Mild Traumatic Brain Injury, Concussion, Post Traumatic Stress Disorder
Conditions
Keywords
Post Traumatic Stress Disorder,, Mild Traumatic Brain Injury, Concussion, Cognitive Rehabilitation
Brief summary
One of the most pressing concerns within the VA currently is the provision of interventions that address the cognitive as well as emotional problems faced by Veterans with concurrent mild TBI and PTSD. One purpose of this study is to learn more about how PTSD and mild brain injury influences how people think, act, and feel. This may include how people pay attention, keep information in memory, organize plans for achieving important goals, and manage stress. Another purpose of this research is to learn more about the effects of cognitive training on the thinking, behavior, and emotions of individuals with PTSD and mild brain injury - both in the short- and long-term. With this research, the investigators hope to better understand and treat cognitive and emotional difficulties that can occur due to PTSD and mild brain injury.
Detailed description
The overall aim of this proposal is to investigate the potential short and long term effectiveness of a cognitive training program Goal-Oriented Attentional Self-regulation (GOALS) that targets executive control functions in Veterans with co-morbid posttraumatic stress disorder (PTSD), history of mild traumatic brain injury (mTBI), and cognitive difficulties. Both PTSD and a history of mild TBI are prevalent in Veterans from the Operation Enduring Freedom (OEF) and Operation Iraqi Freedom (OIF) conflicts, with reported rates for each disorder ranging from 14 - 22%. Both PTSD and TBI have been associated with cognitive dysfunction which may lead to functional impairment and poor community reintegration. PTSD can be highly debilitating not only due to emotional dysregulation, but also due to deficits in the cognitive control processes. Goal-Oriented Attentional Self-Regulation (GOALS) is a therapist administered cognitive rehabilitation training that targets executive control functions of applied mindfulness-based attention regulation and goal management, and links them to participant-defined real-life goals. In a prior study with individuals with chronic brain injury, this training has improved cognitive performance in areas of complex attention / executive function, memory, complex functional task performance, and daily functioning. Furthermore, functional MRI results after training indicated significantly enhanced modulation of neural processing in extrastriate cortex and changes in prefrontal cortex. Preliminary results from a recently completed study with Veterans with a history of chronic TBI also support improvements post GOALS on neuropsychological measures of attention and executive function, performance on complex 'real-life' tasks, and self-report measures of functional performance. Furthermore, participants also showed improvement on the emotional regulation self-report measures. These findings suggest that improving cognitive control may also improve functioning in other domains such as emotional regulation and functional performance in daily life. In a randomized, controlled intervention study design, 42 Veterans with a diagnosis of PTSD, history of mTBI and residual cognitive difficulties will participate in experimental (GOALS), and/or active comparison (Brain Health Education - EDU) interventions matched for time and intensity. Participants will be randomized to start with either 5 weeks of GOALS or EDU training. Those who begin with EDU will cross-over to GOALS, while those begin with GOALS will have 5 weeks of self-driven practice only. Both groups will participate in pre and post intervention measurements at baseline, weeks 5 and 10. Long-term follow-up will be at 6 months. Pre- and post-intervention measurements will include performance on untrained: neuro-cognitive tests assessing targeted and non-targeted cognitive domains, complex functional task performance in low structure 'real-world' setting, and self-report measures of emotional regulation and daily functioning.
Interventions
BEHAVIORALGOALS (Goal-Oriented Attentional Regulation)
Goal-Oriented Attentional Regulation (GOALS) will involve 5-weeks of training (20 hours of group training (2 hour sessions, 2 days per week), 3 hours of individual training (1 hour at the beginning, halfway through and at the end of training), and approximately 20 hours of home practice). Some subjects will only receive the GOALS intervention.
