Metacognitive Training to Enhance Strategy Use in Blast Related TBI
Phase: NA
Conditions: Brain Concussion, Blast Injuries
Sponsor: VA Office of Research and Development

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Protocol ID#: B0902-W 
1. Project Title: Metacognitive Training to Enhance Strategy Use In Blast-Related TBI 
2. Investigator(s): PI: J. Kay Waid-Ebbs, PhD  
3. Abstract: 
     Increasing numbers of veterans are experiencing executive dysfunction due to a mild 
traumatic brain injury (mTBI). Executive dysfunction interferes with participation in home 
and work activities. Therefore, an effective intervention is needed that will provide 
significant and long-lasting improvement in the everyday lives of our veterans. Goal 
Management Training (GMT), an intervention that teaches a five-step strategy to 
improve planning and organization, has demonstrated promising results (Levine et al., 
2000; 2007).  However, there are several weaknesses regarding validation of the GMT 
in individuals with TBI. Therefore, the proposed study is needed to determine the effect 
of the 10-session GMT on veterans with mTBI. This study will 1) administer the 10-
session GMT to individuals that have an objective executive dysfunction; 2) due to 
mTBI; 3) use probes designed to measure the activities trained in GMT, along with a 
measure of generalization; and 4) determine the number of subjects needed to 
demonstrate a treatment effect in a future randomized clinical trial.  
4.  Background:    
Brain Injury has become the signature wound of Operation Iraqi Freedom (OIF) and 
Operation Enduring Freedom (OEF). An estimated 20,000 military personnel have been 
wounded in action primarily due to blasts (US, 2006). However, an even larger number 
are thought to have suffered a mild traumatic brain injury (mTBI) that was left 
undetected (Lew, 2005). A mTBI is diagnosed if any of three following criteria are met: 
1) loss of consciousness less than 30 minutes with a Glasgow Coma Scale of 13 or 
above; 2) any loss of memory for events immediately before and after the event (not 
longer than 24 hours); any alteration of mental state at the time of accident; 3) any focal 
neurological deficits that may, or may not, be transient (ACRM, 1993). Of an at risk 
group evaluated at Walter Reed during 2003-2004 an estimated 59% suffered at least a 
mild TBI while in combat (Warden, 2005). It is known that over 2 million civilians sustain 
a TBI each year, of which an estimated 85% are mild (Sherer and Novack, 2003). 
However, this figure may be an underestimation, since some individuals that sustain a 
mild TBI do not seek treatment.  
     The problems that result from mTBI are diverse. During the acute stage individuals 
may experience obvious problems with attention, verbal retrieval, forgetfulness, 
headache, dizziness, irritability, drowsiness, sleep disturbances and fatigue (Ponsford, 
2000). In addition, military personnel also suffer emotional issues such as PTSD, 
depression and anxiety disorders (Lew, 2005). While the majority of individuals with 

