Developing and Testing Internet-Based Mindfulness Intervention to Reduce Minority Stress and Promote HIV-Related Behavioral Health Among Young Adult Sexual Minority Men: Aim 3, A Randomized Controlled Trial
Phase: NA
Conditions: Hiv, Minority Stress, Mental Health Wellness 1
Sponsor: Brown University

Aim 3: MBQR RCT Study Protocol​
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P.I. – Shufang Sun 
 
 
 
 
 
 
 
 
 
 
K23 Aim 3 MBQR Study Protocol 
 
Brown University School of Public Health 
 
PI: Shufang Sun, PhD 
 
Study Staff: 
Frances Saadeh (Study Coordinator) 
Ty Scott (Teaching and Research Assistant) 
Volta Tran (Research Assistant) 
Matthew Murphy (Research Assistant) 
 
Mindfulness Teachers/Interventionists:  
Teague O’Malley 
TBA 
 
 
 
 
 
 
Funded by: US National Institute of Health K23AT011173, “Developing 
internet-delivered, mindfulness-based intervention to reduce HIV risk and promote 
mental and sexual health among young adult MSM” 
 
 
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1. SPECIFIC AIMS (5-year project; Aim 3 highlighted) 
 
This K23 aims to develop an internet-delivered MBI to address minority stress and its 
negative HIV-related health consequences experienced by young men who have sex 
with men (YMSM). Specifically, we propose to adapt, refine, and pilot-test an 
evidence-based MBI, Mindfulness-based Stress Reduction (MBSR), to promote mental 
and sexual health and HIV testing engagement among distressed, high-risk YMSM. 
Aims 1-3 will support the subsequent production and evaluation of the adapted 
intervention. To maximize reach, scalability, and availability to a population that 
experience challenges seeking in-person counseling and health services, the 
intervention will also be adapted for internet-based delivery.  
 
Aim 1. Adapt MBSR for distressed, high-risk YMSM using internet delivery, guided by 
the ADAPT-ITT model. We will conduct iterative phases of formative research including 
online-based focus groups with YMSM, solicitation of feedback from stakeholders, and 
revision of intervention protocols. This process will result in the first-draft of an 
internet-delivered, mindfulness-based intervention protocol for use with YMSM.  
 
Aim 2. Refine intervention protocol by administering adapted materials to distressed, 
high-risk YMSM (n=18) through internet-based open pilot and gather feedback. 
Following integration of feedback, this process will result in a finalized protocol of an 
internet-delivered, mindfulness-based intervention protocol for YMSM. 
 
Aim 3. Examine the feasibility and acceptability of the internet-delivered 
mindfulness-based intervention (iMBI), called “Mindfulness-based Queer Resilience 
(MBQR)”, for HIV prevention. We will enroll and randomize a sample of 60 distressed, 
high-risk YMSM into one of two groups: MBQR intervention (n=30) or active control 
condition (n=30). We will aim to over enroll YMSM of color (e.g., Black/Latinx YMSM) 
and anticipate the group to include approximately 50-60% Black/Latinx YMSM (or 
YMSM of color). Primary outcomes are HIV and STI testing and self-reported sexual 
risk behaviors. Secondary outcomes are stress biomarker (fingernail cortisol levels), 
psychological health, minority stress and coping. The study will examine recruitment 
and retention, number of sessions attended, self-reported at-home practice of 
mindfulness, completion of assessment, and acceptability of the intervention.  
 
2. Aim 3 Study Design Overview 
 
The methodological approach includes a 2-arm trial of MBQR vs. a health education 
control group, with up to n=30 per arm (total Aim 3 sample size = up to 60 participants 
enrolled and randomized). The study is intended to evaluate the impacts of MBQR on 
the outcomes outlined in the Specific Aims above.  
 
All research assessments will take place digitally using Qualtrics, LLC (Provo, UT, USA) 
survey management tool. Participants will be sent secure links via email and SMS that 
can be accessed with their participant identification number. The MBQR intervention 
classes will be offered online via Zoom by a trained and qualified mindfulness instructor.  
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Baseline assessment links will be sent to all enrolled participants and completed prior to 
the start of the interventions. Follow up assessments will be conducted at three time 
points (post-intervention, 6-months follow up, and at 1-year follow up (for intervention 
participants only)). 
 
