Moderate
• Brain Injury Traumatic Severe
• Dementia

Interventions

Type	Name	Description
BEHAVIORAL	Group Wellness Class 1	Twelve weekly online group wellness sessions for individuals with the disability and their support person. Each class will last for approximately 2 hours.
BEHAVIORAL	Group Wellness Class 2	Twelve weekly online group wellness sessions for individuals with the disability and their support person. Each class will last for approximately 2 hours.

Timeline

• Start date: 2022-12-08
• Primary completion: 2025-09-01
• Completion: 2025-09-01
• First posted: 2021-09-17
• Last updated: 2022-12-16

Locations

1 site across 1 country: United States