NCT05048966 Comparison of Two Group Wellness Interventions for Individuals With Neurologic Conditions and Their Support Persons
| NCT ID | NCT05048966 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Kessler Foundation |
| Condition | Traumatic Brain Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 360 participants |
| Start Date | 2022-12-08 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 360 participants in total. It began in 2022-12-08 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05048966 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Traumatic Brain Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05048966 currently recruiting?
Yes, NCT05048966 is actively recruiting participants. Contact the research team at dmaloku@kesslerfoundation.org for enrollment information.
Where is the NCT05048966 trial being conducted?
This trial is being conducted at East Hanover, United States.
Who is sponsoring the NCT05048966 clinical trial?
NCT05048966 is sponsored by Kessler Foundation. The trial plans to enroll 360 participants.