Participants who were randomized to the control group will be offered a MBQR-hybrid 
course after the 6-month follow-up assessment is complete. This additional course is 
optional. Control group members who opt to take MBQR-hybrid will be invited to 
complete a post-intervention assessment and exit interview. The total length of 
involvement for control group participants who opt not to take MBQR-hybrid will be 
around 6-months from the time of enrollment to the time of the final research 
assessment, while control group participants opting into the MBQR-hybrid will be done 
with participation in the study around 9-12 months after enrollment. Participants 
randomized to the MBQR intervention group will be invited to complete a 1-year follow 
up assessment in addition to the other assessments, thus their involvement in the study 
will last around 12 months from the time of enrollment. The study interventions last 10 
weeks and take place in the first two months of study involvement.  
 
The figure below provides a visual outline of the study flow, including the screening and 
assessment sequence. 
 
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3. Selection Criteria for Aim 3: 
 
The following is the most updated inclusion/exclusion criteria: 
●​ Inclusion criteria:  
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(1) assigned male at birth,  
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(2) being 18 to 34 of age,  
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(3) identify as a cisgender man or nonbinary,  
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(4) reside in the United States,  
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(5) can read and speak English,  
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(6) engaged in condomless anal sex with another man in past 6 months,  
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(7) endorse distress, measured by the PHQ-9 and GAD-7,  
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(8) possess a devise (phone, tablet, computer) that allows for online 
conferencing.  
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(9) HIV-negative at time of screening 
 
●​ About HIV status: HIV status will be assessed in 2 steps: (1) by self-report in 
online survey and (2) by rapid HIV testing via Zoom with a trained study RA 
(optional; other options could include local testing or by self-report). We will 
provide rapid oral HIV testing in Aim 3. At screening, participants will participate 
in rapid oral HIV testing (optional), and at post-intervention and follow-up, 
participants will engage in both HIV and STI testing (see more in HIV/STI testing 
protocol). 
 
●​ Exclusion criteria: YMSM will be excluded from the study if they are determined 
to have symptoms that would prevent them from giving meaningful consent or 
participate in study activities including any of the following criteria:  
(1)​Significant cognitive impairment 
(2)​Psychosis 
(3)​Imminent suicidal risk 
 
 
4. Steps in Recruitment, Screening, and Assessment: 
 
Recruitment Timeline and Procedures 
 
1)​ Timeline for recruitment: 
a.​ Recruitment efforts will commence 2-4 months prior to the start of each 
study intervention. 
b.​ Enrollment for each round will end on the date of the run-in session. Any 
individuals screened for the study after that date will be deferred to the 
next round (if applicable). 
c.​ All preparatory efforts to be ready at least 8 weeks prior to the RCT 
d.​ Participants will be recruited and enrolled into cohorts based on 
intervention scheduling. We anticipate enrolling around 8-10 participants 
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into each intervention and control group (e.g., we anticipate running two 
summer cohorts and one fall cohort). 
 
2)​ Multi-Pronged Recruitment Strategy: Recruitment will be conducted primarily 
through four methods:  
a.​ Community Advisory Board (CAB) member social networks – IRB 
approved recruitment materials will be provided to CAB members to 
distribute to their social networks and for them to post on their social 
media accounts. 
b.​ Online social media (e.g., Facebook-based community groups for gay and 
bisexual men, Reddit threads, Twitter, etc.) 
c.​ Emails to University/College campus groups, Community-based 
Organizations, and partner health groups (e.g., the Fenway Institute in 
Boston) 
d.​ Targeted recruitment through BuildClinical® - see separate BuildClinical® 
recruitment proposal 
 
 
Screening Procedures: Participants will be screened for eligibility in three steps. 
 
1)​ Online Screening Form - First, individuals interested in the study, will be 
prompted to complete a brief (5-15 minute) internet-based screening form via 
Qualtrics to determine their initial eligibility. Individuals who screen eligible will 
then be redirected to a separate Qualtrics form where they can review the 
Informed Consent Form (ICF) and complete a contact form for follow-up. 
 
