Rehabilitation of Executive Functioning in Veterans With PTSD and Mild TBI
Phase: NA
Conditions: Post Traumatic Stress Disorder, Mild Traumatic Brain Injury, Concussion
Sponsor: VA Office of Research and Development

 
 
 
 
 
Rehabilitation of Executive Functioning in Veterans with PTSD and Mild TBI 
 
 
 
Study ID: D1111-I 
 
ClinicalTrials.gov ID: NCT01921179 
 
v1.3: 11-13-2014 
 
 

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Abstract 
 
Both posttraumatic stress disorder (PTSD) and mild traumatic brain injury (mTBI) are 
prevalent in veterans from the Operation Enduring Freedom (OEF) and Operation Iraqi 
Freedom (OIF) conflicts and 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 in areas of complex attention, executive functions, and 
learning. Deficits in these cognitive control functions important have been linked with 
difficulties in community reintegration, educational and occupational functioning in 
individuals suffering from both PTSD and TBI. 
The overall aim of this proposal is to investigate the potential effectiveness (both short 
and longer term) of a training program that targets executive control functions of 
attentional self-regulation and goal management (GOALS), in Veterans with co-morbid 
posttraumatic stress disorder (PTSD), history of mild traumatic brain injury (mTBI), and 
cognitive difficulties. We will assess whether training in hypothetically targeted cognitive 
control mechanisms (attentional self-regulatory functions in particular) leads to improved 
functioning in other domains, such as daily task performance and emotional regulation.  
The effects of the training will be evaluated on multiple domains of functioning:  
We will assess whether training improves performance in targeted neuro-cognitive 
domains of complex attention and executive function, which are commonly impaired in 
veterans with both mTBI and PTSD. 
Executive control functions arguably most need to be engaged in the low structure of 
real-world settings, where direction by external structure is not sufficient to guide 
behavior. We will assess whether training core executive self-regulatory control 
functions via personally-relevant activities, generalizes to improved functioning in 
settings that reflect the complex, low-structure nature of the real world, as reflected both 
in participants’ performance on complex real-life tasks, and on self report of daily 
functioning. 
We will assess whether training in core executive self-regulatory control functions 
generalizes to improvements in emotional regulation and control in participants 
everyday lives as reflected by self-report measures. 
The primary aim of any training is to effect long term behavioral change post 
intervention. Long-term follow-up will be conducted to determine which aspects of the 

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intervention have enduring benefits, and in which domains.  We predict that the GOALS 
approach of training core executive self-regulatory control functions, using functionally 
and personally-relevant activities and goals in participants’ real lives, will make it more 
likely for training benefits to be incorporated maintained six months after training ends. 
This will be reflected by maintained improvement in multiple functional domains (neuro-
cognitive, daily functioning and emotional regulation) relative to their baseline 
functioning.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Rehabilitation of Executive Functioning in Veterans with PTSD 
and Mild TBI 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
List of Abbreviations 

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Provide a list of all abbreviations used in the protocol and their associated meanings. 
PTSD:   
Post-traumatic stress disorder  
mTBI:    
Mild traumatic brain injury 
GOALS:  
Goal Oriented Attentional Self-regulation training – experimental 
intervention 
EDU:   
Brain Health Education – comparison intervention 
OEF:  
Operation Enduring Freedom 
OIF:  
Operation Iraqi Freedom 
OND:  
Operation New Dawn 
SFVAMC: 
San Francisco VA Medical Center 
VANCHCS: VA Northern California Health Care System 

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Contents 
Protocol Title: ............................................................................................................................. 4 
1.0 
Study Personnel .............................................................................................................. 7 
2.0 
Introduction ..................................................................................................................... 8 
3.0 
Objectives ......................................................................................................................11 
4.0 
Resources and Personnel ..............................................................................................12 
5.0 
Study Procedures ...........................................................................................................14 
5.1 Study Design ...................................................................................................................14 
5.2 Recruitment Methods.......................................................................................................16 
5.3 Informed Consent Procedures .........................................................................................18 
5.4 Inclusion/Exclusion Criteria ..............................................................................................18 
5.5 Study Evaluations ............................................................................................................18 
5.6 Data Analysis ..................................................................................................................19 
5.7 Withdrawal of Subjects ....................................................................................................19 
6.0 
Reporting ........................................................................................................................20 
7.0 
Privacy and Confidentiality .............................................................................................20 
8.0 
Communication Plan ......................................................................................................20 
9.0 
References .....................................................................................................................22 
 

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Protocol Title:   
 
1.0 
Study Personnel 
 
• Provide name, contact information, and affiliations/employee status for the 
following: 
 
Principal Investigator: Tatjana Novakovic-Agopian, PhD 
                                     Phone: 415-753-3888;  
                                                 e-mail Tatjana.Novakovic-Agopian@va.gov 
                                     Affiliation: SFVAMC, VANCHCS -Martinez 
Co-Investigators:  
 Anthony J-W Chen, MD; 
                                    Phone: 415-595-1676  
                                                e-mail: Anthony.Chen@va.gov 
 Affiliation: SFVAMC, VANCHCS –Martinez 
 
 Gary Abrams, MD; 
                                    Phone: 415-221-4810 X3861  
                                                e-mail: Gary.Abrams@va.gov 
 Affiliation: SFVAMC 
   
Thomas Neylan, MD;  
                                    Phone: 415-221-4810  
                                                e-mail: Thomas.Neylan@va.gov 
 Affiliation: SFVAMC 
 
John McQuaid, PhD 
                                    Phone: 415-221-4810  
                                                e-mail: John.McQuaid@va.gov 
 Affiliation: SFVAMC 
 
 
Study Coordinator:     Deborah Binder, MS  
                                   Phone: 925-372-2498 
                                   e-mail: Deborah.Binder@va.gov  
                                  Affiliation: SFVAMC, VANCHCS –Martinez 
 

