A Comparative Effectiveness Randomized Controlled Trial of Mindfulness Meditation Versus Cognitive Behavioral Therapy for Opioid-Treated Chronic Low Back Pain
Phase: NA
Conditions: Chronic Low Back Pain
Sponsor: University of Wisconsin, Madison

STAMP Study Protocol 
Dual PI:  Aleksandra Zgierska, MD PhD, Bruce Barrett, MD, PhD 
 
 
 
 
 
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Version 21.0:  4/12/23  
 
 
Strategies To Assist with Management of Pain (STAMP) Study 
 
FINAL PROTOCOL 
 
 
Final (funding agency-approved) protocol changes: April 12, 2023 
Final institutional review board approval: October 31, 2023 
 
 
 
ClinicalTrials.gov ID: NCT03115359 
 
 

STAMP Study Protocol 
Dual PI:  Aleksandra Zgierska, MD PhD, Bruce Barrett, MD, PhD 
 
 
 
 
 
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Version 21.0:  4/12/23  
 
 
MAIN TITLE: STRATEGIES TO ASSIST WITH MANAGEMENT OF PAIN (STAMP) 
 
PCORI-APPROVED PROTOCOL TITLE: A COMPARATIVE EFFECTIVENESS RANDOMIZED CONTROLLED TRIAL 
OF MINDFULNESS MEDITATION VERSUS COGNITIVE BEHAVIORAL THERAPY  
FOR OPIOID-TREATED CHRONIC LOW BACK PAIN 
 
 
Dual Principal Investigators: Aleksandra Zgierska, MD, PhD and Bruce Barrett, MD, PhD 
 
 
 
This document is confidential. 
No part of it may be transmitted, reproduced, published, or used by other persons without prior written 
authorization from the Sponsor or Principal Investigator. 
 
PROTOCOL VERSION and AMENDMENTS 
 
Protocol Version 
Date 
Change 
Initiated 
(Initials) 
Brief description of protocol modification/actions requested, if any 
Template V6 
9/6/16 
TNK 
Input from IRB, OCT, MARCH, IND/IDE services, PIs 
CLBPprotocol_V1-1 
12/9/16 
CAB 
Initial protocol draft 
CLBPprotocol_V1-2 
2/9/17 
TNK 
First review of protocol draft 
CLBPprotocol_V1-3 
2/15/17 
CAB 
Initial protocol revision 
CLBPprotocol_V1-4 
2/20/17 
AZ 
Initial protocol revision 
CLBPprotocol_V1-5 
2/24/17 
CAB 
Initial protocol revision 
CLBPprotocol_V1-6 
2/26/17 
AZ 
Initial protocol revision 
CLBPprotocol_V1-7 
3/1/17 
CAB 
Initial protocol revision 
CLBPprotocol_V1-8 
3/3/17 
TNK 
Initial protocol revision 
CLBPprotocol_V1-9 
3/3/17 
CAB 
Initial protocol revision 
CLBPprotocol_V1-10 
3/5/17 
AZ 
Initial protocol revision 
CLBPprotocol_V1-10 
3/5/17 
RRE 
Initial protocol revision 
CLBPprotocol_V1-10 
3/5/17 
EG 
Initial protocol revision 
CLBPprotocol_V1-11 
3/9/17 
CAB 
Initial protocol revision 
CLBPprotocol_V1-12 
3/9/17 
AZ 
Initial protocol revision 
CLBPprotocol_V1-13 
3/10/17 
CAB 
Initial protocol revision 
CLBPprotocol_V1-14 
3/10/17 
AZ 
Initial protocol revision 
CLBPprotocol_V1-15 
3/15/17 
CAB 
Initial protocol revision 
CLBPprotocol_V1-16 
3/15/17 
AZ 
Initial protocol revision 
CLBPprotocol_V1-17 
3/16/17 
CAB 
Initial protocol revision 
CLBPprotocol_V1-17 
3/17/17 
AZ 
Initial protocol revision 
CLBPprotocol_V1-18 
4/28/17 
CAB, AZ 
Initial protocol revision based on the IRB pre-review comments 
CLBPprotocol_V2-00 
5/31/17 
CAB, AZ 
Initial protocol revision based on the IRB comments 
CLBPprotocol_V3-00 
6/17/17 
CAB 
Change of protocol revision, including adding recruitment sites 
CLBPprotocol_V4-00 
7/13/17 
CAB, AZ 
Change of protocol revision, including change to SLC additional optional 
testing 
CLBPprotocol_V5-00 
7/28/17 
CAB 
Change of protocol revision, relating to EHR data 
CLBPprotocol_V6-00 
11/16/1
7 
CAB 
Change of protocol revision, related to recruitment emails 
CLBPprotocol_V7-00 
11/28/1
7 
CAB 
Change of protocol revision, related to allowing flexibility for contact 
attempts for data collection 
CLBPprotocol_V8-00 
2/16/18 
CAB 
Change of protocol revision, related to the $100 for perfect intervention 
attendance; updated recruitment strategy. 

STAMP Study Protocol 
Dual PI:  Aleksandra Zgierska, MD PhD, Bruce Barrett, MD, PhD 
 
 
 
 
 
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Version 21.0:  4/12/23  
 
CLBPprotocol_V9-00 
4/20/18 
CAB 
Change of protocol revision, related to elimination of the data collection 
portion of the monthly check-in; and clarification of exclusion criteria. 
CLBPprotocol_V10-00 
5/10/18 
CAB 
Clarification of change V9-00 per IRB Reviewer request 
CLBPprotocol_V11-00 
5/18/18 
CAB 
Expansion of recruitment/enrollment window; page 31. 
CLBPprotocol_V12-00 
6/28/18 
CAB 
Expanding screening options to include in-person screening. 
CLBPprotocol_V13-00 
9/21/18 
CAB 
Change to eligibility criteria re: morphine-equivalent dose (MED), 
Elizabeth Jacobs was removed as a key personnel (she is now a 
consultant), and other minor changes for clarification. 
CLBPprotocol_V14-00 
12/7/18 
CAB 
Update to allow viewing of patient lists at clinics regarding upcoming 
medical appointments, to aid in study recruitment; and to allow additional 
participant check-ins as needed for engagement purposes. 
CLBPprotocol_V15-00 
6/11/19 
CAB 
Update to allow up to 4 additional mailings of recruitment materials to 
potential participants; addition of a reminder letter; other minor changes 
for clarification. 
CLBPprotocol_V16-00 
5/7/20 
CAB 
Update to allow tele-health delivery of our group study interventions 
when in-person delivery is not a feasible option; added Hershey site key 
personnel. 
CLBPprotocol_V17-00 
5/27/20 
CAB 
Update to minimization of risk section per IRB request. 
CLBPprotocol_V18-00 
10/1/20 
CAB 
Update to expand “in-person” to “virtual or in-person” study options. 
CLBPprotocol_V18-01 
10/9/20 
CAB 
Update to describe virtual consent process for virtual participants, per 
IRB recommendation. 
CLBPprotocol_V19-00 
1/29/21 
CAB 
Update to recruitment methods. 
CLBPprotocol_V19-01 
2/19/21 
CAB 
Clarification of update to recruitment methods. 
CLBPprotocol_V20-00 
3/7/22 
CAB 
Clarification of withdrawal reasons. 
CLBPprotocol_V21-00 
7/26/23 
CAB 
Update to statistical methods section 8.2, submitted to PCORI on March 
20, approved in April 2023. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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PROTOCOL SIGNATURE PAGE 
 
 
I have read the foregoing protocol and agree that it contains all necessary details for carrying out this study. I will conduct 
the study in accordance with the design and specific provisions outlined herein; deviations from the protocol are acceptable 
only with a mutually agreed upon protocol amendment. 
 
I will provide copies of the protocol and all pertinent information to all individuals responsible to me who assist in the conduct 
of this study. I will discuss this material with them to ensure they are fully informed regarding the study drug or device and 
the conduct of the study.  
 
I will use the informed consent form approved by the SPONSOR and will fulfill all responsibilities for submitting pertinent 
information to the Institutional Review Board or Ethics Committee responsible for this study. 
 
I also agree to report all information or data in accordance with the protocol and, in particular, I agree to report any serious 
adverse experiences as defined in Section 7 of this protocol. 
 
I further agree that the SPONSOR has access to any source documents from which case report form information may have 
been generated. 
 
I also agree to handle all clinical supplies (including study drug or device) provided by the SPONSOR and collect and handle 
all clinical specimens in accordance with the protocol. 
 
The below signed confirm herewith to have read and understood this trial protocol and/or amendment and appendices; 
furthermore, to accomplish this study in accordance to the protocol guidelines, as well as local regulations; and to accept 
respective revisions conducted by authorized personnel of SPONSOR and by regulatory authorities. 
 
 
 
PRINTED OR TYPED NAME(S) 
 
 
 
SIGNATURE 
 
 
 
DATE 
 
 
 
Aleksandra Zgierska, MD, PhD 
 
 
 
 
 
3-6-17 
Study-wide and Hershey Site Principal 
Investigator 
 
 
Bruce Barrett, MD, PhD 
 
 
 
 
5/7/20 
 
 
Study-wide and Madison Site Principal 
Investigator  
 
 
Robert Edwards, PhD 
 
 
 
 
 
 
3-8-17 
Boston Site’s Principal Investigator 
 
 
Eric Garland, PhD, LCSW 
 
 
 
 
3-8-17 
Salt Lake City Site’s Principal Investigator 
 
 
 
 

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STATEMENT OF COMPLIANCE 
The research will be conducted in accordance with the Code of Federal Regulations on the Protection of Human Subjects 
(45 CFR Part 46), and the PCORI Terms of Award. The Principal Investigator will assure that no deviation from, or changes 
to the protocol will take place without prior agreement from the sponsor and documented approval from the Institutional 
Review Board (IRB), except where necessary to eliminate an immediate hazard(s) to the trial participants. All personnel 
involved in the conduct of this study have completed Human Subjects Protection Training. 
 
I agree to ensure that all staff members involved in the conduct of this study are informed about their obligations in meeting 
the above commitments.  
 
 
 
PRINTED OR TYPED NAME(S) 
 
 
 
SIGNATURE 
 
 
 
DATE 
 
 
 
Aleksandra Zgierska, MD, PhD 
 
 
 
 
 
3-6-17 
Study-wide and Hershey Site Principal 
Investigator 
 
 
 
 
 
 
 
5/7/20 
Study-wide and Madison Site Principal 
Investigator  
 
 
Robert Edwards, PhD 
 
 
 
 
 
 
3-8-17 
Boston Site’s Principal Investigator 
 
 
Eric Garland, PhD, LCSW 
 
 
 
 
3-8-17 
Salt Lake City Site’s Principal Investigator 
 
 
 
 
 
 

STAMP Study Protocol 
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Funding Sponsor: 
Patient-Centered 
Outcomes 
Research 
Institute 
1828 L St., NW, Suite 900 Washington, DC  
20036 
Phone:  202-827-7700    Fax:  202-355-9558 
Study Product: 
Mindfulness Meditation group intervention; 
Cognitive 
Behavioral 
Therapy 
group 
intervention 
PCORI Protocol Number: 
 
UW Project ID Number: 
 
UW IRB Number: 
OPD-1601-33860 
 
AAB7469 
 
TBD 
 
 
Participating sites: 
 
       Study Dual-PI and Madison Site PI:  Bruce Barrett, MD, PhD 
 
University of Wisconsin-Madison, School of Medicine and Public Health 
Dept Family Medicine and Community Health 
1100 Delaplaine Court, Madison, WI 53715 
Phone:  (608) 263-4550 
 
Madison-based sites: 
Access Community Health Centers 
2901 West Beltline Highway, Suite 120, Madison, WI  53713 
Phone:  (608) 443-5500 
 
SSM Health 
1808 West Beltline Highway, Madison, WI  53713 
Phone:  (608) 250-1075 
 
Group Health Cooperative of South Central Wisconsin 
1265 John Q. Hammons Drive, Madison, WI  53717  
Phone:  (608) 251-4156 
 
UnityPoint Health - Meriter 
202 South Park Street, Madison, WI  53715 
Phone:  (608) 417-6000 
 
UW Health 
1685 Highland Avenue, Suite 5000 MFCB, Madison, WI  53705 
Phone:  (608) 2263-1300 
 
Boston Site PI: Robert Edwards, PhD  
Brigham and Women’s Hospital 
Department of Anesthesiology 
Pain Management Center 
850 Boylston St, Suite 302, Chestnut Hill MA 02467 
Phone: (617) 732-9486 
 
Boston-based site: 
Partners Healthcare 
Brigham & Women’s Hospital 
75 Francis St, Boston MA 02115 
 

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Salt Lake City site PI: Eric Garland, PhD, LCSW 
University of Utah 
College of Social Work 
395 S 1500 E, Salt Lake City, UT 84112 
Phone: (801) 581-6192 
 
Salt Lake City-based site: 
University of Utah Healthcare 
50 N Medical Drive, Salt Lake City, UT 84132 
Phone: 801-581-2121 
 
Study Dual-PI and Hershey site PI:  Aleksandra Zgierska, MD, PhD 
Penn State Health/College of Medicine 
Department of Family and Community Medicine 
500 University Drive, HS72, Hershey, PA 17033 
Phone:  (717) 531-0003 Ext 320121 
 
 
Hershey-based site:  None. 
 
 
 

STAMP Study Protocol 
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List of Abbreviations 
 
 
AE 
Adverse event 
AHRQ 
Agency for Healthcare Research and Quality 
BPI 
Brief Pain Inventory 
CARDS 
Community Advisors on Research Design and Strategies 
CBT 
Cognitive Behavioral Therapy 
CFR 
Code of Federal regulations 
CLBP 
Chronic Low Back Pain 
COMMS 
Current Opioid Misuse Measure 
CPAQ 
Chronic Pain Assessment Questionnaire  
CRF 
Case Report Form 
DCC 
Data Coordinating Center 
DFMCH 
Department of Family Medicine and Community Health 
DHHS 
Department of Health and Human Services 
DSMC 
Data Safety Monitoring Committee  
EC 
Ethics Committee 
ED 
Emergency Department 
EHR 
Electronic Health Record 
FDA 
Food and Drug Administration 
 
 
GIC 
Global Impression of Change  
HADS 
Hospital Anxiety and Depression Scale 
HIPAA 
Health Insurance Portability and Accountability Act 
 
 
ICTR 
Institute of Clinical and Translational Research 
IOM 
Institute of Medicine 
IRB 
Investigational Review Board 
ITT 
Intention To Treat 
MAAS 
Mindful Attention Awareness Scale 
MBSR 
Mindfulness-Based Stress Reduction 
MD 
Mean Difference 
MIC 
Minimal Important Change 
MM 
Mindfulness Meditation 
MOO 
Manual of Operations 
MOP 
Manual of Procedures 
NSAIDS 
Non-Steroidal Anti-Inflammatory Drugs 
NIH  
National Institute of Health 
NRS 
Numerical Rating Scale 
OCC 
Opioid Compliance Checklist 
ODI 
Oswestry Disability Index 
OHRP 
Office for Human Research Protections 
PCORI 
Patient-Centered Outcomes Research Institute 
PCS 
Pain Catastrophizing Scale 
PFA 
Patient/Family Advisor  
PHI 
Protected Health Information  
PI 
Principal Investigator 
PRO 
Patient Reported Outcomes 
PTSD 
Post-Traumatic Stress Disorder 
QoL 
Quality of Life 

STAMP Study Protocol 
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RCT 
Randomized Controlled Trial 
SAC 
Stakeholder Advisory Committee 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
SE 
Side Effects 
SF-12 
Medical Outcomes Study 12-Item Short Form 
SOWS 
Short Opioid Withdrawal Scale 
SSH 
Secure Shell 
TLFB 
Timeline Followback 
TUG 
Timed Up and Go 
UP 
Unanticipated Problems 
UW 
University of Wisconsin 
VAS 
Visual Analog Scale 
WINRS 
Wisconsin Network for Research Support 
 
 
 

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Study Summary 
Official (Research 
Protocol) Title 
A comparative effectiveness randomized controlled trial of mindfulness meditation 
versus cognitive behavioral therapy for opioid-treated chronic low back pain. 
Short Title and Précis 
Mind-Body Therapies for Back Pain. 
 
