Neurobiological Mechanisms of Perceived Stress and Their Modification Through Behavioral Intervention
Phase: NA
Conditions: Stress, Behavior
Sponsor: University of Wisconsin, Madison

PROTOCOL TITLE: 
Brain and Meditation (BAM) Study 
 
LEAD RESEARCHER: 
Dan Grupe, PhD 
Center for Healthy Minds, UW-Madison 
(608) 263-7572 
grupe@wisc.edu 
 
GRANT TITLE: 
Neurobiological mechanisms of perceived stress and their modification through 
behavioral intervention 
 
GRANT NUMBER: 
 
5 K01 MH117222  
 
FUNDING SOURCE: 
 
National Institute of Mental Health 
 
IRB STUDY ID: 
 
2021-1109 
 
CLINICALTRIALS.GOV ID: 
 
NCT05215314 
 
VERSION NUMBER/DATE: 
7.0; 10/17/2023 
 

PROTOCOL TITLE: Brain and Meditation (BAM) Study 
 
Page 2 of 27 
Revised: February 12, 2021 
REVISION HISTORY 
 
Revision # Version Date Summary of Changes 
Consent Change? 
1.2 
12/10/2021 
Clarified use of GPS data 
Yes 
2.0 
01/28/2022 
Updates to screening procedures, 
clarification of eligibility criteria, updates to 
compensation section, and addition of 
Qualtrics to the data management and 
confidentiality section 
Yes 
3.0 
03/21/2022 
Added ClinicalTrials.gov ID, added 3 
surveys to the “Schedule of study 
procedures” table (Payment Information 
Survey, Payment Information Update 
Survey, & Feedback Survey), added 
procedures to withdraw participants who do 
not complete Timepoint 1 (Initial 
Activities) 
Yes 
4.0 
05/12/2022 
Updated amount of time it takes to 
complete each timepoint in section 13.3 
Research Procedures; added that certain 
survey items are required to be completed 
to sections 17.3 Steps to make 
participants feel at ease & 22.6 
Minimizing risks 
Yes 
5.0 
10/12/2022 
Clarified that we will continue to use data 
collected by the Healthy Minds Program 
app until Timepoint 6 (3-Month Follow-Up) 
in section 13.5 Long-term follow-up 
Yes 
6.0 
2/28/2023 
Clarified that any clinical research 
personnel can provide support for adverse 
responses in section 22.6 Minimizing risks 
 
7.0 
10/17/2023 
Removed the MRI substudy from the 
protocol. 
Yes 
 
 

PROTOCOL TITLE: Brain and Meditation (BAM) Study 
 
Page 3 of 27 
Revised: February 12, 2021 
Table of Contents 
1.0 
Study Summary ........................................................................................................ 4 
2.0 
Background .............................................................................................................. 5 
3.0 
Study Objectives and Endpoints .............................................................................. 6 
4.0 
Number of Participants ............................................................................................ 7 
5.0 
Inclusion and Exclusion Criteria .............................................................................. 7 
6.0 
Special Populations .................................................................................................. 8 
7.0 
Recruitment Methods ............................................................................................... 9 
8.0 
Consent/Assent Process ......................................................................................... 10 
9.0 
Process to Document Consent in Writing .............................................................. 11 
10.0 Setting .................................................................................................................... 12 
11.0 Study Intervention .................................................................................................. 12 
12.0 Study Timelines ..................................................................................................... 12 
13.0 Procedures Involved............................................................................................... 12 
14.0 Comparison of usual care and study procedures .................................................... 17 
15.0 Withdrawal of Participants .................................................................................... 17 
16.0 Data Management and Confidentiality .................................................................. 18 
17.0 Provisions to Protect the Privacy Interests of Participants .................................... 21 
18.0 Sharing of Results .................................................................................................. 22 
19.0 Data and Specimen Banking .................................................................................. 22 
20.0 Study Analysis ....................................................................................................... 23 
21.0 Potential Benefits to Participants ........................................................................... 24 
22.0 Risks to Participants ............................................................................................... 24 
23.0 Provisions to Monitor the Data to Ensure the Safety of Participants .................... 26 
24.0 Economic Burden to Participants........................................................................... 26 
25.0 Resources Available............................................................................................... 26 
26.0 Multi-Site Research ............................................................................................... 27 
27.0 References .............................................................................................................. 27 
28.0 Appendices ............................................................................................................. 27 
 
 
 
 

PROTOCOL TITLE: Brain and Meditation (BAM) Study 
 
Page 4 of 27 
Revised: February 12, 2021 
 
1.0 
Study Summary 
 
Study Title 
Brain and Meditation (BAM) Study 
Brief Summary 
This study is a randomized controlled trial to test the impact of an 
app-based meditation program on perceived stress and behavioral and 
brain correlates of stress. Healthy adult participants between the ages 
of 25-65 will be enrolled in the study for about 4-5 months. 
Number of study sites 1 
Study Design 
Participants will be randomized into one of two groups: the 
intervention group or the waitlist control group. The intervention 
group will use a mobile health app for four weeks. Participants will 
complete pre-intervention, weekly, post-intervention, and 3-month 
follow-up surveys and tasks. 
Primary Objective 
Test for hypothesized group differences in perceived stress and 
hippocampal-dependent behavior following participation in a 4-week 
meditation program. 
Secondary 
Objective(s) 
Within the meditation group, determine whether reductions in 
perceived stress are associated with changes in hippocampal-
dependent behavior. 
Research 
Intervention(s)/ 
Investigational 
Agent(s)  
Healthy Minds Program (HMP) – a mobile health meditation training 
program  
Drugs/devices used 
on study (including 
any IND/IDE #)  
Healthy Minds Program (HMP) – a mobile health meditation training 
program 
Study Population 
25-65 year old healthy adults with no significant experience with 
meditation 
Sample Size 
150 participants 
Study Duration for 
individual 
participants 
4-5 months 
Study Specific 
Abbreviations/ 
Definitions  
mHealth = mobile health 
HMP = Healthy Minds Program 
 
 

PROTOCOL TITLE: Brain and Meditation (BAM) Study 
 
Page 5 of 27 
Revised: February 12, 2021 
2.0 
Background 
 
2.1 Relevant prior experience and gaps in current knowledge 
Meditation training is known to reduce subjective appraisals of stressful life events, or 
“perceived stress”, but access to in-person programs is limited due to high costs and lack of 
available services. The hippocampus is a brain region highly sensitive to stressful and adverse 
life events, and may play a mechanistic role in determining individual differences in perceived 
stress, a hypothesis that is best tested using an intervention with stress-reducing effects. This 
project will address each of these current knowledge gaps by studying the impact of a 4-week 
mobile health (mHealth) meditation training program on perceived stress and hippocampal-
dependent behavior. 
 
2.2 Relevant preliminary data 
We have conducted similar mHealth studies with educators in Wisconsin (IRB Protocol: 2020-
0533) and undergraduate students at UW-Madison (IRB Protocol: 2020-1454). Both studies 
provided evidence that a large number of participants are willing to download and regularly use 
the Healthy Minds Program (HMP) app as well as stay engaged in a longitudinal study. We have 
also identified correlations between elevated perceived stress and compromised hippocampal-
dependent behavior in cross-sectional data.  
 
2.3 Scientific background for, rationale for, and significance of the research  
Meditation training dramatically reduces perceived stress and has benefits for psychiatric 
conditions associated with elevated perceptions of stress, such as depression and post-traumatic 
stress disorder (PTSD). Access to in-person programs, however, is limited due to associated cost 
and lack of available services. 
  
