Feasibility Clinical Trial of Integrated Mind-Body Therapy for Chronic Low Back Pain
Phase: NA
Conditions: Chronic Low-back Pain
Sponsor: University of California, San Francisco

University of California, San Francisco Results Record # 21-34357, 
Development and Feasibility of Mindfulness Based Pain Reduction 
 
Mehling, Study Protocol, IRB approval July 28, 2022 
 

    Study Application (Version 1.11)
1.0
General Information
*Enter the full title of your study:
Feasibility Clinical Trial of Integrated Mind-Body Therapy for Chronic Low Back Pain
 
 
*Enter the study alias:
MBPR - Phase 2
* This field allows you to enter an abbreviated version of the Study Title to quickly identify this
study.
 
 
2.0
Add departments
2.1 and Specify Research Location:
Is
Primary? Department Name
UCSF - 784050 - PSYCHIATRY
UCSF - 101001 - M_Osher Center
 
3.0
List the key study personnel: (Note: external and affiliated collaborators who
are not in the UCSF directory can be identified later in the Qualifications of
Key Study Personnel section at the end of the form)
3.1 *Please add a Principal Investigator for the study:
 
Wolf Mehling MD, MD
Department Chair
Resident
Fellow
If the Principal Investigator is a Fellow, the name of the Faculty Advisor must be supplied below.
 
3.2 If applicable, please select the Research Staff personnel
 
A) Additional Investigators
Hartogensis, Wendy E PhD 
 Other Investigator
Hecht, Frederick MD, MD 
 Co-Principal Investigator
Strigo, Irina PhD, PhD 
 VAMC Principal Investigator

B) Research Support Staff
Goldman, Veronica M 
 Study Coordinator
Menon Vinodkumar, Anitha 
 Study Coordinator
Murphy, Emily 
 Study Coordinator
Rogers, Kirsten, BA 
 Study Coordinator
3.3 *Please add a Study Contact
 
Goldman, Veronica M 
Mehling, Wolf MD, MD 
Rogers, Kirsten, BA 
The Study Contact(s) will receive all important system notifications along with the Principal
Investigator. (e.g. The project contact(s) are typically either the Study Coordinator or the Principal
Investigator themselves).
3.4 If applicable, please add a Faculty Advisor/Mentor:
 
3.5 If applicable, please select the Designated Department Approval(s)
 
Add the name of the individual authorized to approve and sign off on this protocol from your
Department (e.g. the Department Chair or Dean).
4.0
Initial Screening Questions 
Updated May 2021 - Revised Common Rule (January 2018) Compliant / COVID-19 -
v97
4.1  * PROJECT SUMMARY: (REQUIRED) Give a brief overview of this project (250 words or less). Tell us
what this study is about, who is being studied, and what it aims to achieve. If you have an NIH
Abstract, paste it here (Click on the orange question mark to the right for more detailed instructions):
We aim to develop and test an 8-week MBPR (Mindfulness-Based Pain Reduction)
program, which draws on intervention work and clinical experience in the investigative team to
optimize a mindfulness-based intervention for individuals with chronic pain. We hypothesize that
this optimized intervention will be more effective than MBSR for cLBP. The overall goal of this
study is to ensure that the MBPR program has been carefully refined and manualized in an in-
person setting before performing clinical trials comparing MBPR to MBSR to test whether it
improves pain outcomes. This study is funded by an R34 from NCCIH
This project also includes an ancillary brain imaging study designed to build  on neuroscience
reports of markedly decreased brain function and structure in the insular cortex (IC) of cLBP
patients. This ancillary project has the potential to reveal a potential central mechanism by which
mind-body and acceptance-based approaches improve chronic pain conditions, e.g. cLBP may

reveal a new paradigm for the treatment of cLBP with key importance and consequences for
future behavioral treatment studies. The brain imaging is a separately funded study element,
funded by a small ancillary grant through a U19 (PI Dr. Jeff Lotz; REACH study at UCSF as part of
BACPAC nationwide) from NIAMS. The brain imaging will be done pre and post intervention at the
VA by VA personnel and Dr. Irina Strigo as the VA PI.
 
 
4.2  * HUD DEVICE: (REQUIRED) Does this application involve a Humanitarian Use Device (HUD):
No 
Yes, and it includes a research component 
Yes, and it involves clinical care ONLY 
4.3  * TYPE OF RESEARCH: (REQUIRED) Select the option that best fits your project (Click the orange
question mark to the right for definitions and guidance):
Biomedical research (including medical records review, biospecimen collection and/or use,
other healthcare or health outcomes related activities, research database, biospecimen bank,
or recruitment registry) 
Social, behavioral, educational, and/or public policy research 
Hybrid - includes aspects of BOTH types of research (check this option if your research is
mainly social/behavioral but also involves specimen collection or blood draws to look at
biological measures) 
4.4  * SUBJECT CONTACT: (REQUIRED) Does this study involve ANY contact or interactions with
participants:
Yes (including phone, email or web contact) 
No (limited to medical records review, biological specimen analysis, and/or data analysis) 
4.5  * RISK LEVEL: (REQUIRED) What is your estimation of the risk level, including all screening
procedures and study activities:
Minimal risk 
Greater than minimal risk 
4.6  * REVIEW LEVEL: (REQUIRED) Requested review level (Click on the orange question mark to the
right for definitions and guidance):
Full Committee 
Expedited 
Exempt 
4.7  * EXPEDITED REVIEW CATEGORIES: (REQUIRED) If you think this study qualifies for expedited
review, select the regulatory categories that the research falls under: (check all that apply)
Category 1: Research using approved drugs or devices being used for their approved
indications
Category 2: Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture
in certain populations and within certain amounts
Category 3: Prospective collection of biological specimens for research purposes by

noninvasive means (e.g. buccal swabs, urine, hair and nail clippings, etc.)
Category 4: Collection of data through noninvasive, routine clinical procedures (e.g. physical
sensors such as pulse oximeters, MRI, EKG, EEG, ultrasound, moderate exercise testing, etc.
- no sedation, general anesthesia, x-rays or microwaves)
Category 5: Research involving materials (data, documents, records, or specimens) that have
been or will be collected solely for nonresearch purposes
Category 6: Collection of data from voice, video, digital, or image recordings made for
research purposes
Category 7: Research on individual or group characteristics or behavior or research
employing survey, interview, oral history, focus group, program evaluation, human
factorsevaluation, or quality assurance methodologies
4.9  * DATA/SPECIMEN ANALYSIS ONLY: (REQUIRED) Does this study ONLY involve records review
and/or biospecimen analysis (do not check 'Yes' if this is a registry, research or recruitment
database, or biospecimen repository):
  Yes  
  No
4.10  * CLINICAL TRIAL: (REQUIRED)
Is this a clinical trial:
According to The World Health Organization (WHO) and the
International Committee of Medical Journal Editors (ICMJE) a
clinical trial is:
Any research study that prospectively assigns human participants or
groups of humans to one or more health-related interventions to
evaluate the effects on health outcomes.
ICMJE requires registration of a clinical trial in a public database (such as
ClinicalTrials.gov) prior to enrollment, for eventual publication of results in
member biomedical journals.
Guidance: Public Law 110-85 requires that all investigators who perform
an applicable clinical trial must ensure that the trial is registered on a
government web site called ClinicalTrials.gov.
 
The FDA requires registration for 'applicable clinical trials,' defined
as follows:
For any trials of drugs and biologics: controlled clinical investigations,
other than Phase 1 investigations, of a product subject to FDA
regulation.
For trials of biomedical devices: controlled trials with health outcomes
of devices subject to FDA regulation, other than small feasibility
studies, and pediatric post-market surveillance.
For additional information on the ClinicalTrials.gov registration process at
UCSF and the definition of a clinical trial for purposes of registration, visit
the ClinicalTrials.gov section of the UCSF Clinical Research Resource
HUB.
 
 
 Yes  
 No

* Clinical Trial Registration - 'NCT' number for this trial: (REQUIRED)
04980612
4.11  * CLINICAL TRIAL PHASE: (REQUIRED) Check the applicable phase(s):
Phase 0
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
Phase 4
Not Applicable
4.12  * INVESTIGATOR-INITIATED: (REQUIRED) Is this an investigator-initiated study:
 Yes  
 No
The UCSF IRB recommends use of the Virtual Regulatory Binder to
manage your study.
4.13  * CORONAVIRUS RESEARCH: (REQUIRED) Does this study involve research on coronaviruses
(COVID-19, SARS, MERS or other):
  Yes  
  No
4.15  * CANCER: (REQUIRED) Does this study involve cancer (e.g., the study involves patients with cancer
or at risk for cancer, including behavioral research, epidemiological research, public policy research,
specimen analysis, and chart reviews):
  Yes  
  No
4.16  * RADIATION EXPOSURE: (REQUIRED) Does your protocol involve any radiation exposure to
patients/subjects EITHER from standard care OR for research purposes (e.g., x-rays, CT-scans,
DEXA, CT-guided biopsy, radiation therapy, or nuclear medicine including PET, MUGA or bone scans):
  Yes  
  No
4.17  * SCIENTIFIC REVIEW: (REQUIRED) If this study has undergone scientific or scholarly review,
please indicate which entity performed the review (check all that apply):
Funding agency, cooperative group, study section or other peer-review process
Cancer Center Protocol Review Committee (PRC) (Full approval is required prior to final IRB
approval for cancer-related protocols.)
CTSI Clinical Research Services (CRS) Advisory Committee
CTSI Consultation Services
Other:
Has not undergone scientific/peer review

* Specify entity that provided review:  (REQUIRED)
This study was reviewed as a R34 grant application by NIH's National Center for Complementary
and Integrative Health (NCCIH)
4.18  * STEM CELLS: (REQUIRED) Does this study involve human stem cells (including iPS cells and adult
stem cells), gametes or embryos:
No 
Yes, and requires IRB and GESCR review 
Yes, and requires GESCR review, but NOT IRB review 
4.19  * FINANCIAL INTERESTS: (REQUIRED) Do you or any other responsible personnel (or the spouse,
registered domestic partner and/or dependent children thereof) have financial interests related to
this study:
  Yes  
  No
5.0
Funding
5.1  * FEDERAL FUNDING: (REQUIRED) Is this study currently supported in whole or in part by Federal
funding, even by a subcontract, OR has it received ANY Federal funding in the past:
 Yes  
 No
5.2  * DoD INVOLVEMENT: Is this project linked in any way to the Department of Defense (DoD):
(REQUIRED)
  Yes  
  No
5.3  SPONSORS: Identify all sponsors and provide the funding details. If funding comes from a
Subcontract, please list only the Prime Sponsor:
External Sponsors:
 
View
Details
Sponsor Name
Sponsor Type
Awardee
Institution:
Contract
Type:
Project
Number 
UCSF
RAS
System
Award
Number
("A" + 6
digits) 
NIH Miscellaneous
Other 
01 
UCSF 
Grant 
P1234567 A136426 
Sponsor Name:
NIH Miscellaneous Other 
Sponsor Type:
01 
Sponsor Role:
Funding
CFDA Number:
 
Grant/Contract Number:
 
Awardee Institution::
UCSF 

Is Institution the Primary
Grant Holder:
Yes 
Contract Type:
Grant 
Project Number:
P1234567 
UCSF RAS System Award
Number ("A" + 6 digits):
A136426 
Grant Number for Studies Not
Funded thru UCSF:
 
Grant Title:
grant by NIH-NCCIH 
PI Name:
(If PI is not the same as
identified on the study.)
 
Explain Any Significant
Discrepancy:
 
NIH Natl Inst Arthr,
Musculoskel & Skin 
01 
UCSF 
 
P0536633 A134160 
Sponsor Name:
NIH Natl Inst Arthr, Musculoskel & Skin 
Sponsor Type:
01 
Sponsor Role:
Awardee Institution::
UCSF 
Is Institution the Primary
Grant Holder:
No 
if No, then who is the Primary
Grantee?
 
Contract Type:
 
Project Number:
P0536633 
UCSF RAS System Award
Number ("A" + 6 digits):
A134160 
Grant Number for Studies Not
Funded thru UCSF:
 
Grant Title:
ancillary funding provided by U19 REACH study (part of
HEAL - BACPAC initiative of NIH, PI Jeff Lotz, PhD)
Dr. Mehling is the PI of the ancillary study: adding brain
imaging to original R34 from NCCIH
 
PI Name:
(If PI is not the same as
identified on the study.)
 
Explain Any Significant
Discrepancy:
The U19: Core Center for Patient-centric Mechanistic
Phenotyping in Chronic Low Back Pain
Grant Number: U19-AR076737
 
Other Funding Sources and Unfunded Research - Gift, Program,
Departmental or other Internal Funding (check all that apply):
Funded by gift (specify source below)
Funded by UCSF or UC-wide program (specify source below)
Specific departmental funding (specify source below)
Unfunded (miscellaneous departmental funding)
Unfunded student project

6.0
Sites, Programs, Resources, and External IRB Review
6.1  * UCSF AND AFFILIATED SITES (check all that apply): (REQUIRED)
UCSF Benioff Children's Hospital Oakland (BCH OAK)
UCSF Cancer Center Berkeley
UCSF Cancer Center San Mateo
UCSF China Basin clinics and facilities
UCSF Helen Diller Family Comprehensive Cancer Center
UCSF Langley Porter Psychiatric Institute (LPPI)
UCSF Medical Center at Mission Bay (Benioff Children's Hospital, the Betty Irene Moore
Women's Hospital, Bakar Cancer Hospital, or outpatient clinics)
UCSF Mount Zion
UCSF Parnassus (Moffitt-Long hospital, dental clinics or other outpatient clinics)
UCSF Other Sites (including Laurel Heights and all the other sites outside the main hospitals
and clinics)
Fresno - UCSF Fresno OR Community Medical Center (CMC)
Gladstone Institutes
Institute on Aging (IOA)
Jewish Home
SF Dept of Public Health (DPH)
SF VA Medical Center (SF VAMC)
Vitalant (formerly Blood Centers of the Pacific and Blood Systems Research Institute)
Zuckerberg San Francisco General (ZSFG)
Research involving the SF VAMC: Please thoroughly review
the Working with the SF VAMC webpage and/or consult the VA
Research Office (V21SFCHRPP@va.gov or (415) 221-4810 x6425)
prior to submitting your application to the IRB and:
If this study involves both UCSF and the VA, identify who is
serving as the VA PI under 'Descriptions of Study
Responsibilities' in the 'Qualifications of Investigators' section
at the end of this form
Include the additional required VA forms in the Study
Documents section of the Initial Review Submission Packet
form
6.2  LOCATIONS: At what locations will study visits and activities occur:
1) UCSF Osher Center for Integrative Medicine
2) San Francisco Veterans Affairs Medical Center
 
The only in-person study visits will occur at the SFVA for the MRIs. All other activities will occur
online organized by staff at the UCSF Osher Center Participant involvement will be mostly online,
using the Zoom platform.
Recruitment, questionnaires, and curriculum review will be done remotely by UCSF staff. 
Document storage, data storage, data analysis will be done at both (1) and (2).
The intervention program will occur online and will be managed from UCSF Osher Center staff.
MRI scans will take place at the San Francisco Veterans Affair Hospital (2).
 