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mTBI are thought to totally recover within the first three months, several studies have 
found up to 48% continue to experience one or more symptoms up to a year after the 
injury (Alves, 1993; Jacobson, 1995). For example, Drake et al. (2000) found in a 
military sample that 46% were not able to return to their previous duty after three to 
fifteen months; with memory and executive functions impairments as the greatest risk 
factor.  
    The chaos and trauma that occur when an explosive device is detonated make it 
difficult to follow the diagnostic criteria outlined above.  Even so, military personnel 
exposed to a blast may suffer a mild TBI because the brain is especially susceptible to 
the “blast over pressurization” that affects fluid filled organs of the body (Mayorga, 
1997). Exposure to a blast may cause diffuse axonal damage, as well as damage 
sustained from being thrown or having objects hit the head (Lew, 2005). The frontal 
lobes are most susceptible to injury due to the contact of the bony orbital surface to the 
frontal lobes and the frontal poles (Damasio & Anderson, 2003). Therefore, the diffuse 
axonal damage and contusions will occur prominently in the frontal lobes as well as 
other cortical and subcortical structures, which is evident in the cognitive deficits 
following a mTBI.   
     Executive functions are most commonly affected by damage to the frontal lobes.  
They can be disrupted by damage to the focal areas in the frontal lobes or to the frontal-
subcortical circuits that integrate cognitive, self-regulatory, and emotional behavior 
(Stuss, 2007). In fact, disorganization as a result of executive dysfunction is the most 
common complaint about individuals with TBI (Mateer, 1987). The self-regulation of 
behavior is less necessary in well-learned activities that become automatic but is more 
necessary in new activities that require inhibition of an over-learned plan so that a new 
problem-solving strategy can be developed. A new plan requires the ability to maintain 
intentions as well as the execution of those intentions (Levine, 2000). After frontal injury, 
intention and action can become dissociated; individuals with frontal lobe damage may 
be able to tell you the appropriate action to take, but do not follow that action (Luria, 
1966). Several steps need to be coordinated for an individual to achieve his/her 
intentions. First the difference between the current state and the desired state must be 
detected. Second, the steps needed to reach that desired state must be formulated. 
Third, the desired state must be kept in mind while resisting other distractions. Fourth, 
the barriers that occur along the way must be overcome until finally the goal is 
achieved. Once the goal is achieved, the result must be evaluated. Duncan (1986) 
refers to the inability to complete step 3 as “goal neglect”. In order to be able to live 
independently, we must be able to keep in mind what we are doing, avoid distractions, 
respond to novel problems in new ways while inhibiting the ineffective way we have 
responded in the past, and evaluate how well we did.  Individuals with executive 
dysfunction will have difficulty performing the tasks necessary to deal with novel 
situations in an unstructured setting. 
     Given the numbers of military personnel who may be struggling with executive 
dysfunction, an effective intervention to improve executive functions is needed. 
However, there are no treatments for executive dysfunction in mTBI that have been 
rigorously investigated. Robertson (1996) developed a treatment package called goal 
management training (GMT) based on Duncan’s theory of “goal neglect”. GMT is a 7-
session (2 hours/ session) interactive module that is presented in a group format. A 5-

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stage strategy is taught to the participants and is then incorporated into tasks practiced 
in the group session as well as in tasks each participant is to practice at home. The 5-
stage process consists of “stop-what am I doing”, “define the goal”, “list the steps”, 
“learn the steps”, then “check-am I doing what I planned”. Levine validated the GMT by 
randomly assigning 30 TBI patients to either a one-hour version of GMT or motor skills 
training (Levine et al. 2000). The one-hour GMT was associated with improvements 
(being more careful as demonstrated by taking longer to complete the task after 
training) in paper and pencil tasks (proof reading and grouping) that simulated tasks 
requiring cognitive control. Since then, Levine et al. have modified the GMT module and 
increased the length of training to seven, two-hour sessions (14 hours total) (Levine et 
al., 2007). To date the only published use of this expanded GMT has been with an 
elderly sample, embedded in a larger rehabilitation package. The expanded version 
(modified GMT) may offer promise to the mTBI population as well. 
     The proposed study is needed to determine the effect of the expanded GMT in 
veterans with mild TBI. 40-North Florida/South Georgia, Operation Enduring 
Freedom/Operation Iraqi Freedom/Operation New Dawn (OEF/OIF/OND) Veterans will 
be recruited who meet criteria for TBI (ARCM, 1993) and have current executive 
dysfunction.  
     Two screening measures, Delis-Kaplan Executive Function Test System (D-KEFS) 
color word interference test and the Stop Signal Task will be used to select individuals 
that demonstrate deficits in inhibition which is within the domain of executive function.    
    The Computerized Tower of London will be used to assess the improvement of 
inhibition as a result of the intervention.   To measure the effect of the GMT on 
observations of executive functioning in the home environment (generalization) the 
Behavior Inventory of Executive Functioning in Adults (BRIEF-A) was selected.  The 
BRIEF-A is a global measure of executive functioning and will demonstrate whether 
improvements in simulated tasks generalize to overall functioning as observed by a 
proxy in the home.   
     In addition to improved measures, the current 7-session/14-hour version of the GMT 
is the same as the one-hour version, however, the expanded version allows for 
additional practice of the learned strategies in both the group setting and in the home 
setting. The increased practice may decrease the effort needed to apply the strategies 
and increase the use of the strategies beyond the therapy sessions. In fact, Robey 
(1998) demonstrated that two or more hours of therapy a week produced a greater 
change than therapy delivered less than one and a half hours per week. Therefore, the 
expanded version is anticipated to show a stronger effect than the 1-hour GMT. Turner 
and Levine (2004) predicted that individuals with mild TBI would be able to apply the 
strategies learned in GMT easier than individuals with moderate or severe TBI. 
Therefore, it is expected that the proposed study will produce a magnified effect over 
the Levine et al. (2000) study by using improved measures, using a longer treatment of 
20 hours instead of one hour, and applying the intervention to individuals with mild TBI 
versus moderate and severe TBI.  
5. Specific Aims: 

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Specific Aims: The purpose of this Phase I study is to test an innovative treatment for 
executive dysfunction in veterans with mTBI that utilizes formalized and manualized 
procedures that can be exported for use in a subsequent randomized clinical trial.  
 
