Goal-Directed Resilience Training to Mitigate Chronic Pain in Former Football Players
Phase: NA
Conditions: Chronic Pain
Sponsor: Morehouse School of Medicine

 
Goal-Directed Resilience 
Training to Mitigate Chronic 
Pain in Former Football Players 
 
 
6/7/2019 
 
 
 
 
 
 

PROJECT TITLE AND NARRATIVE 
Goal-Directed Resilience Training to Mitigate Chronic Pain in Former Football Players 
How can former football players overcome the physical pain that commonly results from years of 
intense training and performance? This pilot study seeks to test the efficacy of a resilience skills 
training intervention for former football players who experience chronic pain. Chronic pain threatens 
quality of life, and the culture of elite athletes is poorly adapted to the chronic condition of pain. 
Innovative strategies that are both culturally acceptable and effective are needed to address the 
needs of players who may have a reluctance to engage traditional treatment approaches.  
 
PROJECT ABSTRACT 
Our overarching goal is to strengthen the capacity for former football players to maintain adaptive 
engagement in valued activities despite chronic pain. Responding to recent findings from the Harvard 
Football Player Health Study (HFPHS) that identified pain as a significant challenge, we propose a 
pilot study that tests a resilience skills training intervention with former football players who currently 
experience chronic pain. Our proposed study builds on previous work conducted at Morehouse 
School of Medicine engaging retired NFL players and ongoing resilience intervention research 
involving veteran and community-based populations. Specifically, we plan to test a novel Goal 
Directed Resilience Training (GRIT) in a subsample of Atlanta-based former players who have 
chronic pain and would benefit from resilience training. This pilot study has the potential to advance 
strategies to improve the wellbeing and functional status of former players impacted by pain.  
 
OVERVIEW AND BACKGROUND 
1. Chronic pain is a national medical problem and priority as evidenced by the massive opioid 
epidemic. For former professional football players, chronic pain can be the dominant condition 
of life, degrading its quality in multiple domains. We propose to address chronic pain with a 
resilience skills training intervention to improve functions affected by pain, i.e., quality of life, 
personal relationships, and personal growth or development. The specific aim of this study is 
to test an intervention to decrease chronic pain and comorbid symptoms and improve a 
broader adaptive level of functioning through Goal-Directed Resilience Training (GRIT) for 
chronic pain. We hypothesize:  
a. GRIT training intervention versus control training will be associated with reduced 
chronic pain and related symptoms of insomnia, anxiety, depression, improved 
emotional functions, and improved neurocognitive functions. 
b. Improved self-reported physical health, quality of life, personal relationships, and 
personal growth will be evident for intervention versus control participants. 
 
Although the body as internal environment is long recognized as such (milieu intérieur of Claude 
Bernard, 1865 in Gross1998; interoception, Craig, 2009), our approach is innovative in treating pain 
as an internal interoceptive environment, one that is characterized by unpredictability and 
aversiveness. These two qualities also define extreme environments, be these extremes of weather 
or prisoner of war camps. Resilience, if thought of as a process as well as a state, buffers against the 
harshness of the environment, facilitating success and thriving in the midst of adversity. The engine 
that drives, maintains, and increases pain is unpredictability. The unpredictability of pain (in terms of 
intensity, timing, duration, physical and social context, etc.) makes it a powerful, variable, and often 
unstoppable force. We propose an interactive model of Environment x Biobehavioral Control in which 
chronic pain and resistance or resilience to pain are embedded. We believe this model explains the 
preliminary successes and points to the promise of our GRIT intervention.  
Scientific Justification. Reciprocating dichotomies are described in a variety of neuroscience 
approaches, such as the predictive and reactive control systems (PARCS) of Tops (Tops, Luu, 
Boksem, & Tucker, 2014), voluntary and stimulus-driven actions (Hughes, Schütz-Bosbach, & 
Waszak, 2011), and others. The underlying dichotomy is fight-flight or stimulus-driven responding 
(e.g. a tiger jumping through the door of your room, you respond to the threat with fight-flight) and 
goal-directed responding (e.g. taking notes during a lecture which would be incompatible with saving 

 
 
2
your life while the tiger is jumping through the door of the lecture hall). The particular contribution of 
our model is that it goes beyond dichotomies and considers all possible combinations in an interactive 
model of Environment x Biobehavioral control (ExBC). This model recognizes that goal-directed 
responding occurs not only in safe environments (e.g. taking notes during a lecture) but also in 
unpredictable environments (you dive under a table to avoid the tiger scene and continue note taking 
– real dedication here!) and that goal-direction can stop threat and pain. This capacity for goal-
direction led to the develop of Goal-Directed Resilience in Training (GRIT) for chronic pain. 
Preliminary Activities. In 2010, Morehouse School of Medicine (MSM) hosted community huddles 
in 15 cities nationwide over 18 months and included private discussions with former NFL players and 
their families and community town-hall forums.  We engaged nearly 400 former players and family 
members and nearly 1,800 community stakeholders to raise awareness about sports-related head 
injuries, dementia, depression, and other mental illnesses, developing trust within this community. 
Approaches that emphasize the development of strengths and capacities beyond the treatment of 
symptoms are culturally acceptable to former players.  
The proposed GRIT intervention has been applied to pain and PTSD in veteran and civilian 
populations (Kent, Rivers, & Wrenn, 2015; Kent, Davis, Stark, & Stewart 2011).  The unpredictability 
of the pain body environment evokes automatic stimulus-driven responses that displace and inhibit 
goal-directed responses. Through re-experience, GRIT trains goal-direction as a natural 
incompatible response to chronic pain. It consists of taking goal-directed responding from the 
predictable safe environment into dysfunction and pathology and thus transforming dysfunction into 
resilience. This approach can be applied to other unpredictable aversive environments: unpredictable 
aversive cultural experience (minority/marginalized social position), interpersonal stress (divorce), 
discrimination in health care that exacerbate and help maintain pain. The GRIT simulation process is 
indicated by the arrow in Figure 1. 
 
