An interventional study of Brain Training Program 1 and Brain Training Program 2 in Traumatic Brain Injury, sponsored by The University of Texas at Dallas. Completed at 1 site in United States. Open to participants aged 19 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-03-10.
Sponsored by The University of Texas at Dallas · Not applicable, Interventional, and Treatment
This study is being done to improve the ability to diagnose and to achieve higher-levels of functional recovery in soldiers and civilians who have suffered either mild Traumatic Brain Injury (TBIs) or moderate-to-severe TBIs at chronic stages of brain recovery (greater than 12 months).
In the current randomized control trial, we study the efficacy of a functionally relevant cognitive training program applied to individuals who are experiencing the effects of chronic TBI. The top-down training program labeled SMART (Strategic Memory Advanced Reasoning Training) adopts an integrative approach to train functionally relevant complex reasoning abilities (versus specific skills). This integrative approach focused on frontal lobe functions has shown promising results in a preliminary study. SMART is compared to an equally engaging education-based program labeled BHW (Brain Health Workshop). Both SMART and BHW are short-term, intensive (18 h of training over 8 weeks) group training programs that are comparable with regard to training time, amount of information, group discussions, and homework assignments. The overall goal of this trial is to examine how training integrative frontal lobe-mediated processes might improve functioning in brain injury survivors, including military service and civilian populations. We include a range of individuals with different injury types and functional abilities. We use a broad variety of assessment tools, including cognitive, neuroimaging, and functional measures, to compare the training groups.
Our overall goal is to improve the fidelity of TBI diagnoses and to achieve higher levels of functional recovery in soldiers and civilians who have suffered mild to moderate TBIs and are at the chronic stage of brain recovery. This study is also to determine the efficacy of an empirically and theoretically driven framework to enhance frontal lobe-mediated reasoning ability in individuals with TBI, given a relatively short training duration, on trained and untrained cognitive skills, on brain changes, and on measures of real-life function. Toward these aims, this trial is enrolling both soldiers and civilians with a TBI (approximately 50 mild and 50 moderate chronic TBI patients). We use cognitive tests (assessing memory, reasoning, and comprehension abilities), functional MRI scans (performing tests of cognitive function while the subject is receiving an MRI scan), and white matter maps constructed using diffusion tensor imaging (DTI) scans. The MRI scans will be used to provide biomarkers of the contributions of different brain regions to performing cognitive tasks (e.g., memory, reasoning, etc.), as well as assessments of brain efficiency, functional brain connectivity, and brain morphology. We use these measurements to gain an understanding of each individual's cognitive skills and neural measures prior to cognitive intervention. These measures also serve as indicators of the baseline function of each soldier or civilian, to be compared with after intervention, at which point they undergo post-training cognitive, MRI, and DTI assessments, enabling us to make outcome comparisons between the two different cognitive interventions. Finally, we conduct a follow-up assessment with neuropsychological and cognitive measures and neuroimaging 3 months after the interventions to assess how individuals maintain any functional changes that may occur because of the cognitive interventions.
We are targeting this intervention toward mild and moderate TBI participants, who have relatively high functioning skills. The demands of the training can be too high for some individuals falling into the more severe range, in the frequency, duration, and type of strategies and skills emphasized. We also aim to address the high level of need placed upon studies of milder TBI cases, particularly with military populations. This priority is also emphasized by the sponsoring agency, the US Department of Defense, advocating for more studies of mild TBI under the funding mechanism supporting this work.
2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.
This study's enrollment of 108 is above the median of 48 across 1,331 interventional studies indexed under Brain Injuries.
Browse Brain Injuries studies →The University of Texas at Dallas is the lead sponsor of 59 studies on the registry; 18 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 15 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Training Program focusing on providing educational information of cognitive issues related to TBI
Behavioral: Brain Training Program 1
Program focuses on strategies to address cognitive issues following TBI
Behavioral: Brain Training Program 2
The training program includes 12 sessions conducted over 8 weeks. The goal of these treatment sessions is to provide information on brain injury and its recovery process. Activities involved in the sessions include discussion of study material. Participants will be encouraged to apply the information to their daily lives. The program includes additional outside practice of the activities.