 
6.3  OFF-SITE PROCEDURES: Will any study procedures or tests be conducted off-site by non-UCSF
personnel:
  Yes  
  No
6.4  RESEARCH PROGRAMS: Check any UCSF research programs this study is associated with:
Cancer Center
Center for AIDS Prevention Sciences (CAPS)
Global Health Sciences
Immune Tolerance Network (ITN)
Neurosciences Clinical Research Unit (NCRU)
Osher Center
Positive Health Program
Weill Institute for Neurosciences Translational Research Unit (WIN TRU)
6.5  * CTSI CRS SERVICES: (REQUIRED) Will this study be carried out at one of the UCSF Clinical Research
Services (CRS) units or utilize CRS services:
  Yes  
  No
6.6  * MULTI-CENTER TRIAL: (REQUIRED) Is this a multi-center or multi-site research trial:
By 'multi-center trial' we mean a study where the protocol is developed
by an lead investigator, an industry sponsor, consortium, a disease-group,
etc.,and multiple sites across the nation or in different countries participate
in the trial. The local sites do not have any control over the design of the
protocol.
  Yes  
  No
6.8  OTHER SITE TYPES: Check all the other types of sites not affiliated with UCSF with which you are
cooperating or collaborating on this project:
Do NOT check any boxes below if this is a multi-center clinical
trial, UCSF is just one of the sites, and neither UCSF nor one of its
faculty-linked affiliates (SF VAMC, Gladstone, ZSFG) are the
coordinating center.
Other UC Campus
Other institution
Other community-based site
Foreign Country
Sovereign Native American nation (e.g. Navajo Nation, Oglala Sioux Tribe, Havasupai, etc.)

6.14  * RELYING ON AN EXTERNAL IRB: (REQUIRED) Does this application include a request to rely on an
external IRB (a central IRB (other than the NCI CIRB) or an external IRB (other UC campus,
commercial, or institutional):
  Yes  
  No
7.0
Research Plan and Procedures
7.1  HYPOTHESIS: Describe the hypothesis or what the study hopes to prove:
We aim to develop and test an 8-week MBPR (Mindfulness-Based Pain Reduction)
program, which draws on intervention work and clinical experience in the investigative team to
optimize a mindfulness-based intervention for chronic pain. We hypothesize that this optimized
intervention will be more effective than MBSR (Mindfulness-Based Stress Reduction) for cLBP.
The overall goal of this R34 is to ensure that the MBPR program has been carefully refined and
manualized in an in-person setting before performing clinical trials comparing MBPR to MBSR to
test whether it improves pain outcomes.
There are three hypotheses for the ancillary component of this project:
Hypothesis 1: Baseline pain attention style, as determined by the fMRI attention task (e.g.
lower IC and higher DMN activity), is associated with (higher) pain interference post-intervention.
Hypothesis 2: IC-ACC connectivity will trend to improve from pre to post MBPR.
Hypothesis 3: Increased IC-ACC activity will be associated with improved pain interference.
7.2  AIMS: List the specific aims:
Specific Aim 1: To refine and manualize an 8-week MBPR (Mindfulness-Based Pain
Reduction) program for patients with cLBP, integrating mindfulness with (1) interoceptive
awareness, i.e. cultivating a direct, non-judgmental sensory attention focus on the location of
their cLBP, (2) yoga practices targeting cLBP, and (3) elements of both chronic pain education
and CBT, i.e., modifying maladaptive cognition and behavior. In Phase 1 we are convening a
panel of behavioral and yoga therapists with expertise in chronic pain education and management
to obtain expert advice on MBSR optimization and produce a first draft of the new MBPR manual.
Specific Aim 2: To refine ecological momentary assessments (EMA) measures of key
pain outcomes and mobile technology measures of adherence to MBPR home practice.
EMA is emerging as a key tool for measuring pain outcomes and home practice in clinical trials,
but measures are poorly standardized and validated. We will compare pain questionnaires and
EMA and ensure that an EMA measure is refined and vetted before use as a clinical trial outcome.
We will test a meditation timer mobile app to measure adherence.
The aims for the neuroimaging component of this project are as follows:
Aim 1: To determine if attention style at baseline predicts treatment response.
Aim 2: To explore, whether MBPR improves a potential new biomarker for pain attention style:
IC-ACC (anterior cingulate cortex) connectivity.
Aim 3. To explore if there is a preliminary association between treatment-related changes in IC-
ACC connectivity (or IC activity) during immediate sensory attention to pain, and pain-related
outcomes (outcomes are the same as for the BACPAC REACH studies).
7.3  DESIGN: Briefly describe the study design (e.g., observational, interventional, randomized, placebo-
controlled, blinded, cross-over, cross-sectional, longitudinal, pharmacokinetic, etc.):  
interventional for 4 iterations of the intervention, the last iteration as a randomized trial.

 
7.4  BACKGROUND AND SIGNIFICANCE: Briefly provide the background and significance of this study (e.g.
why is this study needed) (space limit: one half page):
If this is a first in humans study, please summarize the safety data from
the animal studies. For pediatric drug or device studies, please identify if
this is the first study in pediatric populations.  
Treatment of chronic low back pain (cLBP) remains a major public health challenge.
cLBP is the leading cause of disability worldwide. Medication is of limited value. Current guidelines
recommend using non-pharmacologic approaches for cLBP as the first-line approach. These
approaches include exercise, multidisciplinary rehabilitation, acupuncture, yoga, tai chi,
Mindfulness-Based Stress Reduction (MBSR), and Cognitive-Behavioral Therapy (CBT). Traditional
first-line pharmacological therapies and physical therapy exercise are not superior to these
currently recommended non-pharmacological therapies. All studied interventions have shown
beneficial effects in randomized controlled trials (RCT), but only of moderate efficacy and often
less than minimal clinically important improvement. There is thus a strong need for more
effective non-pharmacologic treatments for cLBP, as well as other forms of chronic pain. 
Treatment of chronic pain needs to address central processing of pain. Current
research clearly shows that cLBP and other forms of chronic pain are not simply the result of
nociceptive pain receptors signaling tissue damage, but involve extensive central nervous system
processes. cLBP is a complex condition that involves the emotional psychology of the patient and
properties of the emotional learning circuits as determinants of its prognosis. The learned
emotional elements of pain and other aspects of central processing of pain signals are critical
targets to address in chronic pain. Cognitive Behavioral Therapy (CBT) is the best-studied
behavioral intervention for chronic pain, and recommended as first line treatment. It uses a
structured approach that focuses on cognitions, emotions, and behaviors related to pain. It uses
cognitive restructuring to help patients to evaluate, challenge and change thought content,
beliefs and behavior. Coping skills include healthy distraction. However, benefits are
modest. Moreover, distraction from pain is useful for acute pain but of uncertain benefit and not
recommended for chronic pain.
Mindfulness interventions are somewhat effective for pain, but need to be better
optimized for managing pain conditions. Studies of mind-body group interventions,
e.g. MBSR, which teaches mindfulness and aims at changing the way we relate to thoughts, have
shown modest benefits, quite similar to CBT group treatment. Perhaps the most important trial of
MBSR for cLBP was a trial by Cherkin and colleagues that compared three treatment arms: (1)
MBSR,  (2) CBT, and (3) usual care. MBSR was clearly better than usual care; clinically
meaningful improvement in pain bothersomeness at 26 weeks was 43.6% in the MBSR group,
compared with 26.6% in the usual care group (p =.01). However, MBSR was no better than CBT,
in which 44.9% had clinically meaningful improvement in pain bothersomeness. The lack of any
evidence of better outcomes from MBSR compared to CBT clearly indicates there is room to
improve outcomes from a mindfulness-based intervention for cLBP. This is further underlined by
the fact that over half the study population failed to have clinically meaningful improvement in
pain bothersomeness.
In summary, current cLBP management, even with recommended behavioral interventions, is
of modest effectiveness. There is a strong need to develop more effective non-
pharmacologic interventions. 
7.5  PRELIMINARY STUDIES: Briefly summarize any preliminary studies relevant to your proposed
research (space limit: one half page):
The YoMA study: In a mechanistic single-arm study (N =23) of a 12-week yoga intervention
designed for cLBP, we found preliminary evidence that Body Listening, measured by the
Multidimensional Assessment of Interoceptive Awareness (MAIA) increased from baseline to 6
weeks and predicted improved pain at 12 weeks (post intervention) (β =-1.18; p =0.02),
whereas mindfulness scores (FFMQ) did not. Body Listening is a MAIA scale and a key element of
self-reported interoceptive awareness, which we aim at fostering with MBPR.
In a study of Mindfulness-Based Cognitive Therapy (MBCT) in 31 patients with comorbid chronic
pain and depression we found preliminary evidence that the positive effect of MBCT on depression

severity was partially mediated by Not-Distracting, measured by a MAIA scale indicating attention
towards bodily sensations. We will use the updated version of the same self-report measure
(MAIA-2) in our proposed study.
7.6  * TREATMENT PROTOCOL: Is this a treatment study, i.e. does this study intend to provide treatment
to individuals with a medical or psychological condition: (REQUIRED)
 Yes  
 No
7.7  * BILLABLE PROCEDURES: Does this study involve any procedures, lab tests or imaging studies that
have a CPT code and could be billable to patients, their insurance, Medi-Cal, Medicare, or any other
entity (answer 'Yes' even if the study is going to pay for all the procedures): (REQUIRED)
  Yes  
  No
If you are not sure if your study involves billable procedures, send
an email to the UCSF Office of Clinical Research (OCR) for help
answering this question.
7.8  * COMMON RESEARCH ACTIVITIES: Types of research activities that will be carried out. Check all that
apply and describe in more detail in the 'Procedures / Methods' section: (REQUIRED)
Interviews, questionnaires, surveys
Educational or cognitive tests
Focus groups
Social media-based research activities
Observation
Fitness tests or other exertion activities
Use of mobile health apps or other apps
Collection of data from wearable tech such as Fitbit, Apple Watch, Garmin, motion actigraphs,
etc.)
Non-invasive imaging or testing (MRI, EEG, pulse oximetry, etc.)
Imaging procedures or treatment procedures that involve radiation (x-rays, CT scans, CT-
guided biopsies, DEXA scans, MUGA or PET scan)
Administration of contrast agent
Randomization to one intervention versus another
Use of placebo
Biopsy conducted solely for research purposes
Sham surgical procedure
None of the above
7.9  * PROCEDURES / METHODS: (REQUIRED)
Describe the research methods and study activities taking place at each site
(e.g. what will participants be asked to do and what will members of the
study team do?). If there will be multiple participant groups or study sites,
explain what will happen with each group or study sites.
 
If some of the activities would occur even if the person were not in the
study, as in the case of treatment or tests performed for diagnostic
purposes, clearly differentiate between those activities that will be

done solely for research purposes and those that are happening as
part of routine care.
 
Please call our office at 415-476-1814 and ask to speak to someone on the
Expedited Review team if you need help differentiating between what parts
are research and what parts aren't.
At UCSF:
As we described in the application for Phase 1 of this study, MBSR is a standardized and
manualized 8-week program, delivered once a week in 2½-hour group sessions and a daylong
retreat. It trains individuals in several mindfulness practices, e.g. focus on breath, varying
degrees and directions of object orientation, open monitoring of awareness of intero- and
exteroceptive stimuli and thoughts, de-reification (i.e. the notion that thoughts and perceptions
are not always true to reality), and meta-awareness (i.e., awareness of thinking) in addition to
focused attention. The program typically includes an audio-recording and a book for home
practice and has shown benefits in patients with cLBP.
MBPR will be an optimized mindfulness program specifically designed for treating cLBP that
we aim to develop and test in this project. The format is the same as MBSR: 8 weeks of weekly
2½-hour group sessions and a daylong retreat in smaller groups: 10 participants per class to
allow for more individualized support. All sessions include training to enhance mindful
interoceptive awareness through focused attention in the region of pain, the lower back. Key
goals are to reduce avoidance, rumination, catastrophizing, and fear of movement, all key
mechanisms of action in MBSR or CBT. The new elements of these classes will include more pain-
specific education and key elements of CBT, enhance mindful interoceptive awareness and an
expanded yoga component, for which we will provide videos for home practice. 
      In addition, we will identify potentially eligible participants through review of our Medical
Center's electronic medical records and send letters inviting study participation using  the UCSF
CTSI. Randomization for the final cohort will be performed using a computer-based assignment
program, in which study staff must enter the participant ID number before randomization is
revealed; assignment is then locked into the database. It will be stratified by sex, as
responsiveness to mind-body interventions varies by sex. The UCSF study site of the ongoing NIH
HEAL BACPAC initiative, for which both Drs Mehling and Hecht are key personnel, will create a
large cohort of patients with cLBP (recruitment started June 2021), which can be approached for
advertising our study.
MBPR will be delivered by an experienced mind-body practitioner with expert skills in
mindfulness, MBSR and body awareness-enhancing approaches. Phase 1 includes a 2-day
training retreat for the instructor led by Dr. Mehling to prepare the MBSR instructor for the MBPR
program. Home practice will be supported by audio recordings uploaded to the Insight Timer®
smart phone platform. The Insight Timer application will also be used to track and record the
frequency in which participants are doing a meditaton practice in combination with a physical or
electronic log.  The instructor will use a workbook, audio recordings of guided meditation (these
are standard recordings used e.g. in MBSR classes at the Los Angeles Insight Meditation Center),
Outsmart your Pain by Christiane Wolf, MD, PhD, a guide book for mindfulness with pain, and
videos of yoga sequences (as outlined in handout, attached). Study participants will receive
additional printed and audio support material.
Schedule of Measures: Participants will be assessed using computer-
assisted questionnaires in the first and last week of the MBPR courses and will be followed up at 6
months for clinical outcomes. In addition we will use a mobile platform-based EMA, as detailed
below. 
Meditation home practice adherence measure: Rationale: All participants will
be instructed to do daily homepractice. Benefits of any mind-body intervention may depend on
applying the class teaching to practice at home. Home practice for chronic conditions may need a
higher dose than e.g. for experimental pain. We will request a minimum of 30 minutes for an
expected effective duration of 20 minutes (>70%) on at least 5 days per week.  Methods: Our
research team has successfully used the free downloadable mobile app InsightTimer® to monitor
adherence to home practices by asking participants to use it during home practice session. It has
a variety of bell sounds that can be set for desired meditation time periods. The application
includes two other features we have successfully tested at UCSF: 1) It connects with the research
team in our study providing data about when and for how long a participant practiced meditation.
2) The app allows guided meditation recordings that we are preparing for home practice to be
uploaded and made available to participants. Participants will log in with unique pseudonyms and
a participant-specific e-mail address that is created for this study only to eliminate any risk to
loss of privacy, which will be discussed during the consent process. Any identification of the