Biobehavioral 
Control 
Unpredictable Environment 
Predictable Environment 
Stimulus-Guided 
Response (Reactive) 
1. ACUTE THREAT, not safe 
Threat can be stopped through 
fight/flight. 
 
 
ADAPTIVE REACTIVITY TO 
RESTORE HOMEOSTASIS 
Responses are fast, 
here-and-now 
Learning is fast, one-trial 
Focus is narrow on threat 
2.MALADAPTIVE REACTIVITY IN CHRONIC 
CONDITIONS, not safe  
Symptoms cannot be easily stopped; are 
maintained by unpredictability.  
 
DYSFUNCTION  
 
Person declines - pathology  
                                                                            
 
Goal-Directed 
Response (Predictive) 
4.CHRONIC or ACUTE, not 
safe  
Symptoms can be stopped 
through goal-direction and social 
relatedness  
 
 
RESILIENCE 
 
Person grows - eudaimonia 
3.PREDICTABLE, safe 
 
 
DEVELOPMENT & GROWTH 
Goal-directed 
Future oriented 
Learning is slow 
Slow development of skills & projects 
Building models, simulating for prediction 
 
Engagement & social relatedness from every-
day life (e.g. childhood or early adulthood) 
Figure 1. Environment x Biobehavioral Control Model 

 
 
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PROJECT DETAILS 
 
Experimental Design and Methods 
 
Intervention Training for Former Players 
Between 20 to 48 eligible and consented participants from the Atlanta area will be identified (with a 
goal of 40 completing the study). They will undergo a pre-training test session and will then be 
randomized to either the Immediate GRIT (ImT) training intervention or the Delayed Training (DeT) 
control. At this time there will be one intervention immediate (ImT) group and one delayed (DeT) 
control group of 5-12 participants per group. The immediate (ImT) group will be trained for 4 weeks 
with 2 biweekly sessions. At the end of GRIT training they will be post-tested. The delayed (DeT) 
group wait during these 4 weeks and do not receive training. At the end of the 4-week waiting period, 
they will also be post-tested. At this point, they will be offered GRIT training for 4 weeks with 2 
biweekly sessions. At the end of their training, they will be given a second post-testing. This process 
will then be repeated for two additional groups of 5-12 lmT and 5-12 DeT participants. 
     Goal-Directed Resilience Training (GRIT) is a hands-on experiential simulation and repeated 
practice that takes the person back to his/her earlier goal-directed experiences and then applies them 
to episodes of pain and suffering. The brain is inherently a simulation device where actual and 
simulated actions activate the same cortical areas (e.g. Decety & Grèzes, 2006). Goal-directed 
responding is inhibited by stimulus-guided responses to fear or pain. The restoration of goal-directed 
engagement and relatedness are natural capacities we have for pain control (Erpelding & Davis, 
2013). This is the main focus of the training. Participants are asked to identify engagement and social 
relatedness (the goal-directed resources) from childhood or early adulthood, since these early years 
are formative, as well as examples from present time. They are asked to re-experience these in 
descriptions and sensations, then take these episodes into experiences of pain or trauma, thereby 
transforming these into resilience. This is accomplished through a manualized program consisting of 
four modules: engagement, social relatedness, transformation, and defining a good life. GRIT training 
is a small-group intervention consisting of 5-12 participants per group. We propose a pilot study of 20-
48 participants or 4 groups with 2 intervention and 2 control conditions to be conducted in Atlanta. Up 
to eight (8) subjects beyond our goal of 40 will be added to make up for attrition. Individuals 
randomized to control condition will participate in the GRIT the training after post-assessment. 
Training extends over 4 weeks, consists of 90-minute biweekly visits, for a total of 8 visits.  
 
Outcome Measures. To test hypotheses 1 and 2, outcome measures for GRIT training include 
focused pain-relevant symptom measures, adaptive functions measures, neurocognitive measures, 
and PACE, as listed in Table 2. List of outcome measures are provided in Appendix 1. 
 
   Table 2. Proposed Outcome Measures for GRIT Training 
Focused Pain-Relevant Measures 
Pain Outcome Questionnaire (POQ), (20 items) 
PROMIS Pain Interference Short Form. (8 items) 
PROMIS Sleep Impairment (8 items) 
PROMIS Sleep Disturbance (8 items) 
Pain Catastrophizing Scale, (13 items) 
Chronic Pain Acceptance Questionnaire, (8 items)                              [time to completion = 23 
minutes] 
Adaptive Functions Measures 
Physical Health: SF-36 Health Measure: physical & mental health, (36 items) 
Well-Being: Ryff ‘s Positive Relations & Personal Growth, (14 items)  
Perceived Stress Scale (10 items)  

 
 