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2.0 
Introduction 
 
• Provide scientific background and rationale for study: 
The overall aim of this proposal is to investigate the potential short and long term effectiveness 
of a cognitive training program 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 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. The most common cognitive deficits associated with both PTSD and TBI 
involve attention, executive functions, and memory. Attention and executive functions deficits 
commonly found in PTSD include working memory difficulties, problems in sustaining attention 
over time, response inhibition, and impaired ability to gate, monitor, and regulate the flow of 
incoming information and environmental stimuli. Deficits in these cognitive control functions 
important for goal-directed behavior have been linked with difficulties in community 
reintegration, educational, and occupational functioning.  
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%.  A 2005 survey of Iraq/Afghanistan 
veterans found that for the 12% of 2235 respondents with a history of mild TBI, the 
strongest factor associated with persistent post-concussive symptoms was PTSD, even 
after removing overlapping symptoms.  A recent study indicated that 44% of Iraq soldiers 
who reported history of mild TBI also met criteria for PTSD, and that PTSD  may mediate 
the relationship between mild TBI and cognitive dysfunction. The incidence of PTSD 
rates tends to increase in relationship to the occurrence of TBI.  A recent study 
examining TBI and PTSD service utilization of OIF veterans found that one-year post-
deployment,  65% of those with mild TBI-PTSD reported seeking treatment for concerns 
related to reintegration. These findings strongly suggest that the combined syndrome of 
TBI-PTSD is common, complex, debilitating, and requires special consideration beyond 
each alone. The issues from TBI-PTSD include disruption of core cognitive and 
emotional regulation mechanisms that are essential for goal-directed functioning in daily 
life. Interventions that target cognitive and emotional self-regulatory functions may be 
particularly valuable in treating the combined PTSD-TBI syndrome. 
Either TBI or PTSD independently may alter cognitive, emotional, and behavioral 
functioning. Disruption of control over information processing reduces the effectiveness 
of higher level functions such as learning, problem-solving and goal management.  
Additionally, difficulties with emotion regulation and control can significantly affect 
cognition and goal attainment. Emotional and cognitive control are directly tied together 
in that the underlying neural systems interact significantly in achieving self-regulatory 
control necessary for goal-directed behavior. Deficits in these cognitive control functions, 
important for goal-directed behavior, have been linked with difficulties in community 
reintegration, educational and occupational functioning.  For example, individual 
experiencing feelings of anxiety and/or distress will likely be less able to effectively 
complete tasks that require overcoming challenges and solving problems.  Similarly, it is 

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likely that reduced cognitive control would contribute to poorer emotional control. 
Individuals with TBI, with reduced self-regulatory control, may have more difficulty 
managing and altering negative and/or traumatic associations and the ‘triggered’ 
emotions.  For example, an inability to filter out information and demands that are not 
directly related to a current goal may lead to increased feelings of being overwhelmed.  
Given the limitations of neural processing resources, it is expected that an increase in 
‘load,’ whether from cognitive or emotional sources, would lead to less efficient overall 
functioning.    
PTSD and mild TBI may have independent and additive roles, and may also interact at multiple 
levels, including at the genesis of injury, the maintenance of symptoms, different aspects of 
cognitive-emotional functioning, and at the level of neural mechanisms.  Features of each may 
interact to worsen functioning and/or make treatment more difficult. Cognitive dysfunction may 
impede treatment for emotional problems, and emotional dysregulation may impede treatment 
of cognitive dysfunction. Severe emotional control dysfunction, including anxiety, hyper-
vigilance, and avoidance, may become significant barriers to treatment of cognitive issues.  On 
the other hand, cognitive deficits, especially those affecting aspects of attention, learning and 
memory, may become barriers to effective treatment of emotional issues. In current practice, 
most interventions are directed towards a diagnosis of PTSD or TBI, but not both. Treating 
PTSD, in the context of TBI, may differ from treating PTSD alone. For individuals in the chronic 
phase of the disorder, the PTSD treatments with the strongest evidence are cognitive-
behavioral psychotherapies, such as cognitive processing therapy, as well as prolonged 
exposure therapy.  
Modification of these approaches for individuals with cognitive dysfunction remains an important 
frontier for treatment. Current experience suggests that PTSD in individuals who also sustained 
TBI may be more complicated, and the chronicity of symptoms may be extended.  Patients with 
TBI-PTSD may respond differently to standard treatments compared to those with only TBI or 
PTSD. Cognitive limitations may make it necessary to modify cognitive-behavioral therapies, 
and emotion regulation and impulse control problems may complicate the use of exposure 
techniques.  Conversely, the emotional dysregulation, avoidance and potential for triggering 
may impede engagement in cognitive rehabilitation therapies. 
These considerations argue strongly that treatments improving cognitive and emotional self-
regulatory functions may be particularly valuable in treating the combined PTSD-TBI syndrome. 
The issues from TBI-PTSD include disruption of core cognitive and emotional self-regulation 
mechanisms that are essential for goal-directed functioning in life. Interventions that strengthen 
the goal-directed control functions, such as the selection of goal-relevant information along with 
inhibition of distracting information, may be particularly helpful towards improving the 
functionally important / integrated aspects of self-regulation that contribute to goal attainment.  
Dorsolateral prefrontal cortex  and ventromedical prefrontal cortex interact in the regulation of 
emotions with modulation of amygdala.  These interacting circuits are likely to be important for 
cognitive and emotional self-regulation training such as mindfulness-based attention regulation 
(MBSR). A recent study illustrated that a modified MBSR training program, Mindfulness-Based 
Mind Fitness Training, may help healthy military reservists preparing for deployment to regulate 
their emotions. 
 
• 
Include summary of gaps in current knowledge, relevant data, and how the study 
will add to existing knowledge.   

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The above background forms an important foundation for further development of interventions 
for combined TBI-PTSD syndrome. The ultimate goal will be to strengthen key underlying self-
regulatory control functions that improve a person’s ability to adapt, be resilient, problem-solve, 
and in general, accomplish his/her own personal goals. Although studies evaluating the 
effectiveness of cognitive training targeting executive control deficits in individuals with co-
morbid PTSD and history of mild TBI are clearly needed, to our knowledge there have been no 
published studies in this area. 
We have developed a therapist-administered cognitive training program, Goal-Oriented 
Attentional Self-Regulation (GOALS) that targets executive control functions of applied 
mindfulness-based attention regulation and goal management strategies, and links them to 
participant-defined real-life goals. In contrast to training via practice on isolated tasks, this 
training protocol involves application of attention regulation skills and strategies to participant-
defined goals in real life, ecologically valid settings. One of the main training aims is to improve 
self-regulatory control mechanisms as they contribute to goal attainment. 
Two conceptual lines converged to delineate target processes for this intervention. First, 
pathways from perception to action require mechanisms for the selection of information for in-
depth processing, as well as the maintenance and protection of this information from both 
internal and external disruptions during working memory and subsequent learning, decision-
making, and/or problem-solving. Second, many patients with executive control difficulties show 
an overall “life disorganization” or “goal neglect”, with poor ability to manage and attain goals, 
even when they may be able to describe their intentions at the outset. We reasoned that 
selective maintenance of goal-related information, and protection from both internal (e.g. feeling 
anxious) and external disruptions are important for guiding sequences of steps (sub-goals) 
required to accomplish the goal. Therefore, intervening on these processes may help to 
ameliorate symptoms of goal neglect. The experimental training protocol was based on training 
interventions that have been applied to patients with brain injury as well as other populations, 
with special emphasis on mindfulness-based attention regulation strategies applied to 
progressively more challenging daily life situations and complex project-based functional tasks. 
Cognitive and emotional issues are addressed as they become important in achieving goals that 
are relevant to each individual participant. An overarching hypothesis is that training that 
improves self-regulatory goal-directed control over neural processing would benefit all 
subsequent stages of goal-based processing, by making more efficient, better integrated 
functional networks for the performance of relevant tasks, and ultimately goal attainment in real 
life contexts.   
In a prior study, we assessed the feasibility and effectiveness of GOALS training in individuals 
with chronic brain injury. Following training, participants showed improvements in accomplishing 
complex functional tasks in unstructured environment, confirming generalization of training 
effects to ecologically valid settings. In testing whether functional improvements might be 
related to improvements in the targeted cognitive functions, we also assessed domain-specific 
changes utilizing neuropsychological testing.  Participants who completed GOALS training also 
improved on neuropsychological measures of complex attention and executive functions, 
including working memory, mental flexibility, inhibition and sustained attention. Furthermore, 
fMRI results after training indicated significantly enhanced modulation of neural processing in 
extrastriate cortex and changes in prefrontal cortex.   
We have been conducting randomized-control study of the effects of GOALS training with 
Veterans with a history of chronic TBI. Preliminary results indicate improvements on 
neuropsychological measures of attention and executive function, and performance on complex 