participating InsightTimer user will not be possible as the app will not use the personal e-mail of
the participant and only use pseudonyms.
At the VA:
This study includes a Pain Attention Task to be preformed in the fMRI that separates insula
activation during experimental heat application between different pain attention conditions.
     The participants will be patients with cLBP according to the definition of the NIH Task Force on
Research Standards for cLBP: pain at least half the days in the past 6 months, by using 2
questions and a human figure drawing illustrating the region between the lower posterior margin
of the rib cage and the horizontal gluteal fold. Participants will have an average pain intensity in
the past week of at least 4 out of 10 on the numeric rating scale (NRS). They will be recruited
through advertisement in newspapers, social media and fliers, and from the current UCSF Spine
Center cLBP cohort (see below).
MRI Pain Attention Task: The paradigm has 4 stimulus conditions presented in pseudo-random
order. Individually determined, moderately painful (~47.5°C) stimuli will be delivered with a
9cm2 thermode (Medoc) securely placed at the forearm. Subjects are instructed and trained
before scanning as follows: (A: thinking) for the ‘think’- condition: “think about pain stimulus and
your chronic pain, it’s history and impact on your life, your expectation for your future life”; (B:
sensing) for the ‘feel’-condition: “feel the pain stimulus, be aware about how it makes you feel,
its location, intensity and quality.”; (C: metacognition) for the ‘reflect’-condition: “please notice
whether you can observe how thoughts and emotions regarding your pain arise that may be
familiar, whether they are really appropriate or not”; and (D: default) for the ‘none’-condition:
“do nothing specific, just wait for the stimulus to be over”. The instructing cues: think, feel,
reflect, and none, will be presented for 1s, followed by 20s of painful heat stimulation, followed
by 39s baseline with neutral temperature to minimize habituation/ sensitization, until the start of
the next trial. 7 trials of each condition will be performed for each subject. The task will be
administered in four 7-min sequences.
This task has been used in prior studies without any risks for the participant.
A total of 50 participants will be enrolled into this study. 40 participants with cLBP will be
enrolled into 4 consecutive MBPR classes (n = 10 for each course)to iteratively refine the
manualized MBPR protocol through mixed-methods evaluations after each round of MBPR. 10
participants with cLBP will be in the MBSR as the control group. 
The first 30 participants enrolled in the study will be assigned to MBPR classes and the final 20
participants will be randomly assign with (n 10) participants assigned to MBSR and (n 10)
participants assigned to MBPR to test recruitment and randomization approaches.
7.10  STANDARD CLINICAL PRACTICE: To what extent, if any, do the planned research procedures differ
from the care that people would otherwise receive at this institution or the study site if not being
done locally:
 
MBPR is based on MBSR, a program that is part of the national guidelines for treating chronic low
back pain. MBSR programs are currently delivered regularly at the Osher Center at UCSF. The
differences are described above and do not affect the burden or safety of participating patients
with cLBP. Phase 1 of the study developed the manual and support materials and nears
completion with this application. This application is for Phase 2, the implementation of MBPR with
patients.
7.11  INSTRUMENTS: List all questionnaires, surveys, interview, or focus group guides that will be used
for this study:
If the instruments are not complete or not available because they will be
developed as part of this study, describe the basic content or include an
outline and submit the final versions to the IRB with a modification for
approval prior to use.
 
Questionnaires are identical to required instruments in the larger BACPAC study of the NIH HEAL
Initiative.
 

1) BACPAC Baseline Demographics Includes HEAL required questions (22)* only at baseline. This
includes questionnaire items necessary to adjust for MRI, e.g. to fit MRI-compatible correcting
eye glasses.
2) PEG scale assessing pain intensity and interference (Pain, Enjoyment, General Activity) (3)*
3) Generalized Anxiety Disorder (GAD-2) [Kroenke et al, 2007] (2)*
4) Patient Health Questionnaire-2 (PHQ-2) [Kroenke et al, 2003 (2)*
5) Tobacco, Alcohol, Prescription medication, and other Substance use (TAPS) tool (4)*
6) PROMIS Physical Functioning Short Form 6b (2 items not in PROMIS-29)*
7) PROMIS Sleep Disturbance 6a [Yu et al, 2011] (2 items not in PROMIS-29)*
8) Sleep Duration Question [Kurina et al, 2013] (1)*
9) Pain Catastrophizing Scale - short form 6 (PCS)  [McWilliams, 2015] (6)*
10) Patient Global Impression of Change (PGIC) (1) only at 8 weeks.
11) PROMIS-29+2 Profile v2.1 (PROPr) 02Jan2020 [PROMIS] (31)*
12) Charlson Comorbidity Index (CCI), [MDCalc (https://www.mdcalc.com/charlson-
comorbidity-index-cci)]* baseline only
13) PainDETECT Questionnaire (PD-Q) [Freynhagen et al., 2006] (7)*
14) Fear-Avoidance Beliefs Questionnaire Physical Activity (FABQ-PA) [Waddell et al., 1993] (5)*
15) Chronic Pain Acceptance Questionnaire-SF8 [Fish et al. 2010] (8)*
16) Multidimensional Assessment of Interoceptive Awareness (MAIA) [Mehling et al., 2018] (37)
17) Perceived Stress Scale [Cohen et al., 1989] (4)*
18) International Positive (and Negative) Affect Schedule 10-item SF [Watson et al., 1988] (5)*
19) PROMIS Emotional Support 4a V2 [Tucker et al, 2014] (4)* only baseline
20) Pain Self-Efficacy Questionnaire 4-item version (items 4, 6, 8, 9) [Chiarotto et al, 2016] (4)*
21) Primary Care PTSD Symptom Screener [Prins et al, 2016] (1)* only baseline
22) Financial Strain [Puterman et al, 2012] (1)* only baseline
23) Perceived Discrimination [NIMDH] (1)* only baseline
24) Expectation of Pain Relief [Cormier et al, 2016] (1)* only baseline
25) Pain Anxiety Symptoms Scale - Short Form (PASS-20) - (items 6-10, 16-20) [McCracken et
al. 2002] (10)*
26) Five Facets Mindfulness Questionnaire (FFMQ) [Baer et al. 2006] (39)
27) CHILD TRAUMA QUESTIONAIRE (CTQ) – SHORT FORM [Bernstein et al.1995]
28) Ecological Moment Assessment (EMA)
29) Semi-structured exit interviews 
30) Qualitative questions at 6 months, 3 items
Attach any unpublished instruments in the 'Other Study Documents'
section of the Initial Review Submission Packet form after
completing the study application. Published instruments should
NOT be attached.
7.12  * BIOSPECIMEN COLLECTION: Are you drawing any blood or collecting other biosamples (e.g. tissue,
buccal swabs, urine, saliva, hair, etc.) for analysis under this protocol and/or storage for future
research: (REQUIRED)
  Yes  
  No
7.13  STATISTICAL METHODS: Briefly summarize the methods and types of analyses that will be
performed:
Overall Analysis Approach: Preliminary analysis will be performed to confirm that key data
variables are clean and complete. Many of our outcomes will involve descriptive statistics, such as
proportions and means calculated using standard methods. Recognizing the challenge of
missing data, we will take concerted steps to limit missing data. We have extensive experience in
study retention; in a current mindfulness study by Dr. Hecht ( R61-33
AT009333), outcome assessment was completed in 97% of participants at 12 weeks. If indicated,
we will use mixed effects models, which are robust to the effects of missing data.
7.14  REFERENCES: List only the 5-10 most relevant references (a separate bibliography can be attached
for reference purposes if this study involves novel approaches, agents, or an emerging technology
that the IRB may not be familiar with):

1.         Collaborators USBoD, Mokdad AH, Ballestros K, et al. The State of US Health, 1990-
2016: Burden of Diseases, Injuries, and Risk Factors Among US States. Jama. Apr 10
2018;319(14):1444-1472. doi:10.1001/jama.2018.0158
2.         Qaseem A, Wilt TJ, McLean RM, Forciea MA, Clinical Guidelines Committee of the
American College of P. Noninvasive Treatments for Acute, Subacute, and Chronic Low Back Pain:
A Clinical Practice Guideline From the American College of Physicians. Annals of internal medicine.
Feb 14 2017;doi:10.7326/M16-2367
3.         Apkarian AV, Baliki MN, Farmer MA. Predicting transition to chronic pain. Curr Opin
Neurol. Aug 2013;26(4):360-7. doi:10.1097/WCO.0b013e32836336ad
4.         Hashmi JA, Baliki MN, Huang L, et al. Shape shifting pain: chronification of back pain
shifts brain representation from nociceptive to emotional circuits. Brain : a journal of neurology.
Sep 2013;136(Pt 9):2751-68. doi:10.1093/brain/awt211
5.         Butler DS, Moseley GL. Explain Pain, 2nd edition. Noigroup Publications. 2013;ISBN:
978-0-9873426-6-9
6.         Farb NA, Daubenmier J, Price CJ, et al. Interoception, contemplative practice, and
health. Frontiers in psychology. 2015;6:763. doi:10.3389/fpsyg.2015.00763
7.       Vachon-Presseau E, Berger SE, Abdullah TB, Griffith JW, Schnitzer TJ, Apkarian AV.
Identification of traits and functional connectivity-based neuropsychotypes of chronic
pain. bioRxiv preprint doi http://dxdoiorg/101101/421438. 2018
8.0
Drugs and Devices
8.1  * DRUGS AND/OR BIOLOGICS: Are you STUDYING any drugs and/or biologics that are either
approved or unapproved: (REQUIRED)
  Yes  
  No
If you have questions about FDA requirements for drug or device
research, you can send an email to request a consult.
Note: This question is frequently answered incorrectly. If any drugs
or biologics, approved or unapproved, are being administered under
this protocol, you should check 'Yes' unless you are absolutely sure
that NONE of the drugs are part of the research protocol. Tip: Ask
the PI or the sponsor if you are not sure how to answer this
question.
8.3  * MEDICAL DEVICES: Are you STUDYING any medical devices, in vitro diagnostics, or assays that are
either approved or unapproved:(REQUIRED)
  Yes  
  No
If you have questions about FDA requirements for drug or device
research, you can send an email to request a consult.
9.0
Sample Size and Eligibility Criteria
9.1  ENROLLMENT TARGET: How many people will you enroll:

50
 If there are multiple participant groups, indicate how many people will be
in each group:
A total of 50 participants will be enrolled into this study. 40 participants with cLBP will be
enrolled into 4 consecutive MBPR classes (n = 10 for each course). 10 participants with cLBP will
be in the MBSR as the control group. 
Specifically, the first 30 participants of the total 50 enrolled in the study will be assigned to MBPR
classes and the final 20 participants will be randomly assigned to MBSR (n 10) or to MBPR (n 10) 
to test recruitment and randomization approaches.
 
