Establishing Efficacy of a Functional-Restoration Based CAM Pain Management Program in a Combat-Injured Veterans Population
Phase: NA
Conditions: Chronic Pain, Traumatic Brain Injury, Posttraumatic Stress Disorder, Depression, Opioid Use Disorder
Sponsor: The University of Texas Health Science Center at San Antonio

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COVER PAGE  
 
 
 
 
 
Official Study Title: Establishing Efficacy of a Functional 
Restoration-Based CAM Pain Management Program 
in a Combat Injured Veterans Population 
 
 
NCT number: NCT02657317 
 
IRB Approval Date: 11/20/2019 
 
 
Unique Protocol ID: R01 AT008422-01 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Establishing Efficacy of a Functional Restoration-Based CAM 
Pain Management Program in a Combat Injured 
Veterans Population 
A randomized clinical trial of an interdisciplinary program with a strong CAM component (the 
FORT-A Program) to address chronic pain management and persistent opioid use in a sample of 
130 OEF/OIF/OND Veterans with polymorbid chronic musculoskeletal pain  
 
Study Chairman or Principal Investigator:   
Don McGeary, PhD, ABPP 
Associate Professor, Department of Psychiatry 
University of Texas Health Science Center San Antonio 
mcgeary@uthscsa.edu 
1-210-562-6708 
 
Supported by:  
The National Center for Complementary and Integrative Heath  
 
R01 AT008422-01 
 
 
 

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Tool Revision History 
Version Number: 1.0  
Version Date: 17 JUL 2014 
Revision Summary: N/A (New Protocol)  
Version Number: 2.0  
Version Date: 03 OCT 2014 
Revision Summary: Added information on VA Opioid Safety Initiative 
Inclusion of some regulatory procedures based on VA R&D Review for this study (occurred Oct 
2, 2014) 
Version Number: 3.0  
Version Date: 11 NOV 2014 
Revision Summary: Added STRONG STAR SOPs and integrated study operations with 
STRONG STAR regulatory infrastructure  
Version Number: 4.0  
Version Date: 13 JAN 2015 
Revision Summary: Added information about the qualifications of treatment providers for group 
and individual treatments (Sec 5.2); Revised and clarified randomization blocking after 
consultation with Dr. Li (Sec 4.3 & 6.2.2); Added a table of interventions received in PRC Usual 
Care (Sec 5.1); Clarified Physical Therapy in the Treatment as Usual Group (Sec 5.1.1); 
Provided a list of prohibited interventions (Section 5.3.3); Added descriptions of endpoints being 
used in the study (Sec 9.5.1& 9.5.2); Clarified ITT population (Sec 9.3); Added detail to plan for 
minimizing and managing missing data (Sec 9.6); Clarified analytic strategy at Mo. 12 (Sec 9.6). 
 
Version Number: 5.0  
Version Date: 08 JUNE 2015 
Revision Summary: Added Co-Coordinator to Figure 2 (Page 18); Clarified Role of Co-
Coordinator throughout (Various Sections); Added Specific Names for the IE and Fellow in 
Figure 2 (Page 18); Adjustment to Inclusion and Exclusion Criteria (Sec 4.1); Clarification on PT 
referral through PRC (Sec 4.1 and 5.1.1); Added PRC PT/OT personnel (Sec 5.2 and 7.1); 
Added STRONG STAR Interns as study providers (Sec 5.2, Figure 2); Clarification on Exclusion 
for impaired cognition (Sec 4.2); Amended “enrollment” and ensured assessment windows 
reference this definition (Sec 6.2.2, 6.2); Changes to Measures s/p Westat visit and STRONG 
STAR Assessment Core (MINI only given in screening Section 6.1; Change from Actical to 
Actiwatch Sec 6.2.4, 6.2.5, 9.5.2; Change from BDI-2 to PHQ-9 Section 6.2, 7.3; Extension of 
Assessment Windows (Sec 6.1); Clarified assessment windows per STRONG STAR Standard 
Operating Procedure; Removed reference to “quarterly” NCCIH reviews (Sec 10.3.4 and 
10.3.5); Add pregnancy test at screening (Sec 6.2.1). 
 
Version Number 6.0  
Version Date: 14 OCT 2015 
Revision Summary: Added a summary of changes for this Amendment (Page 4). Updated 
Precis to fit new opioid criteria and outcomes (PRECIS). Updated background to include 
information about opioid withdrawal and recidivism (Sec 2.1). Added information about definition 
of opioid recidivism as well as outcomes assessment for opioid and other pain medication 
changes in study design (Sec 3). Changed inclusion criterion for opioid use to include persistent 
opioid users or previous opioid users who were discharged off of opioid medications through the 
OSI (Sec 4.1).  Updated exclusion criteria and prohibited treatments to include veterans enrolled 
in naloxone-based treatment for opioid dependence (Sec 4.2 & 5.3.3). Added information to the 

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section on the OSI as justification for inclusion change (Sec 5.3.4). Updated Precis with new 
opioid criteria. Updated study objectives with new opioid objectives (Sec 1.1). Added an 
explanation of OSI inclusion in study rationale (Sec 2.2). SOWS to be given at baseline (Sec 
6.1).  Updated opioid hypothesis (Sec 9.1).  Updated opioid data methods (Sec 9.5.2).  Added 
info about screening for OSI referral (Sec 6.2).  Added opioid assessments in CPRS/PAT and 
Medication Quantification Scale III (Sec 6.1, 6.2.2, 6.2.4 & 6.2.5). Updated Section 7 to reflect 
weekly phone call / meeting and updated justification for opioid safety monitoring (Sec 7.2 
&7.3). Updated design issues for opioid hypothesis (Sec 9.1).  Updated sample size justification 
to emphasis powering to Aim 1 despite the change to Aim 2 (Sec 9.2).  Updated data analytic 
strategy for opioid medication (including sample size justification; Sec 9.2 & 9.6).  Updated 
secondary outcome description for opioid and other pain medications (Sec 9.5.2).  Added 
references (Sec 14). 
 
Version 7.0 
 
 
Version Date: 19 APR 2016 
Revision Summary: Addition of new measures to assessment battery as Common Data 
Elements of the STRONG STAR Research Consortium (these measures were recently added in 
all Consortium and Affiliate trials) including measures of tobacco (Fagerstrom Test for Nicotine 
Dependence-FTNB; Fagerstrom Test for Nicotine Dependence – Smokeless Tobacco (FTND-
ST), Quick Drinking Scale.  New measures were added to Sections 6.1, 6.2.2, and 6.2.4.  The 
name of the Medical History Interview has been changed to Health Questionnaire/Addendum in 
Sections 6.1 and 6.2.2.  Inclusion criterion for depression in Section 4.1 was changed to reflect 
assessment with the PHQ-9 instead of the BDI-2 (this change was missed when we previously 
amended the protocol to replace the BDI-2 with the PHQ-9 to be consistent with other STRONG 
STAR and Affiliate studies). Broadened opioid Inclusion Criterion #6 to read “on their own or by 
a provider during the OSI period.” 
 
Version 8.0 
 
 
Version Date: 18 JULY 2017 
Revision Summary: Gulf War era Veterans are now eligible to participate in addition to 
Operations Iraqi Freedom (OIF), Enduring Freedom (OEF), or New Dawn (OND) era Veterans. 
 
Version 9.0 
 
 
Version Date: 26 November 2018 
Revision Summary:  Under Section 5, Study Interventions we added that individual sessions 
(depression, PTSD) may be conducted by other clinic providers if subject is already engaged in 
treatment prior to enrollment.  If sessions are conducted by another provider, the quality of care 
will be standard clinical care which is appropriate for this protocol; however, the duration of care 
may be variable so we will be tracking number of sessions attended. For those subjects 
receiving Individual sessions from another clinic provider, the 15 minute pain management 
session will be included with their biofeedback session.  Because we are not allowed to ask 
them to discontinue VA intervention and it is unethical to over-treat another mental health 
provider (per APA and Texas State Board rules), we cannot provide individual sessions to those 
participants.      
 
Revised the inclusion criteria to specify that participants need to have no opioid use for one 
week before the pain management program period (weeks 1-3).  The original criterion of being 
discharged off of persistent opioid medications during the OSI period was used because of the 
decrease in opioid prescriptions in the VA under the opioid safety initiative (such that most 

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participants were going to be discontinued on opioid medications and we wanted a homogenous 
sample).  It must be noted that up to 40% of pain sufferers who try to discontinue opioid 
medications (after persistent use) will fail to discontinue.  The PI has noted that the 
investigational intervention, because of its capacity to lead to decreased need for medications 
(including and especially opioids for pain management) through improved non-pharmacological 
pain management training, is likely to be helpful for veterans who both successfully and 
unsuccessfully discontinue opioids.  Thus, this change was made to maximize benefit of the 
intervention in the VA population without sacrificing scientific rigor.  
 
Version 10.0  
 
Version Date: 9 September 2019 
Revision Summary: Addition of a new measure to capture data from participants who were lost 
to contact or dropped from treatment.  The Missing Data Assessment is a 4-item measure of 
global symptom improvement of pain, perception of satisfaction and burdensomeness of study 
treatments, and reason(s) for discontinuing study participation. This assessment will be used to 
assess missing data randomness and to categorize participants who discontinued study 
participation as a way to help impute missing data and improve future studies with these 
treatments in similar populations. In addition to the Missing Data Assessment, participants who 
withdrew from the study will also be contacted to complete the ODI, TLFB and Concomitant 
Meds Form.

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Summary and Justification for Amendment 6 Changes 
Amendment 6 of this document includes an unusual revision of a Study Aim (Aim 2).  In this 
case, Aim 2 of this protocol is being revised in response to external events that threaten the 
feasibility of the originally proposed research and the clinical utility of the Aim 2 findings.  
Because of the scope of change, this summary was developed to provide an explanation and 
context for why/how this decision was made.  To save space, the reader is encouraged to review 
the changes made throughout the document as described in the Version 6.0 Revision Summary 
on the previous page.  This study was originally proposed as a test of functional restoration 
rehabilitation (with a mindfulness content core) in addressing service-related chronic pain among 
post-9/11 deployment era veterans.  In so doing, the investigators developed a secondary aim to 
address the important question of opioid use for pain management in the VA and the effect of 
functional restoration on opioid sparing.  After this proposal was submitted to NCCIH for 
funding determination, the Department of Veterans Affairs began to implement an Opioid Safety 
Initiative (OSI; see Section 5.3.4 for a thorough description and updates) that resulted in a 
significant shift in opioid prescription patterns in the VA.  The South Texas Veterans Health 
Care System was identified as a “Top 10 Performer” in the OSI in August 2015, and a significant 
number of persistent opioid users in this VA system are no longer using opioid medications.  
 
Changes under the OSI posed two challenges to this research and the VA system as follows: 
1) As this research program progresses, there will be fewer veterans meeting “persistent 
opioid use” inclusion criteria over time; a threat to feasibility of recruitment and 
exemplary of how the population of interest (veterans with polymorbid pain) is likely to 
change over the course of this study.  In order to meet the needs of the population, this 
research needs to adjust Aim 2 to better exemplify Veterans who are prior opioid users 
versus current persistent users.  Because the VA has already implemented an 
administrative protocol to decrease opioid prescriptions given to patients, maintaining a 
clinical aim of opioid sparing after functional restoration treatment makes no sense.  The 
new question is: Can the VA keep veterans from returning to opioid use? 
2) The OSI requires the VA to develop an alternative intervention strategy for veterans in 
pain who discontinue opioid medications, with an emphasis on CAM.  In discussions 
with the STVHCS OSI (as recently as October 14, 2015), the PI and study team have 
confirmed that the proposed study would meet the VA’s needs if the pain program 
addresses return to opioid use (e.g., opioid recidivism) instead of opioid sparing.  Making 
this change would doubly benefit the VA as a referral outlet for alternative pain 
management and a data-gathering mechanism to help them assess progress.  Win-win. 
 
This protocol has made several Aim 2 changes to make the most of this opportunity including: 
changing the Aim 2 endpoint to opioid recidivism (i.e., using an opioid medication 3+ days in a 
30 day period), adapting the MEMS caps to assess other pain medication patterns that may shift 
after veterans stop opioids, using the Medication Quantification Scale to capture the change in 
medication safety over time, and increased frequency of medication assessment to powerfully 
assess Aim 2 with this sample size.  It is important to note that this study must be powered to 
address Aim 1 because improved pain management is the most likely vehicle for decreasing 
opioid recidivism over time.  However, increased frequency of medication assessment does 
provide sufficient power to detect differential rates of recidivism between FORT-A and TAU. 

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TABLE OF CONTENTS 
Page 
Official Study Title: Establishing Efficacy of a Functional Restoration-Based CAM Pain 
Management Program in a Combat Injured Veterans Population .......................................... 1 
Establishing Efficacy of a Functional Restoration-Based CAM Pain Management Program 
in a Combat Injured Veterans Population ................................................................................. 2 
Tool Revision History ................................................................................................................. 3 
TABLE OF CONTENTS ............................................................................................................. 7 
1. STUDY OBJECTIVES ........................................................................................................... 12 
1.1 
Primary Objectives ........................................................................................................ 12 
1.2 
Secondary Objectives .................................................................................................... 12 
2. BACKGROUND AND RATIONALE .................................................................................. 13 
2.1 
Background on Condition, Disease, or Other Primary Study Focus ............................ 13 
2.2 
Study Rationale ............................................................................................................. 15 
3. STUDY DESIGN ..................................................................................................................... 17 
4. SELECTION AND ENROLLMENT OF PARTICIPANTS .............................................. 21 
4.1 
Inclusion Criteria .......................................................................................................... 21 
8) The Veteran will be eligible to be a PRC patient (i.e., have multiple trauma related physical 
and psychological injuries; VA, 2013) and be eligible for Physical Therapy referral through 
the PRC (though the referral for the same service could also come from another VHA 
provider).  All participants will be offered Physical Therapy services before enrollment and 
will be enrolled after completing or denying Physical Therapy. .............................................. 22 
4.2 
Exclusion Criteria ......................................................................................................... 22 
4.3 
Study Enrollment Procedures ....................................................................................... 22 
5. STUDY INTERVENTIONS .................................................................................................. 23 
5.1 
Interventions, Administration, and Duration ................................................................ 23 
5.1.1  
Physical Therapy in the PRC Treatment as Usual .................................................... 28 
All study participants will receive a recommendation for Physical Therapy (PT) at pre-
screening (before enrollment) to ensure that prior participation in “standard” PRC PT does not 
confound study results (and most PRC patients with pain receive a recommendation for PT as 
part of standard care).  This is necessary to ensure that there are not differences in enrolled 
participants based on their prior exposure (or opportunities for exposure) to PT before 
participating in the study.  Those who have previously completed PT through the STVHCS or 
have declined participation will be enrolled and randomized for this research (if they 

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otherwise qualify).  Participants in the PRC Treatment as Usual study arm will not receive 
another recommendation for PT through the PRC because a second recommendation is not 
standard care in the PRC.  They are not prohibited from attending PT again, but a second 
recommendation for PT in the Treatment as Usual arm will not be provided as part of this 
research. .................................................................................................................................... 28 
5.2  
Handling of Study Interventions ................................................................................... 28 
5.3 
Concomitant Interventions ............................................................................................ 31 
5.3.1 
Allowed Interventions ........................................................................................... 31 
5.3.2 
Required Interventions .......................................................................................... 32 
5.3.3 
Prohibited Interventions ........................................................................................ 32 
5.4 
Adherence Assessment ................................................................................................. 34 
6. STUDY PROCEDURES ...................................................................................................... 37 
6.1 
Schedule of Evaluations ................................................................................................ 38 
Health Questionnaire ............................................................................................................. 38 
6.2 
Description of Evaluations ............................................................................................ 42 
6.2.1 
Enrollment and Screening Evaluation (Week -4 to Week 0; See Figure 3) ......... 42 
6.2.2 
Randomization and Baseline................................................................................. 44 
6.2.3 
Blinding................................................................................................................. 47 
6.2.4 
Followup Visits (see Figure 4) .............................................................................. 48 
6.2.5 
Completion/Final Evaluation ................................................................................ 49 
7. SAFETY ASSESSMENTS ..................................................................................................... 50 
7.1 
Specification of Safety Parameters ............................................................................... 50 
7.2 
Methods and Timing for Assessing, Recording, and Analyzing Safety Parameters .... 51 
7.3 
Adverse Events and Serious Adverse Events ............................................................... 51 
7.4 
Reporting Procedures .................................................................................................... 53 
7.5 
Followup for Adverse Events ....................................................................................... 54 
7.6 
Safety Monitoring ......................................................................................................... 54 
8. INTERVENTION DISCONTINUATION............................................................................ 54 
9. STATISTICAL CONSIDERATIONS .................................................................................. 55 
9.1 
General Design Issues ................................................................................................... 55 
9.2 
Sample Size and Randomization .................................................................................. 57 
Treatment Assignment Procedures ....................................................................................... 58 
9.3  
Definition of Populations .............................................................................................. 59 
9.4 
Interim Analyses and Stopping Rules ........................................................................... 59 
9.5 
Outcomes ...................................................................................................................... 60 
9.5.1 
Primary Outcome .................................................................................................. 60 

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9.5.2 
Secondary Outcomes ............................................................................................ 61 
9.6 
Data Analyses ............................................................................................................... 63 
10. DATA COLLECTION AND QUALITY ASSURANCE .................................................. 64 
10.1 
Data Collection Forms .................................................................................................. 64 
10.2 
Data Management ......................................................................................................... 64 
10.3 
Quality Assurance ......................................................................................................... 65 
10.3.1 
Training ................................................................................................................. 65 
10.3.2 
Quality Control Committee ................................................................................... 65 
10.3.3 
Metrics .................................................................................................................. 65 
10.3.4 
Protocol Deviations ............................................................................................... 65 
10.3.5 
Monitoring ............................................................................................................ 66 
11. PARTICIPANT RIGHTS AND CONFIDENTIALITY ................................................... 66 
11.1 
Institutional Review Board (IRB) Review .................................................................... 66 
11.2 
Informed Consent Forms .............................................................................................. 66 
11.3 
Participant Confidentiality ............................................................................................ 66 
11.4 
Study Discontinuation ................................................................................................... 66 
12. COMMITTEES .................................................................................................................... 67 
13. PUBLICATION OF RESEARCH FINDINGS .................................................................. 67 
14. REFERENCES ...................................................................................................................... 67 
15. SUPPLEMENTS/APPENDICES (SOP = “Standard Operating Procedure”) ............... 74 
I. Data Safety Monitoring Plan 
II. Appendix Table 

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Study Title  
Establishing Efficacy of a Functional Restoration-Based CAM Pain Management 
Program in a Combat Injured Veterans Population  
Objectives  
AIM 1: Assess the efficacy of the FORT-A Program for improved pain management 
outcomes in (N=130) polymorbid OEF/OIF/OND Polytrauma Rehabilitation Center 
(PRC) Veterans with chronic musculoskeletal pain (CMP) using a 1:1 randomized 
clinical trial comparing FORT-A to standard PRC care.  We will determine the 
improvement in pain management outcomes attributable to a fully integrated and 
manualized interdisciplinary pain program (FORT-A) compared to standard PRC 
care.  
AIM 2: Assess the efficacy of FORT-A for decreasing the rate of opioid recidivism 
(using any opioid for 3 or more days in any 30-day period) compared to standard 
PRC care in a sample of OEF/OIF/OND polymorbid CMP Veterans discharged off of 
opioid medication in VA care since the start of the OSI.  Unlike the original FORT 
trial, this research will formally and prospectively track opioid medication use among 
polymorbid Veterans to sensitively detect changes in chronic opioid therapy 
attributable to FORT-A versus PRC treatment. FORT-A is expected to produce 
significant reductions in the rate of opioid recidivism by imparting numerous 
strategies to supplant opioid medication as a pain management strategy.  FORT-A 
will avoid the stigma of “traditional” opioid abuse treatment and provide a pain 
management alternative to those who have been discharged from opioid medications 
as part of the OSI. 
EXPLORATORY AIM 3: Based on the PI’s ongoing ESCAPE trial, this research 
team has identified psychological processes (helplessness, perceived 
burdensomeness) that likely play a mechanistic role in pain management among 
OEF/OIF/OND deployers.  We will assess these constructs twice a week and analyze 
latent changes in FORT-A and PRC Veterans to ascertain their role as pain 
management mediators 
Design and Outcomes   
This study is a 1:1 block randomized clinical trial comparing the FORT-A program to 
treatment as usual for polytrauma OEF/OIF/OND Veterans with prior persistent 
opioid use and chronic musculoskeletal pain who are eligible for treatment through 
the STVHCS Polytrauma Rehabilitation Center.  All participants will be offered 
Physical Therapy services before enrollment and will be enrolled after completing or 
denying Physical Therapy (up to 12 sessions as recommended by a PRC Physical 
Medicine & Rehabilitation Physician (Dr. Eapen, Dr. Jaramillo).  If they have already 
completed PRC Physical Therapy before study enrollment, they will not need to do so 
again.  Also, if the Veteran qualifies but refuses PRC Physical Therapy, he or she will 
still be eligible to enroll in this study and will not be asked to complete PRC PT.  
Veterans randomized to PRC (treatment as usual) will then meet with PRC and other 
VA medical providers per usual standards of care (described below).  Those 

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randomized to FORT-A will complete the standardized FORT-A Program (described 
in detail below).  All participants will complete a standardized battery of assessments 
at pre-treatment (Week 0), post-treatment (Week 4/5), 6-month follow-up (Week 
30/31) and 12-month follow-up (Week 56/57; see Figure 1, below). 
  
