Mobile Health (mHealth) Application Called CBCT Sessions to Treat and Reduce Elevated Stress Among Students (C-STRESS)
Phase: EARLY_PHASE1
Conditions: Depression, Anxiety, Stress, Psychological, Mobile Phone Use
Sponsor: Benten Technologies, Inc.

Cover Page for the Study Protocol
Official Title:
Mobile health (mHealth) application called CBCT Sessions to Treat and Reduce
Elevated Stress among Students (C-STRESS)
NCT Number:
NCT05776901
Document Type:
Study Protocol
Document Date:
03/16/2022

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#20195345 - Developing C-STRESS, A Mobile App To
Address Mental Health In College Students
Protocol Information
Approval Comment
The IRB Approval Letter and any approved documentation (e.g. stamped consent forms) can be 
downloaded in the Attachments section of the protocol.
Protocol Amendment Form
Form Navigation
Review Type
Expedited
Status
Approved
Approval Date
Mar 16, 2022
Continuing Review
Date
--
Expiration Date
Aug 11, 2023
Initial Approval Date
Aug 12, 2020
Initial Review Type
Expedited
Feedback
PROTOCOLS
Melissa Dawn Pinto

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Amendment Screener
Translations: May be submitted without transcription, only when non-English speakers are
already included in the approved protocol.
• If non-English speakers need to be added to the protocol, select either 'minor' or 'major'
revisions.
• For more information, visit Anticipating the Need for Written Translations.
Exempt Self-Determinations: The submission of amendments in KRP is NOT required.
Amendments are to be tracked by the Lead Researcher independently. If the amendment
changes the level of review to where IRB review is required, a new protocol must be
submitted in KRP. Please 'Abandon' the amendment for the exempt self-determination.
Yes, changes are required (complete an amendment)
Are you submitting an amendment for an IRB, sIRB, or hSCRO
protocol?
IRB (UCI is the IRB of Record)
If this is a legacy protocol (legacy = IRB number has 8 digits -
20211234), has Electronic Research Administration (ERA)
Transcription already transcribed it?
Yes, ERA has transcribed the legacy protocol
When was the initial IRB approval granted?
On or after January 21, 2019 and it adheres to the 2018 Common Rule
Amendment Instructions
• Complete the amendment form to describe the change(s) and to provide rationale for
the change(s).

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• After the amendment form is complete, review and revise the protocol, as necessary.
• Submit all new and/or revised supporting documents in the Attachments section near
the end of the protocol.
• If the protocol is within 30 days of the expiration date, it is recommended that a
renewal be included with the amendment. If Renew & Amend was not initially selected
and a renewal is required, please Abandon the draft and start again.
• IMPORTANT! Please refrain from making major changes during a renewal as this
could result in a lapse of IRB approval.
• REMINDER! Research Personnel (RP) should be removed from the protocol in
accordance with the RP Heat Map.
• Active RP removed from the protocol may be tracked through the Study team
tracking log (or equivalent) or may be tracked in the Permissions Tab at the top
right of the page.
For more information, visit Protocol Amendment.
IRB Amendment
What type of changes are being proposed for this request?
Minor Revision(s)
Current Status of Enrollments:
Enrollment and research procedures complete - only access to identiSable
data / data analysis ongoing
Are there approved Re-Consent Cover Memos on file? 
IMPORTANT! To verify, review the 'Approved' documents in the Attachments section.
No
Is there significant new information that would warrant

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Is there significant new information that would warrant
notification or reconsenting of participants?
No
List of Protocol Changes
• Select '+Add Line'' for each change.
IMPORTANT! The list below must be complete / comprehensive of all changes as it will be
reflected in the IRB Approval Letter. Failure to provide a complete list of changes will delay IRB
approval.
Change in Recruitment
Provide the details and reason for the recruitment change:
Expanding age range from 18-25 yrs to 18-30 yrs to capture larger sample
of graduate students. New recruitment materials to reXect the expanded
protocol narrative.
Change in Research Procedure(s)
Provide the details and reason for the change in research
procedures:
This change is an expansion of the original protocol narrative with new
aims to examine the C-STRESS application prototype developed based on
the feedback from the completed focus groups and design workshops. The
prototype C-STRESS mobile application content is based on Cognitively-
Based Compassion Training (CBCT©) coursework. An overview of the

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content can be found on the CBCT© website -
https://www.compassion.emory.edu/ A more detailed description of
CBCT© course content can be found in the article “A model for cognitively-
based compassion training: theoretical underpinnings and proposed
mechanisms” at https://doi.org/10.1057/s41285-019-00124-x There will be
3 steps added to the study protocol: Step 3: We will recruit an independent
convenience sample of 8 UCI undergraduate and graduate students aged
18-30 to participate in a Zoom focus group (FG) to provide feedback on
low-Sdelity wireframes of the C-STRESS mobile application. The
participants will complete a short demographic survey prior to the FG and
will review the Study Information Sheet at the beginning the FG.
Participants will view low-Sdelity wireframes of the C-STRESS app (see
example attached in packet). Discussion and feedback will be guided by
the Low-Fidelity Focus Group Discussion Guide. The FG will last
approximately 1 ½ hours. Participants will receive a $30 Amazon Gift Card
for participation in the FG. Feedback from this FG will be used to develop
high-Sdelity wireframes for the next focus group. We will recruit an
independent convenience sample of 8 UCI undergraduate and graduate
students aged 18-30 to participate in a Zoom focus group (FG) to provide
feedback on high-Sdelity wireframes of the C-STRESS mobile application.
The wireframes will be created based on the feedback from the FG in Step
1. The participants will complete a short demographic survey prior to the
FG and will review the Study Information Sheet at the beginning the FG.
Participants will view high-Sdelity wireframes of the C-STRESS app (see
example attached in packet). Discussion and feedback will be guided by
the High-Fidelity Focus Group Discussion Guide. The FG will last
approximately 1 ½ hours. Participants will receive a $30 Amazon Gift Card
for participation in the FG. Feedback from this FG will be used to develop
initial content (onboarding and modules 0-3) of the C-STRESS mobile
application which will be used in the pilot test (Step 4). Step 4: We will
recruit an independent convenience sample of 20 UCI undergraduate and
graduate students aged 18-30 to pilot test the initial content (onboarding
and modules 0-3) of the prototype C-STRESS mobile application.
Participants will complete measures via REDCap survey link: Demographic

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Questionnaire, PHQ9, GAD7, Coping 1, Coping 2, CDC HRQOL4).
Participants will meet via Zoom with a member of the research team to a)
download the prototype app, b) complete app onboarding (eg. indicate
reason(s) for using the app, indicate color scheme & frequency of
notiScation preferences, select avatar if desired, etc.), c) begin to explore
the app and its functionality with a research team member available to
provide technical assistance, and d) complete the SUS and TAM
questionnaires via REDCap survey link. This initial download/onboarding
meeting will last 20-30 minutes. Participants will receive a $20 Amazon
Gift Card for participating in the download/onboarding meeting and
completing the measures. Participants will be asked to use the prototype
C-STRESS application at least once per day for 8 weeks. Daily usage will
range from approximately 2 minutes (opening the app and performing a
one-minute meditation) to as much time as the participant desires
(opening the app, completing available content, and unlimited
meditation/reXection/journaling, etc. multiple times per day). At the end of
week 3 (timepoint 1) and week 6 (timepoint 2) the participants will
complete measures (PHQ9, GAD7, Coping 1, Coping 2, CDC HRQoL, SUS,
TAM) via REDCap survey. Participants will receive a $30 Amazon Gift Card
after completing timepoint 1 measures and a $30 Amazon Gift Card after
completing timepoint 2 measures. Step 5: At the end of week 8, eight
participants will be randomly selected from those who indicated in the Pilot
Study Pre-Screener Recruitment Questionnaire they would be interested in
participating in a post-pilot interview. Participants will take part in an
individual interview via Zoom with questions guided by the Post-Pilot
Interview Guide. The interview will last approximately 60 minutes.
Participants will receive a $30 Amazon Gift Card for completing the post-
pilot interview. Participants may continue using the prototype C-STRESS
application after the end of the 8-week pilot test, however the prototype C-
STRESS application will not be provided with any updates after the
completion of the pilot test. Pilot test participants will be notiSed via email
when the completed C-STRESS mobile application is available for
download.