2)​ Zoom Screening Interview #1: Trained research staff will then follow up with 
eligible participants to schedule a Zoom-based screening interview (the first of 
two). This interview will take 10-25 minutes to complete and will serve the 
following purposes: (a) Review the Informed Consent Form and study 
procedures; (b) Answer any questions the participant might have; (c) Confirm 
participant eligibility; and (d) Inform the participant (if eligible and interested) of 
the next steps, including scheduling the second Zoom screening interview. The 
study RA will then mail out a HIV self-testing kit to the participant along with 
testing instructions (see HIV/STI testing protocol). 
 
3)​ Zoom Screening Interview #2: This second Zoom interview will take place 1-2 
weeks after the initial Zoom call to allow for the HIV test to arrive in the mail. The 
participant will be encouraged to find a private location for the call where they will 
have access to a bathroom for HIV self-testing. The call will take 20-30 minutes 
and will involve having the participant complete a HIV self-test. The study RA will 
walk the participant through the testing procedures (or provide participant with a 
prerecorded instruction video). 
 
a.​ Staff performing Zoom calls will be trained in providing HIV-counseling in 
the event that the test result is HIV-positive.  
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b.​ If HIV-negative, the RA will go over the next study steps with the 
participant, including inviting the participant to complete baseline survey 
via Qualtrics. 
c.​ If excluded, RA will record reason for exclusion.  
d.​ Alternative HIV testing procedures include: 
i.​ Completing a self-test on one’s own and sending a picture to our 
study Qualtrics link (or sharing results on Zoom) 
ii.​ Testing at a local HIV clinic 
iii.​ Opting out of HIV self-testing and instead self-report status 
 
Informed Consent 
Informed consent is an ongoing process. Participants will first be presented with the 
Informed Consent Form (ICF) at the time of initial online screening. They will have the 
option to download and save the ICF and will also be prompted to click through the ICF 
text in full (displayed on multiple screens in Qualtrics). The consent process will 
continue into the Zoom Interviews #1 and #2, where a trained research staff member 
will review the ICF with the participant and answer any questions they might have. A 
waiver of documentation of consent will be requested since data collection procedures 
all take place online. 
 
 
Baseline Procedures, Enrollment, Run-In, and Randomization 
 
1)​ Baseline Procedures:  
a.​ Eligible participants will be asked to complete a baseline survey via 
Qualtrics that is estimated to take 60-80 minutes to complete (see 
separate Assessment document for details). 
b.​ At baseline they will also be mailed a Cortisol genetic testing kit that will 
provide them with the necessary equipment to collect a baseline nail 
sample (see separate cortisol nail sampling protocol for details). 
Participants will then mail back the completed sample back to the study 
staff for further processing. Participants will be compensated $20 for each 
genetic sample provided. 
c.​ Following baseline survey completion, participants are considered as 
“enrolled and ready to be randomized”. 
 
2)​ Run-in Session: Prior to randomization participants will be asked to attend a 
mandatory 30-minute introduction session via Zoom that will serve as a ‘run-in’ 
session for individuals interested in the study. The purpose of this session will be 
to: 
a.​ Provide a brief overview of the randomization process and intervention 
arms. This includes an emphasis on the time commitment required for the 
interventions and for the study as a whole. 
b.​ Introduce the research team and the course interventionists. 
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c.​ Walk through the HIV/STI self testing and genetic cortisol sampling 
procedures; remind participants to mail in their samples / submit their 
results. 
d.​ Answer any questions. 
e.​ Allow participants an opportunity to opt out of the study (submitted 
privately by email, phone, text, etc.) prior to the randomization. Note that 
participants can withdraw at any time. The run-in session allows 
participants an additional opportunity to opt out prior to being included in 
the randomization. This helps with overall group balance and retention. 
f.​ Participants who complete the baseline assessment and opt in to the 
study following the run-in session will be included in the randomization; 
they will be coded as “enrolled and randomized”. 
 
3)​ Randomization:  
a.​ Prior to intervention commencement, participants will be randomly 
assigned to one of two groups: (1) MBQR Intervention group; or (2) a 
health education control group.   
b.​ Control group participants who complete the study will be given the 
opportunity to participate in the intervention (MBQR-hybrid) after the 
6-month follow up assessments are completed. 
c.​ A covariate adaptive randomization process will be used, balancing 
groups based on race (white vs. non-white); anxiety/depressive 
symptomology (high vs. moderate); and gender identity (cis-male vs. 
non-binary) if sample size allows for this. 
 
