FAQS

The RISE-UP Study is a collaborative research project between the University of Pittsburgh and Sage Therapeutics, Inc. focused on testing all components of data collection, data integration, and data analyses for a potential future research program regarding the mental health of university students. The RISE-UP Study is intended to provide the basis for the development of an algorithm that will help identify students who are at risk of developing psychological distress and will also collect data regarding the daily experiences of university students.

The goal of the pilot research study is to test all components of data collection, data integration, and data analyses anticipated for a later research program regarding the mental health of university students. This will increase the potential for the RISE-UP Study to achieve its goals of allowing the University of Pittsburgh to help identify students who are at risk of psychological distress and encourage them to seek care from healthcare professionals thereby improving the psychological wellbeing of students and increasing their chances for academic success.

Data collection within the pilot research study is intended to begin during the first few weeks of the 2023 summer session and will end 28 days after you complete the first survey. The data will be compiled, deidentified, and analyzed during the months after conclusion of the summer session.

The pilot research study is intended to test all components of data collection, data integration, and data analyses anticipated for the future RISE-UP Study regarding the mental health of university students. As such, it will closely mirror all activities that are anticipated for the potential future RISE-UP research program. The primary difference is with regard to the duration of student participation (the summer session for the pilot versus two semesters representing a full academic year for the future research). There will also be some differences in the ways in which the analyses are conducted because the pilot data will be used to evaluate if any changes are needed to help increase the probability that the future research program will be successful.  

The pilot research study is being conducted as a collaboration between the University of Pittsburgh and Sage Therapeutics, Inc. The faculty directly responsible for the pilot research study are from University of Pittsburgh Swanson School of Engineering.

College is a new highly competitive environment far from the support systems students had during adolescence. High rates of psychiatric conditions have been observed among students in that environment. For example, studies report an estimated 50-78% of college students experience symptoms of psychological distress. These brain health issues can have a negative impact on multiple areas of functioning, including but not limited to academic performance, impairment in social functioning, and substance abuse potential, all of which have implications for the future of the student and their families. Early detection of psychological distress and fostering care-seeking to ensure timely management may reduce disease progression and allow students to progress academically and continue pursuit of their educational goals. The University of Pittsburgh and Sage Therapeutics, Inc are working together to develop an algorithm to help detect the early signs of psychological distress in students and subsequently encourage care seeking behaviors with the hope of improving the emotional well-being of students, as well as impacting the associated academic and social outcomes. Your participation in the pilot research study will help increase the potential that these goals can be achieved.

It is not possible to predict all potential risks or benefits associated with joining any study. However, there  is no intended  direct health benefit or risk to you from participating in the pilot research study. However, it is possible that some of the survey questions about mental health might be upsetting to study participants or might make them uncomfortable. You are encouraged to seek care from a healthcare professional or the University of Pittsburgh Counseling Center or contacting a suicide prevention helpline.

We are accepting students with and without mental health diagnoses.  We will not be providing any mental health care as part of this study.  You should seek care from a healthcare professional or if you have any questions regarding mental health and/or diagnosis.

After study enrollment during which your eligibility for the study will be determined and you will sign an Informed Consent document upon eligibility determination, you will be given information on how to download and install the smartphone application that will be used to collect data. After the smartphone application has been set up you will receive notification daily prompting you to answer a one-item survey regarding your physical and mental wellbeing. The Data Collection Period will start when you have completed screening and enrollment and you begin responding to the Baseline Survey provided via the smartphone application. It will take you approximately 10 minutes to complete the baseline survey. You will participate in the study during the summer   session, and you will complete the Follow-up Survey at day 28 which will take you approximately 10 minutes to complete. Your participation concludes with the completion of the Follow-up Survey during the University of Pittsburgh’s 2023 summer session.

After all students have completed their participation in the study by submission of their final survey of the session, the Data Analysis Period will begin. Study analysts will merge the survey data collected from the participating students, additional data collected by the smartphone application, and academic information from the Registrar’s Office for the planned analyses. In order to help protect your privacy, the study analysts will only have access to deidentified data.

In order to be eligible to participate in the pilot research study you must meet each of the following eligibility criteria.

