Comparing the Healthy Minds Program With an Active Control and Waitlist Control in Depression
Phase: NA
Conditions: Depression, Psychological Distress
Sponsor: University of Wisconsin, Madison

 
 
 
 
 
 
 
 
Behavior, Biology, and Well-Being (BeWell) Study 
 
1/16/2025 
NCT05183867 

PROTOCOL TITLE: Behavior, Biology, and Well-Being (BeWell) Study 
 
 
Page 1 of 37 
 
 
PROTOCOL TITLE: 
Behavior, Biology, and Well-Being (BeWell) Study 
LEAD RESEARCHER: 
Simon Goldberg, PhD 
School of Education, UW-Madison 
(608) 265-8986 
sbgoldberg@wisc.edu 
Co-Investigators 
Richard Davidson, PhD 
Center for Healthy Minds, UW-Madison 
(608) 265-8189 rjdavids@wisc.edu 
Dan Grupe, PhD 
Center for Healthy Minds, UW-Madison 
(608) 263-7572 
grupe@wisc.edu 
VERSION NUMBER/DATE: 
19.1; 1/16/2025 
REVISION HISTORY 
Revision # Version Date 
Summary of Changes 
Consent Change? 
1 
1/20/2022 
Changes are largely editorial and to 
introduce word changes based on 
CARDS meeting. 
Yes 
2 
4/5/22 
Changes to sample collection 
window, questionnaires, subject 
time burden, and formatting. 
Yes 
3 
6/2/22 
Changes to sample collection 
window, recruitment methods, 
questionnaire timing, estimated 
subject time burden, NIH funding 
Yes 
4 
8/1/22 
Changes related to Clinical 
Interview in study design, research 
procedures, and quality control 
No 
5 
9/26/22 
Remove inconsistency in data 
sharing plans 
Yes 

PROTOCOL TITLE: Behavior, Biology, and Well-Being (BeWell) Study 
 
 
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6 
12/18/22 
Add healthy control participants at 
baseline only 
Yes 
7 
1/15/23 
Posting recruitment video on third 
party websites, process for emailing 
participants to schedule interviews 
No 
10 
2/19 
Remove Heather Abercrombie from 
staff list 
Yes 
11 
3/31 
Invite past participants to share 
recruitment materials with others 
No 
12 
5/16 
Assess problematic internet use 
No 
13 
6/29 
Assess asthma control 
No 
14 
8/10/23 
Recruit participants through 
ResearchMatch messages 
No 
15 
8/22/23 
Recruit participants through articles 
written for print or online media 
No 
16 
8/28/23 
Modifying inclusion/exclusion 
criteria to allow participants with 
PHQ-9 item 9 (self-harm / suicidal 
ideation) to enroll, if risk is 
determined to be low via clinical 
interview; modify response to 
imminent risk to include contacting 
988 
No 
17 
7/19/24 
Modifying description of where 
dried blood spot analyses will occur 
and updating data sharing details 
Yes 
18 
12/9/24 
Update description of video data 
sharing and obtaining consent to do 
so 
Yes 
19 
1/16/25 
Adding description of video analysis No 
 
 
 

PROTOCOL TITLE: Behavior, Biology, and Well-Being (BeWell) Study 
 
 
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Table of Contents 
1.0 
Study Summary 
3 
2.0 
Background 
3 
3.0 
Study Objectives and Endpoints 
4 
4.0 
Number of Participants 
5 
5.0 
Inclusion and Exclusion Criteria 
5 
6.0 
Special Populations 
6 
7.0 
Recruitment Methods 
7 
8.0 
Consent/Assent Process 
8 
9.0 
Process to Document Consent in Writing 
8 
10.0 Setting 
9 
11.0 Study Intervention 
9 
12.0 Study Timelines 
11 
13.0 Procedures Involved 
12 
14.0 Comparison of usual care and study procedures 
20 
15.0 Withdrawal of Participants 
20 
16.0 Data Management and Confidentiality 
21 
17.0 Provisions to Protect the Privacy Interests of Participants 
24 
18.0 Sharing of Results 
25 
19.0 Data and Specimen Banking 
25 
20.0 Study Analysis 
25 
21.0 Potential Benefits to Participants 
26 
22.0 Risks to Participants 
26 
23.0 Provisions to Monitor the Data to Ensure the Safety of Participants 
28 
24.0 Economic Burden to Participants 
28 
25.0 Resources Available 
28 
26.0 Multi-Site Research 
29 
27.0 References 
29 

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28.0 
Appendices 261.0 Study Summary 
Study Title 
Behavior, Biology, and Well-Being (BeWell) Study 
Brief Summary 
This study is a randomized controlled trial to investigate the 
impact of a 4-week, mobile meditation training app on 
symptoms of depression and psychological distress. Adults 
who have elevated depressive symptoms between the ages of 
18 and 65 will be enrolled in the study for about 4 months. 
We will also recruit a sample of healthy (non-depressed) 
controls who will only complete baseline measures. 
Number of study sites 
1 
Study Design 
Participants will be randomized into one of three groups: 
Healthy Minds Program intervention group, active control 
group, and usual care group. The intervention and active 
control groups will use different versions of the mobile 
health app for four weeks. All participants will complete 
pre-intervention, weekly, post-intervention, and 3-month 
follow-up surveys and computerized tasks. Healthy control 
participants will not be randomized. 
Primary Objective 
Assess acceptability and efficacy of a 4-week mHealth 
meditation training program on depression symptoms. 
Secondary Objective(s) 
Investigate effects of the meditation training program on 
neurocognitive and biological processes implicated in 
depression and psychological distress and through which 
meditation training is hypothesized to operate. Understand 
baseline differences between participants with and without 
depression. 
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 
18-65 year olds with no significant experience with 
meditation 
Sample Size 
1,765 participants 
Study Duration for 
individual participants 
4 months 
Study Specific 
Abbreviations/ 
Definitions 
mHealth = mobile health 
HMP = Healthy Minds Program 