Research on behavioral and neurobiological mechanisms contributing to individual differences in 
perceived stress is largely limited to correlational, cross-sectional studies. The inclusion of 
behavioral outcomes in research on a meditation training program will allow us to draw causal 
inferences regarding mechanisms of perceived stress. 
 
Prior research has demonstrated that greater roaming entropy, or more diverse activity around 
one’s lived environment, is associated with greater psychological well-being in humans (Heller 
et al., 2020) and with greater neurogenesis in the hippocampus of laboratory mice. We are 
interested in examining whether a meditation intervention that seeks to improve well-being will 
do so in part through effects on greater roaming entropy, and whether individual differences in 
roaming entropy (either at baseline, or in response to the meditation intervention) are associated 
with behavioral changes consistent with greater hippocampal neurogenesis. 
 
In this project, we will conduct a randomized controlled trial of the HMP vs. waitlist control to 
test the efficacy of a fully remote, 4-week meditation intervention on reducing perceived stress in 
a healthy adult population. Using behavioral measures with a known neurobiological basis 
(pattern separation and real-world exploratory behavior), we will investigate hypothesized 
mechanisms associated with individual differences in perceived stress and how they may be 
impacted by meditation training.  
 

PROTOCOL TITLE: Brain and Meditation (BAM) Study 
 
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Revised: February 12, 2021 
 
3.0 
Study Objectives and Endpoints 
 
3.1 Specific aims 
● To assess efficacy of a 4-week mHealth meditation training program on reducing 
perceived stress. 
● To investigate the effects of meditation training on candidate behavioral and brain 
mechanisms of perceived stress: behavioral pattern separation and real-world experiential 
diversity. 
● To assess the extent to which lower levels of perceived stress following mindfulness 
training is associated with corresponding changes to these candidate mechanisms. 
 
3.2 Hypotheses 
● Intervention participants will show larger reductions in perceived stress relative to 
waitlist control participants at post-intervention and follow-up timepoints. 
● Intervention participants will show improved pattern separation behavior relative to 
waitlist control participants at post-intervention and follow-up timepoints. 
● Intervention participants will show increased real-world “experiential diversity” assessed 
using GPS location tracking relative to waitlist control participants at post-intervention 
and follow-up timepoints. 
● Changes in hippocampal-dependent behavior will be correlated with reductions in 
perceived stress. 
 
3.3 Primary and secondary study endpoints 
Primary endpoints 
● Scores on the perceived stress scale at post-intervention (T5) controlling for baseline (T1) 
 
Secondary endpoints 
● Performance on the behavioral pattern separation task (post-intervention and follow-
up/T6) 
● PROMIS depression and anxiety (post-intervention and follow-up) 
 
Tertiary and exploratory endpoints 
● Symptoms of PTSD measured using the PCL-5 (post-intervention and follow-up) 
● PROMIS sleep disturbances (post-intervention and follow-up) 
● Five-facet mindfulness questionnaire, awareness subscale (post-intervention and follow-
up) 
● NIH toolbox Loneliness (post-intervention and follow-up) 
● Healthy Minds Index (post-intervention and follow-up) 
● Real-world experiential diversity measured using continuous GPS location tracking 
(Measured continuously throughout study participation) 
● Trajectories of change for self-report outcomes assessed on a weekly basis 
 
 
 
 

PROTOCOL TITLE: Brain and Meditation (BAM) Study 
 
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Revised: February 12, 2021 
4.0 
Number of Participants 
 
4.1 Total number of participants 
This study will enroll 150 participants at UW-Madison. 
 
4.2 Number of participants expected to be enrolled and screened vs. number of participants 
needed to complete the study 
N/A - Only eligible participants will be enrolled in this study. Participants will be screened prior 
to enrollment. 
 
4.3 Criteria for “enrolled” participants and replacing withdrawals 
Participants will be considered enrolled after signing the consent form. If participants leave the 
study prior to randomization, they will be replaced. However, participants who leave the study 
after being randomized will not be replaced. 
 
 
5.0 
Inclusion and Exclusion Criteria 
 
5.1 Screening  
After reading a description of the study, individuals who are interested in participating will 
complete an Online Eligibility Survey in REDCap. The survey will automatically inform 
individuals who do not meet eligibility criteria for auto-exclusion items that they are not eligible. 
Other items will be reviewed by study staff to determine eligibility. We will review those 
responses and inform potential participants about their eligibility via email. We will retain all 
screening data to maintain a record of reasons individuals are not eligible for the study. 
 
5.2 Inclusion criteria 
● 25 to 65 years old 
● Individual can read, write, speak, and understand English 
● Able to provide informed consent 
● Willing and able to complete all study procedures, including the Healthy Minds 
Program 
● Has access to an Android or iPhone (Apple/iOS) smartphone that can download apps 
from Google Play or the Apple App Store 
● For payment purposes, must be a US citizen or a permanent US resident (green card 
holder) 
 
5.3 Exclusion criteria 
● Extensive experience in meditation practice (e.g., regular daily meditation practice for 
the past 6 months or regular weekly meditation practice for the past 12 months), 
experience in substantively similar meditation training programs (e.g., attended a 
meditation retreat or a yoga/body practice retreat with a significant mediation 
component), or substantial previous use of the Healthy Minds Program app 
● Individuals will be excluded if they previously participated in substantively similar 
research at our Center at the discretion of the investigator due to similar tasks being 
used in certain studies 

PROTOCOL TITLE: Brain and Meditation (BAM) Study 
 
Page 8 of 27 
Revised: February 12, 2021 
● History of psychosis 
● History of mania 
● Current psychopathology that interferes with study participation 
 
5.4 Specific population  
This study will include a sample of adults between 25 and 65 years old that is demographically 
representative of the overall population of the United States. We will exclude individuals under 
age 25 and over age 65 due to age-related differences in the brain regions we are studying. 
Young people (under age 25) have brains that are still developing, while older people (over age 
65) are expected to start showing age-related hippocampal decline and behavioral changes that 
would confound our ability to test hypotheses related to stress and the hippocampus. 
 
 
6.0 
Special Populations 
 
6.1 The study will not enroll individuals from any of the following populations. However, 
pregnant women may be incidentally enrolled. We will not be screening for pregnancy because 
there are no known additional risks to pregnant persons or fetuses from study 
procedures/intervention. This study involves activities that are of no greater risk than typical 
activities of daily living. Assessments will be conducted entirely on a smartphone or other digital 
device and consist of completing questionnaires about health and well-being, completing a 
memory task, and passive location tracking. The intervention is smartphone-based and consists 
of listening to podcast-style lessons about well-being and completing meditation practices. We 
have chosen research activities that minimize time and burden for participants that are similar to 
typical activities encountered in daily life; therefore, any risk involved is minimal. There is no 
reasonable expected risk of the study procedures/intervention on pregnant women or fetuses, so 
preclinical studies are not scientifically appropriate. Additionally, this research is unrelated to 
decisions regarding termination of pregnancy and viability of a neonate.   
 
☐  Children/Minors  
☐  Pregnant persons / fetuses 
☐  Prisoners 
☐  Participants with impaired decision-making capacity  
 
6.2 The study will not enroll individuals from any of the following populations. 
☐  Non-English speaking participants  
☐  Illiterate or Low Literacy participants 
☐  Participants with visual or hearing impairments 
☐  Status Relationship: Individuals with a status relationship with the PI or other study 
team members (e.g., employees, students, family members) 
 
6.3 The study will not specifically target enrollment of individuals from any of the following 
populations. However, we will not ask questions about every category (e.g., veterans/military 
personnel), and may, therefore, unknowingly enroll individuals who belong to some of the 
following populations. 

