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

NCT05048966 | Unknown DMC

• 1 other identifier: R-1157-21
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• Change on Self-Efficacy Questionnaire (SEQ)

  self-report instrument that assesses an individual's and support person's self-efficacy as it relates to their ability to manage the effects of the neurologic conditions on their daily functioning

  12 weeks (between pre- and post-testing) and 6 months (between post-testing and 6 month follow-up)

• Change on Satisfaction with Life Scale (SWLS)

  self-report measure that examines life satisfaction component of subjective well-being and quality of life

  12 weeks (between pre- and post-testing) and 6 months (between post-testing and 6 month follow-up)

Study Arms (2)

Group Wellness Class 1

EXPERIMENTAL

Behavioral: Group Wellness Class 1

Group Wellness Class 2

ACTIVE COMPARATOR

Behavioral: Group Wellness Class 2

Interventions

Group Wellness Class 1 BEHAVIORAL

Twelve weekly online group wellness sessions for individuals with the disability and their support person. Each class will last for approximately 2 hours.

Group Wellness Class 1

Group Wellness Class 2 BEHAVIORAL

Twelve weekly online group wellness sessions for individuals with the disability and their support person. Each class will last for approximately 2 hours.

Group Wellness Class 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:
• 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
• 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)
• age 65 and older

Sponsors & Collaborators

• Kessler Foundation: lead
• University of Michigan: collaborator
• Franciscan Health: collaborator
• Rehabilitation Hospital of Indiana: collaborator
• University of California, San Diego: collaborator

Study Sites (1)

Kessler Foundation

East Hanover, New Jersey, 07936, United States

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic; Brain Concussion; Alzheimer Disease; Dementia

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Head Injuries, Closed; Wounds, Nonpenetrating; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Brionna Robinson, B.S.

CONTACT

9733248420; brobinson@kesslerfoundation.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research Scientist

Study Record Dates

• First Submitted: August 26, 2021
• First Posted: September 17, 2021
• Study Start: December 8, 2022
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: December 16, 2022

Record last verified: 2022-12

Locations

US (1)