Mindfulness-Based Intervention for Traumatic Brain Injury

Sponsor

Kessler Foundation (Other)

Overall Status

Recruiting

CT.gov ID

NCT05115656

Collaborator

National Institute on Disability, Independent Living, and Rehabilitation Research (U.S. Fed)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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. A mindfulness-based 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.

Condition or Disease	Intervention/Treatment	Phase
Traumatic Brain Injury Attention Impaired Emotional Regulation	Behavioral: Mindfulness Based Stress Reduction (MBSR) Behavioral: Psychoeducational and Well-being Program (PWP)	N/A

Detailed Description

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 a mindfulness based stress reduction (MBSR), 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Intervention Model Description:

Participants (Moderate to Severe TBI patients) will be randomized into either Mindfulness Based Stress Reduction (MBSR) treatment or a Psycho-Educational and Well-Being Program (PWP) based active control group.Participants (Moderate to Severe TBI patients) will be randomized into either Mindfulness Based Stress Reduction (MBSR) treatment or a Psycho-Educational and Well-Being Program (PWP) based active control group.

Masking:

Double (Participant, Investigator)

Masking Description:

Rigorous, Double-Masked/Double-Blind

Primary Purpose:

Treatment

Official Title:

The Effectiveness and Underlying Mechanism of a Mindfulness Based Stress Reduction Program for Traumatic Brain Injury - A Randomized Clinical Trial

Actual Study Start Date :

Jun 1, 2021

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mindfulness Based Stress Reduction Group (MBSRg) Participants in the MBSRg meet weekly online or in person for a 2-hour group sessions for 10 weeks where they are introduced to concepts and taught meditation exercises on mindfulness. They are also given practical exercises to develop mindfulness in everyday activities as well as home assignments and are instructed to practice mindfulness meditations exercises for 20-30 minutes daily. Mindfulness exercises include body scan meditation, gentle hatha yoga, sitting meditations (mindfulness of breath, body, feelings, thoughts and emotions) and walking meditation. All assignments will be provided in writing to complete.	Behavioral: Mindfulness Based Stress Reduction (MBSR) Modeled after Kabat-Zinn's Mindfulness Based Stress Reduction (MBSR) program, the intervention is specifically tailored to meet particular cognitive standard and satisfy the needs of brain injury patients through rectification of attention and memory dysregulation, disorganization, emotional dysregulation, and other related issues. For 2-3 hours weekly, participants will be immersed in mindfulness exercises designed to help them overcome various challenges in achieving adequate cognitive processing, including body scan meditation, gentle hatha yoga, sitting meditations, and walking meditations. Repetition will be utilized as a strategy to enable the participants to better assimilate, while experience-based teaching, practical exercises and written assignments are provided to teach more abstract concepts. Participants are instructed to engage in mindfulness meditation exercises for 20-30 minutes daily to reinforce their understanding.
Active Comparator: Psychoeducational and Well-being Program Group (PWPg) Similar to the MBSRg, 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 exercise or stretching routines. Participants will also be asked to do 20-30 minutes of daily activities/exercises, where they will be asked to practice simple relaxation exercises (listening to calming music, reading, etc...), light physical exercise (stretching, walking), and read information about Traumatic Brain Injury.	Behavioral: Psychoeducational and Well-being Program (PWP) The theme of the PWPg program will be on educational information and experience sharing around difficulties and challenges living with a traumatic brain injury, with an emphasis on using stress management and healthy habits to cope with symptoms.

Arm

Intervention/Treatment

Experimental: Mindfulness Based Stress Reduction Group (MBSRg)

Participants in the MBSRg meet weekly online or in person for a 2-hour group sessions for 10 weeks where they are introduced to concepts and taught meditation exercises on mindfulness. They are also given practical exercises to develop mindfulness in everyday activities as well as home assignments and are instructed to practice mindfulness meditations exercises for 20-30 minutes daily. Mindfulness exercises include body scan meditation, gentle hatha yoga, sitting meditations (mindfulness of breath, body, feelings, thoughts and emotions) and walking meditation. All assignments will be provided in writing to complete.