PROTOCOL TITLE: Brain and Meditation (BAM) Study 
 
Page 9 of 27 
Revised: February 12, 2021 
☐  Individuals who are receiving inpatient or outpatient services for mental illness, 
developmental disability, or alcohol and other drug abuse (AODA) 
☐  Individuals who are protectively placed by a court in a treatment facility 
☐  Veterans/Military Personnel 
☐  Emancipated minors 
☐  Anyone especially vulnerable to manipulation or inducements for participation as a 
result of their illness or socioeconomic condition 
 
 
7.0 
Recruitment Methods 
 
7.1 Sources of participants 
We will recruit from an ongoing companion study (PI: Richard Davidson; Title: “Individual 
differences in affective chronometry”; IRB Protocol: 2018- 0937), the community, research 
recruitment services, and the Participant Registry at the Center for Healthy Minds (IRB Protocol: 
2019-0330). 
 
7.2 Identifying participants 
Research candidates will self-identify in response to advertisements, such as flyers, website ads 
(e.g., on the Center for Healthy Minds website, Craigslist, and/or other relevant websites), email 
ads, and ads on research recruitment services (e.g., Prolific). Another method of recruitment will 
be contacting participants from the ongoing companion study who have expressed interest in 
other research studies. It will be made clear that this intervention study is separate from the 
companion study and that participation is fully voluntary. We will recruit these individuals based 
on whether they self-identified as having interest in other studies. Finally, we may recruit 
individuals from the Participant Registry at the Center for Healthy Minds who previously 
indicated interest in being contacted about research studies. 
 
7.3 Recruitment method 
Recruitment efforts will take place only during the recruitment phase. All advertisements will be 
removed once recruitment is complete. We may post flyers at various local businesses (e.g., 
libraries, stores, and restaurants) every few months during the recruitment phase, post website 
advertisements at the beginning of recruitment and remove the ads when recruitment is 
completed, and contact individuals through research recruitment services. We may make up to 3 
attempts to contact participants from the companion study by email and/or phone with a brief 
description of the opportunity. We may contact individuals from the Center for Healthy Minds 
Participant Registry one time via email with information about the research opportunity. 
 
7.4 Recruitment materials 
We will use email advertisements, flyers, research recruitment services, and website 
advertisements to inform potential participants about the study. Recruitment will occur on a 
continuous basis during data collection.  
 
7.5 Compensation 
We will pay participants by sending checks or prepaid debit cards in the mail.  Participants will 
be paid twice during the study – once after completion of the Week 4 Activities and again after 

PROTOCOL TITLE: Brain and Meditation (BAM) Study 
 
Page 10 of 27 
Revised: February 12, 2021 
completion of the 3-Month Follow-Up.  If participants choose to withdraw or are withdrawn by 
the study team, they will receive payment for the study components that they completed. 
 
Participants will be compensated up to $150 for participating in the study as follows: 
● Initial (Pre-Intervention) Activities = $10 
● Week 1 Activities = $10 
● Week 2 Activities = $10 
● Week 3 Activities = $10 
● Week 4 (Post-Intervention) Activities = $25 
● 3-Month Follow-Up = $45 
● Daily Movement (Location Tracking; must provide at least 60 days of valid data) = $10 
● Bonus for Completing All Study Procedures = $30 
 
 
8.0 
Consent/Assent Process 
 
8.1 Informed consent process 
To obtain consent we will follow HRP-090 - SOP - Informed Consent Process. 
 
Online Eligibility Survey Consent Process: Research candidates will be provided with an 
Information Sheet prior to completing the Online Eligibility Survey in REDCap. After reading 
the Information Sheet, research candidates will check a box to indicate that they have read the 
information and would like to continue with the survey. Survey data will be stored on REDCap 
and on a password-protected secure server.  
 
Consent Process: 
1. We will email (or mail, upon request) a consent form to research candidates who are 
potentially eligible for the study after completing the Online Eligibility Survey. We will 
ask participants to review the consent form prior to completing the Phone Screen (for 
MRI substudy participants) or Study Consent Call (for non-MRI substudy participants). 
2. Eligible research candidates will be consented over the phone or via a web conferencing 
tool (e.g., Zoom) either during a Study Consent Call or immediately after the Phone 
Screen by trained research staff (i.e., principal investigator, study coordinator, or research 
assistant). We will recommend that participants complete the Phone Screen and/or 
informed consent process in a private room, if possible. If eligibility is not established 
upon completion of the Phone Screen, we will set up a separate time to call participants 
over the phone or by web conference to complete the informed consent process once 
eligibility is determined. 
3. During the Study Consent Call, we will verify the research candidate’s identity, review 
the consent form, and ask the research candidate if they have any questions or need 
further clarification about any aspects of the study. We will let research candidates know 
that they do not need to make a decision about participation right away, but can let us 
know once they have decided. We will inform research candidates that participation is 
voluntary and that they can stop at any time or skip any portion of the study that they do 
not feel comfortable completing. We will ensure that participants know who to contact if 
they have questions or concerns about the study in the future. We are requesting a waiver 

PROTOCOL TITLE: Brain and Meditation (BAM) Study 
 
Page 11 of 27 
Revised: February 12, 2021 
of signed consent for both the non-MRI and MRI substudies. If a research candidate 
chooses to continue with participation, we will document that the participant has given 
oral consent prior to starting study procedures. 
4. If circumstances arise that make it necessary to obtain re-consent of research participants 
(e.g., substantive changes in the research, significant new findings), we will email the 
updated consent form with changes highlighted to the participant and explain the changes 
either over the phone or via a web conferencing tool (e.g., Zoom. We will ask 
participants if they have any questions/concerns. If they would like to continue in the 
study, we will document that the participant has given oral consent prior to continuing 
with the study. 
 
8.2 Altering elements of consent 
We are requesting an altered consent process and waiver of signed consent for the Online 
Eligibility Survey and Phone Screen, which present no more than minimal risk of harm to 
subjects and involve no procedures for which written consent is normally required outside of the 
research context. The Online Eligibility Survey and Phone Screen will be used to determine if 
research candidates are eligible for the study. The forms ask questions for screening purposes 
only, such as age, English proficiency, meditation experience, general health issues, and 
psychiatric symptoms. 
 
The Online Eligibility Survey could not be carried out without the waiver because meeting with 
all research candidates who respond to our ads to obtain written informed consent would not be 
practical. Also, providing more information may decrease understanding of consent information 
and/or reduce study enrollment. If we provided all elements of consent in the Online Eligibility 
Survey, research candidates may not read all the information and be uninformed, or they may not 
sign up for the study at all. We would like to provide the essential elements of consent while 
reducing subject burden as much as possible. 
 
We are requesting a waiver of signed consent for the study, which 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. We will provide participants with a long form 
consent document that they can review and keep, complete a Study Consent Call over the 
phone/Zoom, and obtain oral consent, which we will document in our records prior to starting 
study procedures. 
 
 
9.0 
Process to Document Consent in Writing 
 
9.1 Documentation of consent  
Because this is a remote study, we will not follow HRP-091 - SOP - Written Documentation of 
Consent. Participants will not provide written consent. Instead, they will provide oral consent 
over the phone/Zoom, which we will document on the Oral Consent Script. 
 