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2.0 
Background 
2.1 Depression is highly prevalent and associated with extreme personal and societal costs. 
Meditation training reduces depression symptoms and psychological distress, but access to in-
person programs is limited due to associated cost and lack of available services. The primary aim of 
this project is to investigate the efficacy of a 4-week mobile health (mHealth) meditation training 
program for adults with a wide range of depressive symptoms in an entirely remote randomized 
controlled trial (RCT). 
2.2 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 
HMP app as well as stay engaged in a longitudinal study. 
2.3 Research on neurocognitive and biological mechanisms of meditation training in alleviating 
depression is at a preliminary stage, and an obstacle limiting research progress is over-reliance on 
retrospective self-report measures, which are vulnerable to a host of biases. This project will use 
gold-standard behavioral measures and explore novel measures of relevant neurocognitive and 
behavioral processes, namely pattern separation, self-referential thought, and video-based 
assessment of emotional well-being. Furthermore, the project will investigate effects on the gut 
microbiome (with stool samples) and inflammation (with dried blood spots), which reflect 
biological systems hypothesized to be mechanistically related to benefits of meditation and well-
being training. 
3.0 
Study Objectives and Endpoints 
3.1  Specific Aims 
● Assess acceptability and efficacy of a 4-week mHealth meditation training program on 
candidate behavioral mechanisms of depression and psychological distress. 
● Investigate effects of the mHealth meditation training program on behavioral and 
neurocognitive processes implicated in depression and psychological distress and through 
which meditation training is hypothesized to operate and improve well-being. 
● Investigate effects of the mHealth meditation training program on biological processes 
implicated in depression and psychological distress and through which meditation training is 
hypothesized to operate and improve well-being. 
● Compare depressed and non-depressed participants on self-report, behavioral, and biological 
measures. 
3.2 Hypotheses 
● The intervention participants will show larger reductions in psychological distress relative to 
usual care and active control participants during the intervention period and at follow-up. 

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● The intervention participants will show improved pattern separation behavior relative to 
usual care and active control participants during the intervention period at post-intervention 
and at follow-up. 
● The intervention participants will show reduced self-referential processing (e.g., first-person 
pronoun use) and greater video-based indicators of well-being relative to usual care and 
active control participants during the intervention period at post-intervention and at follow-
up. 
● Speech indicators (e.g., I-talk, negative self-focused statements, and inflexible overly 
general thinking) evident in natural language will predict depression and task performance. 
● Machine learning models will modestly predict depression (Spearman’s rho ≥ .30). 
● The intervention participants will show greater changes in biological processes relative to 
usual care and active control participants during the intervention period at post-intervention 
and at follow-up. 
● Depressed participants will show differences on behavioral and biological markers of 
depression at baseline relative to non-depressed healthy controls. 
 
3.3 Primary and Secondary Study Endpoints 
Primary Endpoint 
● Scores on the Physical Health Questionnaire depression scale (PHQ-8) 
Secondary Endpoint 
● Symptoms of psychological distress (GAD-7, PROMIS Sleep Disturbance and 
Flourishing Index) 
● Performance on the behavioral pattern separation task 
● Self-referential thought measured by the video recording task 
3.4  Primary and Secondary Safety Endpoints 
N/A 
4.0 
Number of Participants 
4.1 
This study will enroll 1,500 participants at UW-Madison. There will also be a pilot of up to 15 
participants. We will recruit approximately 250 healthy control participants who will complete 
baseline measures only. 
4.2 
The expectation is that we will have 20-50% attrition resulting in roughly 750-1200 
participants completing the study. 

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4.3 
Participants will be considered enrolled after randomization. Participants who leave the 
study early will not be replaced. Healthy control participants will only complete baseline 
measures. 
5.0 
Inclusion and Exclusion Criteria 
5.1  Screening 
The screening survey will be accessed and completed in REDCap after potential participants learn 
more about the study and decide to continue with the screening process. Potential participants will 
be informed via a REDCap email of their eligibility up to 1 year after completing the screening 
surveys. This timeframe will be helpful to manage the unpredictability of participant recruitment 
and ensure that participants are enrolling in the study at a manageable rate for study activities that 
require staff time (e.g., clinical interview, sending and receiving biosample kits). If it has been 30 
or more days since participants completed screening, they will be asked to complete the screening 
again before being invited to enroll. They will receive an email inviting them to do so. This email 
will be sent from the study email address (e.g., bewell@chm.wisc.edu). Screening data will be 
retained for all potential participants regardless of whether or not they enroll in order to keep a 
record of reasons individuals are not eligible for the study for reporting purposes (e.g., consort 
diagram). Any identifiers will be removed from the screening data of individuals who are not 
eligible for the study. Contact information will only be retained from individuals who are eligible 
for the study.  
5.2  Inclusion Criteria 
Randomized participants: 
○ Age 18 to 65 
○ Proficient in English 
○ Able to provide informed consent 
○ Have access to a smartphone that can download apps from Google Play or the 
Apple App Store 
Indicate interest in participation after being informed of restrictions to payment  
○ PHQ-8 or PHQ-9 ≥ 5 
Healthy control participants: 
○ Age 18 to 65 
○ Proficient in English 
○ Able to provide informed consent 
○ Have access to a smartphone that can download apps from Google Play or the 
Apple App Store 
Indicate interest in participation after being informed of restrictions to payment  
○ PHQ-8 or PHQ-9 < 5 

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5.3 Exclusion Criteria 
Exclusion criteria apply to both randomized participants and healthy control participants. 
○ Regular daily meditation practice for past 6 months or regular weekly meditation 
practice for past 12 months 
○ Attended a meditation retreat or a yoga/body practice retreat with a significant 
meditation component 
o Previous use of Healthy Minds Program app 
○ Current suicidal intent and/or high self-injury risk (determined from the interview) 
○ Self-reported history of psychosis 
○ Self-reported history of mania 
○ Current psychopathology that interferes with study participation as assessed by 
interview 
○ Living or traveling outside the US during the whole study participation period 
(trips outside US after the interview phase is not an exclusion)   
○ AUDIT score ≥ 13 for women and AUDIT score ≥ 15 for men 
○ DUDIT score ≥ 8 for women and men 
 
5.4 Specific Population 
We will recruit individuals with a wide range of depressive and psychological distress 
symptomatology. We expect the sample to be demographically representative of the overall 
population of the United States. The U.S. Census population estimates for July 2019 are 1.3% 
American Indian or Alaska Native, 5.9% Asian, 13.4% Black or African American, 18.5% 
Hispanic or Latino, 0.2% Native Hawaiian or Other Pacific Islander, 76.3% White, and 2.8% two 
or more races. 
6.0 
Special Populations 
6.1 
☐ Children/Minors 
☐ Pregnant persons / fetuses (HRP-412 – CHECKLIST – Pregnant Women; HRP-413 – 
CHECKLIST – Non-Viable Neonates; HRP-414 – CHECKLIST – Neonates of Uncertain 
Viability) 
☐ Prisoners 
☐ Participants with impaired decision-making capacity 
N/A 
 
6.2 
☐ Non-English speaking participants 
☐ Illiterate or Low Literacy participants 

