Growth, Empowerment, and Mindfulness (GEM): Pilot Trial of a Mindfulness-based Intervention to Address Mental Health in Young Adults With Early Life Adversities
Phase: NA
Conditions: Anxiety, Depression
Sponsor: Brown University

PROTOCOL TITLE: 
Growth, Empowerment, and Mindfulness (GEM): Pilot Trial of a Mindfulness-based 
Intervention to Address Mental Health in Young Adults with Early Life Adversities 
PRINCIPAL INVESTIGATOR: 
Shufang Sun  
Department of Behavioral and Social Sciences, Brown University School of Public Health  
401-863-5735  
shufang_sun@brown.edu 
VERSION NUMBER/DATE: 
v4.2026.3.3 
 
REVISION HISTORY 
 
Revision 
# 
Version 
Date 
Summary of Changes 
Consent 
Change? 
1 
1/13/2026 
- New documents “MINI – Major 
Depressive Episode Referral 
Plan_GEM.docx”; “ICF 
Checklist_GEM.docx”; 
“Outline_GEM.docx”; and 
“Intervention_GEM.docx” have been added 
- Several changes were made to existing 
documents based on request made in 
“STUDY-1023_DR Clarification 
Request.docx” 
Yes 
2 
2/5/2026 
Changes were made to the following 
documents based on request made on 
Huron: 
- HRP 
- “Intervention_GEM.docx” 
- “Outline_GEM.dcox” 
- “Recruitment_GEM.docx” 
- “Recruitment Email Drafts_GEM.docx” 
- “Compiled measures_GEM.docx”  
No 
3 
3/3/2026 
Changes were made to Section 13.1 of the 
HRP to include Today@Brown as a 
recruitment method. A document 
containing all information that will be 
entered on Today@Brown has also been 
added (“Today@Brown_GEM.docx”). The 
inclusion/exclusion criteria (Section 10.2) 
has been modified as well. Changes in 
inclusion/exclusion criteria has been 
 
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reflected across the following documents, 
consistent with the modification in the 
HRP-503: 
- “Recruitment Email Drafts_GEM.docx” 
- “Compiled measures_GEM.docx” 
- “ICF Checklist_GEM_R3.docx” 
 
 
 
 
 
 
 
 
 
 
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Table of Contents 
1.0​
Study Summary​
3 
2.0​
Objectives​
4 
3.0​
Background​
4 
4.0​
Study Endpoints​
4 
5.0​
Study Intervention/Investigational Agent​
4 
6.0​
Procedures Involved​
4 
7.0​
Data and Specimen Banking​
5 
8.0​
Sharing of Results with Subjects​
5 
9.0​
Study Timelines​
5 
10.0​ Inclusion and Exclusion Criteria​
5 
11.0​ Vulnerable Populations​
6 
12.0​ Local Number of Subjects​
6 
13.0​ Recruitment Methods​
6 
14.0​ Withdrawal of Subjects​
7 
15.0​ Risks to Subjects​
7 
16.0​ Potential Benefits to Subjects​
7 
17.0​ Data Management and Confidentiality​
7 
18.0​ Provisions to Monitor the Data to Ensure the Safety of Subjects​
8 
19.0​ Provisions to Protect the Privacy Interests of Subjects​
8 
20.0​ Compensation for Research-Related Injury​
8 
21.0​ Economic Burden to Subjects​
9 
22.0​ Consent Process​
9 
23.0​ Process to Document Consent in Writing​
11 
24.0​ Setting​
11 
25.0​ Resources Available​
12 
26.0​ Multi-Site Research​
12 
 
 
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1.0​
Study Summary 
 
Protocol Information  
Description  
Study Title 
Growth, Empowerment, and Mindfulness (GEM): Pilot Trial 
of a Mindfulness-based Intervention to Address Mental 
Health in Young Adults with Early Life Adversities 
Study Design 
Single-arm feasibility study 
Primary Objective 
Examine the feasibility, acceptability, and preliminary 
efficacy of a mindfulness-based, app-delivered intervention 
to address mental health and emotion regulation challenges 
experienced by young adults with early life adversities 
(ELAs) 
Secondary 
Objective(s) 
Understand mechanisms of change underlying the 
intervention, including the role of mindfulness (i.e., 
interoceptive awareness and de-centering), rumination, and 
sleep using real-time data collection via ecological 
momentary assessments (EMAs) and wearable devices 
Research 
Intervention(s)/ 
Investigational 
Agent(s)  
Growth, Empowerment, and Mindfulness intervention 
IND/IDE #  
N/A 
Study Population 
Young adults aged 18-24 residing in the U.S. 
Sample Size 
n = 44 expected 
Study Duration for 
individual 
participants 
Total study duration for each participant is 3-4 months, 
comprising a baseline assessment,4-6 weeks of active 
intervention, a post-intervention assessment, and a 3-month 
follow-up assessment. 
Study Specific 
Abbreviations/ 
Definitions  
EMA = Ecological Momentary Assessment 
EMI = Ecological Momentary Intervention 
ELA = early life adversity 
 
 
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2.0​
Objectives 
2.1​ The objectives of this study are to: (a) examine the feasibility, acceptability, 
and preliminary efficacy of a mindfulness-based, app-delivered intervention 
to address mental health and emotion regulation challenges experienced by 
young adults with early life adversities (ELAs); and (b) understand 
mechanisms of change underlying the intervention, including the role of 
mindfulness (i.e., interoceptive awareness and de-centering), rumination, 
and sleep using real-time data collection via ecological momentary 
assessments (EMAs) and wearable devices. 
2.2​ We hypothesize that young adults will find the Growth, Empowerment, and 
Mindfulness (GEM) intervention to be both feasible and acceptable, as 
demonstrated by participants’ engagement and quantitative/qualitative 
feedback; we also hypothesize that the engagement with the intervention 
will demonstrate preliminary efficacy for improving outcome measures 
including depression, anxiety, self-compassion, emotion regulation, 
loneliness, and healthier phone use. We further hypothesize that the 
mechanisms underlying the benefits of the intervention will be 
improvements in mindfulness and sleep, as well as reductions in 
rumination.  
3.0​
Background 
3.1​ mHEAL research team has extensive experience in developing and 
evaluating mindfulness-based, transdiagnostic interventions for young 
adults. Examples include Mindfulness-based Queer-Resilience (with over 
200 pages of materials, 30+ created videos, and 50+ recorded audios in 
our lab library) for young adults with depression/anxiety and affected by 
trauma, stigma, and childhood adversity as well as Mindfulness for 
Pandemic Resilience, a mobile app for youth in China with psychiatric 
symptoms and affected by strict pandemic lockdowns. Both programs have 
been evaluated by RCTs and shown acceptability, feasibility, and 
preliminary efficacy. Finidings showed that the intervention was efficacious 
especially for participants with experiences of early life adversities. 
However, there has not been a mindfulness intervention tailored specifically 
towards young adults who have lived experiences of early life adversities, 
representing an important opportunity for action. Further, studies that 
examine mechanisms underlying specific mindfulness practices and their 
effectiveness at addressing specific stressors are lacking. 
3.2​ N/A 
3.3​ Facing early life adversity is common among the United States population, 
with one epidemiological study finding that 53.4% of surveyed participants 
had experienced at least one adverse childhood event (Green et al., 2010). 