This study will compare the effectiveness of two interventions: Mindfulness Meditation 
and Cognitive Behavioral Therapy for improving outcomes (pain, function, quality of life, 
daily opioid dose) in adults with opioid-treated chronic low back pain over a 12 month 
follow-up period. 
Protocol Number 
PCORI#  OPD-1601-33860 
UW Project ID#  AAB7469 
UW IRB#  TBD 
ClinicalTrials.gov 
number and link 
TBD; TBD 
Methodology 
Randomized controlled trial  
Study Duration 
5 years 
Study Center(s) 
The study will include the following sites: Madison, WI (led by University of Wisconsin-
Madison): UW Health, Access Community Health Centers, UnityPoint Health - Meriter, 
SSM Health, Group Health Cooperative; Boston, MA (led by Harvard University, 
Brigham and Women’s Hospital): Partners Healthcare; Salt Lake City, UT (led by 
University of Utah): University of Utah Healthcare Primary Care Clinics 
Objectives 
Main goal: To compare the effectiveness of Mindfulness Meditation (MM) and standard-
of-care Cognitive Behavioral Therapy (CBT) for improving outcomes in adults with 
opioid-treated chronic low back pain. 
Aim 1:  To compare the effectiveness of MM to CBT for reducing pain and increasing 
function over a 12 month follow-up period. 
Aim 2:  To compare the effectiveness of MM to CBT for improving quality of life and 
reducing daily opioid dose over a 12 month follow-up period. 
Aim 3:  To examine if participant baseline characteristics impact treatment response 
to MM or CBT. 
Number of Participants 
Up to 800 participants 
Diagnosis  
Opioid-treated chronic low back pain 
Main Inclusion Criteria 
Moderate to severe chronic low back pain treated with ≥ 15 mg/day of morphine-
equivalent opioid dose for ≥ 3 months; age 21+ 
Main Exclusion Criteria 
Prior formal MM or CBT training; inability to safely or reliably participate; current 
pregnancy; pre-existing borderline personality, delusional or bipolar (manic) disorders 
("active" in the prior 12 months). Competent adults, meeting eligibility criteria, will be 
able to participate regardless of gender, race, ethnicity, religion or socioeconomic 
status. Prisoners, pregnant women and mentally impaired persons will not be included. 
Children, per eligibility criteria, are not eligible. 
Study Interventions 
Two behavioral therapies: Mindfulness Meditation and Cognitive Behavioral Therapy, 
delivered in addition to “usual care” 
Intervention Duration 
Both MM and CBT interventions will consist of 8 weekly two-hour therapist-led group-
therapy sessions (total 16 hours); in addition, participants will be asked to engage in 
home practice of either MM or CBT techniques for at least 30 minutes/day, 6 days/week 
during the 12-month study. 
Statistical 
Methodology 
Primary outcome analysis: Intention-to-treat analysis in the framework of linear mixed 
effects to examine the comparative effectiveness of treatment on the change in pain 
severity, function (Aim 1) and quality of life scores and opioid dose (Aim 2) over 12-
months between the two groups. 
Qualitative analysis for qualitative data. 
 
 
 

STAMP Study Protocol 
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Schematic of Study Design 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Assessed for eligibility (n= 2,500-5,000) 
3-month follow-up 
Online/phone questionnaires 
 
6-month follow-up 
Online/phone questionnaires 
 
9-month follow-up 
Online/phone questionnaires 
 
12-month exit visit 
Completion of questionnaires and videorecorded 
activity 
Mindfulness Meditation Intervention  
+ usual care  (n= 300-400) 
Cognitive Behavioral Therapy Intervention  
+ usual care  (n= 300-400) 
Allocation 
ITT analysis 
Enrollment, Baseline Assessment, Randomization (n= 600-800) 
Completion of questionnaires and videorecorded activity 
Enrollment 
3-month follow-up 
Online/phone questionnaires 
 
6-month follow-up 
Online/phone questionnaires 
 
9-month follow-up 
Online/phone questionnaires 
 
12-month exit visit 
Completion of questionnaires and videorecorded 
activity 
Follow-Up 
Screening 
Subgroup Follow-up 
In-depth qualitative 
interview (n= 20-40) 
In-depth qualitative 
interview (n= 20-40) 

STAMP Study Protocol 
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Contents 
 
Study Summary .................................................................................................................................................................. 10 
Schematic of Study Design ................................................................................................................................................ 11 
1 
Key Roles .................................................................................................................................................................... 15 
2 
Background and Introduction ....................................................................................................................................... 18 
2.1 
Background and Rationale .................................................................................................................................. 18 
2.2 
Hypotheses ......................................................................................................................................................... 18 
2.3 
Study Interventions ............................................................................................................................................. 19 
2.4 
Summary of Relevant Clinical Data ..................................................................................................................... 19 
2.5 
Potential Risks and Benefits to Participants ........................................................................................................ 21 
2.5.1 
Known Potential Risks..................................................................................................................................... 21 
2.5.2 
Protection Against Risks ................................................................................................................................. 21 
2.5.3 
Potential Benefits to Participants ..................................................................................................................... 18 
3 
Study Objectives and Purpose .................................................................................................................................... 23 
4 
Study Design and Endpoints ....................................................................................................................................... 23 
4.1 
General Design ................................................................................................................................................... 23 
4.1.1 
Primary Study Endpoints ................................................................................................................................. 24 
4.1.2 
Secondary Study Endpoints ............................................................................................................................ 24 
5 
Study Participants – Enrollment and Withdrawal ......................................................................................................... 24 
5.1 
Participant Population ......................................................................................................................................... 25 
5.2 
Inclusion Criteria ................................................................................................................................................. 25 
5.3 
Exclusion Criteria ................................................................................................................................................ 25 
5.4 
Participant Screening for Recruitment ................................................................................................................. 26 
5.4.1 
Participant Identification .................................................................................................................................. 26 
5.4.2 
Recruitment and Retention Strategies ................................................................................................................ 26 
5.5 
Vulnerable Populations ....................................................................................................................................... 27 
5.5.1  
Participant Capacity ........................................................................................................................................ 28 
5.5.2  Participant/Representative Comprehension .................................................................................................... 28 
5.6 
Informed Consent ................................................................................................................................................ 28 
5.6.1 
Process of Consent ......................................................................................................................................... 28 
5.6.2 
Combined Consent and HIPAA Form ............................................................................................................. 29 
5.6.3 
HIPAA…………………………………………………………………………………………………………………….25 
5.6.4 
Revoking Consent ........................................................................................................................................... 30 
5.6.5  Costs to the Participant ................................................................................................................................... 30 
5.6.6 
Payment for Participation ................................................................................................................................ 30 
5.7 
Early Withdrawal of Participants.......................................................................................................................... 30 
5.7.1 
Premature termination of study ....................................................................................................................... 30 
5.7.2 
When and How to Withdraw Participants ........................................................................................................ 30 
5.7.3    Data Collection and Follow-up for Withdrawn Participants .............................................................................. 30 

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6 
Description of Study Interventions ............................................................................................................................... 30 
6.1 
Usual Care .......................................................................................................................................................... 31 
6.2 
Randomization and Blinding of Study Intervention .......................................................................................... 31 
7 
Study Procedures ........................................................................................................................................................ 31 
7.1 
LABS ................................................................................................................................................................... 33 
7.2 
Study Visits ......................................................................................................................................................... 33 
7.2.1 
Screening/Baseline: ........................................................................................................................................ 33 
7.2.2 
Follow up: ........................................................................................................................................................ 34 
7.2.3 
Additional contact ............................................................................................................................................ 34 
8 
Study Analysis ............................................................................................................................................................. 34 
8.1 
Sample Size Determination ................................................................................................................................. 34 
8.2 
Statistical Methods .............................................................................................................................................. 35 
8.3 
Planned Interim Analysis ..................................................................................................................................... 35 
9 
Data Collection, Handling and Record Keeping ........................................................................................................... 35 
9.1 
Data Confidentiality ............................................................................................................................................. 35 
9.1.1 
Confidentiality of Participant Records ............................................................................................................. 37 
9.2 
Data Capture ....................................................................................................................................................... 37 
9.2.1 
Source Documents .......................................................................................................................................... 37 
9.2.2 
Missing Data……………………………………………………………………………………………………………..32 
9.2.3 
Data Collection Tools (see Appendix for all data collection tools) ................................................................... 38 
9.3 
Data Management ............................................................................................................................................... 41 
9.4 
Data Monitoring ................................................................................................................................................... 41 
10 
Assessment of Safety ............................................................................................................................................. 42 
10.1.1 Definition of an Adverse Event (AE) ................................................................................................................ 42 
10.1.2 
Definition of a Serious Adverse Event (SAE) .................................................................................................. 42 
10.1.3 
Definition of an Unanticipated Problem (UP) ................................................................................................... 42 
10.2 
Classification of an Adverse Event ...................................................................................................................... 42 
10.2.1 
Severity of Event ............................................................................................................................................. 42 
10.2.2 Relationship to Study Agent……………………………………………………………………………………………37 
10.2.3 Expectedness .................................................................................................................................................. 43 
10.3 
Time period and frequency for event assessment and follow-up ........................................................................ 43 
10.4 
Reporting procedures .......................................................................................................................................... 43 
10.4.1 Events of special interest ................................................................................................................................ 44 
10.4.2 Reporting of pregnancy ................................................................................................................................... 44 
10.5 
Study Halting Rules ............................................................................................................................................. 44 
10.6 
Safety Oversight.................................................................................................................................................. 44 
11 
Study Monitoring, Auditing, and Inspecting ............................................................................................................. 44 
11.1 
Medical/Safety Monitoring ................................................................................................................................... 44 
11.1.1 Study Monitoring Plan ..................................................................................................................................... 45 

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11.2 
Protocol Deviations ............................................................................................................................................. 45 
11.3 Auditing and Inspecting ........................................................................................................................................... 45 
11.4 Participant Compliance Monitoring .......................................................................................................................... 45 
12 Ethical Considerations ................................................................................................................................................... 45 
13 Study Finances .............................................................................................................................................................. 46 
13.1 Funding Source ....................................................................................................................................................... 46 
13.2 Conflict of Interest ................................................................................................................................................... 46 
14 Publication Plan ............................................................................................................................................................. 46 
15 References .................................................................................................................................................................... 46 
 
 
 

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1 
Key Roles 
 
MADISON SITE: 
 
Bruce Barrett, MD, PhD (Study-wide Dual-Principal Investigator) 
Professor 
University of Wisconsin-Madison, School of Medicine and Public Health, Dept Family Medicine and Community Health 
1100 Delaplaine Court, Madison, WI 53715 
Phone:  (608) 263-4550 
bruce.barrett@fammed.wisc.edu  
 
Christian Kastman, MD 
Chief Medical Officer 
Group Health Cooperative of South Central Wisconsin 
1265 John Q. Hammons Drive, Madison, WI  53717  
Phone:  (608) 251-4156 
ckastman@ghcscw.com 
 
Linda Oakley, PhD, PMH-NP (Co-Investigator) 
Professor 
University of Wisconsin-Madison, School of Nursing 
4171 Cooper Hall, Signe Skott; 701 Highland Avenue, Madison, WI 53705 
Phone:  (608) 263-4550 
ldoakley@wisc.edu  
 
Marlon Mundt, PhD (Co-Investigator, Biostatistician) 
Assistant Professor 
University of Wisconsin-Madison, School of Medicine and Public Health, Dept Family Medicine and Community Health 
1100 Delaplaine Court, Madison, WI 53715 
Madison, WI 53715 
Phone:  (608) 263-5123 
marlon.mundt@fammed.wisc.edu  
 
 
Nalini Sehgal, MD (Co-Investigator) 
Professor 
University of Wisconsin-Madison, School of Medicine and Public Health, Department of Orthopedics and Rehabilitation 
6144 UW Med Foundation Centennial Bldg; 1685 Highland Avenue, Madison, WI 53705 
Phone:  (608) 265-0102 
sehgal@rehab.wisc.edu  
 
James H Shropshire, MD 
Division Chief Family Medicine 
UnityPoint Health - Meriter 
202 South Park Street, Madison, WI  53715 
Phone:  (608) 417-8585 
james.shropshire@unitypoint.org 
 
BOSTON SITE: 
Robert Edwards, PhD (Site Principal Investigator) 
Associate Professor 
Harvard Medical School, Department of Anesthesiology and Psychiatry; Brigham and Women's Hospital, Pain 
Management Center 
850 Boylston St, Chestnut Hill, MA 02467 
Phone:  (617) 732-9486 
rredwards@partners.org  

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Robert Jamison, PhD (Co-Investigator) 
Professor 
Harvard Medical School, Department of Anesthesiology and Psychiatry; Brigham and Women's Hospital, Pain 
Management Center 
850 Boylston St, Chestnut Hill, MA 02467 
Phone:  (617) 732-9046 
rjamison@partners.org  
 
Edward Michna, MD (Co-Investigator) 
Assistant Professor 
Harvard Medical School, Department of Anesthesiology; Brigham and Women's Hospital, Pain Management Center 
850 Boylston St, Chestnut Hill, MA 02467 
Phone:  (617) 732-9060 
emichna@partners.org  
 
Edgar Ross, MD (Co-Investigator) 
Associate Professor 
Harvard Medical School, Department of Anesthesiology; Brigham and Women's Hospital, Pain Management Center 
850 Boylston St, Chestnut Hill, MA 02467 
Phone:  (617) 732-9060 
elross@partners.org 
 
SALT LAKE CITY SITE: 
Eric Garland, PhD, LCSW (Site Principal Investigator) 
Associate Professor 
Associate Dean of Research 
University of Utah, College of Social Work 
395 S 1500 E RM 101, Salt Lake City, UT 84112  
Phone:  (801) 581-6192 
eric.garland@socwk.utah.edu 
 
Yoshio Nakamura, PhD (Co-Investigator) 
Research Associate Professor 
University of Utah, Department of Anesthesiology 
30 N 1900 E RM 3C444, Salt Lake City, UT 84132-2101  
Phone:  (801) 585-0419 
yoshi.nakamura@utah.edu 
 
 
Julie Fritz, PhD, PT, ATC (Co-Investigator) 
Distinguished Professor  
Associate Dean for Research College of Health  
University of Utah, College of Physical Therapy & Athletic Training 
383 Colorow Drive RM 389, Salt Lake City, UT 84108  
Phone:  801-581-6297 
julie.fritz@utah.edu 
 
HERSHEY SITE: 
Aleksandra Zgierska, MD, PhD (Study-wide Dual-Principal Investigator) 
Professor 
Vice Chair of Research 
Penn State Health/College of Medicine, Department of Family and Community Medicine 
500 University Drive, HS72, Hershey, PA 17033 
Phone:  717-531-0003 Ext 320121 
azgierska@pennstatehealth.psu.edu 

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Robert Lennon, MD, JD, FAAFP (Co-Investigator) 
Associate Professor 
Penn State Health/College of Medicine, Department of Family and Community Medicine 
500 University Drive, HS72, Hershey, PA 17033 
Phone:  717-531-0003 Ext 284628 
rlennon@pennstatehealth.psu.edu  
 
 
 

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2 
Background and Introduction 
This document is a protocol for a human research study. This study is to be conducted in accordance with Department 
of Health and Human Services (DHHS) regulations, 45 CFR 46, the PCORI Terms of Award, applicable government 
regulations, and Institutional policies and procedures. 
2.1 Background and Rationale 
Opioid-treated chronic low back pain (CLBP) has a substantial impact on US society 
Chronic non-cancer pain is a leading cause of disability and reduced quality of life in the US, affecting over 100 million 
Americans and costing nearly $600 billion annually.1 Existing therapies for chronic pain are suboptimal.1,2 As a result, 
5-8 million patients with chronic pain are treated with opioids and CLBP is the top chronic non-cancer condition for 
which opioids are prescribed.3 There are very limited data on the long-term efficacy of opioids, and much concern about 
their harms, which are dose-dependent and include worsened mental health, addiction and overdose death.4,5 Many 
opioid-treated patients continue to have inadequate pain relief, and impaired function and quality of life; comorbidities 
include depression, anxiety and opioid misuse, the severity of which has been linked to worse treatment response in 
chronic pain.3,4,6,7 With this complex interplay between CLBP, opioids, co-existing mental health problems, and their 
effects on outcomes, treatment strategies must address each of these factors. However, there is little research on how 
to effectively improve outcomes and reduce opioid use; the Institute of Medicine (IOM),1 the NIH8 and the PCORI9 call 
for studies to identify effective safe strategies for chronic pain care and opioid use reduction. 
 
Mindfulness Meditation (MM) is a popular mind-body modality that is widely used for improving health and well-
being10 and may be an effective alternative treatment for CLBP.11,12 Some studies suggest that MM-induced gains 
can be sustained over time.13,14 MM offers unique skills for acceptance-based pain coping that are different from those 
taught by cognitive behavioral therapy (CBT), which is the current “gold standard” of traditional psychological 
approaches for chronic pain.  
 
As supported by the existing evidence, including data from our pilot RCT, MM has the potential to address both 
chronic pain and its comorbidities, depression, anxiety, and opioid misuse, and to help patients reduce their 
reliance on opioids.10,15-17 Even modest dose reduction would be beneficial to patients, decreasing the harms 
associated with opioid therapy.5 Research is needed to evaluate the effectiveness of MM for pain severity, function and 
quality of life, and opioid use, as compared to a suitable alternative treatment such as CBT.  We have chosen these 
outcomes because they are endorsed by our stakeholders and are very patient-centered. We have designed this study 
to help inform decision-making by patients with opioid-treated CLBP and their clinicians as they consider choosing 
between MM and CBT; the proposed work will also provide data on the effectiveness of each approach for those with 
comorbid anxiety, depression and opioid misuse. The proposed mixed methods, pragmatic RCT will compare the 
effectiveness of MM and CBT over 12 months in up to 800 adults with opioid-treated CLBP. We hypothesize that MM, 
relative to CBT, will improve patient-centered outcomes: pain and function (Aim 1), quality of life and opioid use (Aim 
2), especially in those with anxiety, depression or opioid misuse, factors that can impact treatment response (Aim 3). 
2.2 Hypotheses 
Our objective is to compare the effectiveness of MM to standard-of-care CBT, adjunctive to “usual care,” for improving 
outcomes in patients with opioid-treated CLBP. We will follow participants over 12 months and compare quantitative 
(survey, opioid dose, functional test data) and qualitative outcomes that matter to patients and their families in up to 
800 adults randomized (1:1 ratio) to the MM or CBT group, controlling for relevant factors.  
 
