Feasibility of a 4-week, Adapted Mindfulness Program for Adults With Chronic Pain
Phase: NA
Conditions: Chronic Pain
Sponsor: University of North Carolina, Chapel Hill

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Feasibility of a 4-week, Adapted Mindfulness Program for Adults with Chronic Pain 
 
 
 
 
NCT03495856  
April 9, 2018  
 
 
 

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Complete Title: Feasibility of a 4-week, Adapted Mindfulness Program for Adults with 
Chronic Pain  
Short Title: 4-week Mindfulness Program for Chronic Pain Management 
Principal Investigator: Carrie E. Brintz, PhD 
Sponsor: The North Carolina Translational and Clinical Sciences (NC TraCS) Institute 
Version Number: v. 1.0 
Protocol Date: 29 November 2017 
Amendment 1 Date: 9 April 2018 
Amendment 2 Date:  
Amendment 3 Date: 
Amendment 4 Date:  
 
 

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TABLE OF CONTENTS 
Table of Contents ...................................................................................................................... 2 
Abbreviations and Definitions of Terms .................................................................................... 3 
Protocol Synopsis ...................................................................................................................... 4 
1 
BACKGROUND  AND RATIONALE .......................................................................................................................... 7 
2 
STUDY OBJECTIVES ................................................................................................................................................ 8 
3 
INVESTIGATIONAL PLAN ....................................................................................................................................... 9 
4 
STUDY PROCEDURES ........................................................................................................................................... 11 
5 
STUDY EVALUATIONS AND MEASUREMENTS ................................................................................................... 13 
6 
STATISTICAL CONSIDERATIONS .......................................................................................................................... 13 
7 
STUDY INTERVENTION (DEVICE OR OTHER INTERVENTION) ............................................................................ 15 
8 
STUDY INTERVENTION ADMINISTRATION ......................................................................................................... 16 
9 
SAFETY MANAGEMENT ....................................................................................................................................... 16 
10  DATA COLLECTION AND MANAGEMENT ............................................................................................................ 17 
11 RECRUITMENT STRATEGY ................................................................................................................................... 17 
12 CONSENT PROCESS ............................................................................................................................................. 17 
13 PUBLICATION ....................................................................................................................................................... 18 
14 REFERENCES ........................................................................................................................................................ 18 
Appendix A .............................................................................................................................. 21 
Appendix B .............................................................................................................................. 22 
Appendix C .............................................................................................................................. 23 
 
 
 
 
 
 
 
 
 
 
 

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ABBREVIATIONS AND DEFINITIONS OF TERMS 
 
Abbreviation 
Definition 
CNCP 
Chronic non-cancer pain 
MBSR 
Mindfulness-based Stress Reduction 
RA 
Research assistant 
PROMIS 
Patient-Reported Outcomes Measurement Information System 
QOL 
Quality-of-life 
AE 
Adverse Event 
SAE 
Serious Adverse Event 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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PROTOCOL SYNOPSIS 
Study Title 
Feasibility of a 4-week, Adapted Mindfulness Program for Adults 
with Chronic Pain 
Funder 
North Carolina Translational and Clinical Sciences (NC TraCS) 
Institute 
Clinical Phase 
Phase I 
Study Rationale 
Chronic pain is a costly and debilitating condition affecting over 
100 million U.S. adults.1 Over 10% of North Carolinians are affected 
by chronic low back pain alone.2 The nonpharmacologic 
management of CNCP is strongly recommended by the CDC. 
Mindfulness Based Stress Reduction (MBSR) is an established mind-
body intervention shown to improve QOL, functioning and 
depression across pain conditions.3 However, the time demand of 
standard MBSR (26 class hours in 8 weeks) is a key barrier for those 
whose condition or circumstances limit ability to participate.4,5 
Brief mindfulness programs have not been studied in groups with 
CNCP of varied etiologies in a clinical setting.  
 
Study Objective(s) 
Primary  
• 
To determine the feasibility and acceptability of a 4-week 
mindfulness training program adapted from MBSR for adults 
with CNCP recruited from UNC pain management clinics 
Secondary 
• 
To test the preliminary effects of the mindfulness training 
program on pain-related, quality of life (QOL), and 
psychological outcomes. 
 