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☐ 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) 
N/A 
6.3 
☐ 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 
N/A 
7.0 
Recruitment Methods 
7.1  Sources of Participants 
We will recruit from various sources. These sources may include the community, local and national 
mental health clinics, research recruitment services and from the Participant Registry at the Center 
for Healthy Minds (CHM; IRB Protocol: 2019-0330). We may also recruit using CHM social 
media and listservs. 
7.2  Identifying Participants 
Potential participants will self-identify in response to flyers, social media platforms, emails, web 
postings, research recruitment services (e.g., Prolific, Mturk, and/or ResearchMatch). We may send 
an email to individuals who have provided their contact information to CHM’s Participant 
Registry; the email will include a link to the study page on REDCap. We may send messages to 
participants who have registered with recruitment services (e.g., ResearchMatch). Participants who 
are not eligible for the randomized portion of the study due to low depression symptoms (i.e., PHQ-
8 or PHQ-9 < 5) may be invited to participate as a healthy control participant. We may write or 
have written articles about our study to be published in print or online media (e.g., Madison 365). 
7.3  Recruitment Method 
Recruitment materials may be shared with outside groups (e.g., universities), local and national 
mental health clinics and organizations (e.g., NAMI, Mental Health America), as well as posted at 
various local businesses (e.g., libraries, stores, and restaurants) up to several times throughout the 
year and shared by word of mouth. A web posting of the study may be included on CHM’s website 
and social media ads may be placed on various social media platforms (e.g., Facebook, Twitter, 
Instagram) up to several times per year. We may also utilize email listservs at UW-Madison and 
other institutions, research recruitment services, as well as access CHM’s Participant Registry to 
recruit participants via email up to several times per year. Our recruitment video may be posted on 

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third parties as well (e.g., WithPower.com). Past and/or currently enrolled participants may be 
invited to share recruitment materials with others. Participants will be informed that sharing 
recruitment materials is voluntary and unrelated to their study participation. 
7.4 Recruitment Materials 
We may use flyers, web postings, social media ads, emails and a video posted on the REDCap 
study page to inform potential participants about the study. Materials will include a study email 
address for individuals to use if they have questions about the study. Recruitment will occur on a 
continuous basis throughout the 3-year study. 
7.5  Compensation 
○ Pre-Intervention Assessment = $0 
○ Week 1 Assessment = $10 
○ Week 2 Assessment = $10 
○ Week 3 Assessment = $10 
○ Post-Intervention Assessment = $40 
○ 3-Month Follow-Up Assessment = $45 
○ Stool sample collection = $60 ($30 for pre-intervention and $30 for follow-up) 
○ Dried blood spot collection = $40 ($20 for pre-intervention and $20 for follow-up) 
○ Bonus for Completing Above 6 Assessments = $50 
○ Total: up to $265 
Payment will be via check and provided at the end of participation in the study (after the 3-month 
follow-up assessment) or via a pre-loaded and reloadable debit card issued by US Bank. The debit 
card will be mailed to participants after they finish the week 1 assessment. After each assessment is 
completed, the next payment amount will be loaded onto the debit card. If participants choose to 
withdraw or are taken off the study for any reason, they will receive payment for the assessments 
they have completed. Individuals excluded based on the interview will be paid $15 for their time 
spent completing the pre-intervention assessment and interview. 
Individuals who have a visa will be informed in the webscreen and the consent form that due to 
UW-Madison limitations on payments, we can only provide monetary compensation to individuals 
who are US citizens or residents (green card holders). The webscreen asks individuals if they are 
still interested in participating after being informed about this restriction of payment. 
Pilot participants will be paid up to $75: $40 for the Pre-Intervention Assessment, $10 for the Week 
1 assessment, $15 for the stool sample, and $10 for the dried blood spot. 
Healthy control participants will not be paid for the pre-intervention assessment, but will be paid 
$30 for the stool sample collection, $20 for the dried blood spot collection, and a $35 bonus for 
completing all study measures. 
8.0 
Consent Process 

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8.1 
The consent process is a waiver of written documentation of consent. A link to the consent script 
will be emailed via REDCap to eligible potential participants after they complete their screening 
surveys. Individuals are informed in the instructions for the consent script as well as within the 
consent script to reach out to study staff if they have any questions before proceeding. Clicking a 
box will indicate one’s interest in taking part in the study. 
 
9.0 
Process to Document Consent in Writing 
9.1 
N/A 
 
9.2 
We are waiving written documentation of consent. A consent script will be sent to eligible potential 
participants via REDCap after eligibility is confirmed. Individuals will check a box if they agree to 
participate in the study. After clicking the box, participants are informed that the next steps are to 
complete the initial surveys and games, a dried blood spot and stool sample kit will be mailed to 
them, and they will be scheduled for the interview.    
This study involves minimal risk and involves no procedures for which written consent is normally 
required outside of the research context. The waiver will not adversely affect the rights and welfare 
of the participants. It will be made clear that they can withdraw at any time. 
10.0 
Setting 
10.1  Location 
Research procedures will be performed remotely. 
11.0 
Study Intervention 
11.1 
The study intervention will be the Healthy Minds Program (HMP), a 4-week mobile health 
meditation training augmented with depression-specific content. The HMP was developed by our 
affiliated non-profit organization, Healthy Minds Innovations, Inc (HMI). The HMP is designed to 
promote and protect psychological well-being through sustainable skills training, with instruction 
administered through a curriculum of high-quality guided practices. The HMP is based on research 
on eudaimonic well-being (e.g., environmental mastery, purpose) and brain-based skills that 
underlie these qualities (e.g., regulation of attention, mental flexibility). The HMP has >100 guided 
audio practices that address 4 constituents of well-being: awareness, connection, insight, and 
purpose. The intervention and active control groups will download and use a study specific version 
of the HMP immediately after randomization. The intervention group will have access to and 
instructed to listen to both the lessons and meditations (guided practices). The active control group 

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will have access to and instructed to listen to the lessons only (meditation practices are not 
included). The intervention and active control groups will use the HMP for four weeks. The active 
control group and the usual care group will be given the opportunity to download and use the full 
HMP after they finish their 3-month follow-up assessment.  
The following usage data is recorded: date, time, duration, device type, lesson or practice, week, 
foundation (awareness, connection, insight, or purpose), and name of lesson or practice. 
Participants listen to lessons and/or practices and occasionally answer pre and post questions using 
their smartphones. 
This study requested a non-significant risk (NSR) determination for the use of the HMP. Use of the 
HMP may mitigate symptoms of depression, anxiety and/or stress but has not shown to pose a risk 
to health or safety. Below is a copy of the NSR letter. 
 
Request for a Non-Significant Risk Determination from the IRB for an Investigational Device 
 
UW-Madison Health Sciences IRB: 
 
Please accept this letter as a request for non-significant risk (NSR) determination for the 
investigational device evaluation described in the IRB submission titled “BeWell Study”.   
 