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HEMA: Hedonic and Eudaimonic Motives for Activities, (9 items) 
PACE – Predictability as Core Evaluation [as outcome measure], (47 items) 
Emotional Symptoms: 
PHQ-9: Patient Health Questionnaire Depression Scale, (9 items) 
GAD-7: Generalized Anxiety Disorder Scale, (7 items) 
ACE: Adverse Childhood Experience, (10 items)                                 [time to completion = 50 
minutes]                                             
 
Neurocognitive Functions 
D-KEFS: Delis-Kaplan Executive Function: Verbal Fluency, Color-Word Interference 
RBANS: Repeatable Battery for the Assessment of Neuropsychological Status  
NAB: Neuropsychological Assessment Battery: Word Generation         [time to completion = 30 
minutes] 
Preventing Chronic Pain Strategy 
PACE: Predictability as Core Evaluation, for chronic pain (used here as pre-post outcome 
measure) 
Physical Functions Measure e.g. pre-post time measure of walking 
 
Total time required to complete questionnaire scales and neurocognitive tests is 90 to 120 minutes. 
 
Subjects 
Between 20-48 former NFL players will be recruited for participation. The inclusion/exclusion criteria 
are listed in Table 3 below. 
 
Table 3. Inclusion/Exclusion Criteria 
Inclusion criteria 
Exclusion criteria 
Former football player 
between 18 – 65 of age 
who  have passed pre-
selection and are 
referred by HFPHS, 
potentially diverse 
racial & ethnic 
identities 
1. Active suicidality or suicidal intent requiring greater than outpatient 
level of care (Columbia Suicide Severity Rating Scale – C-SSRS)* 
2. High risk drinking of alcohol (based on scoring guidelines of AUDIT-C)* 
3. Active psychosis (Psychosis Screener)* 
4. Inability to participate in a small group setting (self-reported inability to 
regulate constructive social interaction in small group setting)* 
5. Inability to meet projected attendance requirements.** 
* Eligibility screening tools are provided in Appendices 2 and 3; Mental health action required for further evaluation and possible 
treatment are outlined in Appendix 8. 
** Attendance requirements are as follows. Participants are allowed to miss 2 out of 8 sessions. They are also given the option to make 
up one or both sessions. They are allowed to make up a maximum of 2 sessions. If they miss a 3rd session, they are not allowed to 
make it up but can stay in the study. If they miss a 4th session, they will be terminated from the study. 
 
Statistical Considerations 
 
Design. This is a balanced randomized block design. Twenty (20) to forty-eight (48) eligible and 
consenting participants from the Atlanta area will be identified from the cohort of research participants 
at the Football Players Health Study (FPHS) at Harvard University in Boston, MA.  They will be 
selected based on answers previously given to specific FPHS survey questions listed below. They will 
undergo a pre-training test session and consequently be randomized with 1:1 allocation to either the 
Immediate GRIT training (ImT) intervention group or the Delayed (DeT) training control group. There 
will be two Immediate (ImT) intervention groups of  5-12 participants per training group and two 
Delayed training (DeT) control groups with 5-12 participants in each control group.  
 

 
 
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Outcome measures (c.f. Table 2). Sample Size and Power. This is a pilot study. Using focused pain-
relevant or adaptive measures as outcomes with effect size (minimally detectible differences in 
weighted scores between the ImT experimental and DeT control group, scaled by pooled standard 
deviation) of 1, 2, 3, and 4, a regression model with treatment, age and block as effects and an 
overall 0.05 significance level, 20 participants per group yields an 0.80 statistical power.  
For all analyses intent-to-treat principles will be adopted for those who drop out. Pre-treatment scores 
will be used to generate sampling frames consistent with a multiple imputation approach (Rubin, 
1999) to determine post-treatment values.  
 
Statistical Analyses. Summaries will rely on means, standard deviations for continuous variables and 
frequency and percentages for categorical ones. Univariate analyses for weighted scores and 
continuous variables groups comparisons will rely on t-tests (if normality assumptions are upheld) 
and/or non-parametric testing. Categorical variables will be compared using Chi-square/Fisher 
exact/McNamer testing. Multivariate analyses for the responses of scales/subscales weighted scores, 
factoring in covariates effects on interventions vs. control, age, block, pre-treatment scores, will use 
the Generalized Linear Mixed Modeling (GLMM) approach that will allow blocks as random effects 
and grant each subject their own intercept. All analyses will be conducted using SAS version 9.4 
 
 
IMPLEMENTATION STEPS 
 
Study procedures for the GRIT intervention will be submitted to the Institutional Review Boards at MSM.  
 
1. Recruitment & Screening 
 
Recruitment and an initial round of eligibility screening of study participants for GRIT will be conducted at 
Harvard Medical School, the coordinating center of the Harvard Football Players Health Study (HFPHS). They 
have built a cohort of research participants through administering a First Health and Wellness Questionnaire 
(Q1) that included questions relevant to former players’ experience of pain. The HFPHS will recruit for this 
study from this cohort of participants, whose verified eligibility and contact information is stored in the FPHS 
data repository (HMS protocol # 14-2691), and who have not opted-out of receiving study communications 
from the FPHS.  This recruitment will be conducted by telephone and/or email. 
 
Additional participants will be recruited into the HFPHS cohort through the Morehouse study team marketing 
the GRIT study in the Atlanta area.  Morehouse may sponsor announcements in the local media and with 
football players’ organizations in the greater Atlanta area that present information about this study alongside 
the greater HFPHS, and invite former players to participate in the HFPHS Q1 effort in order to be considered 
for this study. 
 