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real-life tasks. Furthermore, participants had post training improvements on self-report 
measures reflecting emotional regulation and emotional health. These findings further suggest 
that improving cognitive control (attentional self-regulation in particular) may also improve 
functioning in other domains including emotional regulation and complex daily tasks, leading to 
a novel hypothesis regarding the value of functional improvements in cognition for emotional 
health. 
One of the main goals of any training is to encourage maintenance of benefits even after direct 
intervention ends. This is of particular practical importance given that therapist time with a 
patient is always limited. We designed the GOALS intervention to include extensive practice and 
active application of trained strategies in participants’ daily life to maximize the likelihood that 
the benefits of training would continue beyond the interactions with the trainer. In a follow-up 
structured interview conducted six months to two years following completion of GOALS training, 
as many as 92% of participants with chronic brain injury reported that they have integrated and 
continued to use some of the trained strategies in their daily lives, even in the absence of 
reinforcements provided by training.  
The overall aim of this proposal is to investigate the potential effects (both short and longer 
term) of Goal-Oriented Attentional Self-Regulation training program that targets executive 
control functions of attentional self- regulation and goal management in Veterans with co-morbid 
posttraumatic stress disorder (PTSD), history of mild traumatic brain injury (mTBI), and cognitive 
difficulties. We will assesses whether training in hypothetically targeted cognitive control 
mechanisms (attentional self-regulatory functions in particular) may lead to improved functioning 
in other domains, such as complex daily task performance and emotional regulation. 
The results of these studies will inform us to what extent a functional approach, training core 
executive self-regulatory attentional control functions via personally-relevant activities, will be 
effective in improving functioning for Veterans with PTSD and mTBI. The study design will 
provide a test not only of potential  benefits on real-life functioning, but also determine to what 
extent these benefits are related to actual changes in hypothetically targeted cognitive and 
emotional functions. These studies will provide a foundation for future studies to investigate the 
neural mechanisms that support improvements in these functions.   
 
• 
Include rationale for including or excluding certain populations – in particular 
vulnerable populations. 
Seniors are more likely to have confounding health or cognitive problems that could influence 
assessment data. The target group for the research study is returning OIF/OEF Veterans, 
majority of whom are under 65. 
3.0 
Objectives 
 
• 
Describe the study’s purpose, specific aims, or objectives.  
• 
State the hypotheses to be tested. 
The overall aim of this proposal is to investigate potential short- and long-term effects of a 
cognitive training program that targets executive control functions of attentional self- regulation 

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and goal management, Goal-Oriented Attentional Self-regulation (GOALS), in Veterans with co-
morbid PTSD - mTBI and cognitive difficulties.  
Aim 1:  Determination of short and long term effects of cognitive training on neuro-cognitive 
performance: 
Hypothesis 1: Participants who perform GOALS training will demonstrate greater 
improvements on untrained standardized neuropsychological measures of complex 
attention and executive function compared to participants who participate in control EDU 
training.  
Hypothesis 2: Improvements in complex attention and executive function will be 
sustained at six months post GOALS training, suggesting persistence of training 
benefits. 
Aim 2:  Determination of short and long term effects of cognitive training on complex real-life 
functional task performance and daily functioning: 
Hypothesis 1: Participants who perform GOALS training will demonstrate greater 
improvements on untrained complex real-life functional task performance compared to 
participants who participate in control EDU training.   
Hypothesis 2: Participants who perform GOALS training will report greater improvements 
on self-report measures of daily functioning compared to participants who participate in 
control EDU training. 
Hypothesis 3: Improvements in complex functional task performance and on self-report 
measures of daily functioning will be sustained at six months post GOALS training, 
suggesting persistence of training benefits. 
Aim 3:  Determination of short and long term effects of cognitive training on emotional 
regulation: 
Hypothesis 1: Participants who perform GOALS training will report greater improvements 
on self-report measures of emotional regulation compared to participants who participate 
in control EDU training. 
Hypothesis 2: Improvements on self-report measures of emotional regulation measures 
will be sustained at six months post GOALS training, suggesting persistence of training 
benefits. 
4.0 
Resources and Personnel 
• 
Include where and by whom the research will be conducted.  
Research activities will take place at San Francisco VA Medical Center (SFVAMC) and 
VA Northern California Health Care System (VANCHCS) in Martinez. Drs. Neylan and 
Abrams will engage in study activities at SFVAMC. All other research personnel will 
engage in study activities at both locations. 
• 
Provide a brief description of each individual’s role in the study.  Be sure to 
indicate who will have access to protected health information and who will be 
involved in recruiting subjects; obtaining informed consent; administering 
survey/interview procedures; and performing data analysis. 
Principal Investigator:  

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Tatjana Novakovic-Agopian, PhD: Oversee the scientific, clinical and administrative aspects of 
the study and manage research activities. 
  
Co-Investigators:  
Anthony J-W Chen, MD: Consult on neurological assessment and treatment of mTBI and 
management of multi site studies. 
 
Gary Abrams, MD: Consult on neurological assessment and treatment of mTBI and assist with  
recruitment.  
 
Thomas Neylan, MD: Consult on all PTSD-related activities in the study including recruitment 
and clinical evaluation. 
 
