Expanding College Student Mental Health With Stress Management Mobile Technologies - Campus Wide Study
Phase: NA
Conditions: Depression, Anxiety
Sponsor: Northwestern University

 
 
Study title: IntelliCare in College Students - Implementation (ICCS-I) 
NCT number: NCT04108429 
Date: November 23, 2021 
Principle Investigator: Emily Lattie, PhD 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Study Protocol: 
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. 
 
Phase 2 Aim: Conduct a trial of the SSM program within two university communities. The 
overall aim of this study is to pilot the SSM program, evaluation metrics, implementation 
strategies, data collection and assessment procedures for a larger implementation trial. 
Counseling center utilization will be measured for one academic year to obtain a baseline for 
both sites. One site will be randomly selected and the SSM program will be implemented, while 
the other site will continue to collect baseline data. After one academic semester, the 
additional implementation strategies will be incorporated for an enhanced implementation 
plan, and both study sites will receive the enhanced implementation plan for one semester. 
During the implementation phases, counseling center utilization and SSM program use, will be 
tracked. 
    
Hypothesis 1: Introduction of the SSM program will impact utilization of counseling 
center resources, and the use of an enhanced implementation plan will increase program 
penetration (e.g., app downloads) and strengthen its impact on utilization. We will explore 
multiple metrics to assess program impact on utilization, and hypothesize the number of 
appointments for crisis and follow-up will 1) be reduced during implementation relative to pre-
implementation and 2) will be reduced in enhanced implementation relative to initial 
implementation.  We will also explore the impact of implementation on seasonal variations in 

counseling center utilization, level of depressive symptoms (as measured by the PHQ-9) at 
intake, and any other evaluation metrics identified during Phase 1. 
    
Hypothesis 2: Sustained use of the SSM program will result in reductions in depression 
and anxiety among individual users, and these reductions will be mediated by increases in 
mental health literacy, knowledge of mental health care services, and cognitive and behavioral 
coping skills. 
 
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.  
 
For Phase 2, students must own a smartphone device compatible with the mobile app (an 
Android-operating or iOS-operating smartphone with a system that operates Android 7 or 
higher or iOS 11 or higher). During Phase 2, we will also conduct feedback interviews with 
students who have not used the program. Because Black male students have been the 

demographic group who appear least likely to engage with the program, we are recruiting Black 
male students aged 18-35 years who have not used the program to provide feedback on what 
they are looking for in technology-based mental health and wellness resources. Therefore, 
students to be included will be those who self-identify as Black/African American men, between 
the ages of 18 and 35, English-speaking, familiar with smartphones, and enrolled at University 
of Illinois at Chicago and Northern Illinois University.  
 
 The following 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 Recruitment Methods: 
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 after receiving approval from administrators. After receiving permission from 
administrators, digital signage teaser advertisements (i.e. brief study advertisements to be 
displayed on televisions across campus) will be used to complement the other advertising 
methods. Online recruitment will be published to both public spaces and existing private groups 
with the permission of the private group administrators (including Facebook, Instagram and 
Reddit).  Participants will be directed to a website with study information and from there they 
will be able to access the study screening form and 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.  
For Phase 2 feedback interviews with Black male students who have not used the program, 
participants will be recruited online, by word-of-mouth and via e-mail at UIC and NIU 
campuses. After receiving IRB approval and approval from NIU and UIC study organizations, 
brief study advertisements and recruitment flyers will be used, as well, and published to social 
media platforms and through email announcements belonging to student organizations that 
aim to serve students, in general, and those from minority populations, e.g. student wellness, 
Black student associations and Greek organizations. Recruitment materials will include 
information about the study and contact information, directing those interested to contact a 
research team member. For students who express interest and contact the research team 
member, another email will be sent, containing information about the study, research team 

member contact information, and a link prompting students to complete an online consent and 
eligibility screening measure via REDCap. For those who do not respond to the recruitment 
email, a “nudge” email will be sent to remind participants 7 days after first contact. The consent 
form describes the study, discusses participant roles and responsibilities and risks, informs 
participants that their data will be confidential and de-identified data will be used for research 
purposes only, and provides important contact information. Participants will  agree to 
participate by checking a “yes” box and typing in their name. Once consent is received, another 
email will be sent to schedule interviews with students and share Zoom meeting information. 
Reminder emails will be sent 24-48 hours in advance and day of. These recruitment procedures 
are similar to those that have been approved by the Northwestern University IRB for prior 
studies conducted by our lab group. 
 
