Comparing two group wellness programs for people with brain injuries and their caregivers
Comparison of Two Group Wellness Interventions for Individuals With Neurologic Conditions and Their Support Persons: A Randomized Clinical Trial
This study is testing two different online wellness programs to see if they can help people with brain injuries and Alzheimer's disease, along with their caregivers, feel better and improve their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 360 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Kessler Foundation Academic / other |
| Locations | 1 site (East Hanover, New Jersey) |
| Trial ID | NCT05048966 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-64 with chronic mild to severe TBI or Alzheimer's disease, who have a support person willing to participate.
Not a fit: Patients with prior strokes, other neurological diseases, or significant psychiatric illnesses may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the long-term wellness and quality of life for individuals with brain injuries and their caregivers.
How similar studies have performed: While similar wellness interventions have been explored, this specific comparison of group treatments for brain injury and dementia is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
For individuals with moderate/severe TBI: Inclusion Criteria: * age 18-64 * at least one year 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 18-64 * 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 this trial is running
East Hanover, New Jersey
- Kessler Foundation — East Hanover, New Jersey, United States (Recruiting)
Study contacts
- Study coordinator: Brionna Robinson, B.S.
- Email: brobinson@kesslerfoundation.org
- Phone: 9733248420
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.