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Confirmation of Changes:
Check here to conSrm that all changes to the protocol are listed above
End of amendment form!
Project Details
Specify the study title (this title should not exceed more than 100 words):
Developing C-STRESS, A Mobile App To Address Mental Health In College
Students
Lead Researcher/Investigator:
Enter the Lead Unit:
Project Screener
Submit a Human Subject Protocol for UCI Institutional Review Board (IRB)
Review
Will this protocol be reviewed under a sIRB process?
No, there is no reliance involved. UCI serves as the IRB of record
Are the research procedures limited to the use/analysis of identifiable private information
Melissa Dawn Pinto
***IR-8110 - ADMINISTRATION (Lead Unit)***

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and/or identifiable biospecimens (no subject contact)?
No
Select the required level of review for this protocol:
Minimal Risk (Expedited)
Check all sites where UCI investigator(s) will conduct research activities (e.g., recruitment,
informed consent, and research procedures including accessing identifiable, private
information about participants):
UCI Facilities or Sites (e.g. school, hospital or clinics, etc.)
Provide a non-technical summary of the proposed research that can be understood by
IRB/hSCRO members with varied research backgrounds, including non-scientists and
community members (this summary should not exceed more than 250 words):
Psychological distress among college students is increasing, and more
than 50% of U.S. college students report signiScant symptoms of
depression, anxiety or stress. Many of these students do not receive
professional help due to the long waiting time and lack of resources for
mental health services at universities. As a result, they may experience
poor performance in college, drop out of college, or even die of suicide. It is
thus crucial to provide new interventions that are aligned with the needs of
college students. C-STRESS addresses the mental health needs of college
students with an innovative mobile application to deliver Cognitively-Based
Compassion Training (CBCT®), a mind-training intervention that builds
skills of attention, mindfulness, and traditional cognitive behavioral
techniques, actualized through meditation, to cultivate compassion for self
and others. The ultimate goal of C-STRESS is to revolutionize the delivery
of CBCT and strengthen college students’ cognitive resilience to stress and
improve mental health outcomes. C-STRESS, a potential digital treatment
intervention for depressive symptoms. This research project involves:s a)a
focus groups and design workshops with 24 students in which they will
discuss their experiences with mental health and complete a brief
demographic survey and a survey about their experience participating in a

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focus group via Zoom; b) focus groups with an independent sample of 16
students in which they provide feedback on low-Sdelity or high-Sdelity C-
STRESS wireframes; c) a pilot study of the prototype C-STRESS app with an
independent sample of 20 students during which they use the app daily
and complete 7 measures of physical/mental health and coping styles at
three timepoints; and d) a post-pilot semi-structured interview to obtain
qualitative data to add in further app development with 8 of the 20
participants. All participants complete a demographic survey.
Instructions
IRB Protocol Instructions
• For research with a Master Protocol or with a detailed project proposal, specify this in
the protocol and an abbreviated protocol will be generated.
• Submit all new and/or revised supporting documents in the Protocol Attachments
section near the end of the protocol.
• The Lead Researcher (LR) is responsible for maintaining all supplemental
documentation (as indicated in the form) in the research records. This documentation
may be requested by Human Research Protections for quality assurance review.
For regulatory or institutional guidance:
• Visit Human Research Protections 
• Contact the Human Research Protections staff
For technical issues or questions:
• Visit the Kuali Research Protocols (KRP) User Guide
• Contact Electronic Research Administration (ERA)
Type of Research
The purpose, specific aims or objectives of the research is:

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Social/Behavioral/Educational
The research protocol is:
Investigator-Initiated
Does the investigator-initiated study have any industry support?
No
Is this study an extension of a UCI IRB approved study (e.g., resubmission of ongoing exempt
research; Open Label Extension) or is it otherwise related to a UCI IRB approved study?
No
Does this research meet the definition of a clinical trial that requires adherence to
Clinicaltrials.gov?
No
Level of Review
Minimal Risk - No more than minimal risk to subjects
Select the applicable category(ies):
6. Collection of data from voice, video, digital, or image recordings made
for research purposes
7. Research on individual or group characteristics or behavior (including,but
not limited to, research on perception, cognition, motivation, identity,
language, communication, cultural beliefs or practices, and social behavior)
or research employing survey, interview, oral history, focus group, program
evaluation, human factors evaluation, or quality assurance methodologies
Study Funding
Select the funding source(s) (check all that apply):

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Select the funding source(s) (check all that apply):
Grant/Contract
Select the sponsor type(s) (check all that apply):
Health and Human Services (HHS) (includes National Institutes of Health
(NIH)
List below all extramural proposals or awards that will support the study (if
applicable):
IMPORTANT! Skip this table if extramural funding is not available.
Sponsor Name
National Institutes of Health
Title of Proposal/Award (if different from study title):
Proposal or Award #:
Scientigc/Scholarly Review
Is the research Sponsor-Initiated?
Yes
The proposed research qualifies as minimal risk research. The Department Chair, Division
Chief, or Institute Director provides assurance that the research uses procedures consistent
with sound research design, the study design can be reasonably expected to answer the
proposed question, and the importance of the knowledge expected to result from the
research is known.
Check here to conSrm the above assurance
Potentially Hazardous Materials

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If any of the following hazardous materials are involved in this research please check below:
N/A
Other UCI Committee Reviews
Check all ancillary committees that apply:
N/A
Study Team
Study Team:
• List only study team members who are engaged in human subjects research below.
• Administrative Contact (AC): Do not add ACs to the study team table. To add
ACs, navigate to the Permissions tab on top-right-hand-side of form. All ACs
must complete the requisite Human Research Protections CITI Training.
• Lead Researcher (LR): LRs must meet requirements specified on the Lead Researcher
Eligibility page for study to be approved.
• Select ‘Oversight of Research’ along with other applicable duties.
• Select 'Full Access'.
• Faculty Sponsor (FS): FSs are required when the person serving the LR role is not
qualified to serve as LR-- the FS must be eligible to be LR.
• Select ‘Oversight of Research’ along with other applicable duties.
• Select 'Full Access'.  
• Co-Researcher (CR): CRs are faculty, staff, students and other academic appointees
who the LR considers to be key personnel for conducting the research study. These
individuals work closely with the LR to design, conduct, and/or report on the research.
 
• Research Personnel (RP): List RP as required per the Research Personnel Heat Map.

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For those RP who do not need to be listed on the protocol, they may be tracked by
alternative methods, see below.
 
• IMPORTANT! Do NOT list non-UCI researchers below, in the Permissions tab at top or
on the Study Team Tracking Log (or equivalent); instead, follow the Single IRB Reliance
(sIRB) process.
• Collaborative Institutional Training Initiative (CITI) Human Research Protections
Training Courses
• Confirm CITI training is complete and current for all study team members.
• Incomplete or expired CITI training will delay IRB approval.
• For more information, visit HRP Training and Education.
Researcher
Training
To promote the objectivity of the research, all researchers are required to disclose their
related disclosable financial interests, per the IRB COI Policy. If you have any questions
about the COI process in general, contact the COI team.
Each member of the study team for this protocol must be asked the following question to
comply:
“Do you, your spouse/registered domestic partner, and dependent children have any
disclosable financial interests* (i) that would reasonably appear to be affected by this
research study; or (ii) in entities whose financial interests would reasonably appear to be
affected by this research study?"
No
Melissa Dawn Pinto
Social/Behavioral Investigators - Refresher
Course
11/06/18 - 11/05/23
Research and HIPAA Privacy Protections
11/06/18 - 11/05/23
IRB-Mandated Compliance - Social/Behavioral
11/06/18 - 11/05/23

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Degree
PhD
Position/Title
Faculty, School of Nursing
Department
Affiliation
UCI Faculty
Researcher Role
Lead Researcher
Permissions
Full Access
Duties
Specify relevant training and experience for the referenced duties/responsibilities:
1. All study team members will be trained by Dr. Pinto (PI) on the protocol,
and will be required to demonstrate their ability to perform study
procedures by practicing with team members. A checklist consisting of
the different steps in the research protocol based on this IRB application
will be developed to ensure ongoing Sdelity of the protocol, and will be
completed by all study personnel. Dr. Pinto will also provide ongoing
oversight with research staff on a weekly basis through team meetings.
2. Not applicable
***IR-8110 - ADMINISTRATION (Lead Unit)***

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Researcher
Training
To promote the objectivity of the research, all researchers are required to disclose their
related disclosable financial interests, per the IRB COI Policy. If you have any questions
about the COI process in general, contact the COI team.
Each member of the study team for this protocol must be asked the following question to
comply:
“Do you, your spouse/registered domestic partner, and dependent children have any
disclosable financial interests* (i) that would reasonably appear to be affected by this
research study; or (ii) in entities whose financial interests would reasonably appear to be
affected by this research study?"
No
Degree
PhD
Position/Title
Faculty, School of Nursing
Department
Candace W Burton
Social/Behavioral Investigators - Refresher
Course
11/23/16 - 11/22/21
! Expired
Biomedical Investigators - Refresher Course
11/23/16 - 11/22/21
! Expired
***IR-8110 - ADMINISTRATION (Lead Unit)***

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Affiliation
UCI Faculty
Researcher Role
Co-Researcher
Permissions
Full Access
Duties
Specify relevant training and experience for the referenced duties/responsibilities:
see above
Researcher
Training
" Jonathan McIntyre has no training courses on Sle.
Jonathan Roland Stewart McIntyre

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To promote the objectivity of the research, all researchers are required to disclose their
related disclosable financial interests, per the IRB COI Policy. If you have any questions
about the COI process in general, contact the COI team.
Each member of the study team for this protocol must be asked the following question to
comply:
“Do you, your spouse/registered domestic partner, and dependent children have any
disclosable financial interests* (i) that would reasonably appear to be affected by this
research study; or (ii) in entities whose financial interests would reasonably appear to be
affected by this research study?"
No
Degree
Other
Degree Other
CNRA, PhD Student
Position/Title
PhD Student at UCI School of Nursing
Department
Affiliation
UCI Grad Student
Researcher Role
Co-Researcher
***IR-8110 - ADMINISTRATION (Lead Unit)***

