Investigating How Incentives Impact Engagement With an Online Mental Health Application (Neuroflow)
Phase: NA
Conditions: Behavioral Economics, Gifts, Financial, Point
Sponsor: University of Pennsylvania

 
 
Official Title of the Study: Investigating How Incentives Impact Engagement With an Online 
Mental Health Application (Neuroflow) 
NCT Number: NCT05121675 
Date of the Document: October 16, 2021 

Page 1 of 13
Protocol Details
Basic Info
Conﬁrmation Number:
deifﬁbj
Protocol Number:
849894
Created By:
NUSKE, HEATHER J
Principal Investigator:
NUSKE, HEATHER J
Protocol Title:
Investigating how Incentives Impact Engagement with an Online Mental Health Application (Neuroﬂow)
Short Title:
Neuroﬂow App Wellbeing Study
Protocol Description:
The primary research goal of the proposed project is to understand how incentives (either points 
alone or points that can be exchanged for gift  certiﬁcates) encourage engagement with an online 
mental health app, Neuroﬂow, for college students at the University of Pennsylvania. The  
secondary aim is to compare participant outcomes across the groups of participants.
Application Type:
EXEMPT Category 3
Resubmission*
Yes
Hospital Sites
Will any research activities and/or services be conducted at a Penn Medicine afﬁliated hospital site?
No
Study Personnel
Principal Investigator
Name:
NUSKE, HEATHER J
Dept / School / Div:
4412 - PS-Psychiatry
Campus Address
Mail Code
3309
Address:
OFFICE BLDG STE 100
3535 MARKET ST
City State Zip:
PHILADELPHIA PA 19104-3309
Phone:
215-746-6041
Fax:
Pager:
Email:
hjnuske@upenn.edu
HS Training Completed:
Yes
Training Expiration Date:
Name of course completed :
CITI Protection of Human Subjects Research Training - ORA
GCP Training Completed:
No
Training Expiration Date:
Name of course completed :

Page 2 of 13
Study Contacts
Name:
PALERMO, EMMA H
Dept / School / Div:
8760 - Research Services
Campus Address
Mail Code
Address:
180 E BENEZET ST 
City State Zip:
PHILADELPHIA PA 19118-0000
Phone:
215-247-0977
Fax:
Pager:
Email:
epalermo@sas.upenn.edu
HS Training Completed:
Yes
Training Expiration Date:
Name of course completed :
CITI Protection of Human Subjects Research Training - ORA
GCP Training Completed:
No
Training Expiration Date:
Name of course completed :
Name:
CHANG, CHERYL
Dept / School / Div:
312 - The College
Campus Address
Mail Code
Address:
4641 Overbrook St
City State Zip:
Little Neck NY 11362-1111
Phone:
Fax:
Pager:
Email:
cherylcc@sas.upenn.edu
HS Training Completed:
Yes
Training Expiration Date:
Name of course completed :
CITI Protection of Human Subjects Research Training - ORA
GCP Training Completed:
Yes
Training Expiration Date:
09/13/2024
Name of course completed :
CITI Good Clinical Practice (GCP) - OCR
Other Investigator
None
Responsible Org (Department/School/Division):
4412 - PS-Psychiatry

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Key Study Personnel
Name:
DESWERT, SKY
Department/School/Division:
PS-Mental Health Services
HS Training Completed:
Yes
Training Expiration Date:
Name of course completed:
CITI Protection of Human Subjects Research Training - ORA
GCP Training Completed:
Yes
Training Expiration Date:
11/11/2025
Name of course completed:
Good Clinical Practice (GCP) Simulation
Name:
BROWN, ALYSSA K
Department/School/Division:
PS-Mental Health Services
HS Training Completed:
Yes
Training Expiration Date:
Name of course completed:
CITI Protection of Human Subjects Research Training - ORA
GCP Training Completed:
No
Training Expiration Date:
Name of course completed:
Disclosure of Signiﬁcant Financial Interests*
Does any person who is responsible for the design, conduct, or reporting of this research protocol have 
a FINANCIAL INTEREST?
No
Penn Intellectual Property*
To the best of the Principal Investigator's knowledge, does this protocol involve the testing, 
development or evaluation of a drug, device, product, or other type of intellectual property (IP) that is 
owned by or assigned to the University of Pennsylvania? Please refer to the Patent and Tangible 
Research Property Policies and Procedures.
No
Certiﬁcation
I have reviewed the Financial Disclosure and Presumptively Prohibited Conﬂicts for Faculty 
Participating in Clinical Trials and the Financial Disclosure Policy for Research and Sponsored 
Projects  with all persons who are responsible for the design, conduct, or reporting of this research; and 
all required Disclosures have been attached to this application.
Yes
The following documents are currently attached to this item:
There are no documents attached for this item.
HRPP
Human Source Material*
Does this research include collection or use of human source material (i.e., human blood, blood 
products, tissues or body ﬂuids)? IF YES, consult the EHRS web site: www.ehrs.upenn.edu/programs/
bio/bbpathogens.html for information on OSHA Bloodborne Pathogens requirements (training, 
vaccination, work practices and Exposure Control Plan). If you have questions, call 215-898-4453. 
No
Image Guided Biopsies*
Does the research involve imaging guided biopsy? IF YES, please contact the Clinical Imaging Core. 