Procedures Involved: 
Monthly data on engagement with counseling center services will be collected from the 
counseling center’s Titanium Electronic Medical Record (EMR) to serve as a predeployment 
“baseline” for Phase 2. For the primary outcome of counseling center resource utilization, we 
will compare the predeployment phase (the 2 semesters prior to program implementation) to 
the implementation phases. During the predeployment phase, weekly data will be collected 
from existing service records at the counseling centers at UIC and NIU on new counseling 
appointments, follow-up appointment, group therapy appointments and crisis appointments. 
The data will be reported in aggregate and will not include individual personal identifiers. The 
SSM program will first be implemented in one study site (UIC or NIU – chosen via random 
selection) using the initial implementation plan (e.g. advertisements, identification of early 
adopters, identification of student leaders to serve as champions) designed in Phase 1. Data 
from individual interviews will be gathered from the first study site will inform an enhanced 
implementation plan. During this third semester, predeployment data will also be collected at 
Site #2. Then, the enhanced implementation plan, updated based on the semester 3 
deployment at Site #1, will be deployed at both study sites and data will be collected for an 
additional semester. When the implementation begins on each campus, the program will be 
made freely available to download, and counseling center intake paperwork will be modified to 
ask students if they used the SSM program which allows for tracking of counseling center 
referrals while maintaining patient confidentiality. This design allows us to examine: a 
predeployment phase for both sites, an initial phase of implementation for Site #1, and an 
enhanced implementation phase for Site #1 and for Site #2. A strength of this implementation 
design is that is allows for learning within itself by comparing initial implementation strategies 
with an enhanced implementation plan. This process of learning and adapting is key for 
effective and sustainable implementation. Staggering the start times of implementation allows 
for within-site targeted comparisons of effect of introducing the SSM program on utilization of 
the counseling center in each site, and for an exploration of between-site differences in the 
impact of the enhanced implementation plan. 
 
The study utilizes an interrupted time-series design, which offers a number of benefits over 
large-N designs and has been shown to be an acceptable approach for examining treatment 
efficacy as well as a useful design for rigorous implementation research when few sites are 

involved. There are both scientific and pragmatic benefits to introducing a program into a 
system with this design approach. Since these time-series measurements are recorded on a 
weekly basis, one can observe how change unfolds across time, examine seasonal effects to 
better evaluate change in these centers that are often at capacity, and investigate the 
trajectory of change. Because all members of the campus community are granted access to the 
program, this design meets the needs of community stakeholders. 
 
To examine outcomes for Hypothesis 2 (sustained use of the SSM program will result in 
reductions in depression and anxiety among individual users, and will be mediated by increases 
in mental health literacy, knowledge of mental health care services, and cognitive and 
behavioral coping skills), we will examine longitudinal data from individual users regarding 
depression and anxiety symptoms, mental health literacy, knowledge and beliefs about mental 
health care services, barriers to mental health care, and cognitive and behavioral coping skills 
to determine if sustained program use is associated with changes in these measures. 
SSM Program: The program will prompt users to complete repeated symptom assessments and 
provide psychoeducation regarding current symptoms while encouraging students in need to 
utilize available campus services. Upon download, the Student Hub app will prompt users to 
complete the PHQ-8 and GAD-7 and will provide feedback on symptoms. Based on symptom 
scores, users will receive automated feedback about depression/anxiety, availability of mental 
health and wellness services on campus, and information and interactive digital tools to 
support continued stress management and wellness. Users will be prompted with ability to use 
interactive self-help tools within the app suite. Interactive, clinical apps (designed for daily use) 
are included to facilitate engagement with mood monitoring, and to appeal to a preference for 
self-reliance.  
 
Risks of the intervention: The primary risk of the intervention is participants being distracted by 
their mobile phones while engaged in activities that demand their complete attention. 
Participants occasionally try to use mobile apps while driving motor vehicles, and therefore will 
be instructed never to use the mobile phone while driving. Participants will be made aware of 
the physical, financial, and legal risks associated with using the phone while driving. If the 
research team becomes aware of a participant engaging in this behavior, the PI and mentors 
will consult to determine the most appropriate way to eliminate this risk. 
 
Protection for risks of worsening mental or emotional state and or self-harm thoughts/events: 
Some participants may show a worsening of depressive symptoms, suicidality or problems 
during the study period. Consistent with past research on internet-based mental health 
screening and intervention for college students, participants will receive automated messages 
information on available resources (e.g. local emergency services, the Crisis Text Line, National 
Suicide Prevention Lifeline, and on-campus crisis counseling).  These are risks inherent in the 
population and would occur whether or not they were enrolled in the study. We do not believe 
that the risk of these depressive, suicidal, or other adverse outcomes are increased as a 
function of being enrolled in this study or receiving the mobile application. All potential risks 
associated with participation in this study will be disclosed in consent documents. 
 