BEHAVIORALEDU (Brain Health Education)
Brain Health Education (EDU) will involve 5-weeks of training (20 hours of group training (2 hour sessions, 2 days per week), 3 hours of individual training (1 hour at the beginning, halfway through and at the end of training), and approximately 20 hours of homework). The EDU intervention involves education on brain health and functioning in a classroom format, with study materials for homework. Some subjects will start with EDU and then cross-over to the GOALS.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of PTSD * History of mild TBI, including concussion \> 6 months ago * Cognitive difficulties affecting daily functioning * Age 18-75 * Veteran * At least 12th grade education or equivalent
Exclusion criteria
* Amnesic/Severe memory problems * Active Substance Abuse/Dependence * Medical condition that may affect mental status/disrupt study participation * Active psychotropic medication changes * Participation in evidence-based PTSD treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Performance on Neurocognitive Measure of Attention and Executive Function Post GOALS Intervention vs EDU Control Training | baseline, 5 weeks | Attention and Executive Function Overall Domain Z Score (primary neuropsychological outcome measure) is calculated as the average of z scores of following tests: Letter Number Sequencing, Auditory Consonant Trigrams, Digit Vigilance, Trails B, DKEFS Stroop Inhibition, DKEFS Stroop Inhibition-Switching, DKEFS Verbal Fluency Switching, DKEFS Visual Fluency Switching. (The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the population mean. Negative numbers indicate values lower than the reference population and positive numbers indicate values higher than the reference population) |
| Long Term Follow-up After GOALS Training - Change in Performance on Neurocognitive Measures of Attention and Executive Function 6+ Months Post GOALS Intervention Relative to Baseline | baseline, 6+ months after GOALS training | Attention and Executive Function Overall Domain Z Score (primary neuropsychological outcome measure) is calculated as the average of z scores of following tests: Letter Number Sequencing, Auditory Consonant Trigrams, Digit Vigilance, Trails B, DKEFS Stroop Inhibition, DKEFS Stroop Inhibition-Switching, DKEFS Verbal Fluency Switching, DKEFS Visual Fluency Switching. (The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the population mean. Negative numbers indicate values lower than the reference population and positive numbers indicate values higher than the reference population) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Performance on Complex Functional Task -Goal Processing Scale Post GOALS Intervention vs EDU Control Training | baseline; 5 weeks | Goal Processing Scale Overall Performance score (Primary functional performance outcome ) is calculated as the average of the 8 sub-domain scores including: Planning, Initiation, Maintenance of Attention, Self-Monitoring, Sequencing and Switching Attention, Flexible Problem Solving, Memory, and Execution. Minimum value is 0, maximum value is 10. Higher scores indicate better outcome. |
| Long Term Follow-up After GOALS Training - Change in Performance on Complex Functional Task -Goal Processing Scale 6+ Months Post GOALS Intervention Relative to Baseline | baseline, 6 months post GOALS training | Goal Processing Scale Overall Performance score (Primary functional performance outcome ) is calculated as the average of the 8 sub-domain scores including: Planning, Initiation, Maintenance of Attention, Self-Monitoring, Sequencing and Switching Attention, Flexible Problem Solving, Memory, and Execution. Minimum value is 0, maximum value is 10. Higher scores indicate better outcome |
| Change on Self Report Measures of Emotional Regulation GOALS Post Intervention vs EDU Control Training | baseline, 5 weeks | Overall psychological distress will be assessed with Profile of Mood States (POMS) questionnaire Total Mood Disturbance Z Score (primary emotional regulation outcome measure). (The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the population mean. Negative numbers indicate values lower than the reference population and positive numbers indicate values higher than the reference population) |
| Long Term Follow-up Change on Self Report Measures of Emotional Regulation 6+ Months Post GOALS Intervention | baseline, 6 months | Overall psychological distress is assessed with Profile of Mood States (POMS) questionnaire Total Mood Disturbance Z Score (primary emotional regulation outcome measure) (The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the population mean. Negative numbers indicate values lower than the reference population and positive numbers indicate values higher than the reference population) |
Countries
United States
Participant flow
Pre-assignment details
Out of 76 enrolled participants: 12 were excluded after in person screening for not meeting inclusion criteria CAPS diagnosis of PTSD (n=11), or substance abuse (n=1); 8 participants left study after consent for scheduling, medical/family issues; and 10 left study during baseline assessment (were not randomized) 46 participants were randomized
Participants by arm
| Arm | Count |
|---|---|
| GOALS (Goal-Oriented Attentional Regulation) Goal-Oriented Attentional Regulation (GOALS) executive training involved 5-weeks of training (20 hours of group training (2 hour sessions, 2 days per week), 3 hours of individual training, and approximately 20 hours of home practice.
