Traumatic Brain Injury
Conditions
Keywords
TBI, Traumatic Brain Injury, combat related injury, blast injury, concussion, sleep problems, attention problems, memory problems, headaches, dizziness, OEF, OIF, Veterans, Civilian
Brief summary
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).
Detailed description
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.
Interventions
BEHAVIORALBrain Training Program 1
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.
BEHAVIORALBrain Training Program 2
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.
Sponsors
University of Texas Southwestern Medical Center
Congressionally Directed Medical Research Programs
The University of Texas at Dallas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 19-65 years of age * Sustained a traumatic brain injury at least 6 months previously * Comprehend simple instructions, perform tasks and take part in intervention * Read, speak and comprehend English * Participate in tasks involving motor abilities such as use of at least one arm or hand
Exclusion criteria
* Not proficient in reading, comprehending or speaking English * Pre-existing Cerebral Palsy, Mental Retardation, Autism, Epilepsy, Schizophrenia, or Pervasive Developmental Disorder * Individuals with Psychosis, Active Behavioral Disorder, or uncontrolled epilepsy * Women who are pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glasgow Outcome Scale-Extended | Pre-training (Baseline) Neuropsychological Test | Assesses disability after brain injury (1 dead to 8 good recovery). A higher score is a better outcome. |
| Community Integration Questionnaire | Neuropsychological changes from baseline to 10 weeks post-training | 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. |
| Functional Status Exam | Measure at 10 weeks post-training | 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. |
| Daneman-Carpenter Reading Span Test | Measure at 10 weeks post-training | 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. |
| Hayling Sentence Completion Test | Measure at 10 weeks post-training | 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. |
| Awareness Questionnaire | Measure at 10 weeks post-training | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Connor-Davidson Resilience Scale | Measure taken at 10 weeks post-training | 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. |
| Wechsler Memory Scale | Measure taken at 10 weeks post-training | 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. |
| Wechsler Abbreviated Scale of Intelligence Vocabulary Scale | Measure taken at 10 weeks post-training | 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. |
| Network Based Statistics in Brain Connectivity | MRI measures taken at 10 weeks and 3 months post-training are combined and compared to baseline MRI yielding one number | 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. |
| Wechsler Abbreviated Scale of Intelligence Similarities | Measure taken at 10 weeks post-training | 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. |
| Satisfaction With Life Scale | Measure taken at 10 weeks post-training | 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. |
| Wechsler Abbreviated Scale of Intelligence Matrix Reasoning | Measure taken at 10 weeks post-training | 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. |
| Beck Depression Inventory (BDI) | Measure taken at 10 weeks post-training | 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. |
| Post Traumatic Stress Disorder (PTSD) Checklist | Measure taken at 10 weeks post-training | 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. |
| Alcohol, Smoking and Substance Involvement Screening Test | Measure taken at 10 weeks post-training | 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. |
| Alcohol Use Disorders Identification Test | Measure taken at 10 weeks post-training | 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. |
| Digit Vigilence Test | Measure taken at 10 weeks post-training | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Brain Health Workshop (BHW) The BHW program focuses on teaching facts about brain functions and influences on cognition. This program was originally developed at the Rotman Institute, Canada \[34\]. The BHW includes topics such as an overview of brain anatomy, neuroplasticity, memory, attention and executive functions, aging and the brain, sleep and stress, diet and physical exercise, and social bonds and the brain. We adapted the curriculum to approximate the general structure of SMART training, including matching for the number of sessions, duration, discussions, and homework assignments. | 52 |