Test Article(s) 
(If Applicable) 
The intervention is based on MBSR, an 8-week mindfulness training 
program developed to help people manage stress-related and 
chronic conditions. The adapted mindfulness intervention will 
consist of four, weekly 1 hour and 30 minute group sessions that 
are modified from the original program to fit the shorter length 
and to directly address chronic pain management.  
Study Design 
 
This feasibility study uses a single-arm, mixed-methods repeated 
measures design, with quantitative measures administered within 
1 week pre and post-intervention, and qualitative semi-structured 
interviews administered within one to two weeks post-
intervention.  
Subject Population 
Inclusion Criteria 

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key criteria for Inclusion 
and Exclusion: 
1. Adults aged 18 and older who are able to read and speak 
English 
2. Diagnosed with one or more CNCP conditions (daily pain at 
least 3 months duration) who report more than minimal 
pain bothersomeness and interference with activities  
3. Has established care with provider who manages pain 
Exclusion Criteria 
1. Diagnosis of mental illness with psychotic features 
2. History of inpatient admission for psychiatric disorder in 
past 2 years 
3. Active substance abuse within the past year 
4. Completed an MBSR or other mindfulness course; has had a 
regular mindfulness practice during the course of the 
chronic pain condition 
Number Of Subjects  
24  
Study Duration 
Each subject’s participation will last up to 12 weeks including 
possible wait-time between screening and intervention start. 
The entire study is expected to last up to 12 months. 
Study Phases 
Screening 
Study Treatment 
Follow-Up   
(1) Screening: Phone screening with study personnel to determine 
eligibility for study. If eligible, the consent form will be reviewed 
with the participant over the phone and online written consent will 
be obtained after the phone call and before completing baseline 
measures. 
(2) Baseline Measures: Administered via online self-report 
questionnaires 
(3) Intervention: Four weekly, 1 hour 30 minute group mindfulness 
training sessions co-facilitated by an experienced mindfulness 
instructor (Faculty advisor Gaylord) and a clinical psychologist with 
pain psychology training (PI Brintz).  
(4) Post-measures: Within 1-2 weeks after intervention, 
administered via online self-report questionnaires and with semi-
structured phone interview. 
Efficacy Evaluations 
Feasibility and acceptability will be measured with 1) enrollment 
statistics, 2) study retention, 3) assessment completion, 4) session 
attendance, 4) home practice diaries, and 5) credibility 
questionnaire and semi-structured phone interviews assessing 
participant satisfaction. Secondary outcomes will be measured with 
self-report questionnaires.  

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Pharmacokinetic 
Evaluations 
N/A 
Safety Evaluations 
Participant self-report of adverse experiences in response to 
mindfulness meditation practice. Will assess during intervention 
sessions. Will monitor AEs/SAEs that may or may not be study 
related as reported by participants. 
Statistical And Analytic 
Plan 
Primary feasibility/acceptability outcomes will be analyzed using 
percentages and 95% CIs. The qualitative description method will 
be used for interview data by identifying major themes within the 
content and producing a descriptive summary of the data. 
Secondary outcomes will be analyzed using paired t-tests and by 
examining the pre/post intervention change in scores and their 
respective standard errors with 95% confidence intervals.  
DATA AND SAFETY 
MONITORING PLAN 
The PI (Brintz) is responsible for data quality management and 
ongoing assessment of participant safety. The faculty advisor 
(Gaylord) will advise PI Brintz on issues of data quality 
management and assessment of safety.  
 
 
 

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1 
BACKGROUND AND RATIONALE 
1.1 
Introduction 
Chronic pain is a costly and debilitating condition affecting over 100 million U.S. adults.1 
Over 10% of North Carolinians are affected by chronic low back pain alone.2 Chronic non-cancer 
pain (CNCP) is commonly treated with pharmacotherapy, with 3-4% of the entire U.S. 
population prescribed long-term opioid therapy.3 Remarkably, the effectiveness of long-term 
opioid use for CNCP has limited evidence4,5; furthermore, chronic opioid use can lead to 
increased pain sensitivity6 and increased risk for opioid use disorders and overdose.7,8 Thus, the 
nonpharmacologic management of CNCP is strongly recommended by the Centers for Disease 
Control and was named a top scientific priority of the NIH-National Center for Complementary 
and Integrative Health.9 
CNCP is associated with disability, decreased quality of life (QOL) and emotional 
distress.10 Mindfulness Based Stress Reduction (MBSR) is an established mind-body intervention 
shown to improve QOL, functioning and depression across pain conditions.11 It has led to 
clinical improvements (>30%) in functional disability in 61% of low back pain patients, similar to 
cognitive behavioral therapy and more effective than usual care.12 Mindfulness training targets 
changing one’s reaction to painful experiences with nonjudgmental, present-moment 
awareness13, and improves the self-management of pain through increased self-regulation of 
emotions and attention.14 Mindfulness training has decreased opioid use disorders and 
cravings.15 However, the time demand of standard MBSR (26 class hours in 8 weeks) is a key 
barrier for those whose condition or circumstances limit ability to participate.16,17 Brief 
mindfulness training programs based on MBSR have been piloted for specific chronic pain 
conditions such as tension-type headache18 and low back pain19, but have not been studied in 
groups with CNCP of varied etiologies in a clinical setting.  
 