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Permissions
Full Access
Duties
Specify relevant training and experience for the referenced duties/responsibilities:
see above
Researcher
Training
To promote the objectivity of the research, all researchers are required to disclose their
related disclosable financial interests, per the IRB COI Policy. If you have any questions
about the COI process in general, contact the COI team.
Each member of the study team for this protocol must be asked the following question to
comply:
“Do you, your spouse/registered domestic partner, and dependent children have any
disclosable financial interests* (i) that would reasonably appear to be affected by this
research study; or (ii) in entities whose financial interests would reasonably appear to be
affected by this research study?"
No
Degree
PhD
Rebecca W Black
Social/Behavioral Investigators - Basic Course
02/12/17 - 02/11/22
! Expired
Research and HIPAA Privacy Protections
02/02/21 - 02/01/26

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Position/Title
Department of Informatics/Donald Bren School of ICS; Faculty
Department
Affiliation
UCI Faculty
Researcher Role
Research Personnel
Permissions
Full Access
Duties
Specify relevant training and experience for the referenced duties/responsibilities:
see above
Researcher
IR-8062 - INFORMATICS
Gillian R Hayes

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Training
To promote the objectivity of the research, all researchers are required to disclose their
related disclosable financial interests, per the IRB COI Policy. If you have any questions
about the COI process in general, contact the COI team.
Each member of the study team for this protocol must be asked the following question to
comply:
“Do you, your spouse/registered domestic partner, and dependent children have any
disclosable financial interests* (i) that would reasonably appear to be affected by this
research study; or (ii) in entities whose financial interests would reasonably appear to be
affected by this research study?"
No
Degree
PhD
Position/Title
Department of Informatics/Donald Bren School of ICS; School of
Education; School of Medicine Robert A. and Barbara L. Kleist Professor
of Informatics;Faculty
Department
Social/Behavioral Investigators - Refresher
Course
04/21/16 - 04/20/21
! Expired
Social/Behavioral Investigators - Basic Course
11/05/21 - 11/04/26
Biomedical Investigators - Refresher Course
03/25/16 - 03/24/21
! Expired
***IR-8122 - GRADUATE DIVISION-OPERATIONS (Lead Unit)***

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Affiliation
UCI Faculty
Researcher Role
Co-Researcher
Permissions
Full Access
Duties
Specify relevant training and experience for the referenced duties/responsibilities:
see above
Researcher
Training
Sharnnia Artis
Social/Behavioral Investigators - Refresher Course
09/17/20 - 09/16/25

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To promote the objectivity of the research, all researchers are required to disclose their
related disclosable financial interests, per the IRB COI Policy. If you have any questions
about the COI process in general, contact the COI team.
Each member of the study team for this protocol must be asked the following question to
comply:
“Do you, your spouse/registered domestic partner, and dependent children have any
disclosable financial interests* (i) that would reasonably appear to be affected by this
research study; or (ii) in entities whose financial interests would reasonably appear to be
affected by this research study?"
No
Degree
PhD
Position/Title
Dean of Osce of Access and Inclusion for Engineering and Information
Sciences
Department
Affiliation
UCI Faculty
Researcher Role
Research Personnel
Permissions
Full Access
IR-7343 - DO STUDENT AFFAIRS

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Duties
Specify relevant training and experience for the referenced duties/responsibilities:
see above
Researcher
Training
" Heather Abrahim has no training courses on Sle.
To promote the objectivity of the research, all researchers are required to disclose their
related disclosable financial interests, per the IRB COI Policy. If you have any questions
about the COI process in general, contact the COI team.
Each member of the study team for this protocol must be asked the following question to
comply:
“Do you, your spouse/registered domestic partner, and dependent children have any
disclosable financial interests* (i) that would reasonably appear to be affected by this
research study; or (ii) in entities whose financial interests would reasonably appear to be
affected by this research study?"
No
Degree
Other
Degree Other
RN PhD Student
Heather Lynn Abrahim

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Position/Title
PhD Student at UCI School of Nursing
Department
Affiliation
UCI Grad Student
Researcher Role
Co-Researcher
Permissions
Full Access
Duties
Specify relevant training and experience for the referenced duties/responsibilities:
see above
Researcher
Training
***IR-8110 - ADMINISTRATION (Lead Unit)***
Lucretia Williams
Social/Behavioral Investigators - Basic Course
07/12/19 - 07/10/24
Research and HIPAA Privacy Protections
02/01/21 - 01/31/26

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To promote the objectivity of the research, all researchers are required to disclose their
related disclosable financial interests, per the IRB COI Policy. If you have any questions
about the COI process in general, contact the COI team.
Each member of the study team for this protocol must be asked the following question to
comply:
“Do you, your spouse/registered domestic partner, and dependent children have any
disclosable financial interests* (i) that would reasonably appear to be affected by this
research study; or (ii) in entities whose financial interests would reasonably appear to be
affected by this research study?"
No
Degree
Other
Degree Other
PhD Student
Position/Title
PhD Student at UCI Department of Informatics
Department
Affiliation
UCI Grad Student
Researcher Role
Co-Researcher
IR-8062 - INFORMATICS

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Permissions
Full Access
Duties
Specify relevant training and experience for the referenced duties/responsibilities:
see above
Are RP tracked outside the approved protocol, in accordance with the RP Heat Map?
Yes, RP are tracked on a Study Team Log or other comparable log
Supplemental Documents
Does this study include supplemental documents?
No
Background & Purpose of the Research
Describe the purpose, specific aims or objectives and specify the hypotheses or research
questions to be studied:
Employ user-centered design (UCD) methodology, to develop a prototype C-
STRESS that leverages focus group sessions with 40 subjects (college
students) , a series of three design workshops with selected participants
from focus group sessions. The second part of this project involves
additional focus groups with an independent sample (n=16) college
students to obtain additional feedback before pilot. A pilot test with an
independent sample (n=20) of college students in which subjects will use
the app and complete 5 measures at 3 timepoints(Baseline, 3 and 6 weeks
after beginning to use the app).. Of the 20 participants who participated in

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the pilot, 8/20 will be invited to complete individual an approximately
60minute semi-structured interview regarding the app.
Provide the scientific or scholarly rationale for the research and describe the relevant
background information and the specific gaps in current knowledge that this study intends to
address:
More than half of U.S. college students experience signiScant symptoms of
depression, anxiety or stress, and three-fourths of these college students
do not obtain professional help due to overburdened mental health
services at universities and colleges. Prevalence of mental disorders and
inadequate utilization of mental health services is a particularly severe
problem for minority students and community college students. CBCT has
been administered to a variety of populations, including college students
(undergraduate students, medical school students) and younger
adolescents in prior completed studies, that collectively showed that CBCT
can signiScantly strengthen cognitive resilience to stress and substantially
reduce depressive symptoms, stress-associated systemic inXammation
(pro-inXammatory markers), improved emotional regulation (including
impulse control) and mindfulness; increase compassion, and improve
empathetic accuracy (measured by fMRI) - a critical skill that aims at
cultivating relationships and connection to others. Currently, as a face-to-
face program, CBCT certiScation at Emory takes 1 year to complete, and
there are only 48 CBCT instructors. Due to the course duration, location,
and time-intensive requirement for certiScation, CBCT has limited reach
and scalability in its current instructional model despite growing demands.
This prompted us to explore the possibility of incorporating CBCT in a
mobile app and we intend to use the ADAPT-ITT model, the most widely
used model for behavioral intervention adaptation, to successfully adapt
the existing CBCT curriculum for C-STRESS.
Provide relevant preliminary data (animal and/or human):
please complete
Describe the primary outcome variable(s), secondary outcome variables, and predictors

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and/or comparison groups as appropriate for the stated study objectives/specific aims:
please complete
List up to ten relevant references/articles to support the rationale for the research:
1. Thielking M. A dangerous wait: Colleges can’t meet soaring student
needs for mental health care. STAT.
https://www.statnews.com/2017/02/06/mental-health-college-students/.
Published 2017. 2. Pinto MD, DiClemente RJ, Higgins MK, Greenlatt AM,
Negi LT, Abbott KL KA. Cognitively-Based Compassion Training (CBCT®):
Promising intervention to improve depressive symptoms, self-regulation,
attention, and executive function. Rev. 3. Jennifer S. Mascaro, Sean Kelley,
Alana Darcher, Lobsang Tenzin Negi, Carol Worthman AM& CR. Meditation
buffers medical student compassion from the deleterious effects of
depression. J Posit Psychol. 2016;(1743-9760 (Print) 1743-9779 (Online)).
http://www.tandfonline.com/loi/rpos20. 4. Desbordes G, Negi LT, Pace
TWW, Wallace BA, Raison CL, Schwartz EL. Effects of mindful-attention and
compassion meditation training on amygdala response to emotional
stimuli in an ordinary, non-meditative state. Front Hum Neurosci. 2012;6.
doi:10.3389/fnhum.2012.00292. 5. Eisenberg D, Goldrick-Rab S, Lipson SK,
Broton K. Too Distressed to Learn? Wisconsin HOPE LAB. 2016;(March). 6.
Rebecca A. Vidourek, Keith A. King, Laura A. Nabors and ALM. Students’
beneSts and barriers to mental health help-seeking. Heal Psychol Behav
Med. 2014;2(1):1009-1022. 7. Paola Pedrelli, Maren Nyer, Albert Yeung,
Courtney Zulauf and TW. College Students: Mental Health Problems and
Treatment Considerations. Acad Psychiatry. 2015;39(5):503-511. 8. CB D.
Processes of mental health service use by adolescents with depression. J
Nurs Sch. 2005;37(2):155-162. 9. Liu CH, Chen JA, Stevens C, Wong SHM,
Yasui M. The prevalence and predictors of mental health diagnoses and
suicide among U . S . college students : Implications for addressing
disparities in service use. Anxiety Depress Assoc Am. 2018;(January):1-10.
doi:10.1002/da.22830. 10. Suicide. National Institute of Mental Health
(NIMH). https://www.nimh.nih.gov/health/statistics/suicide.shtml.
Accessed January 3, 2018.