Interventions and Duration  
FORT-A: An amended version of the military Functional Orthopedic Rehabilitation 
Treatment (FORT) program.  For FORT-A, CBT components of FORT were 
diminished and replaced with mindfulness and Acceptance and Commitment Therapy 
(ACT) components.  Individual FORT treatment sessions have been altered in FORT-
A to focus on PTSD symptom management using an abbreviated, manualized 
Prolonged Exposure treatment.  FORT-A includes: 
• 12 sessions (90-minutes each) of manualized group pain management 
• 12 sessions (90-minutes each) of group-based functional restoration Physical 
Therapy  
• 6 sessions (75 minutes each) of individual psychotherapy for pain and PTSD 
• 6 sessions (30 minutes each) of biofeedback for pain management 
• Weekly interdisciplinary case staffings 
 
PRC: The STVHCS PRC is the only self-contained PRC in the VA’s nationwide 
Polytrauma System of Care.  The PRC is an interdisciplinary treatment center 
including: interdisciplinary assessment and treatment, case management, mental 
health support, physical medicine and rehabilitation (PM&R), physical therapy, 
speech therapy, prosthetists/orthotists, and other integrated specialty services.  The 
PRC sees approximately 30 new patients each month, most of whom (80%) present 
with a chronic service-related musculoskeletal pain condition and military trauma 
comorbidity (traumatic brain injury [TBI], PTSD, depression).  Though individual 
treatment plans may vary, most PRC Veterans will complete up to 12 sessions of 
Physical Therapy and be followed by a PM&R physician for pain and other symptom 
management.  Pain management with PM&R may include medications, injections, 
and other palliative medical interventions.  The PM&R physicians may also make 
recommendations about physical function, health behaviors, and mobility. 
 
Sample Size and Population  
This research study will include 130 OEF/OIF/OND Veterans who meet the 
following criteria: 
• Present with an ongoing chronic musculoskeletal condition (pain that has been a 
problem for more than half the days over the past three months) documented in 
the CPRS record or confirmed by a PM&R physician upon referral to the PRC 
• Display at least moderate disability based on an Oswestry Disability Index score 
Figure 1.  Study Activity Flowchart. 
Recruitment 
Consent 
Screen & 
Randomize 
 
FORTA 
PRC 
Assess 
Pre-Tx 
Treatment 
Phase 
Assess 
Post-Tx 
Long-term Follow-
up  
6 Month 
12 Month 
  --------------------------------- Week -4 to -1  ----------------------------------             Week 0                  Week 1-3                  Week 4/5        Week 30/31  Week 56/57       

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of 20% or greater 
• Primary pain complaint was acquired or exacerbated due to military service or a 
deployment-related injury 
• Chronic musculoskeletal pain presents in the context of comorbid psychiatric 
trauma condition(s) including: mild TBI, PTSD, and/or depression 
• Present with a history of persistent opioid use (using opioid medication for 20 out 
of every 30 days over the past three or more months) and discontinued from 
opioid medications at the request of their VA provider (e.g., as part of the VA 
Opioid Safety Initiative [OSI]). 
• Speak and read English proficiently 
• Eligible to become or are currently enrolled as a STVHCS PRC patient  
1. STUDY OBJECTIVES 
1.1 
Primary Objectives 
Hypothesis 1: FORT-A will result in significantly greater improvements in pain 
management among PRC Veterans compared to standard PRC care based on the 
primary outcome measure of self-report disability (Oswestry Disability Index) at both 
short- (pre- to post-treatment) and long-term (6/12-month) follow-up. 
 
Hypothesis 2: FORT-A will also result in significant improvements on secondary 
pain management outcomes compared to PRC, including pain coping (intensity/ 
cognitions), emotional distress (depression, PTSD, anxiety), and objective disability 
(functional capacity, gait) at short- and long-term follow-up. 
Hypothesis 3: We hypothesize that FORT-A will result in significantly lower rates of 
opioid recidivism compared to standard PRC treatment based on timeline followback 
interview at 12-months follow-up. 
 
Hypothesis 4: We also hypothesize that FORT-A will result in significantly less 
opioid recidivism compared to PRC treatment based on secondary measures of opioid 
medications including Medication Event Monitoring System (MEMS), pill counts, 
and consultation with prescribing providers/ documentation in the VA Electronic 
Health Record (CPRS). 
1.2 
Secondary Objectives 
Based on the PI’s ongoing ESCAPE trial, this research team has identified 
psychological processes (helplessness, perceived burdensomeness) that likely play a 
mechanistic role in pain management among OEF/OIF/OND deployers.  We will 
assess these constructs twice a week and analyze latent changes in FORT-A and PRC 
Veterans to ascertain their role as pain management mediators. 

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2. BACKGROUND AND RATIONALE 
2.1 
Background on Condition, Disease, or Other Primary Study Focus 
Military operations in Iraq (Operation Iraqi Freedom, OIF) and Afghanistan (Operation 
Enduring Freedom, OEF; Operation New Dawn, OND) have now lasted for more than a decade, 
and even as the war effort begins to draw down it is quite likely that the Department of Defense 
(DoD) and the Veterans Health Administration (VHA) will be confronted with the consequences 
of OEF/OIF/OND for years to come.  Military service members and Veterans who served in 
OEF/OIF/OND are at increased risk for debilitating chronic pain, with nearly 50% reporting 
postdeployment pain (Cohen et al., 2005). Our research group has previously published on the 
significant impact that military chronic pain conditions have on disability in military personnel, 
active duty retention rates, costs associated with early discharge, healthcare utilization, and long-
term disability (McGeary et al., 2012; McGeary et al., 2013; USGAO, 2006). These 
consequences are costly. The DoD pays an estimated $1.5 billion per year in benefits to disabled 
services members, approximately 45% of which is accounted for by disability related to chronic 
pain (Berkowitz et al., 1999; Fabrizio, 2002; Hauret et al., 2010; Belmont et al., 2010). The 
mechanisms and circumstances of pain onset associated with combating the war on terrorism are 
unique (e.g., extended use of body armor, turbulent air and ground transport, improvised 
explosive devices, blast injury), and have made OEF/OIF/OND Veterans increasingly likely to 
present with chronic pain conditions in the context of psychiatric trauma symptoms 
(posttraumatic stress disorder/traumatic brain injury; Gironda et al., 2009; McGeary et al., 2011).  
This comorbidity is often referred to as “polymorbid pain,” which many believe is more complex 
and difficult to treat than non-traumatic pain (Lew et al., 2009; Clark, 2002).  Polymorbid pain 
has presented significant challenges to the DoD and VHA healthcare systems, and there are 
significant gaps in chronic pain management that must be addressed to ensure best treatment for 
Veterans with polymorbid pain. 
     Advancements in military combat casualty care and medical transport have contributed to 
increased survivability from battlefield injury (cf Belmont et al., 2010). Injured soldiers who may 
previously have died from a traumatic injury are now surviving with chronic pain and psychiatric 
trauma symptoms. These symptoms often lead to early discharge from military service, so the 
significant costs associated with long-term pain management are being passed from DoD 
military treatment facilities to the VHA (which is likely to serve these chronic pain Veterans for 
decades). Prevalence rates of chronic pain are as high as 50% in some military Veteran samples 
(Maloney & McIntosh, 2001), and Veterans with combat trauma conditions (PTSD and/or TBI) 
are most likely to develop a chronic pain condition 10. Veterans with polymorbid chronic pain 
are at increased risk for depression (Maloney & McIntosh, 2001), sleep difficulties (Chapman et 
al., 2006), PTSD (McGeary et al., 2011; Beckham et al., 1997; Otis et al., 2010), anger 
(Lombardo et al., 2005; Trost et al., 2012), substance abuse (Becker et al., 2009; Goebel et al., 
2011), and suicide (Kanzler et al., 2012). The DoD and VHA medical systems are working to 
address the complexity of polymorbid pain, but our research group has published a description of 
the significant challenges in treating this population (Lew et al., 2009). There are numerous gaps 
in VHA health care continuity that contribute to inadequate care or even iatrogenic symptom 
worsening due to inconsistencies in diagnosis (Reisinger et al., 2012; Roth & Spencer, 2013), 
with about 45% of polymorbid Veterans treated for post-deployment conditions being currently 
unemployed in part due to their polymorbid pain (Cohen et al., 2012). Indeed, the Congressional 

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Budget Office found that VHA treatment costs are 4-6 times higher for polymorbid pain 
compared to any trauma condition alone (CBO, 2012).  
     One-dimensional chronic pain management (i.e., medication, physical therapy alone) has 
failed to adequately meet the needs of this population, and more complex integrated treatment 
approaches are needed to improve outcomes (Gironda et al., 2009; McGeary et al., 2011).  
Unfortunately, most Veterans with polymorbid pain are treated with basic medical management.  
Opioid medications are the most frequently utilized pain management tool for Veterans with 
chronic pain (Dobscha et al., 2013), and long-term opioid use has consistently shown low 
efficacy in the rehabilitation of pain, the potential for abuse and dependency, and the potential 
for worsening pain perceptions (Dobscha et al., 2013; Varney & Bebarta, 2013). A medical 
record review of 762 OEF/OIF Veterans treated for chronic pain in VA ambulatory clinics 
revealed that 64% received at least one opioid prescription during a 12 month period and 41% 
received long-term opioid prescriptions (Macey et al., 2011). Our own research has shown that 
opioid medications are the most commonly prescribed medication overall in the Veterans 
Integrated Service Network covering the San Antonio area (VISN 17), and over 40% of Veterans 
prescribed opioid medications take them for more than 3 months (defined as “chronic opioid 
therapy”). The risks associated with chronic opioid therapy are undeniable, especially for 
polymorbid Veterans who are most likely to use opioid medications long term Howe & Sullivan, 
2013; Dobscha et al., 2013). These Veterans have an increased likelihood (32%) of receiving 
benzodiazepine medication concurrently with opioid prescriptions, which promotes risk of 
overdose-related deaths (Morasco et al., 2010), and they are likely to use opioid medications for 
non-medical reasons, abuse opioids, and experience increased disability due to poor pain 
management (Barry et al., 2011; Becker et al., 2008). Surprisingly, few Veterans (25.7%) are 
ever screened for opioids despite their high rates of opioid use (Morasco et al., 2010).   
Both the VHA and DoD have called for effective ways to address high rates of opioid use for 
OEF/OIF/OND Veterans with chronic pain. Although there are efficacious options for treating 
opioid dependence and chronic opioid use, there is reason to believe that these options are less 
effective than intended because those who need them are not utilizing them.  Data from the 
2005-2008 National Surveys on Drug Use and Health revealed that a vast percentage of young 
opioid-dependent patients with pain (83%) perceived no need for intervention targeting their 
opioid use, reported significant worry about their ability to manage chronic pain without opioids, 
and were concerned about stigma associated with these interventions (Wu et al., 2011).  Indeed, 
these same concerns (particularly stigma) have been identified in military and Veteran 
populations (Sirratt et al., 2012), and the rates of untreated substance abuse among military 
Veterans are now twice as high as rates of untreated serious psychological distress Golub et al., 
2013).  There is now a significant need for research testing non-pharmacological pain 
management programs that can curtail opioid use in polymorbid Veterans.  Interdisciplinary pain 
programs offering alternative pain management strategies may offer a dual benefit of improved 
pain coping and decreased opioid use.  In fact, our research group generated preliminary 
evidence showing a significant reduction in opioid prescriptions after interdisciplinary pain 
treatment in a non-combat injured military sample. 
The Department of Veterans Affairs has recently implemented a broad initiative to address 
opioid dependence, abuse, and misuse in Veterans.  This Opioid Safety Initiative (OSI; described 
in detail in Section 5.3.4) was designed to better manage the opioid prescription process and 
develop alternative pain management options for veterans with chronic pain who, especially 
those who are “chronic opioid users.”  Indeed, ample data exists describing the significant risks 

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of opioid use in the VA and the high rates of persistent opioid use or misuse especially among 
veterans with pain and psychiatric comorbidities (Seal et al., 2012).   
The few publications describing the effectiveness of the OSI show a significant drop in the 
rate of opioid prescription in the VA system, especially for veterans on high doses of opioid 
medications (Westanmo et al., 2015). A PCORI Topic Brief published in June 2015 provides a 
comprehensive review of the data on safety and efficacy of opioid medications, and the available 
data largely show that opioid medications are “weakly” effective in the long-term management 
of chronic pain and there is very little data describing the best way to discontinue opioid 
medications, and no good research describing the long-term consequences for pain management 
and opioid recidivism for those who are discontinued (which mirrors Congressional Testimony 
by VA Official Dr. Robert Petzel in 2014 describing a large reduction in opioid prescriptions 
throughout the VA attributable to OSI.  The South Texas Veterans Health Care System, where 
this study will take place, was recently identified as a top ten performer for OSI outcomes, so 
STVHCS veterans are increasingly likely to become former opioid users.   
Although there is little VA data describing the outcome of opioid prescription tapering or 
discontinuation in veterans, there is some helpful data offering insight into what could occur.  A 
small-scale study of an Opioid Renewal Clinic in the Philadelphia VA found a recidivism rate of 
over 40% for veterans who discontinued opioids (with higher rates for those not engaged in an 
intervention program for high risk opioid abusers; Becker et al., 2009). An older study of 
Vietnam veterans also found a 40% rate of future opioid use after military discharge among 
veterans who were “addicted” to opioid medication during active duty service (O’Brien et al., 
1980). A rat-model study of opiate withdrawal after chronic opioid treatment found an increased 
rate of cocaine-seeking behaviors (He & Grasing, 2004).  
2.2 
Study Rationale 
Interdisciplinary pain management is now a high priority for the DoD and VHA. The United 
States Army assembled a Pain Management Task Force in 2009 with the mission of outlining 
gaps in chronic pain management resources throughout the DoD and VHA medical systems.  It 
completed site visits with pain management specialists at VHA and DoD facilities throughout the 
United States (including with the PI of this proposed research) to identify potential best practices 
in military chronic pain management.  In its 2010 Final Report, the Task Force emphasized a 
need for pain management resources that go beyond medication and other one-dimensional 
interventions, specifically emphasizing the need for Complementary and Alternative Medicine 
(CAM) approaches. They noted that most DoD and VHA providers feel ill-prepared to manage 
chronic pain and are unaware of resources for pain management beyond medications and 
physical therapy.  Specifically, the report outlined the need for standardized interdisciplinary 
programs offering improved pain management with the benefit of decreased risk of opioid abuse. 
These interdisciplinary programs are likely to result in vast improvements in function, healthcare 
utilization, and quality of life for military Veterans with chronic polymorbid pain (McGeary et 
al., 2006; McGeary et al., 2010), and would severely decrease adverse risk associated with long-
term opioid use/abuse in this population saving the federal government billions of dollars in 
healthcare costs.  The study PI recently published a paper in the American Psychologist (March 
2014) describing the significant benefit of integrated/interdisciplinary pain management 
programs over independent pain management interventions (Gatchel, McGeary, McGeary & 
Lippe, 2014).  In this paper, the authors note that psychological interventions for chronic pain are 
most useful as an embedded component of a larger, multi-component program including 

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disciplines oriented toward improving physical functioning.  This is particularly important for 
military and Veteran populations for whom physical functioning is a vital part of their jobs and 
identities.  When developed well and integrated appropriately, psychological interventions can 
significantly enhance and improve outcomes from other pain management interventions (e.g., 
PT).  Previous studies of interdisciplinary pain programs (including the original FORT study) 
have consistently shown that these interdisciplinary programs outperform individual treatment 
like PT. 
     Some steps have already been taken to develop interdisciplinary care for polymorbid 
Veterans. In 2004, the U.S. Congress passed Public Law 108-422, Section 302 and Public Law 
108-447, both of which require the development of integrated VHA specifically addressing 
deployment-related polymorbidity (Cifu et al., 2009; Eapen et al., 2013). One consequence of 
this legislation was the establishment of the VHA Polytrauma System of Care (PSC), which built 
and staffed 5 Polytrauma Rehabilitation Centers (PRCs) across the United States to serve as 
referral hubs for OEF/OIF/OND Veterans with complex polymorbid conditions.  These PRCs 
currently offer the highest level of intervention available to polymorbid Veterans. Despite these 
advances, there are still significant gaps in the management of complex chronic polymorbid pain 
that severely challenge caregivers and Veterans alike. PRCs are equipped with multiple 
disciplines necessary to adequately address the complexity of polymorbid chronic pain, but these 
services are not adequately integrated for polymorbid pain management [9]. This integration is 
difficult, and there are very few interdisciplinary pain management programs that have been 
proven effective in military-relevant pain populations. Our research team was one of the first to 
test a truly integrated model of pain management in a military population which we called the 
Functional Orthopedic Treatment program (FORT).  Recently, the Affordable Care Act has laid 
out plans and instructions for the proliferation and promulgation of interdisciplinary pain 
management services (see Gatchel, McGeary, McGeary & Lippe, 2014). 
     The FORT program was originally tested in a non-polymorbid active duty military chronic 
pain sample. The original trial showed that our model of integrated care can effectively improve 
physical and psychosocial disability among military service members with pain. It has yet to be 
tested in a polymorbid pain population, but we believe that the CAM-based composition of 
FORT makes it an excellent substrate for polymorbid pain management. We have expanded on 
the original FORT trial through several subsequent trials specifically focusing on pain processes 
in polymorbid military members and Veterans. Data from these subsequent trials have allowed 
us to tailor the FORT intervention to the specific needs of a polymorbid OEF/OIF/OND Veteran 
chronic pain population.  We have labeled this amended version of the manualized program 
“FORT-A” (A = Amended), and believe that this new program offers the best available 
opportunity for polymorbid pain management. The proposed study will recruit 130 
OEF/OIF/OND Veterans with polymorbid chronic musculoskeletal pain who are currently using 
chronic opioid therapy for pain (taking opioid medications daily for 20 out of 30 days a month 
for three or more months).  In 2015, the VA Opioid Safety Initiative (OSI) began to 
programmatically work toward improving the safety of opioid medication prescription for San 
Antonio Veterans with chronic pain.  As noted above, very little is known about the potential 
outcomes of this initiative, but the scant available data suggest a rate of opioid recidivism of 30-
40% among prior persistent opioid users who get no specialty intervention. To align with this 
initiative, this study altered the opioid inclusion criterion to include Veterans who were removed 
from opioid medications during the OSI. These Veterans will be randomly assigned to either the 
3-week interdisciplinary FORT-A chronic pain management program (described below) or to 

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treatment in the South Texas Veterans Health Care System’s (STVHCS) PRC in San Antonio, 
TX, which represents the best available care for Veterans with deployment-related polymorbid 
pain.  Primary endpoints for this research include pain management (represented in Aim 1) and 
opioid use (represented in Aim 2) at pre-treatment, post-treatment, 6-month follow-up and 12-
month follow-up. 
3. STUDY DESIGN 
To address the primary and secondary hypotheses, this research study was designed as a 
randomized clinical trial comparing the manualized FORT-A treatment to treatment as usual for 
polytraumatic chronic musculoskeletal pain in the STVHCS Polytrauma Rehabilitation Center.  
Eligible OEF/OIF/OND Veterans will be randomized to either arm in 1:1 random permuted 
block randomization with no stratification.  Because the FORT-A is a group intervention, it is 
vital that we randomize into meaningful blocks of at least three Veterans and no more than 
seven.  Three is chosen as the lower block boundary because the PI had success in the original 
FORT trial with FORT groups of three active duty service members.  Seven Veterans will be the 
upper boundary because FORT groups of more than seven military members were difficult to 
manage.  In block randomization with static boundaries, study staff overseeing randomization 
will lose blinding if they are aware of how many participants have already been randomized into 
each block.  For example, if block boundaries are always 5 participants and the treatment as 
usual condition has 5 participants while the active treatment has 4, then the staff randomizing the 
10th participant will know with certainty that this participant will be in the active treatment 
group.  To protect blinding, we have chosen to implement a variable boundary randomization for 
which the study staff randomizing patients will be blind to the boundaries and the resulting 
condition of the participant (see Sanghaei, 2011). The PI, Independent Evaluators, and 
Biostatistician will be blind to the condition of all participants until data lock.  A research 
assistant overseeing randomization will also be blinded by randomizing unique patient identifiers 
into variable permuted blocks (through the STRONG STAR Data Core) by unique study 
identifier (e.g., first participant identified as #0001).  All assessments given by Independent 
Evaluators will be labeled with just the unique identifier.  Only the study coordinator (and co-
coordinator) will be able to link unique identifiers to individual participants.   
This research study covers two objectives/aims encompassing four formal hypotheses and 
one exploratory objective.  The primary objective of this research is to assess the efficacy of the 
FORT-A program for improved pain management in a sample of 130 polymorbid 
OEF/OIF/OND PRC-eligible Veterans with chronic musculoskeletal pain compared to standard 
care in the STVHCS Polytrauma Rehabilitation Center.  A second objective will assess the 
efficacy of FORT-A in decreasing the rate of opioid use among eligible Veterans with recent and 
ongoing persistent opioid use.  An exploratory objective will explore how certain variables 
(helplessness and perceived burdensomeness) contribute to change trajectory over time. 
Table 1. Pearson correlation between 4 disability 
measures and other notable FORT outcomes. 