The FDA defines significant risk devices as follows (21 C.F.R. § 812.3(m)): 
 “"(1) Is intended as an implant and presents a potential for serious risk to the health, 
safety, or welfare of a subject;  
 
(2) Is purported or represented to be for a use in supporting or sustaining human life and 
presents a potential for serious risk to the health, safety, or welfare of a subject; 
 
(3) Is for a use of substantial importance in diagnosing, curing, mitigating, or treating 
disease, or otherwise preventing impairment of human health and presents a potential for 
serious risk to the health, safety, or welfare of a subject; or 
 
(4) Otherwise presents a potential for serious risk to the health, safety, or welfare of a 
subject”" 
 
The Healthy Minds Program (HMP) in this study is a smartphone app that includes both 
didactic content and guided meditation practices. The device will be used to aid development 
of well-being by training skills that are based on scientific studies (the didactic content). It 
also includes guided meditation practices found in widely available evidence-based treatments 
such as mindfulness-based stress reduction, mindfulness-based cognitive therapy, cognitive 
behavioral therapy, acceptance and commitment therapy, and other widely used smartphone 
meditation apps such as Headspace and Calm.  
 
The use of the device in this study does not meet the definition of a significant risk device as it 
is not an implant, is not used to sustain human life and poses no serious risk to health, safety or 

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welfare of a subject. The device may mitigate symptoms of depression, anxiety and stress, but 
has not shown to pose a serious risk to health, safety, or welfare.  
 
Summary of prior uses: HMP has been tested by our group in two randomized controlled trials 
(ns = 343, 662; Goldberg et al., 2020; Hirshberg et al., 2021). In both trials, HMP was shown 
to produce larger reductions in psychological distress (composite of depression, anxiety, and 
stress) relative to a waitlist control condition. Participants in both studies were drawn from the 
general population, although ~75% in each sample reported elevated depression and/or 
anxiety symptoms at baseline. Effects were similar when restricted to those in the clinical 
range at baseline. No serious adverse effects were reported in either study. In support of 
HM’'s safety, HMP was shown to produce lower rates of clinically significant increases in 
symptoms relative to a waitlist condition. 
 
References: 
Goldberg, S. B., Imhoff-Smith, T., Bolt, D. M., Wilson-Mendenhall, C. D., Dahl, C. J., 
Davidson, R. J., & Rosenkranz, M. A. (2020). Testing a multi-component, self-guided, 
smartphone-based meditation app: three-armed randomized controlled trial. JMIR Mental 
Health, 7(11), e23825. doi: 10.2196/23825 
 
Hirshberg, M. J., Frye, C., Dahl, C. J., Riordan, K. M., Vack, N. J., Sach, J., Goldman, R., 
Davidson, R. J., & Goldberg, S. B. (2021). A pragmatic randomized controlled trial of a 
smartphone-based well-being training in Wisconsin school district employees during the 
COVID-19 pandemic. Manuscript submitted for publication. https://psyarxiv.com/hrvmu/  
 
We respectively request the IRB consider this information in finding that the device does not 
meet the definition of significant risk.  Additional information about the device can be found in 
the application.  Please contact me if you have any questions. 
 
Sincerely, 
 
 
 
Dr. Richard J. Davidson 
 
12.0 
Study Timelines 
12.1 
This will be a 3-year project with participants randomized into 3 groups: HMP intervention group, 
active control group, and usual care group (see “Randomization”, section 13.1.4). Participants will 
be involved with the study for approximately 4 months. Recruitment will start upon UW 
Institutional Review Board (IRB) approval and continue until study goals are reached. We estimate 
that we will complete primary analyses within 3 years of the end of data collection.  
 
In order to ensure that the procedures outlined below are implemented in a feasible and functional 
way for the intended study participants a pilot of up to 15 participants will precede initiation of the 

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full study. Pilot participants will be asked to complete all aspects of the study up to and including 
the week 1 assessments. 
 
A sample of healthy control participants will complete baseline measures only. 
 
13.0 
Procedures Involved 
13.1 Study Design 
After potential participants are informed of their eligibility, they will be invited to complete the 
following steps: 
 
1. Consent Process. Individuals will read a consent script in REDCap and are given the 
opportunity to reach out to study staff if they have any questions or concerns about study 
procedures before clicking on the box indicating interest in participating in the study. 
2. Pre-Intervention Assessment (Timepoint 1). A REDCap link for these surveys and games 
(behavioral task and video task) will be sent after consent is completed. It will take 
approximately 60-90 minutes to complete these measures. Potential participants will be 
given two weeks to complete this assessment. In order to increase study retention, only 
those who complete this assessment will be invited to subsequent parts of the study. A 
microbiome and blood spot collection kit will be mailed to participants to be completed 
before randomization occurs. The kit needs to be returned within one month of completing 
the surveys and games to continue with the randomization step. 
3. Interview. The participant will undergo an interview conducted by research staff who are 
trained in interviewing techniques and supervised by qualified study personnel with mental 
health expertise. The interview will consist of the depression and related modules of the 
Structured Clinical Interview for DSM-5 Research Version (SCID-5-RV). The interview 
will be done via phone or video and will take approximately 60 minutes to complete. 
Participants may be sent an email to confirm their current phone number, interview time, 
and/or other details to assist with interview scheduling. 
4. Randomization. Participants will be assigned to one of three groups: approximately two-
fifths to the HMP intervention group, approximately two-fifths to the active control group, 
and approximately one-fifth to the usual care group. Randomization will be done in 
REDCap (either immediately after the interview or within a few days if consultation with a 
study PI or Co-I is needed; the microbiome and blood spot kit need to be returned before 
randomization). A REDCap alert will inform participants of group status immediately after 
randomization along with instructions for downloading HMP for those in the intervention 
and active control groups. 
5. Weeks 1 to 3 Assessments (Timepoints 2, 3, 4). Participants will complete a small subset of 
the surveys in REDCap as well as the video task at the end of weeks 1, 2, and 3. It will take 

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approximately 30 minutes to complete these measures. Participants will be given one week 
to complete each weekly assessment. 
6. Week 4/Post-Intervention Assessment  (Timepoint 5). Participants will complete the same 
surveys and games (behavioral task and video task) in REDCap as was done for the pre-
intervention assessment; the invite for these measures will be sent at the end of week 4. It 
will take approximately 60-90 minutes to complete these measures. Participants will be 
given 2 weeks to complete this assessment. Participants in the intervention or active control 
groups will have the option to continue using the HMP after this timepoint. We will 
continue to monitor app data throughout the study to learn more about its long-term impact 
on well-being. 
7. 3-Month Follow-Up Assessment (Timepoint 6). Participants will complete the same surveys 
and games (behavioral task and video task) in REDCap as was done for the pre-intervention 
and post-intervention assessments; the invite for these measures will be sent 90 days after 
the date of the post-intervention invite. It will take approximately 60-90 minutes to 
complete these measures. Participants will be given 2 weeks to complete this assessment. 
Another microbiome kit and blood spot collection kit will be mailed to participants to 
collect samples; they will have 1 month to collect.     
Healthy control participants will complete only #1 to #3.                                                                       
13.2 Schedule of Procedures 
Study Phase 
Screening/Pre- 
Intervention 
 