| Strategic Memory Advanced Reasoning Training (SMART) SMART utilizes a strategy-based approach to train individuals in abstract thinking ability. Specifically, participants are trained in cognitive control strategies of strategic attention, integration, and innovation, which facilitate abstraction abilities. Strategic attention involves blocking less relevant details to focus on important information. Integration incorporates strategies to abstract and create meanings or goals from information or tasks. Innovation focuses on generating and discovering novel concepts, ideas, and diverse goals and perspectives. The strategy instruction is hierarchical, with each strategy dynamically building upon previous strategies. The SMART program incorporates a wide range of discourse and task materials relevant in daily life contexts, such as planning an event, going on a job interview, learning from a lecture, or explaining a concept. | 56 |
| Total | 108 |
Baseline characteristics
| Characteristic | Brain Health Workshop (BHW) | Strategic Memory Advanced Reasoning Training (SMART) | Total |
|---|---|---|---|
| Age, Continuous | 42.19 years STANDARD_DEVIATION 13.37 | 40.59 years STANDARD_DEVIATION 13.05 | 41.36 years STANDARD_DEVIATION 13.17 |
| Civilian/Military Civilian | 21 Participants | 31 Participants | 52 Participants |
| Civilian/Military Military (Veteran) | 31 Participants | 25 Participants | 56 Participants |
| Current IQ | 109.94 units on a scale STANDARD_DEVIATION 12.42 | 107.93 units on a scale STANDARD_DEVIATION 10.23 | 108.84 units on a scale STANDARD_DEVIATION 11.25 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 5 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 45 Participants | 51 Participants | 96 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants | 0 Participants | 4 Participants |
| Marital Status Divorced | 4 Participants | 10 Participants | 14 Participants |
| Marital Status Married | 22 Participants | 17 Participants | 39 Participants |
| Marital Status Separated | 2 Participants | 0 Participants | 2 Participants |
| Marital Status Single | 23 Participants | 29 Participants | 52 Participants |
| Marital Status Widow | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 8 Participants | 14 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 4 Participants | 0 Participants | 4 Participants |
| Race (NIH/OMB) White | 42 Participants | 47 Participants | 89 Participants |
| Sex: Female, Male Female | 20 Participants | 21 Participants | 41 Participants |
| Sex: Female, Male Male | 32 Participants | 35 Participants | 67 Participants |
| Socio-economic Status (SES) | 44.81 units on a scale STANDARD_DEVIATION 13.09 | 40.44 units on a scale STANDARD_DEVIATION 14.85 | 42.48 units on a scale STANDARD_DEVIATION 14.16 |
| Type of Head Injury Blast | 6 Participants | 6 Participants | 12 Participants |
| Type of Head Injury Blunt-force trauma | 9 Participants | 5 Participants | 14 Participants |
| Type of Head Injury Falls | 6 Participants | 9 Participants | 15 Participants |
| Type of Head Injury Multiple Injuries | 7 Participants | 11 Participants | 18 Participants |
| Type of Head Injury Sports | 4 Participants | 11 Participants | 15 Participants |
| Type of Head Injury Unknown | 4 Participants | 0 Participants | 4 Participants |
| Type of Head Injury Vehicular Accident(s) | 16 Participants | 14 Participants | 30 Participants |
| Years of Education | 16.34 years STANDARD_DEVIATION 3.07 | 15.80 years STANDARD_DEVIATION 2.43 | 16.05 years STANDARD_DEVIATION 2.74 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 56 | 0 / 52 |
| other Total, other adverse events | 0 / 56 | 0 / 52 |
| serious Total, serious adverse events | 0 / 56 | 0 / 52 |
Outcome results
Primary
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
Population: Community dwelling individuals between the ages of 19 and 65 years with a history of chronic TBI (\> 6 months post-injury).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brain Health Workshop (BHW) | Awareness Questionnaire | 34.94 units on a scale | Standard Deviation 9.08 |
| Strategic Memory Advanced Reasoning Training (SMART) | Awareness Questionnaire | 38.00 units on a scale | Standard Deviation 9.48 |
Primary
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
Population: Community dwelling individuals (41 women and 67 men) between the ages of 19 and 65 years with a history of chronic TBI (\> 6 months post-injury).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brain Health Workshop (BHW) | Community Integration Questionnaire | 16.91 units on a scale | Standard Deviation 5.04 |
