An Evaluation of MBSR and CBT for Veterans With Chronic Pain
Phase: NA
Conditions: Chronic Pain, Pain
Sponsor: VA Office of Research and Development

An Evaluation of MBSR and CBT for Veterans with Chronic Pain
Lay Title: Investigating Methods of Pain Recovery with Outpatient Veteran Education 
( IMPROVE )
Funding Agency: VA Office of Rehabilitation Research and Development
Principal Investigator: Tracy Simpson, PhD
MIRB 01889
Version 8; 8/11/2023
Human Subjects Protocol
VA Puget Sound IRB

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Abstract
Pain is one of the most common reasons Veterans seek health care. 
Mental health conditions (including PTSD, anxiety, and depression) are estimated 
to co-occur for 30-50% of Veterans with chronic pain. Mindfulness-Based Stress 
Reduction (MBSR) and Cognitive Behavioral Therapy for chronic pain (CBT-CP) 
teach skills intended to enhance functionality and quality of life in the face of 
chronic pain.  The study will recruit and randomize up to 222 Veterans with 
chronic musculoskeletal pain. One third of these (n=74) will be randomly assigned 
to the Mindfulness-Based Stress Reduction (MBSR) group, one third of these 
(n=74) will be randomly assigned to the Cognitive Behavioral Therapy for Chronic
Pain (CBT-CP) group, and one third of these will be assigned to Treatment as 
Usual (TAU). The MBSR and CBT-CP sessions meet by video once a week for 8-
weeks, MBSR sessions are 2 hours long per session, and CBT-CP sessions are 
1.5 hours long. The Primary Aim is to assess if MBSR and CBT-CP each result 
in greater reductions in the pain interference subscale of the Brief Pain Inventory 
(BPI) as compared to usual care, from baseline to 6 months post-treatment. The 
Secondary Aim is to evaluate if MBSR and CBT-CP are each superior to usual 
care in producing improvements in pain severity, treatment satisfaction, and 
depression. 
Measures pertaining to the primary outcome of pain interference will be 
collected at baseline, at the post-MBSR/CBT-CP time point, and at 6-month post 
treatment follow-up. In addition, measures of pain intensity, depression, and 
treatment satisfaction will be applied to more fully characterize the impact of 
MBSR relative to CBT-CP and usual care. Exploratory analyses will assess if 
outcomes differ for MBSR and CBT-CP, the impact of the interventions on opioid 
use and indicators of suicidality, and whether Veteran characteristics assessed at 
baseline function as treatment moderators. Mixed models will assess whether 
MBSR, CBT-CP each produce greater reductions in outcome variables from 
baseline to follow-up compared to usual care.  If MBSR and CBT-CP are each 
shown to be superior to usual care for treatment of chronic pain among Veterans, 
it would support providing MBSR and CBT-CP for this population. 
List of Abbreviations 
MBSR  Mindfulness-Based Stress Reduction 
CBT-CP  Cognitive Behavioral Therapy for Chronic Pain 
CPRS  Computerized Patient Record System (electronic medical record) 
PROMIS  Patient-reported Outcome Measures Information System 
TAU- Treatment as Usual 
VVC- VA Video Connect technology (telehealth video portal) 
 

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Contents
Protocol Title: ............................................................................................................................. 4
1.0 
Study Personnel .............................................................................................................. 4
2.0 
Introduction ..................................................................................................................... 4
3.0 
Objectives ....................................................................................................................... 4
4.0 
Resources and Personnel ............................................................................................... 8
5.0 
Study Procedures ............................................................................................................ 9
5.1 Study Design ...................................................................................................................10
5.2 Recruitment Methods.......................................................................................................13
5.3 Informed Consent Procedures .........................................................................................15
5.4 Inclusion/Exclusion Criteria ..............................................................................................16
5.5 Study Evaluations ............................................................................................................17
5.6 Data Analysis ..................................................................................................................19
5.7 Withdrawal of Subjects ....................................................................................................20
6.0 
Reporting ........................................................................................................................21
7.0 
Privacy and Confidentiality .............................................................................................22
8.0 
Communication Plan ......................................................................................................22
9.0 
Information Security and Data Storage/Movement .........................................................23
 
 

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Protocol Title:  A Randomized Clinical Trial of Group Interventions 
Compared to Usual Care for Veterans with Chronic Musculoskeletal 
Pain 
 
1.0 
Study Personnel 
 
Principal Investigator:  
Tracy Simpson, 206-277-3337, Tracy.Simpson@va.gov, VA employee 8/8ths 
 
Co-Investigators: 
Lisa Glynn, 206-277-3224, Lisa.Glynn2@va.gov, VA employee 8/8ths 
Anna Korpak, 206-277-5170, Anna.Korpak@va.gov, VA employee 8/8ths 
Collaborators (at other institutions, not covered under the VA IRB approval): N/A
 
2.0 
Introduction 
 
Pain is one of the most common reasons for seeking health care among both 
Veterans1, 2 and the US population at large.3 When pain persists for at least 3 
months after the initial injury or disease process may have resolved, it is referred 
to as chronic pain. In the US population, it is estimated that chronic pain affects 
approximately 100 million American adults  more than the total affected by heart 
disease, cancer, and diabetes combined.3 Musculoskeletal pain is the most costly, 
debilitating, and prevalent pain condition.2, 4, 5 Chronic pain accounts for nearly 70 
million outpatient visits per year in the United States6 and is associated with lost 
productivity, medical treatment, and disability payments that result in an estimated 
$600 billion per year in costs.7 At least one-third of Veterans report chronic 
musculoskeletal pain, and rates may be even higher among female Veterans.2, 5, 8,
9 Chronic musculoskeletal pain is not limited to older Veterans  an analysis of 
>700,000 OEF/OIF/OND Veterans, found that musculoskeletal disorders affected
 