The training program includes 12 sessions conducted over 8 weeks. The goal of these treatment sessions is to provide strategies to improve brain injury and its recovery process. Activities involved in the sessions include strategies and discussion of study material. Participants will be encouraged to apply the strategies and information to their daily lives. The program includes additional outside practice of the activities.
Glasgow Outcome Scale-Extended
Assesses disability after brain injury (1 dead to 8 good recovery). A higher score is a better outcome.
Time frame: Pre-training (Baseline) Neuropsychological Test
Community Integration Questionnaire
To examine short-term effects of treatment on cognition and real-life outcomes relating to how successful someone is able to integrate within their community (0 lowest integration (worst outcome) to 40 maximal integration (best outcome)). A higher score is a better outcome.
Time frame: Neuropsychological changes from baseline to 10 weeks post-training
Functional Status Exam
To examine short-term effects of treatment on outcomes. - (0 highest function (best outcome) to 31 lowest function (worst outcome)). A lower score is a better outcome.
Time frame: Measure at 10 weeks post-training
Daneman-Carpenter Reading Span Test
Scored as 0 words to 7 words comprehended. Higher scores indicate better comprehension and thus a better outcome. Lower scores indicates a lower degree of comprehension. A higher score is a better outcome.
Time frame: Measure at 10 weeks post-training
Hayling Sentence Completion Test
To examine short-term effects of treatment on cognition by working memory. The Hayling Sentence Completion test measures response initiation (range 0 best to 30 worst). A lower score is a better outcome.
Time frame: Measure at 10 weeks post-training
Awareness Questionnaire
To examine short-term effects of treatment on real-life outcomes. This test measures impaired self-awareness after brain injury. The scale ranges from 17 (lowest self-awareness level, worst outcome) to 85 (highest self-awareness level, best outcome). A higher score is a better outcome.
Time frame: Measure at 10 weeks post-training
Network Based Statistics in Brain Connectivity
Brain network connectivity from functional brain imaging was computed using Network-Based Statistics. Data were adjusted to form one number to characterize the significant connection changes associated with the training. This was accomplished by computing a change score. This change score combined the post-training (10 weeks), and 3-months post-training imaging data and compared that to the baseline (pre-training imaging data). This measure allows for an estimation of the number of statistically increased connections observed between different areas of the brain. A higher score indicates more significant connections and is considered to be a better outcome.
Time frame: MRI measures taken at 10 weeks and 3 months post-training are combined and compared to baseline MRI yielding one number
Beck Depression Inventory (BDI)
To examine short-term effects of treatment on measures current depressive symptoms from 0 (no depressive symptoms (best outcome)) to 63 (maximum depressive symptoms (worst outcome)). A lower score is a better outcome.
Time frame: Measure taken at 10 weeks post-training
Post Traumatic Stress Disorder (PTSD) Checklist
To examine short-term effects of treatment on self-reported measure of symptoms of posttraumatic stress disorder. The test ranges from 0 minimal stress symptoms to 80 maximum stress symptoms. A lower score is a better outcome.
Time frame: Measure taken at 10 weeks post-training
Alcohol, Smoking and Substance Involvement Screening Test
To examine short-term effects of treatment on problem substance use. The range is from 0 low levels of problem substance use to 414 (maximum level of problem substance use). A lower score is a better outcome.
Time frame: Measure taken at 10 weeks post-training
Alcohol Use Disorders Identification Test
To examine short-term effects of treatment on real-life outcomes on alcohol use disorder. The test ranges from 0 lowest use (best outcome) to 40 maximal use (worst outcome). A lower score is a better outcome.
Time frame: Measure taken at 10 weeks post-training
Digit Vigilence Test
To examine short-term effects of treatment on attention. The test is scored as time in seconds with the lowest amount of time indicating the best performance. A lower score is a better outcome.
Time frame: Measure taken at 10 weeks post-training
Connor-Davidson Resilience Scale
To examine short-term effects of treatment on resilience. the scores range from 0 (lowest reslience and worst outcome) to 100 (highest resilience and best outcome). A higher score is a better outcome.
Time frame: Measure taken at 10 weeks post-training
Wechsler Memory Scale
To examine short-term effects of treatment on memory. The scores range from 0 (lowest memory level) to 20 (higher memory level). A higher score is a better outcome.