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 
 
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. 
 
 
Statistical Analysis Plan: 
 
 
We used a mixed-methods approach to analyzing the impact of the IntelliCare for College 
Students program, in that we analyzed quantitative data on app usage and counseling center 
utilization alongside qualitative data generated through interviews with students and staff. 

Demographic data were examined primarily in the form of descriptive statistics, and chi-square 
tests and a student’s t-test were used to examine potential demographic differences between 
the participants who consented to the study that did (n=117) and did not (n=65) download and 
register their participant ID to the IntelliCare for College Students app.  App usage data were 
examined in the form of descriptive statistics.  
 
Due to missing data throughout the trial, multiple imputation methods and separate 
generalized linear mixed models to account for repeated measures from each participant over 
time, were used to examine symptoms of depression and anxiety at baseline, week 1, week 2, 
week 4, week 6 and week 8, and anxiety literacy, depression literacy, and cognitive and 
behavioral coping skills at baseline, month 1 and month 2. 
 
To examine symptom assessments longitudinally, we fit the available weekly symptom 
assessment data into a structure of baseline, week 1, week 2, week 4, week 6 and week 8 
timepoints. Only 2 individuals had complete data. A total of 48 participants only completed the 
symptom assessment at one time period, 16 (17) completed 2 of the 6 assessments (16 for 
GAD, 17 for PHQ), 3 (2) completed 3 of the 6 assessments, 5 had 4 of the 6 assessments, and 5 
were missing just one assessment. Multiple imputation methods were used to account for 
missing data. Participants were also prompted to complete measures of our mental health 
intervention targets on a monthly basis within the app. Many participants did not complete 
these assessments, and data were examined at baseline, month 1, and month 2. Multiple 
imputation methods were used to account for missing data.  
 
As originally planned for this project, counseling center utilization data were examined using 
Simulation Modeling Analysis (SMA) for Time-Series data to determine if there were changes in 
utilization between the pre-implementation and implementation phases. Because we were 
unable to enact an enhanced implementation strategy during the second semester of program 
implementation, we examined implementation as a single phase. SMA evaluates the statistical 
significance of between-phase changes in data streams and also accounts for the presence of 
autocorrelation (the non-independence of data points in time-series data streams). A phase 
effect size (Pearson’s R) is produced for each phase-comparison that is then compared to a 
distribution of data streams, using bootstrapping, resulting in an empirical estimate of the 
probability of the observed effect occurring by chance. 
 
Interviews were transcribed and coded using a thematic analysis approach.     The interview 
transcripts were first reviewed for thematic content. In creating the codebook, coders met to 
review their initial codes to reach initial consensus and identified the primary themes that were 
used to create a codebook. Then, a second round of review took place as the coders reviewed 
the codebook, refined codes as needed, and completed a final round of coding. The coders met 
regularly throughout the analytic process to discuss these codes with the study principal 
investigator, check codes between coders, come to consensus, and ensure validity. 
 
 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Consent form: 
Title of Research Study: Expanding College Student Mental Health with Stress Management 
Mobile Technologies 
IRB Study Number: STU00205589  
Principal Investigator: Emily Lattie, PhD 
Supported By: This research is supported by National Institute of Mental Health and 
Northwestern University. 
Financial Interest Disclosure: The following disclosure is made to give you an opportunity to 
decide if this relationship will affect your willingness to participate in this research study: Emily 
Lattie has received consulting fees in the past (last received in May 2018) from Actualize 
Therapy, LLC (now Adaptive Health, Inc.), the company that holds the license to the IntelliCare 
app platform. 
  
Before you get started with the Expanding College Student Mental Health with Stress 
Management Mobile Technologies study, we would like to share some important information 
about this research study and obtain your consent to participate. Please take the time to read 
the information carefully. If you have any questions feel free to discuss this with research study 
staff. 
Key Information about this research study:  
The following is a short summary of this study to help you decide whether to be a part of this 
study. This study examines usage of a university student-facing stress management mobile app 
program that can serve as both a self-help tool and as a bridge to connecting students in need 
with mental health services on campus. The purpose of this study is to examine use of a stress 
management mobile app program developed for college students, the impact the program has 

on mood symptoms and mental health knowledge, and the impact that program introduction 
has on campus counseling center utilization. You will be asked to download and use a stress 
management app known as the IntelliCare Hub for College Students.  Activities within this app 
include taking brief assessments, journaling, or accessing contact information for various 
campus resources that can be helpful in stress management. 
We expect that you will be in this research study throughout the academic year, and you can 
discontinue participation at any time by removing the app from your phone.  
 