Page 4 of 13
See https://www.med.upenn.edu/cbi for more details. Any questions should be directed to the Director 
of Research Operations, Dept of Radiology, Kathleen Thomas. 
No
HIPAA / Protected Health Information
Does the research proposal involve accessing (viewing / using), collecting, or disclosing of protected 
health information (PHI) directly from participants or their medical or dental record for research 
purposes?
No
HIPAA / Protected Health Information
Does the research proposal involve accessing (viewing / using), collecting, or disclosing of protected 
health information (PHI) directly from participants or their medical or dental record for research 
purposes?
No
Remote Study Visits
Does the research proposal involve conducting research visits remotely via any type of video 
conferencing software?
No
Remote Study Visits
Does the research proposal involve conducting research visits remotely via any type of video 
conferencing software?
No
CHPS Resources*
Does the research involve CHPS resources?
No
HUP Inpatient Nursing Resources
Does this research include an inpatient admission at HUP?
No
Pathology and Laboratory Medicine Resources*
Will samples be collected by hospital phlebotomy and/or processed or analyzed by any of the clinical 
laboratories of the University of Pennsylvania Health System?
No
Research Involves Apheresis, Cell Collection, and/or Blood Product Collection*
Does this research involve collection of blood products in the Penn Donor Center and/or the use of 
apheresis for treatment or collection of cells or other blood components?
No
Research involving blood transfusion or drug infusions*
Will your research involve blood transfusion or infusion of study drug in 3 Ravdin Apheresis Unit for 
research purposes?
No
HUP Perioperative and Procedural Services *
Does the research require the following: The collection of tissue, ﬂuid, or blood in HUP Perioperative 
and Procedural Services&emsp;ORThe administration of medications in HUP Perioperative and 
Procedural Services?This is inclusive to all phases of Perioperative care: pre-operative, intraoperative, 
and postoperative periods in all HUP Perioperative Procedure locations.If you have questions, please 
contact: HUPPeriopClinicalResearch@PennMedicine.upenn.edu
N/A
Trial in Radiation Oncology
Is this research a prospective trial being done in Radiation Oncology, and if so, has this protocol been 
approved by the Radiation Oncology Protocol committee?
N/A

Page 5 of 13
Study in Radiation Oncology
Is this research a retrospective study being done in Radiation Oncology, and if so, has this project been 
reviewed by the Radiation Oncology Clinical Research Group?
N/A
Use of UPHS services*
Does your study require the use of University of Pennsylvania Health System (UPHS) services, tests or 
procedures , whether considered routine care or strictly for research purposes? (UPHS includes all Penn 
hospitals and clinical practices, including the Clinical Care Associates network of community 
practices). Examples of UPHS services/tests/procedures includes the Clinical Translational Research 
Center (CTRC), laboratory tests, use of the pathology lab, cardiovascular imaging tests or radiology 
imaging tests (whether being billed via the Service Center or through UPHS), other diagnostic tests & 
procedures and associated professional services, etc. 
No
Veteran's Affairs (VA) Patients or Subjects
Does your study involve data from Veteran's Affairs (VA) patients or subjects?
No
If yes, was this approved by the Philadelphia VA?
No
Out of State Research
Will any Penn personnel conduct any research activities outside of the State of Pennsylvania?
No
Research involving Virtua Health
Will any Penn personnel conduct any research activities at a Virtua Health site location, OR in 
collaboration with Virtua Health System personnel, OR using any Virtua Health System resources (e.g., 
medical records)?
No
Primary Focus*
Clinical Trial (prospectively assigning subjects to health-related interventions to evaluate outcomes)
Protocol Interventions
x Sociobehavioral (i.e. cognitive or behavioral therapy)
Drug
x Device - therapeutic
Device - diagnostic (assessing a device for sensitivity or speciﬁcity in disease diagnosis)
Surgical
Diagnostic test/procedure (research-related diagnostic test or procedure)
Obtaining human tissue for basic research or biospecimen bank
x Survey instrument
None of the above
The following documents are currently attached to this item:
There are no documents attached for this item.

