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NCT Number: NCT05048966

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

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.

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Key information

About this study

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. Indiana University 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 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.

Primary outcomes

  1. 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

  2. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Diana Maloku, B.S.

CONTACT

[email protected]

973-324-8393

Sponsors and collaborators

Lead sponsor

Kessler Foundation

Other

Collaborators

  • Indiana University
  • Rehabilitation Hospital of Indiana
  • University of California, San Diego
  • University of Michigan

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Sep 17, 2021
Registry last updated
Sep 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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