1.2 
Name and Description of Investigational Product or Intervention  
The current study will use an adapted version of the established mindfulness training 
program called Mindfulness-based Stress Reduction (MBSR). MBSR is the most popular and 
well-tested format for teaching mindfulness skills in the U.S. MBSR was developed by Dr. Jon 
Kabat-Zinn to teach a range of mindfulness skills to help individuals better manage chronic and 
stress-aggravated illnesses.20,21 Mindfulness skills involve the intentional self-regulation of 
attention to present-moment experience, combined with releasing cognitive fixation on 
thoughts and emotions regarding the past or future.13 The MBSR program teaches a range of 
mindfulness-related skills, typically in an eight-week, 2.5 hour per week group format, with a 6-
hour weekend day of mindfulness retreat. It is generally available to medical patients and 
community members with a wide range of stress-related problems or medical conditions. The 
current study will use an adapted version of this program, adapted by PI Brintz and Faculty 
Advisor Gaylord. It will be adapted to fit the shorter length (4 weeks; 1 hour, 30 minute 
sessions) and will be directly related to chronic pain management and coping. See Appendix B 
for a breakdown of sessions content and mindfulness skills taught.  

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1.3 
Non-Clinical and Clinical Study Findings 
 
Potential benefits: Studies indicate that mindfulness-based interventions such as MBSR may 
have a number of pain-related and psychological benefits for individuals with chronic pain of 
mixed etiologies. In studies of CNCP, mindfulness intervention have been shown to reduce 
depression22,23, anxiety, perceived stress, and pain perception23 and improve quality of life22, 
physical functioning12, and pain acceptance.24 
 
Potential risks: Based on results of previous literature, we expect there to be no more than 
minimal risk in this study; however, literature on MBSR has not systematically included adverse 
event reporting, although most studies have not reported any serious risk from participating in 
MBSR. There have been reports of increased emotional distress and increased awareness of 
both positive and negative experiences, which may initially increase distress when participants 
are not used to directing attention towards unpleasant thoughts, feelings, and sensations.25 The 
MBSR curriculum guide by Dr. Jon Kabat-Zinn notes the potential for increased negative 
emotions at the beginning of the course, as well as the possibility that history of trauma, abuse, 
recent loss, or substance addiction could heighten negative emotional reactions. With an 
experienced instructor, reactions can be managed and appropriate referrals made.25 
 
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STUDY OBJECTIVE  
The objective of this study is to determine the feasibility and acceptability of a 4-week 
mindfulness program adapted from MBSR for adults with CNCP treated in UNC clinics. 
2.1 
Primary Objectives:  
1: Determine the feasibility of recruiting via pain management providers and online 
advertisement, retaining participants, session attendance, and online data collection of 
quantitative measures during a 4-week mindfulness program for adults with CNCP 
2: Determine participant acceptability and satisfaction with the intervention using 
quantitative measure of intervention credibility and with individual semi-structured 
interviews.  
2.2 
Secondary Objective: Assess preliminary effects of the intervention on self-reported 
functioning, quality-of-life, depressive and anxiety symptoms, pain severity and 
interference, and other psychological variables that have been shown to improve with 
mindfulness training and may have beneficial impacts on chronic pain management. 
 
 
 

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3 
INVESTIGATIONAL PLAN (brief overview) 
3.1 
Study Design 
This is a single-arm, mixed-methods, repeated-measures study of a 4-week mindfulness 
training program for adults being treated for CNCP within UNC pain management clinics.  
Screening: Potential participants will hear about this study through their pain 
management providers (physician/PA/nurse/clinical pharmacist/mental health) or flyer 
advertisements, and interested patients will contact study personnel for complete a 
phone screening interview. If a participant is deemed eligible, the PI/research assistant 
will review the information in the consent form with the participant over the phone and 
answer any questions. Participants will provide written consent online via a REDCap 
survey link. 
Baseline: Baseline measures will be completed by participants within the week prior to 
starting the intervention. Participants will receive an email with a link to a REDCap 
survey containing the self-reported questionnaires. Questionnaires should take 
approximately 30 minutes to complete. Intervention:  The intervention will consist of 
four weekly, 1 hour and 30 minute group mindfulness training sessions. It will take place 
at a UNC clinic or conference room location. The intervention will be adapted from the 
standard 8-week MBSR program to fit the shorter class duration and to pertain 
specifically to chronic pain management. Mindfulness skills will include sitting 
meditation with attention to breathing, body scan meditation, mindfulness of daily 
routine activities, and expanding practice to notice and release fixation on thoughts, 
emotions, or sensations. Participants will be given guided audio recordings of 
mindfulness practices and course handouts and asked to complete home practice 
assignments daily during the course. They will also be sent a brief REDCap survey daily 
to record their daily home practice of mindfulness skills and daily pain intensity.  
Follow up: Post-intervention measures will be completed by participants via an online 
REDCap survey within one to two weeks after the final intervention session. Also within 
one to two weeks of the final intervention session, participants will be scheduled to 
complete a 20 to 30 minute semi-structured phone interview assessing their experience 
(satisfaction, challenges, suggestions for improvement) with the intervention.  
 
