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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
23
Thirty minutes of training on computerized exercises that targets processing speed, memory and attention.
Thirty minutes of training on computerized, casual video games.
Ten minutes of using an online training course that teaches skills to help overcome ongoing life stressors.
Veterans Affairs Connecticut Health Care System
West Haven, Connecticut, United States
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.
Time frame: At 3 months and at 6 months
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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Ten minutes of viewing traumatic brain injury related news, information, and programs.
Time frame: 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.
Time frame: 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.
Time frame: At 3 months
Changes in task-related brain activation
Change in functional connectivity and brain activation will be measured while performing N-Back Task.
Time frame: At 3 months