John Mc Quaid PhD: Consult on cognitive behavioral training and assist with  recruitment 
 
Study Coordinator: 
 
Deborah Binder, MS: Manage data, assist in recruitment, screening and multi-site logistics, 
coordinate submission of IRB documents and responsible for human subjects regulatory 
compliance  
 
Research Associates: 
Fred Loya, PhD: Screen potential subjects, obtain consent, and either administer assessments 
(as blinded evaluator) or implement interventions for subject that he is not evaluator. 
 
Michelle Murphy, PsyD: Screen potential subjects, obtain consent, and either administer 
assessments (as blinded evaluator) or implement interventions for subject that she is not 
evaluator. 
 
Maya Bruhns, MA: Screen potential subjects and implement interventions. 
 
Annemarie Rossi, MS OTR/L: Screen potential subjects and implement interventions. 
 
Gerald Carlin, MS: OTR/L  Implement interventions. 
 
Nicholas Rodriguez, BA: Assist with administrative aspects, recruitment, screening, data 
management. 
All of the research team will have access to protected health information and will be 
involved in recruiting subjects. 
 
• 
If applicable provide information on any services that will be performed by 
contractors including what is being contracted out and with whom. N/A 

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• 
If applicable provide information on any Memoranda of Understandings (MOUs) 
or Data Use Agreements (DUAs) that are being entered into including with whom 
and for what reason. N/A 
 
5.0 
Study Procedures 
5.1 Study Design 
 
• 
Describe experimental design of the study.  Include sequential and/or 
parallel phases of the study, including durations, and explain which 
interventions are standard of care.   
The proposed study includes two interventions, as well as pre- and post-intervention 
assessments.  
Participants who meet the inclusion criteria will be enrolled in the study and randomized to 
either a five-week comparison intervention (Brain Health Education - EDU) or an experimental 
intervention (Goal-Oriented Attentional Self-regulation training – GOALS).  
After 5 weeks, those who enter with EDU will receive 5 weeks of GOALS, while those who begin 
with GOALS will have no further formal training.  
Both groups will participate in assessments at baseline, week 5 and week 10. Long-term follow-
up will be conducted at 6 months.  
Time Commitment: Assessment: Neurocognitive assessments and self-report forms take up to 3 
hours and functional assessments take up to 2 hours to complete, or up to 4 hours combined. 
Assessments may be completed in one or two sessions.  Participants are free to take breaks 
during testing sessions. Participants participate in assessments four times during the course of 
the study (baseline, at 5 weeks, at 10 weeks, and at 6 months), or up to 20 hours (5 hours x 4 
time points). 
Participants will be randomly assigned to one or two 10-session interventions (GOALS and 
EDU), each lasting about 5 weeks.  Intervention sessions last about 2 hours, with 2 group 
sessions per week and 3 one-hour individual sessions over the period of training. Participation 
in GOALS alone requires about 63 hours total (20 hours group sessions, 3 hours individual 
sessions, 20 hours homework, and up to 20 hours assessments).  Participation in both GOALS 
and EDU requires about 106 hours total (40 hours group sessions, 6 hours individual sessions, 
40 hours homework, and 20 hours assessments). 
The interventions do not involve standard of care. 
 
• 
Include a description of how anticipated risk will be minimized and include 
an analysis of risk vs. potential benefit. 
Potential risks are minimal. The research procedures involved in this study present no 
physical risk and minimal  psychological risk to the subjects.  The primary risk in this 
study is the potential for anxiety (including possibility of exacerbation of PTSD 

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symptoms), discomfort or boredom associated with completing assessments and 
interventions.The test battery is relatively brief and is non-invasive. It consists of 
instruments  (neuro-cognitive and functional assessments and self-report 
questionnaires) that have been previously administered to different patient populations, 
thus the potential for creating undue anxiety or frustration is minimal. There is a 
possibility of fatigue or boredom during presentation of information during interventions 
and performance of cognitive tasks.   
All information will be kept confidential in accordance with all regulations as specified by the 
Department of Veterans Affairs. Any injuries that are a direct result of research procedures will 
be treated at no cost to the participant. Any adverse events will be reported immediately to the 
Institutional Review Board of the VA/UCSF. All associated personnel will have human subjects 
training and certification. All patients will be given a copy of their informed consent and 
encouraged to ask questions if they have any concerns. 
Another potential risk is related to training taking place in a small group setting. Other research 
subjects within the group may become aware of personal information about other subjects. 
Researchers will ask all subjects to keep private all information learned about other group 
members and to not talk about this information outside the group sessions. If a subject 
expresses concern about another subject divulging personal information outside the research 
setting, research staff will inform the study investigator. The study investigator will then contact 
the subjects in question to address any breaches of privacy or confidentiality. However, we 
cannot guarantee that other subjects will not talk about other subject’s personal information 
outside the group.  
Cognitive Testing: There is a possibility of frustration from poor performance or fatigue. 
Cognitive testing will stop if a patient displays frustration or appears tired.   
Cognitive training: There is a possibility of fatigue or boredom from performance of 
cognitive tasks. Participants are allowed frequent breaks during training. Participants are 
allowed frequent breaks during training.  For patients, training will be adjusted for the 
fatigue level, and training sessions will stop if patients are frustrated or fatigued. Thus 
far, participants have generally expressed positive experiences with training.   
It is possible that participation in the study may lead to an exacerbation of PTSD symptoms. All 
research staff directly working with participants have previous training and experience in 
working with this Veteran population (e.g., neuropsychologists; neuropsychology trainees; 
occupational therapist, certified rehabilitation counselor, etc.). Additionally, prior to contact with 
subjects, all research staff will undergo investigator-led training to confirm they recognize 
symptoms associated with PTSD/mTBI, such as subject reports of, or behavior that reflects: re-
experiencing the traumatic event, avoidance, increased anxiety, emotional arousal, anger and 
irritability. Research staff will be instructed to communicate such manifestations as soon as 
possible to the study investigators, who are licensed clinicians with expertise in the assessment 
and management of symptoms associated with PTSD and brain injury. A study investigator will 
immediately attempt to contact the subject for a telephone assessment, or if indicated, to 
schedule an in-person assessment.  Further action will be based on an assessment of the 
subject. Possible actions may include referral for additional appropriate clinical evaluation 
and/or follow-up treatment and possibly terminating the subject’s participation in the study. If a 