Hypothesis 1: Participants in the MM group will report a greater reduction in pain severity and a greater 
increase in function at 6 and 12 months compared to participants in the CBT group. 
 
Hypothesis 2: Participants in the MM group will report a greater improvement in Quality of Life (QoL) and 
a greater decrease in daily opioid dose at 6 and 12 months compared to participants in the CBT group. 
 
Hypothesis 3: Among those with increased baseline symptom severity of negative affect (depression, 
anxiety) and opioid misuse behaviors, MM will be more beneficial than CBT for reducing pain, increasing 
function, improving quality of life, and reducing daily opioid dose. 

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2.3 Study Interventions 
 
CBT, a traditional, standard-of-care behavioral therapy for chronic pain, attempts to teach patients to change unhealthy 
illness-related thoughts, emotions and behaviors so that they can develop more adaptive skills for coping with pain and 
related issues (Fig. 1).18-23 It draws upon a range of strategies and is typically tailored to the specific condition; as such, 
it is usually delivered in separate specialty settings, e.g., pain medicine, mental health or substance abuse programs, 
in the group or individual therapy format.18-23 This study intervention will be delivered in a group format. 
 
MM training encourages enhanced awareness of present-moment experiences (bodily sensations, thoughts, 
emotions).24 An intentional non-judgmental awareness and acceptance of one’s state of body and mind, without 
becoming preoccupied by it, promotes change in the relationship to this experience,24 without trying to change the 
experience itself (Fig. 1). MM fosters an ability to disentangle a given experience (e.g., pain) from associated bodily 
sensations, emotions and thoughts;25 this, in turn, is thought to improve emotion regulation, adaptive response to 
stressors, and a decrease in suffering.26 MM practice can be a foundation for engagement in life from a place of “being 
with,” rather than changing, one’s experiences, an important distinction from traditional CBT that may make MM a more 
effective pain-coping strategy for patients with CLBP.27 This study intervention will be delivered in a group format. 
 
 
 
Fig.1. MM and CBT offer different skills for the management of chronic pain. 
 
2.4 Summary of Relevant Clinical Data 
 
The results from our pilot RCT (N=35) suggest that MM is acceptable, feasible and can improve outcomes in 
patients with high-impact opioid-treated CLBP,17 documenting the need for a large pragmatic study of MM in 
this population. At baseline, participants (80% female; 51.8 ± 9.7 years old) reported substantial daily pain (5.8±1.4 
points on a 0-10 scale), disability (66.7±11.4 on a 0-100 scale) and treatment with a high daily opioid dose (148.3±129.2 
morphine-equivalent mg/day), confirming subpar results of usual care. By 26 weeks, using intention-to-treat repeated 
measures analysis, the MM group (N=21) lowered pain severity ratings by 1.0 point ([95%CI: 0.2, 1.9]; p=0.045; large 
effect size, d=0.86; Fig.3) and decreased pain sensitivity to thermal stimuli (p=0.008), compared to a wait-list control 
(N=14). The largest gains (p<0.05) were in MM participants who engaged in “higher-dose” practice, suggesting a dose-
response relationship. The MM group participants, relative to controls, also improved function by 6.5 points ([95%CI: -
1.0, 14.0]; p=0.21, medium effect size, d=0.68), achieving the minimal important change (MIC) for both pain28,29 and 
function.28-30 The MM group reported reduction in opioid dose by an average of 10 morphine-equivalent mg/day relative 
to controls (p=0.82). Patients and clinicians enthusiastically received this study, completing enrollment within 10 weeks. 
During the study, the MM group reported, on average, 164±122 min/week of formal and 104±112 min/week of brief 
informal MM practice.16,17 Seventeen MM participants evaluated the intervention, indicating satisfaction, and rating it, 
using a 0-10 scale, as “important” (8.0±1.8) and “useful” for pain coping (7.2±2.4), and stating they were likely to continue 
formal (8.1±2.8) and informal (9.4±1.0) practices; the themes identified by qualitative evaluations noted MM as useful 
for improving pain care and opioid use reduction.16 
 
Evidence on MM’s efficacy in CLBP, especially in opioid-treated patients, is promising yet limited and 
inconclusive, presenting a critical knowledge gap, as noted by the Agency for Healthcare Research and Quality 
(AHRQ),10 NIH,31 PCORI’s Stakeholders32 and systematic reviews.11,12,33 Assessment of MM for pain has been 
prioritized by the IOM in the 2nd quartile of its “top 100” comparative effectiveness research topics.34 The AHRQ’s meta-
analysis10 supports MM’s efficacy for pain in general (medium effect size, Cohen’s d=0.33 [95% Confidence Interval, 
CI: 0.03, 0.62]), while noting the limitations of existing studies, such as inadequate longer-term follow-up and an absence 
of studies in opioid-treated pain. Two more recent trials by our team assessed MM for opioid-treated chronic pain.15,17 
Garland et al. (N=115)15 found that MM, compared to an educational intervention, reduced pain severity (medium effect 
size, d=0.5; p=0.038) by 1 point on a 0-10 scale, and decreased pain interference (medium effect size, d=0.78; p=0.003) 
Mindfulness Meditation (MM)  
Non-judgmental, accepting awareness of 
present-moment experiences to change 
one’s relationship to these experiences 
Cognitive Behavior Therapy (CBT)  
Focus on modifying unhealthy thoughts, 
emotions and behaviors to change the 
experience and control symptoms 

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and the desire for opioids (medium effect size, d= 0.5; p=0.027) at 3 months; however, opioid dose was not assessed. 
The PI’s pilot RCT (N=35)17 suggested efficacy of MM in opioid-treated CLBP for reducing pain ratings (large effect 
size, d=0.86; p=0.045) and hyperalgesia (p=0.008) at 6 months, as compared to a wait-list control. Although function 
appeared to improve as well, this change was not statistically significant (medium effect size, d=0.68; p=0.21) in this 
small trial. The change in opioid dose was also non-significant yet encouraging, with participants in the MM group 
reducing dose by an average of 300 morphine-equivalent mg/month relative to controls (p=0.84).17 The pilot study 
participants were satisfied with MM and its effects, viewing it as useful for pain care and opioid use reduction. 
 
Although CBT is considered standard-of-care for chronic pain, evidence supports only modest benefit of CBT 
for CLBP and its long-term effects have not been well studied, especially in opioid-treated groups.18-20,35,36 A systematic 
review of behavioral therapies for CLBP18 noted low quality evidence favoring CBT over no-treatment for short-term 
pain relief (small effect size; pooled weighted mean difference, MD from -7.0 [95%CI: -12.3,-1.7] to -12.7 [95%CI: -
20.3,-5.1]) and, to an even lesser extent, for function (MD -2.9 [95%CI:-7.2, 1.4]). The Cochrane Collaboration’s meta-
analysis19 found CBT to be better than usual care for short-term pain relief (small effect size; MD -5.2 [95%CI: -9.8,-0.6] 
on a 0-100 visual analog scale), but not for longer-term pain relief or function, which was consistent with a second 
systematic review.20 The impact of CBT on opioid use in chronic pain is unclear due to a lack of high-quality research 
on this topic.18-20,35 
 
MM and CBT may produce different gains depending on patient’s individual characteristics. An RCT37 of 143 
patients with rheumatoid arthritis showed that both MM and CBT improved pain, function and negative affect outcomes. 
However, those with a history of depression benefitted more from MM than CBT in terms of improved pain coping, and 
reduced pain catastrophizing and negative affect (p<0.05).38 The authors hypothesized that MM training, focused on 
observing and accepting the experience, helped meditators become more adept at detecting subtle early cues, allowing 
them to start regulating responses to pain or stress before emotions become too intense.37,39 CBT on the other hand 
involves a cognitive reappraisal, which is usually deployed after the emotions have intensified; the usefulness of this 
cognitive strategy is often compromised when the intensity of negative emotions is high.40,41 It is possible that individuals 
with chronic pain and co-occurring anxiety, depression and/or opioid misuse, all conditions common in chronic pain and 
characterized by high-level of negative affect and emotion dysregulation, may respond better to MM than CBT. 
Evaluation of treatment response in relation to these factors is essential because chronic pain patients with comorbid 
anxiety, depression or opioid misuse are the very patients who have been found to be less responsive to existing 
therapies.42-44 Determining the individual patient phenotype most responsive to particular therapy would help guide 
clinical decision-making about optimal treatment choice. 
 
New evidence-based therapies are urgently needed for opioid-treated CLBP, and stakeholders are interested 
in MM. In preparation for this study, we solicited input from the vital stakeholders – patients with opioid-treated CLBP. 
Seventeen patient-participants in our pilot study16,17 expressed strong dissatisfaction with existing therapy options and 
were very interested in MM as a therapy for managing their pain, improving function and quality of life, and helping 
reduce opioid needs. The high patient interest in MM was also reflected in rapid recruitment into our pilot.16,17 Other 
important local stakeholders, including clinicians and health system leaders, have also seen the need and importance 
of MM as a treatment option. Since our pilot RCT, clinicians have continued to inquire about referring patients for MM, 
and leaders of local health systems have shown enthusiasm for MM as a therapy for opioid-treated patients.  
 
This research has the potential to improve healthcare and outcomes in patients with opioid-treated CLBP. 
The proposed RCT will be the first to directly address the effectiveness of MM compared to CBT in opioid-treated 
CLBP, delivered in addition to “usual care”. The study goals and the chosen interventions are very relevant to the 
affected patients, their clinicians and health systems. Outcomes favoring MM would help establish it as standard-of-
care and provide the rationale to increase its availability to patients, thus, improving outcomes in opioid-treated CLBP. 
Offering clinicians effective, safe options for CLBP, such as MM, would help reduce clinician burden related to the 
management of opioid therapy, as described by Co-Investigator Jamison45 and noted by clinician-partners advising on 
this project. The mission of health systems is to deliver evidence-based care and improve health of their patients; this 
mission could be advanced by offering MM, if proven effective. 

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2.5 Potential Risks and Benefits to Participants 
2.5.1 
Known Potential Risks 
The proposed interventions are not anticipated to lead to serious side effects or adverse events, as based on the existing 
literature10,19,20 and our prior studies.17,46-48  
 
Minor, immediate risks associated with this study may include: 
• 
Mild, usually short-lived psychological distress associated with difficult emotions or thoughts that may come up 
during the behavioral interventions. 
• 
Physical distress while staying in one position for a longer period of time. 
• 
Discomfort while answering sensitive survey questions about medications, mental health, pain or disability. 
• 
Risk of loss of confidentiality including legal, insurance, and/or employment issues. 
 
There are no anticipated long-range risks or reproductive risks. 
 
While the risks associated with this study’s interventions are minimal, our study team realizes that opioid-treated CLBP 
patients are generally at increased risk for pain worsening, mental health problems, and substance use disorders; while 
these issues may occur independently of study participation, we are aware that participants may experience these 
issues during the study, and we are committed to helping participants minimize these issues as detailed in 2.5.2. 
 
The value of the information to be gained from this research far outweighs the minimal possible risks associated with 
study participation. The proposed research may be beneficial to the community and society-at-large if mindfulness 
meditation proves an effective therapy for CLBP, a common, debilitating and expensive condition with a high local, 
national, and global burden, and for which existing strategies are unsatisfactory. Information gained could potentially 
lead to the acceptance of MM as a ‘standard of care,’ thus increasing access to these interventions for patients, 
benefitting patient, community, and society. 
 
Site-specific, Optional, Additional Tests 
 
Madison Site: Mindful Attention (Breath Counting) Test (Madison, WI) 
There are no known risks specifically associated with the breath counting test. 
 
Boston Site: Pain Sensitivity and Modulation (QST) Test 
There is a slight chance of mild transient bruising and discomfort associated with use of the probes or algometer. 
In our experience, this is quite rare (< 5 % of cases). There are no known risks associated with hand immersion in 
cold water, with the participant explicitly instructed to remove the hand and stop the task when it becomes painful.  
 
Salt Lake City Site: Emotion Regulation and Cue-Reactivity (ERCR) Test 
There is a slight chance that the ER and CR tasks may result in mild distress. In our experience, this is quite rare 
(< 5% of cases). It is very unlikely that such distress will exceed that which would occur on an everyday basis, given 
that the images used in the proposed study are similar to scenes present in participants’ natural environments.  
2.5.2 
Protection Against Risks 
The investigators have taken multiple steps, tested in prior trials, to protect participants against potential risks of 
participation in a clinical trial of behavioral interventions.  
 
In order to reduce the risk of psychological, emotional, and physical distress due to the study participation, we will 
make every effort to make our participants comfortable during all study procedures. Participants will be informed that 
they can choose not to perform any tasks or answer any question at any time, in the event that certain questions or 
assessment tasks cause emotional, psychological, or physical discomfort. Participants will also be encouraged to 
discuss any potential concerns with the research team members. 
 
In order to minimize the risk of psychological and/or physical risks that patients with opioid-treated CLBP are more 
likely to experience, this study will utilize a robust safety protocol. All study personnel will be trained in this protocol. 
 

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All In-person study assessment and intervention sessions will be held at a clinical or research facility, where access to 
the phone will be readily available. The study interventions will be delivered in a clinical or research facility by a trained 
therapist with at least one other research staff member or clinician present or readily available and access to the phone 
readily available. When remote participation in the study activities (e.g., intervention sessions, assessment visits) is 
needed, the virtual delivery will take place via an approved, secure, HIPAA-compliant platform (e.g., WebEx, HIPAA-
compliant Zoom, etc.) or by phone. During the in-person videorecorded activity (at baseline and exit), a researcher will 
walk alongside the participant for assistance; this will minimize the risk of falls. As pain flares are common in this 
population, participants will be encouraged to implement the study-taught techniques for pain coping and consult their 
regular physician, if needed, for additional pain care. 
 
Drs. Bruce Barrett, Nalini Sehgal (Madison, WI); Edgar Ross, Edward Michna (Boston, MA); Aleksandra Zgierska, 
Robert Lennon (Hershey, PA) are physicians; Dr. Linda Oakley (Madison, WI) is a Nurse Practitioner; Drs. Robert 
Edwards, Robert Jamison, (Boston, MA), and Eric Garland (Salt Lake City, UT) are clinicians practicing in the fields of 
mental health. All the above Investigators are experienced in the management of issues related to the treatment of 
CLBP and mental health problems including acute suicidality. In addition, Dr. Julie Fritz (Salt Lake City, UT) and Evan 
Nelson (Madison, WI) have expertise in physiotherapy for CLBP. Together, the above Investigators as well as the 
study therapists and other designated study clinicians will be able to address any medical or mental health issues that 
may arise. A designated 'on call' study physician will always be readily available via cell phone or pager for study-
related questions or problems; a designated ‘on call’ mental health specialist will be able to address mental health 
related issues, including acute suicidality. A study clinician will always be consulted if the Safety Protocol is initiated 
(see Appendix). The Safety Protocol has been successfully utilized in the PI's prior studies. The data safety monitoring 
committee (DSMC) and the IRB will be timely notified in the case of a serious adverse event.  
 
The therapists delivering the study interventions will have a background in psychology, counseling or social work, thus 
well-equipped to address any potential psychological discomfort in relation to the interventions. In case of worrisome 
symptoms observed during the intervention sessions or assessment sessions, regardless of their mode of delivery (ie, 
in person, by phone, or via online platforms), the therapist or a research staff will discuss the concerns individually with 
the symptomatic participant, follow the Safety Protocol procedures, and contact the designated study clinician for 
consultation as needed if concerns persist for further assessment and directions (see Section 2.5.2 for details). 
Depending on clinical assessment, participants will be cleared to stay home or go home (by themselves, with family 
members/friends or via study-provided cab) or referred to the appropriate Emergency Department (ED). Participants 
who are sent home will be encouraged to contact their regular providers for evaluation, if needed, and receive a follow-
up phone call the following day. Information on the resources available for counseling or other services to help with 
anxiety, distress, or feelings of sadness will be provided as a part of the Safety Protocol; these referred services will 
be paid for by the participant/participant’s health plan. In case of emergency, the therapist or research staff will call 
911, and the participant’s emergency contact person will be notified (this procedure will be outlined in the 
consent/HIPAA form). Study staff will have emergency contact information available for all participants participating in 
a meeting.  
 