 
 
 

PROTOCOL TITLE: Brain and Meditation (BAM) Study 
 
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Revised: February 12, 2021 
9.2 Waiver of written documentation of consent 
We are requesting a waiver of signed consent for the Online Eligibility Survey and Consent 
Form, which present no more than minimal risk of harm to subjects and involve no procedures 
for which written consent is normally required outside of the research context.  
 
For the Online Eligibility Survey, research candidates will be provided with an Information 
Sheet in REDCap prior to completing the survey. After reading the Information Sheet, research 
candidates will check a box to indicate that they have read the information and would like to 
continue with the survey.  
 
We will provide participants with a copy of the consent form and will obtain oral consent over 
the phone/Zoom prior to starting study procedures. We will document that the participant has 
provided consent on the Oral Consent Script. 
 
 
10.0 Setting 
 
 
10.1 Location 
Research procedures will be performed remotely and at the Center for Healthy Minds. 
 
 
11.0 Study Intervention 
 
11.1 Description  
The study intervention is the Healthy Minds Program (HMP), a 4-week mobile health meditation 
training program. HMP was developed by our affiliated non-profit, Healthy Minds Innovations, 
Inc. Participants in the intervention group will download a study-specific version of the HMP 
app to their smartphone and complete the 4-week program. Participants in the waitlist control 
group will be given the opportunity to use the HMP app upon completion of the study. 
 
 
12.0 Study Timelines 
 
12.1 Study timeline 
Participants will be involved in the study for approximately 4-5 months. Recruitment will start 
upon UW Institutional Review Board (IRB) approval and continue until study goals are reached. 
We estimate that we will complete the study, including primary analyses, in approximately 3 
years. 
 
 
13.0 Procedures Involved 
 
13.1 Study design 
This will be a two-group randomized controlled trial assessing the impact of the Healthy Minds 
Program (HMP), a meditation-based well-being app, on behavioral and self-reported outcomes 
associated with stress and well-being in 150 individuals. Participants will be adults ages 25 to 65 

PROTOCOL TITLE: Brain and Meditation (BAM) Study 
 
Page 13 of 27 
Revised: February 12, 2021 
years who have no significant experience with meditation, have access to a smartphone, and are 
willing to follow through on all aspects of the protocol. The primary endpoint will be scores on 
the perceived stress scale. Participants will be randomized to the HMP or waitlist control group 
at a 2:1 ratio. Prior to randomization, participants will complete initial surveys and a 
computerized task remotely. Participants assigned to the HMP group will complete a 4-week 
well-being program remotely using an app on their smartphone. Each week participants will also 
complete a set of online surveys/tasks. Waitlist control participants will also complete the online 
surveys/tasks each week for 4 weeks. All participants will complete a final set of follow-up 
surveys/tasks 3 months later. In addition, we will track participant location using GPS 
smartphone technology throughout the study. 
 
13.2 Schedule of study procedures 
 
 
 
 
4-Week 
Intervention 
 
Study Procedure/Activity 
Web 
Screen 
Phone/
Zoom 
Call 
T1 
T2-T4 
T5 
T6 
Consent via Information Sheet 
X 
 
 
 
 
 
Screening Questions 
X 
 
 
 
 
 
Review Eligibility 
X 
 
 
 
 
 
Informed Consent Process for 
Main Study 
 
X 
 
 
 
 
Payment Information Survey 
 
X 
 
 
 
 
Payment Information Update 
Survey 
 
 
 
 
 
X 
Intervention (i.e., Healthy 
Minds Program) 
 
 
 
X1 
X1 
 
Behavioral Pattern Separation 
Task 
 
 
X 
 
X 
X 
Attention Check Items 
 
 
X 
 
X 
X 
Behavioral Risk Factor 
Surveillance System (BRFSS) 
Adverse Childhood 
Experiences (ACE) Module 
 
 
X 
 
 
 
Demographics 
 
 
X 
 
 
 
Demographics & Meditation 
Experience 
 
 
X 
 
 
 
Determinants of Meditation 
Practice Inventory-Revised 
(DMPI-R) 
 
 
X 
 
 
 
Digital Working Alliance 
Inventory (DWAI) 
 
 
 
X1 
X1 
 
Feedback Survey 
 
 
X 
X 
X 
X 
Five Facet Mindfulness 
Questionnaire (FFMQ), 
Awareness Subscale 
 
 
X 
 
X 
X 
Flourishing Measure 
 
 
X 
 
X 
X 
Global Physical Activity 
Questionnaire (GPAQ) 
 
 
X 
 
X 
X 

PROTOCOL TITLE: Brain and Meditation (BAM) Study 
 
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Revised: February 12, 2021 
Healthy Minds Index 
(HMIndex) 
 
 
X 
 
X 
X 
Mainz Inventory of 
Microstressors (MIMIS) 
 
 
X 
 
X 
X 
Marlowe-Crowne Social 
Desirability Scale (MCSDS)  
 
 
X 
 
 
 
Mindfulness-Based Program - 
Meditation-Related Adverse 
Effects Scale (MBP-MRAES) 
 
 
 
 
X1 
 
Mindfulness Adherence 
Questionnaire (MAQ) 
 
 
 
X1 
X1 
X1 
NIH Toolbox Loneliness 
 
 
X 
 
X 
X 
Pre- & Post-Practice Items 
 
 
 
X 
X 
 
PROMIS Item Bank - 
Emotional Distress - Anxiety 
(Computer Adaptive Version) 
X 
 
X 
X 
X 
X 
PROMIS Item Bank - 
Emotional Distress - 
Depression (Computer 
Adaptive Version) 
X 
 
X 
X 
X 
X 
PROMIS Item Bank - 
Emotional Distress - Sleep 
Disturbance (Computer 
Adaptive Version) 
 
 
X 
X 
X 
X 
Perceived Stress Scale (PSS) 
 
 
X 
X 
X 
X 
PTSD Checklist (PCL-5) 
 
 
X 
 
X 
X 
Location Tracking with 
Passive GPS4 
 
 
X2 
X2 
X2 
X2 
Debriefing Form 
 
 
 
 
 
X 
1HMP group only 
2Location Tracking collected continuously throughout the study 
 
13.3 Research procedures 
For this study, participants will complete tasks remotely, including online surveys and 
computerized tasks, the Healthy Minds Program (if assigned to the HMP group), and location 
tracking using a GPS app downloaded to participants’ phones. We plan to enroll 150 
participants.  
 
Location Tracking: Throughout the study we will track participant location using GPS 
smartphone technology, which allows smartphones to automatically and passively (no participant 
input needed) capture information about the participant’s activity (e.g., if the person is walking, 
remaining stationary, or moving at a rapid speed). After providing informed consent, participants 
will be oriented to the mobile phone application and will be instructed on downloading, 
installing, and optimizing the smartphone application required for participation. Real-world data 
collection will occur for approximately 4-5 months, from the time of consent until the 3-Month 
Follow-Up. Participants will be asked to keep their phone with them and powered on as much as 
possible during the study. The smartphone application will use an activity classifier program to 
determine if the user is remaining stationary, walking, or driving based on how quickly Wi-Fi 
and GPS signals change and on the strength of motion detected by the accelerometer. During the 

PROTOCOL TITLE: Brain and Meditation (BAM) Study 
 
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Revised: February 12, 2021 
3-Month Follow-Up (or if a participant discontinues the study), we will instruct participants on 
disabling the location tracking app. 
 
Timepoint 1 - Pre-Intervention Activities: Participants will complete pre-intervention online 
surveys and tasks remotely using the REDCap system (see section 13.2 Schedule of study 
procedures for measures that will be administered). Timepoint 1 will take 30 to 45 minutes. 
Survey and task completion will be self-paced, but we will ask participants to complete these 
activities within one week of receiving the REDCap link. Participants who do not complete the 
Timepoint 1 activities within one week may be unenrolled from the study. 
 