Intervention  
3-Month 
Follow-Up 
Visit Number 
1 
2 
3 
4 
5 
6 
Informed 
Consent 
X 
 
 
 
 
 
Review Eligibility 
X 
 
 
 
 
 
Interview 
X 
 
 
 
 
 
Surveys 
X 
X 
X 
X 
X 
X 

PROTOCOL TITLE: Behavior, Biology, and Well-Being (BeWell) Study 
 
 
Page 16 of 37 
 
 
HMP or active 
control (Intervention 
and active control 
groups) 
 
X 
X 
X 
X 
X 
Video recording task 
X 
X 
X 
X 
X 
X 
Pattern Separation 
Task 
X 
 
 
 
X 
X 
Microbiome Sample 
X 
 
 
 
 
X 
Blood Spot Sample 
X 
 
 
 
 
X 
Adverse Event 
Assessment 
 
 
 
 
X 
X 
 
13.3 Research Procedures 
1. Clinical Interview. After being consented, participants will undergo a phone or video 
interview assessing the Depressive Disorders module and related modules of the Structured 
Clinical Interview for DSM-5 Research Version (SCID-5-RV). These interviews will be 
conducted by study staff trained in clinical interviewing techniques and supervised by the 
study PIs. The interview will last approximately 30-60 minutes and will occur after the pre-
intervention surveys are completed. If participants reveal during the interview that they are 
at high risk for suicidality or self-harm, or it is revealed that they do not qualify for the 
study based on inclusion/exclusion criteria, they will be excluded. The interview is for 
research purposes only so individuals will not be told of any diagnoses.  
If a participant reveals suicidal ideation, self-harm or intent to harm others, the clinical 
research personnel will assess intent. In the circumstance that an individual indicates that 
self-harm or harm to others is imminent, 988 and/or 911 (or local authorities in the 
county/city where the participant lives) will be called. Participants who have imminent 
intent or an imminent plan to commit an act of self-harm will be excluded. The clinical 
research interviewers will consult with qualified study personnel with mental health 
expertise as needed. These personnel may contact the participant by phone to further assess 
the level of risk and provide additional referrals as needed. All interactions regarding 
suicide risk and referral will be carefully documented and closely tracked by the study 
clinician. A formal incident report will be filed with the IRB in cases in which the clinician 
notifies authorities. A therapeutic resource list will be provided to all individuals. 

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2. Surveys. Participants will complete online surveys in REDCap. It will take approximately 
30-90 minutes to complete surveys depending on the timepoint (see table below). A subset 
of the following surveys will be completed at the various assessments (or before and 
following use of the HMP app): 
✦ Attention Checks 
✦ Alcohol Use Disorders Identification Test (AUDIT) 
✦ Asthma Control Questionnaire (ACQ) 
✦ Behavioral Risk Factor Surveillance System (BRFSS),  
✦ Adverse Childhood Experiences (ACE) Module 
✦ Big Five Inventory (BFI) Conscientiousness Items 
✦ Climate Change Anxiety Scale 
✦ Demographics 
✦ Determinants of Meditation Practice Inventory–- Revised 
✦ Digital Working Alliance Inventory (DWAI) 
✦ Decentering subscale of the Experiencing Questionnaire 
✦ Drug Use Disorders Identification Test (DUDIT) 
✦ Five Facet Mindfulness Questionnaire (FFMQ), Awareness Subscale 
✦ Flourishing Measure 
✦ General Anxiety Disorder (GAD-7) 
✦ General Availability 
✦ Growth Mindset 
✦ Healthy Minds Index (HMIndex) 
✦ Inclusion of Nature in Self 
✦ Lasting Effects Questionnaire 
✦ Life Orientation Test–- Revised (LOT-R) 
✦ Marlowe-Crowne Social Desirability Scale (MCSD) 
✦ Medication Questionnaires (Health History, Current Health and Medication use, and 
biospecimen collection questions) 
✦ Medication and Therapy Questionnaire 
✦ Meditation and App Usage Questionnaire 
✦ Mindfulness Adherence Questionnaire 
✦ Mindfulness-Based Program Meditation-Related Adverse Effects Scale 
(MBP-MRAES) 
✦ NIH Toolbox Loneliness 
✦ NIH Toolbox Meaning and Purpose 
✦ Patient Health Questionnaire Depression Scale (PHQ-8) 
✦ Patient Health Questionnaire Depression Scale (PHQ-9) 
✦ Problematic and Risky Internet Use Screening Scale – 3 (PRIUSS-3) 

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✦ PROMIS Sleep Disturbances–- Computer Adaptive Version 
✦ Perceived Stress Scale (PSS-10) 
✦ Perseverative Thinking Questionnaire (PTQ) 
✦ Post-pattern separation task question 
✦ Post-video task question 
✦ Pre and Post Practice Questions 
✦ PROMIS pain inference measure  
✦ PROMIS pain intensity measure 
✦ Satisfaction with Life Scale (SWLS) 
✦ Subjective Happiness Scale 
✦ Treatment Expectancies 
 
 
 
 
Measures 
# of 
Items 
Web 
Screen 
Interview 
Pre- 
Intervention 
4 Week 
Intervention 
(3 Weekly 
Timepoints) 
Post- 
Intervention 
3-Month 
Follow-Up 
Screening Questions (e.g., 
age, psychotic disorders, 
bipolar, substance use, 
meditation experience, 
device use) 
 
X 
 
 
 
 
 
Consent 
N/A 
X 
 
 
 
 
 
Attention Checks 
3 
 
 
X 
X 
X 
X 
AUDIT 
10 
X 
 
 
 
 
X 
Asthma Control 
Questionnaire (ACQ) 
6 
 
 
X 
 
X 
X 
Behavioral Risk Factor 
Surveillance System 
(BRFSS) Adverse 
Childhood Experiences 
(ACE) module 
11 
 
 
X 
 
 
 
Big Five Inventory (BFI) --
conscientiousness items 
only 
44 
 
 
X 
 
 
 
Climate Change Anxiety 
Scale 
22 
 
 
X 
 
X 
X 

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Demographics 
 
 
 
X 
 
 
 
Determinants of Meditation 
Practice Inventory–- 
Revised 
12 
 
 
X 
 
 
 
Digital Working 
Alliance Inventory 
(DWAI) –- app groups 
only 
6 
 
 
 