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56% of the sample1 and another analysis confirmed that almost 60% have 
musculoskeletal conditions, such as back pain.9 
Management of chronic pain is often compounded by other life problems, 
including medical, psychological, and social difficulties (including disability, 
substance use, and poverty).10, 11 Mental health diagnoses (including PTSD, 
anxiety, and depression) occur in 30-50% of people with chronic pain, and PTSD 
contributes significantly to the level of distress experienced by Veterans with 
chronic pain.12 For Veterans with polytrauma, the overlap of clinical syndromes 
appears particularly common. One study reported a prevalence of chronic pain of 
>80% for polytrauma patients, with pain rarely occurring in the absence of PTSD 
or post-concussive symptoms.11 As a result, Veterans with chronic pain often 
experience impairment of occupational, social, and recreational activities, as well 
as negative mood and increased isolation. When VHA clinicians and decision 
makers seek guidance from the literature regarding how to treat chronic pain, 
recognition of the added complexity of pain presentations among Veterans also
raises questions about whether clinical trials performed outside the VA can be 
generalized to care-seeking Veterans.9 
The recommended VHA strategy for management of chronic pain involves a 
stepped approach.13 In the stepped care model, most Veterans are managed in
primary care, where pharmacological and non-pharmacological treatments are 
provided as indicated. Although opioids are sometimes prescribed for chronic 
pain, a recent RCT compared opioids to non-steroidal anti-inflammatory drugs 
among Veterans with chronic pain and found that outcomes for those treated with 
opioids were not superior to those treated with nonopioid medications.14
Prescribing opioids entails risks, including addiction, overdose, fractures, 
cardiovascular events, bowel obstruction, and cognitive impairment.10, 15, 16
Because of these risks, VA Clinical Practice Guidelines recommend against the 
initiation of opioids for chronic pain and instead recommend the use of self-
management strategies and other non-pharmacological treatments, such as 
Cognitive Behavioral Therapy (CBT).10 Institute of Medicine guidelines also
recommend use of non-pharmacological approaches as standard of care for 
chronic pain before prescribing opioids.17 Similarly, the American College of 
Physicians guidelines for treatment of chronic low back pain recommend non-
pharmacological therapies as initial treatment, and list CBT and Mindfulness-
Based Stress Reduction (MBSR) as options that should be offered as standard 
care.18 
Psychological interventions have been advocated as non-pharmacological
therapies for chronic pain based on evidence that psychological processes 
play key roles in pain outcomes. Depression, pain catastrophizing, and 
 

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anxiety are positively correlated with pain severity and pain disability in
cross-sectional studies, and longitudinal studies indicate that reductions in 
these factors are associated with improved pain severity and disability.12
For example, a clinical trial involving 250 Veterans with chronic pain treated 
with a stepped care strategy demonstrated that the strongest predictor of 
improvement in pain severity, interference, and disability was the change in 
depression score.19 Two categories of psychological interventions for
chronic pain are Mindfulness-Based Interventions (such as MBSR) and 
CBT. Although both MBIs20 and CBT21, 22 are increasingly available for 
chronic pain, there have been few adequately designed studies of MBIs for 
chronic pain, and although the broader research base on CBT for chronic 
pain indicates benefit, 21 there is limited research on clinical outcomes 
using the format of CBT for chronic pain (termed CBT-CP) disseminated by 
VA.23 Formal collection of additional data by VHA in the context of a clinical
trial comparing outcomes of CBT and MBSR to usual care, and performing 
exploratory analyses comparing outcomes for each active intervention,
would help to guide clinical care for Veterans with chronic pain in the 
future. 
Mindfulness-Based Interventions (MBIs) such as Mindfulness-Based Stress 
Reduction (MBSR) emphasize patient education and self-management, 
and foster the ability to attend to thoughts, emotions, and bodily sensations 
with an attitude of curiosity, openness, acceptance, and love.8 Such an 
attitudinal shift has been theorized to promote cognitive and behavioral 
changes, and to foster more adaptive responses to stress and pain.9 There 
is evidence that MBIs also influence the key components of the
biopsychosocial model: biological (e.g. the stress response), psychological 
(e.g. anxiety about symptoms, interpretations of symptoms), and social 
(e.g. 
engagement 
in 
health 
care/self-care 
activities 
and 
social 
support).8,10,11 MBIs can be considered an integrative approach, because of
their potential to foster improvement across multiple domains of health,11-14
and thus  may be particularly well suited to the health concerns of GW 
Veterans. Participation in an MBI can be framed as teaching a person a life
skill, the benefits of which can grow over time.12 MBSR teaches self-care 
practices (mindfulness meditation) that participants are encouraged to 
utilize on a regular basis after finishing the course (and uptake of these 
practices has been shown to occur at a high rate; at least 75% report using 
mindfulness techniques in daily life at follow-up ranging from 6-48 
months).9,15   
 

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MBIs have been applied to the hallmark of symptoms of chronic
musculoskeletal pain; a brief summary of the effect of MBIs on these 
cardinal symptoms of chronic musculoskeletal pain is provided below. 
A meta-analysis of acceptance-based approaches for chronic pain found 
medium effects for pain intensity (d=0.48).14 Another review of 16 trials of 
MBIs showed reductions in pain intensity in 6 of 8 randomized controlled
trials (RCTs), with medium effect sizes.12 Furthermore, when analyses 
were limited to samples involving clinical pain, 9 of 11 studies showed 
reductions in pain intensity.12 There have been few comparisons of MBSR 
to an active control. One non-randomized pilot study (n=50) compared 
MBSR to CBT and found a larger effect size in favor of MBSR (d=0.87).16
Another non-randomized study (n=58) compared MBSR to a social support 
group and found medium effects in favor of MBSR for sensory/affective 
pain, and large effects (d=1.10) using a pain visual analogue scale.17 The 
findings of prior pilots  subject to the limitations of small sample sizes 
are generally consistent with the data from our small pilot study among GW 
Veterans (n=55), which showed greater reductions in  pain severity after 
MBSR as compared to usual care (d=0.66). 
One mechanism hypothesized to account for reduced pain is that 
enhanced mindfulness leads t
elements from the sensory experience of chronic pain, which results in 
decreased distress and suffering18; it has been proposed that the affective 
component of pain can be distinguished from pain intensity, and that the 
affective component can be differentially targeted19. Data from both 
correlational and experimental studies performed in chronic pain 
populations suggest that enhanced mindfulness is associated with reduced 
pain intensity ratings.12,20,21 Studies of healthy volunteers also support 
reduced pain intensity associated with MBIs. One study found that three 
days of mindfulness meditation training led to reduced pain intensity ratings 
following electrical stimuli22 and another study showed that three days of 
mindfulness training was superior to guided imagery in increasing pain 
tolerance to the cold pressor test.22 Other research has found that anxiety 
decreases pain threshold and lowers pain tolerance.23 Thus, interventions 
that reduce anxiety would be expected to lead to reductions in pain 
severity.
Cognitive Behavioral Therapy (CBT) is the most widely used non-
pharmacologic intervention for chronic pain21 and a version of CBT 
specifically addressing chronic pain (CBT-CP) has been developed for use 
in VA with Veterans.23 Fundamentally, CBT is an approach that seeks to 
 

