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Life sciences · Interventional Study
ClinicalTrials.gov · September 21, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT05048966). This is a study registration, not published results. Lead sponsor: Kessler Foundation. Recruitment status: RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 360 participants (ESTIMATED). Conditions: Traumatic Brain Injury, Mild Traumatic Brain Injury, Alzheimer's Disease, Brain Injury Traumatic Moderate, Brain Injury Traumatic Severe, Dementia. Interventions: BEHAVIORAL: Group Wellness Class 1; BEHAVIORAL: Group Wellness Class 2. Primary outcome measures: Change on Self-Efficacy Questionnaire (SEQ) , 12 weeks (between pre- and post-testing) and 6 months (between post-testing and 6 month follow-up); Change on Satisfaction with Life Scale (SWLS) , 12 weeks (between pre- and post-testing) and 6 months (between post-testing and 6 month follow-up). Brief 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.