Recruiting

Wellness Interventions

Sponsor:

Kessler Foundation

Code:

NCT05048966

Conditions

Traumatic Brain Injury

Mild Traumatic Brain Injury

Alzheimer's Disease

Brain Injury Traumatic Moderate

Brain Injury Traumatic Severe

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Group Wellness Class 1

Group Wellness Class 2

Study Details

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

Study ID

NCT05048966

Start date

Dec 8, 2022

Status verified date

Dec, 2022

Completion date

Sep, 2025

Anticipated

Primary completion date

Sep, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

360 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Group Wellness Class 1

active comparator: Group Wellness Class 2

Interventions

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.

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.

Primary outcome measure

  • 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) ]
  • 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) ]

Central Contacts and Locations

Central contacts

Brionna Robinson, B.S.

9733248420brobinson@kesslerfoundation.org

Locations

Kessler Foundation

Recruiting

East Hanover, New Jersey, United States, 07936

Contacts

Matthew Weiner

973-324-3515mweiner@kesslerfoundation.org

More Information

Sponsor

Kessler Foundation

Last update posted

Dec 16, 2022

Last verified

Dec, 2022

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kessler Foundation on 2022-12-16.