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ameliorate dysfunctional relationships between an individua
houghts, 
feelings, and behaviors to improve functioning and quality of life. Evidence 
supports use of CBT as an intervention for chronic pain. A Cochrane 
review of psychological therapies for chronic pain found that there were 
positive effects on pain-related disability and catastrophizing compared 
with active controls,21 and another recent systematic review and meta-
analysis of CBT for low back pain involving 23 studies found that CBT was 
superior to guideline-based active treatment in improving pain and disability 
at both short and long-term follow-up.24 
We will not be including any vulnerable populations in our research, except 
for pregnant women. There is no scientifically supported or theoretical 
reason to believe that participation in the MBSR or CBT-CP group, or other 
study procedures, would pose special risk to a pregnant woman or her 
fetus. Given the reasons that are supported for believing participation in 
either of these groups could provide benefit to a pregnant woman, we will 
not exclude this population (although we are not targeting them specifically 
with any recruitment materials). 
3.0 
Objectives 
 
The Primary Aim of this study is to determine whether MBSR and CBT-CP
each result in greater reductions in the pain interference subscale of the 
Brief Pain Inventory (BPI) as compared to usual care, from baseline to 6 
months post-treatment for Veterans with Chronic Musculoskeletal Pain. 
Hypothesis: Veterans with chronic pain randomized to each active 
intervention (MBSR or CBT-CP) will report changes in BPI pain 
interference that are each superior to usual care, from baseline to 6-month 
follow-up. 
Secondary Aim: Evaluate if MBSR and CBT-CP are each superior to usual care 
in producing improvements in pain severity, treatment satisfaction,
and 
depression. Exploratory Aim 1: Evaluate whether outcomes for patients 
randomized to MBSR and CBT-CP differ for changes in pain interference, pain 
severity, depression, and treatment satisfaction. Exploratory Aim 2: Evaluate the
impact of MBSR and CBT-CP on utilization of opioid analgesics and markers of 
suicidality. Exploratory Aim 3: Evaluate moderators of response to MBSR and 
CBT-CP to lay the groundwork for identifying Veterans more likely to succeed in 
one or the other treatment. Potential moderators assessed will include:  age,
 

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gender, 
baseline 
depressive 
symptoms, 
anxiety 
sensitivity, 
and 
pain 
catastrophizing 
4.0 
Resources and Personnel 
 
The study procedures will take place at VA Puget Sound, Seattle Division,
executed by the IMPROVE study team: 
 
Tracy Simpson, PhD (Principal Investigator): Dr. Simpson will have
overall responsibility for the conduct and performance of the study. She will 
take the lead on recruitment, as well as the organization, quality control 
and oversight of the MBSR courses. She will have primary responsibility for 
supervision of the project manager and research coordinator and will also 
be responsible for human subjects regulatory requirements. She will 
oversee all aspects of data collection, data quality control, and she will take 
the lead on manuscript preparation. Dr. Simpson will have access to PHI, 
and she can obtain informed consent if the Project Manager and Research 
Coordinator are not available to do so. 
 
Lisa Glynn, PhD (Co-Investigator): Dr. Glynn will be actively involved 
in all phases of the project, including planning, recruitment, and 
implementation. She will have primary responsibility for troubleshooting any 
issues with the CBT-CP classes or group leaders. Dr. Glynn will participate 
in all manuscript preparation. Dr. Glynn will have access to PHI. 
Anna Korpak, PhD (Co-investigator): Dr. Korpak will be responsible for 
statistical analyses. She will supervise the work of the analyst and will work 
with the investigative team to design data collection and extraction 
procedure for administrative data and oversee quantitative assessments of 
implementation. Dr. Korpak will participate in all manuscript preparation. 
Dr. Korpak will have access to PHI. 
 
Meghan Storms, MSW, LICSW (Project Manager): Ms. Storms will 
be the Project Manager and will work closely with the principal investigators
to provide day to day oversight of the study activities as well as supervision 
of the research assistant. She will monitor the day-to-day activities of the 
project, including tracking the progress of approvals needed during the 
planning phase and overseeing recruitment and randomization. She will 
directly interface with the MBSR and CBT-CP clinical programs to 
troubleshoot any issues that arise. Ms. Storms will participate in collection 
of study measures and assist in performing fidelity coding. She has 
significant experience in recruitment and assessment, using methodology 
 

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similar to that described in the current project, under the supervision of Dr.
Simpson . She will help manage IRB materials, and will work to help gain 
the necessary approvals necessary to implement the project. She will be 
involved in the creation and management of the necessary databases for 
the study, under the supervision of Drs. Simpson and Korpak and the data 
analyst. Ms. Storms may assist in manuscript preparation. The Project 
Manager will have access to PHI and obtain informed consent. 
 
Rhonda Williams, PhD (Data Safety Monitor): The PI and study 
team will submit periodic reports to the Data Safety Monitor. The Data 
Safety Monitor will review the reasons for study termination for any 
participant who discontinues the study before completion, and any adverse 
events that take place.  
 