Interested former players in the Atlanta area who are not yet enrolled in the HFPHS will be referred to contact 
the HFPHS using a GRIT study-specific email address, so that they take the Q1 survey and become part of the 
entire cohort of participants. They will be asked by FPHS to complete the Q1 questionnaire and thus become 
part of the HFPHS cohort.    
 
These steps will be used for selection and eligibility screening of participants for GRIT: 
1. Identify all former football players living in the Atlanta area from the HFPHS cohort, who are 65 years of 
age or younger (currently about 79 former players) who are interested in continued research 
participation.  
2. Contact those former players by phone and/or email to invite them to participate in the study.   
a. If players communicate via email and are interested, HFPHS will schedule a screening call with 
them.   
b. If a player is reached by telephone and they are interested, they will be asked if they would like 
to go through the screening process at that time, or schedule another call in the future. 

 
 
6
3. Potential participants will be screened on the telephone according to the HFPHS screening guide 
attached.  Screening data will be recorded in the secure internal study portal hosted at HMS.  
4. Once a potential participant has been deemed eligible to participate by HFPHS, and has expressed 
interest, HFPHS staff will ask for their consent to share their contact information with the researchers at 
MSM, so they may be contacted to arrange for final screening, enrollment, and pre-testing.  They will 
be notified that there may be a delay of many weeks until their information is transferred and they are 
contacted by MSM, as MSM cannot begin scheduling consent, final screening, and pre-testing sessions 
for individual participants until they are able to begin doing so with a full group of 10-24 (5-12 for each 
group). 
a. It will be discussed with them that they will undergo two final eligibility screens for suicidality and 
psychosis with MSM researchers, and that it’s possible they may not quality for the study at that 
point.  If they do not qualify for the study, they will be compensated for their time with half the 
amount of the pre-testing session ($25). 
5. Once the MSM research team has access to a potential participant’s contact information through the 
secure study portal, they will contact them by telephone to schedule their final screening, enrollment, 
and pre-testing session.  The participants will be contacted as soon as their information is received by 
MSM researchers.   
 
2. Consenting & Pre-Testing 
 
Subjects will first be consented by the MSM researcher, sign a HIPAA waiver, and then undergo the final two 
eligibility screening assessments for suicidality and psychosis.  If they qualify for the study they will then 
participate in the pre-testing session. 
 
The consenting staff member will go over the consent form that describes the study, the risk and benefits, 
confidentiality and data security, participant rights, and each participant will have his questions answered. If the 
potential participant agrees with the consent information, he and the consenting person sign and date the 
consent form.  
 
If a participant scores high on psychosis or suicidality during the final screening, the following steps will be 
initiated:  They will be referred to professional mental health services as a source of support.  The Georgia 
Crisis and Access Line (1‐800‐715‐4225) will be offered to participant for assistance.  The telephone resource 
is available 24 hours a day/ 7 days a week and offers licensed counselors to assist. Mental Health Action Plan 
in Appendix 8 outlines the steps that will be taken to keep the participant safe and obtain further emergency 
mental health evaluation and treatment. 
 
If deemed fully eligible to participate in the study, the participant will then begin the pre-testing session with the 
tests listed in Table 2. The pre-testing session will also include asking the questions included in Appendix 5.  
No research procedure will take place prior to the informed consent and eligibility screening. Participants will 
be informed that they may skip answering any questions that make them uncomfortable, but that they may not 
skip all questions in any one individual test and if they do, they will be withdrawn from the study. 
 
Participants will be given sufficient time to review the consent and opportunity to ask questions. We will not be 
enrolling patients that cannot participate in the informed consent.  Legally authorized representatives are not 
involved in this study.  There are no medical procedures involved in this study.   
 
The pre-testing session will last 90-120 minutes after the consent process, and will include all of the 
assessments noted above in the Table 2 “Outcome Measures” list. 
 
 
3. Enrollment & Tracking 
 
Once participant contact info has been shared with MSM researchers in the secure study portal, MSM will use 
the portal to track:  

 
 
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a) Participant contact 
b) Final screen failures 
c) Consent / Enrollment Status 
d) Participant dropouts 
e) Withdrawal of participants from study  
f) Termination of participants from the study 
 
This will allow HMS to track interactions of former players with MSM researchers to maintain awareness of 
potential participant burden, to consider the discontinued participants for other HFPHS studies, and to consider 
this information in relation to other ongoing projects.  
 
4. Randomization 
 
After pre-testing of the first 10-24 participants, they will be randomly assigned to either the Immediate ImT 
group (n=5-12) for immediate training or to the Delayed DeT control condition (n=5-12). The method of 
randomization is a balanced randomized block design with 1:1 allocation to either receiving the GRIT 
immediate ImT training intervention or the Delayed DeT control condition. A stratified permuted block design 
randomization scheme will be pursued with a variable but masked block size.  A one–two stratification factors 
will be considered for selection from position played, age, and baseline severity of pain. The randomization 
protocol will further dictate inspection of balance of these factors between the two groups every ten recruited 
participants. 
 
5. Intervention Training 
 
There will be two Immediate Training ImT groups of 5-12 participants per training group and two 
Delayed Training DeT control groups with 5-12 participants in each group. One Immediate ImT 
intervention group will be trained at one time for 4 weeks with 2 biweekly sessions, followed by post-
testing.  During this time the Delayed DeT group waits, since only one group can be trained at one 
time. The Delayed DeT group will receive training after waiting 4 weeks and a first post testing 
session.  At the end of its training, the DeT group will receive a second post-testing session. 
 
