Comparing two group wellness programs for people with brain injuries and their caregivers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This research evaluates the effectiveness of two different online group wellness interventions aimed at improving self-efficacy and quality of life for individuals with chronic mild to severe traumatic brain injuries and Alzheimer's disease, along with their support persons. The study will take place across three sites, with each site focusing on a specific patient population. The Kessler Foundation will coordinate the study, while the University of Michigan and Franciscan Health will enroll participants with chronic mild TBI and Alzheimer's disease, respectively. The study aims to assess treatment outcomes and the impact of neurobehavioral functioning on caregiver burden, as well as identify biomarkers that predict treatment efficacy.

Why it matters

Who can join: the full rules

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

Where it's running

• Kessler Foundation
  East Hanover, New Jersey, United States Recruiting

Study contacts

• Study coordinator: Diana Maloku, B.S.
• Email: dmaloku@kesslerfoundation.org
• Phone: 973-324-8393

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.