Early life adversity has been associated with poorer mental health, which 
can also contribute to a greater likelihood of engaging in risky health 
behaviors (Duffy et al., 2018). Additionally, early life adversity has been 
associated with alterations in neural functioning and compromised 
emotional regulation skills (Krugers et al., 2017). Mindfulness interventions 
have been found to reduce symptoms of anxiety and depression (Hofmann  
& Gómez, 2018) and improve emotional regulation abilities (Goldin & 
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Gross, 2014) across a wide range of populations. Overall, this study aims to 
fill this gap and improve health outcomes for the identified vulnerable 
population. By assessing the feasibility of an app-delivered MBI, we hope to 
contribute to the continued development of effective, accessible methods of 
addressing emotional health challenges attributable to the presence of 
ELAs, thus promoting overall psychological well-being. Further, given the 
landscape of existing research and literature, we aim to further understand 
the role of mindfulness in reducing mental health and emotion regulation 
challenges among young adults, done so through the lens of an 
app-delivered intervention. 
Duffy, K. A., McLaughlin, K. A., & Green, P. A. (2018). Early life 
adversity and health-risk behaviors: proposed psychological and 
neural mechanisms. Annals of the New York Academy of Sciences, 
1428(1), 151–169. https://doi.org/10.1111/nyas.13928 
Goldin, P. R., & Gross, J. J. (2010). Effects of mindfulness-based 
stress reduction (MBSR) on emotion regulation in social anxiety 
disorder. Emotion (Washington, D.C.), 10(1), 83–91. 
https://doi.org/10.1037/a0018441 
Green, J. G., McLaughlin, K. A., Berglund, P. A., Gruber, M. J., 
Sampson, N. A., Zaslavsky, A. M., & Kessler, R. C. (2010). Childhood 
adversities and adult psychiatric disorders in the national comorbidity 
survey replication I: associations with first onset of DSM-IV disorders. 
Archives of general psychiatry, 67(2), 113–123. 
https://doi.org/10.1001/archgenpsychiatry.2009.186 
Hofmann, S. G., & Gómez, A. F. (2017). Mindfulness-Based 
Interventions for Anxiety and Depression. The Psychiatric clinics of 
North America, 40(4), 739–749. 
https://doi.org/10.1016/j.psc.2017.08.008 
Krugers, H. J., Arp, J. M., Xiong, H., Kanatsou, S., Lesuis, S. L., 
Korosi, A., Joels, M., & Lucassen, P. J. (2016). Early life adversity: 
Lasting consequences for emotional learning. Neurobiology of stress, 
6, 14–21. https://doi.org/10.1016/j.ynstr.2016.11.005 
4.0​
Study Endpoints 
4.1​ We will collect quantitative and qualitative data from young adults, aged 
18-24 (n=44). We will end data collection when the target sample size is 
reached or when sufficient data is collected to assess feasibility, 
acceptability, and preliminary efficacy outcomes (whichever comes first). 
4.2​ For safety endpoints, we will monitor for adverse events or any negative 
effects of the intervention; participants are free to withdraw from the study 
at any time, in which case their participation will end immediately with no 
penalty. 
5.0​
Study Intervention/Investigational Agent 
5.1​ The Growth, Empowerment, and Mindfulness (GEM) intervention is a structured, 
mindfulness-based intervention designed to offer support for young adults with 
early life adversities and their negative behavioral health consequences through 
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the development of awareness, emotion regulation, and adaptive coping skills. 
Through psychoeducation content, group practice sessions, and formal and 
informal mindfulness practices, GEM is aimed at helping participants build 
foundational mindfulness and self-compassion skills, increase interoceptive 
awareness, reduce experiential avoidance and de-centering, improve emotion 
regulation and decrease rumination, and integrate mindfulness skills into daily life. 
The specific content of the GEM intervention is currently under development with 
community feedback from relevant Community Advisory Board members (refer to 
“Intervention_GEM.docx” for drafted scripts of Weeks 1-4 and the Bonus Modules, 
which will guide the recorded materials; also refer to “Outline_GEM.docx” for 
intervention outline for each week). 
5.2​ Contents of the GEM intervention is delivered through an existing third-party 
mobile application (i.e., Expiwell) and consists of 4 weeks of “Recommended 
Modules” and 2 weeks of “Bonus Modules”. Each week, participants will gain 
access to a set of 5-11 modules, with each module combining formats of text and 
audio recordings of psychoeducational content and mindfulness practices. Each 
week’s modules are further divided into ‘core’ and ‘optional tailored’ modules.  
 
Recommended Modules 
(i.e., Weeks 1-4) 
Bonus Modules 
(i.e., Weeks 5-6) 
Core 
modules 
Core modules in weeks 1-4 cover topics of 
early life stress and resilience, environmental 
stress and disembodied living, experiential 
avoidance, emotion regulation, mindful 
self-care, and self-compassion 
Core modules in 
weeks 5-6 cover 
topics related to 
media consumption 
and purpose 
Optional 
tailored 
modules 
Throughout Weeks 1-6, Optional tailored modules will focus on 
topics of (a) minority stress for participants who identify as a minority 
member and (b) trauma for participants wanting to receive more 
information about trauma 
On the application, participants will also have access to a list of all mindfulness 
exercises that have been taught each week. 
In addition to the weekly modules, participants will complete EMAs and EMIs 3 
times per day during the Recommended Modules (i.e., first four weeks of 
intervention period). The EMI will be delivered concurrently with the EMA, which 
will collect participant’s response on their current mood, recent stressful 
experience, and type of stressor. Participants will then receive a list of mindfulness 
exercises, which will be tailored to the type of stressor/emotion they will have 
indicated. The intervention as well as EMAs and EMIs will be delivered on a mobile 
application named “Expiwell” (https://www.expiwell.com/). 
At the end of each week, participants will also take part in a weekly “Group practice 
and connect” session on Zoom during the Recommended Modules (i.e., first four 
weeks of intervention period). The weekly sessions will be conducted in cohorts of 
5-10 participants (depending on the recruitment speed), led by a research assistant 
who has previous experiences with mindfulness programs as well as lived 
experiences of early life adversity. Each session will last approximately one hour 
and will be structured roughly to reflect: group check-in, group discussion on past 
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week’s weekly intervention content, one group meditation practice using audio, and 
reflections on the meditation practice. 
5.3​ This study will utilize Fitbit, a commercially available wearable device, for 
the purpose of passive data collection on sleep and physical activity. The 
Fitbit devices will be stored securely by the research team when not in use, 
distributed directly to participants during enrollment by mail, and collected 
at the end of the study. Names and addresses of participants will be shared 
with departmental operations staff through password-protected files to 
create shipping labels and facilitate mailing the Fitbits to participants via 
FedEx. When operations staff submit reconciliation for the transaction, it is 
on an aggregate level (i.e., without specific participant information or 
individual package tracking numbers). This ensures the confidentiality of 
each participant. Participants will be instructed on proper use and care of 
the device, and a pre-paid, pre-addressed return envelope will be provided 
so participants can directly mail the device back to the research team at the 
end of the study. Only authorized study team members will manage device 
distribution, collection, and data linkage. 