9.3  SAMPLE SIZE JUSTIFICATION: Explain how and why the number of people was chosen. For multi-site
studies, this is referring to the number that will be enrolled across all sites:
The primary goal of this study is to prepare for a rigorous RCT comparing efficacy of the MBPR
intervention to alternatives. We are not aiming to test efficacy in the current study and do not
have adequate sample size for this assessment. The proposed sample sizes were selected based
on the numbers we estimate will be needed to adequately refine the intervention and assess its
acceptability and feasibility, and to obtain variance estimates to inform future work. However, we
will conduct exploratory analyses to obtain estimates of ICCs of the repeated measures from
linear mixed models, and run linear mixed models with pain as outcome, and an interaction
between study period and psychological variables (e.g. PCS-SF, FABQ-PA, and MAIA-2) as
predictors, with nested random effects of person nested within class group. Although using all
participants across all iterations of MBPR is limited by variations in the intervention, with a total
MBPR sample size of 40 (out of 50 total enrolled, with a control/MBSR group of n 10), we will
have 80% power (two-tailed alpha = 0.05) to detect a statistically significant correlation if the
expected coefficient of determination is 0.43 or greater.
9.4  * PARTICIPANT AGE RANGE: Eligible age ranges: (REQUIRED)
0-6 years
7-12 years
13-17 years
18-64 years
65+
9.5  * STUDY POPULATIONS: Data will be collected from or about the following types of people (check all
that apply): (REQUIRED)
Inpatients
Outpatients
Family members or caregivers
Providers
People who have a condition but who are not being seen as patients
Healthy volunteers
Students
Staff of UCSF or affiliated institutions
None of the above
9.6  * SPECIAL SUBJECT GROUPS: Check the populations that may be enrolled: (REQUIRED)

Children / Minors
Adult subjects unable to consent for themselves
Adult subjects unable to consent for themselves (emergency setting)
Subjects with diminished capacity to consent
Subjects unable to read, speak or understand English
Pregnant women
Fetuses
Neonates
Prisoners
Economically or educationally disadvantaged persons
None of the above
9.7  INCLUSION CRITERIA:  Briefly describe the population(s) that will be involved in this study. Include
anyone that data will be collected from or about (e.g. patients, healthy controls, caregivers,
providers, administrators, students, parents, family members, etc.):
Inclusion criteria:
1. Chronic low back pain (cLBP) defined according to the NIH Research Task Force
recommendation on Research Standards for cLBP: pain at least half the days in the past 6
months, by using 2 questions and a human figure drawing illustrating the region as the space
between the lower posterior margin of the rib cage and the horizontal gluteal fold.
2. Average pain in the last month at least 3 out of 10 on Numeric Rating Scale [range 0 – 10, for
0 signifying no pain and 10 signifying worst pain imaginable]. This level of pain allows
comparability of the study results with the majority of cLBP studies. Pain rated less than 3 is too
mild to detect improvement.
3. Men and women aged 18 years old and older. We are not enrolling younger children as they
are not part of the Intensive Pain Rehabilitation Therapy program.
4. Eligibility will be assessed using the following questions: “(1) How long has back pain been an
ongoing problem for you? and (2) How often has low-back pain been an ongoing problem for you
over the past 6 months?” A response of greater than three months to question 1, and a response
of “at least half the days in the past 6 months” to question 2 would meet the cLBP eligibility
criterion.
5. Ability to speak English. We do not have the capacity, given the resources available in this
proposal, to translate all course material and conduct groups into another language. We have
previously enrolled Hispanic participants into other studies who were fluent in English, and expect
to do this in the proposed study.
6. Owning a smart phone (for EMA) and a computer (or tablet for Zoom participation in group)
 
7. Veteran subjects may be incidentally enrolled. 
 
INCLUSION OF CHILDREN
Under NIH definition, all individuals under the age of 21 are considered children. Eligible
participants who are 18 years of age or older will be recruited for this study. Younger children will
not be included in this study because a pediatric sample may require different intervention
approaches.
9.8  EXCLUSION CRITERIA: List any exclusion criteria (e.g. reasons why someone would not be included
in the study):
Exclusion criteria:
1. Unable to provide informed consent.

2. A substance abuse, mental health, or medical condition that, in the opinion of investigators,
will make it difficult for the potential participant to participate or that may need immediate
changes in medical management that will affect study outcome measures. Such conditions may
include cancer, diabetes, liver failure, renal failure, pain conditions from inflammatory diseases
(e.g. rheumatoid arthritis, ankylosing spondylitis, lupus), malignancies or abdominal aortic
aneurysm, muscle weakness from radiculopathy. Radiculopathy or sciatic pain is NOT excluded as
long as the condition is stable and does not lead to significant movement restrictions or <4/5
muscle weakness. Persons with significant substance abuse or mental health conditions that
interfere with social functioning may be disruptive. Oher medical or mental health conditions that
need immediate changes in management need to be addressed before starting the study so that
more reliable baseline measurements can be made. Patients who may need assessment for
potentially necessary surgical interventions may not be able to complete the study. Regular
opioid prescription is not an exclusion if stabile over the past 3 months.
3. Spine related current or history of spine fusion surgery, spine infection, spine tumor, vertebral
fracture, cauda equina syndrome. Condition would increase heterogeneity of the sample.
4. Blindness, severe vision problems, deafness, severe hearing problems, bipolar or manic
depression and not taking medication, major depression, psychoses (major), a substance abuse
condition, dementia, unable to get up and down from the floor. Condition might make it difficult
to participate.
5. Some other serious medical conditions that may alter key study outcomes, including untreated
hypothyroidism, renal failure, and cirrhosis. Conditions that may alter key study outcomes.
6. Involvement in a lawsuit related to their back. Complicated medico-legal issues that could lead
to individuals having a financial incentive to not report improvement.
7. Involved in Worker's Compensation claim.
8. Pregnant, breast-feeding, or planning to get pregnant in the next 12 months or less than 3
months post-partum. Particular back problems than may be associated with pregnancy and
delivery may confound study outcomes.
9. Lack of stable housing or plan to move out of the area within the next 6 months.
10. MRI-related exclusion criteria: Cardiac pacemaker, metal fragments in eyes/skin/body
(shrapnel), subjects who have ever been a metal worker/welder; history of eye surgery/eyes
washed out because of metal, aortic aneurysm clips, prosthesis, by-pass surgery/coronary artery
clips, hearing aid, heart valve replacement, subjects with an I.U.D, a shunt (ventricular or
spinal), electrodes, metal plates/ pins/screws/wires, or neuro/bio-stimulators (TENS unit), vision
problems uncorrectable with lenses, claustrophobia; inability to lie still on one’s back for
approximately 60 minutes; prior neurosurgery; older tattoos with metal dyes; unwillingness to
remove nose, ear or face jewelry, braces or permanent dental retainers. Iron-containing metal
parts in the body can potentially be dislocated by strong magnetic fields and preclude assessment
with MRI. As aging changes the brain, and in order to decrease variance in brain structure for the
small study sample, MRI will only be done in participants not older than 65 years of age. If
potential participants are excluded from the MRI due only to MRI exclusion criteria but pass study
eligibility otherwise, they still are eligible for participation in the MBSR-MBPR study at UCSF but
will not take part in the MRI assessment at the SFVA.
11. Received a steroid or botox injection in or near the spine in the last 3 months. This may alter
key study outcomes.
12. Color-blindedness
13. Left-handedness
14. Enrollment in MBSR program within the last year
15. Current regular meditation practice consiting of 20 minutes of meditation or more. 
9.9  * RESEARCH CONDUCTED ON PATIENT CARE WARDS: Do any study activities take place on any
patient care units including inpatient wards, peri- or post-operative care units, operating rooms, or
in the Emergency Department at UCSF Health medical facilities: (REQUIRED)
  Yes  
  No

9.11  * EMERGENCY DEPARTMENT: Does your protocol or study involve any of the following patient
related activities in the emergency department (e.g. subject identification, recruitment, consent,
blood draws, specimen retrieval, involvement of ED staff (nursing, tech, and/or physician), or any
other ED based procedures): (REQUIRED)
 
  Yes  
  No
10.0
Recruitment and Consent
10.1  * COMPETITIVE ENROLLMENT: Is this a competitive enrollment clinical trial? By competitive
enrollment, we mean that sites who do not enroll participants early may not get to participate at all:
(REQUIRED)  
  Yes  
  No
10.2  * SUBJECT IDENTIFICATION METHODS: What kinds of methods will be used to identify potential
participants for recruitment (check all that apply): (REQUIRED)
Review of patients' conditions, history, test results, etc. (includes patients seen in clinic,
scheduled for surgery, a procedure, imaging, or tests, or seen in the Emergency Department
as well as searching through medical record data for possible cohort identification)
Already approved recruitment registry
Re-contact of participants from the investigators' previous studies
Referrals from colleagues (attach the 'Dear Colleague' letter or other recruitment materials
you will provide to colleagues)
Referrals from the community / word of mouth
Advertisements (flyers, brochures, radio or t.v. ads, posting on clinical research sites or social
media, presentation of the study at community events/media, etc.)
Online recruiting tool (describe below)
CTSI Recruitment Services unit
Posting on UCSF Clinical Trials, ClinicalTrials.gov or other publicly available clinical trial
website
Other method (describe below)
Attach your recruitment materials (e.g., flyers, ads, recruitment
letter templates, email text, etc.) in the Other Study Documents
section of the Initial Review Submission Packet Form.
* Provide details about the subject identification methods: (REQUIRED)
    Participants will be recruited through advertisement in newspapers, social media and flyers,
and from the current UCSF Spine Center cLBP
cohort. In addition, we will identify potentially eligible participants through review of our Medical
Center’s electronic medical records and send letters inviting study participation
using a service available through the UCSF CTSI. The CTSI will be given ICD-10 codes applied to
the APEX  electronic medical records at UCSF of the the past 12 months: codes are M54.06,
M54.07, M54.16, M54.17, M54.30, M54.31, M54.32, M54.50, M54.51 and send out MyChart
notices to invite these patients to go to the study website to check for eligibility.
 
   We plan to recruit both males and females. We anticipate that male/female ratio will match the
gender, racial and ethnic composition of San Francisco county population.
    At the UCSF Osher Center: We will hang out flyers in its clinic space and may contact
participants in prior studies who have consented to be contacted for further studies.
    ResearchMatch.org will be utilized as a recruitment tool for this protocol. ResearchMatch.org is
a national electronic, web-based recruitment tool that was created through the Clinical &

Translational Science Awards Consortium in 2009 and is maintained at Vanderbilt University as an
IRB-approved data repository.
* Did all the participants of previous studies provide permission to be
contacted for future studies: (REQUIRED)
 Yes  
 No
10.3  * SEARCHING OF MEDICAL RECORDS: (REQUIRED)
Whose patients are they:
Investigators' own patients or patients seen within the same practice
Patients not under the care of the investigators
How and by whom will records be accessed and searched (check all that
apply):
Self-search in APeX or other medical records source
Self-search using UCSF's Research Cohort Selection Tool
CTSI Consultation Service Recruitment Services
UCSF Academic Research Services (ARS)
University of California Research Exchange (UC ReX)
Other method (describe below)
10.4  DETERMINATION OF ELIGIBILITY: How, when, and by whom will eligibility for recruitment be
determined:
    After making initial contact with the subject and prior to enrollment, eligibility screening will be
conducted by trained research staff. Due to the extentive nature of the eligibility screening,
participants will be asked to give verbal consent (see section 10.7) before the screen is
conducted. If a potential subject is interested in participating and provides verbal consent, he or
she will be asked a series of eligibility questions. If he/she meets initial requirements for
preliminary eligibility and is interested in participating, the potential participant will be invited and
potentially scheduled for a zoom-based appointment with the study team at the UCSF Osher
Center.
 
    Potential participants enrolled in REACH have passed the same eligibility criteria.
10.5  * INITIATION OF CONTACT: Who initiates contact (check all that apply): (REQUIRED)
Investigators/study team
UCSF recruitment unit (e.g. CTSI Consultation Services)
Potential participant
Other (explain below)
Provide details about how contact is initiated:
Investigator's colleagues in clinics (i.e. pain clinic; Osher Center clinic, Family Medicine Clinic,
etc) may introduce study to potential participants and provide them with the study team's
recruitment material(s) and/or contact information.
Click here to review the process and rules for use of CTSI's
Consultation Services for recruitment. 

10.6  * HOW IS CONTACT INITIATED: (check all that apply): (REQUIRED)
In person
Phone
Letter / email
Website or app
Other (explain below)
Attach the telephone recruitment script in the Other Study
Documents section of the Initial Review Submission Packet Form. If
potential participants will initiate contact, attach the telephone
screening script that will be used to provide more information
about the study and determine if callers are eligible to participate.
Attach the recruitment letter or email template in the Other Study
Documents section of the Initial Review Submission Packet Form.
Provide the URL for any website in Recruitment Plan section, or
attach a mock-up of the website or the app screens in the Other
Study Documents section of the Initial Review Submission Packet
Form.
10.7  RECRUITMENT PLAN: Based on the checkboxes you chose above, please provide a narrative
describing your recruitment plan. We want to know:
Who is conducting the search for potential participants, and how?
How are potential subjects being approached for recruitment? By whom, and when?
If there will be more than one participant group (e.g. patients, healthy controls, caregivers, family
members, providers, etc.), provide details about the recruitment plans for each group.
(Recommended length - 100-250 words)
    All recruitment is done by trained research staff who are assigned to this study, using
aforementioned recruitment methods as well as methods listed below. Subjects can either contact
the study staff, or study staff may contact the subject. The study team will not initiate contact
with subjects by telephone unless they have received permission from the potential subject to be
contacted by telephone. Permission is provided verbally (in the case of provider referrals),
implied or written (in the case of VA approved research mailings), or explicitly by the potential
subject. Initial contact by the study team must be in-person (including by phone and/or zoom) or
by mail, unless the subjects initiates contact. Upon contact, subject will be given information
about the study. They will then be asked if they are interested in participating and will be
screened for eligibility.
 In addition, we will identify potentially eligible participants through review of our Medical
Center's electronic medical records and send letters inviting study participation using  the UCSF
CTSI.
    Interested candidates who either 1) respond to recruitment solicitation and initiate contact
with the study team via e-mail or phone or 2) who are approached by the study team directly will
be given an overview of the study and its enrollment requirements, and will be initially screened
by an online screener and telephone. If a potential participant is interested and meets initial
requirements for participation, he/she will be invited for a zoom appointment with a trained staff
member (CRC) at the UCSF Osher Center or the PI. This appointment, which will take place via
zoom, will entail meeting with trained research personnel (CRC) who will describe the study in
detail, address any questions/concerns, and obtain informed consent for study participation.
    Recruitment strategies: Recruitment methods and media may include fliers; in-person
presentations; a study specific webpage; informational letters; print newsletters; press releases
or advertisements in print, internet, television, and radio, public service announcements; public

notice-board postings; contact with and referral from relevant clinicians; social media,
pamphlets; informational sessions about the research. In clinical settings, care providers will also
be given informational materials to distribute to potential candidates.
    The above mentioned recruitment strategies will also take place at social service agencies,
community mental health clinics, community organizations/events, including local professional
organizations, consenting support and recovery centers, local hospitals and healthcare systems,
regional employee assistance programs, religious organizations, cultural centers, public
transportation vehicles and stations, social clubs, and universities.
    Any recruitment materials (fliers, brochures, etc.) that will be used will be submitted to IRB for
approval prior to use.
 
