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| ID | Type | Description | Link |
|---|---|---|---|
| AZ150059 | Other Identifier | eBRAP Log Number |
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| Name | Class |
|---|---|
| VA Connecticut Healthcare System | FED |
| Congressionally Directed Medical Research Programs | FED |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Treatment | Experimental | 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. |
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| Active Comparator | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computerized Plasticity-Based Adaptive Cognitive Training | Other | Thirty minutes of training on computerized exercises that targets processing speed, memory and attention. |
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| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Neurobehavioral Symptoms | Between-group magnitude of change in sum score using the self-report measure, Neurobehavioral Symptoms Index (NSI). The scoring range is 0-88. Higher scores indicate more severe neurobehavioral symptoms. | At 3 months and at 6 months |
| Change in PTSD Symptoms |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kyu Lee, PhD | Posit Science Corporation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Veterans Affairs Connecticut Health Care System | West Haven | Connecticut | 06516 | United States |
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| Commercially available computerized training | Other | Thirty minutes of training on computerized, casual video games. |
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| Mindfulness Training | Other | Ten minutes of using an online training course that teaches skills to help overcome ongoing life stressors. |
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| Traumatic Brain Injury Information Session | Other | Ten minutes of viewing traumatic brain injury related news, information, and programs. |
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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 |
Between-group magnitude of change in sum score using the self-report measure, PTSD Checklist (PCL-5). The scoring range is 0-80. Higher scores indicate more severe PTSD symptoms |
| At 3 months and at 6 months |
| Change in Depressive Symptoms | Between-group magnitude of change in sum score using the self-report measure, Beck Depression Inventory (BDI-II). The scoring range is 0-63. Higher scores indicate more severe depressive symptoms. | At 3 months and at 6 months |
| Change in Health-Related Quality of Life | Between-group magnitude of change in sum score using the self-report measure, Quality of Life after Brain Injury (QOLIBRI). The scoring range is 0-100. Lower scores indicate lower quality of life. | At 3 months and at 6 months |
| Change in Executive Function Symptoms | Between-group magnitude of change in After total T-score using the self-report measure, Frontal Systems Behavior Scale (FrSBe). Raw scores are converted to age- and education-corrected T-scores. The mean T-score is 50, scores greater than 65 are considered clinically significant. | At 3 months and at 6 months |
| Change in Cognitive Symptoms | Between-group magnitude of change in sum score using the self-report measure, Cognitive Failures Questionnaire (CFQ). The scoring range is 0-100. Higher scores indicate more severe cognitive symptoms. | At 3 months and at 6 months |
| Change in Work/School Status | Change in total score using the self-report questionnaire about their work/school status. | At 3 months and at 6 months |
| Change in Physical Activity | Change in total score based on weekly self-report dairy about physical activity during training period. | At 3 months |
| Change in Diet | Change in total score based on weekly self-report dairy about diet during training period. | At 3 months |
| Change in Social Activity | Change in total score based on weekly self-report dairy about social activity during training period. | At 3 months |
| Change in Sleep | Change in total score based on weekly self-report dairy about sleep during training period. | At 3 months |
| Change in Functional Abilities | Change in total score based on weekly self-report dairy about functional abilities during training period. | At 3 months |
| ID | Term |
|---|---|
| D001924 | Brain Concussion |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D016489 | Head Injuries, Closed |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |
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