Time frame: Measure taken at 10 weeks post-training
Wechsler Abbreviated Scale of Intelligence Vocabulary Scale
To examine short-term effects of treatment on vocabulary ability Score ranges from 20 (a lower level of vocabulary) to 80 (a higher level of vocabulary). A higher score is a better outcome.
Time frame: Measure taken at 10 weeks post-training
Wechsler Abbreviated Scale of Intelligence Matrix Reasoning
To examine short-term effects of treatment on cognition with fluid reasoning being the measure ranging from 20 (lowest performance) to 80 (highest performance). A higher score is a better outcome.
Time frame: Measure taken at 10 weeks post-training
Wechsler Abbreviated Scale of Intelligence Similarities
To examine short-term effects of treatment on cognition with a score of 20 indicating lowest similarities performance to 80 indicating the highest similarities performance. A higher score is a better outcome.
Time frame: Measure taken at 10 weeks post-training
Satisfaction With Life Scale
To examine short-term effects of treatment on real-life outcomes. This ranges from 5 lowest satisfaction with life to 35 highest satisfaction with one's life. A higher score is a better outcome.
Time frame: Measure taken at 10 weeks post-training
| Milestone | Brain Health Workshop (BHW) | Strategic Memory Advanced Reasoning Training (SMART) |
|---|---|---|
| Started | 52 | 56 |
| Completed | 52 | 56 |
| Not completed | 0 | 0 |
| Milestone | Brain Health Workshop (BHW) | Strategic Memory Advanced Reasoning Training (SMART) |
|---|---|---|
| Started | 52 | 56 |
| Completed | 35 | 38 |
| Not completed | 17 | 18 |
| Milestone | Brain Health Workshop (BHW) | Strategic Memory Advanced Reasoning Training (SMART) |
|---|---|---|
| Started | 35 | 38 |
| Completed | 35 | 35 |
| Not completed | 0 | 3 |
Assesses disability after brain injury (1 dead to 8 good recovery). A higher score is a better outcome.
| units on a scale | Brain Health Workshop (BHW) | Strategic Memory Advanced Reasoning Training (SMART) |
|---|---|---|
| Glasgow Outcome Scale-Extended | 6.21 ± 0.75 | 6.30 ± 0.76 |
To examine short-term effects of treatment on cognition and real-life outcomes relating to how successful someone is able to integrate within their community (0 lowest integration (worst outcome) to 40 maximal integration (best outcome)). A higher score is a better outcome.
| units on a scale | Brain Health Workshop (BHW) | Strategic Memory Advanced Reasoning Training (SMART) |
|---|---|---|
| Community Integration Questionnaire | 16.91 ± 5.04 | 18.71 ± 5.08 |
To examine short-term effects of treatment on outcomes. - (0 highest function (best outcome) to 31 lowest function (worst outcome)). A lower score is a better outcome.
| units on a scale | Brain Health Workshop (BHW) | Strategic Memory Advanced Reasoning Training (SMART) |
|---|---|---|
| Functional Status Exam | 24.02 ± 6.93 | 22.14 ± 6.23 |
Scored as 0 words to 7 words comprehended. Higher scores indicate better comprehension and thus a better outcome. Lower scores indicates a lower degree of comprehension. A higher score is a better outcome.
| units on a scale | Brain Health Workshop (BHW) | Strategic Memory Advanced Reasoning Training (SMART) |
|---|---|---|
| Daneman-Carpenter Reading Span Test | 2.81 ± 0.89 | 2.89 ± 1.07 |
To examine short-term effects of treatment on cognition by working memory. The Hayling Sentence Completion test measures response initiation (range 0 best to 30 worst). A lower score is a better outcome.
| units on a scale | Brain Health Workshop (BHW) | Strategic Memory Advanced Reasoning Training (SMART) |
|---|---|---|
| Hayling Sentence Completion Test | 5.96 ± 1.22 | 6.05 ± 1.35 |
To examine short-term effects of treatment on real-life outcomes. This test measures impaired self-awareness after brain injury. The scale ranges from 17 (lowest self-awareness level, worst outcome) to 85 (highest self-awareness level, best outcome). A higher score is a better outcome.
