Rehabilitation of Executive Functioning in Veterans With PTSD and Mild TBI

Study Overview
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Brief Summary
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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
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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.

Official Title
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Rehabilitation of Executive Functioning in Veterans With PTSD and Mild TBI

Conditions
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Post Traumatic Stress Disorder, Mild Traumatic Brain Injury, Concussion

Intervention / Treatment
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* Behavioral: GOALS (Goal-Oriented Attentional Regulation)
* Behavioral: EDU (Brain Health Education)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GOALS (Goal-Oriented Attentional Regulation)<br>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. | Behavioral: GOALS (Goal-Oriented Attentional Regulation)<br>* 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.<br>|
| Active Comparator: EDU (Brain Health Education)<br>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. | Behavioral: EDU (Brain Health Education)<br>* 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.<br>* Other names: EDU;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | baseline, 5 weeks | 
| 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) | baseline, 6+ months after GOALS training | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | baseline; 5 weeks | 
| 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 | baseline, 6 months post GOALS training | 
| 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) | baseline, 5 weeks | 
| 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) | baseline, 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Post Traumatic Stress Disorder,, Mild Traumatic Brain Injury, Concussion, Cognitive Rehabilitation