Participants randomized to GOALS intervention, did no receive EDU training after completion of GOALS. | 21 |
| EDU (Brain Health Education) Brain Health Education (EDU) involved 5-weeks of training (20 hours of group training , 3 hours of individual training ,and approximately 20 hours of homework). The EDU intervention involves education on brain health and functioning in a classroom format, with study materials for homework.
Some subjects who completed EDU training during the randomized phase, completed additional 5 weeks of GOALS training. | 19 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 5 Week Randomized GOALS vs EDU Training | Withdrawal by Subject | 3 | 3 |
| Long Term Follow-up After GOALS Training | Lost to Follow-up | 2 | 0 |
Baseline characteristics
| Characteristic | GOALS (Goal-Oriented Attentional Regulation) | EDU (Brain Health Education) | Total |
|---|---|---|---|
| Age, Continuous | 42.1 years STANDARD_DEVIATION 13.95 | 47.53 years STANDARD_DEVIATION 14.86 | 45.08 years STANDARD_DEVIATION 14.74 |
| Attention/Executive Function Overall Z Score | -0.39 z score STANDARD_DEVIATION 0.72 | -0.38 z score STANDARD_DEVIATION 0.77 | -0.39 z score STANDARD_DEVIATION 0.72 |
| Goal Processing Scale (GPS) Overall Performance Score | 7.17 score on a scale STANDARD_DEVIATION 1.48 | 7.31 score on a scale STANDARD_DEVIATION 1.44 | 7.27 score on a scale STANDARD_DEVIATION 1.39 |
| Profile of Mood States (POMS)-Total Mood Disturbance Score | -1.69 z score STANDARD_DEVIATION 1.57 | -1.94 z score STANDARD_DEVIATION 1.06 | -1.81 z score STANDARD_DEVIATION 1.34 |
| Race/Ethnicity, Customized Asian | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Black | 2 Participants | 2 Participants | 4 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized More than one race | 2 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Pacific Islander | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 14 Participants | 14 Participants | 28 Participants |
| Region of Enrollment United States | 21 Participants | 19 Participants | 40 Participants |
| Sex: Female, Male Female | 1 Participants | 4 Participants | 5 Participants |
| Sex: Female, Male Male | 20 Participants | 15 Participants | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 37 | 0 / 22 |
| other Total, other adverse events | 0 / 37 | 0 / 22 |
| serious Total, serious adverse events | 0 / 37 | 0 / 22 |
Outcome results
Primary
Change in Performance on Neurocognitive Measure of Attention and Executive Function Post GOALS Intervention vs EDU Control Training
Attention and Executive Function Overall Domain Z Score (primary neuropsychological outcome measure) is calculated as the average of z scores of following tests: Letter Number Sequencing, Auditory Consonant Trigrams, Digit Vigilance, Trails B, DKEFS Stroop Inhibition, DKEFS Stroop Inhibition-Switching, DKEFS Verbal Fluency Switching, DKEFS Visual Fluency Switching. (The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the population mean. Negative numbers indicate values lower than the reference population and positive numbers indicate values higher than the reference population)
Time frame: baseline, 5 weeks
Population: Out of 21 participants who completed GOALS, 3 participants did not complete one or more neuropsychological tests
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GOALS (Goal-Oriented Attentional Regulation) | Change in Performance on Neurocognitive Measure of Attention and Executive Function Post GOALS Intervention vs EDU Control Training | -0.03 z score | Standard Deviation 0.68 |
| EDU (Brain Health Education) | Change in Performance on Neurocognitive Measure of Attention and Executive Function Post GOALS Intervention vs EDU Control Training | -0.39 z score | Standard Deviation 0.72 |
p-value: <0.01ANOVA
Primary
Long Term Follow-up After GOALS Training - Change in Performance on Neurocognitive Measures of Attention and Executive Function 6+ Months Post GOALS Intervention Relative to Baseline
Attention and Executive Function Overall Domain Z Score (primary neuropsychological outcome measure) is calculated as the average of z scores of following tests: Letter Number Sequencing, Auditory Consonant Trigrams, Digit Vigilance, Trails B, DKEFS Stroop Inhibition, DKEFS Stroop Inhibition-Switching, DKEFS Verbal Fluency Switching, DKEFS Visual Fluency Switching. (The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the population mean. Negative numbers indicate values lower than the reference population and positive numbers indicate values higher than the reference population)
Time frame: baseline, 6+ months after GOALS training
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GOALS (Goal-Oriented Attentional Regulation) | Long Term Follow-up After GOALS Training - Change in Performance on Neurocognitive Measures of Attention and Executive Function 6+ Months Post GOALS Intervention Relative to Baseline | -0.2 z score | Standard Deviation 0.78 |
p-value: <0.001ANOVA
Secondary
Change in Performance on Complex Functional Task -Goal Processing Scale Post GOALS Intervention vs EDU Control Training
Goal Processing Scale Overall Performance score (Primary functional performance outcome ) is calculated as the average of the 8 sub-domain scores including: Planning, Initiation, Maintenance of Attention, Self-Monitoring, Sequencing and Switching Attention, Flexible Problem Solving, Memory, and Execution. Minimum value is 0, maximum value is 10. Higher scores indicate better outcome.