Page 6 of 13
Sponsors
Business Administrator
Name:
COLANGELO, EILEEN E
Dept / School / Div:
4423 - PS-Mental Health Services
Phone:
215-746-6666
Fax:
215-573-0759
Pager:
Email:
emerg@pennmedicine.upenn.edu
Department budget code
000 - 000 - 0 - 000000 - 0000 - 0000 - 0000
Funding Sponsors
Funding sponsors billing address
If you have selected a commercial or industry sponsor, please provide the appropriate address and 
contact information for the Sponsor for the purposes of billing for IRB review fees (initial review, 
continuing review and convened modiﬁcation fees apply here). If the Sponsor is not industry/
commercial, this information is not necessary to provide with your application.
Funding sponsors gift
Is this research being funded by a philanthropic gift?
Project Funding*
Is this project funded by or associated with a grant or contract?
No
Sponsor Funding
Is this study funded by an industry sponsor?
Status of contract
The following documents are currently attached to this item:
There are no documents attached for this item.
Protocol
Objectives
Overall objectives
Primary: Differences in user engagement and retention over four weeks (28 days) by two forms of 
behavior economics incentives (either with its usual system of point incentives or with ﬁnancial 
incentives). User engagement will be measured by the number of active users, the number of activities 
completed, and completion of daily mood and sleep ratings.  Secondary: Differences in user anxiety, 
depression, well-being and emotion regulation levels after engagement with the NeuroFlow app, and 
how it varies by the incentives used for app engagement.
Background
As mental health awareness and intervention has gained more traction throughout the years, 
applications - such as NeuroFlow - have emerged in an effort to facilitate aid to those who are unable to 
afford or access alternative mental health care methods (Huckvale et al, 2020). However, over 95% of 
mental health and wellness applications have not actually been studied (Lecomte et al., 2020). 

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Additionally, a large portion examines user adoption of various mental health applications based on 
different factors, leaving a gap in research regarding client engagement and interest post-installation 
(Huang and Bashir, 2017). Thus, despite promises, applications for promoting mental health often do 
not achieve their intended goals due to lack of sufﬁcient client engagement/interest. In order to address 
this discrepancy, the use of ﬁnancial incentives and other incentives from the ﬁeld of behavioral 
economics may help (Beidas et al., 2019). As an application, NeuroFlow embeds behavioral economic 
principles to increase motivation and engagement with the application (such as personalized pop-up 
notiﬁcation reminders and app gamiﬁcation including points accrual for activity completion and 
celebratory messages for meeting points thresholds) and also provides ﬁnancial incentives whereby 
points accrued can be redeemed into gift cards for popular outlets such as Amazon. However, it is not 
clear if this ﬁnancial incentive increases engagement or has knock-on effects for mental health and 
wellbeing over and above the behavioral economics incentives per se. In this study, we will conduct a 
pilot two-arm randomized controlled trial where we will examine the effect of a treatment group 
(NeuroFlow app with behavioral economics and ﬁnancial incentives vs. NeuroFlow app with behavioral 
economics incentives only) on application engagement and mental health and wellbeing (anxiety and 
depression symptoms, sleep, self-regulation and wellbeing). The purpose of this study is to gain an 
understanding of how incentives encourage participation and engagement with an online mental health 
platform, NeuroFlow.
Study Design
Design
This is a two-arm randomized controlled trial assessing the impact of various incentives (points or 
monetary) on user engagement and retention on the mobile mental health platform, Neuroﬂow. This 
study will utilize a block randomization procedure to assign subjects to one of two treatment groups and 
a between-subjects design in order to understand how the different incentives impact user engagement 
with the platform. After consenting to participate in the study, participants will be asked to complete the 
NeuroFlow daily check in for 28 consecutive days, incentivized by either points only, or points 
redeemable for gift cards (monetary incentive).
Study duration
Participants will be actively in the study for approximately one month including four weeks (28 days) 
of app usage,with time to ﬁll out the pre and post Qualtrics survey to examine changes in mental health 
related outcomes. Overall, participant recruitment for the study will span the Fall 2021 and Spring 2022 
semesters.
Characteristics of the Study Population
Target population
The target population for this study are college students either at the University of Pennsylvania or other 
US universities. Participants will be included if they have a smartphone and are willing to download and 
use the Neuroﬂow app throughout the duration of the study.
Subjects enrolled by Penn Researchers
100
Subjects enrolled by Collaborating Researchers
0