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subject is withdrawn from the study due to increased symptoms, the study investigator will 
personally inform the subject of the decision to terminate involvement and may refer the subject 
to follow-up treatment if the subject is significantly distressed over being withdrawn. 
In the event a subject manifests increased PTSD symptoms that are not minor and 
transient, the investigator will complete Form 119: Report of Unanticipated Serious 
Adverse Event (SAE) and/or Unanticipated Problem (UAP) Involving Risks to 
Participants or Others. 
If a subject expresses concern about another subject divulging personal information outside the 
research setting, research staff will inform the study investigator. The study investigator will then 
contact the subjects in question to address any breaches of privacy or confidentiality. 
Research staff will notify the study investigator within 24 hours if any subjects report or manifest 
more than minor and transient distress. The study investigator will contact the subject to 
evaluate the situation and determine if clinical referral is warranted. If a referral is warranted, the 
study investigator will inform the subject that a referral for treatment will be made. When making 
the referral, the study investigator will request that the subject’s privacy be respected when 
scheduling the appointment. 
All research staff will be trained in the above procedures. The research team will also meet or 
have conference calls weekly to discuss study activities and any issues or concerns about 
subjects. The research staff at both study sites is the same.  
The potential risks in this study are balanced by the potential benefit for participants or 
their families. Some of the procedures involve cognitive task practice and training that 
may improve certain specific cognitive skills.   Prior research with individuals with chronic 
TBI has suggested that participation in this cognitive training may be beneficial towards 
improving executive control skills. The focus of the current study is to test whether 
individuals with PTSD and mild TBI would also benefit from this training. The findings 
from these studies may potentially contribute towards improving rehabilitation for 
patients with Posttraumatic Stress Disorder and mild TBI, leading to an indirect benefit to 
society.  
The findings from these studies may potentially make a major impact in improving rehabilitation 
for patients with Posttraumatic Stress Disorder and mild TBI, leading to an indirect benefit to 
society. Improved treatments for executive control and emotional dysfunction would potentially 
make a major impact in improving outcomes after exposure to traumatic events. The findings 
from these studies will be presented to health care workers and to other scientists in the field, 
and this is expected to influence both clinical care and future scientific investigations.  
This research is designed to contribute to improving care by (1) providing a neuroscientific 
framework for understanding neurorehabilitation therapies and their effects on executive control 
functions and emotional regulation; and  (2) aiding in the design of novel therapeutic 
interventions that more directly target the underlying cognitive bases of dysfunction. Completion 
of the proposed studies will provide an essential foundation for the immediate next steps -- 
directly targeting the elucidated neural pathways using improved behavioral, physiological (e.g. 
transcranial magnetic stimulation) and pharmacologic modulation treatment interventions. 
 

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• 
Provide description of the study population (delineate all categories of 
subjects – patients, providers, family members, employees, etc.). Include 
anticipated enrollment numbers 
Total planned enrollment is 54. Subjects will be Veterans, ages 18 to 55 years, with at 
least 12 years of education, a current diagnosis of PTSD (DSM IV-R), and a history of 
mild traumatic brain injury. 
• 
As applicable, provide information on any added protections for 
vulnerable populations. N/A 
• 
If applicable include information on data and specimen banking. N/A 
5.2 Recruitment Methods 
 
• 
State how many subjects will be needed.  
About 80 subjects will be recruited and enrolled to meet the enrollment target of 54, out 
of which it is anticipated 42 will complete the study. 
• 
Describe when, where, how and by whom potential subjects will be 
identified and recruited.  
Recruitment material includes a brochure, flier, and letters to potential participants, clinicians, 
and service providers. Participants will not be cold called. Researchers will call potential 
participants only if returning a call or a request to call (e.g., if potential participant left a note 
requesting phone contact). Recruitment activities will include presentations to individuals and 
groups associated with PTSD, as well as distribution of approved letters, brochures and flyers.  
Recruitment activities will target VA clinicians, VA Outpatient Clinics, Veteran Centers, State of 
California Department of Rehabilitation Veteran Services Programs, Employment Development 
Department Veterans Outreach programs, County Veterans Services, college programs for 
veterans, and Travis AFB Transition Service Center, as well as mental health and neurology 
clinics in local hospitals. Brochures and fliers will be placed in locations approved by the facility 
being visited, e.g., bulletin boards and brochure display tables. Clinicians on the research team 
may also provide an-IRB approved brochure or letter to selected patients who may be interested 
 
Step-by-Step Recruitment Process: Research team members will contact or visit the above 
entities and request permission to leave off brochures, flyers and letters and will also ask if any 
clinicians or other service staff might be interested in hearing more about the research.  If so, 
researchers will schedule a presentation to clinicians or service providers. Clinicians or service 
providers may invite potential subjects to these presentations. Brochures, flyers and letters will 
be available for distribution at presentations. If clinicians or service providers contact the 
researchers to refer a potential subject, they will be asked to have the subject initiate contact 
with the research team. If a potential subject expresses interest in person (e.g., at a 
presentation or if simply observing brochures being distributed), a telephone appointment will be 
scheduled to discuss the possibility of participation.   
 
Researchers will follow the ‘Initial Contact Script’ for the first telephone contact with potential 
subjects. The Informed Consent will be reviewed during this initial telephone contact. If the 
potential subject continues to express interest and is not clearly ineligible, a telephone 
screening interview will be scheduled. 

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If the potential subject continues to express interest by the end of the telephone screening 
interview, a research clinician or rehabilitation specialist (e.g., neuropsychology fellow, certified 
rehabilitation counselor) will review the medical record in CPRS. Documents reviewed in the 
medical record will be those pertinent to eligibility criteria, e.g., diagnosis of PTSD, history of 
mTBI (not moderate or severe), neurocognitive and psychological testing reports, medication 
history, current symptoms, evidence of substance abuse, etc. A summary of the medical record 
review will be provided to the study investigator, who will determine whether the potential 
subject appears likely eligible and therefore a candidate for the second, in-person screening.  
The types of medical records we may review to assess eligibility include: Patient History and 
Physical Examination, Discharge Summary(ies),     X-rays and other Imaging Reports, 
Diagnostic/Laboratory tests,  Drug Abuse Information, Alcoholism or Alcohol Use, Operative 
Report(s), Progress Notes, and Mental Health (not psychotherapy notes). 
If potential subject appears likely to be eligible, the investigator will contact him/her and 
schedule an appointment for a consent and more in-depth eligibility interview and screen. At this 
in person meeting, the investigator will go through the informed consent process with the 
potential subject, including reviewing and signing Form 10-3203 if the subject is agreeable to 
being videotaped  
 
The above process can be summarized as follows: Screen 1 → Medical Record Review 
→Summary to Investigator → Investigator determines if Screening 2 to be scheduled  → 
Screening 2 (in-person). 
A second pathway for Medical Record Review occurs when investigators identify potential 
subjects through CPRS medical record review or by VA providers providing names of Veterans 
who may quality (with HIPAA waiver), in which case medical record review takes place before 
telephone screening. In this case, investigators will assess eligibility of potential subjects 
through review of medical records in the CPRS database. The subgroup of patients identified as 
potentially eligible will be sent letters introducing the study to them. The letter will include 
contact information if they are interested in further information about the study. If the 
researchers do not hear back from potential subjects within 2 weeks of sending the letter, they 
will contact the potential subjects once to confirm receipt of letter and ascertain interest. 
This second process can be summarized as follows: Identify Potential Subject → Medical 
Record Review → Send Letter →Follow-up Call (if no hear) → Screen 1 (if interested) 
→Summary to Investigator → Investigator determines if Screening 2 to be scheduled  → 
Screening 2 (in-person). 
• 
Describe materials that will be used to recruit subjects, e.g., 
advertisements.  Include materials as an appendix or separate 
attachment. 
 