5.4​ N/A 
6.0​
Procedures Involved 
6.1​ We will conduct a single-arm, mixed methods feasibility trial design to 
evaluate the feasibility, acceptability, and preliminary effects of a 
mindfulness-based intervention (“Growth, Empowerment, and Mindfulness”; 
GEM) among young adults with early life adversities (n=44), with 
exploratory analyses of the preliminary outcomes to potentially inform future 
studies. The GEM intervention is an app-delivered program consisting of 
weekly learning modules, ecological momentary assessments and 
interventions (EMA/EMI), and weekly group practice sessions (described in 
greater detail in Section 5.0 Study Intervention/Investigational Agent). The 
intervention will offer support for young adults with experiences of early life 
adversities and its negative behavioral health consequences by helping 
participants build foundational mindfulness and self-compassion skills, 
increase interoceptive awareness, reduce experiential avoidance and 
de-centering, improve emotion regulation and decrease rumination, and 
integrate mindfulness skills into daily life. GEM is not intended to diagnose, 
treat, mitigate, or cure any mental health disorder. 
6.2​ Over the study duration of 3-4 months for each participant, we will use a 
mixed methods, longitudinal design incorporating (1) baseline, (2) 
post-intervention, and (3) follow-up assessments as well as (4) weekly 
assessments during the first four weeks of the intervention delivery period 
(“Recommended Modules”) and (5) daily EMAs to evaluate the feasibility, 
acceptability, and preliminary effects of the GEM program integrating 
app-based intervention content, weekly group sessions, and EMI delivery. 
The research team will register and maintain the study information on 
ClinicalTrials.gov. Specifically, the study PI, with support from the research 
team members, will be responsible for registering the clinical trial before the 
enrollment of the first subject, regularly updating study record, posting the 
IRB-approved informed consent form after the study is closed to 
recruitment, but no later than 60 days after the last study visit by any 
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participant, and the timely update of the study materials and results when 
they become available. 
Participant contact: The research team will utilize both email and 
Avochato (a messaging platform that facilitates text message 
communication between research staff and study participants without staff 
member using their personal phone numbers for the study; already vetted 
by the OIT) when communicating with participants in the study. Access to 
Avochato inbox used for this study will be limited to necessary study staff. 
Participants will be asked to indicate their preferred method of contact on 
the contact form (after consent) and will be contacted only via their 
selected method. 
Baseline (T1), post-intervention (T2), and 3-month follow-up assessments 
(T3): At each timepoint, participants will complete a Qualtrics survey, 
which will be accessed through a unique link created based on each 
participant’s deidentified participant identification number (PID).  
The Baseline assessment (T1) will include a set of sociodemographic 
questions as well as a total of 27 scales, measuring depression, anxiety, 
PTSD, functional impairment due to depression, functional impairment 
due to anxiety, interoceptive awareness, de-centering, 
rumination/perseverative thinking, theories of psychological distress, 
theories of emotion, internalized stigma, emotion regulation, loneliness, 
mindfulness, self-compassion, perceived stress, political stress, sleep, 
phone use, early life adversity, childhood trauma, experiences of stress 
and adversity, everyday experiences of discrimination, rejection 
sensitivity, Major Depressive Episode, Generalized Anxiety Disorder, and 
overall well-being (see “Compiled Measures_GEM.docx”).  
Additionally during the Zoom call for baseline assessment (T1), the RA 
will “onboard” the participant and (a) review how to use a FitBit, (b) install 
the study application, and (c) problem solve any logistic issues. The 
baseline assessment and onboarding will take a total of 90-120 minutes. 
The post-intervention assessment (T2) will take place 1-2 weeks after the 
recommended modules are completed and include a total of 26 scales, 
measuring depression, anxiety, PTSD, functional impairment due to 
depression, functional impairment due to anxiety, interoceptive 
awareness, Major Depressive Episode, Generalized Anxiety Disorder, 
de-centering, rumination/perseverative thinking, theories of psychological 
distress, theories of emotion, internalized stigma, emotion regulation, 
loneliness, mindfulness, self-compassion, perceived stress, political 
stress, sleep, phone use, applied mindfulness process, overall well-being, 
client satisfaction, session evaluation, and adverse effects. The 
post-intervention assessment will take a total of 60-90 minutes. 
Additionally at T2, participants will be invited to complete an exit interview 
via Zoom, the University approved web conferencing platform. Interview 
will take 90-120 minutes. In line with previous studies from our team, the 
interview will be recorded using the native recording feature on the Zoom 
platform (i.e., capturing both video and audio recording) and saved to the 
interviewer’s Brown Zoom cloud. The RA recording the interview will 
ensure that the setting “Allow cloud recording sharing” is disabled on 
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Zoom. By disabling this setting, nobody other than the person who made 
the recording will be able to access that recording on the cloud. Therefore 
the recording saved to the interviewer’s Brown Zoom cloud will be only 
accessible to the interviewer creating the recording. An audio-only 
recording file will be downloaded from the Zoom cloud to Stronghold, and 
the original recording will be deleted from the Brown Zoom cloud. 
At follow-up assessment (T3), which will take place 3 months after the 
baseline assessment, we will include a total of 21 scales, measuring 
depression, anxiety, PTSD, functional impairment due to depression, 
functional impairment due to anxiety, Major Depressive Episode, 
Generalized Anxiety Disorder, interoceptive awareness, de-centering, 
rumination/perseverative thinking, theories of psychological distress, 
theories of emotion, internalized stigma, emotion regulation, loneliness, 
mindfulness, self-compassion, perceived stress, political stress, sleep, 
phone use, applied mindfulness process, and overall well-being. The 
follow-up assessment will take a total of 60-90 minutes. 
At each of these assessments, participants will join a Zoom meeting with 
an RA. To mitigate confidentiality risks and risk of third-party participants, 
The RA will begin the call by instructing participants to complete the 
procedure in a private location. Participants will be reminded to pause the 
assessment if another person enters the space. Then, the RA will verbally 
administer MINI-Major Depressive Episode and MINI-Generalized Anxiety 
Disorder. Before beginning the MINI modules, RA will remind participants 
that if they disclose information indicating imminent risk of serious harm to 
themselves or others, this information must be reported to relevant law 
enforcement or other authorities. During the assessment, the RAs will 
have access to a Qualtrics survey with both measures, which will serve as 
their guide to administer the measures (refer to “Compiled 
Measures_GEM.docx” for the scale and questions asked). The Qualtrics 
survey will be accessed only by the RA (i.e., the survey won’t be sent 
directly to the participant) and filled out by the RA as the assessment 
progresses. The Qualtrics data will only be linked to the participant ID 
number (deidentified only) and will be kept in a secure location with other 
de-identified data. After both MINI modules are administered, the 
participant will be given access the aforementioned unique Qualtrics link 
to complete the rest of the measures, during which time the participants 
can ask any questions as they come up during the assessment. 
For participants who report suicidality in the MINI-Standard: Major 
Depressive Episode module, the suicide safety assessment and plan will 
be followed accordingly (refer to document named “Suicide Safety 
Plan_GEM.docx and to Section 18.0). Because all eligible participants at 
this point will have only mild to moderately severe symptoms of 
depression (individuals with severe symptoms are screened ineligible at 
the Qualtrics screener survey), there is low likelihood that a participant will 
be at imminent risk of suicide; however, the suicide safety assessment 
and plan has been developed out of an abundance of caution. The 
Suicide Safety Assessment and Plan will be conducted by Dr. Shufang 
Sun, a licensed psychologist and the principal investigator of the study, or 
by a study team member who has been formally trained by Dr. Sun and 
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operates under her direct supervision and oversight, consistent with 
existing clinical trial protocols for NIH-funded studies in the lab. All study 
personnel will receive training from Dr. Sun on identifying and responding 
to suicide risk. In addition, Dr. Sun will be on-call and will be notified 
immediately of any safety concerns. 
