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

NCT ID: NCT05048966
Registry status: Recruiting
Study type: Interventional
Phase: Not applicable
Sponsor: Kessler Foundation
Conditions: Alzheimer's Disease, Brain Injury Traumatic Moderate, Brain Injury Traumatic Severe, Dementia, Mild Traumatic Brain Injury, Traumatic Brain Injury

Overview

ClinicalTrials.gov lists this study as Recruiting.

Official title: Comparison of Two Group Wellness Interventions for Individuals With Neurologic Conditions and Their Support Persons: A Randomized Clinical Trial

Enrollment: 360 participants (Estimated).

What is being studied

Behavioral: Group Wellness Class 1
Behavioral: Group Wellness Class 2

Who may be eligible

Ages: 18 Years to no maximum
Sex: All
Healthy volunteers accepted: No

ClinicalTrials.gov lists the following 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

Study locations

1 study location is listed.

Recruiting site status is explicitly provided for 1 location; 1 is listed as Recruiting.

Countries: United States

New Jersey, United States: 1

Sample of listed locations

Kessler Foundation — East Hanover, New Jersey, 07936, United States — Recruiting

Study details

Start date: December 8, 2022
Primary completion date: September 1, 2027
Completion date: September 1, 2027
First posted: September 17, 2021
Collaborators: Indiana University, Rehabilitation Hospital of Indiana, University of California, San Diego, University of Michigan

Source and update information

Source: ClinicalTrials.gov
NCT ID: NCT05048966
Registry last updated: September 21, 2026
QualifiedStudies registry data refreshed: September 28, 2026
QualifiedStudies record fetched: September 28, 2026

View NCT05048966 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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