4)​ Care Packages: 
a.​ Prior to the start of the interventions, all participants (intervention and 
control) will be sent a study care package, which will contain a yoga mat, 
condoms, lubricant, raisins, pen, journal, stickers, and a fidget spinner / 
stress ball, along with a brief description and purpose for each of the 
items. 
 
 
Weekly Assessments, Post-Intervention and Follow-up Procedures 
 
1)​ Weekly Assessments: During the 10-week intervention period, participants will be 
sent invites (via Qualtrics- individualized links) to complete weekly assessments 
designed to capture: (a) monitoring of sexual risk (condomless sex); (b) 
monitoring of depression (PHQ-9) and anxiety symptoms (GAD-7); and (c) 
self-report of weekly/daily practice time spent on intervention. Participants will be 
compensated $5 per each weekly assessment completed (up to $50 total). 
 
2)​ Post-Intervention Assessment:  
a.​ Similar to the baseline survey, participants will be asked to complete a 
post-intervention assessment via Qualtrics. The assessment is estimated 
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to take 60 minutes to complete, and participants will be compensated $30 
for their time. 
b.​ Cortisol genetic testing kits and STI/HIV self-tests will be mailed out to 
participants post-intervention. Participants will be compensated $20 for 
each completed test ($40 total). 
 
3)​ Exit Interviews (Intervention Group Only):  
a.​ Semi-structured interviews with intervention group participants will be 
conducted one-on-one via Zoom post-intervention to gather qualitative 
feedback on the study intervention. 
b.​ Interviews are estimated to take 90-120 minutes. 
c.​ Participants will be compensated $40 for their time. 
 
4)​ 6-month Follow Up Assessment:  
a.​ Similar to the baseline and post-intervention surveys, participants will be 
asked to complete a 6-month follow up assessment via Qualtrics. The 
assessment is estimated to take 60 minutes to complete, and participants 
will be compensated $30 for their time. 
b.​ Cortisol genetic testing kits and STI/HIV self-tests will be mailed out to 
participants post-intervention. Participants will be compensated $20 for 
each completed test ($40 total). 
c.​ This will be the final assessment for control group participants. Following 
their study involvement, control group participants will be given the option 
to participate in a MBQR-hybrid program. This additional course is 
optional. Control group members who opt to take MBQR-hybrid will be 
invited to complete a post-intervention assessment and exit interview. 
 
5)​ 1-year Follow Up Assessment (Intervention Group Only): 
a.​ Intervention participants will be asked to complete a final 1-year follow up 
assessment via Qualtrics. The assessment is estimated to take 60 
minutes to complete, and participants will be compensated $30 for their 
time. 
b.​ Cortisol genetic testing kits and STI/HIV self-tests will be mailed out to 
participants post-intervention. Participants will be compensated $20 for 
each completed test ($40 total). 
c.​ This will be the final assessment for intervention group participants. 
 
 
5. MBQR Intervention and Health Education Control: 
 
Mindfulness-Based Queer Resilience (MBQR): 
MBQR is an online, Zoom-based mindfulness course that meets 2.5 hour per week for 
ten weeks, facilitated by queer mindfulness teachers, with weekly home practice and 
additional reflection and reading activities that can be completed by participants 
independently via study website portal.  
 
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MBQR is designed to alleviate the burden of minority stress and mental health and 
promote HIV testing and healthy sex behaviors among young adult gay men, bisexual 
men, queer men, and non-binary people assigned male at birth. Principles of MBQR 
include (a) reducing minority stress as a key theoretical guide, (b) affirming 
LGBTQ + identity and facilitating healthy identity development, (c) attending to 
intersectionality, (d) facilitating resilience and self-empowerment, (e) trauma sensitivity, 
and (f) promoting healthy relationships and a healthy community. Key techniques 
include through attention regulation to facilitate agency and self-awareness, enhancing 
emotion regulation, reducing reactivity to minority stress-informed thoughts, 
self-compassion to increase self-acceptance, and reducing behavioral avoidance. 
Formal and informal mindfulness practices will be offered, such as mindful walking, 
body scan, attention practice, self-compassion, etc. In addition to the 10 weekly 
sessions there is an all-day retreat (6hrs) that takes place around week 5. The 
participants also meet one-on-one with the instructor at the beginning and middle of 
class for a 30-minute welcome call and check in. 
 