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The primary outcome of this research 
(addressing AIM 1) is disability rating 
(consistent with functional restoration theory 
emphasizing functional ability over changes 
in pain intensity, frequency, duration, or 
quality).  This study was designed to assess disability objectively (functional capacity evaluation; 
FCE) and subjectively (self-reported disability scale).  Data from the original FORT trial 
revealed that self-reported disability had a stronger relationship with psychosocial and 
socioeconomic pain management outcomes than objective functional capacity (see Table 1 for an 
example).  Furthermore, self-reported disability is likely to be more sensitive to improvements in 
psychological pain management skills (which is central to this research).  For this research study, 
the Oswestry Disability Index (ODI, Version 2) will be used to measure self-reported disability.  
ODI was chosen for this purpose because the significant body of research supporting its use and 
its performance beyond other measures of self-reported disability in the FORT trial.   
The secondary outcome (addressing AIM2) for this research is rate of opioid medication 
recidivism.  In consultation with study co-I and opioid dependence/misuse expert, Dr. Jennifer 
Potter, we decided to adopt a conservative definition of recidivism of use of any opioid for three 
days in any 30-day period.  This definition was chosen (instead of a non-abstinent definition as 
described in McCabe et al., 2013) because this medical population may include veterans given 
short-term opioid therapy for a new injury or surgery and we did not want to count that as relapse 
or recidivism to opioid use.  As was the case for disability, opioid use will be assessed through 
objective (MEMS caps) and subjective (timeline followback interview; TLFB) methods.  
Because some participants may shift patterns of other pain medication use as a result of 
discontinuing opioids, we will also complete TLFB for other pain medications and ask 
participants to use MEMS for their “most helpful” pain medication (if they are not taking an 
opioid med).  All opioid medication use will be measured with MEMS and TLFB.  We will also 
assess pain medication using the Medication Quantification Scale – III (MQS).  The MQS was 
developed through the American Pain Society as a standardized method of quantifying pain 
medication use along dimensions of drug class, drug dose, and drug detriment (Harden et al., 
2005).  Both TLFB and MQS data will be gathered monthly (at all assessment intervals in 
person) and during monthly reminder phone calls.  Previous studies have shown that Timeline 
Followback interviews demonstrate the best reliability and validity for long-term medication use 
(Kunoe et al., 2009), so TLFB was chosen as the focal secondary outcome measure for this 
research. 
Based on our previous FORT trial, for which treatment effects in the FORT study arm were 
maintained at one-year follow-up, it is reasonable to assume that treatment benefits will be 
maintained after post-treatment and that all post-baseline measures can be averaged for a main 
effect of treatment.  To detect a medium effect with power = 0.80 (based on Cohen’s 
standardized mean difference d=0.50) at α = 0 .05, we would require n=50 in each study arm for 
a total sample size of N=100 for data analysis.  Based on our prior FORT research trial and our 
ongoing VA trials through STRONG STAR, we anticipate less than 30% attrition with a target 
recruitment goal of n=65 in each arm to account for dropouts.  Thus the recruitment target for 
this research is 130 OEF/OIF/OND Veterans with military service-related new onset or 
exacerbated chronic musculoskeletal pain and persistent opioid use.  Both the FORT-A and PRC 
treatments will be provided on an outpatient basis through the STVHCS PRC (where the PI has 
several hundred square feet of research space under a VA WOC appointment; see 5.1 and 5.2 in 
Pearson’s   r 
FTW 
WTE 
ODI 
MVAS 
Depression 
-.174 
-.278 
.690 
.424 
Fear Avoidance 
-.106 
-.184 
.622 
.530 
Pain Rating 
-.099 
-.219 
.856 
.816 

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this document for a more detailed description of the treatment arms).  The overall trial will last 5 
years (2014-2019).  The IRB protocol for this research was approved on July 10, 2014 (see study 
binder for most current IRB documents and any amendments submitted and approved to the 
UTHSCSA/VA IRB).  Individual participants will be actively enrolled for one year during which 
time they will: 
• Complete pre-treatment assessments 
• Undergo a three-week treatment phase 
• Complete post-treatment assessment 
• Complete 6-month post-treatment follow-up assessments 
• Complete 12-month post-treatment follow-up assessments 
 
The following diagram (Figure 2) outlines the administration for this research and the 
blinding status of individual study personnel/roles: 
 
 
 
 

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Key: 
 
 
 
 
 
 
 
Don McGeary, PhD
Principal Investigator
* Study Direction
* Training/Staffing
Recruitment
Blessen Eapen, MD
Carlos Jaramillo, MD, PhD
Research Coordinator
Research Assistant
* Monitor Adherence
Assessment
Independent Evaluator
Tabatha Blount, PhD
* Train Psych Assessments
* Quality Assurance
STRONG STAR 
Independent Evaluator (IE)
* Psychosocial Assessment
Maureen Simmonds, PhD
or VA PT/OT
* Train FCE Assessment
* Quality Assurance
Physical Therapy Student
or PT/OT
* FCE Assessment
Jennifer Potter, PhD
Michael Dawes, MD
* Consultation assessment
* Quality Assurance
STRONG STAR 
Independent Evaluator (IE)
* Opioid assessment
MEMS/TLF
Intervention †
Postdoctoral Fellow
Intern
Cindy McGeary, PhD
* Train Group/Indiv/BFB
* Supervise Group/BFB
STRONG STAR Fellows
STRONG STAR Intern
* Group Intervention
* Indiv/BFB Intervention
Tabatha Blount, PhD
* Train Group/Indiv
* Supervise Group/Indiv
Maureen Simmonds, PhD
* PT intervention Training
* PT Supervision
Physical Therapy Student B
* Group PT Intervention
Data Management/Analysis
Timothy Houle, PhD
Mary Jo Pugh, PhD
STRONG STAR
Data Core
Research Coordinator
Co-Coordinator
Blinded to 
Condition and 
Outcomes
Blinded
to Condition
Blinded
to Outcomes
Unblinded
Figure 2. Study organizational hierarchy 

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4. SELECTION AND ENROLLMENT OF PARTICIPANTS  
Participants for this research will include (N=130) U.S. military Veterans treated through the 
South Texas Veterans Health Care System (STVHCS) for chronic musculoskeletal pain 
associated with deployment to OEF/OIF/OND (see Inclusion/Exclusion Criteria below). Eligible 
Veterans can have multiple pain concerns, but their primary pain concern must be 
musculoskeletal pain. All eligible Veterans must be a prior persistent opioid user who was 
removed from their opioid medication by their VA provider. Participants will be recruited 
through the STVHCS Polytrauma Clinic, the STVHCS Pain Management Service, and the 
STVHCS Primary Care Service. They will be eligible for care in the PRC. Our PRC partners 
estimate that they enroll approximately 30 new patients at the PRC per month, roughly 80% of 
whom would meet criteria for this research. We will recruit through direct provider referrals and 
advertisements posted in VHA clinics; both of these strategies have been quite successful in both 
the original FORT trial and our ongoing STRONG STAR research efforts. Our PRC 
collaborators (Dr. Jaramillo and Dr. Eapen) will ask their staff to introduce the study to new PRC 
patients and will be available to answer questions. This research has been adopted as a STRONG 
STAR initiative, and will have access to STRONG STAR resources and procedures for 
recruitment. This will be of significant benefit because STRONG STAR studies routinely 
achieve their recruitment targets through local advertising, media exposure for the consortium, 
and solid working alliances with VHA and DoD service providers. Based on our experience with 
numerous STRONG STAR trials and the original FORT trial, we expect <30% attrition and have 
factored this into our recruitment target. Participants will be reimbursed for time and travel. 
4.1 
Inclusion Criteria 
Study participants must meet all of the inclusion criteria below to participate in this 
study as follows: 
1) Demographics for inclusion in this research include both genders, all racial/ethnic 
groups, and ages 18-72. 
 
2) Present with chronic musculoskeletal pain (CMP) as a primary pain complaint 
 
3) CMP is accompanied by at least moderate disability based on a score of 20% or 
more on the Oswestry Disability Index; 
 
4) Consistent with NIH Task Force recommendations, "chronic" CMP has been a 
problem for the Veteran for at least half the days in the last 3 months and was 
acquired or exacerbated as part of active duty U.S. military service in the Gulf War,  
Operations Iraqi Freedom (OIF), Enduring Freedom (OEF), or New Dawn (OND) 
war eras.   
 
5) CMP presents in the context of comorbid psychiatric symptoms of posttraumatic 
stress disorder (PTSD; based on a score of 25 or more on the PTSD Checklist-
Version 5) and/or depression (based on a score of 10 or more on the PHQ-9). 
 

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6) Demonstrate prior “chronic” opioid use (defined as using opioid medication for 20 
out of every 30 days over three or more months) and discharged off of persistent 
opioid medications on their own or by a provider for at least one week prior to the 
pain management program period (Weeks 1-3).   
 
7) Speak and read/understand English well enough to fully participate in the 
intervention and to reliably complete assessment measures.    
 
8) The Veteran will be eligible to be a PRC patient (i.e., have multiple trauma related 
physical and psychological injuries; VA, 2013) and be eligible for Physical Therapy 
referral through the PRC (though the referral for the same service could also come 
from another VHA provider).  All participants will be offered Physical Therapy 
services before enrollment and will be enrolled after completing or denying Physical 
Therapy. 
4.2 
Exclusion Criteria 
All candidates meeting any of the exclusion criteria below at baseline will be 
excluded from study participation: 
1) Actively engaged in an intervention or program specifically targeting opioid use 
(including those using naloxone). 
 
2) Present with active psychosis or suicidal ideation with intent.  These symptoms 
must be stabilized (i.e., maintained at or below moderate intensity for 6 weeks with 
no acute episodes requiring higher levels of intervention) through a VHA Psychology 
or Psychiatry referral and confirmed by the mental health provider before the Veteran 
is eligible to participate. 
 
3) CMP is not related to or exacerbated by military service during the OEF/OIF/OND 
combat eras. 
 
4) Present with significantly diminished decision-making capacity (e.g., severe 
cognitive dysfunction related to severe TBI).   
 
5) Pregnant women 
 
6) Inability or unwillingness of individual or legal guardian/representative to give 
written informed consent.  
 
4.3 
Study Enrollment Procedures 
• 
Potential participants may be directly referred to the study by their VA 
provider or may directly contact the study coordinator on their own in 
response to flyers/pamphlets distributed at VA clinics  

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• 
Consistent with current STRONG STAR practices, we will maintain an 
Enrollment Log describing the timeline of screening and consent as well as 
the disposition and reason for enrollment/disqualification (see Appendix A3).   
• 
Consent for participation in this research will take place in the South Texas 
Veterans Health Care System (STVHCS) PRC or on the STVHCS Bartter 
Research Unit (BRU).  Potential participants who are referred by a provider or 
who self-refer in response to a flyer will call the study coordinator and arrange 
a time to meet and discuss the study.  Those who sign a Consent to Contact 
form after meeting with their physician at the STVHCS (Appendix A1), will 
receive a phone call from the study Coordinator.  Participants will be asked to 
meet individually in a private room at the PRC/BRU with the Coordinator 
where they will be told about the study and will have an opportunity to ask 
any questions they may have of the Coordinator.  Potential participants will be 
given a copy of the study informed consent document (ICD, Appendix A2) 
and will be allowed to take it home with them if they wish to take time to read 
it.  Upon reading the document, the potential participants will have an 
opportunity to ask questions about the study and may meet with a study 
investigator to address their questions.  Consistent with STRONG STAR 
procedures, the Coordinator will have a checklist of questions about the ICD 
that they will ask the potential participants to ensure that they understand.  
Once understanding is confirmed, the participants will sign the ICD and be 
enrolled into the study and recorded on the NCCIH Enrollment Form 
(Appendix A3).  A unique identifier will be assigned to the participant using a 
code developed in accordance with the STRONG STAR Unique Identifier 
SOP (Appendix A4).       
• 
Participants will be randomly assigned into one of the two study arms (FORT-
A, Treatment as Usual) on a 1:1 ratio.  Participants will be randomized using 
variable sized blocks of an even number to maintain a balance within blocks. 
One weakness of block randomization is that blinded study staff who are 
aware of established block sizes will be able to predict, with increasing 
certainty, how a participant will be randomized as blocks fill.  This does pose 
a threat to blinding and creates an opportunity for non-random assignment 
(e.g., cherry picking a participant who may be a particularly good responder to 
be “randomized” into the experimental condition).  To maintain a blinded 
assignment schedule, we have chosen to work with the STRONG STAR 
Biostatistics and Data Core to execute the randomization schedule, hold the 
blinded assignments, and administer them to the study Coordinator 
sequentially during enrollment (i.e., the Coordinator and study team will 
always remain blinded to the next assignment) 
5. STUDY INTERVENTIONS  
5.1 
Interventions, Administration, and Duration  
FORT-A 

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Although pain programs like FORT-A have been explored in civilian pain populations 
(McGeary et al., 2006; Mayer et al., 2004; Proctor et al., 2004), military and Veteran research 
has been limited. FORT-A is a particularly good fit for military and Veteran populations 
because the focus of treatment is on return to function, not on palliative pain relief. This 
works well for military and Veteran pain sufferers who are used to “biting back” pain and 
pressing on with their mission. When we first developed the FORT program, we included a 
number of newly emerging complementary and alternative medicine interventions that were 
starting to show promise in pain research (mindfulness, biofeedback, relaxation strategies, 
motivational interviewing, acceptance and commitment therapy, guided exercise and activity 
– including mind-body exercises like yoga). Outcomes from our DoD-funded study of FORT 
revealed significant improvements in pain management (Gatchel et al., 2009). CAM 
interventions have been strongly emphasized in the FORT-A manual (see Appendix) based 
on participant feedback from the original FORT trial and from research subsequent to the 
FORT study demonstrating very little beneficial effect of cognitive-behavioral therapy (CBT) 
for military pain management. We have kept some CBT elements to address cognitive 
variables that are implicated in psychosocial adjustment to chronic polytrauma pain based on 
the PI’s current DoD-funded trials (Kanzler et al., 2012). FORT was augmented to include a 
stronger emphasis on CAM interventions that are most likely to promote pain management 
and opioid sparing among polymorbid OEF/OIF/OND Veterans, and the augmented program 
has been labeled “FORT-A.” FORT-A is provided on an outpatient basis and includes 12 
daily group pain management and physical therapy sessions spanning three weeks. Group 
interventions are supplemented by individual psychotherapy, biofeedback, and case staffings. 
CBT sessions were decreased in favor of CAM components. FORT-A participants will 
receive 270 minutes (4½ hours) of intervention a day for 12 days over 3 weeks.  All FORT-A 
interventions will occur at the STVHCS PRC in dedicated research space. FORT-A includes: 
* 12-session outpatient group intervention. The FORT-A group occurs 4 times a week for 
3 weeks (12 total sessions) for 90 minutes each. Topics include:  
- goal-setting (2 sessions) 
- relaxation strategies (4 sessions) 
- mindfulness for pain management (2 sessions) 
- CBT for pain management (2 sessions) 
- communication and social support (1 session) 
- motivational interviewing and managing stages of pain (1 session). 
 
Potential Adverse Effects (risk): discussing pain management may make pain 
more noticeable, resulting in perception of increased pain intensity (NOT 
SERIOUS) 
 
* 2 weekly sessions of outpatient individual psychotherapy for PTSD, depression and pain 
management (6 total sessions) for 75 minutes each (15 minutes to check on pain management 
topics covered in group; 60 minutes for Prolonged Exposure for PTSD symptoms based on 
the manualized approach used in our current STRONG STAR study). Individual sessions 
(depression, PTSD) may be conducted by other clinic providers if subject is already engaged 
in treatment prior to enrollment.  If sessions are conducted by another provider, the quality of 
care will be standard clinical care which is appropriate for this protocol; however, the 
duration of care may be variable so we will be tracking number of sessions attended. For 

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those subjects receiving Individual sessions from another clinic provider, the 15 minute pain 
management session will be included with their biofeedback session.  Most participants 
reported accomplishing little in these sessions beyond what was already done in the group. In 
a polymorbid Veteran sample, it is vital that trauma symptoms (PTSD and depression) are 
addressed along with pain (Lew et al., 2009). PTSD will be addressed using a modified 
Prolonged Exposure (PE) protocol and depression will be addressed through Behavioral 
Activation. 
 
Potential Adverse Effects (risk): PTSD interventions like PE may result in an 
increase in PTSD symptoms severity (as the Veteran overcomes avoidance of 
symptoms) during the first week of treatment (NOT SERIOUS)   
 
* 12-session physical therapy (PT). PT sessions occur 4 times a week for 3 weeks (12 total 
sessions) for 90 minutes each. As in the original FORT trial, PT will occur immediately 
before the group intervention. Each patient will be given an illustrated PT manual 
supplemented with a CD that provides information on pain and activity and includes an 
individualized workbook for setting, prioritizing, and completing activity related goals. Each 
90 minute session will include a presentation/discussion on a key topic and group exercise 
targeting strength, flexibility, and aerobic speed interval training to address psychomotor 
slowing. 
 
Potential Adverse Effects (risk): PT may result in muscle soreness (NOT 
SERIOUS) or musculoskeletal injury/worsening of injury (SERIOUS) 
 
* 2 weekly sessions of biofeedback (6 total sessions) for 30 minutes each. Biofeedback is 
given to all participants as an adjunct to relaxation training, hypnosis/meditation, and 
postural changes. 
 
 
 
Potential Adverse Effects (risk): None 
 
* 1 weekly interdisciplinary case staffing (4 total staffings, one at pre-treatment and one at 
the end of each program week) for 60-90 minutes each. The FORT-A clinical psychologist 
and physical therapist meet with the case manager/coordinator, and a Physical Medicine and 
Rehabilitation physician to discuss each patient’s treatment plan, progress with treatment 
goals, medication, and barriers to care. 
 