Behavioral: Mindfulness Based Stress Reduction (MBSR)

Modeled after Kabat-Zinn's Mindfulness Based Stress Reduction (MBSR) program, the intervention is specifically tailored to meet particular cognitive standard and satisfy the needs of brain injury patients through rectification of attention and memory dysregulation, disorganization, emotional dysregulation, and other related issues. For 2-3 hours weekly, participants will be immersed in mindfulness exercises designed to help them overcome various challenges in achieving adequate cognitive processing, including body scan meditation, gentle hatha yoga, sitting meditations, and walking meditations. Repetition will be utilized as a strategy to enable the participants to better assimilate, while experience-based teaching, practical exercises and written assignments are provided to teach more abstract concepts. Participants are instructed to engage in mindfulness meditation exercises for 20-30 minutes daily to reinforce their understanding.

Active Comparator: Psychoeducational and Well-being Program Group (PWPg)

Similar to the MBSRg, 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 exercise or stretching routines. Participants will also be asked to do 20-30 minutes of daily activities/exercises, where they will be asked to practice simple relaxation exercises (listening to calming music, reading, etc...), light physical exercise (stretching, walking), and read information about Traumatic Brain Injury.

Behavioral: Psychoeducational and Well-being Program (PWP)

The theme of the PWPg program will be on educational information and experience sharing around difficulties and challenges living with a traumatic brain injury, with an emphasis on using stress management and healthy habits to cope with symptoms.

Outcome Measures

Primary Outcome Measures

Pre to Post Change in Sustained attention (Response time variability) [Change from pre (baseline) to post (10 weeks) intervention]
Response time variability of the sustained attention to response task (SART) will provide measure of improvement in sustained attention
Pre to Post Change in Sustained attention (commission errors) [Change from pre (baseline) to post (10 weeks) intervention]
Commission errors of the sustained attention to response task (SART) will provide measure of improvement in sustained attention
Pre to Post Change in Present Moment Awareness [Change from pre (baseline) to post (10 weeks) intervention]
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
Pre to Post Change in Mindfulness/Present Moment Awareness [Change from pre (baseline) to post (10 weeks) intervention]
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
Pre to Post Change in Behavioral Measures of Attention [Change from pre (baseline) to post (10 weeks) intervention]
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.
Pre to Post Change in Self-Efficacy [Change from pre (baseline) to post (10 weeks) intervention]
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
Pre to Post Change in Depression [Change from pre (baseline) to post (10 weeks) intervention]
Depression will be measured using the PHQ-8. Score ranges from 0-24 with higher score indicating greater depression.
Pre to Post Change in anxiety [Baseline (1st day); at 10 weeks; following 6 months]
This will be measured using the Spielberger's State Anxiety Inventory (STAI). Score ranges from 20-80, with higher score indicating greater anxiety
Pre to Post Change in emotional regulation [Change from pre (baseline) to post (10 weeks) intervention]
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.
Pre to Post Change in socio-emotional problem solving [Change from pre (baseline) to post (10 weeks) intervention]
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.

