Comparison of Two Group Wellness Interventions for Individuals With Neurologic Conditions and Their Support Persons
Status unconfirmed · Not applicable
Conditions studied: Traumatic Brain Injury, Mild Traumatic Brain Injury, Alzheimer's Disease, Brain Injury Traumatic Moderate, Brain Injury Traumatic Severe, Dementia
In brief
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.
Key facts
- Study ID
- NCT05048966
- Run by
- Kessler Foundation
- People needed
- 360
- Starts
- 2022-12-08
- Expected to finish
- 2025-09-01
- Last updated by the study team
- 2022-12-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- age 18-64
- at least one year post injury
- can read and speak English fluently
- has a support person who is willing to participate in the study
You may not qualify if…
- 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 18-64
- 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
Where it is running
- Kessler Foundation — East Hanover, New Jersey, United States (enrolling)
Full record on ClinicalTrials.gov
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