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Subject Population(s) (Individuals/Records/Biospecimens)
Check all subject populations/data sources that apply to the research:
Adults Competent to Provide Informed Consent
UCI Students/Staff/Faculty
Use of identiSable or coded data, specimens, records, charts
Maximum and Expected Number of Persons/Records/Biospecimens to be Enrolled
1. Click "Add Line" button above Enrollment Table to add a Category/Group
a. To change visibility of columns, click "Columns" button above Enrollment Table and
select which Column rows to view.
2.  Specify the maximum and expected numbers of individual-level information and/or
biospecimens to be accessed/analyzed within each Category/Group
Category/Group
Undergraduate or graduate college students (focus groups)
Age Range
18-25 years
Maximum Number of Subjects, Subjects to be Consented or Reviewed/Collected
50
Number Expected to Complete the Study or Needed to Address the Research Question
24
Category/Group
Undergraduate or graduate college students (design workshops)
Age Range
18-25 years

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Maximum Number of Subjects, Subjects to be Consented or Reviewed/Collected
50
Number Expected to Complete the Study or Needed to Address the Research Question
24
Category/Group
Undergraduate or graduate students (focus groups)
Age Range
18-30
Maximum Number of Subjects, Subjects to be Consented or Reviewed/Collected
30
Number Expected to Complete the Study or Needed to Address the Research Question
16
Category/Group
Undergraduate or graduate studentsn(pilot test)
Age Range
18-30
Maximum Number of Subjects, Subjects to be Consented or Reviewed/Collected
40
Number Expected to Complete the Study or Needed to Address the Research Question
20

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Will this study only take place at UCI and does not involve other sites?
Yes
Eligibility Factors (Inclusion/Exclusion Criteria)
1. Click "Add Line" button above Eligibility Factors Table to add a inclusion/exclusion criteria
a. To change visibility of columns, click "Columns" button above Eligibility Factors
Chart and select which Column rows to view.
2. Identify the factors for limited eligibility and provide a scientific rationale. Include
additional rows for factors, as needed.
Category/Group Eligibility
Undergraduate or graduate students
Inclusion Criteria
Inclusion criteria: Young adults must be (a) undergraduate or graduate
students; (b) enrolled at University of California Irvine (UCI),); (c) between
the ages of 18-30, which is representative of the age group for the target
population i.e. young adults; (d) speak and understand English; (e) have
access to the internet for 8 weeks to participate in study activities via
Zoom or attend in person (if safe and feasible given Covid-19 pandemic)
(f) report clinically signiScant depression (scores ≥ 10 on the PHQ-9),and
(g) have a smartphone with either iOS or android operating system.
Exclusion Criteria
Exclusion criteria: (a) Potential subjects who report active suicidal
ideation will be excluded unless they obtain a written note from a
psychiatric provider; (b) Female student who self-report pregnancy or
plans to become pregnant within the next 3 months
Is eligibility based on age, gender, pregnancy/childbearing potential, social/ethnic group, or
language spoken (e.g., English Speakers only)?
Yes
Limited Eligibility Factors (Special Populations)

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1. Click "Add Line" button above Limited Eligibility Factors Table to add a special population
a. To change visibility of columns, click "Columns" button above Limited Eligibility
Factors Table and select which Column rows to view.
2. Identify the special populations and provide a scientific rationale. Add additional rows, as
needed.
Eligibility Limited to the Following Factors
Other Factors
Specify the rationale for this group:
Subject eligibility is based on a numbers of factors including: age – we
plan on recruiting young adults between the ages 18-30 years as our
focus is on mental health among young adults, and proSciency in English
– we will only recruit individuals who can speak and understand English;
we do not expect this criterion to discriminate against potential subjects
since the study is set in a college that provides instructions in English.
We also plan on excluding females who self-report pregnancy or plans to
become pregnant to avoid inclusion of post-partum depression, which is
thought to have a potentially different biological etiology/contributors
than depression from non-childbearing women.
Pre-Screening and Determining Eligibility without Informed Consent
Will Identifiable information be obtained for the purpose of screening, recruiting, or
determining eligibility of prospective subjects?
No
Recruitment Methods
Will this study involve NO direct contact with participants (i.e., passive observation of public
behavior)?
No

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Indicate all methods that will be used to recruit subjects for this study:
Recruitment Method
Flyers/Brochures
Specify Where Posted
Part One: Focus Group Potential subjects will be approached through
print ads or email ad or electronic posting of Xyer on UCI websites or
asliated social media and locations in and around UCI campus. Emails
(email will use the Xyer, and a short message from me, the investigator
(see attachment labeled “email/social media message”), will be sent on
behalf the investigator through individuals working in student services in
different departments on UCI campus. Our student services director at
the school of nursing is able to connect with other departments and ask
if they would be willing to send a Xyer out on my behalf to invite
interested students to contact the investigative team. Also, the school of
nursing social media accounts will be used and the Xyer will be used to
notify followers who may meet criteria are aware of the potential study.
Our school social media colleague in the school of nursing has
connections across and we will push out the study Xyer on UCI social
media accounts. Potential subjects will contact us via telephone or email.
Potential subjects will be provided a link to a secure Red Cap survey
which will describe the study,askscreening questions for eligibility, and
provide a list of mental health resources. If subjects are eligible and
interested in participating, they will select a date/time for focus group
participation and provide the research team their email or phone contact
information. Part Two: Design Oriented Focus Groups Focus group
participants will be invited to continue with this project by participating in
up to three more focus groups, which will have a focus on co-design
activities. Potential subjects will be contacted via email following the
focus group if stated interest in design workshop proposes at the end of
focus group. Part Three: Focus Groups Potential subjects will be
h d th
h
i t d
il
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t
i
ti
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approached through print ads or email and/or electronic posting of Xyer
on UCI websites or asliated social media and locations in and around
UCI campus. Emails (email will use the Xyer, and a short message from
me, the investigator (see attachment labeled “email/social media
message”), will be sent on behalf the investigator through individuals
working in student services in different departments on UCI campus. Our
student services director at the school of nursing is able to connect with
other departments and ask if they would be willing to send a Xyer out on
my behalf to invite interested students to contact the investigative team.
Also, the school of nursing social media accounts will be used and the
Xyer will be used to notify followers who may meet criteria are aware of
the potential study. Our school social media colleague in the school of
nursing has connections across and we will push out the study Xyer on
UCI social media accounts. Potential subjects will contact us via
telephone or email. Potential subjects will be provided a link to a secure
Red Cap survey which will describe the study, ask screening questions for
eligibility, and provide a list of mental health resources. If subjects are
eligible and interested in participating, they will select a date/time for
focus group participation and provide the research team their email or
phone contact information by phone or email. Eight participants will be
included in the Srst focus group which will provide the research team with
feedback on low-Sdelity wireframes. Based on feedback from focus
group one participants, the research team will create high-Sdelity
wireframes. Eight participants will participate in the second focus group
which will provide the research team with feedback on high-Sdelity
wireframes. Part Four: Pilot Testing Potential subjects will be approached
in the same manner as prior parts of this protocol. If subjects are eligible
and interested in participating, they will select a date/time to meet with a
member of the study team to download the C-STRESS application,
complete the app on-boarding process, and receive pilot test instructions.
At the time of enrollment, participants will be asked if they would like to
be involved in one follow-up interview (Part Five) for approximately 60
minutes about their experience using the app. Part Five: 8 participants
will be randomly selected from the Part 4 participants who expressed
i t
t i th f ll
i t
i
Th
8
ti i
t
ill
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interest in the follow-up interview. These 8 participants will complete a
post-pilot interview lasting approximately 60 minutes.
Type of Space
Public (i.e., site/media that allows open access to content)
Recruitment Method
Online/Social Media
Specify Where Posted
Part One: Focus Group Potential subjects will be approached through
print ads or email ad or electronic posting of Xyer on UCI websites or
asliated social media and locations in and around UCI campus. Emails
(email will use the Xyer, and a short message from me, the investigator
(see attachment labeled “email/social media message”), will be sent on
behalf the investigator through individuals working in student services in
different departments on UCI campus. Our student services director at
the school of nursing is able to connect with other departments and ask
if they would be willing to send a Xyer out on my behalf to invite
interested students to contact the investigative team. Also, the school of
nursing social media accounts will be used and the Xyer will be used to
notify followers who may meet criteria are aware of the potential study.
Our school social media colleague in the school of nursing has
connections across and we will push out the study Xyer on UCI social
media accounts. Potential subjects will contact us via telephone or email.
Potential subjects will be provided a link to a secure Red Cap survey
which will describe the study,askscreening questions for eligibility, and
provide a list of mental health resources. If subjects are eligible and
interested in participating, they will select a date/time for focus group
participation and provide the research team their email or phone contact
information. Part Two: Design Oriented Focus Groups Focus group
participants will be invited to continue with this project by participating in
t
th
f
hi h
ill h
f
d
i