| Strategic Memory Advanced Reasoning Training (SMART) | Community Integration Questionnaire | 18.71 units on a scale | Standard Deviation 5.08 |
Primary
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
Population: Community dwelling individuals between the ages of 19 and 65 years with a history of chronic TBI (\> 6 months post-injury).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brain Health Workshop (BHW) | Daneman-Carpenter Reading Span Test | 2.81 units on a scale | Standard Deviation 0.89 |
| Strategic Memory Advanced Reasoning Training (SMART) | Daneman-Carpenter Reading Span Test | 2.89 units on a scale | Standard Deviation 1.07 |
Primary
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
Population: Community dwelling individuals between the ages of 19 and 65 years with a history of chronic TBI (\> 6 months post-injury).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brain Health Workshop (BHW) | Functional Status Exam | 24.02 units on a scale | Standard Deviation 6.93 |
| Strategic Memory Advanced Reasoning Training (SMART) | Functional Status Exam | 22.14 units on a scale | Standard Deviation 6.23 |
Primary
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
Population: Community dwelling individuals between the ages of 19 and 65 years with a history of chronic TBI (\> 6 months post-injury).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brain Health Workshop (BHW) | Glasgow Outcome Scale-Extended | 6.21 units on a scale | Standard Deviation 0.75 |
| Strategic Memory Advanced Reasoning Training (SMART) | Glasgow Outcome Scale-Extended | 6.30 units on a scale | Standard Deviation 0.76 |
Primary
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
Population: Community dwelling individuals between the ages of 19 and 65 years with a history of chronic TBI (\> 6 months post-injury).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brain Health Workshop (BHW) | Hayling Sentence Completion Test | 5.96 units on a scale | Standard Deviation 1.22 |
| Strategic Memory Advanced Reasoning Training (SMART) | Hayling Sentence Completion Test | 6.05 units on a scale | Standard Deviation 1.35 |
Secondary
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
Population: Community dwelling individuals between the ages of 19 and 65 years with a history of chronic TBI (\> 6 months post-injury).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brain Health Workshop (BHW) | Alcohol, Smoking and Substance Involvement Screening Test | 19.40 scores on a scale | Standard Deviation 15.5 |
| Strategic Memory Advanced Reasoning Training (SMART) | Alcohol, Smoking and Substance Involvement Screening Test | 22.18 scores on a scale | Standard Deviation 19.12 |
Secondary
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
Population: Community dwelling individuals between the ages of 19 and 65 years with a history of chronic TBI (\> 6 months post-injury).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brain Health Workshop (BHW) | Alcohol Use Disorders Identification Test | 2.94 scores on a scale | Standard Deviation 3.78 |
| Strategic Memory Advanced Reasoning Training (SMART) | Alcohol Use Disorders Identification Test | 3.39 scores on a scale | Standard Deviation 4.12 |
Secondary
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
Population: Community dwelling individuals between the ages of 19 and 65 years with a history of chronic TBI (\> 6 months post-injury).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brain Health Workshop (BHW) | Beck Depression Inventory (BDI) | 18.28 scores on a scale | Standard Deviation 12.51 |
| Strategic Memory Advanced Reasoning Training (SMART) | Beck Depression Inventory (BDI) | 18.41 scores on a scale | Standard Deviation 10.59 |
Secondary
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
Population: Community dwelling individuals between the ages of 19 and 65 years with a history of chronic TBI (\> 6 months post-injury).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brain Health Workshop (BHW) | Connor-Davidson Resilience Scale | 61.26 scores on a scale | Standard Deviation 12.86 |
| Strategic Memory Advanced Reasoning Training (SMART) | Connor-Davidson Resilience Scale | 64.38 scores on a scale | Standard Deviation 22.4 |
Secondary
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