Growth, Empowerment, and Mindfulness (GEM) intervention: Participants 
will complete the intervention through Expiwell, a mobile application 
native to iOS and Android. The intervention will include 4 weeks of 
Recommended Modules followed by 2 weeks of Bonus Modules that 
participants can opt to complete. Each week, participants will gain access 
to (a) a set of 5-7 ‘core’ modules focused on the topics of early life stress 
and resilience, environmental stress and disembodied living, experiential 
avoidance, emotion regulation, mindful self-care, and self-compassion; 
and (b) 0-4 ‘optional tailored’ modules, specifically on the topics of 
minority stress and trauma for participants with interest in these topics. 
On Expiwell, participants will also have access to a list of all mindfulness 
exercises that have been taught each week. As a meditation-based 
intervention, the risk of increased psychological distress from meditation 
(refer to Section 15.1 for more details on foreseeable risks) will also be 
clearly outlined and communicated in the consent form, and participants 
will be encouraged to consult with study staff in the case of any increased 
distress. 
In addition to the weekly modules, participants will take part in a weekly, 
1-hour “Group practice and connect” session on Zoom. The online 
sessions will comprise a cohort of 5-10 participants (depending on 
recruitment) and will be led by a research assistant, who has previous 
experiences with mindfulness programs as well as lived experiences of 
early life adversity. During each session, participants will be invited to 
participate in a group practice and reflection and to join group discussions 
on experiences regarding past week’s practice. In the contact form (which 
is completed after the consent form), participants will be presented with 
the day and time of weekly sessions for the next two cohorts and asked to 
choose the times they are available for. If the participant is not available 
for either of the offered times, they will be marked as “deferred 
enrollment” in our participant tracking spreadsheet. A study RA will follow 
up with information about future cohort scheduling as that information 
becomes available. 
Ecological momentary assessments and interventions: Over the first 4 
weeks of the intervention period (i.e., Recommended Modules), 
participants will also complete 3 EMAs + EMIs per day through Expiwell. 
EMA and EMI will be delivered concurrently; the EMA will collect 
participant’s response on their current mood, recent stressful experience, 
and type of stressor; participants will then receive a list of mindfulness 
exercises, which will be tailored to the type of stressor/emotion they will 
have indicated. The last EMA of the day will also include an option for the 
participants to submit a voice recording, serving as a "daily journal" at the 
end of the day to understand participant’s daily experiences, including 
daily stressors and mindfulness practice application. To mitigate the risk 
of recording third-party participant voices, participants in the study will be 
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instructed to complete the voice recording in a private location and to 
ensure no other individuals are present or speaking during the recording. 
Participants will be reminded to pause, stop, or restart the recording if 
another person enters the space. Participants will also be reminded that 
the voice recording is optional--they may skip voice recording submission 
without penalty and still receive compensation. Audio will be downloaded 
from Expiwell, uploaded to Stronghold, then deleted from Expiwell’s 
storage. The audio housed in Stronghold will be deleted after the they are 
transcribed and vetted for accuracy by study staff. A research assistant 
will monitor responses to the EMA on a daily basis (including the voice 
recording, where a transcript will automatically become available through 
Expiwell’s AWS service). Any reportable events that are observed will be 
reported to the PI, and the PI will be available to meet, if necessary, to 
review concerns regarding a particular participant or any problems that 
may arise for participants. 
Weekly assessments: During first 4 weeks of intervention period (i.e., 
Recommended Modules), participants will be asked to complete a survey 
every week. The survey consists of 2 scales (PHQ-9 and GAD-7) as well 
as 3 items from interoceptive awareness scale, 3 items from de-centering 
scale, 3 items from perseverative thinking scale, and 1 item from theory of 
distress scale. Each survey will take 4-5 minutes, with a total of 16-20 
minutes over the 4 week period. 
Wearable device: Also during the first 4 weeks of intervention period (i.e., 
Recommended Modules), data will be collected from a Fitbit from each 
participant. Data collected include total sleep time, sleep onset latency, 
REM and non-REM sleep duration, sleep/wake variability, and resting 
heart rate. Each participant will be mailed a Fitbit from the study team 
along with a pre-paid return envelope at the enrollment in the study. 
These devices will be assigned to participants and linked to de-identified 
study accounts only. Participants will be instructed to wear the Fitbit 
device daily, before going to bed, for the entire 4-week period. At the end 
of the intervention, participants will be asked to return the Fitbit using the 
pre-paid return envelope.  
Data analysis: Feasibility, acceptability, and preliminary effects will be 
assessed using data from the T1, T2, and T3 surveys as well as EMA 
responses. Qualitative data analysis will also be performed for the 
exit-interviews and voice recordings to further qualify our findings after 
transcription and deidentification. Exit interviews will be transcribed using 
Dedoose (already vetted through OIT), while EMA voice recordings will be 
transcribed automatically through Expiwell’s AWS service. Additionally, 
recruitment and retention rates, completion of weekly modules, 
adherence to daily EMA and EMI prompts, weekly session attendance, 
and other engagement metrics from the application (e.g., frequency of 
EMI-triggered vs. self-initiated practice use, time spent in modules) will be 
used to inform study and intervention feasibility. 
6.3​ We will take all reasonable precautions to prevent adverse events to 
participants. As a meditation-based intervention, 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 
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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. During 
treatment, meditations are created to be relatively short and interspersed 
with dyads and reflections to minimize probability of risk. Developing 
strategies for working with physical and emotional discomfort is also an 
explicit goal of the program.  
No drugs will be administered as part of this study. The only devices used 
are a) the participant’s personal cell phone with the intervention content 
loaded through the Expiwell app and b) a wearable device Fitbit, which is 
commercially available and FDA-cleared for general wellness monitoring; it 
will be used solely to collect sleep and physiological data. 
For all assessments and guides used for data collection, please refer to the 
document named “Compiled measures_GEM.docx”. 
6.4​ A list of all data that and how they will be collected during the study is listed 
below: 
Self-report data on feasibility, acceptability, and preliminary efficacy: Data 
on feasibility and acceptability as well as preliminary efficacy of the 
intervention on study outcomes (including mental health, functional 
impairment, emotion regulation, loneliness, mindfulness, self-compassion, 
stress, sleep, phone use, overall well-being, etc. – refer to Section 6.2 for 
full list of scales measured at each time point) will be collected via 
Qualtrics at baseline, post-intervention, 3-month follow-up, and weekly 
assessments during the first 4 weeks of intervention period (i.e., 
Recommended Modules). 
EMAs: Daily self-reports on stress, mood, and emotional states will be 
collected on the Expiwell application. Furthermore, voice recordings for a 
"daily journal" will be collected during the last EMA of the day. Participants 
will be reminded that the voice recording is optional--they may skip voice 
recording submission without penalty and still receive compensation. 
App engagement metrics: Frequency and duration of EMI-triggered and 
self-initiated mindfulness practice sessions will be collected on Expiwell. 
Sleep metrics: Continuous objective data on sleep metrics (e.g., sleep 
latency, REM/non-REM sleep, sleep fragmentation, total sleep time, sleep 
efficiency) will be collected using wearable devices (i.e., Fitbits). 