 
 
Potential Adverse Effects (risk): None 
 
“Typical” FORT-A Day 
Time 
Activity 
0800-0830 
 
FORT-A Pain Management Group 
0830-0900 
0900-0930 
0930-1000 
 
Group-Based Exercise 
1000-1030 
1030-1100 
1100-1130 
Individual Psychotherapy 

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1130-1200 
-OR- Biofeedback 
 
Polytrauma Rehabilitation Center (PRC) 
PRCs offer the highest level of care for polytrauma Veterans. They serve as a “hub” for 
clinical referrals, training, and education in polytrauma care (Eapen et al., 2013). Each PRC 
includes Physiatry, Rehabilitation Nursing, Physical Therapy, Psychology, Family Therapy, 
Occupational Therapy, and other specialties (VA, 2013). Treatment goals for PRC Veterans 
are decidedly functional, emphasizing return to work, community integration, improved 
psychosocial functioning, and enhanced coping skills (Eapen et al., 2013; Braverman et al., 
1999; McNamee et al., 2009). Chronic pain management is a high priority for the PRC, and 
pain represents the most commonly reported clinical concern among PRC Veterans (Sayer et 
al., 2009). The logistic organization of the PRCs offers an excellent opportunity for clinical 
service and stakeholder integration (Strasser et al., 2008). The proposed research is vital for 
pain management in the PRC. Although PRCs succeed in locating multiple treatment 
resources in the same clinic, they have yet to produce consistent evidence of truly successful, 
integrated chronic pain management (Strasser et al., 2008). Our research group has 
hypothesized that PRC pain management primarily suffers due to a lack of guidance on how 
to most effectively integrate polymorbid pain treatment resources. Indeed, PRC clinicians 
have openly indicated the need for more guidance on service integration in PRCs to help 
them more effectively manage the complexity of deployment-related polymorbidities (Clark 
et al., 2009; Friedemann-Sanchez et al., 2008). An intensive program like FORT-A offers 
surprisingly little treatment burden to PRC staff and patients compared to the current 
standard of care. Veterans treated in the PRC are often required to attend multiple 
appointments throughout the week, requiring substantial time away from work. Current 
protocol for chronic pain management through the San Antonio PRC (our partner for this 
research) is for each PRC Veteran to complete 12 sessions of Physical Therapy over 3 to 4 
weeks, with supplemental appointments for medication, pain injections (e.g., epidural steroid 
injections), and assessment as prescribed by the Veteran’s treatment team. Evaluation clinics 
at the PRC typically last over 4 hours and Veterans typically attend 12 or more sessions of 
PT over 3-4 weeks. Few other services are provided for pain and our PRC collaborators note 
that PRC pain outcomes resemble the moderate functional gains typically demonstrated by 
Veterans undergoing standard physical therapy for chronic pain management (Garcia et al., 
2013; Brooks et al., 2012; Groessl et al., 2012). For this research, Veterans randomized to the 
PRC will receive 3 weeks of PRC services as recommended by their interdisciplinary team 
(which could include PT, occupational therapy, counseling, or medical management; Eapen 
et al., 2013). 
 
 
All study participants will be offered PRC Physical Therapy before randomization.  PRC 
physical therapy (PT) varies in frequency and duration based on pain presentation, but can 
occur daily for up to three weeks.  PT sessions are individualized, so length of the session 
will vary from patient to patient.   
 
Potential Adverse Effects (risk): PT may result in muscle soreness (NOT 
SERIOUS) or musculoskeletal injury/worsening of injury (SERIOUS) 
 

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Not all PRC patients are recommended for, or taken advantage of, the full slate of PRC 
services (e.g., Family Therapy, Psychology, Occupational Therapy), but all are seen and 
followed by a Physical Medicine & Rehabilitation Physician and/or Nurse Case Manager at 
biweekly up to monthly follow-up intervals. 
 
Potential Adverse Effects (risk): Variable (depending on medical or 
psychological interventions (INDETERMINATE) 
 
 
The PRC manages chronic pain in accordance with the VA/DoD Clinical Practice 
Guidelines (CPG; which can be found at http://www.healthquality.va.gov/).  Interventions for 
pain management in the PRC may include (but are not limited to) the following based on the 
CPG (which should be consistent across Polytrauma System of Care sites): 
 
PRC Treatment Component 
Adherence Management/Tracking 
Diagnostics 
(Imaging, ESR) 
 
None 
Self Care 
Advice to Remain Active 
 
Consult Chart 
Interview with Participant 
Education 
Books, Handouts 
 
Consult Chart 
Interview with Participant 
Medication 
Acetaminophen 
NSAIDs 
Antidepressants (TCA) 
Benzodiazepines 
Opioids 
 
Consult Chart 
Opioids and Other Pain Meds: MEMS, 
Timeline Followback, MQS 
Interview with Participant 
Physical Therapy 
PT through PRC/PT Service 
 
Consult Chart 
Functional Capacity Evaluation 
Interview with Participant 
Other Non-Pharmacological Therapy 
Spinal Manipulation 
Exercise Therapy 
Massage 
Acupuncture 
Yoga 
CBT 
Relaxation 
Intensive Interdisciplinary 
Rehabilitation 
 
Consult Chart 
Interview with Participant 
 

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5.1.1  Physical Therapy in the PRC Treatment as Usual 
All study participants will receive a recommendation for Physical Therapy (PT) at 
pre-screening (before enrollment) to ensure that prior participation in “standard” PRC 
PT does not confound study results (and most PRC patients with pain receive a 
recommendation for PT as part of standard care).  This is necessary to ensure that 
there are not differences in enrolled participants based on their prior exposure (or 
opportunities for exposure) to PT before participating in the study.  Those who have 
previously completed PT through the STVHCS or have declined participation will be 
enrolled and randomized for this research (if they otherwise qualify).  Participants in 
the PRC Treatment as Usual study arm will not receive another recommendation for 
PT through the PRC because a second recommendation is not standard care in the 
PRC.  They are not prohibited from attending PT again, but a second 
recommendation for PT in the Treatment as Usual arm will not be provided as part of 
this research. 
5.2  
Handling of Study Interventions  
The active intervention for this study is based on an integrated, interdisciplinary 
approach involving group psychotherapy, individual psychotherapy, physical therapy, 
biofeedback, and weekly interdisciplinary team meetings.  Each phase of the active 
intervention is described below including methods for ensuring intervention 
accountability and masking.  A formal manual is available to guide the group 
intervention (see Appendix B) and the Individual Psychotherapy (which uses a 6-
session manualized intervention for PTSD based on Edna Foa’s Prolonged Exposure 
protocol with some elements of behavioral activation to address depressive 
symptoms).  A Manual of Procedures (MOP) is being developed to guide 
biofeedback, Physical Therapy, and Interdisciplinary Staff Meetings (to be Appendix 
C).  Only basic details are provided for use of intervention in this section.  More 
details for interventions, interventionist training, and assessment of adherence to 
treatment are found elsewhere in this manual as follows:  
* Section 5.1 of this protocol provides more detailed information about the 
content and structure of the intervention components. 
* Section 5.4 of this protocol provides more detailed information about adherence 
assessments and certification of study interventionists) 
Group Psychotherapy (see Group Manual, Appendix B) 
As described in section 5.1 of this protocol, the group psychotherapy component of 
the FORT-A intervention is a twelve-session program occurring in the morning, four 
days a week for three consecutive weeks.  Currently, the group is scheduled to occur 
from 0900-1030 at the PRC.  The group intervention is guided by a comprehensive 
manual to which the group interventionist (a STRONG STAR Intern or Fellow) must 
adhere.  All STRONG STAR Interns and Postdoctoral Fellows are credentialed as 
Without Compensation (WOC) providers in the STVHCS and are supervised by a 
licensed Psychologist (Dr. Cindy McGeary, Dr. Tabatha Blount) and administratively 
overseen by a licensed VA Psychologist (e.g., Dr. Emma Mata-Galan, though this 
may change with Dr. Mata-Galan’s promotion to Psychology Chair).  All group 

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sessions are audiotaped and 10-15% of all audiotaped group sessions will be selected 
for review by a trained independent evaluator who will use a structured checklist to 
ensure that all significant treatment elements are included in the intervention.  Interns 
and Fellows will be formally trained in the manualized group intervention by Dr. Don 
McGeary (who developed the intervention and created the manual) and will co-
facilitate a group intervention with Dr. D or C. McGeary at the PRC to practice the 
intervention in vivo.  All groups will be documented in CPRS using a standard note 
template.  The PI (and other blinded study personnel) will not review any of this 
documentation.  CPRS notes for group and individual treatment components will be 
overseen and cosigned by Dr. C. McGeary and Dr. Tabatha Blount. 
Blinding: To maintain blinding, the PI will not be involved in any group 
interventions.  Independent Evaluators (IEs) assessing group intervention facilitator 
adherence will be different people than the IEs responsible for assessments (because 
the assessing IEs may recognize voices on the tapes from their assessment 
experiences and may become unblinded as a result). 
Providers and Qualifications: FORT-A Group Intervention will be delivered by 
STRONG STAR Clinical Psychology Interns and Postdoctoral Fellows (a total of 4 
possible providers who will rotate through different groups).  The structure of the 
manual and skills contained therein were developed for use by individuals with 
previous exposure to basic CBT and mindfulness skills commonly taught as part of 
the UTHSCSA Clinical Psychology Internship curriculum (and most other APA-
Accredited Psychology Internships). Group intervention providers will be trained by 
Dr. Don McGeary and will observe one iteration of the FORT-A Group with Dr. Don 
McGeary, Dr. Cindy McGeary, or Dr. Tabatha Blount (all of whom have been 
trained on the components of the manual and who had a hand in developing the 
manualized intervention).  To run the group without Dr. C. McGeary or Dr. Blount 
present, the Intern or Fellow must be certified using the procedures outlined in 
Section 5.4 of this document. 
Individual Psychotherapy 
A previous study completed by the PI in collaboration with Dr. Robert Gatchel and 
Dr. Alan Peterson through the STRONG STAR PTSD Research Consortium revealed 
that a brief, Prolonged Exposure (PE) protocol can have a meaningful effect on PTSD 
symptoms, though PE in isolation did not appear to impact chronic pain symptoms.  
The PI has previously described how PTSD symptoms can interact and affect pain 
experience, so PTSD (and concomitant depression) must be addressed as part of this 
interdisciplinary intervention to ensure that PTSD does not act as a barrier to pain 
management intervention. Because of its success in the previous STRONG STAR 
trial, this study will use the brief PE manualized intervention used in the previous trial 
(5 sessions) with an additional session of behavioral activation (serving as the first 
session) to address depression symptoms.  All STRONG STAR Interns and Fellows 
receive world class training in PE and their supervision will be overseen by Dr. Cindy 
McGeary, master trained in PE by Dr. Alan Peterson and Dr. Edna Foa, and Dr. 
Tabatha Blount (also trained in PE through STRONG STAR).  All individual sessions 
will be documented in CPRS. 

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Blinding: Neither Dr. Blount nor Dr. C. McGeary are involved in assessment of 
participants and will be asked not to discuss specific (i.e., identifiable) details of the 
interventions with the PI or other study personnel blinded to treatment condition (see 
Figure 2).    
Providers and Qualifications: Individual treatment providers must he certified in 
Prolonged Exposure for PTSD (PE) or supervised by a certified PE provider.  
Because of this, only STRONG STAR Interns and Postdoctoral Fellows or licensed 
Psychologists (Dr. C. McGeary, Dr. Blount) can provide individual intervention for 
this research (a total of 5 different providers).  Individual providers must have 
completed a two-day training in PE (mandatory for STRONG STAR Faculty, Fellows 
and Interns) and must be certified in PE as described in Section 5.4 of this document. 
PE is commonly practiced and taught throughout the VA system, drastically 
improving the generalizability of this component of the treatment manual. 
Biofeedback (Manual Under Development) 
Biofeedback is an adjunct to behavioral intervention that can have significant benefit 
for a number of behavioral and physical health concerns including chronic pain 
management.  Dr. Don McGeary ran the biofeedback lab for Wilford Hall Medical 
Center (Lackland Air Force Base) for over 5 years and has certified close to 100 
military Psychologists in biofeedback (BFB) use.  He will train all STRONG STAR 
Fellow interventionists for this study and will supervise biofeedback methodology 
(i.e., address questions about instrumentation, interpretation, and clinical application 
of BFB data (which must be deidentified before being shown to the PI).  Because 
BFB will be used differently with each participant, there is no way to manualize this 
part of the intervention.  There will be a section of the MOP (under development at 
the time of this protocol draft) that will cover biofeedback instrumentation procedures 
and clinical documentation of encounters. 
Blinding: Identifiable clinical issues will need to be discussed with Dr. Blount and 
Dr. C. McGeary and will not be shared with the PI. 
Providers and Qualifications: Biofeedback providers must have minimal competency 
in basic principles of health behavior change and mindfulness.  Both STRONG STAR 
Interns and Postdoctoral Fellows may provide biofeedback intervention (for a total of 
4 different providers) and will be certified in biofeedback by Dr. Don McGeary as 
outlined in Section 5.4 of this document).  
Physical Therapy (Manual Under Development) 
Group-based physical therapy will be provided by PRC Physical 
Therapist/Occupational Therapist and supervised by PRC Physical 
Therapist/Occupational Therapist or Dr. Maureen Simmonds.  Dr. Simmonds is 
already WOC-appointed in the STVHCS (as are Dr. C. McGeary, Dr. Blount, and the 
PI) and will enter notes for all encounters in CPRS.  UTHSCSA PT Students will also 
establish WOC appointments in the STVHCS and will meet with Dr. Simmonds 
regularly for supervision.  Group PT will include a didactic session, guided exercise, 
and flowsheets for home-based exercise.  Group PT will occur four days a week for 
three consecutive weeks.  We found during the original FORT trial that patients 

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responded best to group PT on Monday, Tuesday, Thursday, and Friday with a break 
on Wednesday to allow for recovery.  The PRC PT Service has already agreed to 
allow the study to use their space and equipment for study-related PT.  PT providers 
will be encouraged to participate in FORT-A group psychotherapy sessions and 
STRONG STAR Interns/Fellows will be encouraged to sit in on group PT sessions 
(to maintain continuity in this interdisciplinary program). 
Blinding: Dr. Simmonds or a PRC PT/OT will monitor adherence to recommended 
PT practice and will not share details of the PT with the PI or any other blinded 
research personnel.  
Providers and Qualifications: PT will be provided by Dr. Maureen Simmonds, her 
Physical Therapy students with WOC appointments at the VA, or existing PRC PT/OT 
providers.  The number of students PT interventionists over time will vary and is 
indeterminate but will be greater than 2.  Skills required for the PT portion of the 
treatment will include skills for rehabilitation of chronic pain, strength and 
conditioning, and improved range of motion for the back and extremities. 
Interdisciplinary Staff Meetings (Manual Under Development) 
The entire study team (with the exception of IEs) will meet weekly to discuss 
progress of FORT-A participants and PRC participants.  Participants will be 
discussed without identifiers (even using the unique identifier would unblind the PI to 
the condition of the participant.  These meetings will be run by the research 
coordinator and/or co-coordinator who will be aware of patient identity in case an 
adverse event is noted and needs to be addressed.  Issues discussed in these weekly 
meetings include adherence to protocol, treatment goals, problems with treatment, 
and changes in medication or medical status. These meetings will occur from 1200-
1300 in the PRC with the VA PI’s (Dr. Jaramillo, Dr. Eapen) in attendance. 
Blinding: Cases will only be discussed in a deidentified fashion to avoid unblinding 
the PI (who must be present at these meetings to assess progress of the study, 
troubleshoot procedural difficulties, and offer expert clinical guidance on 
implementing the program.  To accomplish this, the team will develop a set of 
identifiers for participants specific to these staff meetings that are discreet from their 
research unique identification number.  The study coordinator/co-coordinator will 
maintain a link for these identifiers to ensure continuity (NOTE: THIS MAY BE TOO 
CONVOLUTED TO IMPLEMENT, SO WE MAY WANT TO CONSIDER SOME 
OTHER WAY – PERHAPS USING PARTICIPANT INITIALS, WHICH WOULD BE 
MEANINGLESS TO THE PI). 
5.3 
Concomitant Interventions  
5.3.1 Allowed Interventions 
All treatments or interventions prescribed or recommended by STVHCS or other 
Veterans Health Administration (VHA) or Department of Defense (DoD) medical 
provider for a study participant is allowed.  The DoD and VHA do not allow 
prohibition of any recommended or prescribed intervention for research purposes. 

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5.3.2 Required Interventions 
All participants must be given an opportunity to participate in a prescribed course of 
as-usual Physical Therapy (PT) through the PRC (as recommended by the STVHCS 
Physician) before enrollment in this research.  If they have already participated in 
Physical Therapy, choose not to participate in PT, or have already participated in PT 
then they may proceed with enrollment and randomization. 
5.3.3 Prohibited Interventions 
Research in Department of Defense and Veterans Administration covered populations 
may not deny or prohibit any interventions to study participants.  DoD and VA IRB’s 
will not approve research prohibiting any access to interventions for any condition, so 
there are no prohibited interventions for this research.  Participants who receive some 
interventions during or after enrollment in this study may need to be excluded from 
per protocol evaluation but not from intent-to-treat as follows: 
 
 Enrollment in another intensive interdisciplinary pain program 
 
 Enrollment in an intensive program for substance abuse (especially those 
treating opioid dependence with agents like naloxone) 
o If a participant was involved in one of these programs before study 
enrollment and still meets inclusion criteria, then they need not be 
excluded from per-protocol evaluation 
 
5.3.4   Enrollment in STVHCS Opioid Safety Initiative   
In October 2013, the VA launched the Opioid Safety Initiative (OSI), designed to 
address high dose opioid users in the VHA system.  Each VISN (i.e., regional VA 
catchment area) is implementing the OSI differently, but the ultimate goal (as 
outlined in Appendix D) is to reduce dependence on opioid medications for the VA’s 
highest utilizers.  In VISN 17 (the catchment including the STVHCS), the OSI is 
being implemented through the Department of Pharmacy in a joint effort with the 
Department of Psychiatry and Primary Care.  VISN 17 OSI efforts include 
surveillance of opioid use (by morphine equivalent dose; MED), categorization of 
STVHCS patients based on MED and misuse risk factors (e.g., diagnosis with PTSD, 
diagnosis with TBI, diagnosis with Depression, diagnosis with formal substance use 
disorder).  Starting in September 2014, STVHCS medical providers will be limited in 
prescribing opioid medications to high utilizers in some ways that may impact 
persistence of use (e.g., providers may only prescribe opioid medications 30-days at a 
time and are not allowed to automate renewal of prescription).  Study participants 
who are enrolled in OSI through VISN 17 may evidence a change in opioid 
medication response that may not be attributable to study participation (i.e., if opioid 
use decreases, it will be difficult to discern if changes in use are attributable to study 
intervention or mechanisms of the OSI).  In September and October 2014, the study 
PI (Don McGeary) met with the VISN 17 OSI committee to discuss how this research 
can function in the VISN without interfering with the OSI.  The OSI committee was 
welcoming of this study (VISN is required to have a CAM intervention program on 

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site and the OSI committee asked to count this research as their CAM effort), and 
agreed to flag study participants and delay their OSI enrollment until study 
participation is complete.  Additionally, the OSI agreed to begin their enrollment with 
high risk opioid users (> 400 MED, with multiple risk factors), representing a sub-
cohort (approximately n=175) of the 1,300+ Veterans in the STVHCS who will likely 
qualify to participate in this study.  Additionally, the OSI offered to allow Dr. 
McGeary to continue to join the OSI committee for regular meetings (they meet twice 
per month) and expressed an interest in working with the PI and the IRB to explore 
how OSI surveillance might be used to assist in recruitment (at the time of this 
protocol amendment – 2.0, October 2014 – this approach to recruitment has not yet 
been discussed with NCCIH, has not been proposed to the IRBs of record, and has 
not been implemented).  At present, STVHCS OSI includes the following 
components for enrolled participants: 
 - One-hour, group-based psychoeducational class on the dangers of opioid 
medications 
- Limit of opioid prescriptions to 30 days at a time with no automatic refills (overseen 
in VISN 17, Chief of Pharmacy) 
- Education for STVHCS on opioid prescriptions and the dangers of opioid 
medications and opioid misuse 
- Referral for substance abuse treatment through STVHCS Psychiatry  
STVHCS is currently in the process of hiring 6 new personnel for this initiative 
including a physician, a nurse, and a social worker (among others).  As of November 
2014, these positions have not been hired. 
* Note: This section of the protocol will continue to be updated as the STVHCS 
OSI develops further.  
UPDATE (August 2015): In March 2015, Dr. Carolyn Clancy (Interim Under 
Secretary for Health, Veterans Health Administration) testified before the Committee 
on Veteran’s Affairs in the United States Senate.  She described the progress of the 
Opioid Safety Initiative in the VA (a transcript of her testimony can be found at: 
http://www.veterans.senate.gov/imo/media/doc/VA%20Clancy%20Testimony%203.2
6.20151.pdf).  In her testimony, Dr. Clancy described a system-wide decrease in 
opioid medication use throughout the VA (13%) and a decrease in persistent opioid 
use (15%).  She noted that rescheduling of hydrocodone prescription has further 
curtailed how opioid medications are dispensed in the VA.  Finally, she reported on 
the significance of CAM programs for pain management as part of the OSI.  Dr. 
Clancy’s report highlights a unique opportunity for this NIH-funded study to add to 
this effort.  The PI has been working the VA Co-PI (Dr. Eapen) to identify how the 
STVHCS PRC is managing OSI referrals and the PI will be working with the San 
Antonio OSI to establish this study as an OSI referral option (if approved by the 
NCCIH).  This would not only vastly increase the feasibility of recruitment, but also 
allow for a comparison between referred and non-referred patients to add in 
programmatic decision making at a Federal level (regarding a program like FORT-A 
as a CAM referral option for OSI patients).  There is no better time to do this, and 
addition of OSI-referred patients to our inclusion criteria would make this possible. 