Participants will complete a behavioral pattern separation task during Timepoints 1 (Pre-
Intervention), 5 (Post-Intervention), and 6 (3-Month Follow-Up). During this task, participants 
will encode pictures of common objects while performing a basic categorization task. 
Participants will then label pictures as “Old” (targets, identical objects to those in the encoding 
phase), “New” (foils, or completely novel objects), or “Similar” (lure items, distinct exemplars 
of objects seen during encoding). We will calculate indices of correct differentiation of similar 
lures from identical targets (“pattern separation”) and correct identification of targets that were 
previously presented (“recognition memory”). 
 
Intervention: Participants will be randomly assigned to one of two groups - approximately two-
thirds to the HMP group and approximately one-third to the waitlist control group. 
Randomization will be done in REDCap; a REDCap email informing of group status will be sent 
to participants immediately after randomization. Participants will be stratified by whether they 
participated in the companion study and randomized to the HMP or waitlist control group. 
Waitlist participants will be informed that they may complete the HMP following study 
participation, if desired.  
 
HMP group participants will be instructed on downloading and installing a study-specific version 
of the HMP app. The 4-week meditation program will take approximately 60 minutes to 
complete each week. The program will be self-paced and completed remotely. While completing 
the HMP each week, participants will listen to podcast-style lessons in the app to learn about 
meditation from scientists and experts in well-being. The app will also guide participants through 
seated and active meditations. Participants may have the option to provide demographic and 
meditation experience information and complete the Healthy Minds Index questionnaire to 
assess their current level of well-being within the app. The app will collect activity data (e.g., 
when, how long, and what content was listened to), device type, and GPS data (if enabled by the 
participant). Participants will also occasionally answer pre- and post-practice questions. The app 
will not collect any identifying information. Participants will have the option to continue using 
the HMP app after completing the 4-week program. If they choose to do so, we will continue to 
monitor their app usage and any other data collected through the HMP app throughout the study 
to learn more about its long-term impact on well-being. The HMP app is considered an FDA 
regulated device that should qualify as a “non-significant risk (NSR) device”.  We are seeking an 
NSR determination and have, therefore, uploaded an NSR request letter in ARROW (see Drug 
and Device Documents section, #2 Device Documentation). 
 

PROTOCOL TITLE: Brain and Meditation (BAM) Study 
 
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Timepoints 2-5 - During & Post-Intervention Activities: HMP group participants will complete 
online measures (see section 13.2 Schedule of study procedures) remotely through REDCap for 
Timepoints 2-5 during the same weeks as the 4-week intervention. The measures will take 10 to 
45 minutes to complete each week. Waitlist participants will also complete most of the same 
measures over 4 weeks. Participants will have approximately one week to complete each set of 
self-paced activities. 
 
Timepoint 6 - 3-Month Follow-Up: About three months after Timepoint 5, participants will 
complete a final set of measures (see section 13.2 Schedule of study procedures) remotely 
online through REDCap, which will take 30 to 45 minutes. 
 
13.4 Data collected during the study 
Data elements: The following data will be collected directly from participants: 
● Behavioral pattern separation task data 
● Data collected from the participant’s smartphone by the HMP app: activity data (e.g., 
when, how long, and what content was listened to), device type, GPS data (if enabled by 
the participant), pre- and post-practice question responses, optional demographic and 
meditation experience information, and Healthy Minds Index questionnaire responses 
● Data collected from the participant’s smartphone by the location tracking app 
(“FollowMee”), such as date, time, GPS location (latitude and longitude coordinates), 
direction, altitude, and speed of travel, device type, and device ID 
 
Surveys: A subset of the following surveys will be completed by participants during each 
assessment time point:  
● Attention Check Items 
● Behavioral Risk Factor Surveillance System (BRFSS) Adverse Childhood Experiences 
(ACE) Module 
● Demographics 
● Demographics & Meditation Experience  
● Determinants of Meditation Practice Inventory-Revised (DMPI-R) 
● Digital Working Alliance Inventory (DWAI) 
● Five Facet Mindfulness Questionnaire (FFMQ), Awareness Subscale 
● Flourishing Measure 
● Global Physical Activity Questionnaire (GPAQ) 
● Healthy Minds Index (HMIndex) 
● Mainz Inventory of Microstressors (MIMIS) 
● Marlowe-Crowne Social Desirability Scale (MCSD) 
● Mindfulness-Based Program – Meditation-Related Adverse Effects Scale (MBP-
MRAES) 
● Mindfulness Adherence Questionnaire (MAQ) 
● NIH Toolbox Loneliness  
● Pre- & Post-Practice Items 
● PROMIS Item Bank - Emotional Distress - Anxiety (Computer Adaptive Version) 
● PROMIS Item Bank - Emotional Distress - Depression (Computer Adaptive Version) 
● PROMIS Item Bank - Sleep Disturbance (Computer Adaptive Version) 
● Perceived Stress Scale (PSS) 

PROTOCOL TITLE: Brain and Meditation (BAM) Study 
 
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● PTSD Checklist (PCL-5) 
 
Source records: All data will be collected directly from participants. No data will be collected 
from any of the following sources: 
☐  UW Health medical or billing records via ICTR’s Clinical Research Data Service 
(CRDS) 
☐  UW Health HealthLink Records (study team will directly access) 
☐  Data from departmental QA or QI database 
☐  Data from UW Health Enterprise Data Warehouse (EDW) 
☐  Data from PACS (Picture Archiving and Communication System); specify whether 
study will use the clinical or research instance in the Radiology Department’s 
warehouse: ___________ 
☐  Data from Center for Medicare/Medicaid Services 
☐  Data from publicly available datasets (e.g., U.S. census data) 
☐  Data from outside institutions or organizations (specify: ______________) 
☐  Other (specify: ____________________________________) 
 
13.5 Long-term follow-up 
There are no current plans for long-term follow-up other than Timepoint 6 (3-Month Follow-
Up), which is part of the research procedures listed above. For those in the HMP group, we will 
continue to use any data collected through the HMP app (e.g., usage data) until Timepoint 6. 
Additional follow-up activities may be planned by study personnel and/or collaborators. The 
consent form includes a section where participants can opt in to future contact. 
 
 
14.0 Comparison of usual care and study procedures  
 
14.1 Alternatives 
N/A - All procedures are performed solely for research purposes. Individuals may elect to not 
enroll in this study, as it is completely voluntary. 
 
 
15.0 Withdrawal of Participants 
 
15.1 Withdrawing participants without their consent 
We anticipate that we will withdraw a participant from the study: 1) if we determine that 
participation in the study is exposing the participant to an unacceptable level of risk, 2) to 
maintain data integrity (e.g., if a participant is not following study procedures or may be 
deliberately providing false information), or 3) if the study is stopped by the sponsor or 
researchers. 
 
15.2 Procedures for orderly termination 
When withdrawing a participant, we will: 1) thank the participant for their participation, 2) 
explain the reason(s) for termination, 3) explain that the participant will be paid for the portion of 
the study that they completed (as described in the consent form), 4) ask the participant if they 

PROTOCOL TITLE: Brain and Meditation (BAM) Study 
 
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have any questions or comments about the study, and 5) inform the participant that the HMP app 
is available to use free of charge. We will change the participant status to withdrawn in REDCap; 
however, we will retain and use data collected prior to withdrawal. 
 
