About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
age 18-70
at least 4 months post injury
can read and speak English fluently
has a support person who is willing to participate in the study
Disqualifiers
has had a prior stroke or neurological disease other than TBI
has unstable or uncontrolled seizures
has been hospitalized due to a significant psychiatric illness (for example, bipolar disorder, schizophrenia, or psychosis) in the past three months
current alcohol and/or drug use that interferes with ability to carry out common everyday functions
Trial design
Parallel
Treatments tested in this trial
Group Wellness Class 1
BehavioralTwelve weekly online group wellness sessions for individuals with the disability and their support person. Each class will last for approximately 2 hours.
Group Wellness Class 2
BehavioralTwelve weekly online group wellness sessions for individuals with the disability and their support person. Each class will last for approximately 2 hours.
Treatment groups
Trial outcomes
Primary outcomes
Change on Self-Efficacy Questionnaire (SEQ)
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
Change on Satisfaction with Life Scale (SWLS)
self-report measure that examines life satisfaction component of subjective well-being and quality of life
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Kessler Foundation
Lead sponsor
University of Michigan
Collaborator
Rehabilitation Hospital of Indiana
Collaborator
University of California, San Diego
Collaborator
Indiana University
Collaborator