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up to three more focus groups, which will have a focus on co-design
activities. Potential subjects will be contacted via email following the
focus group if stated interest in design workshop proposes at the end of
focus group. Part Three: Focus Groups Potential subjects will be
approached through print ads or email and/or electronic posting of Xyer
on UCI websites or asliated social media and locations in and around
UCI campus. Emails (email will use the Xyer, and a short message from
me, the investigator (see attachment labeled “email/social media
message”), will be sent on behalf the investigator through individuals
working in student services in different departments on UCI campus. Our
student services director at the school of nursing is able to connect with
other departments and ask if they would be willing to send a Xyer out on
my behalf to invite interested students to contact the investigative team.
Also, the school of nursing social media accounts will be used and the
Xyer will be used to notify followers who may meet criteria are aware of
the potential study. Our school social media colleague in the school of
nursing has connections across and we will push out the study Xyer on
UCI social media accounts. Potential subjects will contact us via
telephone or email. Potential subjects will be provided a link to a secure
Red Cap survey which will describe the study, ask screening questions for
eligibility, and provide a list of mental health resources. If subjects are
eligible and interested in participating, they will select a date/time for
focus group participation and provide the research team their email or
phone contact information by phone or email. Eight participants will be
included in the Srst focus group which will provide the research team with
feedback on low-Sdelity wireframes. Based on feedback from focus
group one participants, the research team will create high-Sdelity
wireframes. Eight participants will participate in the second focus group
which will provide the research team with feedback on high-Sdelity
wireframes. Part Four: Pilot Testing Potential subjects will be approached
in the same manner as prior parts of this protocol. If subjects are eligible
and interested in participating, they will select a date/time to meet with a
member of the study team to download the C-STRESS application,
complete the app on-boarding process, and receive pilot test instructions.
At th ti
f
ll
t
ti i
t
ill b
k d if th
ld lik t

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At the time of enrollment, participants will be asked if they would like to
be involved in one follow-up interview (Part Five) for approximately 60
minutes about their experience using the app. Part Five: 8 participants
will be randomly selected from the Part 4 participants who expressed
interest in the follow-up interview. These 8 participants will complete a
post-pilot interview lasting approximately 60 minutes.
Type of Space
Private (i.e., site/media that allows control of access to content)
Recruitment Method
Email/Postal Mail/Phone
Specify how contact information will be obtained:
Informed Consent Process
Does this study involve the creation, use, or disclosure of Protected Health Information (PHI)?
No
Methods of Informed Consent
Identify the consent or assent process as applicable for each participant population (check
all that apply):
Oral/Implied informed consent/assent (no signature)
Oral/Implied Informed Consent/Assent
Indicate the waiver of signed informed consent/assent (check all that apply):
Waiver of Signed Informed Consent (oral consent obtained)
D
thi
l
t
i
l d
ll
bj
t ?

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Does this oral consent process include all subjects?
No
Specify cohort:
please complete previous question / verify for accuracy
REQUIRED! Submit a Study Information Sheet in the Attachments Section
UCI IRB requires ALL of the following:
• An IRB-approved Study Info Sheet will be presented prior to administering research
procedures,
• Subjects verify they meet the eligibility criteria,
• Subjects indicate their willingness to participate in the research (e.g., click “Yes”)
You selected Minimal Risk (Expedited) or Greater than Minimal Risk (Full Committee)
Research for the Level of Review.
Check here to conSrm you will complete the Waiver of Documentation
Section
Circumstances of Consent
Indicate the location where the consent process will take place (check all that apply):
Internet
Specify how the research team will assure that subjects, their parents, or their legally
authorized representative (LAR) have sufficient time to consider whether to participate in the
research:
Other
Specify 'Other' timeframe:
Focus Group and Pilot Test: The study team will screen for the
inclusion/exclusion criteria using a secure REDCap survey, and the study
will be described in the survey narrative. Potential focus group participants
who select a date/time or potential pilot study participants who select a
date/time to meet with a study team member for onboarding will receive

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an electronic copy of the Study Information Sheet ahead of time via email
prior to the focus group/meeting with study team member. The potential
participant will be given the opportunity to request a copy of the study
information sheet in the mail as well.
This study does NOT include Non-English Speaking Participants. Scientific
justification/rationale is required in the Eligibility Criteria Section for Subject Populations.
Waiver of Documentation
Select the option for the Waiver of Documentation (Signed) Informed Consent:
OPTION B (*Most Common*): The research presents no more than minimal
risk of harm to subjects and involves no procedures for which written
consent is normally required outside of the research context
OPTION B (*Most Common*): The research presents no more than minimal risk of harm to
subjects and involves no procedures for which written consent is normally required outside
of the research context
Does the research involve no more than Minimal Risk? [45 CFR 46.116(f)(3)(i)]
Yes
Will the subject be provided with a Study Information Sheet or other document that addresses
the basic elements of informed consent?
Yes
Would the research procedures normally require a signed consent form outside the research
environment?
No
Select the following research procedures
that do not normally require signed consent
(Check all that apply):
I t
i
/F
Specify and provide the rationale for 'Other'
research procedures:
Discussing one’s experience with

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Interview/Focus
Group/Survey/Questionnaire
Other research procedures
mental health and providing
information about their experience
of engaging with a focus group
could be topics that individuals
discuss in daily life, and really pose
minimal risk, and would not require
consent to engage in these
activities in daily life.
Research Procedures
Check all boxes that apply to the research:
Audio, Video, Digital or Image Recording and/or Photography for Collection
of Research Data
Surveys/Questionnaires/Interviews/Oral Histories
Will deception or incomplete disclosure be involved in the research?
No
Study Design
Include an explanation of the study design (e.g., randomized placebo-controlled, cross-over,
cross-sectional, longitudinal, etc.) and, if appropriate, describe stratification/
randomization/blinding scheme:
Focus groups, questionnaires, and semi-structured interviews
Provide precise definitions of the study endpoints and criteria for evaluation; if the primary
outcomes are derived from several measurements (i.e., composite variables) or if endpoints
are based composite variables, then describe precisely how the composite variables are
derived:
Study endpoints are completion of focus group(s), end of pilot test, and
end of semi-structured interviews. Outcomes are derived from thematic
analysis of focus group and interview narratives and from results of
usability/acceptability measures.

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y
p
y
Statistical Considerations
Is a statistical analysis plan appropriate for this qualitative study design?
No
Specify a non-statistical analysis plan for assessing study results:
please complete previous question/verify for accuracy
Research Procedures
Provide a detailed chronological description of the clinical or treatment plan:
Part One: Focus Group- This research will be conducted at UCI via Zoom
(because of Covid, there is a low potential for face-to-face data collection
without increasing risk). Each subject will participate in only one focus
group, but there will a series of focus groups conducted to obtain data for
the number of potential subjects outlined in this application. Each focus
group will be approximately an hour and a half long in duration. As part of
participating in these focus group sessions, subjects will also complete a
short demographic survey (age, gender, race, ethnicity, education, and
socioeconomic status) via RedCap as well as brief survey about their
experience of participating in a focus group via Zoom. Part Two: Design-
Oriented Focus Groups - A series of 3 design workshop settings will be
conducted at UCI via Zoom (because of COVID, there is a low potential for
face-to-face data collection without increasing risk). Each participant will
be asked to participate in all three sessions, but they will not be required to
attend all three. Each design workshop will be approximately 90 to 120
minutes. As a part of participating in these groups, participants will be
asked to revisit some of the themes discussed in their initial focus groups
as well as to view and critique existing mental health apps available in the
app store – a sample list of questions is attached, but that list will be
curated based on the results of the focus groups – and discuss what
technologies might be most useful to them. Between focus groups, the
research team will sketch and design prototype versions of the concepts
discussed during the groups and then return these prototypes for critique

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g
g
p
p
yp
q
and discussion at the following session. Part Three: Focus Group - This
research will be conducted at UCI via Zoom (because of Covid, there is a
low potential for face-to-face data collection without increasing risk). Each
subject will participate in only one focus group.There will be two focus
groups to obtain data for the number of potential subjects outlined in this
application. The Srst focus group will view and be asked to provide
feedback on low-Sdelity wireframes of the C-STRESS mobile application
being developed. The feedback from the Srst focus group will be used by
the research team to develop high-Sdelity wireframes. The second focus
group will view and be asked to provide feedback on the high-Sdelity
wireframes. Each focus group will be approximately an hour and a half long
in duration. As part of participating in these focus group sessions, subjects
will also complete a short demographic survey (age, gender, race, ethnicity,
education, and socioeconomic status) via REDCap. Part Four: Pilot Test –
This research will be conducted at UCI via Zoom (because of COVID, there
is a low potential for face-to-face data collection without increasing risk).
Participants will complete a short demographic survey (age, gender, race,
ethnicity, education, and socioeconomic status) and 5 brief online
questionnaires (PHQ9, GAD7, CDC HRQOL4, Coping Styles 1 and Coping
Styles 2) via REDCap. Participants will meet with a study team member
who will walk them through the process of downloading the C-STRESS
mobile application to their personal smart phone (prototype application will
be available for both iOS and android operating systems) and initial
application on-boarding. Participants will be provided an opportunity to
orient themselves/interact with the application for approximately 5-15
minutes with the study team member available to answer
questions/provide technical assistance. After onboarding and app
orientation, the participant will complete usability and acceptability
measures (SUS and TAM) (baseline measurement). This initial meeting and
completion of online survey/questionnaires will last approximately 1 hour.
Participants will be asked to use the C-STRESS app daily for 8 weeks. The
minimum amount of time the participants will interact with the app each
day is approximately 2 minutes. The participants will be able to interact
with the C-STRESS app for longer if they so choose; it is entirely up to them