The additional, optional, site-specific tests will be completed for in-person study visits only. Although they are 
considered overall safe, should unforeseen problems occur, the main study’s Safety Protocol procedures will be 
implemented, and the study’s on-call clinician will be contacted to assess the participant. In addition, in the Salt Lake 
City study site, where Emotion Regulation and Cue-Reactivity (ERCR) test will be implemented, to monitor for potential 
risk of emotional distress, participants will be asked to rate their negative mood on a 5-point numeric rating scale (1= 
none, 5= extreme) before and after the ER and CR tasks, and then again at the end of the assessment session. In the 
unlikely event that participants report distress resulting from the task as determined by an elevation in negative mood 
by 2 points from baseline levels at the end of the assessment, the research staff performing the test will be trained by 
the PI (a licensed clinical social worker and clinician with over 12 years of experience) to debrief participants, assess 
risk, and provide 15 minutes of progressive muscle relaxation to ensure subjects have experienced a reduction in 
negative mood to a level of within 2 points of their baseline level. In three RCTs with opioid-treated chronic pain 
patients, Dr. Garland used the risk management strategy, and no participants remained distressed after this procedure. 
Should the distress level persist though, or unforeseen problems occur, the main study’s Safety Protocol procedures 
will be implemented, and the Utah PI (a licensed clinical social worker with 12 years of clinical experience) or the 
study’s on-call clinician will be contacted to assess the participant. 
 
All efforts will be made to protect participant privacy and confidentiality: 

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• 
The initial screening, informed consent process and all in-person data collection will be conducted in private 
settings.  
• 
During the intervention sessions, participants will be able to use their first names or nicknames, and be asked 
to keep the information shared by others confidential.  
• 
During  virtual study sessions, participants will be recommended to engage in the session in a private location, 
with headphones/earbuds if possible, and to turn off other devices as to protect confidentiality. 
• 
During virtual study sessions, the study staff present for the sessions will engage in the session in a private 
location, with headphones/earbuds, and will turn off other devices as to protect confidentiality. 
• 
During virtual study sessions, the videorecorded activity will be recorded using the institutionally-approved 
HIPAA-compliant virtual platform; after the session, it will be transferred to and stored at the secure UW 
servers. 
• 
During the intervention sessions, the therapist and the research staff will moderate the session to ensure that 
only study participants are present for both virtual and in-person sessions.  
• 
Collection of sensitive information about participants is limited to the amount necessary to achieve the aims of 
the research. 
• 
All of the data related to study participation will be kept confidential; data will be coded with a unique code for 
each participant and stripped of identifiers prior to being viewed by Investigators.  
• 
Electronic outcome data will be managed using the secure REDCap database.  
• 
Experienced EHR data analyst will help link the EHR data on prescribed opioids to other outcome data in a 
way that does not compromise participant confidentiality, using a study ID number for all data linkages.  
• 
A master list with identifiers will be kept in a separate secure database/separate locked filing cabinet, by the 
Site PI or Site Manager at the site’s research office.  
• 
Identifying information will not be recorded on any outcome measures/data.  
• 
All patient identifying data will be destroyed after the trial is completed, per IRB guidance. 
• 
All computerized data will be password-protected and personnel will be restricted to viewing only data 
appropriate to their role in the project; all study personnel will receive the training required by the IRB. 
• 
Outcome data will NOT become a part of the participant medical record; all data will be collected for research 
purposes only.  
2.5.3 
Potential Benefits to Participants 
Participants may experience added benefit should a given study intervention have a positive effect on their CLBP-
related outcomes. All study participants can benefit from the additional safety and support net provided by the study, 
which may facilitate stepped-up care, if needed, more quickly than ‘usual care’ alone. 
3 
Study Objectives and Purpose 
Our objective is to compare the effectiveness of MM to standard-of-care CBT for improving outcomes over a 12-
month follow-up period in patients with opioid-treated CLBP.  
 
• 
Primary Objective: To compare the effectiveness of MM to CBT, delivered in addition to “usual care,” for reducing 
pain and increasing function (primary outcomes) in adults with opioid-treated CLBP. 
 
• 
Secondary Objective: To compare the effectiveness of MM to CBT, delivered in addition to “usual care,” for 
improving quality of life (QoL) and reducing daily opioid dose (secondary outcomes) in adults with opioid-treated 
CLBP. 
 
• 
Tertiary Objective: To examine if participant baseline characteristics impact treatment response to MM or CBT. 
4 
Study Design and Endpoints 
4.1 General Design 
We will conduct a 5-year multi-center RCT (up to 800 participants), comparing the effectiveness of MM and CBT, 
delivered in addition to “usual care,” for improving patient-centered outcomes in adults with opioid-treated CLBP.  
 

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Participants will be recruited by three main study sites: University of Wisconsin-Madison, Harvard University, Brigham 
and Women’s Hospital, and University of Utah. Each participant will be followed-up for a period of 12 months. They 
will be randomly (1:1 ratio) assigned to MM or CBT arms; participants will receive an 8-week MM or CBT intervention, 
and asked to practice MM or CBT, respectively, at home daily during the entire study.   
 
Outcome data will be collected twice virtually or in person at baseline and at exit assessment visits, and three times 
“remotely” (online or by phone) at 3, 6, and 9 months post-intervention start date. A subset of participants will be invited 
to a by-phone in-depth qualitative interview at the end of the study. 
 
Table 1: Timeline of Study Activities, Contact and Data Collected for Individual Participants During the 12-
month Study 
Recruitment & 
screening 
Enrollment, Baseline  
Assessment, 
Randomization 
Study 
Intervention 
Follow-up 
Assessments at 3, 6 
and 9 months 
Exit Assessment 
at 12 months post-entry 
▪Recruitment, 
eligibility screen  
(by phone or in 
person) 
▪Informed consent;  
▪All survey-based data   
(virtually or in person) 
▪Brief videorecorded 
activity (virtually or in 
person) 
▪Randomization 
▪EHR (selected 
participatnts): 
prescribed opioids  
(researcher collected) 
▪MM/CBT course     
(virtually or in 
person; 8 weeks,     
2 hours/week);  
▪MM/CBT practice   
(at home; entire 
study, 30 min/day, 
6 days/week) 
▪Survey-based data 
(online/phone):  
 
outcome, adherence, 
safety data at 3, 6, 
and 9 months 
 
other survey data at 6 
months only 
▪All survey-based data        
(virtually or in person);  
▪Brief videorecorded 
activity (virtually or in 
person);  
▪EHR (selected 
participants): prescribed 
opioids (researcher 
collected) 
▪Subgroup: in-depth 
interview (by phone) 
4.1.1 
Primary Study Endpoints 
 Outcome measures are described in Section 9.2.2 
• Pain intensity will be assessed using the 0-10 point Numerical Rating Scale (NRS) from the Brief Pain Inventory 
(BPI).49,50 
 
• Physical function will be measured using the validated Oswestry Disability Index (ODI);51,52 in addition, we will use 
7 pain interference items from the BPI.49,50,53 
4.1.2 
Secondary Study Endpoints 
• 
Quality of life will be assessed using the validated Medical Outcomes Study Short Form Health Survey (SF-12 
v.2),54,55 a common measure of health and QoL in CLBP.56 
 
• 
Daily dose of prescription opioids for “the past 14 days” will be collected with the Timeline Followback (TLFB) 
method,57-59 and verified against a participant’s EHR data on prescribed opioids. This will enable longitudinal 
evaluation of opioid dose change during the proposed 52 week follow-up. To calculate a “daily opioid dose,” doses 
of all reported opioids will be converted to a morphine-equivalent dose by multiplying daily dose of a given opioid 
by the published conversion factors, as we pilot-tested.60   
 
5 
Study Participants – Enrollment and Withdrawal 
We will enroll English-speaking adults with opioid-treated CLBP who are diverse in terms of gender, race, ethnicity, and 
mental and physical health conditions. Our sample will include participants enrolled by three sites: Madison, WI, Boston, 
MA, and Salt Lake City, UT.  
 
We conservatively estimate the need to screen approximately 4,000 individuals to enroll up to 800 participants within 
the first 4 years, assuming the attrition rate not to exceed 20%. 
 

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5.1 Participant Population  
Our sample will include participants who are patients with opioid-treated chronic low back pain, and enrolled by one of 
the three study sites: Madison, Wisconsin, Boston, Massachusetts, and Salt Lake City, Utah. Eligible participants will 
be English-speaking adults ≥ 21 years old with opioid-treated CLBP who are diverse in terms of gender, race, ethnicity, 
and mental and physical health conditions.  
5.2 Inclusion Criteria 
 
Inclusion Criteria (based on self-report) 
1. English-speaking  
2. ≥ 21 years old 
3. Diagnosis of chronic low back pain (defined as a pain in lumbosacral region or sciatica for ≥3 months) as 
the main pain source 
4. Average daily pain score ≥3 on a 0-10 numerical rating scale (question from the Brief Pain Inventory) 
5. Treatment with ≥15 mg/day of morphine-equivalent dose for ≥3 months 
6. Report at least moderate CLBP-related disability (≥21 score on the Oswestry Disability Index) 52 
7. Capable of giving informed consent 
8. Willing to complete all study activities 
 
Rationale: CLBP is the leading chronic non-cancer pain for which opioids are prescribed. Age 21 years old defines an 
adult per the NIH guidelines, and treatment with long-term opioids for CLBP is uncommon in those younger than 21 
years.61 Because pain severity and function are the main outcomes, we will enroll those reporting at least moderate 
pain/disability. We will enroll patients treated with ≥15 mg/day of morphine-equivalent dose because: a) This dose range 
will enable evaluation of dose change (including any potential increases) across the spectrum of daily opioid dose 
categories. This is important, as the risk associated with opioid therapy is dose dependent. Even those in a lower daily 
dose category of 20-49 mg/day have a 44% increase in the risk of overdose compared to those treated with a daily 
opioid dose of less than 20 mg/day (Hazard Ratio 1.44; 95% CI: 0.57–3.62).62 In addition, the group of patients treated 
with lower daily opioid doses may have the best chance for tapering off opioids completely, should other treatments 
(e.g., MM) prove effective. The enrollment of patients treated with a broad spectrum of daily opioid doses will facilitate 
evaluation of the study intervention effects on opioid use/dose over time, especially in the proposed subgroups of 
participants as those treated with a lower daily opioid dose are more likely to have lower negative affect and opioid 
misuse scores compared to those treated with higher daily opioid doses. 
5.3 Exclusion Criteria 
We will exclude those with specific mental health disorders, described in the exclusion criteria, and other conditions or 
circumstances that may pose concerns for safety or reliable participation. We will not exclude on the basis of common 
mental health (anxiety, depression) or substance use disorders, because they are prevalent in this population and can 
affect outcomes (Aim 3 hypothesis). We will not exclude based on anxiety, depression or substance use disorders, as 
these conditions are common and can impact treatment success in opioid-treated CLBP,4 or based on a socio-economic 
status, gender, race or ethnicity. 
 
Additional Exclusion Criteria for Optional, Additional Tests 
Madison Site: Mindful Attention (Breath Counting) Test (Madison, WI): None 
 
Boston Site: Pain Sensitivity and Modulation (QST) Test (Boston, MA) 
1) Raynaud’s syndrome in the hands 
2) Hemophilia or other clotting disorders (may increase the risk of bruising) 
 
Salt Lake City Site: Emotion Regulation and Cue-Reactivity (ERCR) Test: None 
 
Exclusion Criteria (based on self-report) 
1. Prior formal Mindfulness Meditation or Cognitive Behavioral Therapy training 
2. Current pregnancy 

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3. Diagnosed with borderline personality, delusional, or bipolar (mania) disorders ("active" in the prior 12 
months) 
4. Inability to safely or reliably participate in the study 
5.4 Participant Screening for Recruitment  
5.4.1 
Participant Identification 
Participants will be identified using several mechanisms tested in previous studies26,40,65,66: 
Recruitment activities in Madison will include Access Community Health Centers (ACHC), SSM Health, Group Health 
Cooperative (GHC) of South Central Wisconsin, UnityPoint Health - Meriter, and UW Health; in Boston, they will 
include Brigham and Women’s Hospital/Harvard Medical School health system; and in Salt Lake City, they will include 
University of Utah health system. The recruitment plan includes (1.) direct referral by clinicians, involving for example 
clinicians identifying potential subjects and providing them with contact information for the study team, securely 
sharing of the referred patient’s name and contact information with the research team after the patient signs a 
permission form, which will then be securely faxed to the study team; (2.) self-referral by patients (including contacting 
the study team’s via study-designated phone number or email) via study information posted in clinics, community 
centers, and other locations, via media including television, radio, the web, online streaming services, and others; and 
through the “word of mouth”; (3.) research coordinators working with participating clinics’ clinical staff to identify study-
eligible patients among those receiving care at the clinic and scheduled for an appointment. Once a potentially eligible 
patient is identified, they will be provided study information (such as the study brochure) by the clinic staff and 
encouraged to contact research coordinator to find out more about the study; should the patient indicate interest 
during the appointment and not object to it, the research coordinator will then contact the patient after their 
appointment (e.g., in person at the clinic; by phone) to assess interest in study participation, and if the patient is 
interested and agreeable, to proceed with the screening process; (4.) identification of potential participants through 
referral from other studies. Once a potentially eligible participant is referred, they will be contacted and, if interested, 
provided the study information, and offered an opportunity to be screened for eligibility; and (5.) identification of 
potential participants through electronic health record (EHR) data extraction. The EHR database search will be 
conducted using a protocolized data search algorithm, which will search for adult patients with chronic low back pain, 
treated with chronic opioids. This data search will generate a list of potential participants including the patient’s name, 
gender, age, address, phone number, and primary care provider (if possible), information. No individual health record 
will be reviewed. Recruitment letters and response cards will be sent to those who are identified, and follow-up calls 
made to those who didn’t opt-out by the study team. For those unreachable by phone after the initial mailing of 
recruitment materials, recruitment materials will be re-sent a second time via mail and/or by email, with follow-up by 
phone and/or email. For those unreachable after the second mailing, the recruitment materials will be re-sent up to 3 
additional times, as needed, with follow-up by phone and/or email. Clinicians and clinic staff will not receive any 
incentives for participant recruitment. When sending invitation letters to potential participants, we will include: the 
invitation letter signed by the site PI; and the invitation letter signed by both the site PI and the given health system’s 
leadership representative at the University of Utah, Brigham and Women’s Hospital/Harvard Medical School, UW 
Health, ACHC, UnityPoint Meriter GHC and SSM Health health systems. For all involved research sites, UW IRB will 
serve as the IRB of record. These sites will be engaged in research, including the extraction of data from patient 
medical records for recruitment purposes, and will provide the study team with contact information of potential 
participants to allow for recruitment letters to be mailed and/or emailed and follow-up calls and/or emails to be made, 
as appropriate, by the study team 
 
5.4.2 
Recruitment and Retention Strategies 
Our patient, family and community advisors, including the CARDS group; staff from the Wisconsin Network for Research 
Support; and Investigators with expertise in engaging patients have advised on the recruitment strategies and materials. 
 
Potential participants identified via health record-based data search or by their clinicians will be mailed letters with an 
opt-out/response card (see section 5.4.1. for details). Those who do not return these cards within the pre-specified time 
period will be contacted by the study coordinator by phone. Potential participants will also be able to call the research 
coordinator directly using the contact information found in the study brochure, website or other advertising. 
 

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During the initial screening conversation by phone or in person, study coordinators will read an informational statement 
about the study and about the risks and rights as a participant, in particular the right to cease participation at any time 
without any repercussion or loss of benefits. The coordinator will also ask if the potential participant has any questions 
about the study and will answer questions they may have before seeking a verbal consent to proceed with eligibility 
screening. Those ineligible or uninterested will be offered information about MM and CBT therapy options. Interested 
eligible persons will be invited to a virtual or in-person meeting with the study coordinator to go over the details of study 
participation, review an informed consent and authorization for the use of health information form (one combined form) 
and provide oral (or written, for in-person meetings) consent. The participant will receive a copy of the consent form for 
their records. When a participant provides written consent, a copy will also be kept as part of the study records; for oral 
consent, the provision of consent will be indicated in the study records. All participants will be informed that their 
participation is voluntary, of their right to withdraw at any time for any reason, and will be encouraged to ask questions 
at any time.  
 
We conservatively estimate the need to screen 4,000 individuals to enroll up to 800 participants within the first 4 years 
of the study, with the assumption that the attrition rate will not exceed 20%. These assumptions and estimates were 
based on previous research conducted by the PI and Co-Is, and the results of sample size calculation (see Appendix).  
 
