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

December 14, 2022 updated by: Denise Krch, Kessler Foundation

Comparison of Two Group Wellness Interventions for Individuals With Neurologic Conditions and Their Support Persons: A Randomized Clinical Trial

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

360

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New Jersey
      • East Hanover, New Jersey, United States, 07936
        • Recruiting
        • Kessler Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Group Wellness Class 1
Behavioral: Group Wellness Class 1
Twelve weekly online group wellness sessions for individuals with the disability and their support person. Each class will last for approximately 2 hours.
ACTIVE_COMPARATOR: Group Wellness Class 2
Behavioral: Group Wellness Class 2
Twelve weekly online group wellness sessions for individuals with the disability and their support person. Each class will last for approximately 2 hours.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change on Self-Efficacy Questionnaire (SEQ)
Time Frame: 12 weeks (between pre- and post-testing) and 6 months (between post-testing and 6 month follow-up)
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)
Time Frame: 12 weeks (between pre- and post-testing) and 6 months (between post-testing and 6 month follow-up)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kessler Foundation

Collaborators

University of California, San Diego
University of Michigan
Rehabilitation Hospital of Indiana
Franciscan Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 8, 2022

Primary Completion (ANTICIPATED)

September 1, 2025

Study Completion (ANTICIPATED)

September 1, 2025

Study Registration Dates

First Submitted

August 26, 2021

First Submitted That Met QC Criteria

September 16, 2021

First Posted (ACTUAL)

September 17, 2021

Study Record Updates

Last Update Posted (ACTUAL)

December 16, 2022

Last Update Submitted That Met QC Criteria

December 14, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R-1157-21

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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