10.8  * CONSENT METHODS: How will permission to participate (i.e., informed consent) be obtained from
each potential participant. If there will be multiple groups and different plans for consenting each,
check all that apply. See the orange Help bubble to the right for more detailed guidance.  
Participants will (check all that apply): (REQUIRED)
Sign a paper consent form at the end of the consent discussion (signed consent)
Sign an electronic consent form using DocuSign (signed consent)
Provide online consent through an app, a website, or a survey tool such as Qualtrics or
REDCap (waiver of signed consent)
Be told about the study and be given a handout/information sheet and be asked if they agree
to participate (verbal consent - waiver of signed consent)
Complete the study activities and turn in materials, as in the case of a completed survey that
is placed in a drop box or mailed to the study team (implied consent - waiver of signed
consent)
Not be able to provide consent and will have a family member consent for them, as in the
case of a critically ill or unconscious patient (surrogate consent)
Not able to provide consent (emergency medicine, greater than minimal risk waiver/alteration
of consent - requires an approved community consultation plan)
Not able to provide consent (emergency medicine, minimal risk waiver/alteration of consent)
Not know about the study, as in the case of chart reviews or observations of public behavior
(waiver of consent)
Other method (describe below)
Attach your consent form, information sheet, or electronic consent
text in the Informed Consent Documents section of the Initial
Review Submission Packet Form.
10.9  * CONSENT PROCESS: Describe the process for obtaining informed consent, including details such as
who will have the consent discussion and when participants will be asked to sign the consent form
in relation to finding out about the study: (REQUIRED)   We encourage researchers to review our
guidance on obtaining and documenting informed consent.
If there are multiple groups being consented differently, provide details about the consent
process for each group.
If you are relying on verbal or implied consent, provide details about how that will happen.
For studies using online recruitment and consent or consent via mail, provide details here.
Prior to eligibility determination (phone screening):
    In order to determine a subject's eligibility, a phone screening will be conducted. We will
obtain verbal consent, as in-person consenting is not an option. Verbal consent is obtained by
trained phone screeners. Verbal consent for phone screen is part of the phone screen itself.
Prior to enrollment:
    After determining the subject is preliminarily eligible and prior to enrolling them in the study,
the subject will receive consent documents by mail (with post-marked return envelop) or/and e-

mail.  In a separate phone call or zoom meeting, trained research staff will obtain consent and go
over the various sections of the consent documents, ensuring that the subject has comprehended
the consent documents and does not have any questions. Participants will sign consent via
docusign or mailed forms. We will send the consent forms by mail to those potential participants
who are VA subjects. The UCSF DocuSign option will only be used for non-VA potential
participants.
A total of 50 participants will be enrolled into this study. The first 30 subjects will be participate in
the single arm MBPR study. The final 20 participants will be randomly assigned to MBSR (n 10)
and to MBPR (n 10).
Randomization will be done by a computer-generated randomization program. Blinding is not
necessary, as this is for assessing willingness to be randomized rather than an efficacy study
comparing two interventions.
The VA research team will provide a copy of the HIPAA form to all participants to be signed in
person by hand on paper before any SFVA study procedures (fMRI). This occurs at the SFVA
when participants arrive for the MRI. The SFVA research team is fully trained in obtaining HIPAA
signatures and signing consents.
 
UCSF-DocuSigned consent forms will be stored on secure UCSF Box. Veterans that sign consent
on paper will send the signed consent form back to the UCSF team, which will scan the form and
store it in the secure UCSF Box folder. The VA research team will have access to this secure UCSF
Box folder and will be able to transfer the consent forms to store behind VA firewall on the secure
R-drive. Any paper forms will be stored in secured, locked file cabinets at the SFVA Building 203
in room 1C12.
* It is important that the people obtaining consent are qualified to do so.
Briefly describe the training and experience these individuals have in
obtaining informed consent: (REQUIRED)
    Only trained study staff will be obtaining consent from participants. These study staff will have
gone through training with either the PI or the study coordinator. Training includes but is not
limited to becoming familiar with consenting guidelines, mock consent practice, etc.
10.10  * CONSENT COMPREHENSION: Indicate how the study team will assess and enhance the subjects'
understanding of study procedures, risks, and benefits prior to signing the consent form (check all
that apply): (REQUIRED)   Tip: Review the Consent Comprehension - Learning Notes in the Help
bubble at the right for specific questions that can be asked to assess comprehension, consider
using the UCSF Decision-Making Capacity Assesment Tool, and review our guidance on obtaining
written or verbal informed consent for more detail on how to conduct the assessment.
The study team will engage the potential participant in a dialogue, using open-ended
questions about the nature of the study or the experimental treatment, the risks and benefits
of participating, and the voluntary nature of participation
Potential participants will be asked or shown a series of questions to assess their
understanding of the study purpose, procedures, risks and benefits, as well as the voluntary
nature of participation (especially appropriate when the consent process happens online or
through a mobile health app)
Other method (describe below):
Provide details of the other approaches that will be used, if using another
method to assess comprehension:
N/A
10.11  * DECEPTION: Does this study rely on some deception or misinformation about what the
researchers are observing to get valid data? (REQUIRED)
  Yes  
  No
10.13  * WAIVER OF DOCUMENTATION OF SIGNED CONSENT: Select the regulatory category under which
the IRB may waive the requirement to obtain signed consent for this study:

The only record linking the subject and the research would be the consent document and the
principal risk would be potential harm resulting from a breach of confidentiality. Each subject
will be asked whether they want documentation linking them with the research. 46.117(c) (1)
 
The research presents no more than minimal risk of harm to subjects and involves no
procedures for which written consent is normally required outside of the research context.
46.117(c) (2)  
10.14  TIME: What is the estimated time commitment for participants (per visit and in total):
First round of questionnaires (at home): ~60 minutes
Informed Consent Discussion (via phone): ~30 minutes
The study will include up to 2 in-person visits at the San Francisco VA
Medical Center for fMRI; all other visits are vie zoom:
Visit 1 (fMRI) (at SFVAMC): 1 to 2 hours
Initial check-in phone calls (phone or zoom) ~5-30 minutes each
depending on participant needs.
Visit 2 (MBPR Orientation Session; via zoom): ~2 hour
Visit 3-10 (8 Classes MBPR Intervention; via zoom): 2 1/2 hours x 8
Visit 11 (MBSR retreat day; via zoom): 6 hours
Visit 12 (fMRI): 1 to 2 hours
Second round of questionnaires (at home): ~60 minutes
Potential Visit 5: qualitative interview: ~2 hours (24 of the 50 participants)
Follow-up questionnaires at 6-months: ~60 minutes
Total time involved with the study: ~ 33.6 to 38 hours over 9 - 10
weeks.
The range is so wide, as it depends on the 2-hour exit interview (with 24 of
the 50 participants).
 
IMPORTANT TIP: Ensure this information is consistent with the
information provided in the consent form.
10.15  ALTERNATIVES: Is there a standard of care (SOC) or usual care that would be offered
to prospective participants at UCSF (or the study site) if they did not participate in this research
study:
  Yes  
  No
10.16  OFF-STUDY TREATMENT: Is the study drug or treatment available off-study:

Yes 
No  
Not applicable 
10.17  OTHER ALTERNATIVES: Describe other alternatives to study participation, if any, that are available
to prospective subjects:
Participation is completely voluntary. Potential study participants may chose to not participate in
the study and ask their primary care providers for pain management.
11.0
Waiver of Consent/Authorization for Recruitment
Purposes
This section is required when medical records may be reviewed to
determine eligibility for recruitment.
11.1  * PRACTICABILITY OF OBTAINING CONSENT PRIOR TO ACCESS: Study personnel need to access
protected health information (PHI) during the recruitment process and it is not practicable to obtain
informed consent until potential subjects have been identified: (REQUIRED)
Yes 
If no, a waiver of consent/authorization is NOT needed.
11.2  *  RISK TO PRIVACY: A waiver for screening of health records to identify potential subjects poses no
more than minimal risk to privacy for participants:
Yes 
If no, a waiver of authorization can NOT be granted.
11.3  * RIGHTS/WELFARE: Screening health records prior to obtaining consent will not adversely affect
subjects' rights and welfare:
Yes 
If no, a waiver of authorization can NOT be granted.
11.4  * IDENTIFIERS: Check all the identifiers that will be collected prior to obtaining informed consent:
Names
Dates
Postal addresses
Phone numbers
Fax numbers
Email addresses
Social Security Numbers*
Medical record numbers
Health plan numbers

Account numbers
License or certificate numbers
Vehicle ID numbers
Device identifiers or serial numbers
Web URLs
IP address numbers
Biometric identifiers
Facial photos or other identifiable images
Any other unique identifier
None
Note: HIPAA rules require that you collect the minimum necessary.
11.5  * HEALTH INFORMATION: Describe any health information that will be collected prior to obtaining
informed consent:
    No information will be collected prior to any form of consent.
    To determine eligibility over the phone, information on MRI contraindications, general mental
health, and physical health will be obtained to assess whether someone can complete the study.
All information obtained before informed consent can be seen in the Eligibility Phone Screen,
attached in Other Study Documents. All of the health information collected is necessary to
determine eligibility. Because this information is collected prior to an in-person consent for
eligibility purposes, a verbal consent will be obtained.
Note: HIPAA requires that you collect the minimum necessary.
11.6  * DATA RETENTION/DESTRUCTION PLAN: Describe your plan to destroy any identifiable data
collected to determine eligibility for recruitment. This should be done at the earliest opportunity. If
you plan to retain identifiable recruitment data, provide the justification for doing so:
All data collected for eligibility purposes is collected via RedCap or Qualtrics and will remain
electronic throughout the course of the study. While this data will not be used for analysis, it will
be preserved as it is used to contact potential future participants (upon their consent to do so).
All retained data collected is behind the secure UCSF firewall.
Subject identifiers will be kept separately from the research data in locked cabinets and locked
office at the UCSF Osher Center. 
Participant data will also be stored on VA servers at the Center for Imaging of Neurodegenerative
Diseases at the San Francisco VA.
 
 
12.0
Risks and Benefits
12.1  RESEARCH-RELATED RISKS: Check if your study involves any of these specific research-related risks
to participants that may need to be disclosed in the consent form:
Physical discomforts or pain
Risks to employment, or social or legal standing
Risk that the study team may observe possible evidence of child abuse, elder abuse, or a
threat to self or others that they are required to report
For reportable information, include details of the reporting plan below. (See

the Help link for Mandated Reporter child and elder abuse resources.)
* For any boxes checked above, describe how you will minimize these risks
and discomforts, e.g., adding or increasing the frequency
of monitoring, additional screening to identify and exclude people with
diminished kidney or liver function, or modification of procedures such as
changing imaging studies to avoid giving contrast agent to people who are
more likely to suffer side effects from it, etc.: (REQUIRED)
    Data are password-protected and stored on secured UCSF PHI drive, only accessible on UCSF
server. The computers will be checked regularly for proper and safe operation. Identifiable
information is also stored as a hard copy in a locked office and locked file cabinet. Subjects will
be carefully screened and subsequentially informed about the fact that the principal investigator
will be available at all times during the experiment. Subjects are informed that they may end the
test session at any time and that participation in this research is voluntary.
    Subjects are told that all information obtained is completely confidential and that their medical
treatment at UCSF or the VA will not be affected, whether or not they choose to participate in this
study. Coded numbers are assigned to each file in the data base to ensure patient privacy. To
minimize the risk that sensitive subject information may be disclosed, all subject information will
be kept in locked cabinets or in databases with secured passwords.
    Records and data will be rigorously protected. Examiners will be clinically trained and sensitive
to signs of stress, anxiety, or fatigue so that testing will be immediately terminated should any
subject experience signs of discomfort. Any incidental findings regarding subjects' health will be
submitted to his/her physician at subjects' request.
Reportable information: Evidence of elder or child abuse, as well as threat to self or others,
will be reported. Participants are notified of this in the verbal and in-person consents. If it is
suspected that the subject is in danger of harming him/herself or someone else, or if child abuse
or neglect or elder abuse has occurred, appropriate authorities will be notified as required by law.
Self-report measures: The main risks associated with these procedures are fatigue and
irritability with the testing procedure. The investigator and research assistants are trained to
frequently check the subjects about their willingness and ability to continue with the testing. If
the subjects express concerns about continuing with the testing, the investigator has instructed
the research assistants to stop testing, offer a break, or, in case the subject is not willing to
continue, to terminate the testing session. Overall, however, previous comparable studies have
not resulted in any significant discomfort or anxiety expressed by the participating subjects.
Risks associated with functional magnetic resonance imaging: According to the FDA, there
is currently no evidence that MRI with approved scanners of up to 7 Tesla signal strength are
associated with adverse effects. moreover, other fMRI centers across the country are regularly
using up to 7T MRI scanners for research purposes. However, there are two major sources of
risk. First, the subject may experience discomfort being in the confined and sometimes noisy
environment of the scanner. Second, the strong magnetic field will affect electronic, magnetic,
and metal devices that subjects carry with them or that have been implanted in the subject's
body. Additionally, female subjects capable of child-bearing, will be asked a number of questions
regarding their use of reliable contraceptive methods in order to be as sure as possible that they
are not pregnant. Even though there are no known risks to an unborn child associated with fMRI,
women of child-bearing potential who are not using reliable contraceptive methods will be
excluded from this study.
Data collection: The risks involve some degree of loss of privacy. This will be minimized as
much as possible, as described elsewhere in this application.
Yoga: it is possible that yoga exercises can cause discomfort or pain. To minimize potential side
effects exercises instructed over the internet (interactive Zoom), a second yoga instructor (CRC
Kirsten Rogers) will observe the participants and correct as needed. Furthermore: a questionnaire
for medical spine conditions that would require more individual attention and exercise
modification will be used before the first yoga session. Thereby exercises, although taught in a
group, can be partially individualized, and the risk of injury can be reduced.
12.2  * RISKS: Describe any anticipated risks and discomforts not listed above: (REQUIRED)

See section 12.1.
12.3  
MINIMIZING RISKS: Describe the steps you have taken to minimize the risks/discomforts to
subjects. Examples include:
designing the study to make use of procedures involving less risk when appropriate
minimizing study procedures by taking advantage of clinical procedures conducted on the
study participants
mitigating risks by planning special monitoring or conducting supportive interventions for the
study
having a plan for evaluation and possible referral of subjects who report suicidal ideation
All risks and steps to minimize those risks are described in section 12.1 above.
12.5  * BENEFITS: (REQUIRED) Note: These are the benefits that the IRB will consider during their
review. They are not necessarily appropriate to include in the consent form.
Possible immediate and/or direct benefits to participants and society at
large (check all that apply):
Positive health outcome (e.g. improvement of condition, relief of pain, increased mobility,
etc.)
Closer follow-up than standard care may lead to improved outcomes or patient engagement
Health and lifestyle changes may occur as a result of participation
Knowledge may be gained about their health and health conditions
Feeling of contribution to knowledge in the health or social sciences field
The research presents a reasonable opportunity to further the understanding, prevention, or
alleviation of a serious problem affecting the health or welfare of children
Other benefit (describe below)
None
12.6  RISK TO BENEFIT RATIO: Explain why the risks to subjects are reasonable in relation to anticipated
benefits, if any, to the participant or society:
Chronic Pain is a serious problem, as discussed in section 7.0. Since the risks are relatively small,
we believe the potential benefits to society outweigh the risks to the subjects.
12.7  * DATA AND SAFETY MONITORING: Do you have a Data and Safety Monitoring Plan (DSMP) for this
study (A DSMP is required for Greater than Minimal Risk research): (Click the Help link for guidance
on risk determination) (REQUIRED)
 Yes  
 No
This is not required for minimal risk research but the UCSF IRB
strongly recommends one to ensure the data collected are adequate
to meet the research aims:
13.0
Data and Safety Monitoring Plan
13.1  * DATA AND SAFETY MONITORING PLAN (DSMP): (REQUIRED) Provide a summary of the DSMP:

All greater than minimal risk studies are required to provide a plan.
Lack of an adequate plan is one of the most common reasons why
IRB approval is delayed.
 
