Expanding College Student Mental Health With Stress Management Mobile Technologies - Extended Usability Trial
Phase: NA
Conditions: Depression, Anxiety
Sponsor: Northwestern University

PROTOCOL TITLE:   Expanding College Student Mental Health with Stress Management 
Mobile Technologies – Extended Usability Pilot Trial 
 
PRINCIPAL INVESTIGATOR: 
Emily G Lattie, PhD 
Department of Medical Social Sciences 
312-503-3741 
Emily.Lattie@northwestern.edu 
 
VERSION DATE: 
June 26, 2020 
 
Objectives: 
This research project aims to develop and test a Student Stress Management (SSM) 
mobile program, a suite of apps based within the framework of an evidence-based treatment for 
depression and anxiety that will be integrated within a student health system. This program will 
improve engagement with mental health services by serving as an access point to mental health 
treatment options, and providing an opportunity for self-guided treatment. The SSM program will 
feature components known to be effective both for engagement (symptom assessment and 
promotion of care accessibility) and treatment (thought restructuring, relaxation exercises, and 
behavioral activation). Within the suite, students will be prompted to complete symptom 
assessments on a weekly basis, and those with elevated symptom scores will be provided with 
feedback and recommendations for on-campus services. All users will be able to access and 
use interactive treatment apps. The program will be developed with the University of Illinois at 
Chicago (UIC) and Northern Illinois University (NIU) counseling centers, and will be made 
available to all UIC and NIU students. These studies will establish a research program that will 
expand the reach of services and ease the burden of untreated depression and anxiety for 
college students. 
 
Phase 1 Aim: Develop the SSM program by refining a mobile smartphone intervention 
and develop an optimized multi-component implementation strategy using a user-
centered design process. We will start from a suite of apps developed for a general population 
and, based on needs reported by current students and mental health care providers, they will be 
optimized for the college student population alongside development of an implementation plan 
and evaluation metrics. Laboratory-based usability testing and an 8-week field trial will be 
included as part of the iterative design process to ensure that SSM works optimally both in 
individual interactions, as well as cumulatively over time. 
 
Background: 
College student mental health problems. With rising rates of students demonstrating clinically 
significant symptoms of depression and anxiety, there has been a broadly recognized college 
student mental health crisis in recent years. As students face increased stress and academic 
pressures, 85% of college students report feeling overwhelmed by demands over the last year. 
In a national survey of college students, 20% screened positive for moderate-severe depressive 
symptoms, and 20% screened positive for moderate-severe anxiety symptoms. However, many 
students have low mental health literacy as they do not recognize a need for treatment, 
believing that these depression and anxiety symptoms are typical college stress. As nearly 70% 
of Americans enroll in college following high school (and even more in subsequent years), this is 
an important point for intervention. At this life phase, untreated mental illness can have life-long 
impacts, including increased risk of substance use, academic failure, and impaired 

relationships. Untreated depression is the number one cause of suicide, which is the second 
leading cause of death for this age group. 
Insufficient access to mental health resources for college students. While many students do not 
recognize a need for treatment, students who do recognize a need often endorse difficulties 
accessing care, perceive care available as inconvenient, and are skeptical about the efficacy of 
care. Campus counseling centers are well-positioned to provide mental health care. For many 
students, particularly those from low-income backgrounds without access to a parent’s 
insurance plan, these centers are the main option for affordable care. However, many 
counseling centers across the country are under-resourced, have difficulty reaching students in 
need of treatment, and while there are seasonal variations in capacity, are at full capacity during 
much of the year. Students are increasingly being seen in crisis, rather than when symptoms 
are moderate. Over the last 6 years, rates of students presenting to these clinics with symptoms 
of depression and anxiety trended upward, and utilization of crisis services have increased by 
28%. There is a clear, immediate need to develop accessible methods for delivering 
effective mental health care to college students. 
Need for alternative methods of care delivery Developing accessible and effective interventions 
could facilitate early management and treatment of symptoms – saving many individuals from 
the detrimental impact of untreated mental illness including social, emotional, and financial 
costs. Behavioral intervention technologies (BITs), including smartphone apps, offer the 
possibility to expand treatment options and to reduce barriers to services. Internet-based CBT 
has demonstrated efficacy for treating a wide range of mental health concerns, and self-guided 
treatments are known to be effective for treating common mental health problems such as 
depression. Early work suggests that programs delivered via mobile phone are comparably 
efficacious while circumventing some barriers to computer-based treatments. As smartphones 
are often carried throughout the day, apps provide access in the real-world conditions of 
individuals with mental health concerns. Thus making apps an accessible method for delivering 
mental health care to students, which could keep students with lower levels of distress well-
managed and not in need of counseling center appointments. 
Potential in Mental Health Apps Commercially available mental health apps have been rapidly 
emerging over recent years, and demand for them is high. In the U.S., 85% of 18-29 years olds 
own a smartphone, and more than 75% of Americans are interested in free mobile apps aimed 
at mental health management and treatment. While interest exists, few existing apps have been 
subject to empirical evaluation, fewer have demonstrated clinical efficacy, and those that 
demonstrated efficacy are typically not available to the general public. Appropriate mental health 
apps are challenging for individuals to locate, leading users to face significant barriers to find 
something trustworthy and useful. Empirically tested app-based programs are needed to fully 
realize the promise and potential for their use in clinical care. 
Mental Health Technologies for College Students. College students are ideal candidates for 
mental health technologies. Research on mental health help-seeking in young adults has 
identified a preference for self-reliance and low mental health literacy, resulting in a failure to 
recognize symptoms as signs of treatable mental health conditions, as the most important 
barriers to seeking care. These barriers are a toxic combination but are prime targets in which 
BITs can facilitate mental healthcare. By providing a program that includes self-guided 
treatment, we can appeal to a preference for self-reliance and facilitate program engagement to 
promote mental health literacy and provide further referrals when students need services. A 
recent RCT of a web-based suicide risk screening program for college students found that the 
provision of personalized feedback, with the option of online counseling based on motivational 
interviewing, had a significant impact on students’ readiness to consider mental health 
treatment, and these students were more likely to link up with mental health services. However, 
there were relatively low levels of engagement with the site, and authors noted the site’s subpar 
user interface likely contributed to low utilization by students. 