Aim 1.  
Aim 1 is to test the benefits of GMT for improving executive function.  
Hypothesis 1a: GMT will significantly improve problem solving ability compared to the 
control group (primary measure: time to completion on the Tower of London (cTOL). 
Since PTSD is prevalent and a potentially influencing co-morbidity, we will to investigate 
whether there is a significant interaction between treatment group and PTSD severity. 
Secondary measures include number of optimal moves on the TOL; and measures 
derived from the Stop Signal Task (SST; a measure of inhibition control).  
Exploratory Hypothesis 1.a.GMT will significantly improve everyday activities that 
require executive function skills (primary measure: Behavior Rating Inventory of 
Executive Function-Adult version, secondary measure: CRIS).  
Analysis Plan for Hypothesis 1. and Hypothesis 1.a. To test the first specific aim 
(hypothesis 1), the primary analysis will use two sample t-test to compare group A 
(intervention) and group B (control) on improvements in time to completion on the TOL. 
In addition, as an exploratory analysis, we will perform a regression analysis that 
includes treatment group, PTSD severity and their interaction as independent variables, 
to adjust for PTSD severity and to investigate whether there is interaction between 
treatment group and PTSD severity. Similar analyses will be performed for hypothesis 1 
for secondary outcome variables of change in index of optimal moves on the TOL and 
reaction time (RT) and accuracy on SST. To test hypothesis 1a, exploratory tertiary 
analysis using paired t-tests will determine whether treatment effect generalizes to 
executive function performance in everyday activities (BRIEF-A) or engagement in 
community participation (CRIS).  
Aim 2  
Aim 2 is to investigate factors which affect response to treatment.  
Hypothesis 2. Baseline cognitive ability, depression, sleep, and presence of PTSD will 
have a significant effect on response to treatment.  
Analysis Plan for Hypotheses 2. To test the second specific aim, a general linear 
regression will be used to determine whether any of the four factors is associated with 
response to treatment. The analysis will be restricted to the participants assigned to the 
intervention group. The dependent variable for the regression model will be ‘time to 
completion’ on the TOL, and the independent variables will be CWI, BDI-II, PCL-M and 
PSQI scores.  
6. Research Plan: 
To determine the effect of GMT on veterans with mTBI the following research will be 
conducted.  Clinical staff from the NF/SG VHS will hand out recruitment flyers or refer 
OEF/OIF/ONF veterans diagnosed with mTBI to the Principal Investigator.  Referred 
Veterans will be contacted by the PI or interested Veterans will contact the PI.  Veterans 
that meet the inclusion/exclusion criteria will be scheduled to obtain consent. Once 

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consent has been obtained the veteran will be scheduled for the first screening visit.  
Veterans that meet inclusion criteria will be randomly assigned to either treatment or 
control groups, in a ratio of 38:16. In addition, the Pocock-Simon covariate adaptive 
randomization procedure will be used so that, for each PTSD severity category within 
each of the two sites, approximately 70% (38/54) of subjects are assigned to treatment 
group; consequently, there will be approximately equal proportion of PTSD subjects 
assigned to the treatment and control groups within each of the two study sites.  
Each veteran will complete testing prior to a 10-week intervention or control period; after 
intervention or control period; and at a one-month follow-up. Intervention will be offered 
to participants in the control group once testing is complete. 
 
Participants will also be recruited and run in a parallel study in Durham under a Durham 
VA IRB approval.  A total of 168 participants are anticipated to be enrolled in both 
Gainesville and Durham. Data from Durham will be entered in a VA share drive that 
both Gainesville and Durham staff can access.  Data will not be transferred.  
 