Secondary Outcome Measures

Pre to Post Change in Quality of Life after brain injury [Change from pre (baseline) to post (10 weeks) intervention]
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.
Pre to Post Change in Everyday Function [Change from pre (baseline) to post (10 weeks) intervention]
This will be measured using SF12. Total score ranges from 0-100, with higher score indicating greater physical and mental health functioning.
Pre to Post Change in Behavioral Function [Change from pre (baseline) to post (10 weeks) intervention]
This will be measured using Functional Behavior Profile. Total score ranges from 0-108, with higher score indicating greater behavioral function.
Pre to Post Change in Awareness [Change from pre (baseline) to post (10 weeks) intervention]
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).
Pre to Post Change in Community Integration [Change from pre (baseline) to post (10 weeks) intervention]
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.
Pre to Post Change in Socio-emotional behavior executive functioning skills [Change from pre (baseline) to post (10 weeks) intervention]
This will be measured using the Brock Adaptive Functioning Questionnaire. Score ranges from 20 to 100, with lower scores indicating better functioning.
Pre to Post Change in Satisfaction With Life [Change from pre (baseline) to post (10 weeks) intervention]
This will be measured using Satisfaction With Life Scale (SWLS). Score ranges from 5-35 with higher score indicating greater life satisfaction.
Pre to Post Change in Emotional Regulation [Change from pre (baseline) to post (10 weeks) intervention]
This will be measured using the Emotional Regulation Questionnaire (ERQ). Items averaged score ranges from 1-7 with higher score indicating greater emotional regulation.
Pre to Post Change in Basic Empathy [Change from pre (baseline) to post (10 weeks) intervention]
This will be measured using the Basic Empathy Scale (BES). Items averaged score ranges from 1-5 with higher score indicating greater empathy.
Pre to Post Change in Empathy Quotient [Change from pre (baseline) to post (10 weeks) intervention]
This will be measured using the Empathy Quotient (EQ). Score ranges from 0-80 with higher score indicating greater empathy.
Pre to Post Change in Neuropsychological Measures - Intelligence [Change from pre (baseline) to post (10 weeks) intervention]
This will be measured using the Wechsler abbreviated scale of intelligence manual (WASI)
Pre to Post Change in Neuropsychological Measures - Verbal learning and memory [Change from pre (baseline) to post (10 weeks) intervention]
This will be measured using the California Verbal Learning Test (CVLT-II)
Pre to Post Change in Neuropsychological Measures - Processing speed [Change from pre (baseline) to post (10 weeks) intervention]
This will be measured using the Oral Symbol Digit Modalities Test (SDMT)
Pre to Post Change in Neuropsychological Measures - Alertness and Vigilance [Change from pre (baseline) to post (10 weeks) intervention]
This will be measured using the Digit Vigilance Test
Pre to Post Change in Neuropsychological Measures - Attention/executive function [Change from pre (baseline) to post (10 weeks) intervention]
This will be measured using the Paced Auditory Serial Addition Test
Pre to Post Change in Neuropsychological Measures - Executive function in cognitive set shifting and inhibition [Change from pre (baseline) to post (10 weeks) intervention]
This will be measured using the Delis-Kaplan Executive Function System (D-KEFS ) Stroop
Pre to Post Change in Neuropsychological Measures - Executive function in sequential set-shifting [Change from pre (baseline) to post (10 weeks) intervention]
This will be measured using the Oral Trail Making Test
Pre to Post Change in Neuropsychological Measures in Executive function - Verbal Fluency [Change from pre (baseline) to post (10 weeks) intervention]
This will be measured using the Delis-Kaplan Executive Function System (D-KEFS ) Verbal Fluency

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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:

Post traumatic amnesia > 24 hours
Trauma related intracranial neuroimaging abnormalities
Loss of consciousness exceeding 30 minutes (unless due to sedation or intoxication)
GCS in the emergency department of less than 13 (unless due to intubation, sedation, or intoxication);

At least 12 months post injury
Presence of a deficit in sustained attention as measured by the Attention-Related Cognitive Errors Scale (ARCES) [69] score greater than 3.5 or presence of a deficit in sustained attention as measured by the sustained attention to response task (SART) [64]. Impairment will be defined as having omissions or the reaction time variability scores, two measures of "inattentiveness," one standard deviation above the normative mean.
Willingness and ability to participate in all testing and the 10-week intervention and daily home activities/exercises.
Medically stable and no plan for major change in medications for at least 6 months or for the duration of the study
Have sufficient language functioning to participate in an intervention conducted in English
Average memory functioning to be able to benefit from a progression of treatment (as measured by total learning trials on the California Verbal Learning Test-II within 2 standard deviations of the mean)

General Exclusion Criteria:

Severe cognitive impairment as defined by a Mini-Mental State Examination score < 18.
Any previous neurological injury or illness in addition to the documented TBI (e.g. epilepsy, MS).
Active substance abuse
Acquired brain injury of nontraumatic origin
Be enrolled or currently enrolled in another research study that is likely to affect participation in this research study
Significant psychiatric history (e.g. schizophrenia, bipolar disorder) due to the potential influence of such disorders on cognitive functioning (because of the prevalence of depression/anxiety in the TBI population, subjects will not be excluded based on a history of depression/anxiety; rather, these will be controlled by including measures of depression/anxiety as covariates in group-level analyses)
Had previously participated in regular mindfulness based activities such as meditation and yoga.

MRI-Specific Exclusion Criteria:

Being pregnant or planning to become pregnant
Have had a penetrating TBI
Left handed (to control for hand dominance effect on neuroimaging)
Focal injury if the injury necessitated neurosurgical intervention and/or caused gross derangement of neuroanatomy (Given that TBI is most often represented by mixed pathophysiology and diffuse axonal injury is nearly universal findings, focal injury will not be a systematic exclusionary criteria).
For all study participants, additional exclusionary criteria associated with MRI will be discussed and enforced. This includes, conditions contraindicated for MRI (implanted metallic devices-aneurysm clips, pacemakers, claustrophobia for subject safety), surgical hardware in the head or cervical spine will also be excluded due to potential for severe image artifacts. We will be using the RONIC MRI screening form for this purpose.