15.3 Procedures for participant-initiated withdrawal 
When a participant chooses to withdraw from the research, we will: 1) thank the participant for 
their participation, 2) determine if the participant will be fully or partially withdrawing (if partial, 
determine which procedures the participant will be completing), 3) explain that the participant 
will be paid for the portion of the study that they completed (as described in the consent form), 
4) ask the participant their reason for withdrawing (if they choose to provide it), 5) ask the 
participant if they have any questions or comments about the study, and 6) inform the participant 
that the HMP app is available to use free of charge. We will remove the withdrawn participant 
from REDCap; however, we will retain and use data collected prior to withdrawal.  
 
 
16.0 Data Management and Confidentiality 
 
16.1 Quality control 
Study staff will conduct periodic checks throughout data collection to ensure that all data (e.g., 
survey, behavioral task, HMP app activity, and location tracking) are recorded as expected and to 
look for any missing and/or aberrant data. 
 
16.2 Steps to secure the data 
☒  Data will be coded, and the “key” linking identities to codes will be kept separately 
from the data. 
☐  Data will be coded, and the “key” linking identities to codes will be kept on paper 
only. The study data will be stored electronically and labeled only with codes. 
☒  Only those listed as key personnel will have access to the “key.” 
☐  Access to the “key” will be limited to the following person (e.g., Database 
Administrator): ________________________________ 
☒  This study is funded by the National Institutes of Health and is covered by a 
Certificate of Confidentiality. 
☐  This study is NOT funded by the National Institutes of Health but because it will 
collect sensitive information, the research team will apply for a Certificate of 
Confidentiality to protect data from being requested without the subject’s consent as 
part of a legal proceeding. 
☐  Other: _______________________________________________ 
 
Data collection and storage: Data will be collected, protected, and shared using REDCap, which 
is administered by ICTR at UW-Madison. This is a web-based data collection program that is 
HIPAA and IRB compliant, and allows for the safe and secure collection and storage of clinical 
assessments, questionnaires, and physiological data. Data will also be gathered through the HMP 
app and through a GPS location tracking app (“FollowMee”). A short pre-screening survey for 
participants recruited from Prolific will be administered in Qualtrics. We will not collect any 
identifying information in Qualtrics, and participant responses will only be identified by a 

PROTOCOL TITLE: Brain and Meditation (BAM) Study 
 
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Prolific ID. Location tracking data collected in the FollowMee app will not be associated with 
any participant information other than a non-identifiable device ID and subject ID.  Participant 
data will be coded with subject ID numbers. All data will be managed by the study PI. Access to 
the data will be given only to HIPAA and CITI qualified and trained study team members. Data 
will be kept indefinitely on HIPAA compliant password-protected secure servers. 
 
Confidentiality: We will make every effort to maintain the privacy and confidentiality of 
participants involved in the study. This includes taking the following steps:  
● Staff will participate in initial training, follow-up training, and ongoing monitoring and 
supervision to ensure understanding of ethical issues involved in this research that 
includes, but is not limited to, courses offered by UW-Madison’s Human Research 
Protection Program, and a training on HIPAA and measures to protect confidentiality. 
● The electronic key that links the participant name with ID number will be kept in a secure 
electronic database file on REDCap and on the password-protected secure server for the 
Center for Healthy Minds. It will be accessible only by authorized study staff. 
● Any personal identifiers linked to data will be removed and replaced by code numbers in 
all records. 
● The highest security features in REDCap will be enabled for screening questionnaires. 
Screening data and other questionnaire data collected via REDCap will be downloaded to 
electronic files that will be kept on the HIPAA compliant secure server for the Center for 
Healthy Minds. This is the drive on which patient and research subject data that meet the 
criteria for electronic private health information are stored. We do not store any 
electronic personal health information (including information gathered as part of the 
proposed study) locally on any desktop workstations. These files will be password 
protected and accessible only by the PI and study staff. 
● The Qualtrics prescreening survey for participants recruited through Prolific will not 
collect any identifying information. Participant responses will be identified only by a 
Prolific ID. 
● The HMP app will not collect any identifying information. Information collected on the 
HMP app will be coded with a subject ID number. 
● The FollowMee app will collect minimal data to provide location tracking services (e.g., 
device ID, device type, date, time, latitude and longitude coordinates, direction, altitude, 
and speed of travel). No participant information will be associated with these data within 
the FollowMee app or server other than a non-identifiable device ID and a subject ID. 
Data will be encrypted while transmitted from participant devices to the FollowMee 
server and will be deleted from participant devices after transmission. Data will be 
protected online by an account authentication process. Only authorized study staff will 
have access to the credentials. FollowMee will store all data on a secure server hosted by 
Amazon Web Service. Data will be encrypted when downloaded from the FollowMee 
server, and downloaded data will be saved on the password-protected secure server for 
the Center for Healthy Minds. 
● After location tracking data are downloaded, our staff will protect participant 
confidentiality by not viewing the minute-by-minute data, other than for the purpose of 
conducting quality control checks of these data. When reviewing these data, staff will 
view lists of latitude/longitude coordinates, and will make no effort to link these 
coordinates to specific places that could reveal embarrassing, stigmatizing, or illicit 

PROTOCOL TITLE: Brain and Meditation (BAM) Study 
 
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information. Data analysis will focus on extracted summary measures across a given day; 
for example, total distance traveled, number of distinct locations visited, and diversity of 
locations visited (or “roaming entropy”; see Heller et al., 2020). 
● Prior to signing the consent forms for participation in the study, participants will be 
notified on the consent form that we are included in the list of mandated reporters and 
that by signing the consent form, they understand that in cases of suspected harm to self 
or other, the researcher is required by law to report to the appropriate authorities. 
 
16.3 How and where data and/or specimens will be stored and maintained 
☐  Online Collaborative Research Environment (OnCore) Biospecimen Management 
☒  Research Electronic Data Capture (REDCap) Specify which instance you will be using 
(e.g., ICTR’s, Department of Medicine’s): ICTR’s instance of REDCap 
☐  Other software option that will be stored on departmental server. Specify the 
department: ______________________ 
☒  Locked filing cabinet or drawer inside a locked room. Specify the building: Center for 
Healthy Minds 
☒  Other (describe): Data will be temporarily stored on the secure servers for the HMP 
app and FollowMee app until they are transferred to the password-protected secure 
servers for the Center for Healthy Minds. 
☐  Data will not be stored or accessed on portable devices. 
☒  Portable devices will be used to access secure web-based data collection sites such as 
ICTR’s REDCap and to access the HMP app. The FollowMee app will passively 
collect location data from participant’s smartphones. No data will be stored locally on 
the device. 
☒  Data stored on portable devices will be coded with the key stored separately. No 
identifiers will be stored on portable devices. 
☐  Data stored on portable devices and therefore only encrypted devices will be used. 
 
16.4 Management of identifiers 
☐  Identifiers will be destroyed after all data has been collected. 
☐  Identifiers will be destroyed at study closure. 
☐  Identifiers will be destroyed at study closure or at the time of publication. 
☒ Identifiers will be kept indefinitely so that we can contact participants who consented 
to future contact. All data will be labeled with a participant ID code. The key linking 
participant name with participant ID code will be stored in ICTR’s instance of 
REDCap and on a password-protected secure server with access limited to authorized 
study staff.  
 
