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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
Be older than 18 years old
Must not have
For Individuals with Alzheimer's Disease Related Dementias (ADRD): 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 (e.g. 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
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
No Placebo-Only Group

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.
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.
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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have Alzheimer's or related dementia without recent severe psychiatric issues, uncontrolled seizures, or substance misuse.

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

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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
5,204 Total Patients Enrolled
University of California, San DiegoOTHER
1,180 Previous Clinical Trials
1,574,687 Total Patients Enrolled
Kessler FoundationLead Sponsor
182 Previous Clinical Trials
10,733 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
~101 spots leftby Sep 2025