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5.4 
Adherence Assessment  
Adherence for this research is addressed in the following three ways: 
Adherence of interventionists and assessors to manualized assessment and treatment 
procedures. All interventions (FORT-A group, biofeedback, individual 
psychotherapy) will be provided by one of the licensed Psychologist study 
investigators (or supervised STRONG STAR postdoctoral fellows/interns) and a 
licensed Physical Therapist. Psychologists will be trained in the group intervention by 
the PI and then certified by Dr. Cindy McGeary using a “see one, do one” approach in 
which they will observe the Dr. Cindy McGeary running all 12 sessions of a clinical 
(non-research) group and be observed by her to obtain certification. During her 
observation, Dr. Cindy McGeary will use a checklist of group session content 
(adapted from the same checklist used in the original FORT trial) to ensure that at 
least 90% of required content is covered at each session. If successful (e.g., covers 
90% of each session), the Psychologist will be “certified” and will be eligible to teach 
others. The PI will also train interventionists in biofeedback using the certification 
process he developed for the U.S. Air Force’s biofeedback lab at Lackland Air Force 
Base (e.g., complete two mock biofeedback sessions with the PI before seeing FORT-
A patients). Group psychotherapy and biofeedback will be supervised weekly by Dr. 
Cindy McGeary (the PI will be available to address technical questions about the 
group treatment and biofeedback, but will do this outside of supervision (in order to 
maintain blinding). Independent evaluators (IE’s) will be trained on all psychosocial 
assessments by the PI and Dr. Cindy McGeary.  The IE’s will be trained on the 
timeline followback (TLFB) opioid assessment method by Dr. Blount, who will train 
each IE through 2 role play cases and record two clinical TLFB assessments for 
review. If the IE achieves a 90% success rate or better both times they will be 
certified for TLFB. If they have been certified in TLFB for another study, then this 
step can be skipped. We will randomly audiotape subsequent psychosocial 
assessment, TLFB, and FORT-A group administrations (≈10%) to assess for drift 
from the protocol using standardized checklists of required content to cover and 
ignore in each session (performed by a non-study RA). The Physical Therapy 
assessment and treatment programs will be manualized and videotaped for protocol 
fidelity (accepted if at least 90% of required content is covered). PT’s and/or PT 
students will be trained by Dr. Maureen Simmonds, who will also supervise.  A 
random selection (≈10%) of videotapes will be reviewed by a non-study RA to ensure 
there is no drift from the protocol. Prolonged Exposure (PE) treatment for PTSD 
(implemented during individual FORT-A individual psychotherapy appointments) 
will be supervised by Dr. Tabatha Blount who is trained in PE. 
 
Maintaining the blind during assessment certification: As is the case in other 
STRONG STAR studies, IEs will be trained and certified in assessment using non-
study (i.e., clinical) cases.  This will allow for a more open dialogue about the 
assessment process during training with Drs. Blount, C. McGeary, and Simmonds.  
Fidelity to the intervention will be completed by a STRONG STAR Research Assistant 
who is not part of this study team using standardized checklists. 
 
Participant adherence to FORT-A treatment. As described above, FORT-A is an 

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intensive, multi-component program.  In order to be adherent to treatment, each 
participant will need to attend group sessions, individual psychotherapy session, 
biofeedback sessions, and Physical Therapy sessions.  One benefit of incorporating 
all of these programs into a consolidated, intensive program is an increased likelihood 
that participants will attend all components.  In fact, in the original FORT trial, every 
FORT participant attended all FORT classes and all PT sessions (with the exception 
of one who elected to undergo shoulder surgery during his enrollment in the study 
and ended his participation early).  FORT-A classes and PT session have some serial 
dependency (i.e., individual sessions build on one another), but many can stand alone.  
FORT-A classes include homework, generally in the form of skills practice.  
Individual FORT-A psychotherapy includes a 6-session Prolonged Exposure protocol 
for PTSD symptoms.  Prolonged Exposure requires “trauma rehearsal” to promote 
habituation to traumatic memories.  PT for FORT includes group exercise 4 days a 
week followed home-based exercise on the weekends guided by “flowsheets.” All 
interventionists will be trained in motivational interviewing and problem-solving 
skills to help maximize patient adherence to study tasks.  For this research, 
“adherence” for each FORT-A component will be defined as follows: 
 
FORT-A Component 
Adherence Criterion 
Adherence 
Management 
FORT-A Psychotherapy 
Group (4 days/wk x 3 wks) 
10/12 Classes 
Make-up missed 
class in extra 
individual session 
FORT-A Physical Therapy 
Group (4 days/wk x 3 wks) 
10/12 Sessions 
Make-up missed PT 
with +1 flowsheet 
Individual Psychotherapy 
(2 days/wk x 3 wks) 
5/6 Sessions 
 
Reschedule missed 
IP session 
Biofeedback 
(4 days/wk x 3 wks) 
2/6 Sessions 
 
Reschedule missed 
BFB session 
Homework: 
Group 
Individual Psychotherapy 
PT 
 
8/10 practice sessions 
4/5 trauma rehearsals 
2/2 weekend flowsheets 
Give opportunity 
for practice/trauma 
rehearsal before 
class 
 
Study interventionists will maintain study activity logs (see Appendix E, maintained 
centrally by the Study Coordinator) where they will log the date and completion 
status of each clinical activity (including sessions attended or missed).  These will be 
brought to weekly interdisciplinary staffing meetings where adherence will be 
discussed and problem-solved by the interdisciplinary treatment.  The PI will attend 
parts of these meetings to monitor study progress and troubleshoot general problems 
(he cannot stay when specific patients are discussed, even by study ID, because he 

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would become aware of which IDs are in the FORT-A group).  A study activity log 
example is below: 
FORT-A; Week 1 
ID 
Date 
Activities 
Attended? 
Notes 
10EX1 
01/01/2001 
Group 
PT 
IP 
Y 
Y 
Y 
Patient reported an injury 
on 01/02/2001; entered in 
AE log as non-study-
related; consulted study 
MD on 01/05/2001; pt 
was cleared to continue  
 
Patient given an extra 
flowsheet for the evening 
of 01/05/2001 to make up 
that missed session; BFB 
missed on 01/05/2001 and 
was rescheduled for next 
week 
01/02/2001 
Group 
PT 
BFB 
Y 
Y 
Y 
01/03/2001 
---- Rest Day ---- 
 
01/04/2001 
Group 
PT 
IP 
Y 
N 
Y 
01/05/2001 
Group 
PT 
BFB 
Y 
N 
N 
  
Participant adherence to assessments.  Adherence to assessments is vital to this work.  
For this research, assessment is broken into 3 distinct categories (psychosocial, 
functional, opioid).  Most assessments are administered at pre-treatment, post-
treatment, 6-month follow-up, and 12-month follow-up.  A few measures are 
ongoing.  Adherence to assessment is defined as completion of assessments within a 
specified window of time. Categories of assessment, assessment windows, and 
managing adherence to assessments are as follows: 
 
FORT-A 
Assessment 
Category 
Assessment Window 
Tips to Promote 
Adherence 
Psychosocial 
Assessments 
Pre-treatment/Baseline         
*≤ 2 weeks before treatment 
 
Post-treatment                      
*≤ 2 weeks after Tx completed 
  
6-month follow-up                  
*24 weeks (±2 weeks) after Tx 
completed  
 
12-month follow-up                       
*50 weeks ±2 weeks after Tx 
completed 
Schedule pre- 
and post-tx 
assessment with 
first and last 
days of tx 
Reminder/check 
in phone calls 
every month 
Psychosocial and 
FCE scheduled 
on same day 
Functional Capacity 
Assessments 
Opioid Assessments    

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Ongoing 
Assessments 
MEMS/Actiwatch – Start at pre-
treatment and end at 12-month f/u 
TLFB/MQS – Administered at pre- 
and post-treatment and every month 
after post-treatment. 
 
Study evaluators will maintain active logs for assessments identifying participants by 
unique ID # only and including date of evaluation, whether or not evaluation was in a 
study window, if PI approved out of window assessment (when outside of a window), 
whether an AE was identified in the assessment (e.g., suicidal ideation on the PHQ-9 
item #9), and notes about assessment (see Appendix F).  These logs will be 
monitored by the PI and coordinator weekly to ensure that assessments are completed 
on time.  An example assessment log is as follows: 
ID 
Assessment 
Assessment 
Domains 
Assessment 
Date 
Window? 
(Approved?) 
Notes 
10EX1 Pre-Treatment 
* within 2 wks 
before  tx phase 
Psychosocial 
FCE 
TLFB 
MEMS 
Actiwatch 
01/01/2001 
01/01/2001 
01/01/2001 
01/01/2001 
01/01/2001 
Y 
Y 
Y 
Y 
Y 
Treatment Phase 
Start 01/04/2001 
End  01/25/2001 
 
10EX1 forgot MEMS and 
Actiwatch at Post-Tx; PI 
approved out of window 
download; we can use 
data up to 01/25/2001 
 
10EX1 sustained injury 
playing basketball on 
07/20/2001; not cleared 
for FCE for 3 months; PI 
denied out of window 
assessment due to injury 
delay 
 
10EX1 completed FCE 
on 01/24/2002 but not 
time for testing; r/s for 
when returns from 
vacation (01/24); PI 
approved out of window 
Post-Treatment 
* within 2 wks 
after tx 
completed 
Psychosocial 
FCE 
TLFB 
MEMS 
Actiwatch 
01/25/2001 
01/25/2001 
01/25/2001 
02/10/2001 
02/10/2001 
Y 
Y 
Y 
N (Y) 
N (Y) 
6-Month 
*24 weeks ± 2 
weeks after tx 
completed 
 
Psychosocial 
FCE 
TLFB 
MEMS 
Actiwatch 
07/22/2001 
--- 
07/22/2001 
07/22/2001 
07/22/2001 
Y 
N (N) 
Y 
Y 
Y 
12-Month 
*50 weeks ± 2 
weeks  after tx 
completed 
Psychosocial 
FCE 
TLFB 
MEMS 
Actiwatch 
02/07/2002 
01/24/2002 
02/07/2002 
01/24/2002 
01/24/2002 
N (Y) 
Y 
N (Y) 
Y 
Y 
 
6. STUDY PROCEDURES 

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6.1 
Schedule of Evaluations 
Assessment 
Enroll / 
Screen  
(W-4 to 0) 
≤ 4 Weeks 
BEFORE 
Baseline 
Randomize 
(W-4 to 0) 
≤ 4 Weeks 
BEFORE 
Baseline 
Baseline (W0) 
≤ 2 Weeks 
BEFORE 
Treatment 
 
Post-Treatment 
(W4-5) 
≤ 2 Weeks 
AFTER 
Treatment 
Six-Month 
Follow-up 
(W30) 
±2 Weeks of  
6-Months 
Post-Tx 
 
12-Month 
Follow-up  
(W56) 
±2 Weeks 
of  
12-Months 
Post-Tx 
 
Lost to 
Contact 
OR 
Dropped 
From 
Treatment 
Informed Consent Form   
X 
 
 
 
 
 
 
Demographics 
X 
 
 
 
 
 
 
Health Questionnaire 
 
 
X 
X 
X 
X† 
 
Health Questionnaire 
Addendum 
 
 
X 
X 
X 
X 
 
Inclusion/Exclusion Criteria  
X 
 
 
 
 
 
 
Enroll/Screen 
X 
 
 
 
 
 
 
Randomize 
 
X 
 
 
 
 
 
Concomitant Medications 
 
 
X 
X 
X 
X 
X 
Adverse Events  
 
 
X 
X 
X 
X 
 
Oswestry Disability Index  
X 
 
X 
X 
X 
X 
X 
Quick Drinking Screen (QDS) 
 
 
X 
X 
X 
X 
 
Fagerstrom Test for Nicotine 
Dependence (FTND) 
 
 
X 
X 
X 
X 
 
Fagerstrom Test for Nicotine 
Dependence – Smokeless 
Tobacco (FTNB-ST) 
 
 
X 
X 
X 
X 
 
PROMIS Short Form 
X 
 
X 
X 
X 
X 
 
Timeline Followback Interview 
X 
 
X 
 X 
X 
X 
X 
Ohio State University TBI Scale 
Short Form – VA 
X 
 
 
 
 
 
 
Patient Health Questionnaire – 
9 (PHQ-9) 
X 
 
X 
X 
X 
X 
 

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Assessment 
Enroll / 
Screen  
(W-4 to 0) 
≤ 4 Weeks 
BEFORE 
Baseline 
Randomize 
(W-4 to 0) 
≤ 4 Weeks 
BEFORE 
Baseline 
Baseline (W0) 
≤ 2 Weeks 
BEFORE 
Treatment 
 
Post-Treatment 
(W4-5) 
≤ 2 Weeks 
AFTER 
Treatment 
Six-Month 
Follow-up 
(W30) 
±2 Weeks of  
6-Months 
Post-Tx 
 
12-Month 
Follow-up  
(W56) 
±2 Weeks 
of  
12-Months 
Post-Tx 
 
Lost to 
Contact 
OR 
Dropped 
From 
Treatment 
PTSD Checklist – 5 
X 
 
X 
X 
X 
X 
 
Functional Capacity Evaluation 
 
 
X 
X 
X 
X 
 
Pain Catastrophizing Scale 
 
 
X 
X 
X 
X 
 
Fear Avoidance Beliefs 
Questionnaire 
 
 
X 
X 
X 
X 
 
Chronic Pain Acceptance 
Questionnaire 
 
 
X 
X 
X 
X 
 
Multidimensional Pain Inventory  
 
 
X 
X 
X 
X 
 
Generalized Anxiety Disorder – 
7 item (GAD-7) 
 
 
X 
X 
X 
X 
 
Depressive Symptom 
Inventory-Suicidality Subscale 
X 
 
* 
* 
* 
* 
 
Current Opioid Misuse Measure 
 
 
X 
X 
X 
X 
 
Mini International 
Neuropsychiatric Interview  
X 
 
 
 
 
 
 
Actiwatch 
 
 
X 
X 
X 
X 
 
MEMS eCap 
 
 
X 
X 
X 
X 
 
Treatment Helpfulness 
Questionnaire 
 
 
 
X 
 
 
 
Subjective Opiate Withdrawal 
Scale 
 
 
X 
X 
X 
X 
 
Pain Diary 
X 
 
X 
X 
X 
X 
 
Interpersonal Needs 
Questionnaire 
(Burdensomeness Items) 
X 
 
X 
X 
X 
X 
 
Phone Contact 
(Adherence / AE / MEMS-
Actiwatch)* 
 
 
 
 
 
X* 
X* 
 
Pregnancy Test 
X 
 
 
 
 
 
 

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Assessment 
Enroll / 
Screen  
(W-4 to 0) 
≤ 4 Weeks 
BEFORE 
Baseline 
Randomize 
(W-4 to 0) 
≤ 4 Weeks 
BEFORE 
Baseline 
Baseline (W0) 
≤ 2 Weeks 
BEFORE 
Treatment 
 
Post-Treatment 
(W4-5) 
≤ 2 Weeks 
AFTER 
Treatment 
Six-Month 
Follow-up 
(W30) 
±2 Weeks of  
6-Months 
Post-Tx 
 
12-Month 
Follow-up  
(W56) 
±2 Weeks 
of  
12-Months 
Post-Tx 
 
Lost to 
Contact 
OR 
Dropped 
From 
Treatment 
Medication Quantification Scale 
– Version III 
X 
 
X 
X 
X 
X 
 
Prescription Access in Texas 
 
 
 
 
 
X† 
 
Missing Data Assessment 
 
 
 
 
 
 
X 
*Occurs monthly after the post-treatment visit 
† To assess opioid prescriptions dispensed for the past year 
 
 
 

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Figure 3. Flowchart: Recruitment to Randomization 
Figure 4. Flowchart:  Enrollment to Assessment 
We will recruit from the STVHCS PRC, Pain 
Management Clinic, Primary Care Clinic, and PTSD 
Clinical Team. 
 
Screening can occur within 4 weeks after enrollment; 
otherwise the Veteran will need to be re-screened. 
Screening 
unclear, PI 
will adjudicate 
Vet Enrolled 
Week -4 to 0 
Vet Screened 
Vet Randomized 
Baseline 
Week 0 
Baseline assessment must occur within 4 weeks after enrollment 
Baseline 
Week 0 
Treatment 
(Week 1-3) 
Post-Treatment 
F/U 
6-Month 
F/U 
12-Month 
F/U 
2 weeks 
2 weeks 
24 weeks 
± 2 weeks 
24 weeks 
± 2 weeks 
Recruitment 
Vet Entered in 
Enrollment Log 
Vet Contacts 
Coordinator 
Vet Referred 
by VA 
Provider  
(consent to 
contact)
Vet Consented 
(ENROLLED) 
Vet Screened 
Vet Entered in 
Screening Form 
Screen 
Clear 
Screen Fail 
Vet 
Randomized 
Vet 
Disenrolled 
Pre-
Screening 

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6.2 
Description of Evaluations  
6.2.1 Enrollment and Screening Evaluation (Week -4 to Week 0; See Figure 3) 
All screening will occur within 4 weeks after consent (so consent occurs at Week -4) 
Consenting Procedure 
Potential participants will have the study explained to them in a safe and private 
location. The Veteran will be given a copy of the informed consent document (ICD) 
to read. The research team member obtaining informed consent will then engage the 
Veteran in an interactive explanation of the study guided by the Informed Consent 
Form. After the Veteran has read the ICD, they will be given the opportunity to 
consider participation and discuss the research with other family and friends. The 
Research Team will be available to answer any questions about the research. Once the 
potential participant has reached a decision, the advising staff member will review the 
risks and benefits of study participation and ensure the Veteran has an understanding 
of the material discussed, and the risks and benefits of their potential involvement in 
the study. The advising staff member will have the participant sign the consent form. 
A copy of the signed ICD will be given to the Veteran. STRONG STAR addresses 
issues related to mental capacity of potential participants through ongoing screening 
procedures using trained independent evaluators. Any concern that a potential 
participant is unable to comprehend what is being asked of them to participate in the 
research or the consent document will be referred to a licensed psychologist for 
additional assessment. Similarly, any concerns identified during the course of the 
study that participants may no longer comprehend what is being asked of them or be 
able to engage in the study procedures will be referred to a licensed psychologist and 
the research team.  All Veterans who have provided informed consent will be 
considered enrolled to the study. Consent will be tracked for each participant using 
the NCCIH Screening and Enrollment Log (Appendix A3).   
 