16.5 Data/specimen handling for multi-site research 
N/A - This study is not multi-site. 
 
16.6 Data sharing 
We may share coded data (e.g., questionnaire, behavioral task, location) with researchers within 
or outside of UW-Madison to address future research questions not included in this application, 

PROTOCOL TITLE: Brain and Meditation (BAM) Study 
 
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Revised: February 12, 2021 
with a complementary study being conducted at the Center for Healthy Minds (i.e., the “BeWell 
Study”; PI: Richard Davidson; Protocol: 2021-0991) which is utilizing many of the same survey 
and behavioral task measures, and/or with journals where open data sharing policies are 
encouraged or are a requirement for publication (e.g., PLoS ONE). Coded data may be shared as 
Supplemental Information uploaded to journal websites and/or shared on a UW data sharing 
website such as "Minds@UW" (http://researchdata.wisc.edu/data-access-2/) or UW-Madison 
Box (https://uwmadison.box.com). UW-Madison Box will only be used to transfer coded data 
and will not be used for long-term data storage. Data will be directly uploaded to the journal 
website or the data sharing website. Confidentiality will be protected by coding the data with 
new subject numbers. The code linking the new subject numbers to the original subject numbers 
will be kept on our secure server and will be maintained by study staff. 
 
We may share fully de-identified data from the study on data sharing platforms (e.g., 
OpenNeuro, NIMH Data Archive) for use by non-collaborators. Data shared on data sharing 
platforms will be uploaded via the internet. Confidentiality will be protected by stripping the data 
of all identifiers, including HIPAA identifiers. 
 
We may follow-up with participants from this study in future research studies. We will ask 
participants on the consent form if they would like to be contacted about future studies. If they 
agree, their contact information (e.g., name, phone number, email address, home address) will be 
kept on the Center for Healthy Minds’ secure server indefinitely. Only authorized study staff will 
have access to this information. The participant’s contact information will not be stored with 
their data. Future studies may include analysis of the information from this study alone or in 
combination with data collected in other studies. Any future research utilizing these data will be 
submitted as a separate application to the IRB prior to their use, if required by IRB policies 
and/or guidance.  
 
 
17.0 Provisions to Protect the Privacy Interests of Participants 
 
17.1 Steps to protect privacy interests 
☒  Procedures will be performed in a private area where others cannot see the procedures 
being performed or overhear the conversation between subjects and researchers. 
☒  All members of the study team are up to date on their institutional HIPAA training. 
☐  The study is not collecting information that could pose legal or reputational risks to 
participants. 
 
All study procedures will be completed remotely in a setting of the participant’s choice. We will 
recommend that participants complete remote study procedures in a private room. 
 
17.2 Justification for sensitive information 
The study screener will ask questions about current and/or past symptoms of various mental 
illnesses. The study surveys include questions related to negative childhood experiences, 
depression, anxiety, and stress. One aim of the study is to investigate whether the meditation 
training intervention reduces perceived stress, which is related to depression and anxiety. Current 

PROTOCOL TITLE: Brain and Meditation (BAM) Study 
 
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Revised: February 12, 2021 
or past history of various psychiatric disorders may confound aims of the study and thus are part 
of the exclusionary criteria.  
 
17.3 Steps to make participants feel at ease 
The study description, consent form, and introduction to the surveys/interview will all include 
language stating that 1) participation is voluntary, 2) some questions may be of a sensitive 
nature, and 3) participants may skip any items that they are not comfortable answering, except 
for certain required items (e.g., the PSS is required because it is a primary study measure). We 
will provide participants with a description of the procedures that will be performed during study 
visits and will ask participants if they are comfortable proceeding. We will let participants know 
that they can ask questions or tell us concerns at any time and we would be happy to help. 
 
 
18.0 Sharing of Results  
 
18.1 Whether results will be shared with participants or others 
All measures (surveys, behavioral task, & location) are for research purposes only and individual 
results may not be meaningful. We will not share individual results with participants or report 
results in participant health records.  
 
18.2 Plans to share study results with the public 
We will share study results with the public via manuscripts and/or open source databases. The 
Center for Healthy Minds website and/or other social media platforms may share information 
about study results and/or publications. 
 
 
19.0 Data and Specimen Banking 
 
19.1 Description of data and specimen banking 
We may bank any data collected during this study (e.g., questionnaire, behavioral task, location) 
for future use to address research questions not included in this protocol. Banking of data will 
not be optional. Banked data will be stored indefinitely on ICTR’s instance of REDCap and on a 
password-protected secure server with access limited to authorized study staff. 
 
19.2 Information associated with banked data and specimens 
Study data will be coded with the participant ID. The code linking data to identifying 
information will be kept on a password-protected secure server and ICTR’s instance of REDCap 
with access limited to authorized study staff. 
 
19.3 Procedures to release banked data and specimens 
There are no limits on future use of banked data. Any future research utilizing these data will be 
submitted as a separate application to the IRB prior to their use, if required by IRB policies 
and/or guidance. Other researchers inside and outside of UW-Madison may request banked data 
from the Principal Investigator. 
 
19.4 Withdrawing banked data or specimens 

PROTOCOL TITLE: Brain and Meditation (BAM) Study 
 
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Revised: February 12, 2021 
Participants may withdraw their banked data from future research use. If we receive a 
withdrawal request from a participant, we will destroy all of their banked data. 
 
 
20.0 Study Analysis 
 
20.1 Statistical hypotheses 
H1: HMP vs. waitlist participants will show (a) lower scores on the perceived stress scale, (b) 
improved performance on the pattern separation task, and (c) increased “experiential diversity” 
measured using GPS location tracking. 
 
H2: Within the HMP group, greater decreases in perceived stress will be correlated with 
improvements/increases in outcomes b-c. 
 
20.2 Sample size justification 
We plan to enroll 150 participants, assigning two-thirds to the HMP group and one-third to the 
waitlist control group, and anticipate 10% dropout. This sample size affords us 80% power to 
detect medium effect sizes (d = 0.5) for our primary outcome of perceived stress at p < 0.05. A 
recent study of the Healthy Minds Program vs. waitlist control (Hirshberg et al., 2021) identified 
a similar effect size for a composite “distress” measure, which was an aggregate of perceived 
stress and PROMIS anxiety/depression scores, and another previous study suggested a SD of 0.5 
reflects a minimal clinically important differences for the Perceived Stress Scale (Platinga et al., 
2017). For correlation analyses, we have 80% power to detect medium-to-large correlations (r = 
0.41) at p < 0.0125 (0.05/4 outcomes). 
 
20.3 Participant population(s) for analysis 
Participants will be assigned to HMP and waitlist groups at a 2:1 ratio. 
 
20.4 Statistical methods 
Group differences for the intervention will utilize linear mixed effects models with a random 
intercept and slope for each participant to account for non-independence of error and to 
maximize use of data with missing observations. We will conduct Pearson correlation analyses 
using difference scores between baseline and post-intervention/follow-up timepoints to test 
whether reductions in perceived stress are associated with behavioral or imaging outcomes 
hypothesized to contribute to differences in perceived stress. 
 
20.5 Planned interim analysis 
Given the low risk of the intervention, no interim efficacy or safety analyses are planned. 
 
20.6 Handling of missing data 
Linear mixed effects analyses account for missing data in a robust manner relative to, e.g., 
ANOVA. We will use all available observations and do not plan to impute missing data. We will 
document reasons for missing data, evaluate whether data appear missing at random, and 
evaluate the impact of missing data using sensitivity analyses based on the nature of missing 
data. 
 

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21.0 Potential Benefits to Participants 
 
21.1 Potential benefits  
Participants may benefit from using the HMP, which is designed to introduce meditation practice 
as a way of reducing stress and developing greater balance, ease, and fuller participation in life. 
This meditation training is a way of learning to relate directly to whatever is happening in your 
life including the challenges of stress, pain, illness, and everyday demands. Waitlist control 
participants can use the HMP after completion of the study at no cost. 
 