3.2 
Allocation to Treatment Groups and Blinding (if applicable)   
Not applicable – all eligible participants who provide consent will be enrolled in the 
mindfulness training intervention. The first 12 eligible participants will be enrolled in 
one cohort, and the next 12 eligible participants will be enrolled in the second cohort 
receiving the same intervention.  
 
3.3 
Study Duration, Enrollment and Number of Subjects 

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If recruitment proceeds as planned, the study from the beginning of enrollment to the 
last point of data collection could last approximately 6 months. However, up to one year 
will allocated should there be any issues with recruitment that need to be resolved or 
there is a need to wait to enroll between the first and second cohorts because of the 
time of year (e.g. holidays that would interfere with intervention sessions occurring for 
4 consecutive weeks). One year is the allowable funding period. Participants will be 
enrolled on a rolling basis as they learn about the study, contact the study PI, and 
complete screening and consent procedures. We will attempt to limit each recruitment 
period to approximately 4 to 6 weeks to reduce the likelihood of attrition resulting from 
a prolonged waiting period between enrollment and the start of the group intervention. 
12 participants will be enrolled in each group for a total of 24 participants.  
 
3.4 
Study Population 
Participants will be patients in UNC Clinics that assist with pain management, including 
but not limited to the Department of Anesthesiology Pain Clinic, the Spine Center, 
Physical Medicine and Rehabilitation, and Internal Medicine. 
Inclusion Criteria 
1. Adults aged 18 and older 
2. Diagnosed with one or more CNCP conditions (daily pain for at least 3 months 
duration) 
4. Established with one or more physician providers for pain management (e.g. 
primary care physician, pain specialist, etc).  
5. Report more than minimal pain bothersomeness (>3 on 0-10 scale) and/or pain 
interference with activities (>2 on a 0-10 scale).  
6. Able to read, understand and speak English 
 
Exclusion Criteria 
1. Diagnosis of mental illness with psychotic features 
2. History of inpatient admission for psychiatric disorder in past 2 years 
3. Active substance abuse within the past year 
4. Has completed an MBSR or other mindfulness course; has or previously had a 
regular mindfulness meditation practice. 
5. Unable or unwilling to comply with study procedures (online questionnaires and 
practice diaries, 4 weekly intervention sessions, home practice, and one semi-
structured phone interview).  
 
4 
STUDY PROCEDURES (what will be done) 
See Appendix A for the schedule of evaluations.  

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4.1 
Screening procedures 
Interested individuals will contact study personnel to complete a phone screening 
interview. Alternatively, if potential participants give permission to the referring 
provider to be contacted, the screener will initiate phone contact. The screener will 
provide individuals with a description of the study and the screening procedure and ask 
for permission from the individual to continue with the screening. If the individual 
provides verbal consent to the phone screening, they will be asked several questions to 
determine their eligibility based on age, chronic noncancer pain diagnosis, established 
care with physician, pain bothersomeness/interference, history of mindfulness training, 
psychiatric hospitalization, or psychosis, as well as active substance abuse in the past 
year. If they are deemed eligible based on the phone screening, the screener will 
verbally review the consent form with the individual, and written consent will be 
obtained following the phone call via an online consent form through REDCap. 
Individuals who provide online consent will be enrolled in the study.  
 
4.2 
Baseline procedures 
Participants will be emailed a link to a REDCap survey, where they will complete self-
report questionnaires on 1) demographic information, 2) current pain medications and 
doses, 3) the PROMIS-29 Profile with physical functioning and health-related quality of 
life domains, depression, anxiety, pain interference/severity, 4) psychological variables 
including pain catastrophizing, pain acceptance, mindfulness, positive affect, and 
emotional and behavioral self-regulation. The survey should take approximately 30 
minutes to complete. 
  
4.3 
Intervention procedures (by visits) 
The mindfulness intervention will consist of four, weekly group mindfulness skills 
sessions each lasting 1 hour and 30 minutes. Each session will allow time for a 5-minute 
break in the middle. Sessions will be co-instructed by PI Brintz and faculty advisor 
Gaylord. All sessions will take place at the same location. See Appendix B for session-by-
session content and home practice assignments. Participants will receive guided audio 
recordings for mindfulness skills practice, in addition to a binder with course handouts. 
The instructor will send one email to each participant the day after each session 
summarizing the session content and home practice assignments and encouraging 
participants to complete the daily mindfulness practice diaries. Sessions will be recorded 
to monitor fidelity to the intervention protocol. Participants will be asked to complete 
daily home practice and pain intensity diaries between session weeks 1 and 4 via online 
REDCap surveys that will be sent by email on a daily basis.  
 