Training sessions will be held at the Morehouse School of Medicine in the Research Wing.  There will 
be two 90-minute training sessions per week, taking place between 4-6pm on two days out of 
Mondays through Thursdays.  The exact days and times of the training will be set in advance for each 
group, and will not be accommodating of individual schedules. 
 
Should a participant miss a scheduled training session or be unable to complete a session in full, the 
attendance requirements are as follows: 
 
Participants are allowed to miss 2 out of 8 sessions. They are also given the option to make up 
one or both sessions. They are allowed to make up a maximum of 2 sessions. If they miss a 
3rd session, they are not allowed to make it up but can stay in the study. If they miss a 4th 
session, they will be terminated from the study. The content of the makeup sessions will follow 
the content of the modules: (1) introduction to concepts (2) illustrative examples (3) 
applications to own life with exercises. Makeup sessions will be one-on-one with the 
interventionist, and will last no more than 30 minutes.  Participants will be compensated for 
makeup sessions as they are for group training sessions they attend.  
 
If a participant attends but cannot complete a training session, it will be considered a missed 
session if they leave before the half-way time point (45 minutes).  In this case the above policy 
regarding missed sessions will apply. If they leave the training session after 45 minutes, they 
may complete the rest of the session as a homework assignment, since homework 

 
 
8
assignments are practiced at the end of each session. Participants will only be compensated 
for incomplete sessions if they attend for at least half (45 minutes). 
 
GRIT intervention training is a hands-on group experiential simulation and repeated practice that 
takes participants back to their earlier goal-directed experiences and then applies these to episodes 
of pain and suffering. Participants are asked to identify engagement and social relatedness (the goal-
directed resources) from childhood or early adulthood, to re-experience these in descriptions and 
sensations, then take these episodes into experiences of pain or trauma, thereby transforming 
negative episodes into instances of personal resilience. At the end, participants are asked to design 
and implement a good life for themselves. In this manner, the past is used to construct a future, and 
goal-directed responding is replacing stimulus-guided responses to fear or pain. A manualized 
program consists of four modules that cover engagement, social relatedness, transformation, and 
making a good life, shown in Table 4.  The manual is provided in Appendix 4. 
 
Table 4. A Modular Program for Goal-Directed Resilience Training (GRIT) 
Introduction Introduction and Psychoeducation 
Main elements: engagement, relatedness, transformation, building a good 
life 
Module I 
Approach/Engagement 
Consists of interest, curiosity, appreciation, noticing beauty. 
Find examples from childhood/early adulthood of interest, curiosity, etc. 
Describe examples, what the senses are doing, make a visual 
representation. 
Review written and visual examples, do activities, do homework 
assignments 
Module II 
Social Relatedness 
Consists of empathy, compassion, helping, friendship, love. 
Find examples from childhood/early adulthood of empathy, helping, etc. 
Describe examples, what your senses are doing, make a visual 
representation. 
Review written and visual examples, do activities, do homework 
assignments 
Module III 
Transformation 
Return to pain or traumatic event with an example of engagement or 
relatedness. 
Identify pain or stressful event you wish to return to. 
Be in that scene or pain as (e.g. holding the first frog in your hand when you 
were five while retelling a battle scene in Vietnam, etc.) 
Reading examples of transformation, do activities, do homework 
assignments. 
Module IV 
Building a Good Life 
Imagine and describe a life well lived.  
Describe a good life for yourself, with engagement, with social relatedness. 
Create opportunities for growth when pain has limits and stunts growth.  
Reading examples and activities for creating a good life are provided. 
 
For each Module the training follows the same format. The content is covered in 3 parts: (1) Main concept to 
be covered in the module, (2) Examples of the concept in readings (3) Exercises that apply the concepts to 
personal experiences. Completion of the exercises are started in the training class and assigned to be 
completed as homework and to be turned in the following week.  

 
 
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6. Homework 
 
The Study Workbook (within Appendix 6) contains all assignments, practice exercises, and instructions. Each 
module is to be completed in two sessions of one week. Homework is assigned at the beginning of each week 
and to be turned in at the beginning of the next week. For each module, the homework asks participants to find 
examples from their lives of the main concept covered in that module, note their sensory reactions, and apply 
the examples to change how they experience pain and stress.  
 
The Habit Maker Checklist tracks the application of training concepts and activities in participants’ everyday 
life. Participants are to complete one checklist for each week.  
 
Completion of The Study Workbook and the weekly Habit Maker Checklist questionnaire are required of all 
participants, and participants may be withdrawn from the study if they are not completing their homework 
assignments. 
 
7. Control Condition 
 
As previously described, the control condition is the Delayed DeT group that waits for 4 weeks while 
the Immediate ImT group experiences the GRIT training. At the end of the four weeks of training of 
ImT and waiting of DeT, both groups are post-tested. At that point the Delayed DeT group receives 
the GRIT training and then a second post-testing. 
 
8. Post-Testing 
 
Following completion of 4-week training, the immediate ImT participants and Delayed DeT controls will be 
scheduled for post-intervention assessments, listed in Table 2. These will be nearly identical to the pre-
intervention assessments, will last 90-120 minutes, and will occur within 2 weeks of the final treatment session. 
In case of extreme emergencies, if a participant cannot schedule their post-testing session within 2 weeks of 
completing the training, post-testing can be extended by another 2 weeks for no more than a total of 4 weeks 
from training completion. Delayed DeT Controls will receive training after their first but before a second post-
testing session. 
 