Health Education Active Control: 
 
The online Health Education course, used as an active control in the RCT, is a 
self-paced program that can be largely completed independently (no group meeting, no 
all-day) by control group participants. The ten weekly modules are estimated to take 30 
to 90 minutes each to complete and consist of readings, videos, infographics, and other 
related activities (e.g., reflections, quizzes). 
 
The purpose of the health education course is to provide participants with general 
information on health, factors that affect health, and to promote health behaviors. Topics 
include sleep, exercise, healthy eating and body image, time management, alcohol and 
substance use, sexual health, school/work life balance, and healthy relationships. This 
information is provided without an emphasis on mindfulness.    
 
​
Mindfulness-Based Queer Resilience (MBQR)-hybrid: 
 
MBQR-hybrid is an online-based mindfulness course asynchronously facilitated by 
queer mindfulness teachers, with weekly home practice and additional reflection and 
reading activities that can be completed by participants independently via study website 
portal. Participants will also have the option of participating in weekly live 1-hour 
sessions. MBQR-hybrid is designed to be completed within a 3-months time frame (10 
modules that can be paced to complete in a 10-14 weeks time frame). 
 
 
6. Other Study Details: 
 
Compensation  
Participants will have the opportunity to earn up to $340 (intervention group) and up to 
$300 (control group) for their time and effort in this study. Participants will only be 
compensated for the study components that they choose to complete. Partial 
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compensation will not be provided. If a participant withdraws from the study early, they 
will not be compensated for the study components that are incomplete.  
 
Below is an outline of the compensation structure by study element. 
 
T1: Baseline ($40 Total) 
$20 - HIV testing** 
$20 - Cortisol nail sample 
 
Intervention / Control ($50 Total) 
$50 - $5 per assessment x 10 
 
T2: Post-Intervention ($70 - 110 Total) 
$20 - STI/HIV testing 
$20 - Cortisol nail sample 
$30 - Assessment 
$40 - Exit Interview* 
 
T3: 6-Month Follow Up ($70 Total) 
$20 - STI/HIV testing 
$20 - Cortisol nail sample 
$30 - Assessment 
 
T4: 1-year* Follow Up ($70 Total) 
$20 - STI/HIV testing 
$20 - Cortisol nail sample 
$30 - Assessment 
 
*MBQR Intervention Group Only; Control group will be invited to take part in a 
MBQR-hybrid course after their 6-month follow up is complete. This additional course is 
optional. Control group members who opt to take MBQR-hybrid will be invited to 
complete a post-intervention assessment and exit interview ($30 and $40 each). 
 
**Compensation for HIV testing is not limited to the self-testing kit provided by the study. 
 
Total Possible Compensation for Control Participants = $300 
Total Possible Compensation for Intervention Participants = $340 
 
 
Withdrawal during intervention 
We anticipate some amount of dropout during the study. If a participant in MBQR 
decides to withdraw from the study during the course or if a control participant 
discontinues the health education training, they will still be invited to take part in the 
follow up assessments. 
 
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Confidentiality 
Randomly generated participant identification (PID) numbers will be automatically 
generated and assigned through Qualtrics at screening. All questionnaires and tasks 
will be completed under the assigned participant identification numbers. Consent forms 
and personal identifiable information will be kept separate and securely away from 
participant identification numbers in a secure digital file on closed network servers (i.e., 
Brown Stronghold).  
 
Safety Monitoring 
Oversight of internal monitoring of the participants’ safety will be conducted by the PI, 
Dr. Shufang Sun, who is a licensed psychologist. 
 
Entities Conducting Monitoring: The Institutional Review Board (IRBs) at Brown 
University will review all research procedures and will provide oversight. Internal 
monitoring will be done by the Brown University principal investigator (Dr. Sun) and the 
Brown University IRB. Any serious adverse effects will be immediately reported to the 
principal investigator (Sun). 
 