Table # 2 Study Design  
 
 
1st Measure 
GMT/Wait 
2nd Measure 
3rd Measure 
Group A 
(n=38) 
Pre-treatment 
testing 
GMT/FP 
10 wks 
Post-treatment 
testing 
Follow-up 
testing 
Group B 
(n=16) 
Pre-Control          
testing 
Control          
(Brain Health 
Workshop) 
10 wks 
Post-control 
testing 
Follow-up 
Control testing 
 
Methods 
Subjects 
Proxy/Informant: patient will select a person to answer a questionnaire on their 
executive function that observes the patient at least 2-3 times a week and is at least 18 
years of age.  
    Patient Inclusion Criteria:  
• Diagnosis of Mild TBI or concussion by a physician or neuropsychologist in the 
medical record compliant with the American Congress of Rehabilitation Medicine; 
any of three following criteria are met: 1) loss of consciousness less than 30 
minutes with a Glasgow Coma Scale of 13 or above; 2) any loss of memory for 
events immediately before and after the event (not longer than 24 hours); any 
alteration of mental state at the time of accident; 3) any focal neurological deficits 
that may, or may not, be transient (ACRM, 1993).   
• Executive dysfunction determined by at least 1.5 standard deviation below the 
average scaled score (corrected for age) on either the Delis-Kaplan Executive 
function System (D-Kefs) Color Word Interference Test, or the EXAMINER 
flanker task. 
• Age 18 to 55 years 
• At least 4 months post injury 
• Family member or friend that is willing to provide feedback 
 
     Exclusion Criteria:  

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• History of pre-morbid learning disability 
• History of psychiatric diagnosis sufficiently severe to have resulted in inpatient 
hospitalization.  
• Neurological disease unrelated to TBI (seizure disorder, stroke, ADHD) 
•  Score < 90 on National Adult Reading Test (NART) 
• Failure of validity testing on either the Test of Memory Malingering (TOMM),). 
Score of 45 or less on TOMM Trial 2 or retention trial.  
• Reported alcohol or substance abuse within the past year 
• Reported involvement in current litigation 
• Recent change of medications for seizures, depression or memory. 
• Currently enrolled in other cognitive therapy that cannot be discontinued 
• Does not speak English fluently 
• Not competent to provide consent (also, not able to demonstrate understanding 
of expectations of study and potential risks of participation). 
 
Procedures 
     Intervention: The GMT is a 7-session intervention has been modified to a 10-session 
(2 hours/ session) interactive Power Point module that is presented in an individual or 
group format. Sessions 5, 6 and 7 have been split into two sessions each with time 
added to set-up and review functional practice. If a group format, the subject will be 
incorporated into a therapy session with 3-5 other participants (either other clinical 
patients or research participants diagnosed with TBI). During each session, a 5-stage 
strategy is taught to the participants. The 5-stage process consists of “stop-what am I 
doing?”, “define the goal”, “list the steps”, “learn the steps” then “check-am I doing what 
I planned”. The strategy is then incorporated into tasks practiced in the group session 
as well as in tasks each participant is to practice at home. The participants discuss 
utilization of the strategies and support the other members in the group. Friends or 
family members will participate in a training session prior to beginning GMT with the 
subject. The family member will be called each week during the GMT and asked to 
report whether the subject had an easy or difficulty time completing the homework 
assignments each week.  
Simulated Practice In The Laboratory: Tasks during GMT training include 
exercises such as: 1) clapping to words while inhibiting clapping to a targeted word; 2) 
card sorting; 3) decision making and planning in order to complete five activities within a 
four minute time span; 4) Catalog Task; and 5) Book keeping task. The exercises start 
with relatively easy tasks and progress to more complex tasks.  Participant’s strengths 
and weaknesses are discussed. Improvements are identified and reinforced as they 
learn more efficient planning and problem solving.  The following steps are taught 
during simulated tasks:  1) Identify Main Goal; 2) Break down task into sub-goals and 
steps for each goal; 3) List supplies needed; 4) Recognize potential barriers to 
completing goal; 5) Determine strategy to accomplish task: 6) Prepare to begin task with 
“presence of mindedness” exercise; 7) State goal out loud; 8) Begin task and stop self 
frequently to state main goal out loud and check to be sure one is working toward the 
goal (on target).  
Functional Practice with Smartphone Technology: In addition to GMT in the lab, 
three tasks will be first practice in the lab, than practiced at home.  Participants will 