Kimberly Moore (Research Coordinator): The Research Coordinator 
will work closely with the investigators and administer the study 
assessments, under supervision of the Project Manager and PI. The study 
coordinator will also perform initial telephone screens and assist in 
recruitment and scheduling. She will organize study materials and files, 
carry out data management and cleaning in consultation with Dr. Simpson
and the co-investigators. The Research Coordinator will have access to 
PHI and obtain informed consent. 
Consultant 
Daniel Cherkin, PhD is an Emeritus Scientific Investigator at Kaiser 
Permanente Washington Health Research Institute. He is a national expert 
on non-pharmacologic approaches to managing chronic pain. He has 
previously conducted more than 10 clinical trials involving pain
management, including a large trial that compared MBSR to CBT. He will 
provide advice and input as needed during all phases of the study,
including implementation, data collection and analysis phases. 
5.0 
Study Procedures 
 
5.1 Study Design 
The proposed study is a three-arm comparative effectiveness trial that will 
randomly assign Veterans with chronic musculoskeletal pain to MBSR, CBT for 
chronic pain (CBT-CP) or usual care to assess the effectiveness of MBSR or
CBT-CP for Veterans with chronic musculoskeletal pain. Veterans with chronic 
 

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musculoskeletal pain (N =222) will be randomized to either 8 weeks of MBSR (n 
=74), 8 weeks of CBT-CP (n =74) or usual care (n=74), and will complete 
assessments at baseline, immediately post-treatment and at 6-month post-
treatment. Randomization will be performed through REDCap, and stratified by 
sex assigned at birth and pain severity score. Sessions will be audio recorded 
using both Philips DPM 8000 recorders and OBS Studio software. Fidelity coding 
from audio recordings will evaluate protocol adherence for both MBSR and CBT-
CP. 
 
A comprehensive outline of the various data collection tools/measured to be 
administered at each of the three assessments is provided in Section 5.5 Study
Evaluations.  
 
Risk and Benefit: The risks for this study involve the potential for psychological distress 
associated with collection of self-report data, and the possibility that undergoing either 
the MBSR class or CBT-CP could be stressful and worsen symptoms. There is also a 
risk of confidentiality due to the group nature of MBSR and of CBT-CP, and the delivery 
of these groups by the VVC internet based platform; those who are unwilling to be in an 
MBSR class or CBT-CP group that is being audiotaped will need to seek other services.
Further, there is a risk that MBSR and CBT-CP will not be efficacious for some 
individuals. We plan to educate patients about the possible risks and benefits prior to 
study enrollment by providing a thorough orientation to the research and an overview of
each intervention prior to giving informed consent. Potential benefits for those 
randomized to either condition may take the form of reduced chronic musculoskeletal
pain symptoms, and increased health-related qu
also 
benefit as a result of the shift in emotional state. However, a participant may not benefit 
directly from participation in the study. Information gained in the study may be of benefit 
in the future to persons with chronic musculoskeletal pain.  Specific measures for 
minimizing risk are outlined below. 
 
Procedures to Minimize Risk to Subjects and Protect Confidentiality: 
1) 
Group sessions will include reminders to patients that they can choose 
what they will and will not do, and that it can be flexible in meeting an 
individual
eds (e.g. in MBSR a patient may meditate with eyes open,
choose not to lie down, shorten the meditation time, choose not to practice 
some of the yoga postures, etc., while in CBT-CP a patient may choose to 
share more or less of their personal material with the group, etc.) 
 

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2)
If a research subject experiences distress or worsening of his/her 
condition, we wil
e. If the
condition involves a psychiatric emergency, we will utilize the psychiatric 
emergency services available in order to help stabilize the Veteran
n. 
If needed, the Veteran can be admitted to a psychiatric inpatient unit for further 
care. The Veteran will not bear any additional costs for care. 
3) 
Any decision to withdraw from the protocol due to suicidality, depression,
anxiety or increased PTSD symptoms will be made on a case by case basis, 
with input from the Veteran and his/her mental health provider. If there is clear 
evidence of decompensation or functional regression that is considered likely 
to lead to unsafe behavior, the Veteran will be advised that another course of 
treatment could be better for them, and the study staff will assist them in 
making that change. 
4) 
Confidentiality: We plan to maintain the confidentiality of patient records as 
described below in section 7.0. If at any point in the recruitment process or 
during the course of the study, a participate appears to be at risk to 
themselves or others we will initiate a series of harm-prevention steps
according to our protocol for severe distress, If necessary, a referral will be 
made to the appropriate agency. Any serious adverse events will be 
immediately reported to the IRB and the Data Safety Monitor. 
5) 
If some participants experience unexpected levels of distress following 
participation in the research, we will take the following steps to minimize this 
possibility: We will state clearly in the consent forms that participation in the
research study may involve discussing details about traumatic events and 
about symptoms. In addition, at the beginning and end of each of the 
assessment sessions, we will provide participants with time to ask questions. 
We will inform participants, both prior to the initial screening questions on the 
phone and prior to beginning treatment, that some individuals do experience 
increases in symptoms after discussing aspects of the traumatic experience 
and that if these symptoms do not return to their prior levels within a few days, 
participants are encouraged to call the Investigative Team. We will provide all 
participants with a study phone number they can use to alert us if they are 
experiencing distress. The phones will be checked daily for messages and 
distressed participants will be called the same day (for calls made during 
business hours or the next business day for after hour calls).  
6) 
If any point in the study during the assessments or treatment sessions a 
participant endorses suicidality or homicidality, the group instructor(s) will 
notify the PI (Dr. Simpson), or Dr. Glynn, who will contact the patient. Drs. 
Simpson and Glynn are licensed Clinical Psychologists with extensive 
experience in assessment and treatment of Veterans. Should there be concern 
 

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about risk of harm, a clinical interview will be conducted to assess level of risk
and need for intervention. Participants who indicate acute suicidality or 
homicidality including a plan will be immediately referred for VA mental health 
services. It is important to note that in more than 7 years of conducting clinical 
research, we have never had a participant unwilling to accept referral for 
suicidality and have never had to make an involuntary admission or report. 
7) 
All data and other information in this study will be maintained using 
procedures that preserve confidentiality, but will not be anonymous due to the 
longitudinal nature of participation. Detailed contact information as well as 
responses to study questionnaires will be collected at all assessments. Due to 
the sensitive nature of the study, e.g., the assessment of PTSD, depression, 
alcohol, and substance use, several steps will be in place for data collection 
and storage to protect participant confidentiality. First, a unique ID code (PIN) 
is given to each participant, serving to link their information together in the on-
line database. No names or identifying information will ever be stored in the 
on-line database or data files that will later be used for statistical analyses. All 
information will be secured in a restricted VA network folder.  
8) 
Participants' names, addresses, and phone numbers will be accessible to 
project staff in order to engage in telephone contacts and to schedule study 
visits with participants. However, these data will be kept separate from actual 
study data and from study ID codes. These data will not be shared with 
individuals who are not directly involved in the study. All participant data will be 
coded in a way that does not contain any participant identifiers. The data 
safety and monitoring plan is described below. 
9) 
As per VA regulations, each participant will have their participation in the 
study documented in the Computerized Patient Record System (CPRS; i.e., 
enrollment as well as completion or early termination). No assessment
information will be included. Access to VA medical records is strictly controlled 
and only VA affiliated individuals who have undergone extensive background 
checks and have either clinical privileges or clinical research access may enter 
the system  
 
