NCT05048966 · RECRUITING
Comparison of Two Group Wellness Interventions for Individuals With Neurologic Conditions and Their Support Persons
This study compares two group wellness classes to see which one better supports long-term wellbeing. Participants are people living with a brain injury or Alzheimer's-related dementia, along with a support person such as a spouse or adult child. Neither class is a drug. It is a behavioral study with no phase, so the question is which approach works better.
Eligibility criteria
For individuals with moderate/severe TBI: Inclusion Criteria: * 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 Exclusion Criteria: * 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 For individuals with chronic mild TBI: Inclusion Criteria: * age 18-70 * at least 3 months post-injury * can read and speak English fluently * has a support person who is willing to participate in the study Exclusion Criteria: * has had a prior stroke or neurological disease other than mild 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 For Individuals with Alzheimer's Disease Related Dementias (ADRD) Inclusion Criteria: * age 65 and older * at least one-year post-diagnosis * can read and speak English fluently * has a support person who is willing to participate in this study Exclusion Criteria: * has had a prior stroke or neurological disease other than ADRD * 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 For Support Persons: Inclusion Criteria: * is the support person of an individual with moderate/severe TBI, chronic mild TBI or ADRD who is willing to participate in the study * can read and speak English fluently Exclusion Criteria: * has a significant neurological history (e.g. stroke or multiple sclerosis) * 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
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-09-21