๐ฌIn plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
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
๐
What it tests
- Group Wellness Class 1
- Group Wellness Class 2
Kessler Foundation
East Hanover, United States
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.