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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKessler Foundation

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

360 Participants
are divided into 2 treatment groups
Group A: Group Wellness Class 1Experimental treatment 1 intervention
Group B: Group Wellness Class 2Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
12 weeks (between pre- and post-testing) and 6 months (between post-testing and 6 month follow-up)
2

Change on Satisfaction with Life Scale (SWLS)

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

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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Kessler Foundation

Lead sponsor

University of Michigan

Collaborator

Rehabilitation Hospital of Indiana

Collaborator

University of California, San Diego

Collaborator

Indiana University

Collaborator