BITs for college students need to be strategically designed to promote use. College students 
today are digital natives confident about their ability to access and navigate digital interfaces, 
and, counter to older adults, tend to view usability issues as the fault of the program or website. 
There are challenges in engaging these users to continue to interact with new technologies. 
Young adults are seen to exhibit distinct preferences in interface design relative to both 
teenagers and older adults, and they are quick to dismiss tools that do not meet their 
expectations. In the general population, 1 of 5 apps downloaded are only used once. The risks 
of BIT rejection/non-use are greater among young adults, and can likely be prevented with 
appropriate design. User centered design processes and usability testing, widely used methods 
from the field of Human-Computer Interaction (HCI), are vitally important to develop usable, 
useful programs. Once developed, it can be a challenge to get these programs into the hands of 
people who could benefit from them. Thus, implementation plans must be carefully developed 
and iterated upon as necessary. Implementation scientists have outlined 73 discrete 
implementation strategies; however, use of a single strategy is rare and a multicomponent 
implementation plans are typically developed to address multiple barriers within a system. 
Identification of implementation strategies likely to be successful in a setting is key to program 
success.    
 
To evaluate the needs and preferences of college students seeking digital mental health 
resources, I conducted a pilot study of an internet-based cognitive-behavioral therapy (iCBT) 
program with 15 college students and collected user feedback. The iCBT program was rated 
usable and useful, with an average of 12 logins over the 6-week trial period (range: 2–35 
logins), and nearly three-quarters of participants indicated that they would recommend it to a 
friend. From baseline to end of treatment, students reported an increase in use of cognitive-
behavioral coping strategies, t(10)=3.40,p=.007, and a trend was observed for decreased levels 
of stress, t(11)=2.12, p=.058. However, many students reported that making time to be in front 
of a computer was a barrier to program use. A majority reported interest in app-based 
programs, noting a greater likelihood of frequently utilizing program content and tools if easily 
accessible on their phones. Based on these data, the proposed project will use smartphone 
apps to deliver program content and tools. 
 
Apps used in this study are drawn from IntelliCare and will be optimized based on feedback 
from participants in Phase 1. IntelliCare is a suite of clinical apps, developed at CBITs, that 
feature different methods of managing mental health. To fit with standard app use patterns, the 
apps are lightweight and designed to be used in short bursts of time. In conjunction with 
ongoing trials, the IntelliCare apps were made freely available. In the first 18 months of public 
availability, 8,293 individuals downloaded one or more of the apps, for a total of 19,852 
downloads. 
 