Semi-structured interviews: Qualitative feedback on intervention 
experience, feasibility, acceptability, and suggestions for improvement will 
be collected through a semi-structured Zoom interview with an RA. 
6.5​ Participants will complete a 3-month post-baseline follow-up survey after 
the 4-6-week intervention (4 weeks recommended, 2 weeks 
optional/bonus). Similarly to post-intervention survey, this assessment will 
collect self-report data on mental health, functional impairment, emotion 
regulation, loneliness, mindfulness, self-compassion, stress, sleep, phone 
use, overall well-being, etc. (refer to Section 6.2 for full list of scales 
measured 3-month follow-up). 
6.6​ N/A 
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7.0​
Data and Specimen Banking 
7.1​ De-identified data (i.e., data linked to PID) will be kept indefinitely after the 
completion of the study. These de-identified data include (1) data collected 
from T1, T2, T3, and weekly Qualtrics survey; (2) data from wearable 
devices (e.g., sleep duration, sleep activity); (3) de-identified data 
downloaded from Expiwell (e.g., timestamps of EMA completions and other 
adherence information); (4) de-identified interview and voice recording 
transcripts, with all potentially identifying information removed; and (5) 
de-identified data collected during Zoom screening interview (collected after 
consent). Access to the data will be restricted to authorized study 
personnel, including the principal investigator and designated research staff 
responsible for receipt, storage, and analysis of data. Screening data from 
the screening Qualtrics survey will not be stored or used for any other 
purposes. Qualtrics software will be accessible only to authorized study 
personnel. Identifiable consent information will be downloaded from 
Qualtrics and securely stored on Stronghold and will be deleted from 
Qualtrics once successful transfer and storage have been confirmed. 
As described in section 6.2, video recordings of the exit interview will be 
deleted as soon as the audio can be downloaded from the Brown Zoom 
cloud and successfully uploaded to Stronghold. Audio of the interview will 
be deleted after the interviews are transcribed and vetted for accuracy by 
study staff. Audio recordings obtained through Expiwell will be downloaded 
and transferred to Stronghold. Audio will be deleted from Expiwell’s cloud 
after it is successfully uploaded to Stronghold. These audios will be deleted 
from Stronghold after they are transcribed and vetted for accuracy by study 
staff. Therefore, we will only use deidentified transcripts of all audio data in 
analysis. 
The crosswalk files linking PII to PID will be retained until either a 
manuscript utilizing the data is submitted for publication or for a period of 5 
years after study completion (whichever comes first), consistent with 
institutional policy. This allows for the deletion of a participant’s data upon 
request, at any time prior to dissemination. 
Further, participants will be asked in the future contact form whether they 
would be interested in being contacted about future research studies in the 
lab. For participants who consent to being contacted in the future, we will 
retain their contact information in a separate file not linked to their PID for 
up to 5 years, after which point we will destroy the information. 
7.2​ Data that will be stored for future use will be de-identified and linked to each 
participant’s unique PID. These include (a) Qualtrics survey responses from 
T1, T2, T3, and weekly assessments; (b) data from wearable devices (e.g., 
sleep duration, sleep activity); (c) study participation records (e.g., 
timestamps of survey or EMA completions and other adherence 
information); (d) de-identified transcripts of exit interviews and EMA voice 
recordings; and (e) de-identified data collected during Zoom screening 
interview (collected after consent). The password-protected file linking PID 
to participant name (described in Section 17.2) will also be destroyed 5 
years after study completion. 
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7.3​ Representatives of the institutional IRB or regulatory agencies may request 
to inspect all documents and records related to the study by contacting the 
study PI. 
8.0​
Sharing of Results with Subjects 
8.1​ Results will not be shared with the subjects of this study. 
9.0​
Study Timelines 
9.1​ Each participant will be involved in the study for approximately 3-4 months, 
including eligibility screening, baseline assessment, 4-6 weeks of 
intervention with daily EMA/EMI, post-intervention assessments, and a 
3-month follow-up. We anticipate enrolling participants over a 2–3-month 
period. Primary analyses and study completion will be completed 6 months 
post data collection. 
10.0​ Inclusion and Exclusion Criteria 
10.1​ Screening survey: Individuals interested in the study will access a Qualtrics 
survey via recruitment links. The survey will be developed based on the 
study’s inclusion and exclusion criteria (except for imminent risk of suicide 
and current Major Depressive Episode, which will be assessed during the 
Zoom screening interview). Scores on screening measures within the 
survey will be calculated in real time using Qualtrics’ scoring feature—if a 
potential participant’s score meets the study’s inclusion threshold (see 
section 10.2), the survey flow will set an embedded variable (“eligible”) to 
true; otherwise, it will be set to false. Statement addressing the legal 
concerns of underage consumption of alcohol and illegal substance use 
has been added to the screener. 
Individuals who meet the eligibility criteria will be redirected to a separate 
Qualtrics form where they can review the Informed Consent Form (ICF) and 
complete a contact form, which will collect their full name and email 
address. These individuals will also be asked if they would like to be 
notified for future research. Please refer to the document named “Compiled 
measures_GEM.docx” for the screening survey, contact form, and future 
contact form. A trained research staff will then follow up with the eligible 
participants to schedule a Zoom-based screening interview. 
Zoom screening interview: The interview will take 15-30 minutes to 
complete and will serve the following purposes: (a) confirm participant 
eligibility and identity by participant showing any form of ID including photo, 
name, and age; (b) review informed consent form; (c) review study 
procedures and answer any questions the participant may have; (d), screen 
for current Major Depressive Episode and imminent risk of suicide; and (e) 
inform the participant (if eligible and interested to enroll) of the next steps, 
which includes the next Zoom call meeting for baseline assessment and 
onboarding (refer to section 6.2). At the beginning of the screening call, RA 
will remind participants that if they disclose information indicating imminent 
risk of serious harm to themselves or others, this information must be 
reported to relevant law enforcement or other authorities. The RA 
conducting this interview will use a Qualtrics survey with the 
questions/measures that need to be administered (e.g., the MINI-Major 
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Depressive Episode module or the suicide screener), which will serve as 
their guide during the interview. The qualtrics survey will be accessed only 
by the RA (i.e., the survey won’t be sent directly to the participant) and filled 
out by the RA as the interview progresses. The Qualtrics data will only be 
linked to the participant ID number (deidentified only) and will be kept in a 
secure location with other de-identified data. Please refer to “ICF 
Checklist_GEM.docx” for a full list of screening questions that will be asked, 
including screening for current Major Depressive Episode and suicidal 
ideation. To mitigate confidentiality risks and risk of third-party participants, 
participants will be instructed to complete the procedure in a private 
location. Participants will be reminded to pause the assessment if another 
person enters the space. Please refer to the document named “Compiled 
measures_GEM.docx” for the general structure of the interview and “ICF 
Checklist_GEM.docx” for more detailed interview guide to be used by the 
RA conducting the interview.  
For participants who report suicidality in the MINI-Standard: Major 
Depressive Episode module or during the suicide screener, the suicide 
safety assessment and plan will be followed accordingly (refer to document 
named “Suicide Safety Plan_GEM.docx). Because all eligible participants at 
this point will have only mild to moderately severe symptoms of depression 
(individuals with severe symptoms are screened ineligible at the Qualtrics 
screener survey), there is low likelihood that a participant will be at 
imminent risk of suicide; however, the suicide safety assessment and plan 
has been developed out of an abundance of caution. 