9. Length of Study Enrollment  
 
A participant may be enrolled in this study from 6-18 weeks 
 
10. Compensation & Reimbursement 
 
Per participant, compensation will consist of $75 for their enrollment & pre-testing visit ($25 if they are not 
eligible for the study after final screening), $75 per training session for a total of $600/8 sessions, and $75 for 
their post-testing session. The control group will receive a second $75 payment for second post-testing session  
The total payment for each of the groups will equate to $750 for the ImT group (experimental) and $825 for the 
DeT group (control). Payment will be made at the end of each testing session and at the end of the completion 
of all training sessions. Missed sessions will be offered as makeup sessions of no more than two makeup 
sessions. Participants will be paid for makeup sessions. Participants will be paid for all training sessions they 
attend, regardless of whether they complete the study requirements of 8 sessions & post-testing.  Method of 
payment will be by ClinCard, which works like a debit card.  They will receive the ClinCard after their 
enrollment session at MSM, and it will be reloaded at each payment time.  They will be able to use the funds in 
approximately 1 business day. This is to repay participants for time spent in the study and any inconvenience. 
 
 
 

 
 
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Participant Parking 
The Morehouse School of Medicine has a parking deck available to visitors and study participants for a total 
cost of $5 per visit between the hours of 7:00am-5:00pm Monday-Friday. If they are driving, participants will 
pay out of pocket for the cost of parking when they attend each of the study sessions. The highest amount of 
cost for parking that a participant would incur would amount to $55.  The compensation being provided for their 
participation in the study is intended to offset any incurred costs to the participant. 
 
Compensation Summary 
Final screen & pre-testing- 90-120 minutes: $75 
For participants who attend but who are found not to be eligible for the study: $25 
 
Per training session- 90 minutes: $75 
Total for 8 sessions = $600 
Post-testing session- 90-120 minutes: $75 
2nd post-testing session (for delayed control group only): $75 
 
Totals 
     Immediate experimental group: $750 
     Delayed control group: $825 
 
 
Timeline 
 
The timeline for Group 1 (lmT) and Group 2 (DeT) is summarized in Table 5 below. The time course 
of the steps involved in this study are shown in the timeline diagram.  
Table 5. Timeline 
Timeline 
Mo Intervention 
Mo 
Intervention 
1 
Recruitment Group 1 
8 
Training ImT 2 (N=5-12)   
2 
Pre-Test 1 (N=10-24); Random 
Assignment 
9 
Post-Test 1 (N=10-24) 
3 
Training ImT 1 (N=5-12)  
10 
Training, DeT 2 (N=5-12) 
4 
Post-Test 1 (N=10-24) 
11 
Post-Test DeT 2 (N=5-12) 
5 
Training, DeT 1 (N=5-12) 
12 
Data Analysis 
6 
Post-Test DeT 1 (N=5-12);  
Recruitment Group 2 
13 
Write-up 
7 
Pre-Test 2 (N=10-24); Random 
Assignment 
 
 
 
 
 

 
 
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Timeline for Group 1 Intervention and Control 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Group 1 
Recruitment of 
N= 10-24 
Harvard: Assess for 
eligibility 
Exclusion: 
Don’t meet criteria 
Declined study 
 
Enrollment & Pre-testing (N=10-24) 
     RANDOMIZATION 
     N = 10-24 
Visits 2-9 
Intervention (n=5-12) 
Training for 4 Weeks 
Control (n = 5-12) 
4 Weeks 
Waiting 
Visit 10: 
Post-Testing 
(Intervention) 
Group 2 
The above process is repeated 
for Intervention and Control 
 
Statistical analysis after 
the conclusion of Group 2 
Morehouse final 
assessment for eligibility 
Exclusion: 
Don’t meet criteria 
Declined study 
Visit 2: 
Post-Testing #1 
(Control) 
Visits 3-10 
Control (n=5-12) 
Training for 4 Weeks 
Visit 11: 
Post-Testing #2 
(Control) 
Waiting period for screened participants 
as recruitment continues toward goal N 
Visit 1: Consent 
Accepts, declines 
study participation 

 
 
12
Quality Monitoring of the Study 
 
Blinding Monitor to assure that participants and person conducting the testing are blind as to 
intervention and control conditions.  
 
Fidelity Monitor will assure that therapists will conform to the method as set out in the modularized 
program. 
 
Workbook includes all homework assignments 
 
Habit Maker Checklist will monitor application of program content to daily life. 
 
Workbook Log tracks completed homework 
 
Appendix 6 includes the above items: (1) Monitors – Blinding, Fidelity, (2) Homework – Workbook, 
Habit Maker Checklist, (3) Homework Log. 
 
 
Withdrawal Criteria 
 
Investigators may withdraw a subject from the study at any time for the following reasons: 
 
The participant has not met the training attendance or testing session scheduling requirements of the 
study, as outlined above 
 
The participant has not met the homework requirements of the study, as outlined above 
 
A serious adverse event occurs 
 
The investigator considers, for safety reasons, it is in the best interest of the individual participant or 
other participants that the individual participant stop participation in the study 
 
Data Security and Management   
 
Potential study participants’ contact information including name, phone number, and email address 
will be recorded and accessed through a secure online application, referred hereafter as “the study 
app”, from data contained in the existing FPHS repository protocol (described in HMS protocol #14-
2691). The study app is a secure application that has been specifically created for this project to 
utilize as a secure, HIPAA compliant mechanism for retrieving and transferring participant information 
to and from the HMS data repository. Apart from recording potential participants’ contact information, 
the study app will be used to record and access participants’ responses to the HMS screening guide. 
The study app will additionally serve as a logistics tool to record and access information regarding a 
participants’ study status at MSM (e.g. final screening, consent, enrollment, progress, and 
completion) and assigned study ID, and for the MSM team to keep the HMS team apprised of any 
adverse events or issues with participants.  The study app is the only place where participant contact 
information will reside, and it will also house the study key connecting participant’s identities with their 
study IDs. 
 