Inclusion and Exclusion Criteria: 
 
Participants include both students, counselors, and administrative staff members of the 
University of Illinois at Chicago and Northern Illinois University. Students, to be included in all 
phases of the study, will be 18 years of age or older, English-speaking, familiar with 
smartphones, and living in the university communities (e.g. not studying abroad). Counselors 
and administrative staff members will be current employees at the University of Illinois at 
Chicago Counseling Center or at Northern Illinois University’s Counseling & Consultation 
Services. Potential participants for Phase 1 will be excluded for visual, hearing, voice, or motor 
impairment that would prevent completion of the study procedures or use of mobile phone; 
diagnosis of a psychotic disorder, dissociative disorder, or other diagnosis for which 
participation in this trial is inappropriate, or severe suicidality (has ideation, plan, and intent). For 

Phase 1, Stages III and IV, student participants will have clinically elevated symptoms (defined 
by scores > 10 on the PHQ-9 or GAD-7). For Phase 1, Stage V, half of the participants will have 
elevated symptoms of depression or anxiety as measured by scores > 10 on either the PHQ-9 
or GAD-7, and half of the participants will not have elevated scores on either measure. 
Participants in Phase 1, Stage V will also need to own an Android-operating or iOS-operating 
smartphone with a system that operates Android 7 or higher or iOS 11 or higher.  
 
 The follow populations will be excluded from the study: 
a. 
Adults unable to consent 
b. 
Individuals who are not yet adults (minors): infants, children, teenagers 
c.  
Pregnant women (where the activities of the research may affect the 
pregnancy or the fetus.) 
d. 
Prisoners or other detained individuals. 
 
Study-Wide Number of Participants: 
In Phase 1, a total of 48 students and 20 counseling center staff members will participate in 
user-centered design for, and usability testing of, a mobile app intervention aimed at facilitating 
engagement with existing services, and at reducing depressive and anxious symptoms through 
self-guided treatment tools.  
 
Stage I is a co-design workshop will involve 28 students and 12 counseling center staff 
members in order for both parties to share their design ideas with each other in order to better 
inform the design of the program. 
Stage II is an online questionnaire that will be sent to counseling center staff members at both 
counseling centers. We anticipate that 20 staff members will complete the questionnaire. 
Stage III consists of individual semi-structured interviews (n = 20) which will occur in single 
sessions. Similar to Stage I, students and counseling center staff members will share their 
needs, preferences, and implementation ideas for the mobile app program and its development 
on an individual and confidential basis. 
Stage IV consists of laboratory-based usability testing (n=15) in which we will gain user 
feedback of an interactive model of the mental health mobile app program. These usability 
sessions will be approximately 45 minutes long and will be conducted on an individual and 
confidential basis. 
Stage V, as part of extended usability testing, 20 students will be enrolled in an 8-week 
feasibility field trial of the intervention once all major issues identified by usability testers from 
Stage IV have been addressed. 10 students from each institution will be recruited for the trial. 
Each sample of ten will be composed of 5 students with elevated symptoms of depression or 
anxiety as measured by scores > 10 on either the PHQ-9 or GAD-7, and 5 without elevated 
scores on either measure. 
 
Study-Wide Recruitment Methods: 
Stage I (co-design workshop): participants will be recruited via hard copy study advertisements, 
and via email by a member of the study team. 
Stage II (online questionnaire to counseling center staff): participants will be recruited via email. 
Stage III (individual semi-structured interviews): participants will be recruited in-person, via e-
mail, and via hard copy study advertisements at the University of Illinois at Chicago (UIC) and 
Northern Illinois University (NIU) campuses. Individuals interested in participating will be able to 
call or e-mail study staff for more information, and students interested in participating will be 

emailed a link to the study eligibility screening measure. Counseling center staff will not need to 
complete the eligibility screening measure as all counseling center staff members will be eligible 
to participate. Potential student participants recruited via non-electronic means (e.g. they 
contact the study staff by telephone) will be asked for their email address so that the consent 
and survey link will be emailed to them.  
Stage IV (laboratory-based usability testing): participants will be recruited in-person, via e-mail, 
and via hard copy study advertisements at the University of Illinois at Chicago (UIC) and 
Northern Illinois University (NIU) campuses. Individuals interested in participating will be able to 
call or e-mail study staff for more information, and students interested in participating will be 
emailed a link to the study eligibility screening measure. Potential student participants recruited 
via non-electronic means (e.g. they contact the study staff by telephone) will be asked for their 
email address so that the consent and survey link will be emailed to them. Eligible participants 
will be scheduled for a usability session at their college counseling center.  At this appointment, 
participants will read and sign a paper copy of the informed consent form and be provided a 
copy for their own records. 
Stage V (8-week extended feasibility trial): Participants will be recruited in-person, online, via e-
mail, and via hard copy study advertisements at the University of Illinois at Chicago (UIC) and 
Northern Illinois University (NIU) campuses. Online recruitment will be published to both public 
spaces and existing private groups with the permission of the private group administrators.  
Individuals interested in participating will be able to call or e-mail study staff for more 
information, and students interested in participating will be emailed a link to the study eligibility 
screening measure. Potential student participants recruited via non-electronic means (e.g. they 
contact the study staff by telephone) will be asked for their email address so that the consent 
and survey link will be emailed to them. Eligible participants will be emailed a link to the digital 
consent form. Subjects agree to participate by checking a “yes” box and typing in their name. 
They are instructed to print out the consent form for their records. Participants are enrolled 
remotely to avoid excluding participants with access barriers who are among those who would 
be likely end users.  The digital consent form will describe the mobile app program, show 
participants how to add a PIN to their phone, and inform participants that data entered into the 
phone will be de-identified to the research team, those it cannot replace the need for contacting 
a mental health provider in the case of an emergency. These recruitment procedures are similar 
to those that have been approved by the Northwestern University IRB for prior studies 
conducted by our lab group.  
 