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pp
g
y
y p
based on the activities they choose to do in the app. At the end of weeks 3
(data point 2) and 6 (data point 3), participants will complete 7 online
measures (SUS, TAM, PHQ9, GAD7, CDC HRQOL4, Coping Styles 1 and
Coping Styles 2) (data point 2). These measures will take approximately 30
minutes to complete. Part Five Follow-Up Post-Pilot Semi-Structured
Interview-At the end of week 8, eight randomly selected participants who
participated in part four will be asked to participate in a post-pilot interview
via Zoom. The interview will last approximately 60 minutes.
List all procedures involving the use and/or collection of photographs, or audio/video
recording:
Part one Focus groups, part two design workshops, part four pilot test on-
boarding, and part Sve post-pilot interviews will be completed via Zoom.
The subjects will have the option to turn on their camera if they would like
to be seen. If they do not wish to be seen, they will be able to participate
using audio only. Prior to the scheduled Zoom session, subjects will be
provided information on how to change their screen name if they do not
want their name/full name to be seen by others.. Subjects will be reminded
that the Zoom session will be recorded from Zoom--both audio and video.
Specify the total duration of a subject’s participation in the study and clearly outline the
duration of participation for each study visit and sub-study, as applicable:
Part 1 focus groups = 1 - 1.5 hours Part 2 focus groups = 1.5 - 2 hours Part
2 participants a subgroup of part 1 participants Part 3 focus groups = 1.5
hours Part 3 participants an independent sample Part 4 pilot test = 4 hours
(Initial meeting and completion of online survey/questionnaires = 1 hour;
Interaction with mobile application = minimum of 2 minutes per day for 8
weeks (total of approx. 2 hours) up to as much time as the participant
wants to spend interacting with the mobile application per day for 8 weeks;
completion of online measures at data points 2 and 3 = 1 hour total) Part 4
participants an independent sample Part 5 semi-structured interviews = 1
hour Part 5 participants a subgroup of part 4 participants
List data collection tools (e.g., measures, questionnaires, observational tool) below by clicking
the 'Add Line' button. Include additional rows for study instruments, as needed:

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The 'Columns' button allows you to display or hide columns in the Study Instrument List.
Name of Tool:
Data will be collected through focus groups; an 18-item questionnaire
based on the System Usability Scale (SUS), two 6-item scales based on
the Technology Acceptance Model (TAM), PHQ9, GAD7, CDC HRQOL4,
Coping 1, Coping 2 questionnaires; a demographic survey; and a post-
pilot interview All potential subjects will complete the PHQ-9 to determine
eligibility.All surveys, measures, and questionnaires will be completed via
REDCap link. Part 1 –Focus group participants will complete a short
demographic survey and a survey about their experience participating in
a focus group via Zoom. Focus groups will be guided by the focus group
question guide(s) included with this application Part 2 – Design
workshop participants will complete a short demographic survey. Part 3
– Focus group participants will complete a short demographic survey.
Focus group will be guided by the focus group guides low-Sdelity FG and
high-Sdelity FG included with this application Part 4 – Pilot test
participants will complete a short demographic survey; SUS, TAM, PHQ9,

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GAD7, CDC HRQOL4, Coping 1, and Coping 2 questionnaires at baseline,
the end of week 3 and the end of week 6 of the pilot study. Part 5 – Post-
pilot interview participants will complete a short demographic survey and
an approximately 60 minute interview guided by the Post-Pilot Interview
guide included with this application.
Is the data collection tool standardized or validated?
No, submit a copy of the draft or Snal tool in the Attachments Section
Will this study require clinical items/ services from UC Irvine Health?
No
Does the research involve the use of identifiable private information?
No
Sharing Results with Subjects
Will Individual results be shared with subjects?
No
Will overall study results will be shared with subjects?
N/A, Snal study results will not be shared with subjects
Risk Assessment
Risks and Discomforts
1. Describe and assess any reasonably foreseeable risks and discomforts associated with
each procedure for each subject population — physical, psychological, social, legal or other:
2. If this study will involve the collection of identifiable private information, even temporarily,
for which the disclosure of the data outside of the research could reasonably place the
subjects at risk, include the risk of a potential breach of confidentiality:
P
ibl
i k /di
f
t
i t d
ith th
t d
i k f
f
li
di
f
t i

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Discuss what steps have been taken and/or will be taken to prevent and minimize any
risks/potential discomforts to subjects:
The two primary potential risks in this study are (1) subject could
potentially feel discomfort in discussing mental health—some people Snd
to be a sensitive topic—and (2) potential risk for breach of conSdentiality.
(1) To minimize potential risk for (1), we will instruct all subjects that they
may decline to answer any questions they do not want to answer or makes
them feel uncomfortable. Subjects do not have to use their real names and
can create an alias name to use for the Zoom focus group and design
workshops. All subjects will be supplied with a mental health resource
sheet during initial eligibility screening and at the beginning of the study so
they can seek assistance if needed. (2) To minimize potential risk (2), we
will ensure the information collected by the C-STRESS application will be
protected with password access and designed with security standards that
are HIPAA-compliant for security and privacy.
Certificate of Confidentiality
Is the research partially or wholly funded by NIH (including NIH Institutes and Centers), or
does the research involve identifiable sensitive information that require CoC protections?
Yes
Indicate whether the research is protected by a NIH Certificate of Confidentiality (CoC):
This research is partially or wholly funded by NIH, including NIH Institutes
and Centers. A CoC is automatically issued
Indicate in what situations identifiable private information protected by a CoC will be
Possible risks/discomforts associated with the study are risk for feeling discomfort in
discussing (focus group) mental health because some people find this to be a sensitive topic. A
second potential risk is breach of confidentiality. However, please know we will safeguard data to
the best of our ability, and we will follow all procedures described in this application to protect
data and ensure the security of data.  
[ ü ] This study involves the collection of participant identifiable data (even if temporary such as
for recruitment or compensation purposes), and as such, a breach of confidentiality is a risk
associated with the research.

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Indicate in what situations identifiable private information protected by a CoC will be
disclosed (check all that apply):
As required by Federal, State, or local laws, excluding instances of
disclosure in any Federal, State, or local civil, criminal, administrative,
legislative, or other proceeding. Some examples are laws that require
reporting of child or elder abuse, some communicable diseases, and
threats to harm yourself or others
When necessary for the medical treatment of the individual to whom the
information, document, or biospecimen pertains and disclosed with the
consent of such individual
Disclosed with the consent of the individual to whom the information,
document, or biospecimen pertains
Disclosed for the purposes of other scientiSc research that is in
compliance with applicable Federal regulations governing the protection of
human subjects in research
Potential Benefits
Is there the prospect of a direct benefit anticipated for subjects?
No
Specify the expected potential societal/scientific benefit(s) of this study:
However we believe there are potential beneSts to society. The subjects’
opinions and feedback will help the study team develop a mobile app that
would be available to general public of college students to help them with
their mental health. We believe this research could also help advance
knowledge in the Seld of college mental health and the use of mobile
applications to better promote the mental health of college students in the
future.
Alternatives to Participation
Describe the alternatives to participation in the study available to prospective subjects.
Include routine (standard of care) options as well as other experimental options, as
applicable (check all that apply):

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applicable (check all that apply):
No alternatives exist. The only alternative to study participation is not to
participate in the study
Participant Compensation
Will subjects be compensated or reimbursed?
Yes
Specify whether compensation is applicable and, if so, the method, amount and schedule of
compensation (Check all that apply):
Gift Card
Specify gift card type and amount:
Amazon gift cards - see schedule
Gift Card schedule:
Other
Specify 'Other' gift card schedule:
Subjects will be compensated with the following schedule: Part one
Focus Group: Subjects will receive $30 monetary compensation in the
form of a gift card for focus group participation and brief demographic
and Zoom Focus Group Experience survey. Part two Design-Oriented
Workshops: Subjects will receive $30 monetary compensation in the
form of a gift card for each session in which they participate.
Participants that complete the focus group and all design work shops
will receive an additional $30 in giftcards. In summary, participants who
complete the focus group and all design workshops will for a total max
compensation of $150. Part three focus groups: Subjects will receive
$30 monetary compensation in the form of a gift card for participating
in the focus group session. Part four pilot test: Participants will receive
a total of $80 monetary compensation in the form of gift cards for

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a total of $80 monetary compensation in the form of gift cards for
participation in the pilot study according to the following schedule: $20
gift card after completing demographic survey, downloading C-STRESS
app, completing on-boarding, and completing baseline measures (SUS,
TAM, PHQ9, GAD7, CDC HRQOL4, Coping 1, Coping 2); $30 gift card
after completing 7 measures (SUS, TAM, PHQ9, GAD7, CDC HRQOL4,
Coping 1, Coping 2) at end of week 3; $30 gift card after completing 7
measures (SUS, TAM, PHQ9, GAD7, CDC HRQOL4, Coping 1, Coping 2)
at end of week 6. Part Sve - Eight randomly selected pilot study
participants will be invited to complete a post-pilot interview to provide
feedback about C-STRESS. Participants that take part in this interview
will receive a $30 gift card.
Will the gift card compensation method include all subjects?
Yes
Will subjects be reimbursed for out-of-pocket expenses?
No
Congdentiality of Research Data
Information and/or Biospecimens Storage
Indicate how information and/or biospecimens (including signed consent forms) will be
stored (check all that apply):
Information will be maintained electronically. Information will be password
protected and maintained in an encrypted format
Encrypted Format
Specify where the information will be maintained electronically:
Data will be stored at UCI in RedCap or Qualtrics Data will be stored as