 
5.2 Recruitment Methods 
The recruitment goal is 222 total.  
Similar to a previous trial that compared pain management strategies
among Veterans, we will include Veterans with musculoskeletal pain 
involving the spine, hips and extremities.25 Prior studies indicate that among 
 

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people with musculoskeletal pain, the lower back, legs, hips and knees are 
the most common sites.25  
Recruitment will occur via the following mechanisms: a). IRB- approved 
Informational flyers distributed at both campuses on VA Puget Sound 
research kiosks, hospital health fairs, hallway information tables and bulletin 
boards; at presentations by investigators; and via emails to clinicians and 
staff; b) Provider referral from VA outpatient clinics as a result of
informational inservices and email announcements for VA providers, which 
will 
include 
Primary 
Care, 
Specialty 
Care 
(e.g., 
Rheumatology), 
Rehabilitation Medicine and the Pain Service clinics, Mental Health, and 
others. 
Providers 
will 
be 
given 
detailed 
information 
about 
study
inclusion/exclusion criteria, recruitment process, and treatment goals. If 
needed to increase recruitment, study staff may also attend team meetings 
in relevant clinics to increase awareness of the study. Providers can refer 
Veterans by either alerting study staff in CPRS, via an encrypted VA email 
or TEAMS, via phone call, or in-person. We will ask providers to include
both the contact information of the potential participant as well as
confirmation that the Veteran verbally agreed to be contacted by the 
research study; c) Sending informational letters to patients referred to 
MBSR or the Pain Service for clinical care, which ask if they are interested 
in participating in the study; d) Sending letters to Veterans who have 
received care at VA Puget Sound who have had a clinical encounter with a 
musculoskeletal disorder ICD10 code identified via a VINCI data pull: M05-
M19,M21-M25,M30-M36, M40-M43, M45-M49, M50-M54, M60-M63, M65-
M67,M70-M79, L40.5. We will also use VINCI to eliminate from this list 
Veterans with diagnoses that would make them ineligible- Dementia, 
Schizophrenia, Borderline Personality Disorder or Anti-Social Personality 
Disorder. If the Veteran does not respond to the letter, he/she may receive 
up to 3 phone calls about the study to assess level of interest. (We have two 
recruitment letters for this study- one prompting the Veterans to call us if 
interested, and one stating that the Veteran may receive up to 3 calls. We 
have found in the past that study interest wanes over time, so we have 
given ourselves the flexibility to use an opt-out method with calling if 
necessary for later study Cohorts.) The strategy of sending letters to 
patients with pain codes has been highly effective in a prior trial conducted
by our team; this has met with IRB approval. Veterans who are referred to 
the trial or respond to the letter or phone call indicating interest will undergo 
telephone assessment of inclusion/exclusion criteria. If eligible by telephone 
screening, consent forms will be mailed to the Veteran, and a phone 
appointment will be scheduled to consent the Veteran by phone. The 
 

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Veteran will return these signed consents in a prepaid envelope. Once they 
are received by study staff, a phone baseline visit will be scheduled to fully
assess eligibility and obtain informed consent. Using this method, in our trial 
of MBSR for Gulf War Illness (see preliminary studies) approximately 4% of
Veterans with chronic pain diagnoses who received a letter followed by a 
telephone call were successfully randomized. We plan to duplicate this 
method of recruitment for the proposed trial. Extrapolating to this proposal, 
we estimate that sending out 5,550 letters and making 5,550 telephone calls 
over 27 months of recruitment will result in successful recruitment of at least 
222 Veterans with chronic musculoskeletal pain. Our experience has shown 
us that this number of phone calls takes approximately 2 hours of staff time 
per day. Thus, the recruitment goals are very feasible using these methods. 
As shown below in Table 1, chronic pain is very common; we expect that 
the large number of Veterans at our site potentially eligible for enrollment 
will lead to an adequate number of Veteran enrollees. 
Conditions Included 
No. of Patients With 
1+ Outpatient Visits and 
1+ Pain Musculoskeletal Condition
Musculoskeletal conditions included: ICD10 codes: M05-
M19,M21-M25,M30-M36, M40-M43, M45-M49, M50-M54, 
M60-M63, 
M65-M67,M70-M79, 
L40.5 
(arthropathies, 
osteoarthritis, other joint disorders, connective tissue 
disorders, dorsopathies, spondylopathies, myopathies, 
disorders of synovium and tendons, shoulder lesions, 
bursopathies, soft tissue disorders, arthropathic psoriasis) 
 
 
41,033 
 
Participants will paid $45 for baseline, $60 for the post-assessment, and 
$75 for the 6-month after intervention follow-ups. The maximum 
remuneration is $180 if randomized. Subject payments will be processed 
within a week of the assessment to which they apply. 
 
5.3 Informed Consent Procedures 
 
We request a waiver of informed consent for recruitment/screening 
purposes only. This will allow us to create recruitment mailing lists that can 
target the most-likely-to-be-eligible populations, and not waste resources 
 

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and other pati
time advertising the study to patients who won
eligible to participate.   
We will obtain informed consent prior to beginning any data collection study 
procedures that will be maintained for analysis. Informed consent will take 
place prior to the appointment that includes the subj
final eligibility 
screening and (if still eligible) baseline assessments.  The study coordinator, 
project manager, or other approved researcher will mail or send by docusign 
interested Veterans consent forms, and obtain informed consent over the 
phone.  We will not enroll anyone with impaired decision-making ability who 
requires the use of a legally authorized representative.   
All study personnel will be trained in human subjects protections 
requirements as required by R&D (e.g. Privacy Policy & HIPAA training), 
and the PI or Project Manager will train any other study team members how 
to appropriately obtain informed consent as needed.  
 
