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Online Interventions for Traumatic Brain Injury
Study Summary
This trial is looking at whether or not a mindfulness-based intervention can help people with TBI improve their emotional and behavioral regulation as well as their everyday function.
- Traumatic Brain Injury
- Attention Deficit Disorder
- Emotional Regulation
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- 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.
- Group 1: Online group intervention 2
- Group 2: Online group intervention 1
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Does this clinical trial have any age restrictions?
"This research is looking for participants that are within the age bracket of 18 to 70 years."
Is this research undertaking currently open to new participants?
"Affirmative. Data accessible on clinicaltrials.gov verifies that this medical investigation, which was first announced on June 1st 2021, is actively searching for participants. Approximately 60 patients are meant to be summoned from a single location."
Am I eligible to enroll in this research trial?
"This clinical trial requires 60 participants, aged 18 to 70 years old and currently suffering from a brain injury. Those interested must meet the following criteria: GCS lower than 13 (not caused by intubation, sedation or intoxication); ARCES score higher than 3.5 or SART response time variability scores one standard deviation above the mean; sufficient memory capacity as measured by total learning trials on California Verbal Learning Test-II within two standard deviations of the mean; post traumatic amnesia over 24 hours; 12 months since trauma occurred; willingness and ability to participate in 10-week long interventions with daily exercises at home; loss consciousness exceeding"
How many participants are partaking in this experimental research?
"Affirmative. Clinicaltrials.gov provides evidence that this clinical test, which was initially launched on June 1st 2021, is actively seeking participants. Approximately 60 people need to be enlisted from a single site."
What is the intended outcome of this research endeavor?
"The primary focus of this trial, measured over the pre-intervention and post-intervention period (10 weeks), is to monitor changes in depression. Secondary outcomes such as satisfaction with life (measured using SWLS; 5-35 scale, higher score indicating greater contentment) behavioural functioning (FBP; 0-108 range, higher scores representing better performance), and intelligence (WASI manual) will also be evaluated for change."
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