NCT05048966 · Kessler Foundation
Comparison of Two Group Wellness Interventions for Individuals With Neurologic Conditions and Their Support Persons
What this study is about
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).
View original scientific description
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.
Interventions
BEHAVIORAL
Group Wellness Class 1
Twelve weekly online group wellness sessions for individuals with the disability and their support person. Each class will last for approximately 2 hours.
BEHAVIORAL
Group Wellness Class 2
Twelve weekly online group wellness sessions for individuals with the disability and their support person. Each class will last for approximately 2 hours.
Primary outcome measures
Change on Self-Efficacy Questionnaire (SEQ)
Time frame: 12 weeks (between pre- and post-testing) and 6 months (between post-testing and 6 month follow-up)
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)
Time frame: 12 weeks (between pre- and post-testing) and 6 months (between post-testing and 6 month follow-up)
self-report measure that examines life satisfaction component of subjective well-being and quality of life
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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:
- 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
Where
- East Hanover, New Jersey
Collaborators
University of Michigan, Rehabilitation Hospital of Indiana, University of California, San Diego, Indiana University
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 21, 2026 · Source of record for eligibility and locations