5.4 Inclusion/Exclusion Criteria 
 
Inclusion criteria: All participants must meet criteria for chronic 
musculoskeletal pain, defined as: 1) musculoskeletal pain of low back, 
cervical spine, or extremities (hip, knee, or shoulder)  2) pain for at least 3 
months; and 3) Pain severity (worst or average pain score 
ore of 
4 or greater on BPI items 3 or 5) and average pain interference (BPI items 
9A-9G) rate
 3 of 10 over prior week, as measured using the Brief Pain 
Inventory (BPI).19, 37, 70   
 
Exclusion criteria: At phone screen, researchers will check medical records 
for a diagnosis of schizophrenia, dementia, antisocial personality disorder, 
or borderline personality disorder. Researchers will also exclude anyone 
with a flag in their medical record that indicates they are at high risk of 
suicide or homicide. Veterans will also be excluded if there is mention of 
psychotic symptoms in any recent treatment notes, or if there is an inpatient 
admission for psychiatric reasons in the past month. Veterans will be 
excluded if they endorse attempts to harm themselves or someone else in 
the past 30 days. Veterans will be excluded if they endorse severe medical 
conditions that would limit participation (e.g., Class III or IV heart failure) or  
pending back surgery that would occur during study participation. Additional 
exclusion criteria include prior formal participation in MBSR or CBT-CP, and 
 

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lack of access to internet and the technology needed to participate in a 
telehealth group.  
At baseline, the MINI psychiatric interview26 will determine psychiatric 
exclusion criteria: 1) uncontrolled psychotic disorder; 2) current bipolar 
affective disorder with mania; 3) moderate or higher suicide risk 4) use of 
drugs (besides marijuana or alcohol) more than once in the past 3 months.
We will include subjects with Alcohol Use Disorder (AUD; defined by the 
MINI) but exclude those for whom alcohol use poses a safety threat (defined 
as current drinking and a past-year history of alcohol-related seizures or 
delirium tremens). We will also include those with Opioid Use Disorder 
(OUD) and other Substance Use Disorder (SUD; each defined by the MINI). 
Medication, supportive individual or group counseling, case management, 
and self-help programs will be allowed and assessed as potential 
covariates. 
5.5 Study Evaluations 
Study Construct/Variables 
Study 
Phase
Measurement 
Scale 
Domain/Purpose
Inclusion/Exclusion Criteria (eligibility Evaluation)
MINI International Neuropsychiatric 
Interview V-5 (DSM-V version) (covers 
suicidality, mania, alcohol and drug 
abuse, and psychosis) 
B 
dichotomous 
Sample description, 
exclusion, SUD classification 
(possible moderator)
Brief Pain Inventory (BPI) questions 3, 
5, and 7a-7g, modified to past week 
Phone 
screen 
 
exclusion 
Medical history interview (seizures, 
 
Phone 
screen 
dichotomous 
 exclusion 
Sample Description Data (to describe subject population) 
Demographic information 
B 
dichotomous 
Sample description, blocking 
(sex assigned at birth); 
moderators 
Life Events Checklist (LEC)  
B 
dichotomous 
Sample description; Trauma 
history 
Rome IV  IBS 
B, 6 
Dichotomous 
Sample description (indicates 
current symptoms of IBS)
Anxiety Sensitivity Index 
B 
Continuous  
Sample description, 
 

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moderator
Tracking
 Contact form 
 
B, P, 6 
 
retention 
Primary Outcomes
Pain interference subscale of the Brief 
Pain Inventory (BPI)  
 
B, P, 6 
continuous 
Pain interference / physical 
functioning 
Secondary Outcomes
Pain severity subscale of the Brief Pain 
Inventory (BPI) 
 
B, P, 6 
continuous 
Pain intensity 
Analgesic use and Underlying pain 
B, P, 6 
Continuous 
Underlying pain intensity
PHQ-9 (depression)  
 
B, P, 6 
continuous 
Depressive symptoms
PTSD Checklist (Civilian version) (PCL-
5)  
 
B, P, 6 
continuous 
PTSD symptoms 
SF-12 (Mental and Physical 
Component Summary Scores)  
 
B, P, 6 
continuous 
Sample description; Health-
related quality of life 
(HRQOL) 
Five-Facet Mindfulness Questionnaire 
(FFMQ-15) SF 
B, P, 6 
continuous 
Dispositional mindfulness, 
and mindfulness subscales: 
Observing, Describing, Acting 
with Awareness, Nonjudging
and Nonreactivity to inner 
experiences; potential 
mediator 
Coping Strategies Questionnaire 
B, P, 6 
 
Mediator of pain 
catastrophizing 
NIH Patient Reported Outcome 
Measures Information System 
(PROMIS) for Alcohol Use and 
Negative Consequences, short form 
 
B, P, 6 
continuous 
Substance Use Disorder 
(SUD) symptom severity for 
alcohol 
 

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NIH Patient Reported Outcome 
Measures Information System 
(PROMIS) for Gastrointestinal Distress: 
Belly Pain, Diarrhea, Constipation, Gas 
& Bloating 
 
B, P, 6
Gastrointestinal Symptoms, 
including IBS 
 
Drug Abuse Screening Test (DAST) for 
drug use other than alcohol or tobacco 
 
B, P, 6 
categorical & 
continuous 
Cannabis Use 
Client Satisfaction Questionnaire 
(CSQ-8)  
 
P, 6 
continuous 
Satisfaction 
OME Opioid Use Tracking 
 
B, P, 6 
 
Opioid Use 
VA mental health care
VINCI data pull 
 
 
Opioid use, prescription sleep 
medication use, other care 
(visits for pain, pain-related 
procedures), markers of 
suicidality (high-risk suicide 
flag, psychiatric admissions, 
deaths due to suicide)
CPRS review for engagement in other 
treatments 
8-months 
post-
baseline  
dichotomous 
Other care received during 
study 
Full text of measures in appendix.  
 