21.2 Direct benefits 
There are no direct benefits for participants. 
 
 
22.0 Risks to Participants 
 
22.1 Risks, discomforts, hazards, or inconveniences 
Risk of emotional responses: 
Study surveys include questions about mental health that could affect a participant’s mood or 
make them feel embarrassed. Emotional upset due to study participation is a potential but 
unlikely risk. In our experience from previous studies, it is rare for a participant to find self-
report questionnaires to be extremely upsetting.  
 
Risk of location tracking: 
GPS location data collected from participants’ smartphones could be used to see specific 
locations that participants have visited and whether participants may have engaged in activities 
or visited places that are potentially stigmatizing or embarrassing. 
 
Risk of confidentiality breach:  
There is a slight risk of breach of confidentiality, which could result in legal implications or 
stigmatization. There is a chance that concerns about safety (e.g., self harm, possible child abuse) 
will be discovered during the course of the study, and that these discoveries could require 
mandatory reporting and place subjects at possible legal risk. There is the risk that information, 
such as health information or GPS location information, could become known to subjects, 
doctors, or others. If this happens it may lead to loss of insurance, difficulty obtaining insurance, 
an increase in premiums, job loss, reduced employability, and harmful psychological effects on 
the subject. 
 
22.2 Risks associated with delaying standard treatment 
N/A 
 
22.3 Procedures that have unforeseeable risks 
N/A 
 
22.4 Procedures that have potential risks to an embryo or fetus 
N/A 

PROTOCOL TITLE: Brain and Meditation (BAM) Study 
 
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Revised: February 12, 2021 
 
22.5 Risks to others who are not participants 
N/A 
 
22.6 Minimizing risks 
Minimizing risk of emotional responses: 
We will inform participants in the consent form and in survey instructions that some questions 
may ask about sensitive topics and that they may skip any items that they are not comfortable 
answering, except for certain required items (e.g., the PSS is required because it is a primary 
study measure). As stated in the consent form, participants are free to discontinue at any point 
during the experiment. 
 
If a participant reveals suicidal ideation, self-harm, or intent to harm others, study staff will 
consult with clinical research personnel. A clinician will contact the participant by phone to 
assess intent, the level of risk, and provide referrals as needed. In the circumstance that an 
individual indicates that self-harm or harm to others is imminent, 911 will be called. All 
interactions regarding suicide risk and referral will be carefully documented and closely tracked 
by the clinical research personnel. A formal incident report will be filed with the IRB in cases in 
which a clinician notifies authorities. All participants will be provided with therapeutic resources 
regardless of their responses. 
 
Minimizing risk of location tracking: 
We will inform participants in the consent form about how we will use and protect location data. 
The FollowMee app will not collect any identifying information. Location data will only be 
associated with a non-identifiable device ID and subject ID. Data will be stored on secure 
password-protected servers. Study staff will not view real-time GPS locations, other than to 
confirm that the FollowMee app is functioning correctly. Data will be encrypted during 
download, and security measures for the Center for Healthy Minds network will provide 
protection against data breach. After the data are downloaded, our staff will protect participant 
confidentiality by not viewing or analyzing the minute-by-minute data, other than for the purpose 
of conducting quality control checks of these data. When reviewing these data, staff will view 
lists of latitude/longitude coordinates, and will make no effort to link these coordinates to 
specific places that could reveal embarrassing, stigmatizing, or illicit information. Data analysis 
will focus on extracted summary measures across a given day; for example, total distance 
traveled, number of distinct locations visited, and diversity of locations visited (or “roaming 
entropy”; see Heller et al., 2020). 
 
Minimizing risk of confidentiality breach: 
We will use data storage procedures to reduce the risk of confidentiality breach (e.g., data 
coding, secure storage, trained personnel). Additionally, although GPS location information will 
be collected within the GPS application, this application will not have access to any identifiable 
participant information or other data (e.g., questionnaire responses). This will be made explicitly 
clear to the participants. Because potential safety concerns (e.g., self harm, possible child abuse) 
may require mandatory reporting and place subjects at possible legal risk, we will inform 
participants about this limit to confidentiality in the consent form. Also, this study is funded by 

PROTOCOL TITLE: Brain and Meditation (BAM) Study 
 
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the NIH and has a Certificate of Confidentiality that provides additional confidentiality 
protections.  
 
 
23.0 Provisions to Monitor the Data to Ensure the Safety of Participants 
 
23.1 Data and safety monitoring plan 
Adverse events will be tracked (including details of the incident, actions taken, and follow-up 
steps) by study staff and reported to the PI. The PI will be responsible for the monitoring and 
reporting of adverse events, as necessary, to the IRB.  
 
Other notable incidents that occur during recruitment, consent, or data collection that are 
determined to be unexpected and related to the study procedures will be reported in a detailed log 
on an annual basis (at the time of continuing review). The PI will be responsible for informing 
the IRB immediately of any life threatening incidents as well as take appropriate action to stop 
the study, release a participant from the study, or modify procedures to reduce and/or eliminate 
the occurrence of the risks. 
 
The PI will review information on adverse events, protocol deviations, data quality, participant 
recruitment, accrual, and retention (including reasons for dropout), whether all participants met 
inclusion criteria, and demographics. This information will be provided in biannual reports to an 
Independent Monitor who will make recommendations regarding the safe continuation of the 
study and whether any changes to the protocol are needed to ensure participant safety. Once 
annually the Independent Monitor will forward an approved report to the UW Health Sciences 
IRB and NIMH. 
 
Given the safety and risk level of the intervention and study procedures, we cannot anticipate any 
conditions that would trigger an immediate suspension of the research. 
 
 
24.0 Economic Burden to Participants 
 
24.1 Potential costs 
Since data collection will be done remotely, there are few potential costs associated with 
participation. 
 
 
25.0 Resources Available 
 
● Will the research be conducted 
outside School of Medicine and 
Public Health or UW Hospitals 
and Clinics (e.g. the researcher 
does not have an SMPH 
research feasibility attestation 
for this study)?  
☒ YES (complete 25.1) 
☐ NO (remove text below, but retain this 
section) 

PROTOCOL TITLE: Brain and Meditation (BAM) Study 
 
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Revised: February 12, 2021 
 
25.1 Resources available to conduct the research 
The Center for Healthy Minds has ample experience running large-scale, longitudinal studies. As 
most studies have moved to remote data collection in the past year (IRB protocols: 2020-0533, 
2020-1454, and 2019-0893), we have been successful at recruiting a large number of participants 
with high retention rates.  
 
Data collection for this study will be completed remotely over approximately 3 years. 
 
We will inform participants that they should contact their healthcare provider if any concerns 
arise when answering survey questions. A therapeutic resource list will be provided to all 
participants upon completion of the study. 
 
Study staff will meet on a regular basis to discuss study design, implementation, processing, and 
analyses. We will discuss task assignments and study updates at these meetings. 
 
 
26.0 Multi-Site Research 
N/A 
 
 
27.0 References 
Heller AS, Shi TC, Ezie CEC, Reneau TR, Gibbons C, Baez LM, Hartley CA (2020). 
Association between real-world experiential diversity and positive affect relates to hippocampal-
striatal functional connectivity. Nature Neuroscience. 3(7):800-804. doi: 10.1038/s41593-020-
0636-4. 
 
 
28.0 Appendices 
N/A