An interventional study of Online group 1 and Online group 2 in Traumatic Brain Injury, Attention Impaired and Emotional Regulation, sponsored by Kessler Foundation. Recruiting at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-10-06.
Sponsored by Kessler Foundation · Not applicable, Interventional, and Treatment
Traumatic brain injury (TBI) patients face notable impairments which lead to reduced performance and regulation of daily and overall functioning. There are a number of interventions made to combat these qualms; however, such interventions have historically been therapeutically demanding, which limits their practical benefit. An online therapeutic intervention can provide a cost-effective approach that can be particularly well-suited to the needs and limitations of TBI. It focuses both on developing awareness and attention, which are often impaired, and are critical to improving emotional and behavioral regulation and everyday function.
This project is aimed at assessing the effectiveness and underlying mechanism of modified mindfulness based stress reduction (MBSR) using a rigorous randomized controlled trial. Poised to provide a rigorous approach to efficacy development and analysis, Results of the study will provide valuable information that will ultimately support the refinement of an intervention that can have a real impact on patients' ability to resume a fully functional and satisfying life, and the design of an adequate therapeutic intervention for TBI patients.
TBI patients suffer from a host of cognitive and behavioral deficits that requires a comprehensive therapeutic approach to be effective at improving self-regulation and everyday function. These deficits can affect a number of critical aspects of individual performance such as awareness, emotional regulation, and self-efficacy. As an alchemy, these serve to be instrumental to TBI patients' emotional regulation capability, and serve as complements to overall satisfactory executive functioning. Efforts have been made in therapeutics to supersede barriers to improving these factors in the form of interventions. Those observed in history had required considerable resources, evident in the apparent high cognitive load and by limits to their effective implementation, wide dissemination and, ultimately, their potential benefit to TBI patients. At present, it is fundamental to explore the benefits of an intervention promising a favorable effect on both attention and present moment awareness (Aim 1), effectiveness in developing emotional regulation and everyday life function (Aim 2), and structured to permit investigation of the functional and structural neural effects on attention (Aim 3). This hypothesis aims to prove these attributes are central to the development of adaptive self-monitoring and self-regulation skills that can be used in a real life environment. The study results will provide valuable information that will ultimately support the refinement of an effective intervention that can have a real impact on patients' ability to improve quality of life, community integration, and supporting an active lifestyle. In addition, acquired neuroimaging will aid in analyzing the effect of the intervention on brain function which will allow for a more established comprehension of the underlying mechanisms driving the benefits, permitting improved design of an effective therapeutic intervention for TBI patients.
2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.
This study's planned enrollment of 60 is above the median of 48 across 1,331 interventional studies indexed under Brain Injuries.
Browse Brain Injuries studies →Kessler Foundation is the lead sponsor of 170 studies on the registry; 58 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Confirmed diagnosis of moderate to severe TBI through medical records or interview, based on the Glasgow Coma Scale (GCS) and the definition adopted by the TBI Model Systems National Database (TBIMS NDB), where one of the following criteria must be met:
General Exclusion Criteria:
MRI-Specific Exclusion Criteria:
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.
Behavioral: Online group 1
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.
Behavioral: Online group 2
The intervention is specifically tailored to meet particular cognitive standard and satisfy the needs of brain injury patients. For 2-3 hours weekly, participants will be immersed in mental exercises designed to help them overcome various challenges.
The intervention is specifically tailored to meet particular cognitive standard and satisfy the needs of brain injury patients. For 2-3 hours weekly, participants will be immersed in mental exercises designed to help them overcome various challenges.
Pre to Post Change in Sustained attention (Response time variability)
Response time variability of the sustained attention to response task (SART) will provide measure of improvement in sustained attention
Time frame: Change from pre (baseline) to post (10 weeks) intervention
Pre to Post Change in Sustained attention (commission errors)
Commission errors of the sustained attention to response task (SART) will provide measure of improvement in sustained attention
Time frame: Change from pre (baseline) to post (10 weeks) intervention
Pre to Post Change in Present Moment Awareness
Improvement in the ability to attend to the present moment will be measured using the Five Facet Mindfulness Questionnaire (FFMQ). Total score from 1 to 5, higher score representing greater mindfulness
Time frame: Change from pre (baseline) to post (10 weeks) intervention
Pre to Post Change in Mindfulness/Present Moment Awareness
Improvement in mindfulness will be measured using the Freiburg Mindfulness Inventory (FMI) Questionnaire. Score ranges between 14 and 56 with higher scores indicating higher mindfulness
Time frame: Change from pre (baseline) to post (10 weeks) intervention
Pre to Post Change in Behavioral Measures of Attention
Attention \[lapses\] will be assessed using the Attention-Related Cognitive Errors Scale (ARCES), as it will provide a measure for the frequency of cognitive failure experiences (i.e. getting distracted, reading without paying attention to content, losing track of a conversation, etc.). Score ranges from 1 to 5 with higher scores indicating greater attention lapses.
Time frame: Change from pre (baseline) to post (10 weeks) intervention
Pre to Post Change in Self-Efficacy
Self efficacy will be measured using the Self Efficacy Questionnaire for Symptom Management Scale. Score ranges from 13-130 with higher score indicating greater self-efficacy
Time frame: Change from pre (baseline) to post (10 weeks) intervention
Pre to Post Change in Depression
Depression will be measured using the PHQ-8. Score ranges from 0-24 with higher score indicating greater depression.
