Traumatic Brain InjuryNCT05048966
Comparison of Two Group Wellness Interventions for Individuals With Neurologic Conditions and Their Support Persons
A study testing Group Wellness Class 1 and Group Wellness Class 2 in people with Traumatic Brain Injury and Mild Traumatic Brain Injury, run by Kessler Foundation at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury, Mild Traumatic Brain Injury, Alzheimer's Disease
- What is being tested?
- Group Wellness Class 1 and Group Wellness Class 2
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Dec 2022to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- age 18-70
- at least 3 months post-injury
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- can read and speak English fluently
- has a support person who is willing to participate in the study
- 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
- 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
Who cannot join
- 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:
- has had a prior stroke or neurological disease other than mild TBI
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- 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)
- 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:
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Kessler Foundation
East Hanover, New Jersey, 07936
Matthew Weiner, 973-324-3515, mweiner@kesslerfoundation.org
About this study
Official title: Comparison of Two Group Wellness Interventions for Individuals With Neurologic Conditions and Their Support Persons: A Randomized Clinical Trial
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.
Read the detailed description
The study will involve three sites, with a different clinical population targeted at each site. Kessler Foundation will serve as the Coordinating Center and will enroll individuals with moderate/severe TBI. Indiana University and University of Michigan will serve as partnering sites and will enroll individuals with chronic mild TBI and ADRD respectively. The research protocols at each site will be unique to the patient population, but harmonized through unified project goals: 1) to evaluate the efficacy of two different online group wellness treatments designed to improve self-efficacy and quality of life, and 2) to determine whether patient neurobehavioral functioning moderates the relationship between treatment outcomes and burden in caregivers, and 3) to determine the neural, behavioral, and blood biomarkers that best predict treatment efficacy. It is expected that findings generated from this study will lead to improved holistic approaches for brain injury and dementia systems of care.
- Conditions
- Traumatic Brain Injury, Mild Traumatic Brain Injury, Alzheimer's Disease, Brain Injury Traumatic Moderate, Brain Injury Traumatic Severe, Dementia
- Being tested
- Group Wellness Class 1, Group Wellness Class 2
- Keywords
- Traumatic Brain Injury, Mild Traumatic Brain Injury, Alzheimer's Disease, Caregivers, Moderate Traumatic Brain Injury, Severe Traumatic Brain Injury, Alzheimer's disease related dementia, Support Persons
- Medical subject headings
- Brain Injuries, Traumatic, Brain Concussion, Alzheimer Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group Wellness Class 1Behavioural
Twelve weekly online group wellness sessions for individuals with the disability and their support person. Each class will last for approximately 2 hours.
Group Wellness Class 2Behavioural
Twelve weekly online group wellness sessions for individuals with the disability and their support person. Each class will last for approximately 2 hours.
| Study group | Role | What they receive |
|---|---|---|
| Group Wellness Class 1 | Experimental | Not described Receives: Behavioral: Group Wellness Class 1 |
| Group Wellness Class 2 | Active comparator | Not described Receives: Behavioral: Group Wellness Class 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change on Self-Efficacy Questionnaire (SEQ)
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
Measured: 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)
self-report measure that examines life satisfaction component of subjective well-being and quality of life
Measured: 12 weeks (between pre- and post-testing) and 6 months (between post-testing and 6 month follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2021
- Study start8 Dec 2022
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Kessler FoundationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- University of Michigan, Rehabilitation Hospital of Indiana, University of California, San Diego, Indiana University
- Responsible party
- Principal investigator, Denise Krch, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05048966
- Sponsor's protocol ID
- R-1157-21
- Status last verified
- Aug 2026
- First submitted
- 26 Aug 2021
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Group Wellness Interventions for Individuals With Neurologic Conditions and Their Support Persons: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05048966
- Acronym / sponsor ID
- R-1157-21
- Conditions
- Traumatic Brain Injury, Mild Traumatic Brain Injury, Alzheimer's Disease, Brain Injury Traumatic Moderate, Brain Injury Traumatic Severe, Dementia
- Keywords
- Traumatic Brain Injury, Mild Traumatic Brain Injury, Alzheimer's Disease, Caregivers, Moderate Traumatic Brain Injury, Severe Traumatic Brain Injury, Alzheimer's disease related dementia, Support Persons
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Collaborators
- University of Michigan, Rehabilitation Hospital of Indiana, University of California, San Diego, Indiana University
- Study start
- 8 Dec 2022 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 17 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study will involve three sites, with a different clinical population targeted at each site. Kessler Foundation will serve as the Coordinating Center and will enroll individuals with moderate/severe TBI. Indiana University and University of Michigan will serve as partnering sites and will enroll individuals with chronic mild TBI and ADRD respectively. The research protocols at each site will be unique to the patient population, but harmonized through unified project goals: 1) to evaluate the efficacy of two different online group wellness treatments designed to improve self-efficacy and quality of life, and 2) to determine whether patient neurobehavioral functioning moderates the relationship between treatment outcomes and burden in caregivers, and 3) to determine the neural, behavioral, and blood biomarkers that best predict treatment efficacy. It is expected that findings generated from this study will lead to improved holistic approaches for brain injury and dementia systems of care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Wellness Class 1 | Experimental | Behavioral: Group Wellness Class 1 |
| Group Wellness Class 2 | Active comparator | Behavioral: Group Wellness Class 2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
- age 18-70
Key exclusion criteria (19 listed)
- 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
- has had a prior stroke or neurological disease other than mild TBI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group Wellness Class 1Twelve weekly online group wellness sessions for individuals with the disability and their support person. Each class will last for approximately 2 hours. | Behavioural | Group Wellness Class 1 |
| Group Wellness Class 2Twelve weekly online group wellness sessions for individuals with the disability and their support person. Each class will last for approximately 2 hours. | Behavioural | Group Wellness Class 2 |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group Wellness Class 1 and Group Wellness Class 2 in people with Traumatic Brain Injury and Mild Traumatic Brain Injury, run by Kessler Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Diana Maloku, B.S. (973-324-8393, dmaloku@kesslerfoundation.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.