Instructions:
Describe the plan for monitoring data quality and participant safety. Key
areas that should be included in the plan are:
An explanation of the plan to monitor data collection, study progress,
and safety
A description of who will perform the monitoring and at what
frequency (e.g., the PI only, a contract research organization, a Data
and Safety Monitoring Board or Data Monitoring Committee, etc.)
The type of data and events that will be reviewed (e.g., adverse
events, breaches of confidentiality, unanticipated problems involving
risk to participants or others, unblinded efficacy data, etc.)
Procedures and timeline for communicating monitoring results to the
UCSF IRB, the study sponsor, and other appropriate entities
As appropriate:
A plan for conducting and reporting interim analysis
Clearly defined stopping rules
Clearly defined rules for withdrawing participants from study
interventions
Data and Safety Monitoring Plan (DSMP)
This DSMP was reviewed and accepted by NIH-NCCIH
Independent Monitoring Committee
Feasibility Clinical Trial of Integrated Mind-Body Therapy for Chronic Low Back Pain 
(MBPR Study)
 
 
NIH Institute or Center: National Center for Complementary and Integrative
Health
Grant Number: R34AT010921-01A1
Version Date: 10/02/2020
Version Number: 1
 
 
1      STUDY OVERVIEW
 

1. Purpose of Study
The overall goal of this project is to developing a modified version of Mindfulness-Based Stress
Reduction (MBSR) that we believe will prove to be more effective for chronic low back pain.
Following the initial protocol development informed by a panel of international experts, 4 x 10 =
40 participants will undergo 8-week Mindfulness-Based Pain Reduction (MBPR) classes that are
iteratively improved through participant feedback. This study will enroll a total of 50 individuals
with chronic low back pain, which includes a control group of 10 participants that will receive
MBSR. 
2. Adherence Statement
The Data Safety Monitoring Plan (DSMP) outlined below will adhere to the
protocol approved by the UCSF IRB.
All protocol amendments, other than minor administrative changes as defined by the NCCIH
Guidance on Changes in Clinical Studies in Active Awards will be submitted in a prospective
manner to NCCIH except when necessary to protect the safety, rights, or welfare of subjects.
IRB-approval will not be sought until after NCCIH approval of the protocol amendment has been
obtained.
 3   CONFIDENTIALITY
3.1       Protection of Subject Privacy
Subject confidentiality is strictly held in trust by the investigators, study staff, and the sponsor(s)
and their agents.  This study does not include testing of biological samples and genetic tests in
addition to any study information relating to subjects.
The study monitor or other authorized representatives of the sponsor may inspect all study
documents and records required to be maintained by the investigator, including but not limited
to, medical records (office, clinic, or hospital) for the study subjects.  The clinical study site will
permit access to such records.
3.2       Confidentiality During Adverse Event (AE) Reporting
AE reports and annual summaries will not include subject or group-identifiable material. Each
report will only include the identification code.
4      EXPECTED RISKS
4.1    Behavioral / Psychological Questionnaires: These carry a minimal risk for emotional
discomfort and stress.
4.2    Post-Intervention Interviews: These carry a minimal risk for emotional discomfort and
stress.
4.3    Privacy: Participating in the study may result in a loss of privacy because the intervention
is administered in a group setting. Participants will be asked not to share information
related to other individuals when they are outside of class, but this cannot be guaranteed.
Questionnaires will include background medical information and psychological scales and
all research data will be stored on the secured web-based Research Electronic Data
Capture (REDCap) and Qualtrics systems. Subjects are informed that they are free to
refuse to participate in any stage of the work and can refuse to answer specific questions
or questionnaire items if they wish.
4.4    Unexpected Events: A physician is present or on call during all study procedures, and will
be available if a participant experiences suicidal ideation or other mental health problem.
All subjects will be provided with contact numbers in case distress arises following the
experiment or intervention.

4.5    Yoga-type movements and postures as a component of MBPR/MBSR: Yoga has
been found to be relatively safe in a number of large-scale randomized trials however any
exercise program may result in muscle soreness or strains. Adverse events do occasionally
occur and it is important that participants report any injuries to study staff. To improve
safety, all participants will complete a pre-intervention assessment.
Prior to the start of MBPR/MBSR classes participants will be evaluated to determine if their
pain worsens with flexion or extension. We will monitor pain levels during physical
exercises. Classes are much smaller than common MBSR classes (10 participants instead
of 15-25) and instructors are better able to help participants with individual adjustments
and advice.
Finally, for those doing yoga-type exercises and postures, several minor adverse effects
may occur and include increased low back pain intensity, muscle strain or sprain, or
dizziness and are generally of short duration and alleviated by local physical measures
(such as ice) and physical rest. They will be thoroughly addressed in the intervention.
4.6    Fluctuations in Pain Levels: Study physician Dr. Mehling will weekly review the class
reports and videos. He will be available by cell phone for more urgent problems between
in-person consultations. Primary care physicians for each participant will receive
information about the study before the participant begins the study. Study physician will
help to make sure that primary care physicians are informed of any medical changes, and
will consult with primary care physicians where indicated.
4.7    MBPR and MBSR: Similar interventions have been used with thousands of persons,
including many with serious illness and pain conditions, and there have not been important
adverse events reported to our knowledge. Participants can experience restlessness during
the meditation practices or become aware of distressing emotions and traumatic
memories. Our instructors are highly trained and experienced and will immediately inform
the study physician, who will determine whether referral to behavioral medical care is
warranted.
4.8    Home Exercise Components: Participants will be requested to do yoga-style exercises at
home. Some people may experience initial discomfort when increasing their level of
physical activity. There may also be a slight increase for physical risks when partaking in
exercise activities. There are minor risks of injury during exercise, but these risks are
minor and far out-weighed by the potential benefits of exercise.
4.9    Audio/Video-Taping Instructors During Classes: classes will be audio-videotaped
to ensure intervention fidelity and provide feedback and troubleshooting for
instructors. Some participants may experience a level of discomfort while being
recorded during class. Although the recorders will be placed in front of the class to
record the instructors’ voice, there is a strong likelihood that some of the
participants’ movements and voices will be recorded. They may also feel that they
are being monitored. Participants will be informed of the recording, and can sit
farther from the microphone if they desire. Recordings will be kept on a HIPAA-
compliant research network drive with password-restricted access limited to study
staff. Recordings will be destroyed once the study is complete. Adverse event/
unanticipated problems
5          ADVERSE EVENT/ UNANTICIPATED PROBLEMS
5.1       Definitions
5.1.1    Adverse Event (AE)
An adverse event (AE) is any untoward medical occurrence in a subject during participation in the
clinical study or with use of the experimental agent being studied. An adverse finding can include
a sign or symptom, or any combination of these regardless of relationship to participation in the
study.
5.1.2    Unanticipated Problems (UP)

The Office for Human Research Protections (OHRP) considers unanticipated problems involving
risks to subjects or others to include, in general, any incident, experience, or outcome that meets
all of the following criteria:
Unexpected in terms of nature, severity, or frequency given (a) the research procedures
that are described in the protocol-related documents, such as the IRB-approved research
protocol and informed consent document; and (b) the characteristics of the subject
population being studied;
Related or possibly related to participation in the research (“possibly related” means there
is a reasonable possibility that the incident, experience, or outcome may have been
caused by the procedures involved in the research); and
Suggests that the research places subjects or others at a greater risk of harm (including
physical, psychological, economic, or social harm) than was previously known or
recognized.
5.1.3    Serious Adverse Event (SAE)
Serious adverse events (SAEs) are a subset of all Adverse Events (AEs). A serious adverse event
(SAE) is one that meets one or more of the following criteria:
Results in death
Is life-threatening (places the subject at immediate risk of death from the event as it
occurred)
Results in inpatient hospitalization or prolongation of existing hospitalization
Results in a persistent or significant disability or incapacity
Results in a congenital anomaly or birth defect 
An important medical event that may not result in death, be life threatening, or require
hospitalization may be considered an SAE when, based upon appropriate medical judgment, the
event may jeopardize the subject and may require medical or surgical intervention to prevent one
of the outcomes listed in this definition.
5.2       Time Period and Frequency for Event Assessment and
Follow-Up
Unanticipated problems will be recorded in the data collection system throughout the study.
The PI will record all reportable events with start dates occurring any time after informed consent
is obtained until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study
participation.  At each study visit, the investigator will inquire about the occurrence of AE/SAEs
since the last visit.  Events will be followed for outcome information until resolution or
stabilization.
5.3       Characteristics of an Adverse Event
5.3.1    Relationship to Study Intervention
To assess relationship of an event to study intervention, the following guidelines are used:
1. Related (Possible, Probable, Definite)
a. The event is known to occur with the study intervention.
b. There is a temporal relationship between the intervention and event onset.
c. The event abates when the intervention is discontinued.
d. The event reappears upon a re-challenge with the intervention.
2. Not Related (Unlikely, Not Related)
a. There is no temporal relationship between the intervention and event onset.
b. An alternate etiology has been established.
5.3.2    Expectedness of SAEs
The Study PIs and Independent Monitoring Committee will be responsible for determining
whether an SAE is expected or unexpected.  An adverse event will be considered unexpected if
the nature, severity, or frequency of the event is not consistent with the risk information

previously described for the intervention. 
5.3.3    Severity of Event
The following scale will be used to grade adverse events:
1. Mild: no intervention required; no impact on activities of daily living (ADL)
2. Moderate: minimal, local, or non-invasive intervention indicated; moderate impact on ADL
3. Severe: significant symptoms requiring invasive intervention; subject seeks medical
attention, needs major assistance with ADL
5.4       Reporting Procedures
Serious Adverse Event reporting will be in accordance with the UCSF- Committee on Human
Research Regulations and Code of Federal Regulation Title 21 Volume 5 Part 312.32.
We will also follow the UCSF IRB website for guidance in reporting serious adverse events
 https://irb.ucsf.edu/adverse-event. 
5.4.1    Unanticipated Problem Reporting 
Incidents or events that meet the OHRP criteria for unanticipated problems require the creation
and completion of an unanticipated problem report form.  OHRP recommends that investigators
include the following information when reporting an adverse event, or any other incident,
experience, or outcome as an unanticipated problem to the IRB:
Appropriate identifying information for the research protocol, such as the title,
investigator’s name, and the IRB project number;
A detailed description of the adverse event, incident, experience, or outcome;
An explanation of the basis for determining that the adverse event, incident, experience,
or outcome represents an unanticipated problem;
A description of any changes to the protocol or other corrective actions that have been
taken or are proposed in response to the unanticipated problem.
To satisfy the requirement for prompt reporting, unanticipated problems will be reported using
the following timeline:  
Unanticipated problems that are serious adverse events will be reported to the IRB,
Independent Safety Monitor(s), and NCCIH within 5 working days of the investigator
becoming aware of the event.
Any other unanticipated problem will be reported to the IRB, Independent Safety
Monitor(s), and NCCIH within 10 working days of the investigator becoming aware of the
problem.
All unanticipated problems should be reported to appropriate institutional officials (as required by
an institution’s written reporting procedures), the supporting agency head (or designee), and
OHRP within one month of the IRB’s receipt of the report of the problem from the investigator.
5.4.2    Adverse Event Reporting of Non-IND Studies
SAEs that are unanticipated, serious, and possibly related to the study intervention will be
reported to the Independent Safety Monitor(s), IRB, and NCCIH in accordance with
requirements.  
Unexpected fatal or life-threatening AEs related to the intervention will be reported to the
NCCIH Program Officer, and Independent Safety Monitor(s) within 3 days of the
investigator becoming aware of the event.  Other serious and unexpected AEs related to
the intervention will be reported within 5 working days.
Anticipated or unrelated SAEs will be handled in a less urgent manner but will be reported
to the Independent Safety Monitor(s), IRB, and other oversight organizations in
accordance with their requirements. and will be reported to NCCIH on an annual basis.   
All other AEs documented during the course of the trial will be reported to NCCIH on an
annual basis by way of inclusion in the annual report and in the annual AE summary which
will be provided to NCCIH and to the Independent Monitors.  The Independent Safety
Monitor(s) Report will state that all AEs have been reviewed.

