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Online Interventions for Traumatic Brain Injury
N/A
Recruiting
Led By Jean Lengenfelder, Ph.D.
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 baseline (1st day); at 10 weeks; following 6 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing an online mindfulness program for people with traumatic brain injuries. The program aims to help them focus better and manage their emotions, which can improve their daily lives. The study will also look at how the program affects brain function to understand why it works. Mindfulness-based stress reduction (MBSR) has been studied for its potential to improve quality of life and psychological status in individuals with traumatic brain injuries.
Eligible Conditions
- Traumatic Brain Injury
- Attention Deficit Disorder
- Emotional Regulation
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (1st day); at 10 weeks; following 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (1st day); at 10 weeks; following 6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Pre to Post Change in Behavioral Measures of Attention
Pre to Post Change in Depression
Pre to Post Change in Mindfulness/Present Moment Awareness
+7 moreSecondary study objectives
Pre to Post Change in Awareness
Pre to Post Change in Basic Empathy
Pre to Post Change in Behavioral Function
+15 moreAwards & 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: Online group intervention 1Experimental Treatment1 Intervention
Participants in group 1 meet weekly online for a 2-hour group sessions for 10 weeks where the instructor will provide leadership in discussions, which will include practice of basic routines. Participants will also be asked to do 20-30 minutes of daily activities/exercises, where they will be asked to practice mental exercises.
Group II: Online group intervention 2Active Control1 Intervention
Similar to group 1, participants will meet weekly online or in person for 2-hour group sessions for 10 weeks where the instructor will provide leadership in discussions, which will include practice of basic routines. Participants will also be asked to do 20-30 minutes of daily activities/exercises, where they will be asked to practice mental exercises.
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Who is running the clinical trial?
Kessler FoundationLead Sponsor
181 Previous Clinical Trials
11,019 Total Patients Enrolled
National Institute on Disability, Independent Living, and Rehabilitation ResearchFED
79 Previous Clinical Trials
9,787 Total Patients Enrolled
Jean Lengenfelder, Ph.D.Principal InvestigatorKessler Foundation
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are left-handed.You have had a severe head injury with an object piercing the skull.You have a specific type of brain injury that required surgery or caused major changes in your brain's structure.You are currently using drugs or alcohol excessively.You have a brain injury that did not result from a physical injury, like a bump or blow to the head.You have a history of serious mental health conditions like schizophrenia or bipolar disorder that could affect your thinking ability.You have previously taken part in activities like meditation and yoga on a regular basis.Your level of consciousness was low when you arrived at the emergency room, unless it was because you were being sedated, intubated, or intoxicated.You need to have a certain level of memory skills to benefit from the treatment.You have been diagnosed with moderate to severe traumatic brain injury based on specific measures and definitions used by healthcare professionals.You have experienced memory loss for more than 24 hours after a head injury.You have brain abnormalities from a head injury.If you have been unconscious for more than 30 minutes (unless it was caused by medicine or being drunk).Your injury occurred at least 12 months ago.You have significant problems with memory and thinking, as measured by a test score below 18.If you have trouble paying attention, as shown by specific test scores, you may not be able to participate.You have had any other neurological problems besides the documented TBI, such as epilepsy or multiple sclerosis.
Research Study Groups:
This trial has the following groups:- Group 1: Online group intervention 2
- Group 2: Online group intervention 1
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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