Retention 
Every effort will be made to retain participants through the 12-month study period, encourage completion of all study 
activities and measures, and minimize missing data. We will utilize several methods to retain participants that have 
been successfully used in our prior RCTs17,46-48 
• We will have study-designated phone numbers for ease of contact. 
• We will collect information on different ways for contacting participants (home / email addresses, phone numbers, 
emergency contact) and update it at each follow-up contact. 
• Participants will receive reminder messages prior to scheduled meetings. 
• Study personnel will inquire about participant experience, and solicit comments, questions, and potential problems 
during each contact so that issues can be identified and resolved quickly. 
• We will use brief assessment tools and limit the number of assessments and in-person or virtual meetings. 
• We will allow breaks during study activities. 
• We will reimburse participants for their time/effort. They will be compensated: $30 for each baseline and exit survey 
completion and $20 for each remote follow-up survey completion; $20 for the completion of each videorecorded 
activity; $50 for an in-depth interview (a subgroup of participants); and a $10 for each attended intervention session.  
• We will additionally incentivize adherence by implementing a $100 bonus for those who were adherent to the study 
intervention sessions during a given MM or CBT intervention cycle.  
• We will provide light snacks during each of the 2-hour intervention sessions when conducted in person. 
• We will offer transportation assistance to study activities if needed; we estimate ~6% of study visits will require 
transportation assistance, usually a cab ride.30,41,68   
• In-person interventions and study assessments will be conducted at medical or research facilities that are easily 
accessible by bus and/or have convenient parking. 
• In addition, for those who enroll in the optional additional in-person testing, we will provide the reimbursement of 
$10 per additional test, totaling up to $20 during the study. 
 
Furthermore, this study utilizes several stakeholder groups, including the PFA, the SAC, the WINRS and the CARDS®, 
that have actively guided study planning and implementation, and will engage in problem solving efforts as needed. 
These groups will provide ongoing support for successful participant engagement throughout this study.63  
5.5  Vulnerable Populations 
Competent adults, meeting eligibility criteria, will be able to participate regardless of gender, race, ethnicity, religion or 
socioeconomic status. Prisoners, pregnant women and mentally impaired persons will not be included. Children, per 
eligibility criteria, are not eligible. 
 
TABLE 1: Vulnerable populations included and excluded from this study: 
 
Include 
Exclude 
Vulnerable Population Type 
 
x 
Adults unable to consent 

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x 
Individuals who are not yet adults (e.g. infants, children, teenagers), age <21 years old 
 
x 
Wards of the State (e.g. foster children) 
 
x 
Pregnant women 
 
x 
Prisoners 
5.5.1  
Participant Capacity 
N/A 
5.5.2  
Participant/Representative Comprehension 
N/A 
5.6 
Informed Consent 
The PI will be responsible for ensuring that valid consent is obtained and documented for all participants. Informed 
consent will be obtained as a two part process. This multi-step screening/consent process will allow each potential 
participant to have an ample time to consider and decide about their study participation. 
 
1. Potential participants will discuss the study by phone or in person with the study coordinator and complete the initial 
eligibility screen. During this conversation, the coordinator will read an informational statement about the study and 
about the risks and rights as a participant, in particular the right to cease participation at any time without any 
repercussion or loss of benefits. The coordinator will then obtain oral consent to proceed with the eligibility screening 
process. 
 
2. Persons who pass the initial eligibility screening will be invited to a virtual or in-person meeting with a study 
coordinator to review details of study participation, review an informed consent and HIPAA authorization for the use 
of health information form, provide oral or written for in-person meetings) consent, and receive a study information 
sheet. The participant will also receive a copy of the consent form for their records. When a participant provides 
written consent, a copy will also be kept as part of the study records; for oral consent, the providing of consent will 
be indicated in the study records. 
5.6.1 
Process of Consent 
Prospective participants will discuss the study with a research coordinator. During this conversation, the research 
coordinator will read an informational statement describing the study and informing the participant of the risks and 
his/her rights as a participant, in particular the right to cease participation at any time without any repercussion or loss 
of benefits. The study coordinator will then seek to obtain participant’s verbal consent to proceed with eligibility 
screening. Those not eligible or interested in study participation will be referred back to their usual providers and offered 
information about MM and CBT therapy options. Eligible and interested individuals will be invited to a virtual or in person 
meeting (enrollment meeting) with a study coordinator where informed consent procedures will take place. At both the 
in-person and virtual meetings, the research coordinator will explain the study details and answer questions the 
participant may have about participation. Participants will then have time to privately review (with the study coordinator 
available) the informed consent and authorization for use of health information form, have questions answered and then 
provide oral or written, for in-person meetings consent, if interested in participating in the study.   
 
In-Person Consent 
At the in-person version of the initial meeting, The participant will review the consent form in person with the research 
coordinator present, have an opportunity to ask questions, then decide if they would like to participate in the study. For 
those interested in participating, they will sign a written consent form and receive a copy for their records. A copy will 
also be kept as part of the study records. Participants will also be given a one page info sheet, which briefly explains 
the study and who to contact with questions or concerns. Participants will also be provided explanation and opportunity 
to discuss the site-specific additional, optional testing (see Appendix), which would take place at the end of the in-
person study visits. They will need to complete an additional consent form for the additional, optional testing. Their 
agreeing to, or declining, the additional, optional testing will not impact their participation in the main study. Participants 
will be informed of their right to withdraw from participation at any time, for any reason, and will be encouraged to ask 
any questions at any time. The study coordinator will be trained in confidentiality, informed consent procedures, and 
other aspects of human subject protection. 

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Virtual Consent 
After the participant is screened as eligible through the phone screening process, they will be emailed/mailed the 
consent form and one page info sheet, which briefly explains the study and who to contact with questions or concerns, 
in advance of the virtual initial meeting and asked to review it prior to the meeting. At the virtual initial meeting, the 
research coordinator will confirm that the participant reviewed the consent form, and if not, provide time for the 
participant to read through it. After it’s confirmed that the participant has read the consent form, the participant will have 
an opportunity to ask questions, then decide if they would like to participate in the study. For those interested in 
participating, the research coordinator will read a script (see Virtual Enrollment Script) to obtain participant oral 
consent/HIPAA authorization, and will indicate the obtaining of oral consent in the study records. Participants will be 
informed of their right to withdraw from participation at any time, for any reason, and will be encouraged to ask any 
questions at any time. The study coordinator will be trained in confidentiality, informed consent procedures, and other 
aspects of human subject protection. 
 
 
5.6.2 
Combined Consent and HIPAA Form  
Attached in Appendix. 
5.6.3 
HIPAA 
We will collect the following protected health information (PHI) from each participant: 
• 
Name, date of birth, contact information, emergency contact information, and the name of the participant’s 
primary medical provider. 
• 
Information collected from participants as part of research procedures, including self-reported information about 
participant’s symptoms, health, study experience and health care and medication utilization; objectively-
measured physical function during a videorecorded task; and data from the EHR on prescribed opioids. 
 
In addition, in a subgroup of participants, we will collect the following: 
• 
Interview-based qualitative data on the study-related experiences in selected subgroup of participants who 
completed the study follow-up. 
• 
Site-specific optional, additional data during in-person visits only on the following: ability to focus attention 
(breath counting test, performed on a computer) in Madison Site; pain sensitivity and modulation testing 
(quantitative sensory testing method) in Boston Site; and emotion regulation testing (heart rate variability, 
respiration, facial activity-based measures) in Salt Lake Site. The study participants, once enrolled into the main 
study, will be able to decide, by signing an additional consent, if they wish to participate in these optional 
additional tests.  
The research information collected from participants during this study will be used by researchers at UW-Madison, 
Pennsylvania State University, Harvard University, and University of Utah for research purposes only. Regulatory and 
research oversight boards and offices, accounting and billing personnel, and research support staff at each of these 
institutions may also need to use participants’ health information over the course of this research, e.g., for tracking or 
payment purposes. 
 
Other parties outside these institutions who may need to receive participants’ health information in the course of this 
research include: 
• 
Federal oversight and regulatory groups, such as the U.S. Food and Drug Administration (FDA) and the study’s 
funding agency - Patient-Centered Outcomes Research Institute (PCORI). 
• 
Healthcare providers, in the event that worrisome symptoms that warrant concern about a participant’s health 
or safety during the study require a referral to the Emergency Department. 
 
Participants’ protected health information will be kept confidential. We will protect participants’ confidentiality by 
identifying each participant with a code, and keeping records in secure databases and filing locations. A key to connect 
the codes to identified information about the participants will remain with the researchers who have been granted this 
permission by the PI and have appropriate training. Participant identifiable information will not appear in any publication 
of the results of the study. We may publish selected videorecorded segments for the purpose of result dissemination 
but this will happen only with the explicit written permission from those participants. 

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Unless a participant withdraws their permission in writing to stop the use of their research data or PHI, there is no end 
date for its use in this research study.  
5.6.4 
Revoking Consent 
Withdrawal of permission to use health information can be made at any time in writing to the study or site PIs (Zgierska, 
Barrett, Edwards, Garland). Beginning on the date a participant’s permission ends, no new health information will be 
used. Any health information that was shared before the participant withdrew permission will continue to be used. If a 
participant withdraws their permission, they can no longer actively take part in the research study. 
5.6.5  
Costs to the Participant 
Participants will not be responsible for any costs related to study materials, procedures or intervention delivery. 
5.6.6 
Payment for Participation 
Participants in both intervention groups will be compensated for time and travel, to a total of up to $240 for the main 
study. Compensation will be prorated based on the number of study assessments and intervention sessions completed. 
All participants will receive a total of up to $160 for the completion of the assessments ($30 for each baseline and exit 
assessment and $20 for each of two videorecorded activities [baseline, exit interview]; $20 for each of three remote 
follow-up assessments [3, 6, 9 month follow-ups]). In addition, all participants will also receive up to $80 reimbursement 
for completing the intervention sessions ($10 for each attended intervention session). A subset of up to 80 participants 
will be selected to complete a single in-depth qualitative interview after they complete the study, for which they will 
receive $50. We will additionally incentivize adherence by implementing a $100 bonus for those who were adherent to 
the intervention sessions during a given MM or CBT intervention course. Participants will receive the study interventions, 
along with handouts, and other materials to facilitate daily home practice, free of charge. Bus passes or cab rides for 
study-related transportation will be provided, if needed. Study participants who agree to the optional, additional testing 
(conducted at baseline and exit) will be reimbursed $10 per each additional testing (total up to $20).  
5.7 Early Withdrawal of Participants 
5.7.1 
Premature termination of study 
This study is considered a “minimal risk”. Therefore, we do not plan to implement formal interim safety/efficacy analyses 
with pre-defined stopping rules. However, we will monitor the study and participant progress and safety. If there are 
safety concerns, we will bring them to the DSMC, the IRB and the PCORI and address them appropriately.  
5.7.2 
When and How to Withdraw Participants 
It is possible that participants may need to be withdrawn from the study or the additional testing (if they signed up for it) 
prior to their expected completion date. Participants may be withdrawn if: 
• 
S/he is determined by the Study or Site PI and the DSMC to be unable to continue participation due to safety, 
physical or mental health concerns. 
• 
Submits written notification of consent withdrawal to the Study or Site PI. 
5.7.3    Data Collection and Follow-up for Withdrawn Participants 
If a participant chooses to stop attending the intervention sessions, but does not withdraw from the study, outcome data 
will be collected per usual data collection protocol. If a participant is withdrawn from the study for reasons as described 
in 5.7.2, no further data will be collected.   
6 
Description of Study Interventions 
This study evaluates a comparative effectiveness of two behavioral interventions, MM and CBT, delivered in addition to 
“usual care,” which will be provided to the study participants for their opioid-treated CLBP by their regular providers. 
 
The choice of CBT as a comparator intervention to MM is appropriate because CBT is standard-of-care for CLBP,1,18-
20,35 and, similarly to MM, is a psychological therapy that can be delivered in a group format.21,22  
 

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Both MM and CBT interventions have been patterned after existing programs21,22,24,64,65 and adapted to meet the needs 
of patients with opioid-treated CLBP, with input from content experts and patient advisors who were participants in the 
PI’s pilot RCT.36 These interventions will be matched in terms of duration, setting and contact time to limit intervention 
bias. Each intervention will follow a written manual and be delivered by a trained therapist with at least one other 
research staff member or clinician present or easily accessible by phone over 8 weeks (weekly two-hour group 
sessions). In-person delivery will take place in a clinical, research- or community-based facility. When remote 
participation in the study activities (e.g., intervention sessions, assessment visits) is needed, the telehealth delivery will 
take place via an approved, secure, HIPAA-compliant platform (e.g., WebEx, HIPAA-compliant Zoom, etc.) or by phone. 
In addition, participants will be asked to practice MM or CBT strategies at home for at least 30 minutes/day, 6 days/week 
during the 12-month study and log their practice minutes. The session format will be comparable between the 
interventions. Each session will start with the review of home practice, experiences, concerns and questions, followed 
by a MM or CBT exercise, then introduction to the session-specific core concepts and 2-3 MM or CBT exercises 
(concept application), each followed by discussion of participant experiences and MM skills for coping with challenges 
related to opioid-treated CLBP. This interactive format will enable monitoring and enhancement of participant treatment 
receipt and enactment, essential elements of treatment fidelity. Each session will end with a review of the home practice 
for the following week. These methods and targets are feasible.16,17,47,66 The outline of the MM and CBT interventions is 
attached in Appendix.   
6.1 
Usual Care 
All participants will be asked to continue their usual treatment, including opioid therapy management and other 
treatments for CLBP, through their regular providers. Usual treatment for CLBP includes: physical therapy, surgery, 
acupuncture, chiropractic care, hydrotherapy, medication therapy (including but not limited to:  tricyclic antidepressants, 
selective serotonin reuptake inhibitors, serotonin and norepinephrine reuptake inhibitors, NSAIDs and other over the 
counter pain medication), and vitamins and herbal remedies. 
 
In addition to study-specific outcome measures, which include self-reports on the daily opioid dose, we will also obtain 
data from the participant’s EHR on opioids prescribed in the course of usual care; study participants will consent to the 
release of this medical information as a part of their consent form. 
6.2 
Randomization and Blinding of Study Intervention 
N/A Participants will be randomized equally between MM and CBT arms (1:1 ratio), using a permuted blocks of random 
size strategy, stratified by site and prepared by the study statistician. Sealed envelopes with group assignment will be 
distributed consecutively; participants will break the seal after completing the baseline assessments. 
 
Although participants, therapists and outcome assessors cannot be blinded to the study intervention, investigators and 
analysts will be blinded to the group status until the first stages of analysis and reporting are completed. 
7 
Study Procedures 
The initial eligibility screening will take place by phone or in person (see Section 5.4.2 for details). Those eligible and 
interested in participation will meet in person with the study coordinator. 
 
In-Person Consent/Enrollment/Baseline/Randomization 
During the in-person meeting at baseline, eligibility will be confirmed. Eligible, interested individuals will complete the 
written informed consent procedures and be assigned a study ID number (approximately 20 minutes to complete, on 
average). Then they will complete the baseline questionnaires (approximately 55 minutes to complete, on average), 
followed by a brief videorecorded activity focused on the assessment of physical function (approximately 10 minutes to 
complete). This videorecorded activity will involve the participant performing the standardized Timed Up and Go (TUG) 
test, evaluating a participant ability to stand up from a chair, walk 3 meters, before walking back to the chair and sitting 
down,110,111 and a brief interview about the impact of back pain and opioid therapy, and expectations/impact of the study. 
Then participants will be randomized (1:1 block scheme prepared by the study statistician) to the MM or CBT groups, 
and receive information about details and scheduling of their respective interventions. All baseline questionnaires can 
be completed verbally, electronically, or on paper if the participant requests it. 
 
Virtual Consent/Enrollment/Baseline/Randomization 

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During the virtual meeting at baseline, eligibility will be confirmed. Eligible, interested individuals will complete the verbal 
informed consent procedures and be assigned a study ID number (approximately 20 minutes to complete, on average). 
Then they will complete verbally or electronically the baseline questionnaires (approximately 55 minutes to complete, 
on average), followed by a brief videorecorded activity (approximately 9 minutes to complete), which will only involve a 
brief interview about the impact of back pain and opioid therapy, and expectations/impact of the study. Then participants 
will be randomized (1:1 block scheme prepared by the study statistician) to the MM or CBT groups, and receive 
information about details and scheduling of their respective interventions. All baseline questionnaires will be completed 
verbally, electronically, or on paper if the participant requests it. 
 
Intervention Sessions 
Participants in each intervention group will be asked to attend eight weekly 2-hour sessions of their respective 
intervention, practice the intervention-taught techniques at home (at least 30 minutes/day; 6 days/week during the 12-
month study), and log/report their home practice. The standardized form for collecting the home practice data is 
attached in Appendix.  Intervention sessions will be audio-recorded and monitored/audited for fidelity. In each 
course’s final session, participants will fill out a survey (see Appendix) reflecting on their intervention- and study-
related experiences. The content for both the in-person and virtual versions of the interventions is the same. They are 
both delivered in group format, both include a break halfway through, and both encourage active participant 
engagement and discussion.  
 
In-person sessions 
In-person intervention sessions will occur in a group format in a clinical, research, or community-based location. 
Participants will receive hard copies of the intervention materials in the first class they attend. Home practice and 
intervention session specific materials will be collected during the in person sessions when possible.  
 
Virtual sessions 
Virtual intervention sessions will occur in a group format using a given site’s institutionally-approved HIPAA-
compliant virtual video platform. Participants that do not have video capabilities will be able to call in to the 
sessions. Participants will receive electronic copies of the intervention materials, along with hard copies of 
worksheets/logs which are expected to be filled out by the participants during each session. These materials will 
be collected using a unique, secure link from REDCap, verbally, by phone, or per participant preference.  
 