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Data will be stored at UCI, in RedCap or Qualtrics. Data will be stored as
an encrypted Sle with password protection on a secure drive that is
HIPAA-compliant for security and privacy maintained by UCI.
Will subject/patient identifiers be collected or retained?
Yes
Subject/Patient Identifiers
Will any subject/patient identifiers be collected or retained for data analysis, recruitment,
consenting and/or compensation (check all that apply)?
All elements of dates (except year) for dates that are directly related to an
individual: birth date, admission date, discharge date, death date, and all
ages over 89
Email addresses
Full-face photographs and any comparable images
Names
Telephone numbers
Will a code be used to link subject/patient identifiers with the information and/or
biospecimens?
A code will be used. Subject/Patient identiSers will be kept separately from
the information and/or biospecimens. The code key will be destroyed at
the earliest opportunity, consistent with the conduct of this research
Will research data/biospecimens be transported or maintained on portable devices (e.g.,
laptop, smartphone, external hard drive, etc.)?
No
Specify who will have access to
subject/patient identifiable
information/biospecimens as part of this
protocol (check all that apply):
Authorized UCI personnel (such as
the research team) and appropriate
institutional oscials: such as the
Specify 'Other' group or personnel who will
have access to subject/patient identifiable
information/biospecimens:
Non-UCI collaborating researchers
(see Appendix U)

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institutional oscials: such as the
Osce of Human Research
Protections (OHRP) Regulatory
entities such as the Food and Drug
Administration (FDA), the National
Institutes of Health (NIH)
Other
Specify whether subject/patient identifiers be disclosed in presentations and/or publications:
Subject/Patient identiSers will not be disclosed
Specify how long all subject/patient identifiers will be retained. This includes identifiers
stored in paper format, stored electronically as well as video recordings, audio recordings,
photographs, etc.:
Destroyed after publication/presentation or end of protocol
Will any identifiable photos or audio/video recordings be collected or used?
Yes
Collection of Photographs, or Audio/Video Retention & Recording
Will identifiable audio recordings be collected?
Yes
How will the audio recordings be
transcribed?
IdentiSable audio recordings
transcribed by the study team
Specify timeframe for the audio
transcription:
60 days
Will the identifiable audio recordings be de-identified?
Yes
Specify timeframe for the audio recordings de-identification and how will the recordings be
de-identified:
60 days. Participant name will be replaced with participant study ID# in
transcription

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Will identifiable video recordings be collected?
Yes
How will the video recordings be
transcribed?
IdentiSable video recordings
transcribed by the study team
Specify timeframe for the video
transcription:
60 days
Will the identifiable video recordings be de-identified?
Yes
Specify timeframe for the video recordings de-identification and how will the recordings be
de-identified:
Participants 60 days. Participant name will be replaced with participant
study ID# in transcription
Will identifiable photographs be collected?
No
Research Information and/or Biospecimens Retention
Indicate how long research information/biospecimens will be retained:
Other
Specify time frame and provide the rationale for research information and/or biospecimens
retention:
Audio or video recordings destroyed within 60 days of the completion of
Snal transcription and analyses..
Will research information and/or biospecimens be shared?
No
Attachments

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If required documentation is not provided, the submission is incomplete and your Application
will be returned to you. Be sure to upload each document as required. If changes are needed, go
back to the sub-section to revise your selections.
All UCI templates are available on the Applications & Forms page, subsections "Human Research
Protections or Human Stem Cell Research"
To access approval documents where UCI will rely on another IRB, including commercial IRBs,
visit their respective online portals. Frequently used commercial IRB portals include:
• WIRB Copernicus Group's WCG IRB Connexus
• Advarra’s CIRBI
Attachment
Attachment Type
File Comments
File Name
Status (IRB/hSCRO Use Only)
Approved
Attachment
Attachment Type
File Comments
2019-5345 DEMOGRAPHIC BACKGROUND INFORMATION QUESTIONNAIRE 8-12-
20_NORMAL_391884.DOC
2019-5345 FOCUS GROUP ZOOM QUESTIONS 8-12-20_NORMAL_391889.DOCX

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File Name
Status (IRB/hSCRO Use Only)
Approved
Attachment
Attachment Type
File Comments
File Name
Status (IRB/hSCRO Use Only)
Approved
Attachment
Attachment Type
File Comments
2019-5345 IIA (DICLEMENTE) 8-12-20_NORMAL_391890.PDF
2019-5345 PHQ-9 8-12-20_NORMAL_391891.PDF

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File Name
Status (IRB/hSCRO Use Only)
Approved
Attachment
Attachment Type
File Comments
File Name
Status (IRB/hSCRO Use Only)
Approved
Attachment
Attachment Type
Recruitment Material
2019-5345 RESOURCE SHEET 8-12-20_NORMAL_391894.DOCX
2019-5345 SOCIAL MEDIA RECRUITMENT 8-12-20.DOCX_NORMAL_391895.DOCX

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File Comments
File Name
Status (IRB/hSCRO Use Only)
Approved
Attachment
Attachment Type
Recruitment Material
File Comments
File Name
Status (IRB/hSCRO Use Only)
Approved
Attachment
Attachment Type
File Comments
2019-5345 SOCIAL MEDIA RECRUITMENT 8-12-20.DOCX_APPROVED_391895.PDF
2019-5345 MOD 28596 APPROVAL LETTER 3-2-21_APPROVED_405520.PDF

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File Name
Status (IRB/hSCRO Use Only)
Approved
Attachment
Attachment Type
File Comments
File Name
Status (IRB/hSCRO Use Only)
Approved
Attachment
Attachment Type
Recruitment Material
2019-5345 FOCUS GROUP INTERVIEW GUIDE 3-2-21_NORMAL_405521.DOCX
2019-5345 FOCUS GROUP RECRUITMENT POSTER 3-2-21_NORMAL_405522.DOCX

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File Comments
File Name
Status (IRB/hSCRO Use Only)
Approved
Attachment
Attachment Type
File Comments
File Name
Status (IRB/hSCRO Use Only)
Attachment
Attachment Type
Recruitment Material
File Comments
2019-5345 FOCUS GROUP RECRUITMENT POSTER 3-2-21_APPROVED_405522.PDF
2019-5345 FOCUS GROUP SOCIAL MEDIA RECRUITMENT 3-2-
21_NORMAL_405523.DOCX

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File Comments
File Name
Status (IRB/hSCRO Use Only)
Approved
Attachment
Attachment Type
Recruitment Material
File Comments
File Name
Status (IRB/hSCRO Use Only)
Approved
Attachment
Attachment Type
Study Information Sheet
2019-5345 FOCUS GROUP SOCIAL MEDIA RECRUITMENT 3-2-
21_APPROVED_405523.PDF
2019-5345 FOCUS GROUP STUDY INFORMATION SHEET 3-2-
21_NORMAL_405524.DOCX

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File Comments
File Name
Status (IRB/hSCRO Use Only)
Approved
Attachment
Attachment Type
Study Information Sheet
File Comments
File Name
Status (IRB/hSCRO Use Only)
Approved
Attachment
Attachment Type
2019-5345 FOCUS GROUP STUDY INFORMATION SHEET 3-2-
21_APPROVED_405524.PDF
2019-5345 PRE-SCREEN QUESTIONNAIRE 3-2-21_NORMAL_405525.DOCX

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File Comments
File Name
Status (IRB/hSCRO Use Only)
Approved
Attachment
Attachment Type
Data Collection Tool/Instrument
File Comments
File Name
Status (IRB/hSCRO Use Only)
Attachment
Attachment Type
Data Collection Tool/Instrument
20195345 EXAMPLE OF A LOW-FIDELITY WIREFRAME 03-16-22.DOCX
20195345 FG PRE-SCREENER RECRUITMENT QUESTIONNAIRE 03-16-22.DOCX

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Data Collection Tool/Instrument
File Comments
File Name
Status (IRB/hSCRO Use Only)
Attachment
Attachment Type
Recruitment Material
File Comments
File Name
Status (IRB/hSCRO Use Only)
Approved
Attachment
Attachment Type
20195345 FG RECRUITMENT POSTER 03-16-22.DOCX
20195345 FG RECRUITMENT POSTER 03-16-22.PDF

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Recruitment Material
File Comments
File Name
Status (IRB/hSCRO Use Only)
Approved
Attachment
Attachment Type
Recruitment Material
File Comments
File Name
Status (IRB/hSCRO Use Only)
Approved
Attachment
Attachment Type
20195345 FG SOCIAL MEDIA RECRUIT 03-16-22.DOCX
20195345 FG SOCIAL MEDIA RECRUIT 03-16-22.PDF

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Recruitment Material
File Comments
File Name
Status (IRB/hSCRO Use Only)
Approved
Attachment
Attachment Type
Recruitment Material
File Comments
File Name
Status (IRB/hSCRO Use Only)
Approved
Attachment
Attachment Type
20195345 PILOT RECRUITMENT POSTER 03-16-22.DOCX
20195345 PILOT RECRUITMENT POSTER 03-16-22.PDF