• Enrolled at the University of Pittsburgh
• Adult at least 18 years of age
• Willing to sign an Informed Consent Form
• Willing and able to download a smartphone application using the iPhone or Android operating system and participate in data collection through a provider plan with data coverage
• Agree to adhere to all other program requirements
•  

iOS

• Operating System
  • iOS 13 or later
  • *Please talk to your study if you are currently running iOS 16
• Phone Models
  • iPhone 7 Plus or later
  • *iOS 16 will only work on iPhone 8 or later
• Base Storage
  • At least 32GB

Android

• Operating System
  • OS 6 or later
• Phone Models
  • Android manufacturers handle background processes differently. You may notice issues with some phones (e.g., Huawei and Xiaomi). Several steps have been implemented to help alleviate this, but it may still be an issue. See dontkillmyapp.com for more information.
• Base Storage
  • At least 32GB

You may contact any of the study leads:

• Scott Streiner: scs147@pitt.edu
• Steven Abramowitch: sdast9@pitt.edu
• April Dukes: aprila@pitt.edu
•  

Potential participants can register to see if they are eligible for the study via this website. The specific URL is as follows Rise Up (pitt.edu) . You will fill out a Qualtrics survey to determine eligibility and will then be provided with further instructions (e.g., providing consent and receiving payment if eligible).

You will complete a brief set of questions via Qualtrics to determine if you are eligible for the pilot of the RISE-UP Study. If you are determined eligible and would like to participate you will sign an Informed Consent document. You will then be given information on how to download and install the smartphone application that will be used to collect data. Within the next 24 hours you will receive notification to begin completing the first of a daily one item survey and the Baseline Survey provided via the smartphone application. It will take you approximately 10 minutes to complete the baseline survey. You will participate in the study during the summer session and you will complete a Follow-up Survey at day 28. It will take you approximately 10 minutes to complete the Follow-up Survey. Your participation concludes with the completion of the Follow-up Survey during the University of Pittsburgh’s 2023 summer session.

Participants will be paid $25 for the first completed survey, and an additional $40 if they have completed the second survey 28 days later, totaling $65 over the course of the pilot research study.

A small number of students who complete all study activities and those who do not may be contacted to participate in a short interview to obtain information regarding their experience with the study for which they will be compensated an additional $25.

If a participant does not complete a particular survey no compensation will be given.

Please navigate to Ksana’s website to learn more about their mission: About Ksana Health

The following video offers a concise explanation of EARS:

You may also reference the EARS FAQ document found at this link:

EARS FAQ Document

Please reach out to your study coordinator (contact information in the ‘General’ section of FAQ) with any questions, issues, or problems with EARS. The study coordinators can then reach out to the Ksana team if additional troubleshooting is required.

You can continue to participate in the study even if you miss a survey. However, you will not be eligible for the $40 bonus that is given to those who complete all surveys available during the course of the study.

You could be disqualified from the study if you no longer meet the eligibility criteria. Those are:

• Enrolled at the University of Pittsburgh
• Adult at least 18 years of age
• Willing to provide consent
• Willing and able to download a smartphone application using the iPhone or Android operating system and participate in data collection through a provider plan with data coverage
• Agree to adhere to all other program requirements
• Enrolled students may also discontinue participation at any time

The following video offers a concise explanation of EARS:

Student champions are Pitt students that have been hired by the study to facilitate communication between study coordinators and participants. They will reach out to participants to answer technical questions related to participation and to provide reminders/updates as the study progresses. 

You are free to stop participating at any time. However, the aggregated data that has been provided prior to your termination will potentially be included in the study. Please also note that your compensation for participation will also be terminated at that time as well. Any compensation up until the point of termination will be yours to keep.

To stop participating, you can simply delete the app from your phone. That will cause any monitoring to be discontinued and you will not receive any further notifications. The study coordinators would appreciate an email at RISE-UP@pitt.edu or you can reach out to one of our student champions to let us know of your decision. You may be asked to participate in a focus group to better understand why you chose to withdraw from the study. However, participation in this focus group is not required.

A variety of mental health resources for Pitt students can be found on the following website: https://pitt.libguides.com/assistanceresources/health

You could also call the University of Pittsburgh Counseling Center (412-648-7930), or a nationwide suicide hotline that is answered 24 hours a day with a skilled, trained counselor such as the National Suicide Prevention Lifeline at 1-800-273-TALK (1-800-273-8255), or the Suicide Helpline at 1-800-SUICIDE (1-800-784-2433), or you can text the word HOME to the Crisis Helpline at 741741.

The pilot will collect academic records data, data from the Ksana EARS app, and your survey data. Please see the dedicated subsections with specific information regarding the data collected from each of these categories.

At the time students enroll in the study, there will be two random alphanumeric identifiers created and used to link data from the smartphone app and academic records. Only one study coordinator, Dr. April Dukes, will have access to the data key that associates these identifiers with the individual students. This is for payment purposes only and to address any technical issues should they arise.