The primary risks of participation are breaches in privacy and/or confidentiality. The 
information collected may only be protected to the extent technologically possible.  is 
participants being distracted by their mobile phones while engaged in activities that demand 
their complete attention. You may also feel emotional discomfort or increased anxiety as a 
result of reading, logging or talking about mental health. The main benefit of participation is 
helping researchers understand the impact IntelliCare for College Students can have on student 
mental health and counseling center utilization.  
Why am I being asked to take part in this research study? 
We are asking you to take part in this research study because you are a student at Northern 
Illinois University. You have a smartphone that operates Android 7 (or higher) or iOS 11 (or 
higher) and have expressed interest in using a smartphone app to track and manage stress.  
How many people will be in this study? 
We expect about 3000 people here will be in this research study. 
What should I know about a research study? 
• 
Whether or not you take part is up to you. 
• 
You can choose not to take part. 
• 
You can agree to take part and later change your mind. 
• 
Your decision will not be held against you. 
If you say that “Yes, you want to be in this research,” here is what you will do 
After you read this consent form and agree to participate by signing the form, you will receive 
information and instructions about how to download the study app onto your personal 
smartphone.  You will be asked to use the app in your daily life, to complete weekly mood 
symptom assessments, and monthly mental health knowledge assessments.  
Mental Health App tools 
As a participant in the study, you will be also able to use the IntelliCare suite of mobile 
applications developed by researchers at the Center for Behavioral Intervention Technologies 
(CBITs).  The IntelliCare apps teach people skills they can use to manage stress, depression and 
anxiety.  You will be encouraged to use the study app a few minutes each day.   
If you do not wish to participate in this research study, you will have the option to download 
the IntelliCare apps and use them on your own. In this case, the developers of the app will 
receive your usage data but it will not be used for this research study. 

Will being in this study help me in any way? 
We cannot promise any benefits to you or others from your taking part in this research. 
However, possible benefits include: 
● 
Learning helpful strategies to manage stress and mood. 
● 
Access to tools and lessons that may help you develop positive health behaviors and 
habits. 
● 
Access to contact information for stress-management resources.  
Is there any way being in this study could be bad for me? 
The risks from being in this study are minimal. The primary risks of the study are breaches in 
privacy and/or confidentiality. The information collected may only be protected to the extent 
technologically possible. An additional risk of this study is participants being distracted by their 
mobile phones while engaged in activities that demand their complete attention. Participants 
might experience distress reading, or logging information about mental health. The study app is 
not intended to replace the need for contacting a mental health provider or emergency services 
if you are at risk of harm to yourself or to others. However, the study app provides resources on 
how to contact a mental health provider. Participants who express distress to research staff will 
be assessed for suicide risk and provided with both on-campus and off-campus health 
resources. The study will not provide payment for the use of any additional health resources. 
There are additional risks due to the nature of this intervention being delivered via smartphone. 
Depending on the nature of your smartphone service plan, there is the potential for data plan 
overages. We encourage you to discuss your plan with research staff before enrolling in the 
study. There is also the potential for loss of confidentiality if someone else were to use your 
phone and read information you have entered into the app. We recommend password 
protecting your phone to reduce confidentiality risks. 
This study involves the use of your identifiable, personal information and there is a chance that 
a loss of confidentiality could occur. The researchers have procedures in place to lessen the 
possibility of this happening.  See the section below titled: “What happens to the information 
collected for the research?”. 
What happens if I do not want to be in this research or if I say “Yes”, but I change my mind 
later? 
Participation in research is voluntary. You can decide to participate or not to participate.  
You can leave the research at any time and it will not be held against you.  Your decision to 
participate in this study will not affect your status at your university.  
If you decide to leave the research, contact the investigator so that the investigator is aware. 
Your consent of the use of your information will never expire unless you change your mind. You 
may stop giving permission (and end participation of the research study) by calling Dr. Lattie. 
Even if you end your permission, the researcher may use your personal information that was 
collected prior to you stopping permission. 