Follow Up Assessment Sessions (all participants regardless of study participation method) 
The follow-up assessments will take place at 3, 6, 9 and 12 months after the start of a given participant’s intervention. 
The follow-up assessments will “remotely” (online or by phone; or by participant preference) gather self-reported data 
at 3, 6 and 9 months (30-60 minutes to complete, on average). These assessments will also include collection of home 
practice minutes for the past 14 days, and side effects diaries (used to assess for any potential interval SAEs/AEs/UPs).  
 
The final “exit” assessment at 12 months will be conducted in person or virtually. For in-person exit assessments, a 
participant will meet with a researcher to complete the final set of questionnaires (55 minutes to complete, on average) 
and the brief videorecorded activity (10 minutes to complete, on average). The virtual exit assessments will be similar 
to the in-person assessments, except the walking portion of the videorecorded activity will not be conducted (only the 
interview portion will be completed). Please see Section 9.2.3 for a summary, and Appendix for details of outcome 
measures.  
 
In-depth exit interviews 
In-depth exit interviews (30-45 min to complete, on average) with a subset of up to 40 participants from each arm will 
allow for in-depth exploration of the experience of those who reduced their daily opioid dose the most. They will be 
conducted by phone after the participant – in a Boston, Salt Lake or Madison site - exited the study by the qualitative 
methods specialists from the UW Survey Center.  
 
Participant “check-ins” 
In addition to the study contact for the intervention sessions and outcome data collection, participants will be contacted 
approximately every 2-4 weeks (and additionally as needed for engagement purposes) to “check in”, to inquire about 
how the study is going for them and if they have any questions, and answer questions they may have.  
 
Optional, Additional Testing (in-person participants only) 

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Participants who are eligible for it will be given the choice to consent to participate in optional, additional testing, when 
offered in person. The testing will be site-specific, conducted at the end of the two in-person study assessment visits 
(at baseline and exit). Each test will take on average approximately 15 minutes. For Madison participants, this test will 
involve a breath counting test using a laptop to measure mindful attention; for Boston participants, it will involve 
application of mechanical pressure to several body sites (pressure similar to the sensation of pressing a fingertip with 
steadily increasing pressure against the skin) and submerging hand in cold water at the temperature of 4 degrees 
centigrade (approximately the temperature of ice water) for no more than 2 minutes, to measure pain sensitivity and 
modulation; for Salt Lake City participants, it will involve engaging in computer-based emotional regulation and cue 
reactivity tasks using images from the International Affective Picture System (IAPS) and photos taken from media 
libraries on the internet. IAPS Images will include negative (angry faces, violent scenes), pain-related (accident scenes, 
injuries, medical conditions), and neutral images; opioid-related images (pills, pill bottles) will be taken from media 
libraries. The photographs will not be any more explicit than those seen in an R-rated movie.  It is very unlikely that 
distress from the photos would exceed a distress which would occur on an everyday basis, given that the images we 
use are similar to images seen in our usual environments. Psychophysiological assessment (heart rate variability, 
respiration, facial activity) will be measured during these tasks. 
 
The study manager, site managers, the PI, site-PIs and Co-Is will be responsible for monitoring and coordination of all 
study activities.  
7.1 LABS 
N/A- No labs will be obtained as part of the study. 
7.2 Study Visits 
7.2.1 
Screening/Baseline:  
Potential participants will be identified through the methods described in Section 5.4.1. Potential participants, meeting 
pre-specified eligibility criteria, will be sent invitation letters with opt-out/response card; those not opting out will be 
contacted by phone by the study coordinator. Potential participants will also be able to obtain the information about the 
study through their clinicians, study brochures, and media advertisement, and contact the study coordinator directly to 
inquire about the study. 
 
A study coordinator will call potential subjects to introduce the study and answer any questions. During this conversation, 
the researcher will read an informational statement describing the study and informing the participant of the risks and 
his/her rights as a participant, in particular the right to cease participation at any time without any repercussion or loss 
of benefits. The researcher will then seek to obtain the participant’s verbal consent to proceed with eligibility screening. 
Screening will be based on self-report and take 10-15 minutes to complete (see Appendix for the scripted text). Those 
not eligible for or interested in study participation will be referred back to their usual providers.   
 
Those who are eligible and interested will be invited to schedule a virtual or in-person meeting with the study coordinator 
to complete the screening, enrollment and consent procedures. This meeting will be held virtually or at a clinical or 
research facility in person. The study participant will be assigned a unique, study-specific ID number, and complete 
baseline assessments (questionnaires, followed by the videorecorded activity). Enrolled participants will also be given 
the option to sign an additional consent for optional additional testing, when in person visits are offered (see Section 7, 
Study Procedures). 
 
Finally, the participant will be randomized to one of the study arms and scheduled for the MM or CBT intervention. A 
reminder letter, emphasizing the importance of research participation, will be sent to the enrolled participants prior to 
the intervention start date and/or handed out at the beginning of the intervention course. 
 
For those screened but not enrolled in the study, all identifiable information will be destroyed. We will retain non-
identifiable information collected during the screening process to help determine main reasons for ineligibility or 
declining participation and inform future research. All potential subjects will provide verbal consent for obtaining these 
data at the beginning of their screening process. 

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7.2.2 
Follow up:  
 
Table 4. Acceptable Window for Study Visits (including weekends) 
 
Visit 
Window 
Activities 
Initial Visit (Screening, 
Enrollment, Baseline 
Assessment, Randomization) 
+ up to 12 weeks 
from the last 
contact / 
screening 
Virtual or in-person visit. Confirm eligibility; consent/HIPAA 
authorization form; enrollment; completion of baseline 
questionnaires and videorecorded activity; randomization; 
scheduling for the intervention; compensation. 
3-month follow-up 
+ up to 8 weeks 
from due date 
Online/phone/mail (if necessary) questionnaires, 
compensation mailed 
6-month follow-up 
+ up to 8 weeks 
from due date 
Online/phone/mail (if necessary) questionnaires, 
compensation mailed 
9-month follow-up 
+ up to 8 weeks 
from due date 
Online/phone/mail (if necessary) questionnaires, 
compensation mailed 
12- month follow-up (exit) 
+ up to 16 weeks 
from due date 
Virtual or in-person visit. Completion of exit questionnaires 
and videorecorded activity, compensation. Completion by 
phone or mail if necessary. 
In-depth qualitative interview 
(subset of 80 participants) 
+ up to 16 weeks 
from due date 
Qualitative interview by phone; compensation mailed. 
 
The final study visit, the “Exit Visit”, will occur approximately 12 months from the intervention start date for a given 
participant (Table 4). A subset of participants who completed the final study visit will be invited to undergo an in-depth 
qualitative interview by phone about their experience with the study intervention and its effects (Table 4). 
 
7.2.3 
Additional contact 
In addition to the contact with study team members during the scheduled intervention and follow-up assessment 
sessions, participants will be contacted approximately every 2-4 weeks (and additionally as needed for engagement 
purposes) to “check in”, to inquire about how the study is going for them and if they have any questions, and answer 
questions they may have. Participants who had undergone the videorecorded activity and are interested in receiving 
this material will be mailed a DVD with his/her own video recordings after their study completion. 
8 
Study Analysis 
8.1 Sample Size Determination 
We conservatively estimate the need to screen approximately 4,000 individuals to enroll up to 800 participants. In our 
pilot RCT of MM for opioid-treated CLBP, 304 potential participants were identified through the EHR data and clinician 
and self-referrals; 87 were screened, 48 were eligible and 35 were enrolled.17 During the 26-week pilot study, no 
participant withdrew, and two (5.7%) missed the final assessment. In the PI’s other trial of MM, 92% of 123 alcohol 
dependent adults completed a 1-year follow-up.47 Our other studies have also had excellent recruitment and retention. 
Two RCTs of MM led by Bruce Barrett had an overall 95% (540/567) retention rate over a 9 month follow-up. For these 
studies, 2,080 adults were screened, 183 were found eligible but declined and 567 (27.3%) were enrolled.46,48 
 
Using estimates from systematic reviews and meta-analyses, comparing MM and CBT to a wait-list controls,10,18-20,35 
and from two previous trials of MM in opioid-treated chronic pain,15,17 as outlined in the Background, we assume an 
effect size d=0.25 of MM vs CBT for pain severity and function, and a dropout rate of not more than 20%. We adjust for 
multiplicity of the co-primary outcomes by using a significance level of 0.025 for each Aim 1 outcome, for an overall 
significance level of at most 0.05. With 383 participants randomized to each of the treatment arms (766 total), a two-
sample test with a significance level 0.025 and at most a 20% dropout rate is powered to detect an effect size of 0.25 
of MM versus CBT for primary outcomes with power of 0.80. 
 
To assess power to detect treatment differences between the proposed subgroups, we used the sample size of N=383 
per group and a significance level α=0.05 (i.e., not adjusting for multiplicity). Based on the existing literature and prior 
studies by Co-Investigators, we anticipate that approximately 35% of the study participants will show an elevated level 
of negative affect and approximately 45% of the sample will have an elevated level of opioid-related aberrant drug use 

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behaviors. For the power to assess Aim 3, we wish to be able to detect a difference of 0.5 (moderate effect size) between 
the subgroups, assuming no effect for the subgroup with less pathology (lower HADS [score ≤11]42,67 or COMM [score 
<9]68 scores) and an effect size of 0.5 for the intervention effects in the subgroup with elevated negative affect and/or 
opioid misuse scores. The proposed subgroup analyses are based on the assumptions for the prevalence of elevated 
scores of negative affect (score > 11 on the HADS) and opioid misuse behaviors (score ≥ 9 on the COMM) that indicate 
a person’s increased risk for anxiety, depression or opioid use disorders.42,43,68 We chose the effect size of 0.5 for the 
proposed subgroup analyses per existing recommendations; this doubles the proposed main effect size of the study, 
assumed to be 0.25, for the subgroup hypothesized to benefit most from the intervention. 69 Based on the statistical 
simulations of size 10,000 (so that the margin of error is approximately 0.01) we conducted, we will have at least 80% 
power (84% for negative affect subgroup and 86% opioid misuse subgroup) to detect a significant (subgroup x 
treatment) interaction effect for each of these two main subgroups. 
8.2 Statistical Methods 
There are no planned interim analyses for this minimum-risk study. Primary, secondary, and exploratory analyses will 
be tested in the framework of linear mixed effects to examine the comparative effectiveness of treatment on the change 
in pain severity, function (Aim 1) and QoL scores and opioid dose (Aim 2) over 12-months between the two groups. 
Tests will be performed at a two-tailed significance level of 0.025 for each co-primary outcome (Aim 1) and a 0.05 
significance level for the secondary outcomes (Aim 2). Contrasts will be used to test for an overall treatment effect at 6 
and 12 months. Detailed Statistical Analysis Plan is located in Appendix. 
 
If and only if, the planned superiority analysis does not find statistically significant differences between the two groups, 
we will employ a formal non-inferiority analysis as a pre-specified secondary analysis. This analysis would employ mixed 
effects models to determine 95% confidence intervals for the difference between the mean scores of the primary 
outcomes of pain (BPI) and function (ODI) between the two groups, with the purpose of assessing whether MBT is non-
inferior to CBT for treatment of people with opioid-treated chronic low back pain, using acceptable difference delta 
values of 0.8 for the BPI pain scale and 8.0 for the ODI function scale. 
8.3 Planned Interim Analysis  
There are no planned interim analyses for this minimum-risk study. 
9 
Data Collection, Handling and Record Keeping 
9.1 Data Confidentiality 
All efforts will be made to protect subject confidentiality. The initial interview, informed consent process,  in-person 
and virtual data collection, and in-person and virtual intervention conduct will be conducted in private settings (when 
conducted virtually, all parties will be encouraged to use headphones/earbuds for added privacy and asked to turn off 
any ‘smart devices’). During the intervention sessions, participants will be able to use their first names or nicknames, 
and be asked to keep the information shared by others confidential.  
 
All data related to study participation will be kept confidential. Participant identity, medical record number, health 
information, and answers to questions will be kept confidential. Identifiable subject information will be linkable to a 
given subject outcome data via the unique identifier, and will be stored in a locked filing cabinet and a secure 
electronic tracking database. Only Investigators and Investigator-approved staff will be able to access these data. 
Outcome data will be coded with a unique code for each subject and stripped of identifiers, and will be stored and 
managed using the secure electronic REDCap database, housed at the UW Department of Family Medicine and 
Community Health (DFMCH). The servers storing the REDCap database are in a physically secure location and 
backed up nightly, with the backups stored in accordance with the DFMCH-ITS retention schedule of daily, weekly, 
and monthly tapes retained for 1 month, 3 months, and 6 months, respectively. Weekly backup tapes are stored 
offsite. The DFMCH servers provide a stable, secure, well-maintained, and high-capacity data storage environment. 
Access to study data in REDCap will be restricted to the IRB approved members of the study research team who will 
be able to log into this database using person-specific username and password.  
 
In-person baseline and exit surveys will be completed by participants in a clinical or research-based location, on a 
study-designated secure laptop, provided and administered by the DFMCH IT specialists. For virtual assessments, if 

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the participant is not able or willing to provide data via online system, s/he will have an option to complete these 
surveys “on paper” or online or by phone with the assistance from the researcher. Follow-up surveys (at 3, 6, and 9-
months) will be completed online and by phone, and check-ins (approximately every 2-4 weeks) will be conducted per 
participant communication preference. For surveys completed online, each participant will follow a unique web link 
(emailed to each participant at the time of follow-up) that will allow answering survey questions online. The online 
responses will be entered by the participant directly into the DFMCH-housed secure REDCap database using a 
participant-specific web link. At follow-up, those who prefer to provide data by phone will be called by the study 
coordinator who will mark the participant responses “on paper” or enter directly into the electronic database. Data 
collected “on paper” (e.g. because of participant preference; as a result of a phone interview; due to computer 
malfunction; data on prescribed opioids extracted from participant electronic health record) will be labeled with 
participant ID only, entered into the REDCap database by a research staff member and stored in a separate locked 
filing cabinet. Only participant ID will be linked to the participant outcome data stored in the REDCap database. 
 
Participant videorecorded data will be uploaded to the UW DFMCH secure storage system via a web-based interface. 
During virtual study sessions, the videorecorded activity (interview portion) will be recorded using the institutionally-
approved HIPAA-compliant virtual platform; after the session, it will be transferred to the UW DFMCH secure storage 
system.  Security will be provided by utilizing Secure Shell (SSH) with shared/private-key encryption on all 
connections to and from the DFMCH storage system. Additionally, security and identify verification will be provided 
utilizing individual usernames and passwords (adhering to DFMCH/UW Health password complexity policy) as well as 
an added two-factor authentication system. This will provide an extra layer of security for access into the system. The 
storage system will be housed in the DFMCH server facility, which is secured 24x7 and has limited access, and will 
provide full-disk encryption (at rest encryption) for all files. 
 
Participant name and/or video/photos will not appear in any publications or other materials stemming from the study 
and designed for dissemination, or in any electronic/print media without participant’s explicit written consent.  
 
All study-essential documents and records (including participant paper data and electronic data records) will be 
retained for a period of time specified by the IRB after the close of the study, and destroyed after that time. Before the 
shredding of participant’s study documents, records with participant’s identifying number only, not name, may be 
evaluated by study monitors, auditors, or members of the UW Ethics Committee (Institutional Review Board). The 
Universities’ Research Subject Advocates, the Data and Safety Monitoring members, the US Food and Drug 
Administration and the funding agency (PCORI) may review study records and information to ensure that the research 
methods comply with all ethics rules. Computer data will be protected by a password and electronic “firewall” and will 
be kept for 7 years as required by the University of Wisconsin policy. 
 
For those screened but not enrolled in the study, all identifiable information will be destroyed. We will retain the non-
identifiable information obtained during the screening process to help us determine main reasons for and/or correlates 
of ineligibility or declining participation and inform future research. All potential participants will provide verbal consent 
for obtaining this data at the beginning of their screening. 
 
After all identifiers have been removed and shredded, the screening data will be entered and stored in the UW 
DFMCH-housed subject tracking REDCap database. Access to the database will be password protected; the study 
team will have full control over which users can see what parts of the data, giving us the ability to provide de-identified 
views of the data where required. The development of the subject tracking database is NOT the purpose of the study.  
 
Certificate of Confidentiality (CoC)  
 A Certificate of Confidentiality was provided by the National Institutes of Health; language indicating the receipt of the CoC 
will be incorporated into the revised consent form, and those already enrolled will be informed about the receipt of the CoC 
per approved study protocol. 
 
Data Sharing 
Registration: We will register our trial on www.clinicaltrials.gov in order to ensure transparency of our research and 
comply with ethical standards of the field. 
 

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Study protocol and materials: We will provide PCORI a final protocol of the study when all study activities are complete 
that includes all changes made throughout the process. All versions of the protocol will be saved with track changes 
and will include reasons for changes throughout the study.  
 