Screening 
All participants will be screened after consent (i.e., enrollment) and screening will be 
tracked by the Coordinator and Research Assistant using the STRONG STAR 
Screening Form, see Appendix H).  Initial contact will either be made with the 
participating Veteran directly (in response to an advertisement of flyer, the Veteran 
will contact a member of the research team) or on referral from the Veteran’s 
STVHCS provider in the PRC, Pain Management Clinic, PTSD Clinical Team, or 
Primary Care Clinic.  Each clinic where we recruit for this research will be given a 
list of inclusion and exclusion criteria for this research.  After providing informed 
consent, each Veteran will be screened to confirm their suitability for participation in 
this research.  Those who are found to be ineligible for this research study will be 
disenrolled from the study as a “screen failure” and this will be tracked using the 
NCCIH Screening and Enrollment Log.  Screening will be completed by an 
Independent Evaluator (IE) and a Clinical Psychology Fellow or Intern (who will 
complete the clinical interview).  The following assessments, assessment windows, 
and inclusion thresholds must be completed as part of screening: 

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Assessments 
(Inclusion Criterion) 
Assessment Window 
Inclusion Threshold 
Clinical Interview 
PROMIS – SF 
 
(Deployment-Related Chronic 
Musculoskeletal Pain; CMP) 
Within 4 weeks after 
enrollment 
 
Veteran must report pain 
that has interfered in daily 
functioning more days than 
not for the past 3 months 
 
CMP must be related (e.g., 
exacerbated or cause by) to 
OEF/OIF/OND deployment 
 
Service Member must not be 
currently engaged in 
treatment specifically 
targeting opioid use 
 
Veterans not on opioid 
medication were referred by 
any of their VA medical 
providers. 
 
Oswestry Disability Index 
 
(Moderate Disability) 
 
Veteran must score ≥ 20% 
disability for enrollment 
Timeline Follow-back 
Interview 
 
(Persistent Opioid Use) 
 
Veteran must report using 
opioid medication for 20 out 
of 30 days for the past 3 
months 
Patient Health Questionnaire - 
9 
 
(Moderate Depression or PTSD) 
Pain must present in the 
context of depression (based 
on a PHQ-9 Score of 10 or 
more) or PTSD 
 
PTSD Checklist – 5 
 
(Moderate Depression or PTSD) 
Pain must present in the 
context of PTSD (based on a 
PTSD Checklist Score of 25 
or more) or depression 
 
Depressive Symptom 
Inventory-Suicidality Subscale 
 
(No active suicidal ideation or 
intent) 
Veterans cannot enroll if 
they report suicidal ideation 
with intent.  There is no 
widely accepted cutoff score 
for this on the BSSI, so any 

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positive BSSI score will 
need to be reviewed by the 
PI and Psychologist Co-
Investigators and the PI will 
make a decision on inclusion 
 
Ohio State University TBI 
Scale Short Form – VA 
 
(No severe TBI-related cognitive 
difficulty) 
Veterans cannot participate 
with severe TBI-related 
cognitive impairment 
MINI (Psychosis Module) 
Screen out psychosis 
Pregnancy Test 
Screen for pregnancy 
 
The outcome of all screening will be briefed to the PI and Co-Investigators during a 
weekly study meeting (in a de-identified format) for a final determination of each 
enrolled participant’s eligibility for the study.  Once confirmed eligible, participants 
are randomized.  The PI will adjudicate any unclear determinations of eligibility for 
enrollment and the determination will be entered into the enrollment log. 
6.2.2 Randomization and Baseline 
Randomization  (Wk -4 to 0) 
Once the PI and Co-Investigators have determined that a participant has satisfactorily 
met all inclusion/exclusion criteria, the participant will be randomized by the study 
coordinator (this could be done at any time from week -4 to week 0 as long as 
consenting and screening come first).  The date of randomization will be recorded on 
the Enrollment Log. 
The maximum allowable time between enrollment and randomization is 4 weeks.  If 
screening and determination of eligibility goes beyond this allowable window, the 
participant will need to be re-screened before randomization. 
Baseline Assessments (Week 0; See Figure 4) 
Baseline assessment occurs within 4 weeks from the time of enrollment (regardless of 
when baseline assessment occurs relative to screening, Baseline Assessment is 
identified as Week 0). 
 
For participants who have successfully been screened for eligibility and are 
randomized into the study, baseline assessments are performed to measure the study 
outcomes. They also ensure that the groups are balanced with respect to baseline 
characteristics.  
Baseline evaluations for this study include: 
Assessments 
(Domain Assessed) 
Assessment 
Window 
Special Instructions 

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Health Questionnaire / Addendum 
(previous pain treatments) 
(comorbid pain/medical conditions)  
≤ 2 weeks before 
treatment start 
Balance Sample 
Past medical history will not 
change, so this  measure is 
only given once 
Concomitant Medications and 
Medication Quantification Scale-
III 
(medications that may impact pain) 
(medications that may impact mood) 
Control: Other Medications 
Medications may change, so 
this will be assessed at all 
assessment visits; self-report 
and CPRS review 
Timeline Follow-back Interview 
(opioid & other pain medication use) 
Endpoint: Hypothesis 3 
Assessed at all assessment 
visits  
Oswestry Disability Index 
(self-report disability) 
Endpoint: Hypothesis 1 
Veterans cannot participate 
with moderate to severe TBI-
related cognitive impairment 
PHQ-9 
(depression symptoms) 
Endpoint: Hypothesis 2 
Assessed at all assessment 
intervals 
PTSD Checklist – 5 
(PTSD symptoms) 
Endpoint: Hypothesis 2 
Assessed at all assessment 
intervals 
Depressive Symptom Inventory-
Suicidality Subscale (DSI-SS) 
(suicidal ideation or intent) 
Risk Surveillance 
Suicide risk is not a research 
endpoint, but if suicide risk is 
present at a previous 
assessment (e.g., any positive 
response for BSSI screening 
items) then BSSI will be 
repeated at the next 
assessment interval (unless 
participant is disenrolled for a 
VA mental health treatment 
referral) 
Functional Capacity Evaluation 
(objective disability) 
Endpoint: Hypothesis 2 
Assess at all assessment 
intervals 
Pain Catastrophizing Scale 
(pain-related cognitions) 
Endpoint: Hypothesis 2 
Variable: Exploratory 
Interpersonal Needs Questionnaire 
(Burdensomeness) 
Endpoint: Hypothesis 2 
Variable: Exploratory 
Fear Avoidance Beliefs 
Questionnaire 
Endpoint: Secondary 
Objectives 
Variable: Exploratory 
Chronic Pain Acceptance 
Questionnaire 
Endpoint: Secondary 
Objectives 

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Variable: Exploratory 
Multidimensional Pain Inventory 
Endpoint: Secondary 
Objectives 
Variable: Exploratory 
Generalized Anxiety Disorder- 7 
item 
Endpoint: Hypothesis 2 
Assess at all assessment 
intervals 
Current Opioid Misuse Measure 
Endpoint: Hypothesis 4 
Assess at all assessment 
intervals 
Actiwatch 
Endpoint: Hypothesis 2 
Assess at all assessment 
intervals 
MEMS eCap 
Endpoint: Hypothesis 4 
Assess at all assessment 
intervals 
Treatment Helpfulness 
Questionnaire 
Endpoint: Secondary 
Objectives 
Variable: Exploratory 
Only given post-treatment 
Subjective Opiate Withdrawal 
Scale 
Endpoint: Hypothesis 4 
Assess post-treatment and at 
follow-ups 
Pain Diary 
Endpoint: Hypothesis 2 
Assess at all assessment 
intervals 
Phone Contact 
(Adherence/AE/MEMS/Actiwatch 
Treatment Adherence 
Occurs at all assessment 
intervals 
Quick Drinking Scale (QDS) 
 
Common Data Element with 
STRONG STAR Studies 
Fagerstrom Test for Nicotine 
Dependence (FTND) 
 
Common Data Element with 
STRONG STAR Studies 
Fagerstrom Test for Nicotine 
Dependence – Smokeless Tobacco 
(FTNB-ST) 
 
Common Data Element with 
STRONG STAR Studies 
 
Randomization 
As noted above, participants will be randomly assigned to the FORT-A or PRC on a 
1:1 allocation ratio using a randomly selected block size with randomly permuted 
assignments within blocks. 
 
In the original FORT study we found that the ideal treatment group size for each 
iteration of the program was 5 participants (though successful groups were able to run 
with as few of 3 members and as many as 7). Thus, we will attempt to fill treatment 

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cohorts for FORT-A and PRC with between 3 to 7 participants (as described in Efrid, 
2011). The coordinator and co-coordinator will be blinded to all randomization 
assignments but will initiate a treatment cohort when a sufficient number of 
participants have been assigned. 
 
There is a four-week window between enrollment and baseline assessment (Week -4 
to Week 0, as shown in 6.1).  Study intervention must begin within 2 weeks after 
baseline to ensure that baseline assessment data adequately represent current 
functioning at the time of treatment, especially functional capacity evaluation [FCE] 
data that are used to guide the physical therapy portion of the interdisciplinary 
intervention.  Test-retest reliability of FCE has been confirmed over a period of two 
weeks (Brouwer et al., 2003), with only slight fluctuations in more frequent testing 
resulting in a slight increase in lifting capacity if repeated across two days, likely due 
to practice effects (Reneman et al., 2002). Thus, intervention will generally begin 
within 5 weeks of enrollment. 
 
6.2.3 Blinding 
Blinding in an interdisciplinary behavioral intervention is extraordinarily difficult 
since the intervention requires face-to-face contact and continuity of an 
interdisciplinary approach requires different interventionists to be able to talk to one 
another about patient progress.  This is particularly true in trials of openly 
symptomatic conditions (like chronic pain; see Friedberg, Lipsitz, & Natarajan, 
2010).  There is no placebo control for an intervention like this (nor would the VHA 
allow one), so blinding is best accomplished through careful consideration of “need to 
know” privileging.  Figure 2 provides a visual representation of who needs blinding 
and who is allowed to maintain awareness of patient identity.  The entire study staff 
will be thoroughly briefed on the importance of maintaining blinds and the study 
coordinator will attend all study meetings and help ensure that blinds are maintained 
when blinded and unblinded personnel discuss the study participants.  We have 
chosen to use a multi-level blinding scheme (as described by Friedberg et al.) in 
which study personnel will be blinded to randomized treatment condition, assessment 
outcomes, or both (as shown in Figure 2). 
Study interventionists and their supervisors (for group psychosocial treatment; 
individual psychotherapy; biofeedback, and physical therapy) cannot be blinded to 
condition because they will be aware of the treatment condition of the patients they 
treat.  Research Assistants (RA’s), blinded to participant identity, will listen to audio 
recordings of treatment sessions and will rate adherence to the treatment manual 
using a standardized checklist (see Section 10.3 Quality Assurance) for more 
information about this.  The Research Coordinator and Co-Coordinator will be aware 
of participant condition (because they are responsible for randomizing and because 
they need to assist with adverse events monitoring and administrative oversight of 
treatment and assessment procedures), but they will be blinded to outcomes.  The 
Coordinator and Co-Coordinator will not be directly involved in treatment or 
assessment and will be asked to only refer to participants by their unique identifiers 
when discussing participants with RA’s, the PI, or IE’s.  Independent Evaluators will 

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become aware of outcomes during the course of their assessments, but will be blind to 
condition of the participants they assess. 
6.2.3.1 Maintaining Blinds 
During treatment sessions, interventionists are asked not to refer to the participant 
by name and all quality assurance audio files are labeled only with the date of 
intervention, the session number, and the unique study identifier for the 
participant(s) involved.  Because it is possible that the Research Assistant (RA) 
completing quality assurance may become aware of the identities of participants 
in the individual or group treatments, RA’s who complete quality assurance will 
not take part in outcomes assessments (which will only be completed by 
Independent Evaluators through STRONG STAR).    
Independent Evaluators will enter participant data from assessments directly into 
the secure STRONG STAR SQL Database using standard STRONG STAR 
operating procedures (see STRONG STAR Data Entry SOP, Appendix I). 
** The PI and study physicians (Dr. Jaramillo, Dr. Eapen) will sit in on weekly 
interdisciplinary staff meetings with study interventionists to discuss the progress 
of all study participants (both FORT-A and Treatment-As-Usual) during which 
participants will be discussed by case number only.  
6.2.4 Followup Visits (see Figure 4) 
Follow-up assessments will occur in the following intervals: 
 
Visit 
Measure 
Assessment Window 
Visit 2 
(Baseline) 
Psychosocial Assessment 
Pain Diary 
Functional Capacity Evaluation (FCE) 
Upload  Actiwatch 
Provide and Train for MEMS 
Adverse Events 
Opioid/Medication Assessments 
(TLFB/SOWS/COMM/Concomitant 
Medications) 
MQS 
STRONG STAR Common Data 
Elements 
 
≤ 2 weeks before treatment 
Visit 14 
(Post-Treatment) 
Psychosocial Assessment 
Pain Diary 
FCE 
 
≤ 2 weeks after treatment 

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Upload Actiwatch 
Upload MEMS 
Adverse Events 
Opioid/Medication Assessment 
MQS 
STRONG STAR Common Data 
Elements 
Phone Assessments 1-
11 
Opioid/Med Assessment (TLFB) 
MQS 
Monthly 
±1 week 
Visit 15 
(Six-Month Follow-
Up) 
Psychosocial Assessment 
Pain Diary 
FCE 
Upload Actiwatch 
Upload MEMS 
Adverse Events 
Opioid Assessment/Medication 
MQS 
STRONG STAR Common Data 
Elements 
 
 
± 24 weeks after treatment 
±2 weeks 
 
6.2.5 Completion/Final Evaluation 
List each assessment to be performed at the participant’s final visit.  
Visit 16 
(One-Year Follow-Up) 
Psychosocial Assessment 
Pain Diary 
FCE 
Upload Actiwatch 
Upload MEMS 
Adverse Events 
Opioid/Medication Assessment 
(including CPRS and PAT) 
MQS 
STRONG STAR Common Data 
 
± 50 weeks after treatment 
±2 weeks 

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Elements 
Exit Interview 
 
All participants will be asked to complete all final assessments, regardless of whether 
or not they complete the study.  After completing the intervention, we will maintain 
monthly telephone contact with all participants to promote adherence to follow-up 
assessments and to give them an opportunity to report any adverse events they may 
have experienced since finishing the three-week intervention phase.  This monthly 
contacts will also include monthly administration of the TLFB for pain medication 
and opioid medications and administration of the MQS. We will also use these 
monthly calls to identify and troubleshoot any potential problems with the Actiwatch 
or MEMS Caps.  
Participants who  were lost to contact at any point before the 12 month follow-up 
assessment will be contacted to complete the Missing Data Assessment, ODI, TLFB 
and Concomitant Meds Form. Participants will be mailed a letter explaining why they 
are being contacted, how long the phone interview will take, and what information we 
will collect. The letter will also include opt-out information. Within two weeks of the 
participants receiving this letter, we will contact participants to discuss whether they 
would like to participate. The Missing Data Assessment is a 4-item measure of global 
symptom improvement of pain, perception of satisfaction and burdensomeness of 
study treatments, and reason(s) for discontinuing study participation. This assessment 
will be used to assess missing data randomness and to categorize participants who 
discontinued study participation as a way to help impute missing data and improve 
future studies with these treatments in similar populations. 
7. SAFETY ASSESSMENTS  
Upon enrollment, all participants will be monitored for relevant risks through adverse 
events monitoring protocols (guided in part by the STRONG STAR AE SOP (see 
APPENDIX J).  For this study, there is risk for adverse events related broadly to 
psychological distress, physical injury, and opioid withdrawal.  
7.1 
Specification of Safety Parameters 
Section 7.3 of this protocol describes a number of formal assessment measures and 
related safety thresholds.  Along with these formal assessment measures, we will also 
assess pain intensity ratings for each participant before and after each session of 
study-related Physical Therapy.  The PI published a study of pain intensity ratings in 
functional restoration programs and noted that participants who reported pain on a 0-
10 Numeric Rating Scale between 8-10/10 generally demonstrated worse outcomes 
after treatment.  Thus, individuals reporting pain after PT sessions with pain ratings 
between 8-10/10 will be assessed for safety by Dr. Simmonds or a PRC PT/OT and 
discussed with the PI (using unique identification number). 

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7.2 
Methods and Timing for Assessing, Recording, and Analyzing Safety 
Parameters 
Adverse Events tracking is highly recommended for pain research based on 
IMMPACT recommendations (Turk et al., 2003) and will be tracked, monitored, and 
adjudicated for this research in accordance with Appendix J.  Physical Therapy and 
Psychotherapy treatment providers will maintain regular clinical notes input within 24 
hours of each appointment into the VA Electronic Medical Record (in accordance 
with Appendix K).  These data will be discussed and analyzed during the weekly 
research meeting with the PI and Co-Investigators during which the risk profile will 
be determined and addressed. 
Behavioral health interventions for chronic pain tend to be safe compared to medical 
interventions (Morley et al., 1999).  Although there are data describing the adverse 
effects associated with introducing opioid medications to a pain management program 
(see Moore & McQuay, 2005), there is little in the extant literature describing the 
risks of opioid sparing in the context of a program like the OSI (including risk for 
opioid recidivism and withdrawal symptoms).  Indeed, data from the original FORT 
trial did not reveal any adverse consequences of opioid reduction among those who 
voluntarily suspended opioid medication use.   
A comprehensive review of Physical Therapy outcomes among military PT service 
recipients covering 472,013 PT visits across 40 months revealed no significant 
adverse effects of PT for active duty and Veteran patients seeking PT services (Moore 
et al., 2005).  However, Carlesso and colleagues (2010) suggest that this negative 
finding is likely a function of poor adverse event surveillance in research utilizing PT.  
The STRONG STAR Consortium recently published a description of Adverse Events 
monitoring guidelines and recommendations for behavioral health trials including a 
PTSD diagnosed population (Peterson et al., 2013).  These recommendations have 
been incorporated into the risk monitoring procedures used for the proposed study.  
7.3 
Adverse Events and Serious Adverse Events  
An adverse event (AE) is generally defined as any unfavorable and unintended 
diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or 
disease which either occurs during the study, having been absent at baseline, or if 
present at baseline, appears to worsen. Adverse events are to be recording regardless 
of their relationship to the study intervention.   
A serious adverse event (SAE) is generally defined as any untoward medical 
occurrence that results in death, is life threatening, requires inpatient hospitalization 
or prolongation of existing hospitalization, results in persistent or significant 
disability/incapacity, or is a congenital anomaly. 
AEs and SAEs may be related directly to research participation or unrelated to 
research. Potential research-related AEs and SAEs for this study include the 
following: 
 
Adverse Event 
Serious Adverse Event 

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Research Related 
Increased PTSD symptoms 
Increased pain intensity 
Increased emotional distress 
Opiate withdrawal symptoms 
 
Increased Suicidal Risk 
Hospitalization for mood or 
pain 
Research Unrelated 
Example: Flu 
Example: New Injury  
 
 
All AE and SAE monitoring will be completed using the STRONG STAR procedures 
for Adverse Events Monitoring, Documentation, and Adjudication (Appendices J, L, 
and M).  Any study member who identifies an AE or SAE will immediately report it 
to the study coordinator and begin the process for prompt reporting to the IRB 
pursuant to the SOP.  SAE and AE report forms (see attachment SOPs) will be 
forwarded to STRONG STAR Regulatory Personnel who will prepare the official 
report to the IRB.  Each participant chart includes an AE/SAE tracking form in which 
AEs and SAEs will be documented by hand as soon as they are identified (per the 
SOP) 
Adverse events will be monitored through the following mechanisms: 
AE/SAE 
Assessment Tool 
Notes 
PTSD Symptoms 
PCL-5 
Given at every assessment interval and 
at every individual PTSD treatment 
session for FORT-A participants 
Clinical significant change for the PCL-
5 has not yet been established, so we 
will use a 20-point increase in 
symptoms as a clinically significant 
indicator of PTSD symptoms (based on 
the previous version of the PCL; see 
Appendix N) 
Pain Intensity 
Numeric Rating Scale 
(NRS) 
Assessed at every assessment interval 
and at every physical therapy 
appointment for FORT-A participants 
Opinions vary on a clinically 
meaningful change in pain numeric 
rating, but many agree that an increase 
in pain rating > 2 points is clinically 
significant (see McGeary et al., 2006) 
Emotional Distress 
PHQ-9 
Given at every assessment interval and 
once a week during group treatment 

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sessions for FORT-A participants 
Change in PHQ-9 scores is clinically 
significant if the total score rises above 
15 (as defined in Kroenke & Spitzer, 
2002).  Those who begin the study with 
a score above 15 show significant 
change (requiring AE report) if the 
score rises 5 points or more.  If item #9 
increases at all, this will be reported an 
AE.  An increase of Item #9 by 2 points 
or more will be considered a SAE.  
Opiate Withdrawal 
SOWS 
The Subjective Opiate Withdrawal 
Scale will be given to all FORT-A 
participants once a week during 
treatment and at all assessment intervals 
for all follow-up intervals.  A SOWS 
score of 11 or more will indicate an AE 
requiring follow-up (based on 
established cut-off scores). 
Turner JA, Mancl L, Huggins KH, Sherman JJ, Lentz G, LeResche L.  Targeting 
temporomandibular disorder pain treatment in hormonal fluctuations: A randomized 
clinical trial.  Pain 2011;152:2074-2084.  
 