Recruitment material includes a brochure, flier, and letters to potential participants, 
clinicians, and service providers.  
• 
Describe any payments to subjects, including the amount, timing (at the 
end of the study or pro-rated for partial study participation), method (e.g., 
cash, check, gift card), and whether subjects will experience a delay in 
receiving the payment. 

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Participants will be paid $20/hour for the in-person Consent meeting and final screening, $100 
per testing session and $.55 mile for over 20 miles each way for travel to testing or 
interventions.  If Participants do not participate in any further study activities after the 
consent/screening meeting, they will be paid by mailed check within 6-8 weeks. If they 
continue to participate, they will be paid by mailed check within 6-8 weeks of participation in 
testing sessions. If they decide to withdraw from the study, they will be paid by mailed check in 
6-8 weeks after any testing time they already completed before withdrawing.            
5.3 Informed Consent Procedures 
 
• 
Indicate if informed consent will be obtained and/or or if you are 
requesting a waiver of informed consent or waiver of documentation of 
informed consent.  If the research involves multiple phases, specify for 
which phases of the research the waiver(s) is being requested and/or the 
informed consent will be sought. 
Informed Consent will be obtained. 
• 
Describe who will be obtaining informed consent, if applicable, and any 
circumstances that may need to be addressed (e.g. subjects with 
impaired decision making ability and the use of a legally authorized 
representative, etc.) 
The principal investigator will train all research staff in documenting and obtaining 
informed consents.  No subjects will have impaired decision making ability or require the 
use of a legally authorized representative. 
• 
If applicable, indicate how local site study personnel will be trained 
regarding human subjects protections requirements and how to obtain 
and document informed consent. 
The same research staff will be at both sites. All research staff will be trained in 
obtaining and documenting informed consent. 
5.4 Inclusion/Exclusion Criteria 
 
• 
Describe the criteria that determine who will be included in or excluded 
from the study.  
Inclusion Criteria: Veterans, ages 18 to 75  years, with at least 12 years of education, 
a current diagnosis of PTSD (DSM IV-R), and a history of mild traumatic brain injury, 
defined by the American Congress of Rehabilitation Medicine (ACRM) and VA, as a 
traumatically-induced physiological disruption of brain function as demonstrated by at 
least one of the following: (1) loss of consciousness of up to 30 minutes; (2) any loss 
of memory for events immediately before or after the event; (3) any alteration in 
mental state at the time of the event, for example feeling dazed, disoriented, or 
confused; and (4) a focal neurological deficit or deficits that may or may not have 
been transient, for example loss of coordination, speech difficulties, or double vision. 

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Participants must be in the chronic, stable phase of recovery (>6 months from injury), 
with residual cognitive difficulties that are affecting daily functioning; on stable 
psychoactive medications (> 30 days); and able and willing to commit to participate 
in 10 weeks of training and assessments. 
The original inclusion criteria  included OIF/OEF/OND Veterans, ages 18 to 55 years, with 
12-16 years of education.  The protocol was amended to eliminate the OIF/OEF/OND 
requirement, raise the age limit to 65, and  extend the education years.  The rationale for 
these changes were to:  1) expand number of potential subjects to increase likelihood of 
reaching study enrollment target; 2)  increase the eligibility pool to include  older veterans 
with PTSD who may be able to benefit from cognitive interventions, given that PTSD 
symptoms can last for several years, even decades, after the original trauma; and 3) to 
expand the eligibility pool to include veterans with more than 4 years of college education, 
as many veterans have more than 4 years of college. 
 
The amended inclusion criteria included Veterans, aged 18 to 65 years. The protocol was 
amended to raise the age limit to 75 years. The rationale for this change was to  once again 
expand number of potential subjects to increase likelihood of reaching study enrollment 
target; 2)  increase the eligibility pool to include  older veterans with PTSD who may be able 
to benefit from cognitive interventions, given that PTSD symptoms can last for several years, 
even decades, after the original trauma.              
 
Exclusion Criteria: A history of moderate or severe TBI (defined by ACRM as having an 
injury that includes a loss of consciousness  lasting longer than 30 minutes, or post-
traumatic amnesia lasting longer than 24 hours). Unstable medical, neurologic, or 
psychiatric condition, including severe cognitive dysfunction, or other reasons for being 
unable or unwilling to participate in the training and assessments; ongoing illicit drug or 
alcohol abuse (AUDIT>8); psychosis, severe depression, anxiety or PTSD precluding 
participation in research activities; current (past 60 days) evidence-based PTSD 
remediation therapy; poor English comprehension. Eligible participants may have other 
co-morbid stable neuropsychiatric disorders, including depression.  There will be no 
restriction in regard to gender, race and socioeconomic status. 
Inclusion and Exclusion criteria will be verified through the first screening telephone interview 
(e.g., English speaking ability), medical record review and assessment by the principal 
investigator during the in-person screening interview. 
To ensure that participants’ providers (e.g., PCPs and mental health providers) are aware of 
their participation in a research intervention, we will work with local facilities to flag in CPRS that 
the patient is enrolled in a cognitive rehabilitation research study. Both the participant and 
his/her providers will be informed that unless it is medically contra indicated, the participant 
should stay on the same therapy regiment (particularly with regard to psychoactive medications 
regiment, or new evidence based behavioral interventions) for the 6 month duration of the study.    
5.5 Study Evaluations 
 
• 
Describe all evaluations to be conducted (including screening; 
tests/questionnaires that will be administered; any procedures that 