5.6 Data Analysis 
 
Sample size calculations were determined using Stata statistical software.27 The 
study is powered for the overall omnibus F test used in the Fisher protected least 
significant difference test. The study is also powered for the ability to detect at 
least a moderate effect size between each pairwise sub-test (MBSR/usual care, 
CBT-CP/usual care, and as an exploratory aim MBSR/CBT-CP), which will be 
performed if the omnibus test is significant. The study is powered to detect a 
difference of Co
 between treatment arms (which represents a 
change of 1.05 points on the BPI pain interference subscale, based on data from 
Veterans with chronic pain).28 Sample size calculations for the omnibus ANOVA
 

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assume a 1:1:1 treatment allocation, desired power of 80%, 2-t
, and 
estimate that BPI pain interference scores will be 1.05 points lower in both the 
MBSR and CBT-CP arms compared to usual care (using a SD=2.1 for BPI 
scores).28 Using these parameters, 59 patients per arm of the study are needed 
(N=177). The sample size was inflated to 222 to account for possible attrition.
Sample size estimates for comparisons between subtests (e.g., MBSR/usual care, 
CBT-CP/usual care) were also calculated using t-tests. For a desired power of 
80% and a 2-
ients for each of the three arms of the study 
are required (N = 192). Further inflation of this sample size by 15% to account for
attrition or the effects of clustering resulted in a total of 222 patients. Detecting an 
 0.50 has been advocated as a reasonable threshold of 
clinical significance when assessing patient reported outcomes, including pain 
and physical and emotional functioning.29 In our pilot study of MBSR for Veterans
with Gulf War illness (preliminary studies) the intraclass correlation for measures 
of p
-up, indicating that we likely do not need to account 
for clustering in our sample size estimates. To provide 80% power if ICC = 0.02 is 
found, inflation of the sample size by 6% would be required; the inflation of the 
sample size by 15% was performed as a conservative measure to account for 
possible clustering or attrition. The sample size required per arm of the study for 
treatment comparison (at 80% and 90% power) is 
presented across a range of  
effect sizes in Table 2. 
 
 
 
 
 
Data will be analyzed following the completion of the final assessments of the last 
subject cohort, which is projected to take place in the last six months of Year 
Three of the study.  The dataset will be analyzed by Dr. Korpak. 
5.7 Withdrawal of Subjects 
 
Table 
2.
Effect size 
(d) 
two-tailed 
two-taile
0.10
0.40 
100 
133
0.50 
64 
86
0.60 
45 
60
0.70 
34 
44
 

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If the study subject becomes a threat to the safety of others in his or her treatment 
group, or to the research team, that s
termintated, and they will be withdrawn from the research without their consent. 
If a study subject demonstrates behavior that repeatedly violates the community 
guidelines of their treatment group, so much so that they actively prevent the group 
from being able to achieve the day s curriculum or they create a hostile 
environment for other group members or research staff, that subject s participation 
in the groups will be terminated, and the PIs will determine if they can continue to 
participate in the study and complete the research assessments with study staff. 
If a subject wishes to withdraw from the study before all procedures are complete, 
he or she simply needs to notify 
coordinator, or 
other study team member by phone or in person that he or she no longer wishes to 
participate, and the subject with be withdrawn from the study and no longer 
contacted regarding study procedures. A primary study contact number will be 
provided to each participant, so they know how to reach the study team to request 
early withdrawal (or for any other questions). 
6.0 
Reporting 
 
Safety Monitor: Rhonda Williams, PhD, a clinical psychologist based at the 
Seattle division of VA Puget Sound, will serve as the unbiased safety monitor for 
the study. Dr. Williams has extensive experience in clinical psychology. She is 
outside of the key study investigators and she will review any adverse or 
unanticipated events and provide an unbiased written report to the 
thin 10 
calendar days.  She will assess whether there is a relationship between the 
adverse or unanticipated event and the study procedures, and will indicate 
whether they concur with the details of the report 
Any 
events deemed by the safety mo
study procedures will be promptly forwarded to the VA Puget Sound IRB Office of 
Risk Management. 
When an unexpected serious adverse event occurs, 
Events & Problems
be used for providing reports to the Data Safety 
Monitor, in addition to submitting a report to the IRB within 5 days as required. All 
other adverse events, problems, and protocol deviations will be logged and 
reported to the Data Safety Monitor and the IRB with annual reviews. 
 

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At the midpoint of the study, the data monitor would then analyze whether 
significantly greater adverse events occur in one arm of the study, which might 
warrant stopping the study. 
7.0 
Privacy and Confidentiality 
 
The study will obtain Protected Health Information by collecting data (e.g. 
medications and other treatment relevant to the symptoms evaluated for the 
n (PII) for 
following up with subjects regarding ongoing study procedures. Health information 
will also be collected through the questionnaires and interviews. This health 
information will be maintained as de-identified study data and will not be disclosed
to unauthorized entities.  We will be obtaining a Certificate of Confidentiality for 
this study, as we ask about substance use. 
Because we are using VVC for group delivery, and internet based platform, we 
will warn participants of potential risks to confidentiality of this delivery method, do 
visual confirmations of group participants, and lock group rooms to prevent 
intrusions.  
A password-protected crosswalk will be maintained to link identifying information 
 unique study IDs (e.g. 695-001, 
695-002, 695-00
-308).  All files containing study data, hard copy or 
directly to an individual.  All study team members, as VA employees (WOC or 
otherwise) are required to undergo Privacy & HIPAA training as well as VA 
Privacy and Information Security Awareness and Rules of Behavior.  Any non-VA-
affiliated study team members will be required to undergo equivalent training.  
Only study team members will have access to the electronic study folder, located 
on the R: drive on the VA server. Hard copy data and consent forms will be stored 
in locked filing cabinets in the offices of the PI and/or the Project Manager.
8.0 
Communication Plan 
N/A, this is not a multi-site research project. 
 
9.0      Information Security and Data Storage/Movement 
Consent forms and other hard copy documents with identifying information 
(e.g. emergency contact page) will be filed in separate hanging folders from 
 

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any documents with study IDs and study data on them, so that the 
identifying information cannot be linked to the corresponding data.  
Data from self-report measures will be collected through REDCap. The 
administering researcher will open the REDCap database from the study 
folder on a VA computer, and then ask the participants the questionnaires
over the phone and record their answers directly into REDCap. Each set of 
questionnaires will be linked to subjects through their study IDs or other 
unique identifiers (no PII recorded in REDCap), and these identifiers will be 
recorded and tracked by the study team.  When needed, a report or query 
of these outcome/response data from these questionnaires will be 
generated from REDCap and saved to the study folder. 
Data pertaining to medication usage and other treatment received during
riod will be gathered from VINCI and
saved to the study folder. This data will be linked to participants by Study 
ID only.  
 