This study maintains a weekly research meeting (starting September 2015; currently 
set for Thursday morning from 1030-1100 at the STRONG STAR Conference Room 
with an open phone line for those who need to call into the meeting) to discuss 
research progress and to discuss participant status and flow throughout the research 
process.  All Adverse Events (AEs) and Serious Adverse (SAEs) will be discussed at 
these meetings (attended by all study staff).  To protect blinding, participants will be 
discussed by unique identifier only.  
AE reporting procedures (as described in the attached SOP) will begin immediately 
after an AE is noticed and will be reported to the IRB after discussion at the weekly 
research meeting.  SAEs must be reported to the IRB within 24-48 hours.  If a 
protocol deviation, SAE or UPIRSO is not reported within 48 hours, a reason will 
need to be documented on the P50 form. 
7.4 
Reporting Procedures 
Reporting procedures for all AEs and SAEs are described in Appendices J and L 
(STRONG STAR Adverse Events SOP).  The P50 reporting template (included with 
the SOP Appendix J) will be used to document all AEs and to record their 
classification and reporting timelines.  The severity and research relatedness of AEs 
and SAEs will be determined by the study PI (Dr. Don McGeary) pursuant to the 
STRONG STAR Adverse Events Adjudication SOP (Appendix M). 

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7.5 
Followup for Adverse Events 
If an adverse event does not require disenrollment and referral to VA physical or 
mental health services, then the research team will offer adjunctive services for 
attrition prevention as outlined in the STRONG STAR ASAP SOP (Appendix O).  
Adjunct services and attrition prevention (ASAP) involves the structured provision of 
extra adjunctive psychotherapy or medical consultation services designed to mitigate 
risk of adverse events and maintain participants on protocol (within the limits of good 
ethics and clinical practice). ASAP sessions can be prompted by the participant, an 
IE, or an interventionist.  These sessions are defined in the SOP as “any out of 
protocol contact (in person or by telephone) lasting longer than 20 minutes.  Each 
participant is allowed three ASAP sessions during protocol intervention.  If more 
intervention is needed, or the PI believes that a higher level of intervention is needed, 
then the participant will be dropped from protocol treatment and referred for 
appropriate intervention in the VA.  For participants remaining on protocol with 
ASAP or referral services, progress will be briefed to the PI daily to monitor progress.  
When the participant and provider report resolution or stability of symptoms, the 
participant will be re-assessed with the index measure (e.g., PHQ-9 for depression, 
NRS for pain) and the results will be discussed with the PI (using only the unique 
identifier for the participant to maintain blinding) for a final determination of 
resolution and continuation on protocol. 
Please note that STRONG STAR maintains a separate SOP for the monitoring, 
management, and intervention of suicide risk in study participants (as detailed in 
Appendix P).  As detailed in the Suicide Risk SOP, all study staff are thoroughly 
trained in suicide risk assessment, with formal assessments overseen by a licensed 
psychologist.  This SOP describes specific algorithms for risk level determination and 
pathways for intervention, follow-up, and implications for research involvement. 
7.6 
Safety Monitoring  
STRONG STAR does maintain a SOP for External Monitoring of all consortium 
studies (see Appendix Q).  This has been attached for NCCIH’s information, and 
safety will be monitored in a manner consistent with standard STRONG STAR 
practice and will be overseen by the STRONG STAR DSMP. 
8. INTERVENTION DISCONTINUATION  
There are few reasons for discontinuing any participant from this study.  However, 
under certain circumstances, it may be necessary to buttress study-related treatment to 
stabilize temporary conditions needing immediate intervention.  The STRONG STAR 
Research Consortium has established an Adjunctive Services and Attrition Prevention 
(ASAP) policy (see Appendix O) describing a preliminary step for intervention in 
which a distressed participant will be allowed three out-of-protocol intervention 
sessions (with their individual or group psychotherapist) of 20 minutes or less to 
stabilize their condition.  Should a pre-determined recovery criterion be met (it is 
impossible to predict all potential emergencies and goals are determined by 
committee as described in the ASAP SOP), then the participant will remain enrolled 
in the study.  If recovery is not achieved, then the research team (led by the PI) will 

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decide on whether the participant should be retained.  Those requiring a referral for 
services outside of the study (i.e., if ASAP is not sufficient for symptom 
management) will be referred to the appropriate services based on the STRONG 
STAR Suicide Risk SOP (Appendix P), through the VA Hospital (i.e., STVHCS), or 
using the San Antonio area referrals as described on the STRONG STAR Referral 
Form (Appendix R1).  All participants referred for services outside of the study 
protocol will be tracked using the STRONG STAR Referral Form (Appendix R2). If 
a participant needs to be screened for safety when he/she is outside of the immediate 
San Antonio area, a distance assessment will be completed as described in Appendix 
R3. The following are examples of conditions/circumstances subject to the ASAP 
process (all of which would qualify as AEs and be tracked/documented accordingly): 
1. Presence of Suicidal Ideation: If suicidality is identified during the course of 
study participation, it is vital that this be addressed and stabilized as quickly as 
possible.  Suicide risk will be monitored, classified, and acted-upon based on the 
STRONG STAR Suicide Risk SOP. 
2. Physical Injury during PT: If a participant sustains an injury during PT, Dr. 
Simmonds will collaborate with Dr. Eapen or Dr. Jaramillo to determine if brief 
ASAP intervention will help restore function and allow continuation of the study 
protocol. 
3. Exacerbation of PTSD or Depression Symptoms: In any study involving the 
treatment PTSD, there is a chance that emotional distress may temporarily 
worsen.  If this happens, adjunctive treatment will be provided using the ASAP 
protocol. 
4. Opioid Withdrawal Symptoms: During the course of this study, some participants 
may choose to stop taking opioid medications (though this is not mandatory), 
which is increasingly likely in light of recent federal changes to VA prescription 
practices and the VA’s Opioid Safety Initiative.  Those who discontinue persistent 
opioid use may report adverse symptoms of opioid withdrawal that will be 
monitored at all individual, group, and assessment appointments.  Should these 
symptoms be identified, Dr. Eapen and/or Dr. Jaramillo will be notified.  They 
will meet with the PI to discuss if these symptoms can be reasonably addressed 
under the ASAP protocol. 
Participants will continue to be followed with their permission if study intervention is 
discontinued. There will be no modifications to the schedule and duration of 
continued followup if the participant is referred to the VA system for treatment and 
stabilization (though we will ask permission for frequent checks with the participant 
on their status to ensure that they are doing well and recovering). They will still be 
asked to complete all measures at all remaining follow-up intervals.   
9. STATISTICAL CONSIDERATIONS  
9.1 
General Design Issues  
Primary Hypothesis: FORT-A participants will demonstrate significantly greater 
improvements in self-reported than those receiving PRC treatment as usual (TAU).  

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“Greater improvement” is defined in this study as statistically significant lower ODI 
scores for FORT-A compared to TAU at one-year post-treatment follow-up 
controlling for differences in ODI at pre-treatment.  Logic for selection of ODI as the 
primary outcome is described in Section 3 of this protocol.  Validity and reliability of 
the ODI has been well-established in over 100 published studies, and use of the ODI 
will allow comparison of the proposed study results to numerous other pain 
populations and interventions (allowing for better prediction of result generalizability 
outside of the population of interest; Fairbank et al., 1980; Fairbank & Pynsent, 
2000). 
Study Design and Rationale: To test the primary hypothesis, the proposed research 
needs to simply determine that the experimental intervention (FORT-A) is superior to 
treatment as usual.  The unique requirements of the VA and DoD systems preclude a 
truly controlled trial (i.e., military and VA IRBs will not approve research denying 
access to treatment for their covered constituents).  Thus, FORT-A cannot be 
compared to a no-treatment control condition.  Because of the variability in chronic 
pain intervention in the VA system, definition of treatment-as-usual can be difficult.  
In the original FORT trial, we chose to compare the FORT program to the best 
available intervention that the DoD had to offer for chronic pain.  If FORT was truly 
an innovative and high-impact intervention, then it should be better than anything else 
that the military was using to manage chronic pain.  Similar logic applies to the 
present study.  FORT-A was developed to improve upon the original FORT program 
for application to a more complex patient population than that treated in the FORT 
study.  Fortunately, the best available intervention for complex chronic pain in the 
VA right is through the Polytrauma Rehabilitation Center, making the PRC a natural 
comparator for this study.  Better yet, the PRC is a structured, interdisciplinary 
program in which all enrolled participants have access to PT services and an 
interdisciplinary treatment team.  If FORT-A is a truly innovative and high-impact 
intervention, then it should out-perform the PRC (which has openly expressed 
difficulty in managing chronic pain; Strasser et al., 2008; Clark et al., 2009; 
Friedemann-Sanchez et al., 2008).  Thus, the most parsimonious design for this 
research is a two-arm, randomized clinical trial comparing 3 weeks of FORT-A to 3 
weeks of PRC intervention.  After completion of the three week intervention phase, 
all participants will be permitted to seek additional treatment through the VA system 
(which is mandated by the VA IRB).  We will track treatment engagement through a 
review of the VA electronic medical record (CPRS, to which all study team members 
will have access) and interviews with participants at all follow-up assessment 
intervals. 
Secondary Hypothesis: FORT-A participants will demonstrate significantly lower 
rates of opioid recidivism than TAU participants at one-year post-treatment.  Opioid 
and other pain medication use is being assessed using a timeline follow-back 
interview and MEMS caps (with the timeline follow-back as the primary measure 
based on its documented reliability and validity; Sobell & Sobell, 1992).   
• We are currently discussing the value of adding urine tox screens at pre-
treatment, post-treatment, and one-year follow-up.  The study team 
previously eschewed the use of a urine tox screen for this research endpoint 

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because of concerns about the validity and sensitivity of urine tox screens for 
opioid use.  However, in consultation with Dr. Dawes and the VA Opioid 
Safety Initiative, we have identified certain tests applied to a urine sample that 
can reliably and validly illuminate opioid use patterns.  We are still examining 
this addition and how we might be able to partner with the VA to add this to 
our outcome battery (after discussing this with NCCIH more, of course) 
without additional cost.  The VA system has increased implementation of 
urine tox screens for opioid using Veterans (see 
http://www.veterans.senate.gov/imo/media/doc/VA%20Clancy%20Testimony
%203.26.20151.pdf).  However, studies in the PRC population using urine tox 
screening risk high attrition because Veterans may feel mistrusted.  Because 
timeline followback has shown reliability and validity in the past, we have 
chosen to stay with this method for tracking opioid use and recidivism to 
opioid use.  However, we will have access to electronic medical records 
(CPRS) to identify new opioid prescriptions in the VA system and Dr. Eapen 
and Dr. Jaramillo can access the Prescription Access in Texas website (see 
https://www.texaspatx.com/Tutorial/Doc/PATIIFAQs.pdf), the Texas State 
prescription monitoring program, to identify opioid prescriptions dispensed 
outside of the VA.  We are able to keep all opioid medication use confidential 
as part of the research record and hope that this will increase the reliability 
and validity of reporting. 
Tertiary Hypotheses: 
• We plan to use mixed effects hierarchical regression with polynomial change 
parameters to assess differences in change trajectories for variables related to 
physical function (functional capacity evaluation, Actiwatch), psychosocial 
functioning (PHQ-9, PTSD Checklist), and pain variables (Pain Acceptance 
Questionnaire, Pain Catastrophizing Scale, Pain Intensity Rating).  All of 
these measures were used in the previous FORT study with established 
reliability and validity. 
Exploratory Hypothesis:  Based on the PI’s ESCAPE trial, we will evaluate the 
contribution of perceived burdensomeness and pain-related helplessness as potential 
mediators of the study’s primary and secondary endpoints.  A subsequent analysis of 
the ESCAPE data (currently in preparation for publication) has also shown that 
depression symptoms may mediate these outcomes as well.   
9.2 
Sample Size and Randomization 
The study is powered to detect a clinically meaningful difference between the two 
intervention groups on the primary outcome (ODI score) at the 12-month follow-up 
time period. This endpoint was chosen as it represents the durability of the treatment 
effect and best reflects the potential utility of the FORT-A program for improving the 
life of patients. The effect sizes used in the calculation are based on our previous 
FORT trial, for which treatment effects in the FORT study arm were maintained at 
the one-year follow-up. 

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Although Aim 2 changed in September 2015, it is important to note that the study 
must be powered for Aim 1 for two reasons.  First, Aim 1 represents the most 
immediately relevant clinical endpoint, demonstrating that the FORT-A program is 
clinically superior to Treatment As Usual in this complex patient population.  Second, 
the PI’s previous military FORT study revealed a significant decrease in opioid 
medication use for program completers (compared to TAU).  The resulting data 
suggest that improved pain management through functional restoration is a likely 
mechanism opioid medication reduction in military pain populations.  Thus, Aim 1 
must be met to maximize between-groups differences in Aim 2. 
To best assess Aim 2, we have chosen to assess medication (opioid and non-opioid) 
use on a monthly basis (during follow-up assessments and monthly phone calls) using 
the TLFB and the MQS.  The increased frequency in assessment (each measure will 
be given 12 times) will provide ample power to detect between-groups difference in 
opioid recidivism over the 12-month study period.  Assuming a sample size of N = 
130 (n = 65/group), 12 data collection periods (monthly follow-ups for one year), and 
a statistical significance level of 0.05, the analysis will have power = .80 to detect a 
clinically meaningful difference between the study groups. For example, if the control 
group exhibits a recidivism rate of 45% (as suggested in Section 2.1 of this 
document) and the active treatment group exhibits a recidivism rate of 22.5%, the 
study will have power = .80. 
We will enroll n = 65 (N = 130) and anticipate <= 30% all-source attrition rate as in 
our previous study. Assuming that at the 12-month follow-up the standard care 
treatment arm will report mean (SD) ODI scores of 19.5 (6.6), using a two-tailed α = 
0.05, we will have power = 0.80 to detect effect sizes as small as d = 0.50.  For the 
ODI, this is equivalent to a clinically meaningful 3.3 point difference between groups. 
In our original FORT trial, we observed a 9.2 point difference between individuals 
who were not lost to follow-up at 12-months. Thus, for the intention-to-treat analyses, 
where we expect that up to 30% of individuals will require imputation of some kind, 
our expected effect sizes can be attenuated by ~ 60% with sufficient power to detect a 
clinically meaningful difference. Differences smaller than 3.3 points on the ODI are 
unlikely to be clinically meaningful. 
Treatment Assignment Procedures 
Participants will be randomly assigned to each of the study arms based on the 
rationale and procedures outlined in sections 6.2.2 and 6.2.3 of this protocol.  
Masking will be managed using the diagram shown in Figure 2.  Pursuant to this 
diagram, masking will be overseen and maintained through a collaboration between 
the study coordinator (who will not be blind to any part of this study to all for better 
tracking of participant flow and AEs; though the Coordinator will not take part in any 
evaluations and is forbidden to discuss blinded information with any study team 
member without first discussing it with the PI and the STRONG STAR 
Administrative Core) and the STRONG STAR Data Core (which maintains the link 
between identity and participant number).  Masking of treatment arm to the 
participant or provider is absolutely impossible in a behavioral trial.  Plans for 

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retention of the blind are described in sections 5.2, 5.4, and 6.2.3.1 of this protocol.  If 
a blind must be broken (e.g, to protect the safety of a participant), then the blind can 
only be broken by the study Coordinator and/or Co-Coordinator after consultation 
and permission from the PI and the STRONG STAR Admin Core.  To break the 
blind, the Coordinator will contact the STRONG STAR Data Core and request 
revelation of the participant identity and linked unique identifier.  
9.3  
Definition of Populations 
For this study, the per-protocol population will include all participants who completed 
all assessments and interventions with no major protocol deviations (as defined by 
Gupta, 2011). The primary analysis will be conducted on the Intent-to-Treat (ITT) 
population that will include all randomized participants who have completed baseline 
assessments. .In the original trial, all FORT completers participated in all 
assessments, but approximately 20% of Treatment as Usual participants were lost to 
follow-up.  Analysis of baseline data revealed that most missing data were missing at 
random.   
9.4 
Interim Analyses and Stopping Rules 
Interim analyses will not be completed as part of this research.  We were fortunate to 
have solid data from the original FORT trial to help estimate power for the proposed 
research, and the resulting power analyses are solid.  Thus, we do not anticipate 
uncovering changes in the primary outcome that would necessitate a need for early 
stoppage or futility of the proposed research and do not feel that we have any 
preliminary impetus for spending alpha in pursuit of these interim analyses.  In 
conclusion, we do not anticipate observing evidence for early futility or superiority in 
this trial until all data are gathered in accordance with our in-place power analysis. 
The interventions used in this study have been thoroughly studied in other research 
and it is predicted that the need for a safety review will be low.  However, there are 
some circumstances that would require suspension of study activity and review of 
safety by an ad hoc safety review committee as follows: 
• This is one of the first studies of an interdisciplinary pain program for chronic 
pain and trauma polymorbidity.  The PIs STRONG STAR Pain and PTSD 
Study revealed no significant exacerbation of PTSD symptoms in a combined 
pain and PTSD protocol, but PT was not involved in that protocol.  There is 
no reason right now to believe that Physical Therapy will exacerbate PTSD 
symptoms, but if this were to occur (based on a 20 point increase on the PCL-
5) then a safety review would be needed to determine if the study must stop.  
This finding would also need to be adjudicated through the AE process. 
• As noted above, opioid withdrawal effects will be monitored, and a score 
above 11 on the SOWS will require safety review. 
• If physical injury or emotional disruption AEs accumulate (more than 4 
minor; easily recovered within one day – or 2 major; requiring more than 
ASAP intervention to stabilize) then a safety review will be in order. 

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Such findings are presented to the study statistician or to the Independent Monitoring 
Committee (IMC) statistician to review the events by group to determine whether 
there are statistical as well as clinical concerns. The statistician reports his findings to 
a closed session of the IMC or to the Safety Officer and/or NCCIH. The findings are 
used to determine what steps will be taken.  
9.5 
Outcomes  
9.5.1 Primary Outcome   
The primary outcome for this research is self-reported disability based on the 
Oswestry Disability Index (ODI). The ODI is a ten-item self-report disability measure 
assessing an individual’s perception of limitation in a number of different life 
domains due to pain.  Each of the ten items asks the participant to use a 0 to 5 
numeric rating scale (each with a specific anchor) to rate the extent to which they feel 
that their functioning is restricted because of their pain.  To score the measure, the 
individual score for each item is summed into a total score and the total score is then 
divided by 50 and multiplied by 100 to generate a total score ranging from 0 to 100.  
This total score represents a % disability score which can be categorized as Minimal 
(0-20%), Moderate (21-40%), Severe (41-60%), Crippled (61-80%), or Bed 
Bound/Exaggerating (81-100%).   The ODI has been cited over 200 times in the 
scientific research literature with firmly established validity for self-report disability 
due to chronic pain (Fairbank & Pynsent, 2000).  The original ODI (a measure 
specific to spinal pain) has been updated in Version 2.0 to include extremities in the 
instructions allowing the measure to validly assess spinal and extremity pain-related 
disability (Roland & Fairbank, 2000).  When compared against the Roland-Morris 
Disability Questionnaire (another gold-standard spinal disability measure that has 
been successfully adapted to include extremity pain), the ODI has shown better 
sensitivity to change at higher levels of disability and is the better measure for this 
research (Roland & Fairbank, 2000). The ODI can be completed in 5 minutes and 
scored in one minute. 
The ODI will be given at every assessment encounter including screening and will be 
administered by an IE who is blinded to the randomized condition of the participant.  
Because this measure is a straightforward, self-report assessment, there is hardly ever 
a need to adjudicate responses and scoring.  However, in some circumstances (e.g., an 
item is left blank, selection of a response is not clearly marked or covers more than 
one response) a response will need to be adjudicated between the IE, the Coordinator, 
and the PI.  Meetings for adjudication will occur on an as-needed basis and the 
Coordinator will ensure that testing materials are not identifiable before discussion 
with the PI (all assessments will be recorded using only the participant’s unique 
identifier).  Adjudication will need to occur within 2 business days from the time that 
an aberrant or unclear response is noted. 
Among the numerous options for pain-related disability assessment, the Oswestry 
was chosen because of its strength as a predictor of long-term outcome in the original 
FORT trial and the attention this measure has received in back pain research.  The 
original FORT trial included many outcome measures.  Measures of functional capacity were 

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most responsive to changes (which makes sense based on FORT’s emphasis of function over 
palliative pain control). We compared 4 functional measures (Floor-to-waist lift [FTW], 
waist-to-eye level lift [WTE], Oswestry Disability Index [ODI], Million Visual Analog Scale 
[MVAS]).  Of the 4 measures, the ODI produced the strongest correlation to other measures 
of pain management and adjustment. 
     