4.4 
Follow- up procedures (by visits) 
Post-Test Questionnaires: After the final intervention session (week 4), participants will 
be emailed a link with a REDCap survey containing all of the questionnaires from the 

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baseline survey, excluding demographic information. It will also include questions on 
intervention credibility.  
Post-Test Interview: With-in 1 to 2 weeks after the final session, participants will be 
scheduled for a 15 to 30-minute semi-structured phone interview with the PI to assess 
participants’ experience with the intervention sessions and overall study. Questions will 
address the following: satisfaction and usefulness of the skills and content, acceptability 
of the format, any challenges, and any suggestions for improvement of the intervention 
or study procedures.  
 
4.5 
Unscheduled visits 
We do not anticipate having unscheduled visits. Study staff may speak with participants 
over the phone outside of scheduled visits should participants have questions about the 
study, their participation, or experience any adverse events during their study 
participation 
 
4.6 
Concomitant Medication documentation 
Data will be collected regarding participants’ pain medication use at the baseline and 
post-intervention assessments. As this study is a behavioral intervention trial and other 
types of medication are not of importance for the research, we do not anticipate 
needing to document other concomitant medications.   
 
4.7 
Rescue medication administration ( if applicable) 
Not applicable 
 
4.8 
Subject Completion/ Withdrawal procedures 
Subject Completion: Participants’ enrollment in the study will be considered complete 
once the intervention sessions have ended, post-test measures and phone interview are 
complete, and study compensation provided. Should participants not complete the 
post-test survey or phone interview, their participation will be complete when the 
window to complete such assessments has passed and they have been compensated for 
any completed study procedures.  
Subject Withdrawal: Should a participant choose to withdraw from the study for any 
reason, their withdrawal will be documented in the case report form (see Appendix D) 
and they will be provided with any study compensation that may still be pending based 
on completed study procedures. Should any adverse event occur during study 
enrollment that prohibits a participant from completing study procedures, the 
participant will be withdrawn from the study and provided with any study compensation 
that may still be pending based on completed study procedures. 
 
4.9 
Screen failure procedures 

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Individuals who are deemed ineligible during the phone screen will be informed by the 
screener that they are not eligible and thanked for their time. The screener will provide 
a reason for exclusion if requested by the individual. 
 
5 
STUDY EVALUATIONS AND MEASUREMENTS (how measurements will be 
made)   
All study evaluations and measurements will be made via the following methods: 1) Participant 
self-report (online survey questionnaires, phone screening, phone interview, adverse 
experience/event reporting during or between sessions), 2) Behavioral observation of 
instructor fidelity to the intervention protocol during intervention sessions, and 3) 
documentation of feasibility variables, including participants’ session attendance, survey 
completion, enrollment and withdrawal. No variables will be abstracted from medical charts. 
See Appendix C for all self-report measures included and Appendix D for case report forms. 
5.1 
Efficacy Evaluation ( if applicable) 
Not applicable – this is a feasibility study and is not designed or powered to test efficacy 
of the intervention 
5.2 
Pharmacokinetic Evaluation ( if applicable) 
Not applicable 
5.3 
Safety Evaluations 
Participants will be asked to report on any unwanted reactions to the mindfulness skills 
practice. Reports will be collected via online surveys daily when collecting home practice 
data. Observations will be made during intervention sessions.   
 
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STATISTICAL CONSIDERATION    
A repeated-measures single group design will be used to test the feasibility and 
acceptability of the intervention. The study is not powered to test efficacy or significant 
changes in secondary outcome measures. There is no control group, as the research 
question pertains to feasibility and acceptability of the mindfulness skills group.  
6.1 
Primary Endpoint 
The primary outcomes are feasibility and acceptability of the intervention and study 
procedures. Feasibility will be assessed as 1) ability to enroll 12 participants for one 
intervention group within 4-6 weeks, 2) participant retention, with a goal of 85% 
retention, 3) session attendance, with a goal of 75% sessions attended, 4) proportion of 
completed assessments and practice forms.  
Acceptability will be assessed via credibility questionnaire and semi-structured interview 
assessing satisfaction with the intervention, barriers to engagement, and suggestions for 
improving the intervention or study procedures.  