What is Monitored: Monitoring is done of all procedures to ensure that they conform to 
the approved protocol; of unforeseen circumstances that might arise and affect safety; 
of all reports of serious adverse events as defined in US Department of Health and 
Human Services regulations for the protection of human research subjects 45 CFR Part 
46, and the FDA 312.32 (death, life-threatening experience, new or prolonged 
hospitalization, persistent or significant disability/incapacity); of other significant adverse 
events (adverse events that lead to drop out by participant or termination by the 
investigator); of unexpected adverse events resulting from the study; and of expected 
adverse events.  
 
Monitoring is done of all study inclusion and exclusion criteria. During this clinical trial, 
we will notify officials, as mandated by law, if a participant reports intention to harm 
him/herself or others, or reports child abuse or abuse of an elder.  
 
Frequency of Monitoring: All adverse events will be continuously monitored by the PI as 
they are documented by the study staff in accordance with the protocol. Participants will 
be given contact information so that they can inform us of events that occur in between 
study visits. The PI will meet with staff regularly as schedules allow to review participant 
progress and to check in about the experiences with the experimental procedures, 
including adverse events. Any adverse events that are observed and/or reported will be 
reported to Dr. Sun. The Investigator will be available to meet outside of the regularly 
scheduled meetings, if necessary, due to concerns regarding a particular participant or 
any problems that may arise for participants. If necessary, they will make appropriate 
recommendations for changes in protocol, or terminate the study. The Brown University 
IRB conducts the monitoring at the continuing reviews as scheduled, whenever 
modification requests are considered, and upon receiving reports of serious adverse 
events from the PI or anyone else.  
 
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Reporting Plan: Any serious adverse events that are observed and/or reported will be 
immediately reported to Dr. Sun. Unexpected serious adverse events related to the 
study are to be reported to the Brown University IRB. Brown University’s IRB requires 
fatalities related to the study be reported within 24 hours. All serious adverse events 
related to this study will be reported to the Brown University IRB immediately by 
telephone and by written report within 48 hours of our receipt of information regarding 
the event.  
 
Any actions taken by the IRB, other than acceptance of the adverse event report. 
Proposed changes or amendments to the protocol in general must be approved in 
writing by both the Brown University IRB.  
 
 
Risks and Benefits 
 
Possible Risks 
Meditation-related risks: The National Center for Complimentary and Integrative Health (NCCIH) 
states that meditation is generally safe for healthy people, but that adverse effects have also 
been reported. 34 Undesirable side effects and risks of meditation have been documented in 
more than 40 scientific reports [for reviews see 35-37] and are listed in the Mindfulness-Based 
Intervention Guidelines.38,39 More common, less serious side effects that have been reported by 
individuals within the context of MBIs or of individuals who are meditating less than an hour per 
day include: increased depression, anxiety or panic, re-experiencing of traumatic memories, 
dissociation, executive dysfunction, headaches/body pain and insomnia.35,40-45 A few case 
reports of more serious side effects including mania, psychosis, and suicidality have been 
reported, mostly in the contexts of intensive retreats (>5 hrs/day) or in conjunction with 
pre-existing psychopathology.35,37,38,46 The frequency of serious adverse effects in the context of 
MBIs is estimated to be less than 1%, although adequate estimates are not available.47 
 
A number of actions have been taken to minimize meditation-related risks at different stages of 
the study. During the pre-enrollment stage, individuals with severe mental illness that could 
preclude regular class attendance or impact group participation (i.e., symptomatic, untreated 
bipolar disorder or a history of psychosis and/or schizophrenia are excluded from the study and 
all risks are clearly communicated in the consent form. During treatment, meditations are 
relatively short and interspersed with dyads and reflections. Mindfulness homework assigned as 
part of the intervention is optional and is recommended to not exceed 1 hour per day. Teachers 
query participants about their experiences with meditation, and provide corrective feedback or 
modifications when needed. Developing strategies for working with physical and emotional 
discomfort is an explicit goal of the program. Because not all participants feel comfortable 
disclosing difficulties in class, an online “safety check-in” questionnaire will query 
meditation-related risks.  
 