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Vulnerable Populations
Children Form
Pregnant women (if the study procedures may affect the condition of the pregnant woman or 
fetus) Form
Fetuses and/or Neonates Form
Prisoners Form
Other
x None of the above populations are included in the research study
The following documents are currently attached to this item:
There are no documents attached for this item.
Participant recruitment
Please describe the plan to equitably identify and recruit a diverse group of participants that is reﬂective 
of the population under study. If this is a multicenter protocol, the recruitment plan should describe the 
local (Penn) site's plan. Describe:how potential participants may be identiﬁed (review of medical 
records, Slicer Dicer, DAC reports including referrals from physician ofﬁces and clinics);who may 
approach potential participants;methods to achieve sample diversity and inclusiveness;what information 
may be presented to or discussed with them; andthe context and setting in which recruitment will 
happen.
Subjects will primarily be recruited from the University of Pennsylvania through the online participant 
study pool, SONA. Individuals will receive a link to a web-based form after signing up where they will 
give their consent to participate in the study. If participant recruitment through SONA is insufﬁcient to 
meet our target sample size, we will additionally recruit other University students from the United 
States through class email lists, social media platforms (e.g., Facebook class groups), and ﬂyers (with a 
scannable barcode and detablable pieces with contract information) around campus. No participants 
under the age of 18 will be enrolled.
Recruitment Materials
Is the research team using any recruitment materials? These may include but are not limited to: phone 
call scripts, radio/video scripts, ﬂyers/brochures, internet postings, email, letters to potential 
participants, letters to patient physicians, My Penn Medicine (MPM), other direct messaging, etc. For 
guidance regarding recruitment materials, please review the IRB's guidance on Participant Recruitment 
Materials online:https://irb.upenn.edu/recruitment
No
Use of Penn Media & Social Media Services
Will the recruitment plan propose to use any Penn media services (communications, marketing, etc.) for 
outreach via social media avenues (examples include: Facebook, Twitter, blogging, texting, etc.) or does 
the study team plan to directly use social media to recruit for the research?
Yes
Please identify which method(s) of social media you will utilize, the content of the text to be used, and 
the method(s) for posting this information (i.e., using Penn supported communication services). When 
proposing the text to utilize, please be aware of any social media limitations (i.e., number of characters 
allowed in a tweet) and any appropriate conﬁdentiality practices necessary to be compliant with posting 
research recruitment text.NOTE: Penn Medicine must utilize one of the centralized PM Facebook 
Pages:ClinicalResearch@Penn Facebook pagePenn Medicine Facebook page@PennCancer Facebook 
pageAll clinical research paid Facebook ads must be listed on Clinical Research @ Penn Facebook 
page,www.facebook.com/ClinicalTrialsAtPenn. Exceptions to the above must get approval from the 
Penn Medicine Social Media Committee: pennmedicinesocialmediacommittee@uphs.upenn.edu. 
Social Media Text:  Facebook: Researchers at @UPenn are seeking college students studying at the 
University of Pennsylvania who have access to a smartphone capable of downloading the Neuroﬂow 
application to spend approximately 1 minute each day completing the daily check in for 28 days and a 
maximum of 15 minutes ﬁlling out a pre and post study qualtrics survey. This study aims to understand 
incentives that encourage engagement with a mental health app in order to promote mental wellness 

