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RecruitingNCT05048966Updated Sep 21, 2026

Comparison of Two Group Wellness Interventions for Individuals With Neurologic Conditions and Their Support Persons

An interventional study of Group Wellness Class 1 and Group Wellness Class 2 in Traumatic Brain Injury, Mild Traumatic Brain Injury and Alzheimer's Disease, sponsored by Kessler Foundation. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-21.

Primary conditionBrain ConcussionRegistry: Brain Injuries, TraumaticReclassifiedWhy we changed it
Registry
Brain Injuries, Traumatic — the first condition term the registry derived for this study.
ClinicalTrials.gg
Brain Concussion
Why
  1. The study's listed conditions name Brain Concussion, a narrower term within Brain Injuries, Traumatic.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Kessler Foundation · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Dec 2022; still recruiting 3 years 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
360
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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). 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.

02

Conditions studied

  • Traumatic Brain Injury
  • Mild Traumatic Brain Injury
  • Alzheimer's Disease
  • Brain Injury Traumatic Moderate
  • Brain Injury Traumatic Severe
  • Dementia

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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
03

In context

Brain Concussion Reclassified

637 studies on the registry are indexed under Brain Concussion; 163 are open to participants now.

This study's planned enrollment of 360 is above the median of 63 across 446 interventional studies indexed under Brain Concussion.

Browse Brain Concussion studies →

Lead sponsor

Kessler Foundation is the lead sponsor of 175 studies on the registry; 61 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Browse Kessler Foundation studies →

Compared within Brain Concussion, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Brain Injuries, Traumatic. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
360 participants (estimated)

Study arms

  • Experimental
    Group Wellness Class 1

    Behavioral: Group Wellness Class 1

  • Active comparator
    Group Wellness Class 2

    Behavioral: Group Wellness Class 2

Interventions

  • BehavioralGroup 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.

  • BehavioralGroup 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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 12 weeks (between pre- and post-testing) and 6 months (between post-testing and 6 month follow-up)

  2. Change on Satisfaction with Life Scale (SWLS)

    self-report measure that examines life satisfaction component of subjective well-being and quality of life

    Time frame: 12 weeks (between pre- and post-testing) and 6 months (between post-testing and 6 month follow-up)

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2022 (actual). Primary completion is estimated for Sep 2027, 57 months after the start.

Of 248 non-industry interventional studies with no phase under Brain Concussion, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 47. This study's planned 57 months is above that.

Counting every sponsor, half of 264 studies reached it within 28 months; a quarter within 19 and three quarters within 47.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 26, 2021
First posted
Sep 17, 2021
StartActual
Dec 8, 2022
Primary completionEst.
Sep 2027
CompletionEst.
Sep 2027
Last update
Sep 21, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05048966
Lead sponsor
Kessler Foundation
Collaborators
University of Michigan, Rehabilitation Hospital of Indiana, University of California, San Diego, Indiana University
Responsible party
Denise Krch (Senior Research Scientist, Kessler Foundation) — Principal investigator
First posted
Sep 17, 2021
Start date
Dec 8, 2022
Primary completion
Sep 2027 (estimated)
Completion
Sep 2027 (estimated)
Last update
Sep 21, 2026

Study contacts

Diana Maloku, B.S.
Contact
dmaloku@kesslerfoundation.org
973-324-8393

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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