The Suicide Safety Assessment and Plan will be conducted by Dr. Shufang 
Sun, a licensed psychologist and the principal investigator of the study, or 
by a study team member who has been formally trained by Dr. Sun and 
operates under her direct supervision and oversight, consistent with 
existing clinical trial protocols for NIH-funded studies in the lab. All study 
personnel will receive training from Dr. Sun on identifying and responding to 
suicide risk. In addition, Dr. Sun will be on-call and will be notified 
immediately of any safety concerns. 
10.2​ Inclusion criteria: 
(1)​
Age 18-24 
(2)​
Reside in the US 
(3)​
Experiences of psychosocial forms of early life adversity, defined as 
saying yes to at least one of these following questions: 
○​ Did you ever miss school due to fear of being bullied? 
○​ Were you ever injured or threatened with a weapon or otherwise 
assaulted by a peer at school? 
○​ Were you ever physically attacked, hit, hurt, or injured by a parent, 
primary caregiver, or guardian? 
○​ Were you ever touched sexually against your wishes or forced to 
touch someone else sexually? 
○​ Were you ever forced to engage in sexual intercourse? 
○​ Were you ever forced to have sex or were you ever sexually 
abused (e.g., being touched or fondled by an adult?) 
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(4)​Experience more than minimal symptoms of anxiety (GAD-7 score of 5 or 
higher) and/or mild to moderately severe depression symptoms (PHQ-9 
score between 5–19) 
(5)​Not currently in mental health treatment  
(6)​Being willing to answer 3-4 short surveys daily, each 2-5 mins  
(7)​Being willing to engage in recommended daily mindfulness practices for 
4-6 weeks 
(8)​Have not been extensively exposed to mindfulness, defined as meditation 
retreat experience, consistent mindfulness practice (> once/week) within 
the past 6 months, or prior participation in a mindfulness course/program 
Exclusion criteria: 
(1)​
At imminent risk of suicide 
(2)​
Have a history of psychotic disorder (e.g., schizophrenia) or psychotic 
episode 
(3)​
Have a current diagnosis of Major Depressive Disorder 
(4)​
Meet the criteria for Major Depressive Episode based on the 
MINI-Major Depressive Episode module at screening 
(5)​
Score 20 or higher on Alcohol Use Disorders Identification Test 
(AUDIT) at screening 
(6)​
Score 25 or higher on Drug Use Disorders Identification Test (DUDIT) 
at screening 
(7)​
Have ever been diagnosed with bipolar disorder 
10.3​ We will not include any of the listed special populations in this research. 
11.0​ Vulnerable Populations 
11.1​ N/A 
12.0​ Local Number of Subjects 
12.1​ We anticipate enrolling 44 participants in the single-arm trial. 
12.2​ A larger number of young adults will be screened for eligibility, and 44 
participants will be recruited to enroll in the single-arm trial. From these 44 
participants, we aim to have at least 35 participants (i.e., approximately 
80%) who complete all intervention procedures and follow-up assessments. 
Screening more participants ensures that we can meet the target 
enrollment despite ineligible candidates, and enrolling more ensures that 
we collect enough data points even with potential withdrawals. 
13.0​ Recruitment Methods 
13.1​ We will implement a nationwide, remote recruitment strategy using a 
multi-pronged approach. Potential participants will be recruited over a 2-3 
month period from various recruitment sources: (1) providing IRB approved 
recruitment materials (see section 13.4) to CAB members for them to 
distribute to their social networks and post on their social media accounts; 
(2) posting recruitment materials on online social media, such as 
Facebook-based community groups, Reddit threads, X, etc.; (3) targeted 
recruitment through OpenClinica (also formerly known as BuildClinical and 
vetted and approved by Brown OIT; OpenClinica is a specialized service 
that uses targeted digital outreach and pre-screening to connect 
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researchers with qualified participants by running data-driven digital 
advertising campaign across their digital network;); (4) sending emails to 
university/college campus groups, community-based organizations, and 
partner health groups (e.g., Project Weber/RENEW)—the email will include 
the recruitment material and a script, which the organizations can use to 
share information directly with potentially eligible participants (e.g., via 
email) or post the materials on their community channels (e.g., newsletters, 
listservs, websites); and (5) sharing study information on Today@Brown, a 
daily email delivered to all students, faculty and staff at Brown (also refer to 
Today@Brown_GEM.docx for language). Specifically, OpenClinica’s 
involvement in recruiting is in digital outreach (e.g., using targeted digital 
ads through their pre-existing channels). It connects researchers with 
potential participants by engaging and generating leads from individuals 
interested in the study, and these individuals will be provided with link to the 
study team’s Qualtrics survey screener. Therefore, OpenClinica itself will 
not have any access to identifiable information or the screening survey, 
independently perform consent, make screening decisions, or enroll 
participants into the study; instead, those will remain as functions of the 
research team, per the screening protocol described in this document. 
Please refer to the document titled “Recruitment Email Drafts_GEM.docx” 
for the email draft as well as the written script, which will be used to explain 
the study purpose and procedures. 
13.2​ The source of participants will be local and online communities where 
individuals with lived experiences of early life adversities and mental health 
challenges may be present. These communities include, but are not limited 
to social networks, LGBTQ+ groups, foster care and youth residential 
programs, and networks that provide support for survivors of abuse and 
violence. 
13.3​Potential participants will be identified by having them self-report their age, 
experiences of early life adversities, and depression or anxiety symptoms 
through the screening Qualtrics survey. The research team will contact 
individuals for further screening (i.e., schedule Zoom screening interview) if 
they are deemed potentially eligible from the screening survey (see 
Sections 10.1 and 10.2). 
13.4​ Other than the email draft and written script described in Section 13.1, 
recruitment materials will include flyers and graphics for social media posts. 
Each material will provide a brief study description, eligibility criteria, and 
contact information. Please refer to the files titled “Recruitment_GEM.docx” 
for flyers and social media graphics. Furthermore, recruitment materials 
created by OpenClinica will be submitted to the IRB for review when they 
are created, after a contract is finalized. 
13.5​ Participants will only be compensated for the study components that they 
choose to complete. If a participant withdraws from the study early, they will 
not be compensated for the study components that are incomplete. 
Compensation will be provided through Amazon gift cards. Total possible 
compensation for participants is $168: 
Study Procedure 
Compensation 
Compensation period 
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Baseline assessment 
(T1) 
$25 
Paid after survey 
completion 
Ecological momentary 
assessment (during the 
first 4 weeks of 
intervention period; i.e., 
recommended modules) 
Maximum of $56: 
$2/day for completing at 
least 2 of 3 daily EMA 
prompts over a maximum 
of 28 days (i.e., 4-weeks) 
Paid in a single 
installment at the end of 
Week 4 
Weekly assessments 
(during the first 4 weeks 
of intervention period; 
i.e., recommended 
modules) 
Maximum of $12: 
$3 for completing each 
assessment, once a 
week over 4 weeks 
Post-intervention 
assessment (T2) 
$25 
Paid after (1) 
survey/interview 
completion AND (2) 
Fitbit device is returned 
to the study team 
Exit interview (T2) 
$25 
Follow-up assessment 
(T3) 
$25 
Paid after survey 
completion 
 
14.0​ Withdrawal of Subjects 
14.1​ Circumstances under which participants will be withdrawn from the 
research without their consent include significant cognitive impairment, 
psychosis, and/or imminent suicidal risk. 