Page 9 of 13
among college students. For more information: Please contact Cheryl Chang, Research Assistant at the 
Penn Center for Mental Health, at cherylcc@upenn.sas.edu [link to ﬂyer]   Twitter: @UPenn seeking 
college students with smartphone access to download Neuroﬂow app to help understand the role of 
incentives in user engagement/promote mental wellness. Interested? Contact Cheryl Chang, @Penn 
Center for Mental Health, cherylcc@upenn.sas.edu [link to ﬂyer]   Flyers have been uploaded under the 
Recruitment Materials tab.
The following documents are currently attached to this item:
Subject recruitment (neuroﬂow-ﬂyervertical3.pptx)
Subject recruitment (neuroﬂow-ﬂyerhorizontal3.pptx)
Subject compensation*
Will subjects be ﬁnancially compensated for their participation?
No
The following documents are currently attached to this item:
There are no documents attached for this item.
If there is subject compensation, provide the schedule for compensation per study visit or session 
and total amount for entire participation, either as text or separate document
There will be no ﬁnancial compensation for participation in this study. For students enrolled at the 
University of Pennsylvania who registered through the SONA system, 4 credits will be awarded after 
the completion of the study and prior to the end of the semester.  Additionally, participants will not be 
compensated for enrollment in the study but if randomized to the controlled group they will be able to 
cash in accrued points received for completing app activities for gift cards(maximum points = 1000 per 
month = ~$10).
Study Procedures
Suicidal Ideation and Behavior
Does this research qualify as a clinical investigation that will utilize a test article (ie- drug or biological) 
which may carry a potential for central nervous system (CNS) effect(s)? Centeral nervous system(CNS) 
effect: the ability of a test article to enter into and potentially interact with the central nervoous system 
(brain and spinal cord). Clinical Investigation: Any experiment that involves a test article and one or 
more human subjects that either is subject to requirements for prior submission to the Food and Drug 
Adminstration (FDA) under section 505(i) or 520(g) of the Federal Food, Drug, and Cosmetic Act, or is 
not subject to the requirements for prior submission to the FDA under these sections of the act, but, the 
results of which are intended to be submitted later to, or held for inspection by, the FDA as part of an 
application for a research or marketing permit. 
No
Procedures
This study is a two-arm pilot randomized controlled trial to assess differences in user retention and 
usage rates associated with two incentive structures within the NeuroFlow app (I.e., general structure 
versus ﬁnancial compensation). We will assess user engagement with utilization data (ie., daily, weekly, 
and monthly active users) and measures of the total number of activity counts completed by a user. 
After consenting to participate in the study, participants will be randomly assigned to use Neuroﬂow 
either with points only or with points and the opportunity to exchange those points for gift cards. In 
both conditions, participants will begin by completing a consent form and a brief questionnaire with 
their contact information, which will be used to grant them access to the Neuroﬂow platform.   In both 
recruitment methods, participants will be required to sign up for a 15 minute check in and check out 
meeting before and after the trial to answer participant questions regarding the app/app set up or 
concerns about the consent form. Furthermore, a Qualtrics survey will also be dispersed to participants 
to be taken during this time along with an initial baseline assessment (to be administered in the 
NeuroFlow app).   Baseline and post-app usage Qualtrics survey links will also be sent with measures 