Study Endpoints: 
The primary study endpoint for Phase 1 is the development of the Student Stress Management 
program.  
 
Procedures Involved: 
 
For Phase 1:  
 
User-centered design and usability testing will be conducted in 5 iterative stages.  
 
Stage I of user-centered design will consist of a 2 hour co-design workshop at each study site, a 
participatory design method with demonstrated ability to engage young adults to develop 
acceptable, efficacious technologies. The goal of this workshop will be to develop prototypes of 
the managing hub app and advertising materials of the SSM program. See attached for a 
proposed schedule of the co-design workshop and proposed design activities. Two workshops 
will occur at each study site, and at each of the 4 workshops, we aim to recruit 7 students and 
three mental health counselors will be recruited at each site for this stage, for a total of 40 

participants. Participants will be given the option of receiving a text message reminder about the 
co-design workshop. Sessions will be video- and/or audio-recorded. While the end users of the 
SSM program will be students, input and expertise from mental health providers from the UIC 
and NIU counseling centers will be used to inform the design process to promote meaningful 
integration into the center’s existing services. Through the co-design workshop, we will bring 
together students and counselors to integrate stakeholder input into the final design of the 
program. 
 
Stage II is an online questionnaire in which counseling center staff members will complete 
implementation readiness and capacity assessments on their needs and goals, as well as the 
organizational factors that could facilitate or impede integration of the SSM program into the 
counseling center. This questionnaire will be sent to all counseling center staff mental health 
providers. We anticipate that 20 staff members will complete the questionnaire. 
 
The goal of Stage III of user-centered design is to further identify needs and preferences for 
SSM program tools and implementation procedures. During recruitment for Stage III, interested 
students will be prompted to complete an online consent for Stage III and a survey determining 
depression and anxiety symptomology and eligibility before being invited to participate in an 
interview. The individual interviews will be 30-45 minutes with students with clinically elevated 
symptoms (defined by scores > 10 on the PHQ-9 or GAD-7), and counseling center staff 
members (both mental health providers and administrative staff), who will complete a semi-
structured interview and view advertising materials and low-fidelity paper prototypes of tools to 
be included in the SSM program. Staff members will be prompted to generate ideas and give 
feedback on metrics for assessing impact of the program on counseling center utilization (e.g. 
the number of appointments for crises, intakes, and follow-up therapy sessions, and level of 
depressive symptoms [as measured by the PHQ-9)] at intake). This stage guides our evaluation 
plan and proposed data informed implementation process in Phase 2 (described below). 
Recruitment will continue at each study site until we reach data saturation. We estimate a 
sample size of 10 participants per site, for a total of 20 participants, based on research 
demonstrating 95% of usability problems can be identified with 10 users. Use of paper 
prototypes, or mock-ups, is an established, cost-effective method for gaining user experience 
and usability data early in the design process. This step will identify any design flaws before app 
development and programming are completed and will identify metrics for assessing program 
impact on utilization in Phase 2. 
 
Stage IV: Following app development and initial quality assurance testing by the research team, 
the next stage will consist of laboratory-based usability testing sessions. Student participants 
with elevated symptoms (> 10 on either the PHQ-9 or GAD-7) will be recruited for 45 minute 
testing sessions. Participants will be audiotaped while using a “think aloud” framework to have 
them verbalize their thoughts when using the program to complete a set of tasks. For each task, 
we will use standard objective measures to empirically evaluate recommended attributes of 
system usability. Following the think aloud protocol, participants will complete a brief structured 
interview on the user experience of the program, including learnability, acceptability, and 
usefulness, and overall satisfaction with aesthetics and perceived efficiency. Recruitment will 
continue at each study site until we reach data saturation, and we estimate a sample size of 15. 
Participants will also complete brief quantitative questionnaires. Problems will be addressed as 
they are identified. This will ensure the apps are usable and acceptable for single use. 
 