14.2​ In the event of withdrawal, the study staff will debrief the participant, provide 
mental health resources if needed, and provide guidance for safely 
discontinuing participation (e.g., closing out their application account) and 
instructions for returning any study-provided materials (e.g., Fitbit devices).  
14.3​ When a participant withdraws from research, they may request their data to 
be deleted. Compensation will be provided based on completed study 
assessments; they will not be compensated for the study components that 
are incomplete. For participants who partially withdraw with continued data 
collection, only agreed-upon assessments (e.g., only EMAs) will continue to 
be used to gather data on study experience, acceptability, and feasibility. If 
they partially withdraw before the exit interviews are conducted, they will 
still be contacted and be invited to participate in the exit interview. 
15.0​ Risks to Subjects 
15.1​ Meditation-related risks: The National Center for Complementary and 
Integrative Health (NCCIH) states that meditation is generally safe for 
healthy people, but that adverse effects have also been reported. 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 
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hour per day include: increased depression, anxiety or panic, 
re-experiencing of traumatic memories, dissociation, executive dysfunction, 
headaches/body pain and insomnia. 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. The frequency of serious adverse effects 
in the context of MBIs is estimated to be less than 1%, although adequate 
estimates are not available. 
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 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,” we 
expect that the risk will be low. 
Loss of confidentiality: Confidentiality will be maintained by using 
deidentified data sets. All electronic data files containing identifying 
information will be encrypted with cloud-based software. Although these 
measures have been taken to protect participants’ personal information and 
the likelihood of loss of confidentiality is minimal, complete confidentiality 
cannot be guaranteed when transmitting information over the internet. All 
information obtained from participants will be accessible only to research 
staff. 
Risks Related to Wearable Devices: Wearing the Fitbit device may cause 
minor physical discomfort (e.g., skin irritation) or inconvenience in daily 
routines. 
Oversight of internal monitoring of the participants’ safety will be conducted 
by the PI, Dr. Shufang Sun, who is a licensed psychologist. 
15.2​ N/A 
15.3​ N/A 
15.4​ N/A 
16.0​ Potential Benefits to Subjects 
16.1​ Potential benefits from participating in the research include (a) increased 
awareness of daily mood, stressors, and present experience through 
EMAs; (b) development of a personal mindfulness meditation practice, 
which may help participants develop healthy coping strategies, improve 
emotion regulation, and reduce stress; and (c) practice of identifying and 
attempting behavioral change, which may lead to improvements in mental 
health indicators such as anxiety, depression, and loneliness. While the 
magnitude and duration of these benefits may vary by individual, 
participation offers the opportunity for personalized insight into their own 
behavioral and emotional patterns as well as skill-building. 
16.2​ N/A 
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17.0​ Data Management and Confidentiality 
17.1​ Quantitative data will be analyzed using a combination of descriptive and 
inferential statistics. Feasibility and acceptability data (e.g., CSQ-8 and SEF 
scores, proportion of completed EMA prompts, engagement metrics such 
as weekly practice rates and frequency of practice use) will be summarized 
using means and standard deviations. Preliminary effects on other primary, 
secondary, and exploratory outcomes (e.g., depression, anxiety, sleep 
quality, emotion regulation, mindfulness) will be evaluated using repeated 
measures analyses, such as mixed-effects models, to characterize effect 
sizes (e.g., Cohen’s d). We will use mixed-effects modeling with time as 
fixed effect and participant as random effect to model trajectories, 
incorporating baseline covariates, to account for within-subject correlations 
across time points. EMA data will be analyzed using mixed-effects models 
to assess within-person day-to-day associations between stress and 
intervention engagement. 
Qualitative exit interview data will be transcribed using Dedoose, 
deidentified, and analyzed using thematic analysis. Framework analysis, a 
structured qualitative analysis method, will be used. We will follow a 
standard procedure, including (1) data familiarization, (2) deductive coding 
based on relevant research questions and inductive coding emerging from 
the data, (3) development of a framework of codes specific to intervention 
messages and content, (4) organization of relevant codes into themes, and 
(5) integration and interpretation of the themes to provide meaning and 
explanation for the results. Multiple coders will be involved in the data 
analysis process to ensure analyst triangulation and rigor. We will follow 
best practices on enhancing rigor of qualitative research, adhere to 
reporting standards outlined by the American Psychological Association, 
and demonstrate trustworthiness (credibility, transferability, dependability, 
and confirmability). Voice recording data will similarly be transcribed 
automatically through Expiwell’s AWS and be verified/deidentified before 
analysis. Natural language processing will be used for the deidentified 
transcripts of the voice recordings, for example, to run sentiment analysis to 
examine changes in participant’s emotions over time. To mitigate the risk of 
recording third-party participant voices, participants in the study will be 
instructed to complete the voice recording in a private location and to 
ensure no other individuals are present or speaking during the recording. 
Participants will be reminded to pause, stop, or restart the recording if 
another person enters the space. 
17.2​ Access to documents and records produced with study data will be limited 
to the PIs, project managers, research coordinators, and other related 
research personnel. All personnel involved will be required to sign 
confidentiality agreements and strict confidentiality will be maintained. Files 
with personal identifiable information (e.g., password-protected file linking 
PID to participant name, signed informed consent forms, interview 
recordings, and voice recordings) will be kept in closed network servers 
(i.e., Brown Stronghold) that only research staff have access to. Specifically 
for exit interview recordings, the interview will be recorded using the native 
recording feature on the Zoom platform (i.e., capturing both video and audio 
recording) and saved to the interviewer’s Brown Zoom cloud. The RA 
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recording the interview will ensure that the setting “Allow cloud recording 
sharing” is disabled on Zoom. By disabling this setting, nobody other than 
the person who made the recording will be able to access that recording on 
the cloud. Therefore, the recording saved to the interviewer’s Brown Zoom 
cloud will be only accessible to the interviewer creating the recording. An 
audio-only recording file will then be downloaded from the Zoom cloud to 
Stronghold, and the original recording will be deleted from the Brown Zoom 
cloud. 
17.3​ Data will be monitored regularly for accuracy and cleaned according to set 
protocols. Standardized protocols will be followed by research staff for all 
data collection procedures, and regular audits will be conducted. All 
research staff will be trained in consistent data handling and confidentiality 
procedures.  
17.4​ The crosswalk files linking personally identifiable information (e.g., name, 
contact information) to PID will be stored separately from study data in 
encrypted, password-protected files and will remain there until either a 
manuscript utilizing the data is submitted for publication or for a period of 5 
years after study completion (whichever comes first), consistent with 
institutional policy. This allows for the deletion of a participant’s data upon 
request, at any time prior to dissemination. The same will be applied to the 
contact information of participants who consent to being contacted about 
future research studies in the lab--their contact information (not linked to 
PID) will be retained for up to 5 years, after which point we will destroy the 
information. All de-identified study data, including survey responses, EMA 
data (including transcripts of the voice recordings), passive data from 
wearable devices, and exit interview transcripts, will be linked to a unique 
PID. De-identified data will be stored on secure, HIPAA-compliant servers 
at the Brown University School of Public Health indefinitely after the 
completion of the study. Access to data with personally identifiable 
information will be restricted to authorized study personnel, including the 
principal investigator and designated research staff, who are responsible for 
receipt and storage of data. The de-identified data can be shared with other 
researchers upon request after signing data confidentiality agreement; this 
process will be handled by the PI. 