| units on a scale | Brain Health Workshop (BHW) | Strategic Memory Advanced Reasoning Training (SMART) |
|---|---|---|
| Awareness Questionnaire | 34.94 ± 9.08 | 38.00 ± 9.48 |
Brain network connectivity from functional brain imaging was computed using Network-Based Statistics. Data were adjusted to form one number to characterize the significant connection changes associated with the training. This was accomplished by computing a change score. This change score combined the post-training (10 weeks), and 3-months post-training imaging data and compared that to the baseline (pre-training imaging data). This measure allows for an estimation of the number of statistically increased connections observed between different areas of the brain. A higher score indicates more significant connections and is considered to be a better outcome.
| number of significant brain connections | Brain Health Workshop (BHW) | Strategic Memory Advanced Reasoning Training (SMART) |
|---|---|---|
| Network Based Statistics in Brain Connectivity | 0 | 14 |
To examine short-term effects of treatment on measures current depressive symptoms from 0 (no depressive symptoms (best outcome)) to 63 (maximum depressive symptoms (worst outcome)). A lower score is a better outcome.
| scores on a scale | Brain Health Workshop (BHW) | Strategic Memory Advanced Reasoning Training (SMART) |
|---|---|---|
| Beck Depression Inventory (BDI) | 18.28 ± 12.51 | 18.41 ± 10.59 |
To examine short-term effects of treatment on self-reported measure of symptoms of posttraumatic stress disorder. The test ranges from 0 minimal stress symptoms to 80 maximum stress symptoms. A lower score is a better outcome.
| scores on a scale | Brain Health Workshop (BHW) | Strategic Memory Advanced Reasoning Training (SMART) |
|---|---|---|
| Post Traumatic Stress Disorder (PTSD) Checklist | 46.76 ± 18.03 | 44.09 ± 15.84 |
To examine short-term effects of treatment on problem substance use. The range is from 0 low levels of problem substance use to 414 (maximum level of problem substance use). A lower score is a better outcome.
| scores on a scale | Brain Health Workshop (BHW) | Strategic Memory Advanced Reasoning Training (SMART) |
|---|---|---|
| Alcohol, Smoking and Substance Involvement Screening Test | 19.40 ± 15.50 | 22.18 ± 19.12 |
To examine short-term effects of treatment on real-life outcomes on alcohol use disorder. The test ranges from 0 lowest use (best outcome) to 40 maximal use (worst outcome). A lower score is a better outcome.
| scores on a scale | Brain Health Workshop (BHW) | Strategic Memory Advanced Reasoning Training (SMART) |
|---|---|---|
| Alcohol Use Disorders Identification Test | 2.94 ± 3.78 | 3.39 ± 4.12 |
To examine short-term effects of treatment on attention. The test is scored as time in seconds with the lowest amount of time indicating the best performance. A lower score is a better outcome.
| seconds | Brain Health Workshop (BHW) | Strategic Memory Advanced Reasoning Training (SMART) |
|---|---|---|
| Digit Vigilence Test | 413.06 ± 99.06 | 359.20 ± 72.74 |
To examine short-term effects of treatment on resilience. the scores range from 0 (lowest reslience and worst outcome) to 100 (highest resilience and best outcome). A higher score is a better outcome.
| scores on a scale | Brain Health Workshop (BHW) | Strategic Memory Advanced Reasoning Training (SMART) |
|---|---|---|
| Connor-Davidson Resilience Scale | 61.26 ± 12.86 | 64.38 ± 22.40 |
To examine short-term effects of treatment on memory. The scores range from 0 (lowest memory level) to 20 (higher memory level). A higher score is a better outcome.
| scores on a scale | Brain Health Workshop (BHW) | Strategic Memory Advanced Reasoning Training (SMART) |
|---|---|---|
| Wechsler Memory Scale | 12.96 ± 4.05 | 12.79 ± 4.08 |
To examine short-term effects of treatment on vocabulary ability Score ranges from 20 (a lower level of vocabulary) to 80 (a higher level of vocabulary). A higher score is a better outcome.
| scores on a scale | Brain Health Workshop (BHW) | Strategic Memory Advanced Reasoning Training (SMART) |
|---|---|---|
| Wechsler Abbreviated Scale of Intelligence Vocabulary Scale | 61.44 ± 7.84 | 58.14 ± 8.14 |
To examine short-term effects of treatment on cognition with fluid reasoning being the measure ranging from 20 (lowest performance) to 80 (highest performance). A higher score is a better outcome.
