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Group Wellness Interventions for Neurologic Conditions

N/A
Recruiting
Research Sponsored by Kessler Foundation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
For Support Persons: 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
For Individuals with Alzheimer's Disease Related Dementias (ADRD): 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks (between pre- and post-testing) and 6 months (between post-testing and 6 month follow-up)
Awards & highlights

Study Summary

This trialwill look at how two types of group wellness treatments can help those with TBI or dementia and their loved ones.

Who is the study for?
This trial is for adults aged 18-64 with mild or severe TBI at least a few months post-injury, and those 65+ with ADRD at least one year post-diagnosis. Participants must speak English fluently and have a support person willing to join the study. Excluded are individuals with significant neurological history other than their condition, uncontrolled seizures, recent psychiatric hospitalization, or substance abuse affecting daily functions.Check my eligibility
What is being tested?
The study compares two group wellness programs designed for people living with chronic mild to severe traumatic brain injuries (TBI) or Alzheimer's disease-related dementias (ADRD), along with their support persons. The goal is to evaluate which program better promotes long-term wellness in these populations.See study design
What are the potential side effects?
Since this trial involves non-medical interventions like wellness classes rather than drugs or medical procedures, traditional side effects are not expected. However, participants may experience emotional discomfort or fatigue related to discussing personal experiences during sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a support person for someone with TBI or ADRD and can participate in English.
Select...
I am 65 or older with Alzheimer's, diagnosed over a year ago, speak English, and have a supportive participant.
Select...
I am 18-64 with a mild TBI over 3 months ago, speak English, and have a supportive person.
Select...
I am 18-64 with a TBI over a year ago, speak English, and have a supportive person.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks (between pre- and post-testing) and 6 months (between post-testing and 6 month follow-up)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks (between pre- and post-testing) and 6 months (between post-testing and 6 month follow-up) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change on Satisfaction with Life Scale (SWLS)
Change on Self-Efficacy Questionnaire (SEQ)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Group Wellness Class 1Experimental Treatment1 Intervention
Group II: Group Wellness Class 2Active Control1 Intervention

Find a Location

Who is running the clinical trial?

Rehabilitation Hospital of IndianaOTHER
12 Previous Clinical Trials
5,189 Total Patients Enrolled
University of California, San DiegoOTHER
1,117 Previous Clinical Trials
1,519,928 Total Patients Enrolled
Kessler FoundationLead Sponsor
172 Previous Clinical Trials
10,303 Total Patients Enrolled

Media Library

Group Wellness Class 1 Clinical Trial Eligibility Overview. Trial Name: NCT05048966 — N/A
Traumatic Brain Injury Research Study Groups: Group Wellness Class 1, Group Wellness Class 2
Traumatic Brain Injury Clinical Trial 2023: Group Wellness Class 1 Highlights & Side Effects. Trial Name: NCT05048966 — N/A
Group Wellness Class 1 2023 Treatment Timeline for Medical Study. Trial Name: NCT05048966 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are potential participants currently welcomed for this experiment?

"According to clinicaltrials.gov, this active study is recruiting participants as of December 14th 2022. Initially posted on the 8th of December, potential volunteers are encouraged to apply soon."

Answered by AI

What is the capacity of participants for this scientific investigation?

"Affirmative. According to the data on clinicaltrials.gov, this trial which was inaugurated on December 8th 2022 is currently recruiting patients - 360 in total from one site. Furthermore, it has been recently updated as of December 14th 2022."

Answered by AI
~191 spots leftby Sep 2025