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subjects will be required to complete) and data collection methods.  
Include materials as an appendix or separate attachment. 
Mayo Portland Adaptability Inventory (Malec, et al. 2001 ), Goal Processing 
questionnaire; Novakovic-Agopian, Chen, Rome 2007),  Profile of Mood States (Lorr and 
McNear et al., 1988), PCL-M (PTSD Checklist - Military Version),  Auditory Consonant 
Trigrams, Digit Vigilance,  Delis-Kaplan Executive Function System (DKEFS), Hopkins 
Verbal Learning Test - HVLT-R, Brief Visual Memory Test Revised - BVMR-R, Trails A, 
Trails B, Wechsler Test of Adult Reading-WTAR (Psychological Corporation, 2001), 
Letter Number Sequencing, WAIS IV, Goal Processing Scale (Novakovic-Agopian, Chen 
et al 2012), Clinician-Administered PTSD Scale (CAPS- Blake et al, 2000), Beck 
Depresion Inventory,  Difficulties in Emotional Regulation Scale (Gratz and Roemer, 
2004). There is also a screening questionnaire. 
Mayo Portland Adaptability Inventory does address substance abuse. However, The purpose of 
the data is to conduct scientific research and that no personnel involved in the study may 
identify, directly or indirectly, any individual patient or subject in any report of such research or 
otherwise disclose patient or subject identities in any manner that would suggest the individual 
patient or subject has been involved or referred to any drug or alcohol treatment program. 
The evaluator will videotape the Goal Processing Scale functional assessment if the subject 
agreed and signed the VA 10-3203 Consent form and continues to agree to being videotaped 
during the assessment. The subject has the option to refuse this without affecting participation 
in the study. The video camera will be placed unobtrusively by the subject. Videotaping GPS 
sessions will allow the evaluator to review the functional assessment later to address any 
questions or issues related to rating subject performance. Videotaped assessments may be 
reviewed by other raters to confirm ratings. Videotapes will be stored in locked cabinets in 
locked VA offices and viewed in locked VA offices.  
 
 
5.6 Data Analysis 
 
• 
Provide sample size determination and analysis (include anticipated rate 
of screen failures, study discontinuations, lost to follow-up etc.). 
We estimated sample size requirements for the primary hypotheses for each aim based 
on the actual preliminary data from veterans who underwent GOALS training.  For 
Attention and Executive Function Overall Domain z score (AVEXE) we found a 
standardized effect size of 1.2, for the GPS Overall Domain Score (GPSTA) and the 
Mayo Portland Adaptability Inventory Total Score (MPTST) we found a standardized 
effect size of 1.1, and for the POMS Total Mood Disturbance Score (POMSTMDZ) we 
found a standardized effect size of 0.8. Therefore, using the lowest effect size we would 
estimate that a feasible sample size of 42 patients (21 per group) for each intervention 
(GOALS and EDU) should yield a power of .80 at an alpha level of 0.05 to detect a 
standardized effect size of 0.8 or larger. 
• 
Describe how, where and by whom the data will be analyzed. 

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Tests of repeated measures will be used to assess the effects of the training 
interventions on pre- and post- intervention measurements. Intervention group x time 
interactions will be assessed using ANOVA and specific relationships will be tested 
using paired T-tests. 
Practice Effects: Because of repeated testing, improvements on some assessments may 
be partially due to practice. As a sensitivity analysis, we will compare tests using 
absolute change scores (as described above) to those using a change index that 
corrects for practice effects [70]. Specifically, change is operationalized as ((X2-X1)-(M2-
M1))/SED, where X1, M1, and X2, M2 are the baseline and follow-up scores for a 
participant and corresponding group means, respectively; SED is the standard error of 
the difference.  These results will be compared to those obtained from the regression 
models. 
The PI and co-investigators will perform data analysis. 
5.7 Withdrawal of Subjects 
 
• 
Describe any anticipated circumstances under which subjects will be 
withdrawn from the research without their consent.  
A subject may be withdrawn if the event of severe increase of PTSD symptoms, disruptive 
behavior (e.g., yelling during sessions, conflict with another subject), non-compliance (e.g., 
never attends training sessions), changes in medical condition (e.g., severe illness 
precluding participation), changes in psychotropic medications, and unforeseeable 
circumstances (e.g., death in family; offer of full-time employment). 
• 
Describe the consequences of a subject's decision to withdraw from the 
research and the procedures for orderly termination of participation by the 
subject (e.g., the subject contacting the investigator for an end-of-study 
visit). 
 
Participants are told they can withdraw at any time. Should the investigator decide to terminate 
a subject’s participation, she will contact the participant to discuss the reasons for termination.  
The investigator will also make a follow-up appointment if requested by the participant to 
discuss further any concerns expressed by a participant.  
6.0 
Reporting 
 
• 
Include procedures for reporting unanticipated problems, serious adverse events, 
and protocol deviations. 
All research staff has been directed to document unanticipated problems or adverse events and 
to notify the Principal Investigator of any unanticipated problem or adverse event.  Investigators 
will follow up with subjects (in person or by telephone call) until the resolution of the adverse 
event and will ensure that appropriate medical care is provided. Researchers will complete SAE 

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or UAP reports. Reports will be submitted to the VA Central IRB within 5 business days after the 
reporting individual becomes aware of the occurrence.   
7.0 
Privacy and Confidentiality 
 
• 
Describe whether the study will use or disclose subjects’ Protected Health 
Information (PHI).  
Screening subjects will include review of VA medical records.   
• 
Describe the steps that will be taken to secure the data (e.g., training, 
authorization of access, password protection, encryption, physical controls, 
Certificates of Confidentiality, and separation of identifiers and data) 
Electronic data will be stored on VA computer hard drives and server, all encrypted per VA 
guidelines. Paper records will be kept in locked cabinets in locked VA offices. 
If VA desktop computers are unavailable (e.g., being used by other researchers), research staff 
may use VA laptops to enter/save research data (e.g., de-identified test scores) and then 
transfer data to r drive directly from laptop or, if applicable, transfer to VA desktop computer via 
USB drive. Researchers will also use laptops for email and files that don’t involve subject data 
(e.g., research design, materials for presentations or publications, if desktop computers 
unavailable or if out of the office). 
The USB drives have security features (activated by thumb swipe or password) that prevent 
them from being used by anyone other than the researcher to whom they are assigned. 
Researchers may use the USB drives to transfer information from a VA laptop to a VA desktop 
computer for further data entry/calculations when the desktop computer becomes available. The 
data would be uploaded to the VA server when data entry/calculation is complete.  
8.0 
Communication Plan 
 
• 
Include plan for ensuring all required local site approvals are obtained and 
notifying the Director of any facility where the research in being conducted but 
the facility is not engaged. 
 
o N/A – both sites are engaged 
• 
Include plan for keeping all engaged sites informed of changes to the protocol, 
informed consent, and HIPAA authorization 
 
o The staff will be the same at both sites. 
 
• 
Include plan for informing local sites of any Serious Adverse Events, 
Unanticipated Problems, or interim results that may impact conduct of the study. 