Psychological distress: Research subjects participating in this study may experience possible 
psychological distress caused by questions asked during the in-person and online 
questionnaires that bring up painful memories or feelings. However, the resulting potential for 
injury to research subjects is judged to be minimal. With regard to psychological distress from 
taking part in the MBQR intervention, given that screening questions will exclude participants 
with substantial mental illness, and given the NCCIH statement above that “Meditation is 
considered to be safe for healthy people.”48 we expect that risk of psychological distress will be 
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low. The risk of increased psychological distress from meditation will be clearly outlined in the 
consent form and participants will be encouraged to consult with both the course instructor and 
study staff in the case of any increased distress. 
 
Loss of confidentiality: Likelihood: rare. Minimization: Confidentiality will be maintained by using 
deidentifying data sets. All electronic data files containing identifying information will be 
encrypted with a cloud-based software. Note that although these measures have been taken to 
protect participants’ personal information, complete confidentiality cannot be guaranteed when 
transmitting information over the internet. All information obtained from participants will be 
accessible only to research staff. 
 
Possible Benefits 
Possible direct benefits to participating students include, but are not limited to: 
development of a personal mindfulness meditation practice, increased awareness of 
their present experience, and practice identifying and attempting behavioral change.  
Possible benefits to the current body of science include, but are not limited to: the 
fine-tuning of a protocol for future mindfulness-based randomized controlled trials, 
influence on the next generation of researchers to have first-hand experience in 
mindfulness meditation, and increased knowledge about the potential impact of tailored 
mindfulness-based interventions, specifically those designed for YMSM. 
Data Collection and Quality Assurance  
Data Collection Forms  
Questionnaire data will typically be collected using Qualtrics, LLC (Provo, UT, USA) survey 
instruments, so that participants can complete questionnaires on their own time within the 
defined assessment windows, using their computers or smart phones. Exceptions to this include 
the Zoom interviews and intervention course work.  
 
Data Management  
Data management will be performed by downloading data routinely during active data collection 
periods, and assessing data for missingness and errors. Data will be maintained in 
password-protected Microsoft Excel Spreadsheets, and then exported using .csv or SPSS 
functions for data analysis.  
 
Quality Assurance  
Provider Training: MBQR delivery will be performed by (a) qualified or certified MBSR 
instructor(s), or (b) PhD-level psychologists/licensed mental health professionals with 
more than 400+ clinical hours as well as extensive experience in working with LGBTQ+ 
populations and/or mindfulness49. MBQR instructor training involves a 20-30 hour 
intensive training that covers the principles of MBQR, specific teaching content, 
diversity-related issues, group dynamics, and inquiries. Training will take the format of 
presentations, group discussion, role-play, and feedback from PI and peers. Training will 
be delivered by PI Sun.  
 
 
MBSR teacher certification is fairly extensive, and accreditation occurs through qualified schools 
/ centers for mindfulness. Examples of criteria for becoming a certified MBSR teaching include 
(i) completion of an eight-week MBSR course as a participant, (ii) completion of several 
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multi-day residential training courses in mindfulness based stress reduction practice and 
teaching, (iii) substantial experience in teaching MBSR, (iv) strong references letters from 
colleagues and participants who have taken your MBSR courses, (v) completion of several 
multi-day mindfulness meditation retreats, (vi) have a graduate degree in a field connected to 
MBSR (e.g. education, psychology, medicine) or demonstration of equivalent understanding 
through work experience in a related field.  
 
Delivery of treatment: We will assess participants’ perceptions of provider warmth and credibility 
using brief measures based on the validated Working Alliance Inventory,53 and Therapist 
Empathy Scale54 at Weeks 4 and 8 of the intervention. Feedback will be provided to the 
interventionist.  
 
Receipt of treatment and enactment of treatment skills: Adherence to the prescribed MBQR 
practices will be monitored through class attendance, practice logs and diaries. Adherence data 
will be collected weekly during the course of the intervention.  
 