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Recruitment Material
File Comments
File Name
Status (IRB/hSCRO Use Only)
Approved
Attachment
Attachment Type
Recruitment Material
File Comments
File Name
Status (IRB/hSCRO Use Only)
Approved
Attachment
Attachment Type
20195345 PILOT SOCIAL MEDIA RECRUIT 03-16-22.DOCX
20195345 PILOT SOCIAL MEDIA RECRUIT 03-16-22.PDF

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Recruitment Material
File Comments
File Name
Status (IRB/hSCRO Use Only)
Approved
Attachment
Attachment Type
Data Collection Tool/Instrument
File Comments
File Name
Status (IRB/hSCRO Use Only)
Attachment
Attachment Type
Data Collection Tool/Instrument
20195345 STEP 3 03-16-22.PDF
20195345 STEP 4 03-16-22.PDF

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Data Collection Tool/Instrument
File Comments
File Name
Status (IRB/hSCRO Use Only)
Attachment
Attachment Type
Data Collection Tool/Instrument
File Comments
File Name
Status (IRB/hSCRO Use Only)
Attachment
Attachment Type
Study Information Sheet
20195345 STEP 5 03-16-22.PDF
20195345 STUDY INFORMATION SHEET (FG) 03-16-22.DOCX

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Study Information Sheet
File Comments
File Name
Status (IRB/hSCRO Use Only)
Approved
Attachment
Attachment Type
Study Information Sheet
File Comments
File Name
Status (IRB/hSCRO Use Only)
Approved
Attachment
Attachment Type
20195345 STUDY INFORMATION SHEET (FG) 03-16-22.PDF
20195345 STUDY INFORMATION SHEET (PILOT) 03-16-22.DOCX

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Study Information Sheet
File Comments
File Name
Status (IRB/hSCRO Use Only)
Approved
Attachment
Attachment Type
Study Information Sheet
File Comments
File Name
Status (IRB/hSCRO Use Only)
Approved
Attachment
Attachment Type
20195345 STUDY INFORMATION SHEET (PILOT) 03-16-22.PDF
20195345 AMENDMENT APPROVAL 03-16-22.PDF

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UCI IRB Approval Letter
File Comments
File Name
Status (IRB/hSCRO Use Only)
Approved
Lead Researcher Certigcation
Investigator's Assurance
As Lead Researcher, I have ultimate responsibility for the performance of this study, the
protection of the rights and welfare of the human subjects, and strict adherence by all co-
investigators and research personnel to all Institutional Review Board (IRB) requirements,
federal regulations, and state statutes for research involving human subjects.
I hereby assure the following:
1. The information provided in this application is accurate to the best of my knowledge.
2. The information provided in this application has been discussed and shared with my
Department Chair. Any requests for changes based on this discussion are included in
this application upon submission or will be initiated by the research team either during
the IRB review process or via an amendment.
3. All named individuals on this project have read and understand the procedures outlined
in the protocol and their role on the study.
4. All named individuals on this project have completed the required Educational research
tutorials and have been made aware of the "Common Rule" (45 CFR Part 46), applicable
Food and Drug Administration (FDA) regulations (21 CFR Parts 50, 56, 312 and 812),
have read the Belmont Report, and UCI's Federalwide Assurance (FWA) that are
available on the Human Research Protections Program (HRP) website.
5. All experiments and procedures involving human subjects will be performed under my
supervision or that of another qualified professional listed on this protocol.

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6. I understand that, if the study described in this IRB application is supported by a federal
award or used as a basis for a proposal for funding, it is my responsibility to ensure that
the description of human subjects activities in the proposal/award is identical in
principle to that contained in this application. I will submit modifications and/or
changes to the IRB as necessary to assure the proposal/award and application are
identical in principle.
I and all co-investigators and research personnel agree to comply with all applicable
requirements for the protection of human subjects in research including, but not limited to,
the following:
1. Obtaining the legally effective informed consent of all human subjects or their legally
authorized representatives (unless waived) and using only the currently approved,
stamped consent form (if applicable).
2. Per federal regulations, once a human research study has received IRB approval, any
subsequent changes to the study must be reviewed and approved by the IRB prior to
implementation except when necessary to avoid an immediate, apparent hazard to a
subject. See Reporting of Unanticipated Problems.
3. Reporting any unanticipated problems involving risk to subjects or others, including
protocol violations per UCI IRB policy. In addition, HIPAA privacy violations must be
PROMPTLY disclosed to the UCI Privacy Officer. There are time requirements for
reporting these breaches of confidentiality, which, if not met, may result in monetary
damages to the researcher and the institution.
4. Responding appropriately to subjects' complaints or requests for information about the
study; and reporting to the IRB any subject complaints that are not resolvable by the
study team.
5. Promptly providing the IRB with any information requested relative to the project.
6. Assuring the appropriate administration and control of investigational test articles (i.e.,
investigational drugs, biologics or devices) by a qualified investigator or other
appropriate individual or entity (e.g., UCI Health pharmacy), and assuring use and
maintenance of an Investigational Drug/Biologic Accountability Log or Device
Accountability Log.
7. Registering applicable clinical trials with clinicaltrials.gov. For more information about
this topic, visit the ClinicalTrials.gov web page or the HRP webpage. The consequences
of not meeting the registration and reporting requirements include monetary damages
to the researcher and the institution.
8. Obtaining continuing review prior to study expiration (I understand if I fail to apply for
continuing review, approval for the study will automatically expire, and all human
research activities must cease until IRB approval is obtained).
9. Promptly and completely complying with an IRB decision to suspend or terminate its
approval for some or all research activities.
10
. Submitting to a routine review of human subject research records. The Compliance &
Privacy Office at UCI Health performs ongoing routine reviews of open biomedical
research protocols, in an effort to ensure in part that human subject research activities

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are conducted in accordance with regulations, laws and institutional policies regarding
the protection of human subjects. In addition, the HRP unit of the Office of Research
has developed the Education Quality and Improvement Program (EQUIP). Through
EQUIP, HRP staff conduct periodic quality improvement monitoring and educational
outreach.
11
. For clinical trials initially approved by the IRB on or after January 21, 2019, posting one
(1) IRB-approved clinical trial consent form at a publicly available federal website. The
consent form must be posted after recruitment closes, and no later than 60 days after
the last study visit. For additional guidance, refer to the OHRP FAQs on Informed
Consent.
12
. Filing a final report with UCI HRP at the conclusion of this project.
As the Lead Researcher, I assure all of the above
Financial Disclosure
Investigators' Disclosure of Financial Interest
In order to inform research subjects of circumstances that may affect their decision to
participate in this study, all researchers are required to disclose their financial interests with
outside institutions.  
            
The Lead Researcher of the protocol must ask the following question of all study team
members:     
“Do you, your spouse/registered domestic partner, and dependent children together have any
disclosable financial interests (i) that would reasonably appear to be affected by the
research; or (ii) in entities whose financial interests would reasonably appear to be affected
by the research?"  
A member of the study team who answers in the affirmative will be contacted by the Conflict
of Interest Oversight Committee (COIOC) to obtain additional information regarding their
specific financial interest(s). 
IMPORTANT! If there has been a change in the financial disclosures of the LR or the study
team, please also request a 'Change in Financial Interests'.
As Lead Researcher, I certify that the disclosures for all study team
members are accurate
End of form Please review responses for accuracy and

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End of form. Please review responses for accuracy and
completeness.
Please ignore the Admin Details Section below. This section is for
IRB/hSCRO use only.

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Administrative Details Form
General Information
ERA Transcribed
November 18, 2021
Pre-2018 Common Rule
No
Review Type
Minimal Risk
Research Type
Social/Behavioral/Educational
Study Status
Amendment Type:
Right to Try
No
Clinical Phase of Study
Not Applicable
COVID-19
No
Research Department

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Sue and Bill Gross School of Nursing
Author
Investigator Authored
To be Destroyed Date
December 31, 1969
Scientific Scheduled Review Type
Dept
Clinical Trial
No
NCT #
Legacy Systems (HRP/hSCRO Only)
Link to HPS or hSCRO Report
Link to FileNet Documents

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Subject Population Tab
Project Allocation
100
Subject Group
NONE - Use of identiSable or coded data, specimens, records, charts
Subject Notes
Subject Group
COMP - Adults Competent to Provide Informed Consent
Subject Notes
Subject Group
UCI - UCI students/staff/faculty
Subject Notes
Procedures Tab
PHI
No

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Procedure Type
ISQ Surveys/Questionnaires/Interviews/Oral Histories
Procedures Notes
Procedure Type
DATACOLL Audio, Video, Digital or Image Recording and/or Photography
for Collection of Research Data
Procedures Notes
Drugs Tab
Devices Tab
Sites Tab
Sites
UCI Facilities or Sites (e.g. school, hospital or clinics, etc.)
Sites
Locations within the United States
Funding Tab

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KR Award Report
Consent Tab
Reliance Tab
Agreement
Reviewing Site
https://cognos.oit.uci.edu/ibmcognos/bi/?
pathRef=.public_folders%2FOffice%2Bof%2BResearch%2FReports%2FCampus%2FDrill-
Through%2BReports%2FINCR-OR-012-
Protocol%2BFunding%2BLookup&ui_appbar=true&ui_navbar=false&prompt=false&p_param_Prot
ocol_ID=19471