X 
X 
X 
Decentering subscale of the 
Experiencing Questionnaire 
11 
 
 
X 
X 
X 
X 
DUDIT 
11 
X 
 
 
 
 
 
Five Facet Mindfulness 
Questionnaire (FFMQ) – 
Awareness and Non-
Judgment Subscales 
8 
 
 
X 
X 
X 
X 
Flourishing Measure 
12 
 
 
X 
X 
X 
X 
General Anxiety Disorder 
(GAD-7) 
7 
 
 
X 
X 
X 
X 
General Availability 
1 
 
 
X 
 
 
 
Growth Mindset Scale for 
Well-Being 
3 
 
 
X 
 
X 
X 
Healthy Minds Index 
(HMI) 
17 
 
 
X 
 
X 
X 
Inclusion of Nature in Self 
1 
 
 
X 
 
X 
X 
Lasting Effects 
Questionnaire 
2 
 
 
 
 
 
X 
Life Orientation Test 
Revised (LOT-R)   
10 
 
 
X 
 
X 
X 
Marlowe-Crowne Social 
Desirability Scale (MCSD) 
13 
 
 
X 
 
 
 
Medication Questionnaires 
(Health History, Current 
Health and Medication use, 
and biospecimen collection 
questions) 
Varies  
 
X 
 
X 
X 
Meditation and App Usage 
Questionnaire 
5 
 
 
X 
 
X 
 

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Mindfulness Adherence 
Questionnaire informal 
practice items only –- app 
groups only 
12 
 
 
 
X 
X 
X 
Mindfulness-Based 
Program 
Meditation-Related 
Adverse 
Effects Scale 
(MBP-MRAES) – app 
groups only 
15 
 
 
 
 
X 
 
NIH Toolbox Loneliness 
5 
 
 
X 
X 
X 
X 
NIH Toolbox Meaning and 
Purpose 
18 
 
 
X 
X 
X 
X 
Patient Health 
Questionnaire -- depression 
scale (PHQ-8) 
8 
 
X 
X 
X 
X 
X 
Patient Health 
Questionnaire – depression 
scale (PHQ-9) 
9 
X 
 
 
 
 
 
Patient-Reported Outcome 
Measurement Information 
System (PROMIS) 
Computer Adaptive 
Version for Sleep 
Disturbances 
Varies  
 
X 
X 
X 
X 
Perceived Stress Scale 
(PSS) 
10 
 
 
X 
 
X 
X 
Perseverative Thinking 
Questionnaire (PTQ) 
15 
 
 
X 
 
X 
X 
Post-pattern separation 
question 
1 
 
 
X 
 
X 
X 
Post-video task question 
1 
 
 
X 
X 
X 
X 
Pre and Post Practice 
Questions 
3 
 
 
 
X 
X 
 
Problematic and Risky 
Internet Use Screening 
Scale (PRIUSS) 
3 
 
 
X 
 
X 
X 

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PROMIS pain inference 
measure 
40 
 
 
X 
 
X 
X 
PROMIS pain intensity 
measure 
1 
 
 
X 
 
X 
X 
Satisfaction With Life 
Scale 
 
5 
 
 
X 
 
X 
X 
Subjective Happiness Scale 
 
4 
 
 
X 
 
X 
X 
Treatment Expectancies – 
app groups only 
6 
 
 
 
 
X 
 
SCID-5-RV 
Varies  
X 
 
 
 
 
Video Recording Measures 
N/A 
 
 
X 
X 
X 
X 
Pattern Separation 
(Mnemonic Similarity 
Task) 
N/A 
 
 
X 
 
X 
X 
Dried Blood Spot 
Collection 
N/A 
 
 
X 
 
 
X 
Microbiome Collection 
N/A 
 
 
X 
 
 
X 
Environmental Toxin 
Questionnaire 
6 
 
 
X 
 
 
 
 
3. Behavioral Measures. Participants will receive the link for the behavioral tasks in REDCap. 
The behavioral task completion will take approximately 10 minutes. 
✦ 
Pattern separation. Meditation training has the capacity to normalize the 
overgeneralized inflexible cognition endemic to depression, which is hypothesized to relate 
to alterations in the hippocampal-dependent process of pattern separation. We will use a 
pattern separation task sensitive to meditation training to be completed at the pre-
intervention, post-intervention, and 3-month follow-up assessments via a REDCap link. 
✦ 
Video recording measures. Participants will be asked to provide video recordings of 
their face and voice while responding to prompts at all time points (T1 to T6). These 
prompts may involve responding to a recorded prompt (e.g., cartoon image), watching brief 
videos of positive or negative valence (e.g., baby giggling, someone telling a sad story), or 
sharing information about their day or week (e.g., “tell us something positive that happened 

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this week”). These recordings provide the opportunity to explore indicators of self-referent, 
inflexible, & over-generalized thinking within natural language that can be compared to 
behavioral measures indicated above. Data from recordings will be used to explore novel 
measures that once developed can be acquired without active input from the user on mobile 
devices and extracted from several data streams including facial features, vocal indicators 
and content analysis of text. Video data will be analyzed using various machine learning 
methods (e.g., Google’s Gemma). Data will be analyzed using models run locally which 
will eliminate confidentiality risks. Platforms used for video analysis will be vetted by the 
HIPAA security office prior to use. 
4. Blood Spot Collection. A blood spot collection kit will be mailed to participants. 
Participants will collect approximately 5 spots of blood (approximately 50µL each) at home. 
The participant's finger will be sterilized and pricked using a disposable lancet, and blood 
collected on filter paper. Instructions will be included on how to mail samples, once dried, 
back to CHM. Samples will be stored at room temperature or put in biospecimen designated 
freezers at CHM until enough samples are collected for analyses (which will include 
looking at inflammatory markers and other measures of immune function). Dried blood spot 
samples will be used to measure two inflammatory cytokines (C-reactive protein [CRP] and 
interleukin-6 [IL-6]). Additionally mRNA assays will be used to detect and quantify 
inflammatory gene expression detect and monitor cellular immune responses. Analyses will 
focus on transcripts from ~200 genes known to be involved in the regulation of inflammation, and 
will consider key transcripts (e.g., IL-1beta, TNF-alpha) as well as summary measures reflecting the 
activity of transcriptional networks that coordinate inflammation (NF-kB, AP-1). We will not 
conduct genetic analyses of the whole human genome. Samples will be labeled with 
participant id. 
5.  Microbiome Collection. A home-kit for stool sample collection will be mailed to 
participants. Participants may have concerns surrounding issues of hygiene when it comes to 
collecting stool samples. They might also experience feelings of embarrassment around 
collecting the sample. In order to reduce the chances of this occurring, participants will be 
provided with detailed instructions and information regarding how to hygienically collect 
their stool sample. Genetic analyses of the microbiome of the stool sample (microorganism 
DNA, not that of the person) will be performed. DNA extraction with bias reduction 
(triplicate extraction processing) of the stool community of microorganisms will provide the 
sequencing data to do alpha and beta diversity analysis and phenotypic cluster assessments 
(similar to IRB protocol 2021-0580). Samples will be labeled with participant id. 
Healthy control participants will complete only the baseline measures. 