For Stage V, students will be recruited for an 8-week field trial in which they will be given the 
SSM program and encouraged to use it daily. To ensure a sample representative of likely end 
users, 10 students from each site will be recruited: 5 with elevated distress as measured by 

scores > 10 on either the PHQ-9 or GAD-7, and 5 without elevated scores on either measure, 
for a total of 20 participants. The rationale for 10 participants in each group is based on past 
usability research indicating saturation is typically reached within 10 participants. The aim of this 
trial is to identify software bugs and usability problems that emerge over extended use, and to 
examine preliminary effects of program use. During the trial, participants will be prompted to 
complete the PHQ-8 and GAD-7 on a weekly basis. At baseline, 4 weeks, and 8 weeks, 
participants will be prompted within the app to complete the Depression Literacy Questionnaire 
and Anxiety Literacy Questionnaire to measure mental health literacy, the Knowledge and 
Beliefs about Services scale to measure knowledge of campus mental health services, the 
Barriers to Mental Health Help-Seeking questionnaire to measure treatment barriers, and the 
Cognitive and Behavioral Response to Stress Scale to measure cognitive and behavioral coping 
skills.  Additionally, at weeks 4 and 8 of the 8-week trial, we will conduct 30-minute semi-
structured user feedback interviews to gain insights on the use of the study app.  These 
interviews will be audio-recorded and conducted via telephone. 
 
Data and Specimen Banking: N/A 
 
Data and Specimen Management: 
Data analysis plan for Phase 1: Qualitative data from interviews and quantitative data from 
questionnaires and video recordings from usability testing will be incorporated for mixed 
methods data analysis. This mixed methods approach was chosen because, while quantitative 
data can identify usability errors and dissatisfaction with program components, qualitative data 
provides guidance to the root of those errors and methods for program optimization. Qualitative 
data will be analyzed using a grounded theory approach, in which interviews will be analyzed 
using iterative codes that are used to identify core concepts, from which we will determine the 
needs, concerns, and impressions of our prototypes, implementation strategies and evaluation 
metrics. This analytic approach was selected due to the expectation that participants will raise 
unanticipated needs. Mean rating values of app components from the quantitative data will be 
calculated, and the components will lowest rated values will be flagged for further refinement. 
Video recordings of usability testing sessions will be coded for navigation errors (difficulty 
locating a function), content errors (difficulty due to labeling of information), and usage errors 
(improper tool use). For the extended usability study, app usage data will be examined in the 
form of descriptive statistics. Due to the small sample size of each symptom group (higher 
symptoms and lower syptoms), we will examine symptoms of depression and anxiety by 
subgroup in the form of descriptive statistics. Measures of our treatment targets (anxiety 
literacy, depression literacy, cognitive and behavioral coping skills) will be analyzed using 
Wilcoxon signed rank tests across higher symptom and lower symptom participants.Qualitative 
data will be analyzed using a thematic analytic approach. 
Prior to moving to the hybrid implementation-effectiveness study, we will ensure that the 
program does not have a detrimental impact on students’ self-reported symptoms, needs initially 
reported by the students and counselors are represented as components in the SSM program, 
and the components have a satisfactory rating or greater.  
 
Protection for risks associated with potential loss of confidentiality. Data for all participants will 
be kept strictly confidential, except as mandated by law. All research files are kept on secure, 
password protected departmental and medical school servers. All electronic data will be stored 
on secure servers behind firewalls meeting all security requirements of the medical school. Any 
paper documentation is kept in locked file cabinets or a locked file room. Participants will be 
assigned a numerical code for identification in the files. Names and other identifiers will be kept 

in separate password protected files. Audio data will be stored on secure servers and will only 
be available for coding by study staff. Online assessments will be conducted through REDCap.  
This platform uses up to date security measures that are consistent with those used by 
Electronic Medical Records and are HIPAA compliant.  In Stages III - V of Phase 1, data for all 
participants who consent to participate in the screening will be kept, including those participants 
who are found ineligible to participate in these stages of the study and those participants who 
are eligible but decline to participate in these stages of the study.   
 
Provisions to Monitor the Data to Ensure the Safety of Participants: 
Adverse events will be reported by the PI to the Northwestern IRB, the NIMH Program Officer, 
and clinicaltrials.gov where the trials will be registered. The PI will closely monitor all incoming 
data, recruitment progress, and retention in assessments and treatment. For the eligibility 
screening measures for Phase 1, Stages III-V, student participants will respond to a question on 
suicidality, with suicidal ideation considered to be a score of 1 or higher on the ninth question of 
the Patient Health Questionnaire-9 (i.e., “Over the last 2 weeks, how often have you been 
bothered by thoughts that you would be better off dead or of hurting yourself in some way”). If a 
participant responds to the PHQ-9 item 9 with a score of 1 or higher, then the REDCap 
questionnaire will branch to item 9 from the Beck Depression Inventory: 
0 
I don't have any thoughts of killing myself. 
1 
I have thoughts of killing myself, but I would not carry them out. 
2 
I would like to kill myself. 
3 
I would kill myself if I had the chance. 
 
