Clinical trial NCT05048966: Comparison of Two Group Wellness Interventions for Individuals With Neurologic Conditions and Their Support Persons
Official title: Comparison of Two Group Wellness Interventions for Individuals With Neurologic Conditions and Their Support Persons: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Traumatic Brain Injury
Mild Traumatic Brain Injury
Alzheimer's Disease
Brain Injury Traumatic Moderate
Brain Injury Traumatic Severe
Dementia
Keywords: Traumatic Brain Injury
Mild Traumatic Brain Injury
Alzheimer's Disease
Caregivers
Moderate Traumatic Brain Injury
Severe Traumatic Brain Injury
Alzheimer's disease related dementia
Support Persons
Lead sponsor: Kessler Foundation
Sponsor class: OTHER
Collaborators: name: University of Michigan
name: Franciscan Health
name: Rehabilitation Hospital of Indiana
name: University of California, San Diego
First posted: 2021-09-17
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: The study will involve three sites, with a different clinical population targeted at each site. Kessler Foundation will serve as the Coordinating Center and will enroll individuals with moderate/severe TBI. Franciscan Health in Indiana and University of Michigan will serve as partnering sites and will enroll individuals with chronic mild TBI and ADRD respectively. The research protocols at each site will be unique to the patient population, but harmonized through unified project goals: 1) to evaluate the efficacy of two different online group wellness treatments designed to improve self-efficacy and quality of life, and 2) to determine whether patient neurobehavioral functioning moderates the relationship between treatment outcomes and burden in caregivers, and 3) to determine the neural, behavioral, and blood biomarkers that best predict treatment efficacy. It is expected that findings generated from this study will lead to improved holistic approaches for brain injury and dementia systems of care.

Eligibility 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

Primary outcomes:
measure: Change on Self-Efficacy Questionnaire (SEQ)
timeFrame: 12 weeks (between pre- and post-testing) and 6 months (between post-testing and 6 month follow-up)
measure: Change on Satisfaction with Life Scale (SWLS)
timeFrame: 12 weeks (between pre- and post-testing) and 6 months (between post-testing and 6 month follow-up)
Secondary outcomes:
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Kessler Foundation
state: New Jersey
Study officials:
References: