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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
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.
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
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
1,130 Previous Clinical Trials
1,552,496 Total Patients Enrolled
Kessler FoundationLead Sponsor
174 Previous Clinical Trials
10,378 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.
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
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