Data organization and management: Data will be organized following the PCORnet Common Data Model to standardize 
data labeling, entry and enable sharing.70 To further promote data and information sharing, we will collect the “minimum 
data set” data, in addition to other outcome measures, as recommended by the NIH Task Force describing the best 
research practices for clinical trials on CLBP.71 
 
All data dictionaries, programming codes, qualitative codebooks, and other study materials developed will be provided 
to PCORI within 3 months of funding completion in order to promote replication of our research process. PCORI may 
share any and all of our materials with requested researchers after consultation with the PI, Dr. Zgierska. 
 
A final clean dataset will be available for data sharing after the project and analysis completion. All de-identified 
quantitative data will be exported from our database and available as csv file. Qualitative data will be made available 
including the coding taxonomy and coded themes. The coding taxonomy will include definitions and rich description in 
order to promote transparency of our coding structure. We will set up an online sharing tool for interested researchers 
in order to accommodate data sharing requests. 
9.1.1 
Confidentiality of Participant Records 
By signing the protocol, the Investigator agrees that the PCORI, DSMC, IRB, or Regulatory Agency representative may 
consult and/or copy study documents in order to verify CRF data. By signing or orally consenting to (when unable to 
sign) the consent form, the subject agrees to this process. If study documents will be photocopied during the process 
of verifying CRF information, the subject will be identified by unique code only and full names and similar identifying 
information (such as medical record number or social security number) will be masked. 
 
The Investigators will ensure that the identity of subjects is protected. All study records will be maintained in a secure 
fashion with access limited to essential study personnel only. The Coordinating Center will maintain, in a secure 
database, participant enrollment documentation that includes subject identifying information and links subjects to their 
study-specific identification number. This database (identifiable information) will be separate from the outcome 
measures database (de-identified data). 
9.2 Data Capture  
9.2.1 
Source Documents 
• 
EHR data on prospective participants, identified through an EHR database search for appropriate patients meeting 
the study criteria. See Appendix for data extraction protocol. 
• 
EHR data on prescribed opioids (past 3 months) for selected participants at baseline and exit assessments. See 
Appendix for data extraction protocol. 
• 
Self-report survey data at baseline, 3-month, 6-month, 9-month, and exit (12-month) assessments (see section 
9.2.2 and Appendix for details). 
• 
Videorecorded data, collected at baseline and exit assessments (see section 9.2.2 and Appendix). 
• 
Qualitative in-depth interview data on participant experiences (subset of participants) that facilitated, and were 
related to, opioid dose reduction (see section 9.2.2 and Appendix). 
• 
Madison site-specific optional, additional data (collected during in-person visits only): ability to focus attention 
(breath counting test, performed on a computer). The study participants, once enrolled into the main study, will be 
able to decide, by signing an additional consent, if they wish to participate in this optional additional testing. 
• 
Boston site-specific optional, additional data (collected during in-person visits only):  pain sensitivity and modulation 
testing (quantitative sensory testing method). The study participants, once enrolled into the main study, will be able 
to decide, by signing an additional consent, if they wish to participate in this optional additional testing. 
• 
Salt Lake City site-specific optional, additional data (collected during in-person visits only):  emotion regulation 
testing (heart rate variability, respiration, facial activity-based measures) The study participants, once enrolled into 
the main study, will be able to decide, by signing an additional consent, if they wish to participate in this optional 
additional testing. 

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9.2.2 
Missing Data  
To minimize the extent of missing data, all surveys conducted electronically will be built to require a response for each 
question before proceeding. All non-electronic surveys will be double-checked for completeness by study personnel 
prior to conclusion of the assessment session. If missing data is discovered in a given participant’s record after they 
have left the assessment session, the research coordinator will contact them by phone and attempt to collect the data 
within 14 days of the participant’s assessment session. 
 
The majority data at 3, 6 and 9 month follow-up visits is expected to be collected remotely, online or by phone. In cases 
where internet or phone access is not available, data may be collected by mail. The exit follow-up will be conducted in 
person when feasible. Data on main outcomes is planned to be collected at all assessments. Other survey-based data 
is planned to be collected at selected follow-up assessments and other contact times as outlined in Appendix. To 
minimize recall bias, subjects will be asked to keep a log of MM and CBT home practice, adverse effects, and opioid 
medication use with standardized data collection forms (see Appendix) and submit it by internet, phone or mail. We will 
design the study’s RedCap database to send participants reminders about keeping track of the above data. We will call 
those unable or unwilling to use the online reporting and/or reminders. 
 
We will implement statistical methods to assess for and minimize the impact of missing data (see Appendix). 
9.2.3 
Data Collection Tools (see Appendix for all data collection tools)  
Outcome measures will assess pain intensity, physical function, quality of life, opioid dose, depression, anxiety, opioid 
misuse, pain acceptance, pain catastrophizing, mindfulness level, sleep problems, neuropathic pain, change in pain 
and function, health care utilization, loss of productivity, PTSD, loneliness, feeling loved, sites of pain, NIH minimum 
data set, treatment expectations/satisfaction, non-protocol treatment, MM/CBT practice, adverse events, demographics, 
well-being, and experiences of those who reduced their opioid dose the most. 
 
Primary Outcomes 
Pain intensity will be assessed using the 0-10 point Numerical Rating Scale (NRS) from the Brief Pain Inventory 
(BPI).49,50 The NRS is reliable and valid in CLBP (α=0.85).53 A 1-point between-group difference is considered a minimal 
important change (MIC).28,29  
 
Physical function will be measured using the validated Oswestry Disability Index (ODI),51,52 which has good internal 
consistency (0.76-0.90), is reliable (0.83-0.99) and responsive to change.56,72 Its total score (0-100) reflects the percent 
of disability. A reduction of 4-10 points constitutes the MIC.28-30 In addition, functional status will also be assessed with 
7 pain interference items from the BPI.49,50,53  
 
Secondary Outcomes 
Quality of life (QoL) will be assessed using the validated Medical Outcomes Study Short Form Health Survey (SF-12 
v.2),54,55 a common measure of health and QoL in CLBP.56 The SF-12 has good reliability in CLBP (α=0.76-0.89), and 
yields one composite and two component (mental and physical) scores measuring general health and QoL.54,55  
 
Daily dose of prescription opioids for “the past 14 days” will be collected with the Timeline Followback (TLFB) method, 
a validated tool for daily substance use evaluation, with good test-retest reliability (0.79-0.97),57-59 and verified, when 
possible, against a participant’s EHR data on prescribed opioids. This will enable longitudinal evaluation of opioid dose 
change during the proposed 52 week follow-up. We will work with the collaborating health systems to leverage the EHR 
data and collect information on the prescribed opioids at baseline and exit (“past 3 months”). When possible, data on 
prescribed opioids will be obtained in one of the 2 ways depending on each health system’s preference and method 
feasibility: 1) Extraction of data on prescribed opioids directly from the EHR by the health system’s EHR database 
analyst or research team member with appropriate clearance provided by a given health care system; the UW Health 
data analyst will ensure process integrity across the health systems and appropriate data linkage. 2) If needed, we will 
obtain prescription data through medical records with participant’s written permission, if a request to medical archives 
is sent for the medical records pertaining to medication data. Because a health system’s prescription record may not 
accurately reflect the actual use of opioids, we will rely on participant self-report as the primary measure of opioid use. 
To calculate a “daily opioid dose,” doses of all reported opioids will be converted to a morphine-equivalent dose by 
multiplying daily dose of a given opioid by the published conversion factors, as we pilot-tested.60 
 

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Tertiary Outcomes (hypothesized main prognosticators) 
The proposed subgroup analyses are based on the assumptions for the prevalence of elevated scores of negative affect 
(score > 11 on the Hospital Anxiety and Depression Scale) and opioid misuse behaviors (score ≥ 9 on the Current 
Opioid Misuse Measure) that indicate a person’s increased risk for anxiety, depression or opioid use disorders.42,43,68  
 
Negative affect (anxiety, depression) will be assessed by the Hospital Anxiety and Depression Scale,67,73 the increased 
score of which has been associated with worse treatment outcomes in opioid-treated patients.1,4,6  
 
Opioid misuse behaviors will be assessed with the validated Current Opioid Misuse Measure74 and Opioid Compliance 
Checklist,75,76 both developed by Co-Investigator Jamison. We will also evaluate the potential impact of other factors 
that might influence treatment effects.  
 
Other Measures 
 
Survey-based Other Measures: 
Pain catastrophizing, pain acceptance and mindfulness level can impact outcomes in chronic pain;77,78 and neuropathic 
pain and sleep problems have been linked to worse outcomes.79,80 Pain catastrophizing will be assessed with the Pain 
Catastrophizing Scale.81 Pain acceptance will be assessed with the Chronic Pain Acceptance Questionnaire.82 
Mindfulness level will be assessed with the Mindful Attention Awareness Scale.83 Neuropathic pain will be evaluated 
with the painDETECT.84 Sleep problems will be assessed with the “minimum data set” sleep questions.71 
 
Change in pain, function and opioid use: Because it is not well-established what level of improvement (or worsening) 
constitutes a clinically meaningful change in individuals with chronic pain, we will ask the study participants to both rate 
their pain and function as well as the importance of change at each assessment by asking them if they are “better,” 
“about the same,” or “worse,” compared with the beginning of the trial.29 This approach will enable us to classify each 
trial participant as “improved,” “stable” or “worse” and conduct a secondary responder analysis.  
 
Health Care Utilization (number of clinic visits, emergency department visits; number of nights hospitalized) and Loss 
of Productivity (days missed of work and leisure), will be assessed using a survey developed for prior studies.17,47  
 
PTSD symptom severity will be assessed with the 4-item Primary Care PTSD Screen (PC-PTSD).85,86 
 
Loneliness will be assessed with the validated 3-item scale87 and Feeling Loved with the 4-item Feeling Loved 
instrument.88 
 
The number of location of the Sites of Pain will be assessed using the NIH-recommended instruments.71,89 
 
The Minimum Data Set will be collected using the NIH-recommended survey for back pain studies.71 
 
Treatment expectation/satisfaction will be assessed with the Global Impression of Change survey90 and the Looking 
Back Survey. 
 
Adherence to the intervention protocol will be assessed through participant session attendance of their assigned 
intervention (researcher-recorded); participant logs of home MM/CBT practice; and survey on non-protocol treatments. 
 
Adverse events (AEs), Unanticipated Problems (UPs), Serious Adverse Events (SAEs), and side effects (SEs) will be 
evaluated at each study contact, with a standardized UW Institute of Clinical and Translational Research’s Adverse 
Events Tracking Log. We will also collect data at the baseline and follow-up scheduled assessments on potential 
adverse effects in relation to opioid dose reduction with the 10-item brief validated instrument, the Short Opiate 
Withdrawal Scale, which assesses the presence and severity of opioid withdrawal symptoms.91,92  
 
Demographics will be collected using the NIH “minimum data set” form71 and additional questions developed by the 
research team and implemented in prior studies. 
 
Qualitative measure of pain, function, and well-being will be assessed using a brief videorecorded activity of all 
participants at baseline and exit. It will complement quantitative measures of pain, function and QoL, and provide context 

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to our quantitative measurement of outcomes.93,94 Selected recordings will bring patient voices and experiences into 
view and help promote dissemination.95 The use of a brief videorecorded activity for outcome evaluation is novel and 
patient-driven; it was recommended by Penney Cowan, a patient advocate, and endorsed by our Patient Advisors. The 
premise is to enable a comparison of participant’s qualitative presentation of pain, physical function and well-being (as 
a proxy for QoL) over time and across the two study arms, and to contrast it with the results from the validated patient-
reported outcomes (PROs). 
 
For this activity, we will use a standardized simple functional task (for in-person meetings only) and semi-structured 
interview (see Appendix). The functional assessment task will be carried out by a trained researcher and utilize the 
Timed Up and Go (TUG) test,96,97 which is standardized and routinely used in clinical settings, including UW Health. 
TUG takes 1-3 minutes to complete and includes getting up from the chair, walking 3 meters, then coming back to sit 
down. The task performance will be scored, using the standardized scoring protocol developed by the research team 
to measure the perceived level of pain, ease of physical function, and general well-being. Following the TUG test, 
participants will be asked several open-ended questions about their thoughts and experience with the test, the study 
and the disease impact on their lives. The test administration and scoring protocol will be fine-tuned in an iterative 
manner, derived from the qualitative research methodological approach, based on the information from initial 
videorecorded activity data. 
 
Qualitative measure of experience of those who reduced daily opioid dose the most will be assessed with in-depth exit 
interviews (30-45 min) with a subset of up to 40 participants from each arm (total: up to 80 participants) will allow for in-
depth exploration of the experience of those who reduced their daily opioid dose the most. They will be conducted by 
phone after the participant exited the study by the qualitative methods specialists from the UW Survey Center. The UW 
Survey Center’s team will help develop the protocols, conduct the interviews, and assist with data transcription, analysis 
and result summary. They will work with our research and stakeholder team to optimize and then continue fine-tuning 
the protocols in an iterative manner, derived from the qualitative research methodological approach, based on the 
information from initial interviews. 
 
Optional, additional tests 
These additional tests will be site-specific and only offered for in-person meetings, when in-person meetings are 
available. The enrolled study participants will have the choice to agree to or decline this optional testing. A separate 
consent will be obtained for this additional, optional testing. The additional tests (one per site) are non-invasive, and will 
take, on average, approximately 15 minutes to complete (see Appendix for details). 
 
Madison Site: Madison Site Participants will be offered the breath counting test, developed by Dr. Richard Davidson’s 
team.98 This test will provide an objective evaluation of participant ability to sustain attention and complement the self-
reported measures of mindfulness (Mindfulness Attention Awareness Scale survey) and logs of at-home practice. We 
hypothesize that participants in mindfulness meditation group will achieve greater improvements in their ability to sustain 
attention (better accuracy of breath counting) compared to those in the CBT group; this may mediate potential 
differences in treatment effects. For this test, participants will be instructed to “be aware of the movement of breath” and 
count their breaths in cycles from one to nine. They will be asked to press one of two different keys on the 
laptop/computer indicating which breath they are on, and a third key if they miss a breath. During the test, a set of 3 
probes will appear on the screen inquiring about attention and breath count. This test will be administered by a trained 
research staff.  
 
Boston, MA (Site PI: Rob Edwards): 
Boston Site Participants will be offered the standardized Quantitative Sensory Testing (QST) to non-invasively measure 
pain sensitivity and pain modulation.17,99 This brief "bedside" QST testing paradigm will conveniently measure 
mechanical pain sensitivity (pain threshold), temporal summation of pain (reflecting pain-promoting processes), and 
conditioned pain modulation (reflecting endogenous pain inhibition). We hypothesize that participants in mindfulness 
meditation group will achieve greater improvements in pain sensitivity and modulation parameters than those in the 
CBT group, which may mediate potential differences in treatment effects. For this test, participants will receive pain 
pressure stimulation from a Somedic pressure algometer, which will be measured using a standard set of weighted 
probes. Pain threshold and tolerance will be measured on the following sites on both the left and right sides of the body:  
low back, trapezius, and thumb. Participants will also immerse their hand in a cold water bath twice and rate intensity 
of the code pain on a numeric rating scale. This test will be administered by a trained research staff. 
 

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Salt Lake City, UT (Site PI: Eric Garland):  
Salt Lake City Site Participants will be offered a test of the biological effects of mindfulness meditation and CBT 
interventions on the ability to regulate emotional responses to negative emotional cues and opioid-related cues using 
brief, non-invasive objective tasks100,101 and physiological measures (e.g., heart rate variability, respiration, facial 
activity).The proposed testing will enable us to examine to what extent the study interventions can impact the ability to 
regulate negative emotions and unhealthy responses to opioid cues. We hypothesize that participants in mindfulness 
meditation group will increase regulation ability in response to negative cues and opioid cues to a larger extent than 
those in the CBT group, which may mediate potential differences in treatment effects, especially on the daily opioid 
dose. For this test, there will be three parts: participants will 1) view negative emotional images and regulate their 
emotional response to the images based on an instructed strategy; 2) view neutral and pain-related photos; their cue-
reactivity will be assessed using a dot-probe task; 3) have heart rate, respiration, and facial activity assessed using 
ECG leads, respiration belt, and EMG sensors, respectively, while engaging in part 1 and 2 above. This test will be 
administered by a trained research staff on the study. 
9.3 
Data Management 
Study-collected data will be stored “centrally” on a secure UW DFMCH server. These data will be accessible locally or 
remotely to authorized research team members in Madison, Hershey, Boston and Salt Lake who will be able to view 
and/or enter data. Data provided online by the study participants will be “deposited” directly into the UW DFMCH-housed 
RedCap database, with required response to all questions, ensuring data are complete and updated in a timely manner. 
The REDCap database will be developed and managed by a UW database administrator experienced with the proposed 
methods.17,46-48 Data from the in-person or virtual assessment sessions (at baseline and exit) and follow-up data 
collected online or by a trained researcher by phone will be recorded by the researcher through the participant’s web 
link; or “on paper,” prior to being entered by a research staff into the outcome database. All visits will be encouraged to 
be completed via electronic web link, regardless of meeting in-person or remotely, however phone / paper completion 
will be an option. The participant will be encouraged to access the web-link during their initial study visit, so they can 
have practice with the web-link surveys prior to completing them remotely on their own. Outcome data, labeled by the 
subject’s study ID only, will be stored in an outcome database, separate from the identifiable data, used for subject 
tracking. If data on the prescribed opioids are extracted by a database analyst from the EHR, the UW database analyst 
will ensure standardized extraction of EHR data across the health systems and will facilitate linking of de-identified EHR 
data to other outcome data. The videorecorded activity and in-depth qualitative interviews will be stored on a secure 
UW server and managed by the UW Information Technology team. 
9.4 
Data Monitoring  
Data and Safety Monitoring Plan Prior to the subject enrollment, a detailed data/safety monitoring plan will be 
submitted to the IRB and the PCORI for approval. Although we do not anticipate serious adverse events (see item 3), 
should any occur, the site PI will report it to the Research Subjects Advocate and the IRB and the Project Officer at the 
PCORI within 48 hours, using the subject ID number. Annual reports of adverse events will be submitted to the PCORI. 
The data and safety monitoring will be provided through the regular study team meetings and by the Data and Safety 
Monitoring Committee (DSMC).  
 