Time frame: baseline; 5 weeks
Population: Out of 21 participants who completed GOALS training 3 participants did not complete one or more sub-tests of GPS.~Out of 19 participants who completed EDU training 2 participants did not complete one or more sub-tests of GPS
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GOALS (Goal-Oriented Attentional Regulation) | Change in Performance on Complex Functional Task -Goal Processing Scale Post GOALS Intervention vs EDU Control Training | 8.10 score on a scale | Standard Deviation 1.1 |
| EDU (Brain Health Education) | Change in Performance on Complex Functional Task -Goal Processing Scale Post GOALS Intervention vs EDU Control Training | 7.60 score on a scale | Standard Deviation 1.04 |
p-value: >0.05ANOVA
Secondary
Change on Self Report Measures of Emotional Regulation GOALS Post Intervention vs EDU Control Training
Overall psychological distress will be assessed with Profile of Mood States (POMS) questionnaire Total Mood Disturbance Z Score (primary emotional regulation outcome measure). (The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the population mean. Negative numbers indicate values lower than the reference population and positive numbers indicate values higher than the reference population)
Time frame: baseline, 5 weeks
Population: Out of 21 participants who completed GOALS training 3 participants did not complete one or more questions on POMS Out of 19 participants who completed EDU training 2 participants did not complete one or more questions on POMS
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GOALS (Goal-Oriented Attentional Regulation) | Change on Self Report Measures of Emotional Regulation GOALS Post Intervention vs EDU Control Training | -1.37 z score | Standard Deviation 1.82 |
| EDU (Brain Health Education) | Change on Self Report Measures of Emotional Regulation GOALS Post Intervention vs EDU Control Training | -2.09 z score | Standard Deviation 0.94 |
p-value: <0.05ANOVA
Secondary
Long Term Follow-up After GOALS Training - Change in Performance on Complex Functional Task -Goal Processing Scale 6+ Months Post GOALS Intervention Relative to Baseline
Goal Processing Scale Overall Performance score (Primary functional performance outcome ) is calculated as the average of the 8 sub-domain scores including: Planning, Initiation, Maintenance of Attention, Self-Monitoring, Sequencing and Switching Attention, Flexible Problem Solving, Memory, and Execution. Minimum value is 0, maximum value is 10. Higher scores indicate better outcome
Time frame: baseline, 6 months post GOALS training
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GOALS (Goal-Oriented Attentional Regulation) | Long Term Follow-up After GOALS Training - Change in Performance on Complex Functional Task -Goal Processing Scale 6+ Months Post GOALS Intervention Relative to Baseline | 8.23 score on a scale | Standard Deviation 1.2 |
p-value: <0.001ANOVA
Secondary
Long Term Follow-up Change on Self Report Measures of Emotional Regulation 6+ Months Post GOALS Intervention
Overall psychological distress is assessed with Profile of Mood States (POMS) questionnaire Total Mood Disturbance Z Score (primary emotional regulation outcome measure) (The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the population mean. Negative numbers indicate values lower than the reference population and positive numbers indicate values higher than the reference population)
Time frame: baseline, 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GOALS (Goal-Oriented Attentional Regulation) | Long Term Follow-up Change on Self Report Measures of Emotional Regulation 6+ Months Post GOALS Intervention | -1.01 z score | Standard Deviation 1.4 |
p-value: <0.01ANOVA