Fidelity Monitoring: Intervention fidelity will be ensured by (1) rigorous, program specific training 
for the instructor with feedback (2) recording of all sessions with a 10% quality audit reviewed 
with instructor after each cohort (3) monitoring participant attendance, home practice of 
treatment skills, and understanding of skills (see Feasibility) (4) a comprehensive mixed 
methods approach (e.g. practice logs) for understanding of treatment enactment. In assessing 
MBQR Instructor competency and treatment fidelity, a randomly selected 10% or more of the 
recorded sessions will be reviewed by trained research assistants and rated for proportion of 
adherence to the MBQR curriculum guide. Intervention integrity for MBQR will be assessed 
using the Mindfulness-Based Interventions-Teaching Assessment Criteria (MBC-TAC), which is 
the most respected quantitative approach world-wide for assessing mindfulness-based 
programs. In order for the MBQR intervention and its associated data to be included in the 
sample, the instructor needs to demonstrate 90% or greater curriculum adherence. 
 
Protocol Deviations: 
Protocol deviations will be reported to the Brown University IRB. A description of the deviations, 
and any effects on the protection of human subjects will be documented. Investigator(s) will 
review protocol deviations and determine on a case by case base which data (if any) will be 
excluded from the final data set.  
Participant Rights and Confidentiality  
Institutional Review Board  
The protocol, the informed consent document, and any subsequent modifications, will be 
reviewed and approved by the Brown University IRB responsible for oversight of the study.  
 
Informed Consent Documents  
Prior to enrollment, all participants will be provided with an IRB-approved Informed Consent 
document. The consent form will describe the purpose of the study, the procedures to be 
followed, and the risks and benefits of participation. Informed consent is an ongoing process. 
Participants will first be presented with the Informed Consent Form (ICF) at the time of initial 
online screening. They will have the option to download and save the ICF and will also be 
prompted to click through the ICF text in full (displayed on multiple screens in Qualtrics). The 
consent process will continue into the Zoom Interviews #1 and #2, where a trained research 
staff member will review the ICF with the participant and answer any questions they might have. 
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A waiver of documentation of consent will be requested since data collection procedures all take 
place online. 
 
Participant Confidentiality 
The clinical data will be de-identified but linked. Private information such as name, contact 
information, and mailing address will be kept in a password protected, encrypted database on a 
different disk that the clinical data help by the Project Coordinator. All computer entry and 
networking programs will be done using PIDs only. The principal investigator will only be given 
access to identifiable personal information for the purposes of patient safety, data safety 
monitoring boards or HIPPA compliance officer approved agents.  Information will not be 
released without written permission of the participant, except as necessary for monitoring by 
IRB and the OHRP. 
 
Certificate of Confidentiality 
This research is covered by a Certificate of Confidentiality from the National Institutes of Health 
(NIH). The researchers with this Certificate may not disclose or use information, documents, or 
biospecimens that may identify participants in any federal, state, or local civil, criminal, 
administrative, legislative, or other action, suit, or proceeding, or be used as evidence, for 
example, if there is a court subpoena, unless the participant has consented for this use. 
Information, documents, or biospecimens protected by this Certificate cannot be disclosed to 
anyone else who is not connected with the research except, if there is a federal, state, or local 
law that requires disclosure (such as to report child abuse or communicable diseases but not for 
federal, state, or local civil, criminal, administrative, legislative, or other proceedings, see below); 
if the participant has consented to the disclosure, including for their medical treatment; or if it is 
used for other scientific research, as allowed by federal regulations protecting research 
subjects.  
 
The Certificate cannot be used to refuse a request for information from personnel of the United 
States federal or state government agency sponsoring the project that is needed for auditing or 
program evaluation by NIH.  A Certificate of Confidentiality does not prevent participants from 
voluntarily releasing information about themselves or their involvement in the research. If they 
want their research information released to an insurer, medical care provider, or any other 
person not connected with the research, they must provide consent to allow the researchers to 
release it. The Certificate of Confidentiality will not be used to prevent disclosure as required by 
federal, state, or local law of situations of child abuse and neglect, or harm to self or others.  
 
Finally, Brown University staff sometimes review studies like this one to make sure they are 
being done safely and correctly. If a review of this study takes place, participant records may be 
examined. The reviewers will protect participant confidentiality. 
 
Entities Conducting Monitoring:  
The Institutional Review Board (IRBs) at Brown University will review all research procedures, 
and will provide oversight. Internal monitoring will be done by the principal investigators (Dr. 
Sun) and the Brown University IRB. 
 
 
 
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