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select from the following: meal planning and shopping; planning a party; building a 
birdhouse; or paying monthly bills. A Smartphone application (AP) specifically 
developed to utilize the strategies taught in GMT will be loaded onto the participant’s 
Smartphone (iPhone, iTouch, or Droid).  Veterans that do not already possess one of 
the devices will receive one as part of their clinical service through prosthetics. Training 
will begin during the first session to learn the features of the technology they will need 
(calendar, list, alarms) using Michelle Wild’s standardized learning procedure outlined in 
her guide books (http://pda4memory.com) that have been designed to train individuals 
with TBI how to use Smartphones.  Participants will use the application features to 
break down tasks, estimate time to complete, check off each step as completed, 
respond to visual/vibrating alert of “Goal” and respond to alert if “On Target”. 
Information, such as accuracy of planned steps, time to complete task, and number of 
distractions from goal will be collected by the AP.   Data will not be electronically 
transferred; the participant’s performance in functional practice at home will be reviewed 
and documented at the next lab session.  
  
Control Group Intervention. The Brain Health Workshop (BHW; Levine 2011) was 
developed specifically for consistency with GMT session length and contact with the 
facilitator (Levine, 2011). BHW is an education presentation on brain function and 
cognitive principles of learning. Information about stress reduction, sleep hygiene, 
energy management, exercise and communication are covered, with homework and 
quizzes on information covered. 
 
 
Table 1: Testing Schedule 
Screening  
Pre-Treatment  
Post Treatment # 
One-Month f/u# 
D-KEFs Color-
Word Interference 
Test  
 
D-KEFs Color-Word 
Interference Test 
D-KEFs Color-Word 
Interference Test 
NART  
*BRIEF-A 
 *BRIEF-A 
*BRIEF-A 
TOMM  
PSQI 
 PSQI 
 PSQI 
 
Tower of London 
Tower of London  
Tower of London 
EXAMINER 
EXAMINER 
EXAMINER 
EXAMINER 
PCL-M 
RBANS 
RBANS 
RBANS 
 
Stop-Signal Task 
Stop-Signal Task 
Stop-Signal Task 
 
Beck Depression 
Inventory-II 
Beck Depression 
Inventory-II 
Beck Depression 
Inventory-II 
 
CRIS 
CRIS 
CRIS 
*patient and family or friend 
Description of Measures 

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Screening Measures 
Color-Word Interference Test or the Flanker Task will be used to determine an objective deficit 
in inhibition by a score of ≥ 1.5 standard deviations (SD) below the normative mean. The Delis-
Kaplan Executive Function System (D-KEFS) was designed to detect executive dysfunction 
believed to be mediated by the frontal lobes. Since it is generally believed that solders, 
diagnosed with mTBI and PTSD due to blast injury, have damage to the frontal lobes, the Color-
Word Interference Test of the D-Kefs will be used to screen for subjects that have, deficits in 
inhibition. The D-KEFS Tower Test, which is a version of the TOL, loads onto the same factor 
(Inhibition) as the Color-Word Interference Test (Latzman, 2010).  Therefore, a deficit of ≥ 1.5 
SD on the DKEFS Color-Word Interference Test would negate possible ceiling effects on the 
primary outcome measure.  The test retest of the Color-Word Interference Test is suitable with a 
range of.49 to .86 for ages 20-49. The validity was “reasonable” for detecting patients with 
frontal lobe lesions from normal patients (Homack, 2005).  
 
EXAMINER 
A battery of 10 executive function tasks have developed by a NINDS funded project to use in 
clinical research studies.  The tasks take approximately 60 minutes to administer via a computer 
and result in 12 primary variables.  Tasks include: Dot counting (count blue dotes on a series of 
screens and recall the number of dots across screens), N-back (identify whether a series of 
locations match the location presented 1 or 2 before), Flanker (indicate the direction of an arrow 
that is flanked by arrows pointing in the opposite direction), Continuous Performance Test 
(respond to certain stimuli and withhold response to other stimuli on a computer screen), Anti-
saccades (move eyes toward a stimulus and moves eyes away from a stimulus), Set-shifting 
(switch between a homogeneous matching task and a heterogeneous matching task), 
Phonemic Fluency (name as many words as possible with the same letter), Category Fluency 
(name as many items as possible in a category), Unstructured Task (complete puzzles within 6 
minutes with the goal of earning as many points as possible), and the Social Norms 
Questionnaire (answer yes no questions about socially appropriate behaviors). Test re-test 
reliability is .94 and correlated with the FrsBe -0.57 in a multi-neurologic population. Patients 
that score at least 1.5 SD below the mean on the Flanker task will be included in the study. 
Secondary analysis will be conducted to determine the effect size on each of the EXAMINER 
tasks.    
National Adult Reading Test (NART) is an oral reading test consisting of 50 words (Nelson 
and Willison, 1991). The NART can be used to estimate premorbid intelligence and will be 
used as a screen. Similar to Levine et al. (2007), we will use the cut off score of > 90 as an 
inclusion criterion to ensure that frontal lobe impairment is not the result of low premorbid 
intelligence, and that the subject will be able to read the material during treatment.  
 