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6.2 
Secondary Endpoint 
Secondary outcomes will all be measured via self-report and include 1) PROMIS-29 adult 
profile measuring physical functioning and health-related quality of life domains, pain 
intensity/interference, anxiety and depressive symptoms, 2) psychological variables 
including pain acceptance, pain catastrophizing, positive affect, emotional/behavioral 
self-regulation, and mindfulness. Adverse events will be evaluated via self-report, and 
participants will have the opportunity to report adverse events during intervention 
sessions, and by contacting study staff at any time during participation in the study.. 
6.3 
 Statistical Methods 
Quantitative Analyses: Baseline demographic, pain medication use, and pain condition 
variables will be characterized using means and percentages and their standard 
deviations. Primary feasibility/acceptability outcomes will be analyzed using 
percentages (proportions) and 95% confidence intervals (CIs). Secondary outcomes will 
be analyzed by using paired t-tests and examining the pre/post intervention change in 
scores and their respective standard errors with 95% confidence intervals. Influence of 
the pretest score on change (i.e., ceiling and floor effects) will be investigated.  
 
Qualitative Analyses: The qualitative description method will be used for interview 
data.26  Major themes within the content will be identified and a codebook created. A 
test sample of interviews will be coded and the codebook refined, followed by coding 
remaining interviews. The outcome will be a descriptive summary of the contents of the 
data.  
 
6.4 
Sample Size and Power 
Anticipating a participant retention proportion of 0.85, the estimated half-width of a 
95% CI for the proportion based on 24 enrolled participants is 0.14, which would give a 
CI of (0.71,0.99). Assuming the overall proportion of sessions attended is 0.75 and an 
intra-participant correlation of 0.10, the estimated half-width of a 95% CI for the 
proportion out of a total of 96 possible participant-sessions is 0.10, which would give a 
CI of (0.65,0.85). Assuming a 15% dropout rate, a sample size of 20 across two groups at 
post-test is adequate to estimate the feasibility and to generate preliminary data for 
planning a larger trial. 
 
6.5 
Interim Analysis 
We are not planning any pre-specified interim analyses for any reason. The study may 
be suspended by the PI if a serious adverse event occurs that is deemed to be secondary 
to our intervention. We do not expect any serious adverse events given the low risk of 
this study. 

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7 
STUDY INTERVENTION (drug, device or other intervention details) 
 
The mindfulness intervention will consist of four, weekly group mindfulness skills 
sessions each lasting 1 hour and 30 minutes. Each session will have approximately 85 
minutes of intervention material scheduled, with time for a 5-minute break in the 
middle. Sessions will be co-instructed by PI Brintz and faculty advisor Gaylord. All 
sessions will take place at the same UNC clinic or conference room location on a week-
day or week-night. Participants will receive guided audio recordings for mindfulness 
skills practice, in addition to a binder with course handouts. Participants will be asked to 
practice for up to 30 minutes daily and to log their practice in the home practice 
questionnaires that will be emailed and completed using REDCap surveys. Home 
practice questionnaires will ask about which mindfulness skills were practiced and the 
number of minutes practiced. Participants will be asked to attend all four sessions as is 
possible and session attendance data will be collected and evaluated.   
 
 Mindfulness skills taught will include sitting meditation with mindfulness of breath, 
thoughts, emotions, or physical sensations; body scan meditation; walking meditation; 
and mindfulness of routine daily activities. Mindfulness training involves the intentional 
self-regulation of attention towards a specific aspect of present-moment experience 
(e.g. the breath, physical sensations, thoughts, emotions, sounds) while noticing and 
releasing cognitive fixation on thoughts and emotions about the past or future, or 
judgments and resistance towards present-moment experience. Didactic content will be 
presented and discussed amongst the group, with content focusing on topics such as 
defining mindfulness and how it can help with stress and pain management, the 
difference between mindfulness and being on autopilot, stress and its relationship to 
chronic pain, how our perceptions affect stress, the relationship between pain and 
distressing thoughts and emotions, acceptance of pain and unwanted experiences, using 
mindfulness in daily life. See Appendix B for session-by-session content and home 
practice assignments.  
 
 
8 
STUDY INTERVENTION ADMINISTRATION(if applicable)  
 
Not applicable – this is a single-group study, so participants will not be randomized, and 
 
it is not  possible to blind to intervention condition. 
 
9 
SAFETY MANAGEMENT 
Adverse Event/Serious Adverse event monitoring procedures: Participant safety will be 
monitored through contact with the intervention instructors (PI and faculty advisor) and 

17 
 
 
RA. If study staff should learn of any safety issues or injuries among study participants, 
the appropriate information will be gathered by the PI, including the date of 
event/injury, the nature/description of the event or injury, and any treatment received 
as a result of the event or injury. This information will be recorded in adverse event 
monitoring forms (see Appendix D). We anticipate based on previous research of 
mindfulness training interventions that the study will pose minimal safety risk; however, 
AEs/SAEs will be assessed by PI Brintz, faculty advisor Gaylord, and Co-I Kim Faurot as to 
the likelihood that the event is study-related and appropriate action taken if necessary 
(e.g. participant withdrawal from study). In addition, participants will have opportunities 
to report any unwanted experiences related to practice of mindfulness skills or 
participation in the group sessions (e.g. emotional or physical discomfort or distress) 
during intervention sessions, home practice questionnaires, post-intervention interview, 
and by contacting the study staff between sessions. Participants will be made aware 
that they can contact study staff to discuss any discomfort they experience as a result of 
the intervention at any time.  
 