Population: Community dwelling individuals between the ages of 19 and 65 years with a history of chronic TBI (\> 6 months post-injury).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brain Health Workshop (BHW) | Digit Vigilence Test | 413.06 seconds | Standard Deviation 99.06 |
| Strategic Memory Advanced Reasoning Training (SMART) | Digit Vigilence Test | 359.20 seconds | Standard Deviation 72.74 |
Secondary
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
Population: The participants included in this analysis completed Magnetic Resonance Imaging Scans. This analysis does not include all 108 participants. Some participants data were not included due to the fact that they were not adequate for the analysis due to motion artifacts which severely affect this type of imaging measurement.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Brain Health Workshop (BHW) | Network Based Statistics in Brain Connectivity | 0 number of significant brain connections |
| Strategic Memory Advanced Reasoning Training (SMART) | Network Based Statistics in Brain Connectivity | 14 number of significant brain connections |
Comparison: A network-based statistics analysis was carried out to determine brain connectivity differences observed at time points two (initial post-intervention testing phase) and three (the final post-intervention phase) occurring three months post-intervention.p-value: 0.01Network Based Statistics analysis
Secondary
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
Population: Community dwelling individuals between the ages of 19 and 65 years with a history of chronic TBI (\> 6 months post-injury).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brain Health Workshop (BHW) | Post Traumatic Stress Disorder (PTSD) Checklist | 46.76 scores on a scale | Standard Deviation 18.03 |
| Strategic Memory Advanced Reasoning Training (SMART) | Post Traumatic Stress Disorder (PTSD) Checklist | 44.09 scores on a scale | Standard Deviation 15.84 |
Secondary
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
Population: Community dwelling individuals between the ages of 19 and 65 years with a history of chronic TBI (\> 6 months post-injury).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brain Health Workshop (BHW) | Satisfaction With Life Scale | 17.56 scores on a scale | Standard Deviation 7.6 |
| Strategic Memory Advanced Reasoning Training (SMART) | Satisfaction With Life Scale | 16.54 scores on a scale | Standard Deviation 7.85 |
Secondary
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
Population: Community dwelling individuals between the ages of 19 and 65 years with a history of chronic TBI (\> 6 months post-injury).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brain Health Workshop (BHW) | Wechsler Abbreviated Scale of Intelligence Matrix Reasoning | 26.56 scores on a scale | Standard Deviation 4.3 |
| Strategic Memory Advanced Reasoning Training (SMART) | Wechsler Abbreviated Scale of Intelligence Matrix Reasoning | 27.64 scores on a scale | Standard Deviation 4.68 |
Secondary
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
Population: Community dwelling individuals between the ages of 19 and 65 years with a history of chronic TBI (\> 6 months post-injury).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brain Health Workshop (BHW) | Wechsler Abbreviated Scale of Intelligence Similarities | 37.69 scores on a scale | Standard Deviation 4.39 |
| Strategic Memory Advanced Reasoning Training (SMART) | Wechsler Abbreviated Scale of Intelligence Similarities | 36.96 scores on a scale | Standard Deviation 3.71 |
Secondary
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
Population: Community dwelling individuals between the ages of 19 and 65 years with a history of chronic TBI (\> 6 months post-injury).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brain Health Workshop (BHW) | Wechsler Abbreviated Scale of Intelligence Vocabulary Scale | 61.44 scores on a scale | Standard Deviation 7.84 |
| Strategic Memory Advanced Reasoning Training (SMART) | Wechsler Abbreviated Scale of Intelligence Vocabulary Scale | 58.14 scores on a scale | Standard Deviation 8.14 |
Secondary
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
Population: Community dwelling individuals between the ages of 19 and 65 years with a history of chronic TBI (\> 6 months post-injury).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Brain Health Workshop (BHW) | Wechsler Memory Scale | 12.96 scores on a scale | Standard Deviation 4.05 |
| Strategic Memory Advanced Reasoning Training (SMART) | Wechsler Memory Scale | 12.79 scores on a scale | Standard Deviation 4.08 |