10.0 References 
 
Bibliography of cited literature 
 
1. 
Spelman JF, Hunt SC, Seal KH, et al. Post Deployment Care for Returning Combat 
Veterans. Journal of General Internal Medicine 2012;27:1200-1209. 
2. 
Gironda RJ, Clark ME, Massengale JP, et al. Pain among veterans of operations 
enduring freedom and Iraqi freedom. Pain Medicine 2006;7:339-343. 
3. 
Care and Education Committee on Advancing Pain Research, Institute of Medicine. 
Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and 
Research. Washington, DC: National Academies Press; 2011  
4. 
Elliott AM, Smith BH, Penny KI, et al. The epidemiology of chronic pain in the community. 
Lancet 1999;354:1248-52. 
5. 
The Iowa Persian Gulf Study Group. Self-reported Illness and Health Status Among Gulf 
War Veterans: A Population-Based Study. JAMA 1997;277:238-245. 
6. 
Schappert SM. National Ambulatory Medical Care Survey: 1989 summary. Vital Health 
Stat 13 1992:1-80. 
7. 
Simon LS. Relieving pain in America: A blueprint for transforming prevention, care, 
education, and research. Journal of Pain & Palliative Care Pharmacotherapy 
2012;26:197-198. 
8. 
Haskell SG, Heapy A, Reid MC, et al. The prevalence and age-related characteristics of 
pain in a sample of women veterans receiving primary care. Journal of Women's Health 
2006;15:862-869. 
 

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9.
Gallagher RM. Advancing the Pain Agenda in the Veteran Population. Anesthesiol Clin 
2016;34:357-78. 
10. 
VA/DoD Clincial Practice Guidelines. Management of Opioid Therapy (OT) for Chronic 
Pain, 2017. 
11. 
Lew HL, Tun C, Cifu DX. Prevalence of chronic pain, posttraumatic stress disorder, and 
persistent postconcussive symptoms in OIF/OEF veterans: polytrauma clinical triad. 
Journal of rehabilitation research and development 2009;46:697. 
12. 
Kroenke K, Wu J, Bair MJ, et al. Reciprocal relationship between pain and depression: a 
12-month longitudinal analysis in primary care. The Journal of Pain 2011;12:964-973. 
13. 
Edmond SN, Moore BA, Dorflinger LM, et al. Project STEP: Implementing the Veterans 
ain management. Pain Medicine 
2018;19:S30-S37. 
14. 
Krebs EE, Gravely A, Nugent S, et al. Effect of opioid vs nonopioid medications on pain-
related function in patients with chronic back pain or hip or knee osteoarthritis pain: The 
space randomized clinical trial. JAMA 2018;319:872-882. 
15. 
Von Korff M, Kolodny A, Deyo RA, et al. Long-term opioid therapy reconsidered. Ann 
Intern Med 2011;155:325-8. 
16. 
Seal KH, Shi Y, Cohen G, et al. Association of mental health disorders with prescription 
opioids and high-risk opioid use in US veterans of Iraq and Afghanistan. Jama 
2012;307:940-947. 
17. 
Institute of Medicine. Relieving Pain in America: A blueprint for Transforming Prevention, 
Care, Education, and Research. Washington, DC: National Academies Press, 2011. 
18. 
Qaseem A, Wilt TJ, McLean RM, et al. Noninvasive Treatments for Acute, Subacute, and 
Chronic Low Back Pain: A Clinical Practice Guideline From the American College of 
Physicians. Ann Intern Med 2017;166:514-530. 
19. 
Scott EL, Kroenke K, Wu J, et al. Beneficial Effects of Improvement in Depression, Pain
Catastrophizing, and Anxiety on Pain Outcomes: A 12-Month Longitudinal Analysis. The 
Journal of Pain 2016;17:215-222. 
20. 
Jacob JA. As Opioid Prescribing Guidelines Tighten, Mindfulness Meditation Holds 
Promise for Pain Relief. Jama 2016;315:2385-2387. 
21. 
Williams ACdC, Eccleston C, Morley S. Psychological therapies for the management of 
chronic pain (excluding headache) in adults. The cochrane library 2012. 
22. 
Stewart MO, Karlin BE, Murphy JL, et al. National Dissemination of Cognitive-Behavioral 
Therapy for Chronic Pain in Veterans: Therapist and Patient-level Outcomes. The Clinical 
journal of pain 2015;31:722-729. 
23. 
Murphy JL, McKellar JD, Raffa SD, et al. Cognitive behavioral therapy for chronic pain 
among veterans: Therapist manual. Washington, DC:  U.S. Department of Veterans 
Affairs. 
24. 
Richmond H, Hall AM, Copsey B, et al. The Effectiveness of Cognitive Behavioural 
Treatment for Non-Specific Low Back Pain: A Systematic Review and Meta-Analysis. 
PLoS One 2015;10:e0134192. 
25. 
Bair MJ, Ang D, Wu J, et al. Evaluation of Stepped Care for Chronic Pain (ESCAPE) in 
Veterans of the Iraq and Afghanistan Conflicts: A Randomized Clinical Trial. JAMA Intern 
Med 2015;175:682-9. 
26. 
Sheehan DV, Lecrubier Y, Sheehan KH, et al. The Mini-International Neuropsychiatric 
Interview (MINI): The development and validation of a structured diagnostic psychiatric 
interview for DSM-IV and ICD-10. Journal of Clinical Psychiatry 1998;59:22-33. 
27. 
Stata Statistical Software. Volume IC 13.1. College Station, TX: StataCorp LP, 2016.
28. 
Wetherell JL, Afari N, Rutledge T, et al. A randomized, controlled trial of acceptance and 
commitment therapy and cognitive-behavioral therapy for chronic pain. Pain 
2011;152:2098-2107. 
 

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29.
Dworkin RH, Turk DC, Wyrwich KW, et al. Interpreting the clinical importance of treatment 
outcomes in chronic pain clinical trials: IMMPACT recommendations. The Journal of Pain 
2008;9:105-121.