Test of Memory Malingering (TOMM): is frequently used to detect poor effort on 
neuropsychological assessment and has been validated with TBI patients (Tombaugh, 
1996; Slick et al., 2004; DeBoar, 2007). This test will be used to screen out patients scoring 
45 or below on Trial 2 or the Retention Trial (Trial 1 scores will not be used) to provide a 
level of confidence to the results of outcome measures.  
 
 
Primary Outcome Measure: Tower of London (TOL): is a computerized program in which 
patients are shown two pictures simultaneously of a goal board and a test board 
(Unterrainer et al, 2006).  Each picture shows three balls of different colors arranged on 
three pegs, with the balls in a unique arrangement in each picture.  Patients are instructed 
to determine the fewest possible moves of the balls in the test picture to make the 

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arrangement of balls identical to that of the goal picture within 60 seconds. The screen 
reports whether the response is correct or incorrect.  Test administration is less than 45 
minutes for each session (pre/post/follow-up). Each set consists of 70 problems of variable 
difficulty, determined by variables, such as, the number of moves needed to solve the 
problem (Berg and Byrd, 2002).  In turn, each set consists of the same number of 4, 5, 6 or 
7 move problems and has the same average difficulty level.  Difficulty rating is based on 
global and specific problem parameters shown to affect the planning process (Kaller, 2007, 
2008, 2009; Berg, Byrd, McNamara, & Case, 2010; Kaller, Unterrainer, Rahm, & Halsband, 
2004). The dependent variables are the total time spent solving the problem and the optimal 
moves made toward the goal display.  
 
Based on our previous studies, executive function represents three factors (behavior 
regulation, emotional regulation and metacognition) (Waid, Wen, Heaton, and Velozo, 
submitted to Neuropsychology).  GMT is a metacognitive training with emphasis on 
planning prior to engaging in a complex task. Therefore, a primary measure that captures 
the planning and problem solving of a multi-step task, called the Tower of London (TOL), 
was selected. Based on results from our preliminary study, the dependent variables of total 
time and optimal moves will be used to determine treatment effect.  While, not all of the 
participants in our previous work demonstrated significant improvement on these variables, 
group differences based on paired T-tests were significant in Total Time (p=0.026) and 
Optimal Moves (p=0.022) from baseline to treatment.  In addition to our findings, Levine 
(2011) demonstrated a significant change in the TOL following GMT for a mixed 
neurological sample compared to a control group.  Thus, the TOL appears to be sensitive to 
the effects of GMT. 
 
Stop Signal Task 
An “X” or “O” stimuli is presented visually on a computer screen. Participants are asked to press 
the left button for an “X” and to press the right button for an “O” as quickly and as accurately as 
they can.  If the stimuli are followed by an auditory tone (stop signal) they are asked to not press 
the button. Dependent measures are Response Time on Go Trials (RT) and Stop Signal 
Response Time (SSRT). Three sessions lasting approximately 10 minutes each will be 
conducted.  Stop Signal will be used as a secondary outcome measure to determine the effect 
size.   
 
Measures for Secondary Analysis 
Beck Depression Inventory (BDI):  is a 21-item questionnaire filled out by the individual 
diagnosed with TBI in the presence of the Principal Investigator.  Questions are rated using 
a 4-point scale and cover symptoms of depression such as hopelessness, irritability, guilt, 
fatigue, weight loss and lack of interest in sex. The reliability of the BDI in TBI has been 
reported at .92 (Green, 2001; Beck et al, 1996).   
 