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o Notify by telephone and email local facility’s institutional official and R & D 
Committee of any SAE, UAP and interim results that may impact conduct of the 
study 
o Complete and submit SAE/UAP documentation as required by the local facility 
and local facility’s R&D Committee. These documents will be uploaded to the 
Central IRB website 
 
• 
Include plan for ensuring the study is conducted according to the IRB-approved 
protocol. 
 
o Prior to implementation of study, thoroughly train all research team members in 
study and IRB procedures and documents 
o Create and distribute written study procedure protocols kept in paper and 
electronic copy formats 
o Distribute IRB materials on procedures and report forms and maintain current 
IRB materials in paper and electronic copy formats 
o Hold weekly conference calls to address questions and resolve issues regarding 
study conduct, protection of human subjects, and IRB guidelines and forms. 
o Encourage open communication between research team members and PI/SC to 
address questions or concerns about study procedures and protection of human 
subjects. Open communication will be encouraged by holding weekly meetings 
and/or conference calls in which the PI specifically asks members of the team to 
voice questions and concerns about any aspect of the study. The PI will also 
encourage the research staff to email or call about issues or concerns if they 
prefer to use those channels.  
• 
Include plan for notifying all local facility directors and LSIs when a multi-site 
study reaches the point that it no longer requires engagement of the local facility 
(e.g., all subsequent follow-up of subjects will be performed by the PI from 
another facility). 
o The PI/SC will notify the Local Facility Director in writing (paper and 
email) when the study no longer requires engagement of the local facility  
 
9.0 
References 
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Their Consequences, and Services to Assist Recovery. 2008, Santa Monica, CA: RAND. 
2. 
Seal, K., Metzler, TJ, Gima, KS, Bertenthal, et.al. Increasing Prevalence of Mental 
Disorders among Iraq and Afghanistan Veterans: Trends and Risk Factors for Mental 
Health Diagnoses in New Users of VA Healthcare, 2002-2008. American Journal of 
Public Health, 2009. 99(9): p. 1651-1658. 
3. 
Hoge, C.W., et al., Mild traumatic brain injury in U.S. Soldiers returning from Iraq. N Engl 
J Med, 2008. 358(5): p. 453-63. 

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4. 
Hoge, C.W., H.M. Goldberg, and C.A. Castro, Care of war veterans with mild traumatic 
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Vasterling, J., PTSD and Neurocognition. National Center for Posttraumatic Stress 
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Vasterling, J., Brewin, C. R. , Neuropsychology of PTSD. 2005: The Guilford Press. 
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Geuze, E., Vermetten, E, de Kloet, CS, Hijman, R, Westenberg, HG., 
Neuropsychological performance is related to current social and occupational functioning 
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Ownsworth, T. and K. McKenna, Investigation of factors related to employment outcome 
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Drake, A.I., et al., Factors predicting return to work following mild traumatic brain injury: 
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Vanderploeg RD, B.H., Curtiss G.(2009) Mild traumatic brain injury and posttraumatic 
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Chen, A.J., et al., Training of goal-directed attention regulation enhances control over 
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Brandes, D., et al., PTSD symptoms and cognitive performance in recent trauma 
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Gilbertson, M.W., et al., Multivariate assessment of explicit memory function in combat 
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Vasterling, J.J., et al., Attention, learning, and memory performances and intellectual 
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Leskin, L.P. and P.M. White, Attentional networks reveal executive function deficits in 
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Vasterling, J.J., et al., Attention and memory dysfunction in posttraumatic stress 
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Schneiderman, A.I., E.R. Braver, and H.K. Kang, Understanding sequelae of injury 
mechanisms and mild traumatic brain injury incurred during the conflicts in Iraq and 

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Afghanistan: persistent postconcussive symptoms and posttraumatic stress disorder. Am 
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Taber, K.H. and R.A. Hurley, PTSD and combat-related injuries: functional 
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Polusny, M., et al., Longitudinal effects of mild traumatic brain injury and posttraumatic 
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Chen, A., Novakovic-Agopian, T. , Intervening to improve cognitive functioning after 
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Vasterling, J., Bryant, R. & Keane, T.  PTSD and Mild Traumatic Brain injury. 2012, New 
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Cahill, S., et al., Cognitive-behavioral therapy foradults, in Effective Treatments for 
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E.B. Foa, et al., Editors. 2009, Guilford Press: New York. p. 139-222. 
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Monson, C., et al., Cognitive processing therapy for veterans with military-related 
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Schnurr, P., et al., Cognitivebehavioral therapy for posttraumatic stress disorder in 
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Phelps, E.A., et al., Extinction learning in humans: role of the amygdala and vmPFC. 
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protective effects of mindfulness training on working memory capacity and affective 
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Duncan, J., et al., Intelligence and the frontal lobe: the organization of goal-directed 
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VonCramon, D., G.M.-v. Cramon, and N. Mai, Problem-solving deficits in brain-injured 
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33. 
Levine, B., et al., Rehabilitation of executive functioning: an experimental-clinical 
validation of goal management training. J Int Neuropsychol Soc, 2000. 6(3): p. 299-312. 
34. 
Rath, j., et al., Group treatment of problem-solving deficits in outpatients with traumatic 
brain injury: A randomised outcome study. Neuropsychological Rehabiltation, 2003. 
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35. 
Levine, B., et al., Cognitive rehabilitation in the elderly: effects on strategic behavior in 
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Nezu, A.M., C.M. Nezu, and T.J. D'Zurilla, Solving Life's Problems. 2007, New York: 
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37. 
Novakovic-Agopian, T., Chen, A., Rome, S., Rossi, A., Murphy, M., Abrams, G., & 
D’Esposito, M, Long Term Effects of Executive Functioning Training in Attention 
Regulation Applied to Individually Defined Goals, in TBI Research Meeting, March. 
2011: Palo Alto VA. 
38. 
Novakovic-Agopian, T., Chen, A., et al. , Long Term Effects of Executive Functioning 
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39. 
Novakovic-Agopian, T., A.J.-W. Chen, and S.R. Rome, Goal Oriented Attentional Self-
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Corporation: San Antonio, TX. 
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processing: An extension. The Clinical Neuropsychologist 1988. 1: p. 139-152. 
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Demographically Adjusted Neuropsychological Norms for African American and 
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Delis, D., E. Kaplan, and J. Kramer, Delis-Kaplan Executive Function System. 2001, 
Pearson Assessment and Information: San Antonio, TX. 
44. 
Novakovic-Agopian, T., et al., Relationship between neuropsychological performance, 
and immune parameters in HIV-1 infected patients with and without AIDS dementia 
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