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13.4 
The data elements collected will be questionnaires, a structured interview, behavioral tasks, and 
biospecimens. All study materials will be uploaded to the ARROW application. Data will not 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) 
• Data from Center for Medicare/Medicaid Services 
• Data from publicly available datasets (e.g., U.S. census data)  
• Data from outside institutions or organizations 
• Other  
 
13.5 
There are no current plans for long-term follow-up besides the 3-month follow-up that is 
part of the study procedures listed above. For those in the HMP intervention or active 
control groups, any data collected through the HMP app (e.g., usage data) will continue to 
be collected until the 3-month follow-up assessment. Additional follow-up assessments may 
be planned by study personnel and/or collaborators. The consent form will include language 
pertaining to permission for future contact. 
13.6 
N/A 
14.0 
Comparison of usual care and study procedures 
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 
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. 

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15.2 
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 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 
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. 
 
15. 4 
 
Participants who withdraw or do not complete baseline may be asked why they did not continue 
with participation. 
 
16.0 
Data Management and Confidentiality 
 
16.1 Quality Control 
Simon Goldberg will conduct periodic checks throughout each year of the study to ensure 
survey, behavioral task, biospecimen and interview data are recorded as expected and to look 
for any missing and/or aberrant data. 
16.2 
☒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.” 

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☐ 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 apply for 
and received 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. Participant data will be coded with participant 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 study servers. 
Data will also be gathered through the HMP app and a separate app participants will download for 
video recordings. 
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 list that links the participant name with ID number will be kept in a secure 
electronic database file on REDCap, a database administered by ICTR at UW-Madison and 
will be accessible only by the PI and study staff; 
● Any personal identifiers linked to data will be removed and replaced by code numbers in all 
records; 
● The highest security features of the service used to create and implement the screening 
questionnaires (REDCap, administered by ICTR at UW-Madison) will be enabled. 
Screening data and other questionnaire data collected via these online questionnaires will be 
downloaded to electronic files that will be kept on the HIPAA compliant secure network 
drive 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; 

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● Prior to signing the consent form 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 
☐ 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 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. 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 
All data will be labeled with a participant ID code (e.g., surveys, computerized tasks, and 
interview data will not include the participant’s name). The key linking participant name 
with participant ID code will be stored in ICTR’s instance of REDCap. Identifiers will be 
kept indefinitely so that we can contact participants who consented to future contact. 
 
16.5 Multi-Site Research 
N/A 
16.6  Data Sharing 
As part of the consent process, participants are notified that data collected as part of the study may 
be shared with other researchers upon request or shared publicly in an open science format. 
However, we clarify that the data will be deidentified. This includes standard identifiers as well as 
other dates and demographics that might allow for re-identification. One exception to data sharing 
that will involve identifiable data, is the recording of voice and face during the video measure. This 

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measure may be shared along with the decryption key with other researchers who sign a data use 
agreement with us. 
The Picard Lab at MIT will analyze video records only after signing a data use agreement. The 
videos will be coded with a participant ID. The dried blood spot samples will be coded with a 
participant ID and sent to Northwestern or a similarly qualified laboratory for analysis. The 
similarly qualified laboratory will sign a business associate agreement before any dried blood spot 
samples are shared with them. Collaborators at other institutions (e.g., Weizmann Institute of 
Science) will not have access to identifiable study data before they have signed a data use 
agreement.  
Data shared with collaborators outside of UW-Madison that are not currently named in this 
protocol will also be de-identified whenever possible (e.g., self-report, behavioral, and biomarker 
measures). If it is not possible to fully de-identify data (e.g., video recordings) we will share data 
only after a data use agreement has been signed.  
We may also want to follow-up with these participants in future research studies. 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. There is a complementary 
study (led by co-PI Dan Grupe; IRB 2021-1109) starting at the same time as this study that will 
utilize many of the same survey and behavioral task measures. We plan to share data between these 
two studies. 
Data may be shared as Supplemental Information uploaded to a journal website and/or shared on a 
data sharing website. Again, these data would not include identifiers. Data sharing would not 
require any further participation from participants. 
To enhance the impact and understanding of our research, we plan to send a consent 
addendum to participants to obtain explicit permission to share their video data publicly. The 
addendum will emphasize that due to the nature of video data content, complete 
confidentiality cannot be guaranteed. Participants will be given the option to either agree or 
decline without any impact on their participation in the study. Additionally, no personally 
identifiable information, such as names or addresses, will be shared alongside the video data. 
Future Contact 
We will ask participants via the consent form if they wish to be contacted for future studies. If they 
agree, their contact information (name, phone number, and address) will be kept on the Center for 
Healthy Minds’ secure network drive indefinitely. Only study staff will have access to this 
information. The participant’s contact information will not be stored with their data. 
If future collaborations with other researchers will be conducted with this participant pool, the 
proper steps and approval will be taken with the IRB before conducting such research. 

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17.0 Provisions to Protect the Privacy Interests of Participants 
☐ 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.  
 
17.1 
All study procedures will be done remotely using their smartphone in a setting of the 
participant’s choosing. 
17.2 
The study screener will ask questions about alcohol and other drug use and about current 
and/or past symptoms of various mental illnesses. The surveys and interviews 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 
psychological distress post-intervention and again at the 3-month follow-up assessment. 
Current or past history of alcohol/drug use or various psychiatric disorders may confound aims 
of the study and thus are part of the exclusionary criteria. 
17.3 
The study description, consent form and introduction to the surveys/interview will all 
include language that participation is voluntary and that some questions may be of a 
sensitive nature. 
17.4 
N/A 
18.0 Sharing of Results 
18.1 
All measures (surveys, games, microbiome, blood spot, and interview) are for research purposes 
only and individual results may not be meaningful. Participants will not be told of individual results 
for any measures. No study data will be shared with participants’ health records. 
 