18.0​ Provisions to Monitor the Data to Ensure the Safety of Subjects 
18.1​ Data collected in this study regarding potential suicidality will be evaluated 
at each timepoint (i.e., Zoom Screening Interview, T1, T2, and T3) to 
ensure the safety of participants. Specifically, we will review results of the 
MINI-Major Depressive Episode module, including participant response for 
question A3.g in the MINI-Major Depressive Episode module: “Did you 
repeatedly think about death (fear of dying does not count here), or have 
any thoughts of killing yourself, or have any intent or plan to kill yourself? 
Did you attempt suicide?”  
The MINI-Major Depressive Episode module will be administered verbally 
by a research staff conducting the assessment on Zoom call (Refer to 
Section 6.2 for more details). At any time point, Dr. Sun will be notified of 
participants who have current Major Depressive Episode according to the 
module. At screening, if they screen positive they will be provided with 
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resources and excluded. while those who have current Major Depressive 
Episode at T1, T2, or T3 assessments will be provided with local mental 
health resources after the assessment is completed without being excluded 
from the study (refer to “MINI – Major Depressive Episode Referral 
Plan.docx”). 
Further, as described in “Compiled Measures_GEM.docx”, for any 
participant saying Yes to question A3.g in the MINI-Major Depressive 
Episode module, the suicide safety and assessment plan will be 
automatically triggered through Qualtrics by redirecting the RA to a 
message telling them to stop assessment and administer the safety and 
assessment plan (refer to document named “Suicide Safety 
Plan_GEM.docx). Because all eligible participants at this point will have 
only mild to moderately severe symptoms of depression (individuals with 
severe symptoms are screened ineligible at the Qualtrics screener survey), 
there is low likelihood that a participant will be at imminent risk of suicide; 
however, the suicide safety assessment and plan has been developed out 
of an abundance of caution. The Suicide Safety Assessment and Plan will 
be conducted by Dr. Shufang Sun, a licensed psychologist and the principal 
investigator of the study, or by a study team member who has been formally 
trained by Dr. Sun and operates under her direct supervision and oversight, 
consistent with existing clinical trial protocols for NIH-funded studies in the 
lab. All study personnel will receive training from Dr. Sun on identifying and 
responding to suicide risk. In addition, Dr. Sun will be on-call and will be 
notified immediately of any safety concerns. Participants who have active 
suicide ideation according to the suicide safety assessment will be 
excluded from the study, and study staff will take actions according to the 
suicide assessment and safety plan (please refer to “Suicide Safety 
Plan_GEM.docx”) 
19.0​ Provisions to Protect the Privacy Interests of Subjects 
19.1​ All participant data will be de-identified and linked to unique study PIDs. 
Personally identifiable information (names, emails, phone numbers) will be 
stored separately in a password protected file in Stronghold. Only 
authorized study personnel will have access to these files. Links for the 
Qualtrics survey will be tailored to each participant's PID, eliminating the 
need for participants to provide any identifying information. Furthermore, all 
study data collected through Expiwell will only be linked to each 
participant’s PID. 
19.2​ Participants will be informed that the study data collected will remain 
confidential and that they may skip any questions or withdraw from the 
study at any time without penalty. Study staff will use neutral, supportive 
language during participant interactions and provide clear explanations of 
procedures. Sensitive topics will be discussed with nonjudgement, and 
participants will have access to resources and support if needed (e.g., 
mental health resources). 
19.3​ The research team’s access will be restricted to team members who have 
signed confidentiality agreements, including PIs, project managers, 
research coordinators, and interviewers. Only these authorized personnel 
will access deidentified datasets and qualitative transcripts. Access to 
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identifiable information will be managed through Stronghold, which will be 
used for scheduling interviews or follow-up, will be strictly controlled and 
limited to necessary staff. 
20.0​ Compensation for Research-Related Injury 
20.1​ N/A 
20.2​ N/A 
21.0​ Economic Burden to Subjects 
21.1​ Participation in this study is not expected to impose economic costs on the 
participants. There can be instances where participants will want to 
download data-heavy materials from the application. We will encourage 
them to download these materials in a wifi-supported environment. 
22.0​ Consent Process 
22.1​ Informed consent will be an ongoing process. Participants will first be 
presented with the IRB-approved ICF at the time of initial online screening, 
which will describe the purpose of the study, procedures to be followed, and 
the risks and benefits of participation. 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. Consent will be documented 
electronically within the Qualtrics survey; participants must confirm 
electronically that they have read and understood the ICF before beginning 
study activities. The consent process will continue into the Screening Zoom 
Interview, where a trained research staff member will review the ICF with 
the participant and answer any questions they might have (also see section 
10.1). 
23.0​ Process to Document Consent in Writing 
23.1​ Consent will be documented electronically within the Qualtrics survey; 
participants must confirm electronically that they have read and understood 
the ICF before beginning study activities.  
23.2​ The research presents no more than minimal risk of harm to participants 
and involves no procedures for which written documentation of consent is 
normally required outside of the research context. Waiver to obtain written 
documentation of consent is requested. 
23.3​ A copy of the Informed Consent Form is attached, under file name 
“Informed consent form_GEM.docx”. 
24.0​ Setting 
24.1​ To fully leverage the potential of mobile health interventions, we will use a 
national, remote recruitment and participation strategy using social media, 
online communities, contact with community-based organizations and 
universities. All procedures, including study onboarding, data collection, 
intervention delivery, and exit interviews, will be conducted virtually. This 
remote model enables accessibility across geographic backgrounds. 
A community advisory board (CAB) will be formed and be asked to provide 
input in all stages of research, including informing study protocol, facilitating 
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results interpretation, and disseminating study findings. The CAB will meet 
regularly (monthly/biweekly depending on study phase). Two CAB 
members will be selected and recommended as co-chairs through CAB 
group discussion, and they will be responsible for preparing meeting 
agendas and providing a discussion summary to the research team. The 
investigative team will be present at the start of the CAB, and a team 
member (e.g., study coordinator) will attend CAB meetings as needed (e.g., 
to present the measurement package and solicit feedback). Consistent with 
our team’s practice, members will be compensated for their time, and we 
will involve CAB in dissemination (e.g., co-writing certain products, 
authorship and/or acknowledging their contributions in papers, summary 
reports, etc.) as a capacity building activity.  
25.0​ Resources Available 
25.1​ The research team will have full access to the Brown School of Public 
Health’s facilities and core resources, including dedicated office space at 
155 South Main Street, Providence, RI 02903, data management support, 
and access to any additional necessary tools and infrastructure. The 
feasibility of recruiting 44 participants within 2 months is made possible 
through the team’s past experiences and subsequent development of 
rigorous protocols regarding outreach (via social media, online 
communities, universities, and 300+ community-based organizations from 
previous research). The study is expected to be completed within a 
one-year period from the start date. Brown University IRB will be notified 
after study completion. This notification will include a final report 
summarizing the study findings, protocol adherence and other related 
documents. Any protocol deviations will be recorded and reported promptly. 
Oversight of internal monitoring of the participants’ safety will be conducted 
by the PI, Dr. Shufang Sun, who is a licensed psychologist. Researchers 
involved in this study will receive appropriate training regarding study 
procedures from team members with experiences conducting clinical trials 
and have their CITI training completed before beginning the study. 
26.0​ Multi-Site Research 
26.1​
N/A 
26.2​
N/A 
​
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