Data and Safety Monitoring Committee The PI’s prior RCTs evaluating MM intervention for opioid-treated CLBP and for 
alcohol dependence were both considered to be of “minimal risk” by the UW IRB.17,46-48 Therefore, an independent Data 
and Safety Monitoring Board and an interim data analysis are not expected to be required. However, to maximize 
participant safety, and the validity and integrity of the data, we will form a DSMC, which we successfully implemented 
in our prior similar trials.17,46-48 This committee will include 4 individuals who are not involved in the trial as investigators 
or research staff: two clinicians (Michael Miller, MD; Michael Gerst, LCSW, MSW, MDiv, MA); patient stakeholder and 
advocate (Janet House, member of the Community Advisors on Research Design and Strategies (CARDS); and a 
statistician (Kevin Buhr, PhD; Director, Statistical Data Analysis Center, University of Wisconsin-Madison– Chair of the 
DSMC). During the course of the study, the DSMC will meet twice a year for data and safety monitoring, and to approve 
continuation of the study protocol.  Details of the DSMC operations and procedures are described in the Data Safety 
and Monitoring Plan and DSMC Charter document (see Appendix). 
 
Study Team Meetings The study team meetings will be scheduled on a regular basis and will include Site Manager 
Meetings, and regular Site Team Meetings. A plan for communication within and between sites will be established and 
included in the Manual of Operations. The Investigator Meetings will be led by the study or site PIs, or the study 

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manager, with meetings scheduled on average every 1-2 months, will follow a written agenda and produce meeting 
minutes. The Investigator Meetings will invite participation of all Investigators, consultants, the study manager and site 
managers, and other team members.  
 
Annual Site Visits The Study Manager and/or PI will conduct a site visit each site 1-2 times per year to monitor and 
ensure compliance with the study protocol and data integrity. Site visits will include monitoring/auditing of protocol 
compliance, study procedures, safety and related reporting, regulatory and other study documents, and random 
sampling of data collected. A report of visit results will be generated and sent to the Study PI, Site PI, and Site 
Manager for the audited site. 
10   Assessment of Safety 
10.1.1 Definition of an Adverse Event (AE)  
We will report Adverse event means any untoward medical occurrence associated with the use of an intervention in 
humans, whether or not considered intervention-related (21 CFR 312.32 (a)). 
10.1.2 Definition of a Serious Adverse Event (SAE)  
A Serious Adverse Event is any of the following: 
• Fatal; 
• Life-threatening; 
• Persistent or significantly disabling or incapacitating; 
• An inpatient hospitalization or prolongation of hospitalization; 
• A congenital anomaly or defect; OR 
• A significant medical incident that, based upon appropriate medical judgement, may jeopardize the participant 
and requires medical or surgical intervention to prevent one of the outcomes listed above 
10.1.3 Definition of an Unanticipated Problem (UP)  
An Unanticipated Problem is an event that meets all of the following criteria: 
• Is more likely than not related to the research; 
• Negatively affects the risk/benefit ratio of the research (this includes physical as well as psychosocial risks); AND 
• Was not described in the protocol, Investigator's Brochure, IRB application, or informed consent document OR 
exceeds the specificity, frequency, or severity described in these documents 
10.2 
Classification of an Adverse Event 
10.2.1 Severity of Event 
All AEs will be assessed by the clinician using the below grading system. For AEs not included in the protocol defined 
grading system, the following guidelines will be used to describe severity.  
 
Mild – Events require minimal or no treatment and do not interfere with the participant’s daily activities.  
Moderate – Events result in a low level of inconvenience or concern with the therapeutic measures. Moderate events 
may cause some interference with functioning.  
Severe – Events interrupt a participant’s usual daily activity and may require systemic drug therapy or other treatment. 
Severe events are usually potentially life-threatening or incapacitating. 
Life-Threatening – Events that result in life threatening consequences, and urgent intervention is indicated. 
Death – Events that result in death. 
 
10.2.2 Relationship to Study Agent 
For all collected AEs, the clinician will determine the AE’s causality based on temporal relationship and his/her clinical 
judgment. The degree of certainty about causality will be graded using the categories below.  
 
Definite – There is clear evidence to suggest a causal relationship, and other possible contributing factors can be ruled 
out. The clinical event occurs in a plausible time relationship to the study intervention and cannot be explained by 
concurrent disease or other interventions, drugs or chemicals. 

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Probable – There is evidence to suggest a causal relationship, and the influence of other factors is unlikely. The clinical 
event occurs within a reasonable time after the study intervention, is unlikely to be attributed to concurrent disease or 
other the study interventions, drugs or chemicals. 
Possible – There is some evidence to suggest a causal relationship (e.g., the event occurred within a reasonable time 
after the study intervention). However, other factors may have contributed to the event (e.g., the participant’s clinical 
condition, other concomitant events). Although an AE may rate only as “possibly related” soon after discovery, it can be 
flagged as requiring more information and later be upgraded to “probably related” or “definitely related,” as appropriate. 
Unlikely – A clinical event whose temporal relationship to the study intervention makes a causal relationship improbable 
and in which other interventions, drugs or chemicals or underlying disease provides plausible explanations (e.g., the 
participant’s clinical condition, other concomitant treatments). 
Unrelated – The AE is completely independent of the study intervention, and/or evidence exists that the event is 
definitely related to another etiology. There must be an alternative, definitive etiology documented by the clinician. 
10.2.3 Expectedness 
The Principal Investigator or other delegated PI will be responsible for determining whether an AE is expected or 
unexpected. An AE will be considered unexpected if the nature, severity, or frequency of the event is not consistent 
with the risk information previously described for the study agent. 
10.3 
Time period and frequency for event assessment and follow-up 
Monitoring for AEs, including UPs and SAEs, will be conducted by the study team at each of the assessment visits and 
other contact times. Any medical or mental health condition that is present at the time that the participant is screened 
will be considered as baseline and not reported as an AE. Participants will be asked if they experienced any potential 
side effects related to their participation in the study. AEs will be further assessed at the assessment sessions by the 
Short Opioid Withdrawal Scale. Any AE occurring any time after informed consent is obtained will be reported to the 
study or site PI, with SAEs reported immediately (or as soon as possible if the situation does not allow for immediate 
reporting). AEs/UPs and SAEs will be recorded by research staff on an ICTR’s Adverse Events tracking log, and entered 
into the study database. See Section 10.4 for the timeline of reporting of AEs/UPs/SAEs. 
10.4 
Reporting procedures 
Adverse Events, unanticipated problems (such as subject complaints, breach of confidentiality, etc.), and 
complications across all sites will be promptly reported to the site-PI and coordinating-center PI, who will evaluate, 
and report to the IRB in accordance with posted guidelines. 
 
For reporting of UPs/AEs/SAEs, we will follow the UW IRB reporting procedures as described in the UW Health 
Sciences IRB Unanticipated Problems Reporting Decision Tree 
(https://kb.wisc.edu/images/group78/18324/AEdecisionguidewithFDAVAupdate2.6.13.pdf).  
 
In case of the serious adverse events, the PI will complete a SAE Form within the following timelines:  
All deaths and immediately life-threatening events, whether related or unrelated, will be recorded on the SAE Form and 
submitted to the DCC/study funder within 24 hours of site awareness. Other SAEs regardless of relationship, will be 
submitted to the DCC/study funder within 72 hours of site awareness.   
 
All SAEs will be followed until satisfactory resolution or until the site investigator deems the event to be chronic or the 
adherence to be stable. Other supporting documentation of the event may be requested by the DCC/study funder and 
should be provided as soon as possible.  
 
In case of the unanticipated problems (UPs), we will report UPs with the following information: 
• Protocol identifying information: protocol title and number, PI’s name, and the IRB project number; 
• A detailed description of the event, incident, experience, or outcome; 
• An explanation of the basis for determining that the event, incident, experience, or outcome represents an UP; 
• A description of any changes to the protocol or other corrective actions that have been taken or are proposed in 
response to the UP. 
 

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In addition, routine reporting of the number and type of adverse events (UPs/AEs/SAEs) will be compiled for the DSMC 
meetings and included in all PCORI-required progress reports. 
10.4.1 Events of special interest  
N/A 
10.4.2 Reporting of pregnancy  
Although we will not enroll women who report pregnancy, and later on do not obtain laboratory testing toward pregnancy, 
if a female participant reports pregnancy after the enrollment, we will discuss this situation with the DSMC to make a 
determination about further participation on a case by case basis. 
10.5 
Study Halting Rules 
While the study interventions and procedures are minimal risk and not expected to produce any unanticipated serious 
adverse events, the study may be halted or temporarily suspended if it is discovered that the interventions pose a 
serious consistent life- or health-threatening risk to participants. Should SAEs occur, the DSMC and other study 
oversight agencies will be involved in a timely manner as specified above to determine further course of action. 
10.6 
Safety Oversight 
Our Data Safety and Monitoring Committee (DSMC) will provide Safety Oversight. See Section 9.4.  
11 Study Monitoring, Auditing, and Inspecting 
11.1 
Medical/Safety Monitoring 
Safety protocol will be implemented by a trained researcher or therapist in case of presence of any worrisome 
symptoms, including inappropriate behavior during the study sessions or assessments. In case of worrisome symptoms 
during the intervention or assessment sessions, regardless of their mode of delivery (ie, in person, by phone, or via 
online platforms), a therapist or a research staff will discuss the concerns individually with the symptomatic participant, 
follow the Safety Protocol procedures, and call the study clinician as needed if concerns persist for further assessment 
and directions (see Section 2.5.2 for details). For those who are experiencing mental health problems, information on 
the resources available for counseling or other services to help with anxiety, distress, or feelings of sadness, will be 
provided. Depending on clinician’s assessment, participants will be cleared to stay at home or go home (by themselves, 
with a family member or a friend, or via study-provided cab) or referred to the appropriate further assessment, including 
in the Emergency Department (ED) if needed. Participants who are excused from the assessment meeting will be asked 
to reschedule it; however, they will not be able to reschedule a missed intervention session. In case of emergency, the 
therapist or research staff will call hospital security or 911. 
 
At each assessment session (baseline, 3, 6, 9, 12 months) participants will be screened for an intent to self-harm 
through their answers to item 5 on the existing outcome measure, the Current Opioid Misuse Measure (COMM): “In the 
past 30 days, how often have you seriously thought about hurting yourself?” (with responses ranging from 0=Never, 
1=Seldom, 2=Sometimes, 3=Often, to 4=Very Often). Scores 3 (Often) and 4 (Very Often) will be considered a “positive 
screen” and trigger the research staff to initiate the Safety Protocol, which includes involving the designated study 
clinician for assessment of the participant’s intent to harm and disposition. Depending on clinician’s assessment, 
participants will be “cleared” or referred for appropriate further assessment, including in the Emergency Department 
(ED), if needed. All participants assessed by the study clinician will be provided information on the local resources 
available for counseling or other mental health services. COMM responses are monitored by the research staff during 
business hours. 
 
If the Safety Protocol is implemented, the assessed participants will be encouraged to contact their regular providers 
for evaluation, if needed, and will receive a follow-up phone call from the study site clinician the following day, if needed. 
Notification of participant’s regular provider or a designated emergency contact person will not be required unless an 
ED assessment is necessary. Participants who are excused from the assessment session will be asked to reschedule 
it; however, they will not be able to reschedule a missed intervention session. They will be encouraged to continue study 
activities. In case of ED referral, the site PI or designated study clinician will notify the receiving physician in the ED, 
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11.1.1 Study Monitoring Plan 
Clinical site monitoring is conducted to ensure that the rights and well-being of human participants are protected, that 
the reported trial data are high-quality, accurate, complete, and verifiable, and that the conduct of the trial is in 
compliance with the currently approved protocol, and with applicable regulatory requirement(s).  
• The Study Manager and/or PI will conduct a site audit 1-2 times per year to monitor and ensure compliance with 
the study protocol and data integrity.  Site visits will include monitoring/auditing of protocol compliance, study 
procedures, safety and related reporting, regulatory and other study documents, and random sampling of data 
collected.  
• Scheduled independent audits are not planned, however, Patient Centered Outcomes Research Institute 
(PCORI) or UW Institute for Clinical and Translational Research may choose to conduct an audit of the study.  
• Each Site Manager and/or PI will perform will perform internal quality management of study conduct, data 
collection, safety monitoring, documentation and completion. 
11.2 
Protocol Deviations 
The PI, site PIs, Investigators and staff will be responsible for continuous vigilance to identify and report deviations 
from the protocol. Noticed protocol deviations will be reported to the IRB per existing guidelines. The PI / site PIs are 
responsible for knowing and adhering to the IRB requirements.  
11.3 Auditing and Inspecting 
Patient Centered Outcomes Research Institute, UW Institute for Clinical and Translational Research, and the UW IRB 
may require auditing/inspecting of all study related documents. The PI will ensure the capability for inspections of 
applicable study-related facilities. The Study Manager will audit each site in years 1 and 2, and as needed in years 3-5, 
to conduct site visits for compliance with the study protocol and data integrity 
11.4 Participant Compliance Monitoring 
The study team will assess and track participant compliance with the study interventions, through collection of home 
practice logs of home practice, attendance log for the intervention sessions, and phone follow-up with any participant 
that misses a given intervention session to collect any home practice data and set up a time to touch base with the 
intervention instructor to ensure the participant does not fall behind in the material. 
 
The study team will monitor electronically received self-reported assessment data from participants, and if a given 
participant has not completed their assessments at 3, 6, or 9 months, they will be contacted by a member of the study 
team to facilitate collection of data either online or by phone. 
12 Ethical Considerations 
This study is to be conducted according to US and international standards of applicable government regulations, 
applicable local and state laws, and Institutional research policies and procedures. 
 
This protocol and any amendments will be submitted to a properly constituted independent Ethics Committee (EC) or 
Institutional Review Board (IRB), in agreement with local legal prescriptions, for formal approval of the study conduct.  
The decision of the EC/IRB concerning the conduct of the study will be made in writing to the investigator and a copy 
of this decision will be provided to the sponsor before commencement of this study.  The investigator should provide a 
list of EC/IRB members and their affiliate to the sponsor. 
 
All participants for this study will be provided a consent form describing this study and providing sufficient information 
for participants to make an informed decision about their participation in this study.  See Appendix for a copy of the 
Participant Informed Consent Form. This consent form will be submitted with the protocol for review and approval by 
the EC/IRB for the study. The formal consent of a participant, using the EC/IRB-approved consent form, will be obtained 
before that participant undergoes any study procedure.  The written consent form will be signed by the participant or 
legally acceptable surrogate during the in-person initial meeting. For those participants who are unable to sign the 
consent form in person, oral consent will be obtained by the research coordinator, and will be indicated in that 
participant’s study record, all written consent forms will be signed by the investigator-designated research professional 
obtaining the consent.   

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13 Study Finances 
13.1 Funding Source 
This study is funded through a contract with Patient Centered Outcomes Research Institute (PCORI) and internal funds 
of each participating site’s institution: UW-Madison, Pennsylvania State University, University of Utah and Harvard 
University.  
13.2 Conflict of Interest 
Any investigator who has a conflict of interest with this study (patent ownership, royalties, or financial gain greater than 
the minimum allowable by their institution, etc.) must have the conflict reviewed by a properly constituted Conflict of 
Interest Committee with a Committee-sanctioned conflict management plan that has been reviewed and approved by 
the study sponsor prior to participation in this study.  All investigators will follow the IRB-recommended conflict of interest 
policy. 
14 Publication Plan 
Neither the complete nor any part of the results of the study carried out under this protocol, nor any of the information 
provided by the Patient Centered Outcomes Research Institute (PCORI) for the purposes of performing the study, will 
be published or passed on to any third party without the consent of PCORI and the PI.  Any investigator involved with 
this study is obligated to provide PCORI and the PI with complete test results and all data derived from the study. 
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