Post-Traumatic Stress Disorder (PTSD) symptom checklist-military (PCL-M): The checklist is a 
17-item self-report measure of the 17 DSM-IV symptoms of PTSD with a 5-point rating scale 
ranging from rarely to extremely frequent. The range of total score is 17 to 85.  Internal 
consistency for the overall scale is .95 with cross validation to clinician-administered interviews 
ranging from .64 for Vietnam veterans to .83 for motor vehicle accident and assault victims 
(Weathers, 1991 & 1993; Blanchard et al, 1996). The PCL-M will be used to determine the 
impact of PTSD on the response to treatment.  
 

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Pittsburgh Sleep Quality Index (PSQI): is a 19-item self-rated questionnaire for evaluating 
subjective sleep quality over the previous month. Seven component scores are added to 
obtain a global score ranging from 0–21, with higher scores indicating worse sleep quality. 
The PSQI has a sensitivity of 89.6% and specificity of 86.5% for identifying cases with sleep 
disorder and has been used in a wide range of population-based and clinical studies. Since 
sleep disturbances are common complaints for Veterans returning from deployment and 
has been known to impair cognition, the PSQI will be used to determine whether sleep 
disturbances interfere with treatment response. 
 
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS): is a 
cognitive screening instrument The RBANS is composed of 12 subtests that yield 5 index 
scores and a total score. The subtests of List Learning and Story Memory comprise the 
Immediate Memory Index; Figure Copy and Line Orientation yield the 
Visuospatial/Constructional Index; Picture Naming and Semantic Fluency yield the 
Language Index; and Digit Span and Coding comprise the Attention Index. Four subtests 
make up the Delayed Memory Index, specifically, List Recall, List Recognition, Story Recall, 
and Figure Recall (Randolph, Tierney, Mohr, & Chase, 1998). Administration is 
approximately 20 minutes and has been used to assess cognition in mTBI (Cooper et al., 
2010). The index scores of the RBANS will be used to characterize the patient’s cognitive 
capacity and to determine whether particular aspects of cognitive ability impact response to 
treatment.  
 
Exploratory Generalization Measure  
Generalization measures will be examined in a tertiary analysis to explore whether 
treatment effects generalize to everyday activities or participation in the community. Based 
on our previous study, treatment effect did not generalize to everyday activities as 
measured by the BRIEF-A. However, with the proposed methodological changes and the 
addition of functional practice with a Smartphone application, generalization to activities and 
community participation is anticipated to improve. The Metacognitive Index of the BRIEF-A 
was confirmed as a factor in our previous factor analysis and represents the executive 
function components targeted by GMT. The BRIEF-A was selected over the recommended 
common data element measure, the Frontal Systems Behavior Scale (FrSBe); since the 
FrSBe has not been tested in a homogenous TBI sample. While, our previous study did not 
reflect a significant improvement at the activity level, we will conduct a tertiary analysis to 
detect generalization using the BRIEF-A. In addition to the activity level of executive 
function, we would like to determine the effect of treatment at the community participation 
level. The TBI Outcomes Workgroup on common data elements (Wilde, 2010) has 
recommended the PART-O to measure participation in the community.   
 
Behavior Rating Inventory of Executive Functions–Adult (BRIEF-A) is a self and informant 
report questionnaire consisting of 75 statements about executive behaviors. There are three 
possible responses to items: often, sometimes, never. There are nine subscales: inhibit, 
self-monitor, plan/organize, shift initiation, task monitor, emotional control, working memory, 
and organization of materials. Normative self-report (n=1,050) reliability ranges from .73 to 
.90 for the scales and .93 to .96 for Index and Global Executive Composite scores. While 
the reliability in a mixed clinical sample (n=233) ranged from .80 to .94 for scales and .96 to 
.98 for Index and Global Executive Composite scores. Test-retest reliability over 4 weeks 
averaged .82 to .93 on the scales and .94 for Index and Global Executive Composite 

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scores. The total BRIEF-A score correlates at .84 with the Dysexecutive Questionnaire 
(Roth, 2005). In a sample of patients diagnosed with TBI, the MI reported a Cronbach alpha 
of 0.96 (Waid-Ebbs et al., 2012). The Metacogntive Index of the score of the BRIEF-A will 
be used to detect a change of executive functioning in the subject’s home environment.  
 