Page 10 of 13
(Generalized anxiety disorder (GAD), Patient Health Questionnaire (PHQ), World Health Organization- 
Five Well-Being Index (WHO-5), and Difﬁculties in Emotion Regulation Scale (DERS)) to participants 
in order to assess differences in user retention.   In both conditions, participants will use the Neuroﬂow 
app throughout the duration of the 4-week study (28 days). Participants will be sent a push notiﬁcation 
each day through the app to complete their daily activities, which could include surveys, videos, or 
skill-based practice materials.   With the collaboration of the Neuroﬂow team, the usage metrics of the 
app will be pulled after the end of the study. The user metrics of interest are identifying factors that 
include ﬁrst name, last name, gender, age, date of birth, and the applicable assignments to each 
participant - care team manager and behavioral health specialist. Additionally, the ﬁrst and last score, 
ﬁrst and last date, and time between the ﬁrst and last assessment dates for the measures of interest 
(PHQ-9, GAD-7, WHO-5, DERS). Furthermore, the total activity number and the total activity rate 
across all measures will be collected. No additional data from or about participant phone usage or 
activities will be pulled as part of the study other than the usage metrics speciﬁed above, speciﬁc to 
Neuroﬂow.
The following documents are currently attached to this item:
There are no documents attached for this item.
Deception
Does your project use deception? Deception could be considered any direct misinformation presented to 
the subject or omission of key information pertaining to the design or nature of the project. 
No
International Research
Are you conducting research outside of the United States? 
No
Analysis Plan
The anticipated statistical analyses to be conducted for this study is a Linear-mixed effects model 
(LMMs). These models will be used to examine the effect of different incentives (behavioral economics 
and ﬁnancial vs. behavioral economics only) on user engagement (measured by the number of active 
users, the number of activities completed, and completion of daily mood and sleep ratings) and 
retention. We will also examine the effect of incentive type on secondary mental health outcomes such 
as anxiety symptoms (GAD-7total score), depression symptoms (PHQ-9 total score), wellbeing 
(WHO-5total score)and emotion regulation (DERS total score).
The following documents are currently attached to this item:
There are no documents attached for this item.
Subject Conﬁdentiality
There will be no paper-based records kept for this study. Computer-based ﬁles will only be made 
available to personnel involved in the study through the use of access privileges and passwords. Prior to 
access to any study-related information, personnel will be required to sign statements agreeing to 
protect the security and conﬁdentiality of identiﬁable information. Whenever feasible, identiﬁers will be 
removed from study-related information. Precautions are in place to ensure the data is secure by using 
passwords and encryption, because the research involves web-based surveys.  The information that will 
be collected include responses to health questionnaires, responses to ease of use questionnaires, and 
data on how participants engage and use content in the platform. This de-identiﬁed information will be 
seen by the people involved with this research. Steps will be taken to protect participants identity 
through de-identifying information, and information collected will be kept secure. All information 
collected will be protected by HIPAA (Health Insurance Portability and Accountability Act), this is the 
law that protects participants personal health information. To do this study, we need to collect and 
analyze participant data. This will be done by personnel at University of Pennsylvania and NeuroFlow, 
Inc. for the purpose of this research, data will not be shared outside these two entities.  The identifying 
information that will be collected includes participant ﬁrst and last name, email, phone number and date 
of birth (which is needed in order to set up participant accounts), and Qualtrics survey responses with 
other demographic information. We will also have an excel sheet that contains identifying data in 
connection to assigned participant ID. These identifying data will be kept in a password protected excel 
sheet which will be stored in Penn Box and kept separate from study data. In order to de-identify data, 

Page 11 of 13
we will take a participants assigned participant ID number in place of any identifying data which will 
be connected to their deidentifying data (detailed below). De-identiﬁed study data that includes baseline 
assessment and post app usage assessment results via the Neuroﬂow application will be collected about 
participants for this study.  For people who consented to have their contact information on ﬁle for future 
research, we will store it in a password protected excel sheet. For other participants, all identifying data 
will be destroyed within one year from their participation end date.  The information from this study 
may be published in scientiﬁc journals or presented at scientiﬁc meetings, but participants will not be 
personally identiﬁed. participant private information, with the identiﬁers removed, could be used for 
future research studies or distributed to other researchers for future research studies without participants 
additional permission
Sensitive Research Information*
Does this research involve collection of sensitive information about the subjects that should be excluded 
from the electronic medical record? [NOTE: This does not apply to: 1) research information that would 
not normally be included in the electronic medical record or 2) information that is in the electronic 
medical record as part of clinical care.]
No
Disclosures
Will any data or specimens from Penn participants OR other research generated work product (e.g., 
intellectual property) be disclosed to any individuals, entities, or vendors, etc. outside of Penn?
No
Data Protection*
x Name
Street address, city, county, precinct, zip code, and equivalent geocodes
All elements of dates (except year) for dates directly related to an individual and all ages over 89
x Telephone and fax number
x Electronic mail addresses
Social security numbers
Medical record numbers
Health plan ID numbers
Account numbers
Certiﬁcate/license numbers
Vehicle identiﬁers and serial numbers, including license plate numbers
Device identiﬁers/serial numbers
Web addresses (URLs)
Internet IP addresses
Biometric identiﬁers, incl. ﬁnger and voice prints
Full face photographic images and any comparable images
Any other unique identifying number, characteristic, or code
None
Does your research request both a waiver of HIPAA authorization for collection of patient information 
and involve providing Protected Health Information ("PHI") that is classiﬁed as a "limited data set" 
(city/town/state/zip code, dates except year, ages less than 90 or aggregate report for over 90) to a 
recipient outside of the University of Pennsylvania covered entity?
No