If a respondent selects a 2 or 3 on this item, they will be prompted with the message “CBITs 
Health is NOT an emergency service. If you do not feel safe and need immediate police or 
medical assistance, call 9-1-1 or go directly to your nearest emergency room.”  
 
Incoming questionnaires will be monitored daily by study staff, and any participants who have 
selected a 2 or 3 on item 9 from the Beck Depression Inventory will be contacted via telephone 
by study staff who will administer the Columbia Suicide Risk Assessment (see attached). This 
measure has been used telephonically in past studies within the Center for Behavioral 
Intervention Technologies, and provides instructions on handling psychiatric emergencies.  
In the case of a psychiatric emergency, all necessary efforts will be made to ensure the safety of 
the participant. This may include contacting psychiatric liaison teams in the local police 
department to conduct a health and safety check and possibly to hospitalize the patient 
participant. If the person assessing the individual is a staff member (e.g. RA), the staff member 
will immediately contact the PI. However, all staff will be trained in crisis management, in the 
event the PI or another licensed clinician on staff cannot be immediately contacted. 
For all stages involving participant interviews, the PI (or one of the mentors if the PI is 
unavailable) will discuss responses to interviews with the assessor immediately after 
assessments should there be any concerns regarding participant safety or deterioration; 
otherwise, the PI will examine interview responses the same or next business day. 
Participants in the user-centered design and early usability stages of this study will only enter 
the lab once to review treatment prototypes. This portion of the proposed research does not 
constitute a clinical trial and poses minimal risk.  
 
For stage V the feasibility trial embedded in usability testing and the pilot study constitute a 
phase I, and an early phase II, clinical trial respectively. While the risk of this intervention is low, 
we are proposing use of an independent Data Safety Monitoring Board (DSMB) because there 
are two clinical sites. The independent Data Safety Monitoring Board (DSMB) that will oversee 
the study and offer guidance to the PI. The DSMB will meet at the discretion of the chair but not 

less that once every 6 months. The chair, Michael Levin, PhD, was selected by Drs. Lattie and 
Mohr, and is external to Northwestern, UIC and NIU. To ensure that that chair will understand 
many of the issues we confront in this research and evaluate these issues as related to the 
safety of trial participants, requirements for the chair will include expertise with implementation 
trials, the treatment of depression, and digital mental health. Drs. Lattie and Mohr will be a non-
voting members of the DSMB and will attend all meetings to provide and receive information. 
Study data will be reviewed for evaluation of the safety of the intervention and the procedures 
used to detect and respond to deterioration and/or suicidality. Reports from all meetings will be 
submitted to the NIMH Program. 
 
Withdrawal of Participants: 
Patients can be taken off the study treatment and/or study at any time at their own request, or 
they may be withdrawn at the discretion of the investigator for safety, behavioral or 
administrative reasons. The reason(s) for discontinuation will be documented and may include: 
Patient voluntarily withdraws from treatment (follow-up permitted); 
Patient withdraws consent (termination of treatment and follow-up); 
Patient is unable to comply with protocol requirements. 
 
Risks to Participants: 
The proposed study poses minimal risks. All potential risks associated with participation in this 
study will be disclosed in consent documents. Any potential risks that might exist fall into four 
categories: (a) risks associated with the intervention; (b) risks associated with research 
assessments, consisting of questions about depression, anxiety, and personal functioning, and 
other mental and emotional problems; (c) risks associated with potential loss of confidentiality; 
and (d) risks of worsening mental or emotional state.  We address each in turn below. 
Risks of the intervention: Mobile phone based mental health intervention programs have not 
been shown to cause any harm. 
Risks associated with research assessments: Research assessments include questions about 
depression and other mental and emotional problems. Participants will give voluntary responses 
to interview questions; they are told that they can decline to answer any questions that they 
choose. The instruments and methodologies are well tested and are not known to cause 
problems or distress on the part of the participants. All research interview-based assessments 
are audio-recorded, for the purpose of review to ensure quality assurance ratings of assessment 
performance, including ensuring that patients are comfortable with the interview procedures. 
Audiotapes will be maintained on a secure server with no identifying information in the labels for 
the duration of the funded study, unless other arrangements are made. On occasion patients 
may request that audio files be deleted before the end of the study, in which case we will 
comply. 
Risks associated with potential loss of confidentiality. There is a slight risk of loss of 
confidentiality.  While transmissions are protected using a Transport Security Layer and 
communication occurs within a secure messaging platform, there is some possibility that others 
may see the participant’s open webpage or smartphone.  Measures to protect security in these 
instances are described below. Confidentiality may be broken by research staff to ensure the 
patient’s safety if there is an imminent threat to self or others. There is also the remote 
possibility that research records will be subpoenaed by a court of law. All of these potential 
losses of confidentiality will be disclosed in the consent documents.  
Risks of worsening mental or emotional state and or self-harm thoughts/events: Some 
participants may show a worsening of depressive or anxious symptoms, suicidality or problems 
during the study period. The development of suicidal ideation during the study remains the most 