Community Reintegration of Service Members (CRIS): will be used to measure 
participation. The CRIS was developed specifically for soldiers with disabilities (Resnik et 
al., 2009, 2011) and is available in two formats, a paper and pencil version with 128 items 
and a computer adapted version that takes no more than 10 minutes to complete. Three 
scales are found in the CRIS and have good internal reliability: Extent of Participation = 
0.91, Perceived Limitations = 0.93, and Satisfaction with Participation = 0.97 (Resnik et al, 
2009). Meaningful detectable change indices were 5.9, 6.2, and 3.6, respectively for Extent, 
Perceived and Satisfaction subscales (Resinik et al, 2012). CRIS-CAT scores were 
predictive of SF-12 physical and mental health related quality of life scores at the 1-year 
follow-up (Resinik et al, 2012). Preliminary analysis described reveals good internal 
reliability and separation into ability levels in a sample of 44 mTBI Veterans. Test Retest 
reliability is 0.95 for Extent of participation; 0.85 for Perceive limitation; and 0.95 for 
Satisfaction scales.  
 
7. Statistical Methods 
Statistical Analysis Plan 
Participants, who attend less than 90% of the treatment sessions, have medication changes 
during treatment that affect cognition and/or receive more than 5 hours of therapy (other than 
GMT) from a mental health specialist during the study will not be included in the final analysis. 
 
Aim 1. 
Aim 1 is to test the benefits of GMT for improving executive function. 
Hypothesis 1a: GMT and home practice device will significantly improve problem solving 
ability compared to the control group (primary measure: time to completion on the Tower 
of London (cTOL).  Since PTSD is prevalent and a potentially influencing co-morbidity, 
we will to investigate whether there is a significant interaction between treatment group 
and PTSD severity. Secondary measures include number of optimal moves on the TOL; 
and measures derived from the Stop Signal Task (SST; a measure of inhibition control). 
 
Exploratory Hypothesis 1.b.GMT and functional practice will significantly improve 
everyday activities that require executive function skills (primary measure: Behavior 
Rating Inventory of Executive Function-Adult version, secondary measure: CRIS). 
 
Analysis Plan for Hypothesis 1.a. and Hypothesis 1.b. To test the first specific aim 
(hypothesis 1a), the primary analysis will use two sample t-test to compare group A 
(intervention) and group B (control) on improvements in time to completion on the TOL. In 
addition, as an exploratory analysis, we will perform a regression analysis that includes 
treatment group, PTSD severity and their interaction as independent variables, to adjust for 
PTSD severity and to investigate whether there is interaction between treatment group and 
PTSD severity. Similar analyses will be performed for hypothesis 1 for secondary outcome 
variables of changes in index of optimal moves on the TOL and reaction time (RT) and accuracy 
on SST. To test hypothesis 1b, exploratory tertiary analysis using paired t-tests will determine 
whether treatment effect generalizes to executive function performance in everyday activities 
(BRIEF-A) or engagement in community participation (CRIS).  

Protocol 
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January 27, 2015 
Aim 2  
Aim 2 is to investigate factors which affect response to treatment. 
 
Hypothesis 2a. Baseline cognitive ability, depression, sleep, and presence of PTSD will 
have a significant effect on response to treatment. 
 
Analysis Plan for Hypotheses 2a. To test the second specific aim, a general linear 
regression will be used to determine whether any of the four factors is associated with response 
to treatment. The analysis will be restricted to the participants assigned to the intervention 
group. The dependent variable for the regression model will be ‘time to completion’ on the TOL, 
and the independent variables will be CWI, BDI-II, and PCL-M scores.  
8. Possible Discomforts and Risks: 
     The potential risks are minimal for the proposed intervention (group therapy).  The 
standard of care for Veterans with mTBI is to receive cognitive therapy in group or 
individual settings. The risks of the proposed research would not increase from the 
current risks that patients experience in traditional therapy. 
     Patients may become anxious when discussing the trauma, they experienced and 
the deficits they continue to face on a daily basis. Fatigue and/or anxiety may occur 
while performing screening tests and tests prior to each session. Subjects with attention 
and concentration deficits may have difficulty completing the testing within one session. 
The PI will monitor patient anxiety and recommend alternative therapies such as 
individual speech therapy and additional psychological services that are available to the 
patient.   
9. Possible Benefits: 
The proposed therapy has the potential to improve the subject’s ability to organize and 
complete tasks by utilizing a strategy that can be used in various settings. The group 
therapy process also will provide peer support to help cope with the frustration of living 
with executive dysfunction.  A group therapy also allows for more than one subject to 
receive therapy during the same time frame.  
9. Conflict of Interest: 
None of the investigators have a conflict of interest in any part of this study.