18.2 
Study results may be shared with the public via manuscripts and/or open source databases. 
The Center for Healthy Minds website and/or other social media platforms will share 
information on study results and/or publications. 
19.0 Data and Specimen Banking 

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19.1 
Banking of data and specimens will not be optional. Coded data and specimens from 
participants may be banked for future use to address research questions not included in this 
protocol. The code linking to identifying information will be kept on a password-protected 
server and ICTR’s instance of REDCap with access limited to specific study personnel. 
19.2 
The code linking data and specimens to identifying information will be accessed in ICTR’s 
instance of REDCap and on a password-protected server with access limited to specific study 
personnel. 
19.3 
We are not placing any limits on the intended future use of data, and 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. Genetic analyses are limited to the following: 
• Whole genome analysis of the bacterial genome.  
• mRNA analyses of dried blood spot to evaluate gene expression. Analyses will focus 
on transcripts from ~200 genes known to be involved in the regulation of inflammation and 
summary measures reflecting the activity of transcriptional networks that coordinate 
inflammation (NF-kB, AP-1).   
Data may be requested by other researchers at UW-Madison as well as by researchers outside of 
UW-Madison to the study PI and/or Co-Investigators. 
19.4 
Participants may withdraw their samples and data from banking for future research. If there are 
any residual amounts from their dried blood spot and stool samples, they will be destroyed. Any 
data that has been shared in an open source format or as part of a journal database will be de-
identified and thus cannot and will not be withdrawn.  
 
20.0 Study Analysis 
20.1 
HMP will show greater improvements in (a) depression, (b) psychological distress, (c) well-being, 
(d) and performance on the pattern separation task vs. both the active control (HMP 
psychoeducation) and usual care conditions. 
20.2 
We plan to enroll 1500 participants in this study, assigning two fifths to HMP, two fifths to the 
active control, and one fifth to a usual care. Anticipating 20% dropout, this sample will provide 
80% power to detect small differences between HMP and the active control (d = 0.20) and 80% 
power to detect small-to-moderate differences between HMP and the usual care (d = 0.28). 

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We plan to recruit approximately 250 healthy controls at baseline. This will allow statistical power 
to detect small between-group differences on baseline measures. 
20.3 
Participants will be randomized into 3 different groups: two-fifths to intervention, two-fifths to 
active control and one-fifth to waitlist control. All study procedures will be the same across all 
groups except the use or non-use of HMP. 
Healthy control participants will not be randomized. 
20.4 
Group differences for the intervention will utilize linear mixed effects models to account for non-
independence and to maximize use of data with missing observations. 
20.5 
Given the low risk of the intervention, no interim efficacy or safety analyses are planned. 
20.6 
Linear mixed effects analyses account for missing data in a robust manner relative to, e.g., 
ANOVA. If differential attrition is observed (e.g., between HMP and usual care), we may conduct 
sensitivity analyses to evaluate the potential impact of data missing not at random.  
21.0 
Potential Benefits to Participants 
21.1 
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 teaches well-being skills which can be used in everyday life to cope with the 
challenges of stress, pain, illness, and everyday demands. Usual care and active control participants 
can use the full version of HMP after completion of the study at no cost. 
21.2 
There are no direct benefits for participants. 
22.0 Risks to Participants 
22.1 
Breaches of Confidentiality 
Risk of confidentiality breach is minimized due to data storage procedures employed (i.e., data 
coding, secure storage, trained personnel). We obtained a certificate of confidentiality due to the 
nature of some of the data collected. 

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Because there is potential for the study to capture information that could lead to reporting intention 
to harm self, participants will be informed in the consent form of this limit to confidentiality before 
they agree to participate. The researchers would report to the study psychologist on call and/or 
emergency services, as dictated by the specific circumstances. We have well-established protocols 
for handling suicidality and threat of harm to self. 
Emotional Upset 
Emotional upset due to study participation is a potential but unlikely risk of study activities. In our 
experience, it is rare for a participant to find self-report questionnaires to be extremely upsetting. 
Participants will be informed that they are free to decline answering any question for any reason. 
The interview consists of the Depressive Disorders and related modules of the Structured Clinical 
Interview for DSM-5 Research Version (SCID-5-RV). If a participant reveals suicidal ideation, 
self-harm or intent to harm others, the clinical research personnel will assess intent. In the 
circumstance that an individual indicates that self-harm or harm to others is imminent, 988 and/or 
911 (or local authorities in the county/city where the participant lives) will be called. The clinical 
research interviewers will consult with qualified study personnel with mental health expertise as 
needed. The clinicians may contact the participant by phone to further assess the level of risk and 
provide additional referrals as needed. All interactions regarding suicide risk and referral will be 
carefully documented and closely tracked by the study clinician. A formal incident report will be 
filed with the IRB in cases in which the clinician notifies authorities. All eligible participants will 
be provided with the “Therapeutic Resources” list regardless of their responses. All individuals 
who are excluded from the study during the screening process or interview will be given the 
"Therapeutic Resources - Exclusion" list which has links to the Virtual Hope Box, suicide hotline, 
and mental health website. 
There are no physical risks involved in collecting the microbiome sample. It will be integrated as 
part of their regular routine, with the only difference being that this bowel movement will be 
collected in a plastic container. They may experience some slight psychological discomfort or 
embarrassment about collecting this sample. 
Physical Risks 
Some tenderness may be experienced at the site of the finger prick for the blood spot collection. 
Occasional bruising at the site can occur and is not permanent. In very rare cases, infection at the 
site can occur. Single-use lancets will minimize the risk of infection.  
 
22.2 
N/A 
22.3 
N/A 
22.4 
N/A 

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22.5 
N/A 
22.6 
The exclusion criteria limits the number of people who are at high risk for self-harm from the 
study. Conducting the interview only after all of the pre-intervention surveys are completed, 
decreases the number of potential participants who have sensitive information collected as part of 
the screening process. 
23.0 Provisions to Monitor the Data to Ensure the Safety of Participants 
23.1 
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 UW IRB. 
Other notable incidents that occur during recruitment, consent, study assessments, but 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 mentioned above. 
24.0 Economic Burden to Participants 
24.1 
Since most of the study collection will be done remotely, there is little to no expense to 
participating. 
 
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) 
 
25.1 
The Center for Healthy Minds has extensive experience running large-scale, longitudinal 
studies. As most studies have moved to remote data collection in the past year (IRB 

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protocols: 2020-0533, 2020-1454, and 2019-0893), we have been successful at recruiting a 
large number of participants with high retention rates. 
This study will be conducted over a three-year period, with all study collection being done 
remotely. Each participant will be involved with the study for approximately 4 months. 
Study staff will meet on a regular basis to discuss study design, implementation, processing 
and analyses. Any task assignments and study updates will be discussed at these meetings. 
The study also uses the Basecamp platform (a project organization platform) to discuss any 
questions, updates, and changes to the study. 
All participants will be informed to contact their healthcare provider if any concerns arise 
when answering survey questions. A therapeutic resource list will be provided to all 
participants via REDCap. 
26.0 Multi-Site Research 
 
26.1 
N/A 
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21.0 
Appendices 
Provide any additional information relevant to management of the study, such as instructions for 
specialized procedures, charts or workflow diagrams.