Time frame: Change from pre (baseline) to post (10 weeks) intervention
Pre to Post Change in anxiety
This will be measured using the Spielberger's State Anxiety Inventory (STAI). Score ranges from 20-80, with higher score indicating greater anxiety
Time frame: Baseline (1st day); at 10 weeks; following 6 months
Pre to Post Change in emotional regulation
This will be measured using the Difficulty in Emotional Regulation Scale (DERS). Total score ranges from 36-180, with higher score indicating greater problems with emotional regulation.
Time frame: Change from pre (baseline) to post (10 weeks) intervention
Pre to Post Change in socio-emotional problem solving
This will be measured using the Social Problem-Solving Inventory - Revised (SPSI-R). Total score ranges from 0-100, with higher score indicating greater social problem-solving ability.
Time frame: Change from pre (baseline) to post (10 weeks) intervention
Pre to Post Change in Quality of Life after brain injury
This will be measured using Quality of Life After Brain Injury (QOLIBRI).Total score ranges from 0-100, with higher score indicating greater health related quality of life after TBI.
Time frame: Change from pre (baseline) to post (10 weeks) intervention
Pre to Post Change in Everyday Function
This will be measured using SF12. Total score ranges from 0-100, with higher score indicating greater physical and mental health functioning.
Time frame: Change from pre (baseline) to post (10 weeks) intervention
Pre to Post Change in Behavioral Function
This will be measured using Functional Behavior Profile. Total score ranges from 0-108, with higher score indicating greater behavioral function.
Time frame: Change from pre (baseline) to post (10 weeks) intervention
Pre to Post Change in Awareness
This will be measured using Awareness Questionnaire (AQ).Total score ranges from 17-85 with higher score indicating greater function after TBI. Difference scores ( family subtracted from patient ratings) range from -68 to 68, with greater/lower score than 0 associated with greater impaired awareness (rating his function greater/lower than family).
Time frame: Change from pre (baseline) to post (10 weeks) intervention
Pre to Post Change in Community Integration
This will be measured using the Community Integration Questionnaire (CIQ). Score ranges from 0 to 29, with higher scores indicating greater independence and community integration.
Time frame: Change from pre (baseline) to post (10 weeks) intervention
Pre to Post Change in Socio-emotional behavior executive functioning skills
This will be measured using the Brock Adaptive Functioning Questionnaire. Score ranges from 20 to 100, with lower scores indicating better functioning.
Time frame: Change from pre (baseline) to post (10 weeks) intervention
Pre to Post Change in Satisfaction With Life
This will be measured using Satisfaction With Life Scale (SWLS). Score ranges from 5-35 with higher score indicating greater life satisfaction.
Time frame: Change from pre (baseline) to post (10 weeks) intervention
Pre to Post Change in Emotional Regulation
This will be measured using the Emotional Regulation Questionnaire (ERQ). Items averaged score ranges from 1-7 with higher score indicating greater emotional regulation.
Time frame: Change from pre (baseline) to post (10 weeks) intervention
Pre to Post Change in Basic Empathy
This will be measured using the Basic Empathy Scale (BES). Items averaged score ranges from 1-5 with higher score indicating greater empathy.
Time frame: Change from pre (baseline) to post (10 weeks) intervention
Pre to Post Change in Empathy Quotient
This will be measured using the Empathy Quotient (EQ). Score ranges from 0-80 with higher score indicating greater empathy.
Time frame: Change from pre (baseline) to post (10 weeks) intervention
Pre to Post Change in Neuropsychological Measures - Intelligence
This will be measured using the Wechsler abbreviated scale of intelligence manual (WASI)
Time frame: Change from pre (baseline) to post (10 weeks) intervention
Pre to Post Change in Neuropsychological Measures - Verbal learning and memory
This will be measured using the California Verbal Learning Test (CVLT-II)
Time frame: Change from pre (baseline) to post (10 weeks) intervention
Pre to Post Change in Neuropsychological Measures - Processing speed
This will be measured using the Oral Symbol Digit Modalities Test (SDMT)
Time frame: Change from pre (baseline) to post (10 weeks) intervention
Pre to Post Change in Neuropsychological Measures - Alertness and Vigilance
This will be measured using the Digit Vigilance Test
Time frame: Change from pre (baseline) to post (10 weeks) intervention
Pre to Post Change in Neuropsychological Measures - Attention/executive function
This will be measured using the Paced Auditory Serial Addition Test
Time frame: Change from pre (baseline) to post (10 weeks) intervention
Pre to Post Change in Neuropsychological Measures - Executive function in cognitive set shifting and inhibition
This will be measured using the Delis-Kaplan Executive Function System (D-KEFS ) Stroop
Time frame: Change from pre (baseline) to post (10 weeks) intervention
Pre to Post Change in Neuropsychological Measures - Executive function in sequential set-shifting
This will be measured using the Oral Trail Making Test
Time frame: Change from pre (baseline) to post (10 weeks) intervention
Pre to Post Change in Neuropsychological Measures in Executive function - Verbal Fluency
This will be measured using the Delis-Kaplan Executive Function System (D-KEFS ) Verbal Fluency
Time frame: Change from pre (baseline) to post (10 weeks) intervention
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