Pearson correlation between 4 disability measures and other notable FORT 
outcomes 
r-value 
Floor-to-
Waist Lift 
Waist-to-Eye 
Lift 
Oswestry 
Disability 
Index 
Million Visual 
Analog Scale 
Depression 
-.174 
-.278 
.690 
.424 
Fear 
Avoidance 
-.106 
-.184 
.622 
.530 
Pain Rating 
-.099 
-.219 
.856 
.816 
9.5.2 Secondary Outcomes   
There are numerous secondary outcomes for this study that can be meaningfully 
categorized as physical measures (functional capacity evaluation, Actiwatch), 
medication (MEMS, timeline followback interview, MQS), psychosocial pain (Pain 
Catastrophizing Scale) and psychosocial trauma and emotional distress (measures of 
PTSD, depression, suicide risk, etc.).  Because these measurement categories all 
require separate skillsets for interpretation of problematic or ambiguous results, they 
must all be adjudicated through separate subcommittees within the study team and the 
STRONG STAR Consortium as follows: 
Physical Measures will be adjudicated by the PI, the Research Coordinator, and Dr. 
Maureen Simmonds (an internationally-recognized expert in Physical Therapy 
assessment for chronic pain) or a PRC PT/OT.  Functional Capacity Evaluation 
(FCE) data will be recorded by UTHSCSA PT students and/or PRC PT/OT providers 
and will be discussed with Dr. Simmonds or a PRC PT/OT within two business days 
after each assessment.  Data will be scrutinized by Dr. Simmonds or a PRC PT/OT in 
raw format and interpretations will be recorded.  Any ambiguity in the data will be 
adjudicated by an assessment sub-committee including the PI, the PT 
Interventionist(s), and Dr. Simmonds OR a PRC PT/OT.  Data will be examined and 
discussed using unique identifiers only.  Actiwatch data will be uploaded by a 
STRONG STAR IE at pre-treatment and all follow-up assessments and uploaded data 
will be scrutinized by the IE (who will be trained in the use of the Actiwatch system 
by the PI – with consultation from the manufacturer if needed) who will identify any 
aberrations in data that may require adjudication.  Actiwatch data will be adjudicated 
using the same timeframe, methods, and subcommittee as the PT data. 
NOTE: Actiwatch was chosen over Actical for this research based on data suggesting 
that actigraphy offers usable data after 10 days of wear time (Freedson, 2014; Mailey 
et al., 2014) and that wrist-worn actigraph is more sensitive to intensity of movement 

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than hip-worn actigraph (Mendoza et al., 2014). Thus, we will use the Actiwatch in 
10-day epochs (participants will be asked to wear them for 12 or more hours per day; 
per Hermann et al., 2012) at every assessment period (instead of continuous wear for 
6-months at a time). Previous studies have shown higher rates of adherence using 10-
day epochs. 
Medication Data will be adjudicated by the PI, the Research Coordinator, and Dr. 
Tabatha Blount (an expert in trauma and addiction comorbidity). Timeline 
followback interview and MQS-III data will be discussed for each participant by the 
IE and the Coordinator within two business days of each assessment.  If there are any 
noted problems with the TLFB data, then the assessment will be adjudicated by the 
above sub-committee within 2 days of review.  MEMS cap data will be gathered for 
each participant’s reported “most helpful” pain medication and any opioid 
medications they are prescribed by VA or other providers outside the VA system 
during the course of the study.  MEMS data will be downloaded for each participant 
at each assessment follow-up visit.  Upon download, the IE will scrutinize 
downloaded data to ensure that it falls within an expected range.  If aberrant or 
missing data are noted, these will be adjudicated with the above sub-committee (and 
potentially discussed with the manufacturer if hardware or software problems are 
suspected) in a deidentified format. 
The primary opioid endpoint will be the timeline followback (TLFB) interview. The 
TLFB represents the primary measure of opioid use because of its reliability and 
sensitivity as a daily measure of opioid use and its lack of perceived stigma compared 
to regular urine tox screen.  A trained and masked IE will administer TLFB asking 
participants about any opioid medication use and use of other medications for pain.  
The TLFB Interview for this study was adapted from Sobell and Sobell (1992) as a 
semi-structured clinical interview asking the participant to use a blank calendar to 
describe the number of pain pills taken each day for 30 days. Instructions are 
provided to help the interviewer guide the participant in completing the recall as 
accurately as possible.  This method has been reliably used in other trials of 
medication/opioid use and abuse (Kunoe et al., 2009). 
Study personnel blind to participant randomization can use the VA electronic health 
record (CPRS) to identify active and new opioid medication prescriptions from 
providers working in the VA system.  Study physicians (Dr. Eapen and Dr. Jaramillo) 
get free access to the Prescription Access in Texas (PAT) prescription monitoring 
program to examine any and all Schedule II through V medications given by any 
provider in the State of Texas.  Both CPRS and PAT (which maintains records of 
medications dispensed to a patient for 365 days) will be accessed at each Veteran’s 
one-year follow-up visit to identify medications prescribed over the one-year study 
participation period. 
 
Psychosocial Trauma and Emotional Measures will be adjudicated through the 
STRONG STAR Assessment Core using existing SOP for surveillance and 
adjudication of these measure.  STRONG STAR has implemented this process for 
military and VA studies serving thousands of study participants across dozens of 

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studies (see Appendix J).  
9.6 
Data Analyses  
Data Analysis: To examine our aims and hypotheses we will utilize the generalized 
linear model, which allows specification of an appropriate distribution for each 
outcome that can accommodate continuous outcomes (e.g., normal distribution with 
identity or log link for self-reported disability) and presence/absence outcomes (e.g, 
binomial with logit link for probability of daily opioid use). We will not stratify our 
analyses by PTSD or depression, but will account for these variables in our data 
analysis. Furthermore, we will attend to the influence of missing data on our analyses, 
and plan on conducting missing values analysis to inform several sensitivity analyses 
(e.g., LOCF, multiple imputation, etc.) to ensure an intent-to treat principle is 
observed. Specifically, we will examine the MAR assumption by examining patterns 
of missingness conditional on baseline assessments, treatment adherence, or other 
time-varying predictors. Our RCT has one primary endpoint (Oswestry), so both 
primary and secondary outcomes will be interpreted at a conventional level of 
statistical significance, p < 0.05. To adhere to NIH policy of examining gender and 
ethnic subgroup analyses, we will add interaction terms (i.e., treatment group x 
subgroup) for each of our planned analyses. Each analysis is further detailed below:  
AIM 1: Assess the efficacy of the FORT-A Program for improved pain 
management outcomes in (N=130) polymorbid OEF/OIF/OND PRC Veterans with 
chronic orthopedic pain using a 1:1 randomized clinical trial comparing FORT-A to 
standard PRC care. To examine our primary hypothesis, we will compare the self-
reported disability scores of the two groups at 12-month follow-up while controlling 
for baseline scores (i.e., an ANCOVA approach). A statistically significant main 
effect will be interpreted as the groups exhibiting differential change in regards 
disability. Secondary analyses will use growth curve modeling (mixed effects 
hierarchical regression with polynomial change parameters) which will model 
differences in change trajectory over time between the groups across assessment 
occasions.  
AIM 2: Assess the efficacy of FORT-A for decreasing the rate of opioid 
medication recidivism compared to standard PRC care in a sample of OEF/OIF/OND 
polymorbid LBP Veterans. To examine our primary hypothesis, we will compare the 
rate of opioid medication recidivism between the two groups monthly from baseline 
to 12-month follow-up. As noted above, 30-40% of TAU participants are expected to 
meet criteria for opioid recidivism (use of any opioid medication for 3 days or more 
in the last 30 days at each assessment). A statistically significant main effect will be 
interpreted as the groups exhibiting differential change in regards disability. 
Secondary analyses will be conducted using growth curve modeling (i.e., mixed 
effects hierarchical regression with polynomial change parameters to model 
differences in the trajectory of opioid use over time between the groups by time).  
EXPLORATORY AIM 3: To examine the role of helplessness and perceived 
burdensomeness in predicting the trajectory of change over time, we will use latent 

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growth curve modeling. We will first model the trajectory of change in the two 
primary outcomes as a function of group (Aim 1 and Aim 2). We will then model the 
trajectories of helplessness and perceived burdensomeness as a function of group. 
Assuming both associations are observed (i.e., that group status is related to changes 
in the outcomes and the mediators), we will conduct hierarchical entry of group status 
and each mediator to examine if group status is still associated with outcome after 
adjusting for changes in the mediators. This will allow us to assess the role of the 
mediators in predicting the outcome and the proportion of change trajectory attributed 
to changes in these mediators.  
10. DATA COLLECTION AND QUALITY ASSURANCE 
10.1 Data Collection Forms  
Data will be collected by an Independent Evaluator blind to the randomized condition 
of the participant and entered into an online SQL database on the STRONG STAR 
server that is designed specifically for this study.  As described in the STRONG 
STAR Data Entry SOP (see Appendix S), data are double-entered to minimize 
transcription errors and all data entry forms include appropriate data entry masks that 
limit the format and scope of entered data (to ensure that out-of-range values are not 
erroneously recorded) with provided feedback if entered data exceed expected ranges.  
STRONG STAR has developed strict rules guiding the translation of assessment 
measures and data recording forms into digital formats as outlined in Appendix T. 
Paper copies of assessments are also uploaded and tagged to the assessment record 
for review by the IEs or other study staff if adjudication of responses is needed.  The 
STRONG STAR Network is FISMA compliant and has received permission from the 
VHA for the storage of Veteran study data (which is very strictly controlled by the 
VA system).  Because the STRONG STAR Database is accessible through a secure 
internet portal, data can be entered into the system directly from any VA computer 
with internet access (of which this study currently has dedicated access to two 
through the PRC).  To ensure confidentiality of patient records, all data are entered 
into study records using the participant’s unique ID.  A link between identifiers and 
the ID is maintained in a separate data table with access restricted to individuals who 
are not blind to patient identifiers (e.g., study Coordinator, interventionists).  
10.2 Data Management  
Data will be coded using an assigned number. Data collected during treatment will be 
entered into a secure STRONG STAR database, and hardcopies will be placed into a 
lock box which will be transported by car to University of Texas Health Science 
Center San Antonio (UTHSCSA) STRONG STAR offices by a STRONG STAR staff 
member who will place it into the locked cabinets at the STRONG STAR offices. 
Audio and video recordings will be uploaded to a secure STRONG STAR server over 
an encrypted network connection between VA networks and UTHSCSA networks. 
Members of the study team will have access to the data. Every member of the 
Research Team will be trained and monitored about how to handle and protect both 
medical and research records. Furthermore, the Research Team strictly controls 
access to study data using policies and procedures developed specifically for the 

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STRONG STAR Research Consortium. Adverse Events will be immediately brought 
to the study PI and reported to the IRB and funding agency. AE’s will be identified 
by unique identifier to protect blinding of the PI.  If the participant’s identity is 
needed to effectively manage an AE, then the Study Coordinator will link the unique 
identifier to the specific participant (the Coordinator will maintain a link between PHI 
and unique identifiers through the STRONG STAR Data Core dashboard). A 
STRONG STAR Data Safety and Monitoring Plan (DSMP) has been developed in 
accordance with the National Institutes of Health (NIH) Office of Human Research 
Protection (OHRP) to assure the appropriate clinical safety monitoring of study 
subjects participating in all of its studies. The STRONG STAR database has been 
certified as FISMA-compliant and has been formally cleared for the management of 
Veteran data through the VA.  
10.3 Quality Assurance  
10.3.1 Training 
Sections 5.1, 5.2, and 5.4 of this protocol describe various components of training for 
assessment and intervention for this study.  STRONG STAR uses circumscribed 
certification processes for assessment and intervention to ensure that individuals 
completing assessment and intervention are trained to an acceptable standard and that 
resulting assessment and intervention is of sufficient quality to provide and 
sensitively assess systematic treatment effect to the greatest extent possible. 
10.3.2 Quality Control Committee  
A STRONG STAR Research Assistant outside of this study will be asked to complete 
a quarterly External Protocol Monitoring Checklist (Appendix U) for submission to 
the Study Coordinator, PI, and the STRONG STAR Admin Core for review.  
Discrepancies or problems will be addressed by the Admin Core and the PI acting as 
the quality control committee.   
10.3.3 Metrics 
As shown in Appendix U, quality control metrics include appropriate organization of 
study documents, confirmation of regulatory document versions, verification of 
enrollment protocols, documentation and adjudication of AEs, storage of data, and 
documentation/report/adjudication of protocol deviations. 
10.3.4 Protocol Deviations 
The STRONG STAR Protocol Deviation and AE SOP (Appendix V and W) 
thoroughly describes the mechanisms and responsibilities for tracking, documenting, 
and adjudicating protocol deviations.  Briefly, each participant chart will include a 
Protocol Variance and Deviation Log that will be used to track and document 
deviations from protocol.  Responsibility for tracking deviations lies with the study 
staff member who first discovers a provider or participant deviation from protocol 
(advertent or inadvertent).  STRONG STAR Regulatory (aka the STRONG STAR 
Admin Core) is responsible for working with the PI and the Coordinator to assess the 
nature of the deviation and the adjudication of the deviation.  Deviations are entered 

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in the STRONG STAR Database, reported to the IRB (the SOP describes the BAMC 
IRB, but this protocol will report to the UTHSCSA and VA IRBs), and included in 
annual reports to the funder. 
10.3.5 Monitoring 
Monitoring of study data and protocol deviations is described in Appendix V and as 
outlined in the Data Safety Monitoring Plan (DSMP) for this study.  The Study 
Coordinator  is responsible for updating the STRONG STAR Regulatory Coordinator  
about all protocol deviations.  The Regulatory Coordinator will ensure that the IRB, 
PI, and funder are aware of deviations through regular reporting mechanisms (e.g., 
Progress Reports, Progress Reviews, ad hoc meetings) and the PI is ultimately 
responsible for all reporting.  The Study Coordinator will review all study charts 
within 3 business days of assessment and once a week during intervention phase to 
identify any noted deviations (notated in the chart by the study personnel responsible 
for the deviation as described in Appendices V and W). 
11. PARTICIPANT RIGHTS AND CONFIDENTIALITY  
11.1 Institutional Review Board (IRB) Review  
This protocol and the informed consent document (Appendix D) and any subsequent 
modifications will be reviewed and approved by the IRB or ethics committee 
responsible for oversight of the study. The consent form should be separate from the 
protocol document.  Regulatory review will occur through the UTHSCSA/VA IRB 
(of which the PI currently serves as the Alternate Chair) and the VA R&D Committee 
(see Appendix X). 
11.2 Informed Consent Forms 
A signed consent form will be obtained from each participant. For participants who 
cannot consent for themselves, such as those with a legal guardian (e.g. person with 
power of attorney), this individual must sign the consent form. The consent form will 
describe the purpose of the study, the procedures to be followed, and the risks and 
benefits of participation. A copy will be given to each participant or legal guardian 
and this fact will be documented in the participant’s record.  
11.3 Participant Confidentiality  
Any data, specimens, forms, reports, video recordings, and other records that leave 
the site will be identified only by a participant identification number (Participant ID, 
PID) to maintain confidentiality. All records will be kept in a locked file cabinet at 
the VA PRC.  Data will be entered into the secure STRONG STAR Database from 
the VA. All computer entry and networking programs will be done using PIDs only. 
Information will not be released without written permission of the participant, except 
as necessary for monitoring by IRB, the FDA, the NCCIH, and the OHRP. 
11.4 Study Discontinuation  
The study may be discontinued at any time by the IRB, the NCCIH, the OHRP, the 

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FDA, or other government agencies as part of their duties to ensure that research 
participants are protected.  
12. COMMITTEES 
STRONGSTAR Administrative Core – The STRONGSTAR Administrative Core 
provides administrative support and oversight for all STRONGSTAR and 
STRONGSTAR affiliated studies.  Support functions include: assistance of 
recruitment and hiring for study personnel, assistance with regulatory and compliance 
paperwork and procedures (e.g., IRB, annual progress reviews), VA and DoD 
integration (e.g., securing and maintaining research infrastructure in VA and DoD 
facilities).  The Administrative Core will arrange a kick-off meeting including all 
study personnel (overseen by the study PI) during which all logistical issues for this 
research will be discussed and finalized (see Appendix Y).  A summary of the kick-
off meeting will be submitted to the funder during quarterly progress reports. 
STRONGSTAR Biostatistics, Data, and Computing Services Core (BDCS Core) 
– The STRONGSTAR BDCS Core oversees the input, storage, and output 
infrastructure and policies for all STRONGSTAR and affiliate study data.  BDCS 
works with the PI to develop a customized SQL database with a secure online portal 
capable of maintaining VA data (based on a standing agreement between the VA and 
STRONGSTAR; storing VA data offsite must be approved by the VA).  
https://delta.uthscsa.edu/strongstar/cores.asp?c=3 
STRONGSTAR PI Committee – The STRONG STAR Principal Investigators 
Committee is responsible for overseeing who each STRONG STAR and affiliated 
study fits into the local (i.e., STVHCS) research landscape and how data are 
disseminated.  The PI Committee helps explore how a study may intersect of overlap 
with other STRONG STAR studies and helps troubleshoot how a study can recruit 
and intervene in light of other research activities in the geographic area.  
Additionally, the PI Committee has established guidelines describing how decisions 
should be made if a participant seeks involvement in more than one STRONG STAR 
study (see Appendix Z). 
Opioid Safety Initiative Committee – The OSI Committee plans and implements 
OSI efforts in the STVHCS (see 5.3.4).   
13. PUBLICATION OF RESEARCH FINDINGS  
All STRONG STAR and STRONG STAR affiliated studies must request and approve 
publication and/or presentation of research findings through the STRONG STAR 
Principal Investigators Committee (see Appendix ZZ). Any presentation, abstract, or 
manuscript will be made available for review by the sponsor and the NCCIH prior to 
submission.  
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15. SUPPLEMENTS/APPENDICES (SOP = “Standard Operating Procedure”) 
Appendix 
Contents 
-- none -- 
Data Safety Monitoring Plan (DSMP) 
A1 
Consent to contact form 
A2 
IRB-approved consent form 
A3 
NCCIH Screening Log 
A4 
SOP – Unique ID assignment 
B 
FORT-A manual 
C 
Manual of Procedures for PT, individual psychotherapy, team staffings 
(still under development) 
D 
OSI information 
E 
Attendance form 
F 
Adherence assessment 
H 
Screening call sheet (I accidently skipped G!  There is no Appendix G) 
I 
Data entry SOP 

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J 
Adverse events monitoring SOP 
K 
Medical record documentation SOP 
L 
Adverse events documentation SOP 
M 
Adverse events adjudication SOP 
N 
PCL scoring guidelines 
O 
ASAP session SOP 
P 
Suicide risk monitoring and management SOP 
Q 
External safety monitoring protocols 
R1 
Referral resources 
R2 
Referral tracking form 
R3 
Distance assessment SOP 
S 
Data entry and access SOP 
T 
Instrument review SOP 
U 
External monitoring checklist 
V 
Data safety monitoring plan 
W 
Protocol deviation SOP 
X 
Regulatory policies and procedures 
Y 
Kick off meetings 
Z 
Multiple study enrollment policy 
ZZ 
Publication SOP