5.5  HALTING RULES
Review of any serious, unexpected, and related AEs by the Medical Monitor, DSMB/ Independent
Safety Monitors, IRB, the sponsor, or relevant local regulatory authorities may result in
suspension of further study interventions/administration of study product at a site. The study
sponsor retains the authority to suspend additional enrollment and study
interventions/administration of study product for the entire study, as applicable.
6  QUALITY CONTROL AND QUALITY ASSURANCE
We will develop standard operating procedures (SOPs) that will describe:
Staff training methods and how such training will be tracked: All key study personnel and
those involved in obtaining consent will maintain updated CITI human subjects training.
This will be tracked and reviewed by the Project Director yearly or more frequently, with
submission of each IRB modification or renewal (i.e. at least yearly). 
How data will be evaluated for compliance with the protocol and for accuracy in relation to
source documents. 
The documents to be reviewed (e.g., CRFs, attendance lists, questionnaires, audio or
video recordings), who is responsible, and the frequency for reviews.  
Who will be responsible for addressing quality assurance issues (correcting procedures
that are not in compliance with protocol) and quality control issues (correcting errors in
data entry). It is anticipated that QA review and data verification will be performed by
someone other than the individual originally collecting the data, or by double-data entry. 
The frequency of internal QA review and measures to be taken for corrective action, e.g.,
for trends in errors, should be included.  A statement reflecting the results of the ongoing
data review will be incorporated into the Annual Report for the Independent
Safety Monitor(s).
6.1       Subject Accrual and Compliance
6.1.1    Measurement and Reporting of Subject Accrual
Review of the rate of subject accrual and compliance with
inclusion/exclusion criteria will occur monthly during the recruitment phase
to ensure that a sufficient number of participants are being enrolled, in
keeping with proposed recruitment projections, and that they meet eligibility
criteria and fulfill the targeted ethnic diversity goals outlined in the grant
proposal (Targeted/Planned Enrollment Table).
6.1.2    Measurement and Reporting of Participant Adherence to
Treatment Protocol 
Data on adherence to the treatment protocol will be collected weekly by research staff and
reviewed monthly by the PI (Dr. Mehling).  Adherence of participants will be evaluated by
attendance list. Available data on adherence to all three indices using an earlier version of the
study intervention suggests that 20% or fewer participants had poor adherence.  If adherence
falls below the suggested rate, which might inhibit the ability of the study to test its primary
hypotheses, the PI will suggest a conference call for study investigators to discuss methods for
improving adherence.
6.2      Justification of Sample Size 
The primary goal of this study is to prepare for a rigorous RCT comparing efficacy of the MBPR
intervention to alternatives. We are not aiming to test efficacy in the current study and do not
have adequate sample size for this assessment. The proposed sample sizes were selected based
on the numbers we estimate will be needed to adequately refine the intervention and assess its
acceptability and feasibility, and to obtain variance estimates to inform future work. However, we
will conduct exploratory analyses to obtain estimates of ICCs of the repeated measures from
linear mixed models, and preliminary estimates looking at Pearson correlations between changes
in pain outcomes and changes in psychometric scale measures that we understand to be potential
mediators of change in pain intensity following mindfulness interventions, e.g. PCS-SF, FABQ-PA,
and MAIA-2. Although using all participants across all iterations of MBPR is limited by variations in

Data type
Frequency of review
Reviewer
Subject accrual (including
compliance with protocol
enrollment criteria)
Monthly
PI, Internal QA Reviewer
Annually
Independent Monitors
Status of all enrolled subjects, as
Monthly
PI, Internal QA Reviewer
the intervention, with an exploratory total MBPR sample size of 40, we will have 80% power
(two-tailed alpha = 0.05) to detect a statistically significant correlation if the expected Pearson
correlation coefficient comparing change scores for pain outcomes with change scores for
psychometric scale measures is 0.43 or greater. If we experience a loss to follow-up rate of 10%
in our classes, the sample size per subsequent class will be increased to 11 subjects.
6.3       Stopping Rules
This study will be stopped prior to its completion if: (1) the intervention is associated with
adverse effects that call into question the safety of the intervention; (2) difficulty in study
recruitment or retention will significantly impact the ability to evaluate the study endpoints; (3)
any new information becomes available during the trial that necessitates stopping the trial; or (4)
other situations occur that might warrant stopping the trial.
6.4       Designation of a Monitoring Committee 
The Independent Monitoring Committee for this study is comprised of Drs. Zeidan (UCSD), Saper
(Boston University), and Lazar (Harvard University).  Drs. Zeidan, Saper, and Lazar are not
associated with this research project and work independently of the PIs, Dr. Mehling and Dr.
Hecht. They are not part of the key personnel involved in this grant. No member of the
Committee has collaborated or co-published with the PI within the past three years. They are
qualified to review the patient safety data generated by this study because of their unique
expertise.
6.5       Safety Review Plan
Study progress and safety will be reviewed monthly (and more frequently if needed).  Progress
reports, including patient recruitment, retention/attrition, and AEs will be provided to the
Independent Monitors semi-annually.  An Annual Report will be compiled and will include a list
and summary of AEs.  In addition, the Annual Report will address (1) whether AE rates are
consistent with pre-study assumptions; (2) reason for dropouts from the study; (3) whether all
participants met entry criteria; (4) whether continuation of the study is justified on the basis that
additional data are needed to accomplish the stated aims of the study; and (5) conditions
whereby the study might be terminated prematurely.  The Annual Report will be sent to the
Independent Monitors and will be forwarded to the IRB and NCCIH.  The IRB and other applicable
recipients will review progress of this study on an annual basis
6.6       Study Report Outline for the Independent Monitors(s)
(Interim or Annual Reports) 
The study team will generate Study Reports for the Independent Monitors and will provide
information on the following study parameters:  Accrual, demographics, study subject status,
error rate pertaining to adherence to inclusion/exclusion criteria and the study protocol, number
and type of serious adverse events. Study Report tables will be generated only from aggregate
(not by group assignment) baseline and aggregate safety data for the study population.
6.7       Submission of On-Site Monitoring/Audit and Inspection
Reports
The IRB, IMC, and NCCIH Program Officials will receive copies of all study monitoring/audit or
inspection reports within 14 day of PI receipt.
6.8       Table A

of date of reporting
Annually
Independent Monitors
 
 
 
Adherence data regarding study
visits and intervention
Monthly
PI, Internal QA Reviewer
Annually
Independent Monitors
AEs and rates (including out-of-
range lab values)
Monthly
PI, Internal QA Reviewer
Annually
Independent Monitors
Annually
NCCIH, FDA
SAEs (unexpected and related)
Per occurrence
PI, Independent Monitors
NIH/NCCIH
SAEs (expected or unrelated)
Per Occurrence
PI, Internal QA Reviewer
Annually
Independent Monitors,
NIH/NCCIH
Unanticipated Problems
Monthly
PI, Internal QA Reviewer
Per Policy
IR
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
 
 
 
7  DATA HANDLING AND RECORD KEEPING
The investigators are responsible for ensuring the accuracy, completeness, legibility, and
timeliness of the data reported.  All source documents should be completed in a neat, legible
manner to ensure accurate interpretation of data.  The investigators will maintain adequate case
histories of study subjects, including accurate case report forms (CRFs), and source
documentation.
Participants will be assigned unique, coded, confidential identifiers (code numbers), which will be
used to label all data forms, data entries and biological specimens. Identifiable information, such
as name, will not appear on these materials. The key linking the subject’s identity to their unique
coded identifier will be kept in a confidential manner in a database on a secure UCSF server, with
access only by the principal investigator and the research staff. No names or individual identities
will be used in publications resulting from the study. Physical records will be kept in an area
accessible only to research staff. Research data will be stored on a secure, HIPAA-compliant
server and drive with monitored and controlled access for study staff and investigators. The
web-based survey will be hosted on secure servers. In addition, participants will enter only a
study ID number, thus no identifying information will be associated with their questionnaire data.
                7.1  Data Management Resposibilities
Data collection and accurate documentation are the responsibility of the study staff under the
supervision of the investigators.  All source documents and laboratory reports must be reviewed
by the study team and data entry staff, who will ensure that they are accurate and complete. 
Unanticipated problems and adverse events must be reviewed by the investigators or designee.
7.2       Database Protection
This study will use a REDCap database.  The database will be secured with password protection. 
The informatics manager will receive only coded information that is entered into the database
under those identification numbers.  Electronic communication with outside collaborators will
involve only unidentifiable information. The database incorporates an electronic audit trail to show
change(s) to data after original entry including the date/time and user making the change.
               7.3       Source Document Protection
Source documents, including all paper records for all subjects, e.g. consent forms, data collection
forms, laboratory reports, will be kept in a locked filing cabinet in a room requiring badge access
for entry and within a locked suite, accessible only to research staff. Electronic records will be
stored on a secure, HIPAA-compliant server and drive with monitored and controlled access for
study staff and investigators. The web-based survey will be hosted on secure servers. In addition,
participants will enter only a study ID number, thus no identifying information will be associated
with their questionnaire data.
                 7.4       Schedule and Content of Reports
The PI (Dr. Mehling) will ensure continuous and close monitoring of participant safety and will
report to the DSMB. Study progress and safety will be reviewed weekly by the PI and core study
team. A report that will be submitted to the outside reviewer will be compiled annually and will
include a list and summarization of adverse events. In addition, the report will address (1)

whether adverse event rates are consistent with pre-study assumptions; (2) reason for dropouts
from the study; (3) whether all participants met entry criteria; and (4) whether continuation of
the study is justified on the basis that additional data are needed to accomplish the stated aims
of the study. If the DSMB requires an interim analyses based on the occurrence of severe adverse
events, we will develop plans for conducting these in consultation with the statistician on this
RCT.
The outside monitoring reports will be increased in frequency if two or more Serious Adverse
Event’s (SAE’s) with attribution to study related procedures as possibly, probably or definitely
related occur in a 6-month period of time. In this situation, SAE’s will be reported monthly, and
study procedures will be reviewed to determine if changes are needed to reduce the risk of SAEs.
8          INFORMED CONSENT
Informed consent is a process that is initiated prior to the individual agreeing to participate in the
study and continues throughout study participation.  Extensive discussion of risks and possible
benefits of study participation will be provided to subjects and their families, if applicable.  A
consent form describing in detail the study procedures and risks will be given to the subject. 
Consent forms will be IRB-approved, and the subject is required to read and review the document
or have the document read to him or her.  The investigator or designee will explain the research
study to the subject and answer any questions that may arise.  The subject will sign the informed
consent document prior to any study-related assessments or procedures.  Subjects will be given
the opportunity to discuss the study with their surrogates or think about it prior to agreeing to
participate.  They may withdraw consent at any time throughout the course of the study.  A copy
of the signed informed consent document will be given to subjects for their records.  The rights
and welfare of the subjects will be protected by emphasizing to them that the quality of their
clinical care will not be adversely affected if they decline to participate in this study.
The consent process will be documented in the clinical or research record.
To complete the informed consent process at the end of study participation, study staff will
inform the subject when his/her participation has come to an end and will document the
discussion in the study record.
9          REPORTING CHANGES IN STUDY STATUS
During the funding of this study, any action by an IRB, the Independent Monitoring Committee,
or one of the study investigators that results in a temporary or permanent suspension of the
study will be reported to the NCCIH Program Official within 3 business days of notification.  
 
13.2  * DATA AND SAFETY MONITORING BOARD (DSMB): (REQUIRED) Will a Data and Safety Monitoring
Board (DSMB) be established:
Yes 
No 
13.3  DSMB DETAILS: Provide details about the DSMB, including meeting frequency, and the affiliations
and qualifications of members:   Attach the DSMB charter to the Other Study Documents section. If
the DSMB has not yet been established, submit details and the charter to us as soon as they become
available.
see details above in 13.1
DSMP and DSMB were approved by NIH-NCCIH:
 
Fadel Zeidan, PhD: faculty at UCSD, renown pain and neuroscience researcher on mindfulness for
pain using MRI
Robert Saper, MD, faculty at Boston University, renown clinical researcher on yoga for chronic
low back pain and on psychosocial factors in chronic low back pain

Sarah Lazar, PhD, faculty at Harvard University, renown neuroscience researcher on meditation,
mindfulness and neuroplasticity using MRI and EEG
14.0
Confidentiality, Privacy, and Data Security
14.1  PROTECTING PRIVACY: Indicate how subject privacy will be protected:
Conduct conversations about the research in a private room
Ask the subject how they wish to be communicated with – what phone numbers can be
called, can messages be left, can they receive mail about the study at home, etc.
Take special measures to ensure that data collected about sensitive issues do not get added
to their medical records or shared with others without the subject’s permission
Other methods (describe below)
14.2  SENSITIVE DATA: Do any of the instruments ask about illegal or stigmatized behavior:
 Yes  
 No
IMPORTANT NOTE: Indicate in the consent form what kinds of
sensitive information will be collected.
14.3  SIGNIFICANT CONSEQUENCES OF A LOSS OF PRIVACY OR CONFIDENTIALITY: Could a breach of
privacy or confidentiality result in any significant consequences to participants, such as criminal or
civil liability, loss of state or federal benefits, or be damaging to the participant's financial standing,
employability, or reputation:
 Yes  
 No
Check all that apply:
Embarrassment
Criminal or civil liability
Loss of state or federal benefits
Damaging to the participant's financial standing, employability, or reputation
Potential risks to insurability (health, disability, or life insurance)
Describe the potential consequences:
    Information regarding drug/alcohol will be obtained via the attached eligibility phone interview,
and may be considered embarrassing or may be illegal/stigmatized. Subjects are reminded that
they are free to decline any questions that they are not comfortable providing a response for.
    Reports of elder or child abuse, or indications of harm to self or others, will be reported and
may result in criminal or civil liability.
    Only designated study personnel included explicitly on the current IRB application will have
access to any study records (both paper and electronic). No research results will be added to the
patient's medical record unless medically necessary. Data will only be shared with those parties
specified on the HIPAA form, which includes UCSF, UCSF IRB personnel, VA regulatory personnel,
and the subject's primary care physician in the event of a medical complication.
    Additionally, U.S.C 7332-protected sensitive information will be protected by the same
rigorous standard as all other data. identifying information associated with this data will never be
shared in reports or at conference proceedings, as with all other data.

