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Can group wellness classes improve life after brain injury or dementia?

NCT ID NCT05048966

NEW Symptom relief Sponsor: Kessler Foundation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 21, 2026 · Last updated Sep 21, 2026

Summary

Researchers are comparing two types of online group wellness programs for people with chronic traumatic brain injury or dementia and their support persons. Each program involves twelve weekly two-hour sessions. The study measures changes in participants' confidence to manage daily effects of their condition and their overall life satisfaction.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
online group wellness sessions for people with neurologic conditions and their support persons
What this could lead to
If one approach works better, it could give families a practical, low-cost way to improve daily life and well-being after brain injury or dementia.
What could go wrong
Wellness classes may not change self-efficacy or life satisfaction, and results from this group may not apply to everyone. Online sessions can be hard to attend regularly.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 360 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2022

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Alzheimer disease Brain Concussion Brain Injuries, Traumatic dementia traumatic brain injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Alzheimer's disease Brain injury traumatic moderate Brain injury traumatic severe Dementia Mild traumatic brain injury Traumatic brain injury

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Kessler Foundation

    RECRUITING

    East Hanover, New Jersey, 07936, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.