Adverse Event/Serious Adverse Event reporting procedures: All AEs/SAEs will be 
monitored by the PI, who will gather all safety-related information from participants, 
record the event in the monitoring form, and report events as soon as possible (same 
day or next business day) to the UNC IRB.  
 
Medical Emergency Procedures: Participants will be informed in the consent form and 
upon enrolling in the study that they should call 911 or go to their nearest emergency 
department should they experience a medical or psychiatric emergency during the time 
of their study participation. Should a medical emergency occur during a study 
intervention session, the emergency department will be contacted immediately.   
 
 
 
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DATA COLLECTION AND MANAGMENT  
 
All participant self-report questionnaires will be completed through secured data 
collection programs (REDCap). Every participant will have a unique identifier and will 
receive unique survey links connected with their identifier. After data collection, raw 
survey responses will be converted into the required file types for analysis. Case report 
forms (see Appendix D) will be used to monitor safety and to record feasibility data, 
such as eligibility, attendance, assessment completion, and study withdrawal. All case 
report forms, survey responses, and data files will be stored on UNC’s secure network, 
and will be accessible by approved study staff only in a secured network folder. 
Participant identifying information (name, birth date) will be kept in a separate secured 
file on UNCs secure server, linking each participant to their unique study identifier, and 
will not be linked to any study data. This file will only be accessible by the PI and any 
approved study staff. All study staff will have completed a required training course in 

18 
 
 
the protection of human subjects before interacting with research participants or with 
study-related files or data. 
 
 
 
11 
RECRUITMENT STRATEGY 
 
We will recruit via pain management providers within UNC clinics and by UNC email 
advertising. Providers and clinic staff in UNC clinics that assist with pain management 
will be informed of the study, given a brief written description of the study, and given 
written information (flyers) to provide to patients that includes study information and 
contact information. Providers may also ask patients for verbal permission to give the 
study investigator their name and contact information so study personnel can contact 
them directly about the study. Clinics will include but not necessarily be limited to the 
Department of Anesthesiology Pain Clinic, the Spine Center, Physical Medicine and 
Rehabilitation, and Internal Medicine.  
 
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CONSENT PROCESS 
Individuals will complete phone screening with the PI or RA. Participants will be given 
information about the nature of the phone screening and asked if they give permission 
to continue with the phone screen. If an individual is eligible for the study, the screener 
will review the information provided in the consent form with the individual over the 
phone, including the purpose of the research, the nature of involvement, the estimated 
risk of involvement, the potential benefits of participation, the right to stop 
participation at any time, and who to contact with questions about the research or 
consent process. The individual will have the opportunity to ask any questions over the 
phone. They will then be sent an email with the link to the online consent form, asked to 
read the consent form, and if they agree to participate, to sign the online consent form. 
Participants will have the opportunity to contact study staff to ask additional questions 
after reading the online consent form and before signing it.  
 
13 
PLANS FOR PUBLICATION 
A manuscript reporting the results of this study with regards to feasibility, acceptability, 
and preliminary effects of the intervention will be submitted for publication in a peer-
reviewed journal that has interest in nonpharmacological interventions and/or 
mindfulness-based interventions for chronic pain management. The results may also be 
disseminated at a conference (e.g. American Pain Society, Integrative Medicine and 
Health), and results will be used to provide preliminary data for future grant proposals.  
 
14 
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22 
 
 
APPENDIX A. 
Schedule of Evaluations 
 
Assessment 
Phone 
Screening  
Consent: 
Online 
form 
Pre-test: 
Online 
Survey 
Treatment 
Visit 1 
(Week 1) 
Treatment 
Visit 2 
(Week 2) 
Treatment 
Visit 3 
(Week 3) 
Treatment 
Visit 4 
(Week 4) 
Post-test: 
Online 
Survey 
Post-test: 
Phone 
Interview 
Inclusion/Exclusion Criteria  
X 
 
 
 
 
 
 
 
 
Informed Consent Review 
and Form   
X 
X 
 
 
 
 
 
 
 
Feasibility: Enrollment, 
retention, attendance, 
data collection 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Acceptability: Satisfaction, 
barriers, suggestions to 
improve intervention 
 
 
 
 
 
 
 
X 
X 
Demographics, pain 
conditions/regions 
 
 
X 
 
 
 
 
 
 
Instructor fidelity to 
intervention protocol 
 
 
 
X 
X 
X 
X 
 
 
Daily home practice and 
pain intensity/interference 
(exploratory outcomes) 
 
