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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks (between pre- and post-testing) and 6 months (between post-testing and 6 month follow-up)
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)
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
1,574,696 Total Patients Enrolled
Kessler FoundationLead Sponsor
181 Previous Clinical Trials
10,719 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a support person for someone with TBI or ADRD and can participate in English.I am 65 or older with Alzheimer's, diagnosed over a year ago, speak English, and have a supportive participant.I have Alzheimer's or related dementia without recent severe psychiatric issues, uncontrolled seizures, or substance misuse.I am 18-64 with a mild TBI over 3 months ago, speak English, and have a supportive person.I have mild TBI without past stroke, uncontrolled seizures, recent severe psychiatric issues, or substance misuse affecting daily life.As a support person, I have no major neurological issues, uncontrolled seizures, recent psychiatric hospitalizations, or substance use that affects daily functions.I am 18-64 with a TBI over a year ago, speak English, and have a supportive person.I have TBI but no recent severe psychiatric issues, uncontrolled seizures, or substance misuse.
Research Study Groups:
This trial has the following groups:- Group 1: Group Wellness Class 1
- Group 2: Group Wellness Class 2
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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