serious risk. However, these are risks inherent in the population and would occur whether or not 
they were enrolled in the study. It is not believed that the risk of these depressive, anxious, 
suicidal, or other adverse outcomes are increased as a function of being enrolled in this study. 
All potential risks associated with participation in this study will be disclosed in consent 
documents. 
Antidepressant medications are permissible within this trial.  Treatment alternatives outside of 
the primary care setting include treatment from an outpatient psychiatrist or psychologist, 
electroconvulsive therapy, or inpatient treatment. The benefits of these alternatives are that they 
are evidence-based, more intensive and specialized. 
 
Potential Benefits to Participants: 
The potential benefits of participation are that some participants may receive support for their 
depression and anxiety. The potential to future patients is that the study may provide 
fundamentally new and more effective low-intensity treatment approaches that would be more 
widely available.  
 
Vulnerable Populations: n/a 
 
Community-Based Participatory Research: The user-centered design processes described in 
Phase 1, and the user feedback interviews described in Phase 2 will involve members of the 
community in both the design and conduct of the research.  
 
Sharing of Results with Participants: 
Aggregate results will be shared with participants at the conclusion of the research study 
through written summaries and infographics. 
 
Setting: 
The PI, Dr. Lattie, has an office within the Center for Behavioral Intervention Technologies 
(CBITs) within the Northwestern University Department of Preventive Medicine and has access 
to secure data storage through the Feinberg School of Medicine.  The majority of research 
activities will take place online or on site at the University of Illinois at Chicago (UIC) Counseling 
Center and at Northern Illinois University (NIU) Counseling & Consultation Services.  
The UIC Counseling Center has more than 25 rooms for individual therapies, three group 
therapy rooms, two or more smaller rooms for self-directed programming (e.g. biofeedback), 
and three furnished conference/multi-purpose rooms for workshops, staff meetings and 
gatherings that can each accommodate upwards of 25 people. Counseling Center staff also 
have access to larger conference spaces in their building and elsewhere on campus. NIU 
Counseling & Consultation Services operates in a space with 19 individual therapy rooms, a 
relaxation room (capacity 2-3 people, two group therapy rooms (capacity 10-12 people), and a 
conference room that can accommodate 20 people.  
 
Resources Available: 
The PI, Emily Lattie, is a licensed clinical psychologist and research assistant professor within 
the Department of Preventive Medicine. Dr. Lattie has training and expertise in mobile and web-
based interventions, and more recently, has begun working on methods to leverage 
technologies to expand mental health care accessibility for university students. Dr. Lattie has 
built strong relationships with the directors of the UIC and NIU counseling centers. The mobile 
app programmer who is scheduled to work on this project has several years of experience 
building mobile mental health apps, and has collaborated with researchers from the Center for 
Behavioral Intervention Technologies for the past 10 years.  
 

Both universities involved in this study have large student bodies, and serve more than 1,000 
students per year. Based on the size of these student bodies, it is expected that it will be 
feasible to recruit the 68 participants proposed in Phase 1 to conduct user centered design 
work. In Phase 2, we are interested in assessing the uptake of the intervention program and do 
not have a set number of participants to recruit.  
 
The PI and a research assistant devote full-time effort to this research project. The PI and 
research assistant have designated office space within the Center for Behavioral Intervention 
Technologies, along with a personal computer and have access to a printer and scanner 
(available software includes SPSS/SAS, MS Office, Adobe, etc.). Both have access to research 
databases, administrative support, hardware, and software assistance available directly within 
the Department. The Department has a secure server with data security features ensuring 
confidentiality of participant data. All laptops are encrypted and the network has firewall 
protection. In addition, Northwestern University’s information technology program supports 
researchers with the software, hardware, and data storage and retrieval facilities to conduct 
large-scale projects. 
 
Prior Approvals: 
Approval will be obtained by the University of Illinois at Chicago and Northern Illinois University 
prior to commencing research activities.  
 