The study app will only be accessible to designated study staff members, PI’s and investigators via 
an online portal that requires a distinct username and password and login to a virtual private network 
(VPN) client. Potential participants who are deemed to be ineligible for the study will have their 
collected information removed from the study app within 14 days of being notified of their ineligibility. 
 

 
 
13
Confidentiality of participants’ records will be maintained in secure offices at the research site.  
Personally identifiable data (except full names and contact information as outlined above) will be 
stored in locked cabinets in locked rooms and/or in a password protected file on secure computer 
drives and study specific folder. Data will be stored in accordance with regulations required by PI and 
Co-I respective institutions. HIPAA laws and regulations will be implemented.  
 
Captured data for the Goal-Directed Resilience Training (GRIT) study will be housed on the 
platform of the Research Electronic Data Capture (REDCap) on one of Morehouse School of 
Medicine’s (MSM) research studies servers. MSM servers are positioned behind multilayered 
firewalls to prevent unauthorized internal or external access. Electronic data capture protocols and 
forms will be devised and interfaced using REDCap.  Data capture, management, and use 
procedures and protocols at MSM are governed by the rules and policies of the Health Insurance 
Portability and Accountability Act (HIPAA) to protect the privacy, confidentiality and well-being of 
study participants. Captured data will be de-identified through assignment of study IDs to participants 
that are not conducive of revealing their identity. All analyses, reporting and query of the data will be 
conducted using participants’ study IDs.  Master list of linked names and identifiers to study IDs will 
only be accessible to designated study personnel and the study PI through the study app outlined 
above. Once the captured data is deposited, verified and checked for completeness, integrity and 
accuracy, only designated study team will have various levels-privileges to access the data for query, 
reporting and analyses purposes, through verifiable user’s name and passwords. 
 
Responses to enrollment questions and outcome measures that are directly administered and 
recorded on answer sheets will be coded and transferred onto a spreadsheet.  Answer sheets and 
spreadsheets will not contain any identifiable information, with only the subject ID used. 
 
When the study is closed, duplicate copies of data collected and stored by MSM will be securely 
transferred to HMS. 
 
 
Risks/Assessment 
 
Risks and discomfort to the participant may arise form:  
 
(1) Questions in the screening tests. The final screening assessments will consist of questions 
concerning possible risk for considering and pursuing suicide. The questions range from whether a 
participant has thought of suicide to whether they have an actual plan and intend to carry it out. They 
will also assess presence of disturbed thinking typical of psychosis. The questions range from 
another source planting thoughts in the participant’s mind to the participant believing they have 
special powers. The Mental Health Action Plan in Appendix 8 describes our approach for assessing 
and keeping patients safe with regard to suicidality and psychosis. 
 
(2) Questions from the scales during pre- and post- testing. Participants may experience the 
questions to be sensitive and/or unsettling. The participant may choose not to answer any questions if 
they do not want to. Skipping an entire test is not an option, and participants will be informed that if 
they choose to do this they will be withdrawn from the study. Further details are described in 
Appendix 8. 
 
(3) Topics raised during the small group intervention. The interventionist will explore a subject within 
the training group – how the participants have experienced a subject, solved it, and how to 
incorporate it into the training concept and learn from it. If a participant experiences discomfort and/or 

 
 
14
concerns that extend beyond the group’s concerns and are not suitable for this approach, or a 
participant expresses a desire to end their participation in a given training session, the session will be 
ended for that individual participant and postponed until the participant feels ready to return for the 
next session. Incomplete sessions will be dealt with per the attendance requirements outline in the “5. 
Intervention Training” section above.  If the participant and the trainer feel that more time is needed, 
therapy outside of the study training sessions may be recommended and dropping out of the study 
may be considered. Participants will be given referral information for outside evaluation and 
assistance as needed. 
The Mental Health Action Plan in Appendix 8 describes our approach for assessing and keeping 
participants safe. 
 
Dissemination of GRIT Training and the ExBC Model  
 
To make GRIT training broadly available, we plan to post an outline of the four modules and a 
summary of the introduction on the Internet. Interested participants can order the GRIT manual as a 
self-study program.  
 
STUDY PERSONNEL 
 
Roles and Responsibilities 
 
PI (Herman Taylor, MD, MPH) will oversee the conduct of the intervention study (GRIT) in Atlanta. He 
will oversee all Atlanta-based study staff, and the recruitment of potential participants residing in 
greater Atlanta who have not yet taken the first questionnaire to become a part of the Harvard Study. 
He will assist in referring potential participants, assist in the final stage of participant screening, assist 
in medical issues when they arise with participants, review main documents of the study such as the 
protocol, and contribute to write-up and publication of studies and exploration of funding.  
 
Co-PI – (Ross Zafonte, DO) will supervise participating study staff members in Boston, communicate 
with the IRB in Boston, review main documents of the study such as the protocol, and participate in 
analysis and write-up of the study.  
 