At the conclusion of the summer session, “Device ID” and “Student ID” will be used to link all data that will be merged for the planned analyses. Once linked, the data are “deidentified” and other RISE-UP study team members only have access to this deidentified data for use in the planned analyses. The deidentified data will be transferred to Sage Therapeutics who will be responsible for maintaining the data environment where your data for analyses will be stored and will provide access to Sage and University of Pittsburgh data science teams. Sage uses Alation for Data Governance:

• Alation maintains a list of approved data owners for each data set
• Access to data must be requested through Alation
• Alation keeps an audit trail of all access requests and granted requests
• Alation also shows the lineage of how data sets are used

• Data collected from any student, including those who withdraw from the study, who initiated data collection through the smartphone app will have information recorded in the database. This data will be deidentified.
• Deidentified data will be retained in a standard s3 bucket for 7 years
• Sage will apply a Lifecycle policy to the bucket to move deidentified data to a deep archive after 7 years
• Deidentified data can be retrieved from deep archive with 5 days of notice
• Deidentified data will not be deleted

Your academic records will be used to monitor academic performance and will serve the study in two ways. First, it will be used as a variable along with your survey and app data to determine if there are signals that can be associated with the onset of mental distress. Second, it will be used to determine if there are signals in the student surveys and/or app data that are predictive of academic performance.

At the time you enroll in the study, there will be two random alphanumeric identifiers created and linked to your data to maintain your privacy. The first identifier is from the app and is linked to the data collected by the app. The second identifier will be a Participant ID number that is linked to your academic records. Those two identifiers will be linked upon your consent into the study and for the remainder of the study that is how you will be identified. Only one study coordinator, Dr. April Dukes, will have access to the key data that associates these identifiers with your name. This is for payment purposes and to address any technical issues should they arise. Otherwise, your name or any personal identifiable information will not be used beyond the time of consent for any other reason.

Only your cumulative GPA, term GPAs, and number of credit hours will be collected.

Clarification of Data Collected for the Study from the Ksana App

Keyboard data

Keyboard tracking will be enabled and all analysis will be done within the vendor’s cloud storage environment. The output that is generated includes the app being typed into, the exact keystrokes, the number of words typed on device, the time and date for each entry, and the device’s time zone. Data is used to generate language variables including: % of words that are: 1) positive; 2) negative; 3) indicative of self-focus; and 4) indicative of rigidity/extremity of language.

The typed content will be captured, processed, and then permanently deleted within 48 hours of data upload. The only information that will be stored are the characteristics about the language as outlined above, for example, the number of positive words typed, and not the language itself. Information about the language sent as replies to you in a text thread are not recorded in any way. The identities of users and respondents are never captured.

Accelerometer and GPS data

Sleep measurements will be estimated based off input data including the raw accelerometer. For example, bedtime will be achieved by analyzing the combination of accelerometer + GPS, and the screen time to estimate the time that a participant stops using their phone and is asleep (not moving). Using the movement sensors in the phone, we are able to estimate the time that you go to sleep and wake up.

The Ksana app collects your phone’s exact location and will process this for parameters to provide to study team only limited distance data. Your location data will be sampled from time to time, and these data are used to calculate measures of your pattern(s) of movement, similar to other apps like Google Maps or Find My (eg. the amount of time that you spend in different places and how you move between them). GPS location is exact. This is enabled and controlled by the participant, and is used to gauge location entropy, location of consistent presence, gross movement and routine, etc.

Motion tracking is done both through the onboard accelerometer (motor movement) as well as GPS (location – noted above). Patterns of movement (eg. walking, running, cycling, driving) are detected by the motion sensors in the phone.

Please see the ‘EARS Data Appendix’ for sensor descriptions based on your mobile device.

EARS Data Appendix

Please allow all permissions that you are prompted to enable by the app. This will allow the research teams to collect as full a data set as possible.

App data is saved to Ksana's secure Azure cloud and is then processed by data scientists into sets of feature data by sensor type and raw data by sensor type. This data is then provided to the UPitt and SageRx research teams. 

The only people with access to the data collected via the app is the Ksana data scientists and the members of the UPitt and SageRx research team members.  All data is de-identified of all personal information and is only referred to by the Participant ID and Device ID. 

App data is not accessible to EARS app study participants. 

After all students have completed their final survey of the 2023 summer session, study analysts will merge the survey data collected from the participating students, additional passive data collected by the smartphone application, and academic information from the Registrar’s Office for the planned analyses. In order to protect your privacy, the study analysts will only have access to deidentified data. The pilot research study will test all components of data collection, data integration, and data analyses anticipated for the potential future RISE-UP Study regarding the mental health of university students. As such, it will closely mirror all activities that are anticipated for the future research program. The primary difference is with regard to the duration of student participation (one session for the pilot versus two sessions representing a full academic year for the future research). There will also be some differences in the ways in which the analyses are conducted because the pilot data will be used to evaluate if any changes are needed to increase the probability that the potential future research program will be successful.

The only people with access to the data collected via the app is the Ksana data scientists and the members of the UPitt and SageRx research team members. All data is de-identified of all personal information and is only referred to by the Participant ID and Device ID. 

No. All data that is available to the research team will be deidentified and will not be linked to you as an individual for this purpose or any other.