Confidentiality: 
Data for all participants will be kept strictly confidential, except as mandated by law. All research 
files are kept on secure, password protected Northwestern University departmental and medical 
school servers. All electronic data will be stored on secure servers behind firewalls meeting all 
security requirements of the medical school. Any paper documentation is kept in locked file 
cabinets or a locked file room. Participants will be assigned a numerical code for identification in 
the files. Names and other identifiers will be kept in separate password protected files. Audio 
data will be stored on secure servers and will only be available for coding by study staff. Online 
assessments will be conducted on REDCap. This platform uses up to date security measures 
that are consistent with those used by Electronic Medical Records and are HIPAA compliant. All 
data collected via the interventions (e.g. mobile application) and assessments are transmitted 
using Transport Layer Security (TLS) encryption to prevent eavesdropping and tampering 
information while it is in the transmission pipeline. In addition, all data stored within the 
intervention is de-identified with a unique key. We will instruct patients on how to add a PIN to 
their phone to prevent unwanted access. We will clearly inform the patients of the risk of data 
insecurity. All data presentation will be of aggregate-level data; participants are never 
individually named. 
 
Financial Compensation 
Participants in the codesign workshop (Stage I) will be offered $30 cash for participation. 
Financial compensation will not be offered for survey completion (Stage II). Participants in the 
semi-structured interviews (Stage III) and in the usability testing sessions (Stage IV) will be 
offered $20 cash for participation. For the Stage V trial, participants will be compensated $10 for 
each of the monthly in-app assessments, and will be compensated $20 for each of the 
telephone-based user feedback interviews. Thus, participants are eligible to receive up to $70 
for their efforts in the Stage V trial. Participants in the Phase 2 trial will earn entries into a lottery 
for completing monthly Knowledge Check questionnaires. Lottery winners will be selected on a 
monthly basis and will win a $50 Amazon giftcard.  Participants completing semi-structured 
interviews during Phase 2 will be compensated $20 cash for in-person interviews or by a $20 
Amazon gift card for phone interviews.  

 
Provisions to Protect the Privacy Interests of Participants: 
Participation in all aspects of the study is voluntary and data will be stored without personal 
identifiers. Participants will be reminded of the voluntary nature of study procedures.  
 
Compensation for Research-Related Injury: 
n/a 
 
Economic Burden to Participants: 
n/a 
 
Consent Process:  
For the codesign workshop (Stage I), participants will read and sign a paper copy of the 
informed consent form and be provided a copy for their own records. They will be given an 
opportunity to discuss the consent form with a member of the research study staff in private 
before the start of the codesign workshop. 
 
For the survey sent to counseling center staff (Stage II), participants will read and click “agree” 
or “do not agree” on an online consent form. They will be encouraged to print the page for their 
own records, and will be provided with contact information of the PI in case they want to discuss 
the consent form before agreeing to participate.  
 
For the semi-structured interviews (Stage III), participants will read and sign a paper copy of the 
informed consent form and be provided a copy for their own records. They will be given an 
opportunity to discuss the consent form with a member of the research study staff. To determine 
if students are eligible to participate in the Stage III semi-structured interviews, they will be 
prompted to complete an online eligibility screening measure. Participants will read and click 
“agree” or “do not agree” on an online consent form for this screening measure. They will be 
encouraged to print the page for their own records, and will be provided with contact information 
of the PI in case they want to discuss the consent form before agreeing to participate. 
 
For the usability testing (Stage IV), to determine if students are eligible to participate in the 
usability testing session, they will be prompted to complete an online eligibility screening 
measure.  Upon determination of eligibility, study staff will contact eligible participants to 
schedule a date and time for the participant to come in for the usability session.  Before the 
usability session begins participants will be guided through a written consent and will sign if they 
agree with the written consent presented to them with research staff signing as witness.  
Research staff will then copy the consent to provide the participant for their own records as well 
as be asked if they have any questions before they would like to participate.  
 
For the 8-week feasibility trial (Stage V), to determine if students are eligible to participate in the 
usability testing session, they will be prompted to complete an online eligibility screening 
measure.  Upon determination of eligibility, study staff will contact eligible participants by email  
With a link to the digital consent form. Subjects will agree to participate by checking a “yes” box 
and typing in their name. They will be instructed to print out the consent form for their records. 
Participants are to be enrolled remotely to avoid excluding participants with access barriers who 
are among those who would be likely end users. The digital consent form will describe the 
mobile app program, show participants how to add a PIN to their phone, and inform participants 
that data entered into the phone will be de-identified to the research team, those it cannot 
replace the need for contacting a mental health provider in the case of an emergency.