| scores on a scale | Brain Health Workshop (BHW) | Strategic Memory Advanced Reasoning Training (SMART) |
|---|---|---|
| Wechsler Abbreviated Scale of Intelligence Matrix Reasoning | 26.56 ± 4.30 | 27.64 ± 4.68 |
To examine short-term effects of treatment on cognition with a score of 20 indicating lowest similarities performance to 80 indicating the highest similarities performance. A higher score is a better outcome.
| scores on a scale | Brain Health Workshop (BHW) | Strategic Memory Advanced Reasoning Training (SMART) |
|---|---|---|
| Wechsler Abbreviated Scale of Intelligence Similarities | 37.69 ± 4.39 | 36.96 ± 3.71 |
To examine short-term effects of treatment on real-life outcomes. This ranges from 5 lowest satisfaction with life to 35 highest satisfaction with one's life. A higher score is a better outcome.
| scores on a scale | Brain Health Workshop (BHW) | Strategic Memory Advanced Reasoning Training (SMART) |
|---|---|---|
| Satisfaction With Life Scale | 17.56 ± 7.60 | 16.54 ± 7.85 |
Collected over Each participant was involved in the study for a total of twenty-one weeks. This consisted of one week during which the first assessment took place followed by eight weeks of cognitive intervention training in either of the two arms of the study and the first post-training assessment). Lastly, there was one additional testing session carried out twelve weeks after the completion of the training (and the first post-training assessment).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Strategic Memory Advanced Reasoning Training Group | 0/56 (0%) | 0/56 (0%) | 0/56 (0%) |
| Brain Health Workshop | 0/52 (0%) | 0/52 (0%) | 0/52 (0%) |
| Age, Continuous(years) | Brain Health Workshop (BHW) | Strategic Memory Advanced Reasoning Training (SMART) | Total |
|---|---|---|---|
| Mean | 42.19 ± 13.37 | 40.59 ± 13.05 | 41.36 ± 13.17 |
| Sex: Female, Male(Participants) | Brain Health Workshop (BHW) | Strategic Memory Advanced Reasoning Training (SMART) | Total |
|---|---|---|---|
| Female | 20 | 21 | 41 |
| Male | 32 | 35 | 67 |
| Ethnicity (NIH/OMB)(Participants) | Brain Health Workshop (BHW) | Strategic Memory Advanced Reasoning Training (SMART) | Total |
|---|---|---|---|
| Hispanic or Latino | 3 | 5 | 8 |
| Not Hispanic or Latino | 45 | 51 | 96 |
| Unknown or Not Reported | 4 | 0 | 4 |
| Race (NIH/OMB)(Participants) | Brain Health Workshop (BHW) | Strategic Memory Advanced Reasoning Training (SMART) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 6 | 8 | 14 |
| White | 42 | 47 | 89 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 4 | 0 | 4 |
| Years of Education(years) | Brain Health Workshop (BHW) | Strategic Memory Advanced Reasoning Training (SMART) | Total |
|---|---|---|---|
| Mean | 16.34 ± 3.07 | 15.80 ± 2.43 | 16.05 ± 2.74 |
| Socio-economic Status (SES)(units on a scale) | Brain Health Workshop (BHW) | Strategic Memory Advanced Reasoning Training (SMART) | Total |
|---|---|---|---|
| Mean | 44.81 ± 13.09 | 40.44 ± 14.85 | 42.48 ± 14.16 |
| Civilian/Military(Participants) | Brain Health Workshop (BHW) | Strategic Memory Advanced Reasoning Training (SMART) | Total |
|---|---|---|---|
| Civilian | 21 | 31 | 52 |
| Military (Veteran) | 31 | 25 | 56 |
| Marital Status(Participants) | Brain Health Workshop (BHW) | Strategic Memory Advanced Reasoning Training (SMART) | Total |
|---|---|---|---|
| Married | 22 | 17 | 39 |
| Single | 23 | 29 | 52 |
| Widow | 1 | 0 | 1 |
| Divorced | 4 | 10 | 14 |
| Separated | 2 | 0 | 2 |
2 further baseline measures are reported on the registry.
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The University of Texas at Dallas