Page 12 of 13
Consent
1. Consent Process
Overview
Participants will receive a brief introduction to study via the description section of the SONA system or 
via the ﬂyers that will be distributed for recruitment. Participants will all need to contact the study team 
via SONA or other methods of recruitment to express interest in participating before any next steps 
commence. All participants will have access to a brief introduction of the study aims and objectives via 
the ﬁrst page of the mandatory Qualtrics form that must be ﬁlled out in order for study participation as 
well.  In both cases, participants will be required to sign up for a 15 minute check in and check out 
meeting before and after the trial to answer participant questions regarding the app/app set up or 
concerns about the consent form. Informed consent will take place digitally for this study.  An outline of 
the Qualtrics form is that, after providing a brief introduction of the study, participants will be prompted 
to ﬁll out a consent to contact form and a brief demographics survey before being presented with a 
consent form. After reading through it, participants will have to select I have read the above terms and 
consent to participate in this study before they will be eligible to continue with the study. Participants 
will be informed that they can withdraw from the study at any time without any consequences by 
emailing the PI or any other researchers afﬁliated with the study. The consent form will be written in 
comprehensible language and we expect all participants to be able to give their own consent. 
Participants will not receive an invitation to the NeuroFlow platform until they have consented to 
participate in the study.
Risk / Beneﬁt
Potential Study Risks
We anticipate very few risks associated with participating in the study. Participants may feel 
uncomfortable answering certain questions, but all questions will be optional and there will be no 
penalties or consequences associated with choosing to opt out of providing certain information. As with 
any study taking personal information, there is the risk of a possible data breach that could expose 
information about participants mental health, However, we will be deidentifying our dataset and any 
datasets with identifying information will be password locked. Only study personnel will have access to 
any data associated with the study. In the event of a mental health crisis or reports of suicidal ideation, 
the NeuroFlow platform lists emergency resources within the app.
Potential Study Beneﬁts
Our study will allow participants to engage with a mental health platform where they can learn skills to 
manage their mental health and improve their mental well-being. Additionally, through the study, we 
will gain a better understanding of which incentives increase engagement on a mental health platform, 
which can inform more effective delivery of mental health resources and information. Online mental 
health platforms, such as NeuroFlow, have the potential to improve wellbeing in college students, which 
would provide a major beneﬁt to public health.
Risk / Beneﬁt Assessment
There is minimal to no risk associated with this study, and the beneﬁts of improving college student 
mental health and developing an understanding of the incentives that increase mental health platform 
engagement and utilization is a major beneﬁt associated with the study. Therefore, the beneﬁts of the 
study outweigh any potential risks associated with the study.
General Attachments
The following documents are currently attached to this item:
Additional forms (modiﬁcationform2019.6-clean_01.doc)

Page 13 of 13
Additional forms (citi_emma.pdf)
Recruitment materials (neuroﬂow-ﬂyerhorizontal.pptx)
Additional forms (deswert_citi_2021.pdf)
Additional forms (brown_citi_2021.pdf)
Additional forms (chang_citi_2021.pdf)
Additional forms (nuske_citi_2019_05.pdf)
Additional forms (neuroﬂow-termsofservice.docx)
Additional forms (gad-7.doc)
Additional forms (phq-9.pdf)
Additional forms (who-5.pdf)
Additional forms (ders1.pdf)
Questionnaires (demographicquestionnaire.doc)
Questionnaires (screenerandconsenttocontact.docx)
Recruitment materials (neuroﬂow-ﬂyervertical.pptx)
Cover Letter (neuroﬂow-revisioncoverletter_hn1.docx)
Informed consent form (neuroﬂow-consentformsﬁnalre2.docx)
Informed consent form (neuroﬂow-consentformsﬁnalre-trackedchanges1.docx)