Biostatistician for Study design and Analysis (Mohammad Mubasher, PhD) will draw the 
randomization scheme, generate the assignments and implement the randomization process. He will 
also prospectively evaluate the adequacy of the randomization scheme for possible corrections. 
Additionally, will be responsible for the integrity and accuracy of the collected data and conduct 
univariate and multivariate analyses.  Finally, he will generate statistical reports and co-author the 
findings of the study.   
 
Consultant (Martha Kent, PhD) will be responsible for the implementation of the content to be trained 
in this intervention, including training the co-therapist, training and supervising pre-post testing, 
reviewing and monitoring fidelity of intervention training by co-therapist, further development and 
adaptation of the training manual, participation in the testing process of PACE and its development as 
an at-risk screen. Participate in the interpretation and write-up of findings. Participate in the 
development of main documents of the study such as the protocol, contribute to write-up and 
publication of studies and exploration of funding. On staff as Research Scientist and 
Neuropsychologist at Phoenix VA Health Care System. Adjunct Faculty at Arizona State University. 
 

 
 
15
Consultant (Glenda Wrenn, MD, MPH) will assist in cultural relevance aspects of the program in focus 
groups and broader applications of the intervention to relevant areas of players’ lives. On staff in 
Psychiatry Department, Morehouse School of Medicine; appointment at VAMC, Atlanta. Oversight in 
the implementation of intervention elements: consenting, pre-post testing, intervention & control 
training. Contribute to the development of the content for control condition with emphasis on chronic 
pain in football players. Contribute to cultural adaptation of the manual.  
 
Consultant (Leroy Reese. PhD) will assist in cultural relevance aspects of the program in focus 
groups and broader applications of the intervention to relevant areas of players’ lives. On staff in the 
Community Health & Preventive Medicine department at Morehouse School of Medicine; and will 
provide oversight in the implementation of intervention elements: consenting, pre-post testing, 
intervention & control training. Contribute to the development of the content for control condition with 
emphasis on chronic pain in football players. Contribute to cultural adaptation of the manual.  
 
 
Interventionist (Gilberte Bastien, PhD, MPH) 
The interventionist will work with one group at a time and meet in small group sessions of no more 
than 10 twice a week. She will be trained by Dr. Kent in the application of the GRIT intervention and 
control conditions. She will be required to follow Dr. Kent’s method exactly in their implementation. 
Each intervention visit and control visit lasts for 90 minutes. Any participant concerns that arise that 
cannot be addressed in the session will be brought to the attention of the Co-PI and Project Manager.  
 
Interventionist (Brian McGregor, PhD) 
This interventionist will substitute as needed for the primary interventionist (Bastien) in facilitating 
small group sessions.  He will work with one group at a time and meet in small group sessions of no 
more than 10 twice a week. He will be trained by Dr. Kent in the application of the GRIT intervention 
and control conditions. He will be required to follow Dr. Kent’s method exactly in their implementation. 
Each intervention visit and control visit lasts for 90 minutes. Any participant concerns that arise that 
cannot be addressed in the session will be brought to the attention of the Co-PI and Project Manager.  
 
 
Psychiatry Residents (Ru Hasan, MD / Chris Villongco, MD) 
The psychiatry residents are needed because the persons administering the testing has to be blind as 
to which participant belongs to the intervention or the control condition. The psychiatry residents will 
be responsible for administering all the neuropsychological screening tests, pre-tests, and post-tests 
throughout the study. Individual neuropsychological tests will be administered in individually 
scheduled sessions. If not familiar with a required test, he or she will be trained by the consultant to 
administer it. The residents will also score the neuropsychological tests and enter these scores into a 
data file.  
 
Project Manager/ Atlanta site (Marques Harvey, MPH, MDiv) Assists with the recruitment, data 
collection, tracking, and follow-up of participants at the Atlanta, Georgia site. Helps to ensure timely 
and accurate completion of any local regulatory requirements, budgetary compliance, as well as 
completing any required progress reports.  Coordinates ongoing meetings, conference calls with 
study personnel to ensure progress.  Responsible for IRB reporting, and will conduct all consent 
sessions with participants.  
 
Project Manager / HMS (Sarah Cohan, PMP) Oversees all recruitment and screening activities 
at the HFPHS. 

 
 
16
 
Other HMS Study Staff: 
 
 
Dean Marengi – Harvard Medical School – Data Coordinator 
 
James Drummey – Harvard Medical School – Data Coordinator 
 
Daniel Runt – Harvard Medical School – Data Coordinator 
 
Dylan Keating – Harvard Medical School – Research Assistant 
 
Ilaria Amato – Harvard Medical School – Research Assistant 
 
Soo Kyung Sarah Kim – Harvard Medical School – Research Assistant 
 
Nicole Jones – Harvard Medical School – Research Project Coordinator 
FUTURE PLANS 
This pilot study has the potential to identify a strategy to enable remote self-assessment for pain to 
inform treatment seeking decision-making among football players. The pilot intervention is a 
necessary first step in gathering preliminary data and assessing the need for cultural tailoring of a 
resilience intervention previously studied in veteran populations. Although the pilot study is a face-to-
face intervention, future studies with adequate funding to support a large-scale comparison of in 
person and hybrid online and live-video intervention format. There is a significant need for accessible, 
effective interventions that minimize stigma, while establishing an ecosystem of resilience for football 
players impacted by pain. In Year 2, we will submit a proposal for R21 or equivalent to advance the 
development of a remote intervention to address pain.