What happens to the information collected for the research? 
Efforts will be made to limit the use and disclosure of your personal information, including 
research study, to people who have a need to review this information. We cannot promise 
complete secrecy. Organizations that may inspect and copy your information include the IRB 
and other representatives of this institution and the National Institute of Mental Health.  
This research is covered by a Certificate of Confidentiality from the National Institutes of 
Health. The researchers with this Certificate may not disclose or use information or documents, 
that may identify you in any federal, state, or local civil, criminal, administrative, legislative, or 
other action, suit, or proceeding, or be used as evidence, for example, if there is a court 
subpoena, unless you have consented for this use. Information or documents protected by this 
Certificate cannot be disclosed to anyone else who is not connected with the research except, if 
there is a federal, state, or local law that requires disclosure (such as to report child abuse or 
communicable diseases but not for federal, state, or local civil, criminal, administrative, 
legislative, or other proceedings, see below); if you have consented to the disclosure, including 
for your medical treatment; or if it is used for other scientific research, as allowed by federal 
regulations protecting research subjects.  
 
The Certificate of Confidentiality will not be used to prevent disclosure as required by federal, 
state, or local law of child [or elder] abuse and neglect, or intent to harm self or others.  
A description of this study will be available on http://www.ClinicalTrials.gov, as required by U.S. 
law. The ClinicalTrials.gov identifier is NCT04108429. This website will not include information 
that can identify you.  At most, the website will include a summary of the results.  You can 
search this website at any time. 
 
These surveys will be hosted by Adaptive Health, Inc on AWS servers and involves a secure 
connection. Adaptive Health, Inc will also have access to your app usage data. Terms of service, 
addressing confidentiality, may be viewed at https://www.actualizetherapy.com/privacy.  No 
personal identifiers are submitted with your survey results and you will only be identified by a 
unique subject number. All data is kept on a password protected server only accessible by 
Adaptive Health staff.  
 
Data Sharing 
You have the right to decide if we can use and share information gathered about you through 
this research study with others. By signing this consent form, you will give us permission to 
share some of your information with the researchers at Northwestern University who are 
conducting this study.  
De-identified data from this study may be shared with the research community at large (listed 
below) to advance science and health. We will remove or code any personal information that 
could identify you before files are shared with other researchers to ensure that, by current 
scientific standards and known methods, no one will be able to identify you from the 

information we share. Despite these measures, we cannot guarantee anonymity of your 
personal data 
● 
The following entities may have access to identifiable information under limited 
circumstances: 
○ Authorized members of the Northwestern University workforce, who may need 
to see your information, such as administrative staff members from the Office 
for Research, Office for Research Integrity and members of the Institutional 
Review Board (a committee which is responsible for the ethical oversight of the 
study.) 
○ Study monitors and auditors, for example from funding agencies, who make sure 
that the study is conducted properly. 
 
● 
The following entities may have access to study data without identifiable 
information. 
○ Other researchers and contractors working on this study and other studies who 
are collaborating to further research and agree to protect the data. 
○ Readers and reviewers of scientific journals that may publish the results of this 
and other studies that involve your data. 
 
The consent to share your information will not expire, unless it is revoked by you. 
What else do I need to know? 
Compensation: For completing monthly in-app mental health knowledge assessments, 
participants will be entered into a lottery with the potential to win one of multiple $50 Amazon 
gift cards. Because the research team does not know how many participants will use the app 
and complete these assessments, we cannot provide the approximate odds of winning a gift 
card. Due to payment restrictions, only participants who are U.S. Residents or Citizens are 
eligible for the gift card lottery. If selected for the lottery, a participant can decline the gift card 
for any reason, and will not be prompted to further report on their citizenship status.  
Who can I talk to? 
If you have questions, concerns, or complaints, or think the research has affected you in some 
way, talk to the research team at 312-503-3741 or at Emily.Lattie@northwestern.edu. 
This research has been reviewed and approved by an Institutional Review Board (“IRB”) at 
Northwestern University. You may talk to the Northwestern IRB office at (312) 503-9338 or 
irb@northwestern.edu if: 
• 
Your questions, concerns, or complaints are not being answered by the research team. 
• 
You cannot reach the research team. 
• 
You want to talk to someone besides the research team. 
• 
You have questions about your rights as a research participant. 
• 
You want to get information or provide input about this research. 
 

Consent 
If you want a copy of this consent for your records, you can print it from the screen.  
Agreeing to this consent documents your permission to take part in this research. 
 
 
[first_name] [last_name], if you wish to participate, please select “I Agree” and you will be 
taken to the instructions on how to install the app.  If you do not wish to participate in this 
study, please select “I Disagree” or select X in the corner of your browser.  
 
__________________ 
Today’s Date