    If MRI findings appear abnormal during the MRI procedure or analysis process these will be
shown to a SFVA radiologist and may be shared with the participants' primary care physician in
the event of abnormal MRI. Such results may be relevant to the patient's health. 
14.4  EXTRA CONFIDENTIALITY MEASURES: Explain any extra steps that will be taken to assure
confidentiality and protect identifiable information from improper use and disclosure, if any:
    Only designated study personnel included explicitly on the current IRB application will have
access to any study records (both paper and electronic). No research results will be added to the
patient's medical record unless medically necessary. Data will only be shared with those parties
specified on the HIPAA form, which includes UCSF, UCSF IRB personnel, VA regulatory personnel,
and the subject's primary care physician in the event of a medical complication.
    Additionally, U.S.C. 7332-protected sensitive information will be protected by the same
rigorous standard as all other data. Identifying information associated with this data will never be
shared in reports or at conference proceedings, as with all other data.
    VA research records will be retained within the VA-protected environment (e.g., VA server –
please include the R Drive folder location/name, VA lab location, etc.), only accessible by
authorized VA personnel, and disposed in accordance with the VHA Records Control Schedule
(RCS 10-1). Any VA data shared with an external entity will be transmitted via FIPS 140-2-
compliant encrypted methods as required per VA policy.
When using the external Insight Timer meditaton apps, the study coordinator wll create log ins
for each participant connected to the participants study ID, to ensure that no identifiable
information will be made public via the app. The key/speadsheet connecting study participants
with their study ID will be stored in a secure UCSF server.
However, we are unable to protect participants' privacy against spyware such as Pegasus .
14.5  * REPORTABILITY: Do you anticipate that this study may collect information that State or Federal
law requires to be reported to other officials, such as elder abuse, child abuse, or threat to self or
others: (REQUIRED)
 Yes  
 No
The confidentiality and privacy section of the consent form should
include this as a possible risk of participation.
 
* Describe the types of reportable information the research team may
encounter and provide the details of the reporting plan: (REQUIRED)
    If it is suspected that the subject is in danger of harming him/herself or someone else, or if
child abuse or neglect or elder abuse has occurred, appropriate authorities will be notified as
required by law.
14.6  CERTIFICATE OF CONFIDENTIALITY: Will this study obtain a Certificate of Confidentiality:
 Yes  
 No
Please include the recommended Certificate of Confidentiality
language in the consent form. 
14.7  SHARING OF RESEARCH RESULTS: Will there be any sharing of EXPERIMENTAL research test results
with subjects or their care providers:

 Yes  
 No
Note: This is unusual and not recommended, particularly in cases
where the tests are carried out in a non-CLIA certified laboratory,
the results are of unproven clinical significance, or where there are
not known preventative strategies and/or treatments. If these are
the most likely scenarios for your study, you should check 'No.'  
 
If you have an incidental finding of clear clinical significance, call
the HRPP QIU at 415-476-1814 for a consult. 
Explain under what circumstances research results may be shared:
Abnormal MRI findings identified by the reserach team and confirmed by a radiologist witll be
shared with the participant's care provider.
14.9  * HIPAA APPLICABILITY: Study data will be: (REQUIRED)
Derived from a medical record (e.g. APeX, OnCore, etc. Identify source below)
Added to the hospital or clinical medical record
Created or collected as part of health care
Used to make health care decisions
Obtained from the subject, including interviews, questionnaires
Obtained ONLY from a foreign country or countries
Obtained ONLY from records open to the public
Obtained from existing research records
None of the above
Derived from the Integrated Data Repository (IDR) or The Health Record Data Service
(THREDS) at SFGH
14.10  * IDENTIFIERS: Check all identifiers that will be collected and included in the research records,
even temporarily: (REQUIRED)
Names
Dates
Postal addresses (if only requesting/receiving zip codes check Yes to the Zip Code question
below instead of checking this box)
Phone numbers
Fax numbers
Email addresses
Social Security Numbers*
Medical record numbers
Health plan numbers
Account numbers
License or certificate numbers
Vehicle ID numbers
Device identifiers or serial numbers
Web URLs
IP address numbers
Biometric identifiers

Facial photos or other identifiable images
Any other unique identifier
None
* Required for studies conducted at the VAMC
* Could study records include ANY photos or images (even 'unidentifiable'
ones): (REQUIRED)
 Yes  
 No
14.12  * PATIENT MEDICAL RECORDS: Will health information or other clinical data be accessed from
UCSF Health, Benioff Children's Hospital Oakland, or Zuckerberg San Francisco General
(ZSFG): (REQUIRED)
 Yes  
 No
You indicated this research qualifies for Expedited Review but did
not check Expedited Review Category 5. Please go back to Section
4: Initial Screening Questions and check Category 5 in question 4.7.
14.19  * DATA COLLECTION AND STORAGE: (check all that apply): (REQUIRED)
Collection methods:
Electronic case report form systems (eCRFs), such as OnCore or sponsor-provided clinical
trial management portal
UCSF ITS approved Web-based online survey tools: Qualtrics or RedCap
Other web-based online surveys or computer-assisted interview tool
Mobile applications (mobile or tablet-based)
Text Messaging
Wearable devices
Audio/video recordings
Photographs
Paper-based (surveys, logs, diaries, etc.)
Other:
* What online survey or computer assisted interview tool will you
use: (REQUIRED)
Qualtrics (Recommended)
RedCAP (Recommended)
Survey Monkey (NOT recommended and may require UCSF ITS Security review)
Other
* For each app and device, please provide: (REQUIRED)
the name of the mobile application or wearable device
name  of the manufacturer / application owner
the FDA status (required for mobile health applications and mobile
health devices)

Qualtrics, RedCap, Insight Timer
* Data will be collected/stored in systems owned by (check all that
apply): (REQUIRED)
Study sponsor
UCSF data center (including OnCore, RedCap, Qualtrics, and MyResearch)
UCSF encrypted server, workstation, or laptop residing outside of UCSF data center
Personal devices, such as laptops or tablets that are not owned or managed by UCSF
SF VAMC
Zuckerberg San Francisco General Hospital
Benioff Children's Hospital Oakland
Langley Porter Psychiatric Institution
Other UCSF affiliate clinic or location (specify below)
Cloud vendor such as Amazon Web Services (AWS), Salesforce, etc. (specify below)
Other academic institution
3rd party vendor (business entity)
Other (explain below)
Please consult with the VA's Clinical Research Office at 415-221-
4810 x 2-6425 about the VA's requirements for data storage and
security.
14.20  * ADDITION OF RECORDS TO A REGISTRY: Will patient records reviewed under this approval be
added to a research database, repository, or registry (either already existing or established under
this protocol): (REQUIRED)
  Yes  
  No
14.21  * DATA SHARING: During the lifecycle of data collection, transmission, and storage, will
identifiable information be shared with or be accessible to anyone outside of UCSF: (REQUIRED)
  Yes  
  No
15.0
Financial Considerations
15.1  * PAYMENT: Will subjects be paid for participation, reimbursed for time or expenses, or receive any
other kind of compensation: (REQUIRED)
 Yes  
 No
15.2  PAYMENT METHODS: Subjects payment or compensation method (check all that apply):
Payments will be (check all that apply):
Cash
Check
Gift card
Debit card

UCSF Research Subject Payment Card
Reimbursement for parking and other expenses
Other:
15.3  PAYMENT SCHEDULE: Describe the schedule and amounts of payments, including the total subjects
can receive for completing the study:
If there are multiple visits over time, explain how payments will be prorated for partial
completion
If deviating from recommendations in Subject Payment Guidelines, include specific
justification below
In return for their time, effort, and travel expenses, participants will be paid $100 per visit at the
San Francisco VA Medical Center, plus $15 travel reimbursement, in the form of a check or a gift
card. Participants will receive $1.00 for each smart phone response during weeks 1 and 8 of the
classes (up to $40). They will receive $50 each time after completing the questionnaires at 8
weeks and 6 months (up to $100). If participants take part in the exit interview they will be paid
$100. The total payment amount will be up to $440 plus up to $30 for travel expenses. This is
the total amount and includes the amount for the study activities at the VA. Participants will be
reimbursed for time when undergoing fMRI for each of two visits ($100 per visit) and up to $15
for travel and parking expenses for each visit.
 
Timing of payment: VA visits at the end of the visit; smart phone responses and 8 week
questionnaire after responding to questionnaire; 6-month questionnaire after responding to the
questionnaire.
15.4  COSTS TO SUBJECTS: Will subjects or their insurance be charged for any study activities:
  Yes  
  No
16.0
Other Approvals and Registrations
16.4  OTHER APPROVALS: Indicate if this study involves other regulated materials and requires approval
and/or authorization from the following regulatory committees:
Institutional Biological Safety Committee (IBC)
Specify BUA #:
Institutional Animal Care and Use Committee (IACUC)
Specify IACUC #:
Controlled Substances
17.0
Qualifications of Key Study Personnel and Affiliated
Personnel
 
NEW: January 2019 - Affiliated personnel who do not
need access to iRIS no longer need to get a UCSF ID.
Instead, add them below in the Affiliated Personnel table
below. 

17.1  Qualifications of Key Study Personnel:
Instructions:
 
For UCSF Key Study Personnel (KSP)* listed in Section 3.0, select the KSP
from the drop down list and add a description of their study responsibilities,
qualifications and training. In study responsibilities, identify every individual
who will be involved in the consent process. Under qualifications, please
include:
Academic Title
Institutional Affiliation (UCSF, SFGH, VAMC, etc.)
Department
Certifications
NOTE: This information is required and your application will be
considered incomplete without it. If this study involves invasive or
risky procedures, or procedures requiring special training or
certification, please identify who will be conducting these
procedures and provide details about their qualifications and
training. Click the orange question mark for more information and
examples. 
 
Training Requirements: 
The IRB requires that all Key Study Personnel complete Human Subjects
Protection Training through CITI prior to approval of a new study, or a
modification in which KSP are being added. More information on the CITI
training requirement can be found on our website.  
 
* Definition of Key Study Personnel and CITI Training Requirements (Nov,
2015): UCSF Key Study Personnel include the Principal Investigator, other investigators
and research personnel who are directly involved in conducting research with study
participants or who are directly involved in using study participants’ identifiable private
information during the course of the research. Key Personnel also include faculty
mentors/advisors who provide direct oversight to Postdoctoral Fellows, Residents and
Clinical Fellows serving as PI on the IRB application.
 
KSP Name
Description of Study
Responsibilities - Briefly
describe what will each
person be doing on the study.
If there are procedures
requiring special expertise or
certification, identify who will
be carrying these out. Also
identify who will be obtaining
informed consent.
Qualifications, Licensure, and
Training
Dr. Mehling, Wolf MD, MD
Principal Investigator at
UCSF Osher Center:
Oversee the overall
study, oversee
recruitment, obtain
informed consent,
oversee subjects testing,
oversee data collected
and management,
analyze data and report
UCSF/VA personnel. Dr.
Mehling is a Prof. of
Clinical Family and
Community Medicine and
on faculty at the Osher
Center for Integrative
Medicine. His research
focuses on body-oriented
complementary therapies
and mind-body

results.
interactions.
Dr. Strigo, Irina PhD, PhD
Other Principal
Investigator at SFVAMC:
Oversee the overall
study, oversee
recruitment, oversee
subjects testing, oversee
data collected and
management, analyze
data and report results
UCSF/VA personnel.
Research Physiologist at
the SFVAMC and
Associate Professor of
Psychiatry at UCSF, is an
expert in conduction
human pain research in
veteran and non-veteran
populations
Dr. Hecht, Frederick MD,
MD
Co-Investigator: Advises
in questions of
mindfulness and task
design, is included in
data analysis and
reporting of results
UCSF personnel. Dr.
Hecht is a Prof. of
Medicine and the director
of research at the Osher
Center for Integrative
Medicine. His research
focuses on mind-body
interventions.
Rogers, Kirsten, BA
Study coordinator will be
responsible for
coordination with study
staff and scheduling.
UCSF personnel. Clinical
Research Coordinator at
the Osher Center for
Integrative Medicine
Goldman, Veronica M
Study coordinator will be
responsible for
coordination with study
staff and scheduling.
UCSF personnel. Clinical
Research Coordinator at
the Osher Center for
Integrative Medicine
Dr. Hartogensis, Wendy E
PhD
Statistician will be
responsible for data
analyses
UCSF personnel.
Statistician at the Osher
Center for Integrative
Medicine
Murphy, Emily
Study coordinator will be
responsible for
coordination with study
staff and scheduling.
UCSF and VA personnel.
Clinical Research
Coordinator at the VA
Medical Center
Menon Vinodkumar, Anitha
Study coordinator will be
responsible for
coordination with study
staff, scheduling,
reviewing and analyzing
data .
UCSF Personnel. Medical
Resident.
17.2  Affiliated Personnel:
Instructions:
 
This section is for personnel who are not listed in Section 3.0: Grant Key
Personnel Access to the Study because their names were not found in

the User Directory when both the iRIS Database and MyAccess directories
were searched. Add any study personnel who fit ALL of the following criteria
in the table below:
They meet the definition of Key Study Personnel (see above), and
They are associated with a UCSF-affiliated institution (e.g., VAMC,
Gladstone, Institute on Aging, Vitalant, NCIRE, SFDPH, or ZSFG), and
They do not have a UCSF ID, and
They do not need access to the study application and other study
materials in iRIS.
Note: Attach a CITI Certificate for all persons listed below in the Other
Study Documents section of the Initial Review Submission Packet
Form after completing the Study Application.
 
Click the orange question mark icon to the right for more information on
who to include and who not to include in this section.
 
Do not list personnel from outside sites/non-UCSF-affiliated institutions.
Contacts for those sites (i.e. other institution, community-based site,
foreign country, or Sovereign Native American nation) should be listed in
the Outside Sites section of the application.
 
If there are no personnel on your study that meet the above
criteria, leave this section blank.
 
Name
Institution
Telephone
E-mail
Role
No External Personnel has been added to this IRB Study
Please describe the study responsibilities and qualifications of each affiliated
person listed above:
18.0
End of Study Application
End of Study Application Form
 
To continue working on the Study Application:
Click on the section you need to edit in the left-hand menu. Remember to save through
the entire Study Application after making changes.
 
If you are done working on the Study Application:
Important: Before proceeding, please go back to Section 4.0 Initial Screening
Questions and Save and Continue through the form to make sure all the relevant
sections and questions have been included. If you've changed any answers since you
started, the branching may have changed. Your application will be incomplete and it will
have to be returned for corrections. 
 
Once you are sure the form is complete, click Save and Continue. If this is a new
study, you will automatically enter the Initial Review Submission Packet Form,
where you can attach consent forms or other study documents. Review the Initial
Review Submission Checklist for a list of required attachments.

 
Answer all questions and attach all required documents to speed up your
approval.
 
 
 
 
 
The UCSF IRB welcomes feedback about the IRB Study Application Form. Please click the link to
answer a survey about the application form.