 
 
X  
X (daily 
from W1-
2) 
X (daily 
from W2-
3) 
X (daily 
from W3-
4) 
 
 
Pain medication usage 
 
 
X 
 
 
 
 
X 
 
Secondary outcomes: 
PROMIS outcomes, 
psychological variables  
 
 
X 
 
 
 
 
X 
 
Credibility Questionnaire 
 
 
 
 
X 
 
 
 
 
Adverse Reactions/Events  
 
 
 
X 
X 
X 
X 
 
 

23 
 
 
Appendix B. Measures 
Scale or Item 
Description 
Screening Measures/Items 
Drug Abuse Screening Test27 (DAST)-10 
10 items; assess drug use in the past 12 months 
Alcohol Use Disorders Identification Test 
(AUDIT)28,29 
3 items; assesses alcohol consumption, drinking 
behaviors, and alcohol-related problems 
Chronic pain  
Have you experienced pain on a daily basis for at least 
3 months?  
Pain bothersomeness 
How bothersome was your pain in the previous week? 
(rating scale 0-10).  
Pain interference with general activities 
How much did your pain interfere with your general 
activities in the past week? (rating scale 0-10). 
Diagnosis of mental illness with psychotic 
features 
Have you ever been diagnosed with schizophrenia, 
schizoaffective disorder, or another psychiatric 
disorder with psychotic symptoms?  
Psychiatric hospitalization in past 2 years 
Have you ever been hospitalized for mental health 
reasons? When was the last hospitalization?  
Previous mindfulness training 
Have you ever participated in mindfulness training or 
course? Have you ever had a regular mindfulness 
practice? When? 
Baseline-only Measures 
Demographic variables 
Age, race/ethnicity, education, income, marital status 
Pain conditions and regions 
e.g. fibromyalgia, osteoarthritis, low-back pain, 
migraine, neck pain, etc 
Baseline and Post-test Measures* 
Pain Medication Use 
Pain medications taking, frequency, and dose 
Physical Function (short-form 4a)30 
4 items; difficulty with activities of daily living 
Anxiety (sf 4a) 
4 items; suggestive of anxiety in the past 7 days 
Depression (sf 4a) 
4 items; suggestive of depressed mood in past 7 days 
Sleep Disturbance (sf 4a) 
4 items; sleep quality and disturbance in past 7 days 
Pain Interference (sf 6b) 
6 items; degree to which pain interferes with life 
Pain Intensity  
1 item; average pain intensity past 7 days (0-10) 
Positive Affect and Wellbeing 
9 items;  
Perceived Stress Scale – 4  
4 items; global measure of perceived stress 
Pain Catastrophizing Scale31 
13 items; 3 subscales characterizing thoughts and 
feelings when in pain – rumination, magnification, 
helplessness 
Chronic Pain Acceptance Questionnaire32 
20 items;  acceptance of experiencing pain 
Freiberg Mindfulness Inventory 
14 items; measures all aspects of mindfulness 
Intervention Satisfaction 
1 likert-type item asking how satisfied are with the 
intervention oveall 
Credibility Questionnaire34,35 (after session 
2)  
5 items assessing opinions about the intervention 
including how logical it seems, confidence, likelihood 
of recommending it, importance, and success 
*Italicized items are PROMIS Measures 

24 
 
 
Appendix C. Case Report Forms 
 
 
Phone-Screening 
Screen ID 
Date 
Eligible (Y/N) 
Reason Ineligible 
 
 
 
 
 
 
 
 
 
 
Subject Status 
 Status: 
 
A = Active 
W = Withdrew 
C = Completed 
L = Lost to follow-up 
 
Session Attendance 
 
Adverse Events 
Severity of AE: 
 
Relatedness to Intervention: 
 
1 = Mild 
 
0 = Definitely unrelated 
2 = Moderate 
 
1 = Unlikely 
3 = Severe 
 
2 = Possibly related 
4 = Life threatening or disabling 
3 = Probably related 
4 = Definitely related 
 
 
 
Participant 
ID 
Date 
Enrolled 
Group 
(1,2) 
Date 
Completed 
Study 
Study 
Status 
Reason for 
Withdrawal 
Baseline 
Assessment 
(Date) 
Incentive? 
Post-Intervention 
Assessment 
(Date) 
Incentive? 
Post-Intervention 
Phone Interview 
(Date) 
Incentive? 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Pt. ID 
Session 1 
(Y/N) 
Session 2 
(Y/N) 
Session 3 
(Y/N) 
Session 4 
(Y/N) 
Notes (reasons missed) 
 
 
 
 
 
 
 
 
 
 
 
 
Pt. ID 
AE 
Onset 
 
AE 
End 
Severity 
 
SAE? 
(Y/N) 
Relatedness 
Action 
Taken 
Outcome 
Comments