Home-Based, Online, Mindfulness and Cognitive Training for Soldiers and Veterans With TBI

Study Overview
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Brief Summary
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This study is a parallel arm, double-blind, randomized, controlled clinical trial to assess the safety and efficacy of an experimental software program designed to improve cognitive functions versus a computer-based software control. Both the study and the software being investigated meet the criteria of Non-Significant Risk.

Detailed Description
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The primary objective of this study is to evaluate the effects of combination of mindfulness training (MT) and adaptive cognitive training (CT) on the cognitive abilities, functional status and quality of life of soldiers and veterans diagnosed with traumatic brain injury (TBI, also referred to as a concussion, or blast exposure), as compared to a computer-based control.

Official Title
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Home-Based, Online, Mindfulness and Cognitive Training for Soldiers and Veterans With TBI

Conditions
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Mild Traumatic Brain Injury

Intervention / Treatment
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* Other: Computerized Plasticity-Based Adaptive Cognitive Training
* Other: Commercially available computerized training
* Other: Mindfulness Training
* Other: Traumatic Brain Injury Information Session


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants must be 18 years of age or older Participants must have diagnosis of mild traumatic brain injury (mTBI) confirmed by Ohio State University TBI Identification Method-Short Form (OSU TBI-ID-SF) Participants must have persistent cognitive dysfunction confirmed by an objective measure (Automated Neuropsychological Assessment Metrics (ANAM) TBI Battery with a score at least one standard deviation below the age-adjusted norm for a military sample) or a subjective measure (Ruff Neurobehavioral Inventory (RNBI) with a score of greater than 70 on any of the four cognitive scales (Attention, Memory, Language, Executive) Participants must be at least six months out from their most recent traumatic brain injury (TBI), concussion, and/or blast exposure Participant must be a fluent English speaker Participants must score ≥ 70 on the Wechsler Test of Adult Reading (WTAR) Participants must have adequate sensorimotor capacity to perform the program, including visual capacity adequate to read from a computer screen at a normal viewing distance, auditory capacity adequate to understand normal speech, and motor capacity adequate to control a computer mouse Exclusion Criteria: Participants with history of TBI with loss of consciousness for more than 24 hours or post-traumatic amnesia for more than 7 days Participants with a history of penetrating head wounds Participants who are in-patients Participants with a diagnosis of an illness or condition with known cognitive consequences (e.g., schizophrenia, bipolar disorder, cancer, multiple sclerosis) Participants with active suicidal ideation with specific plan and intent or suicide-related behaviors within 2 months of consent as measured by the Columbia-Suicide Severity Rating Scale (C-SSRS) Participants showing signs of intoxication due to current substance abuse (including alcohol and/or illegal drugs) during any in person visit Participants with clinically significant visual field deficits Participants judged to be lacking effort Participants with problems performing assessments or comprehending or following spoken instructions Participants enrolled in a concurrent clinical trial involving an investigational pharmaceutical, nutraceutical, medical device, or behavioral treatment for TBI that could affect the outcome of this study Participant with self-reported claustrophobia or physician-reported implanted devices (e.g. pacemakers, cochlear implants, aneurysm clips, etc.) and pregnant women will not be able to participate in MRI portion of study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Treatment<br>Computerized plasticity-based adaptive cognitive training and mindfulness training requiring a total maximum of 60 treatment sessions, up to 5 sessions per week, 40 minutes per session. | Other: Computerized Plasticity-Based Adaptive Cognitive Training<br>* Thirty minutes of training on computerized exercises that targets processing speed, memory and attention.<br>Other: Mindfulness Training<br>* Ten minutes of using an online training course that teaches skills to help overcome ongoing life stressors.<br>|
| Active Comparator: Active Comparator<br>Commercially available computerized training and traumatic brain injury information session requiring a total maximum of 60 treatment sessions, up to 5 sessions per week, 40 minutes per session. | Other: Commercially available computerized training<br>* Thirty minutes of training on computerized, casual video games.<br>Other: Traumatic Brain Injury Information Session<br>* Ten minutes of viewing traumatic brain injury related news, information, and programs.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in performance on global cognitive composite score | Change in performance on global cognitive composite score based on the average of all normalized assessment measures. | At 3 months and at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in performance on processing speed composite score | Change in performance on processing speed will be measured using the composite score created by averaging the z-scores of Pattern Comparison, Letter Comparison, and Digit Symbol Coding tasks. | At 3 months and at 6 months | 
| Changes in performance on memory composite score | Change in performance on memory will be measured using the composite score created by averaging the z-scores of N-Back task, Spatial Working Memory task, WAIS-IV Digit Span and Rey Auditory Verbal Learning Test (RAVLT). | At 3 months and at 6 months | 
| Changes in performance on executive function composite score | Change in performance on executive function will be measured using the composite score created by averaging the z-scores for the Trail Making, Flanker, and Stroop tasks. | At 3 months and at 6 months | 
| Change in functional performance | Between-group magnitude of change in sum time of all tasks in the Timed Instrumental Activities of Daily Living (TIADL). Higher scores indicate greater impairment in functional performance. | At 3 months and at 6 months | 
| Change in TBI functional status | Between-group magnitude of change in overall T-score using the self-report measure, Mayo-Portland Adaptability Inventory (MPAI-4). The overall T-score range is -38 to 106. Higher scores indicate more severe TBI functional status. | At 3 months and at 6 months | 
| Changes in brain function | Change in resting state functional connectivity will be measured by 12-minutes of resting state functional MRI. Participants will be instructed to keep their eyes open and maintain attention on a white fixation cross on a black screen. | At 3 months | 
| Changes in brain structure | Structural brain integrity will be measured with a high resolution 3D T1-weighted scan with good gray/white matter contrast and a complementary high-resolution T2-weighted anatomical scan. | At 3 months | 
| Changes in task-related brain activation | Change in functional connectivity and brain activation will be measured while performing N-Back Task. | At 3 months |