NCT05048966Recruiting
Comparison of Two Group Wellness Interventions for Individuals With Neurologic Conditions and Their Support Persons
Comparison of Two Group Wellness Interventions for Individuals With Neurologic Conditions and Their Support Persons: A Randomized Clinical Trial
Source: ClinicalTrials.gov · Last updated 21 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 360 (estimated)
- First submitted
- 26 Aug 2021
- Start date
- 8 Dec 2022
- Primary completion date
- 30 Sept 2027
- Lead sponsor
- Kessler Foundation
- Diseases
- Alzheimer disease
- NCT number
- NCT05048966
What you commit to
- Study type: Interventional
- Planned participants: 360
- From 8 Dec 2022 to the primary completion date, 30 Sept 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- has had a prior stroke or neurological disease other than TBI
- 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
- has had a prior stroke or neurological disease other than ADRD
- current alcohol and/or drug use that interferes with ability to carry out common everyday functions
- For Support Persons:
- current alcohol and/or drug use that interferes with ability to carry out common everyday functions
Other illness
- 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
- 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 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
- 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
Who the study is looking for
- 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
- 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
Criteria the registry did not label
- For individuals with moderate/severe TBI:
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Kessler Foundation Coordinator of this site? Confirm its status | East Hanover | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.