Research

Informed Consent

Participation in: Integrated Evaluation of Digital Mental Health Tools: Correlating Behavidence and Wellness Apps with Standardized Psychological Assessments

Protocol No.

BEH2024

Sponsor

Behavidence Inc.

Investigator

Janine Ellenberger, MD 767 S. Ithan Ave Bryn Mawr, Pennsylvania 19010 United States

Study-Related Phone

847-722-8324

Introduction

You are being invited to take part in research. This research is being carried out by Behavidence Inc. Behavidence (www.behavidence.com) is a commercial company that builds mental health navigation tools to help monitor mental health conditions such as Depression, Anxiety, Stress and ADHD (Attention Deficit Hyperactivity Disorder) using the technology of digital phenotyping. (Digital phenotyping refers to the science of leveraging behavioral data from smartphones to characterize individual human traits.) Before you decide to join the research, it is important that you understand why this research is being done and what activities will be involved. Please take time to read and understand the following information sheet carefully. Please email us at support@behavidence.com if you have any questions. Please note that this research study is not meant to diagnose or treat medical problems. Information provided through the downloaded apps in the research are only for informational purposes and the participant will have to contact their medical care provider for any medical concerns. In this research no private data is collected or used. The participant will be requested to periodically open the apps and answer certain standardized questionnaires.

Why am I being invited to take part in a research study?

We invite you to take part in this study because you have agreed to help research in developing a digital similarity score for mental health conditions.

Why is this research being done?

The purpose of this investigational study is to learn if usage of Behavidence app along with publicly available wellness tracking apps may be helpful in understanding more about mental health conditions. This will enable us to understand the effectiveness of using combined app and create accurate digital behavioural models for mental health conditions based on this data. This study involves downloading the Behavidence app to your smartphone, along with a publicly available wellness app and answering a short-standardized questionnaire(s) that are used to assess conditions such as depression, anxiety, stress, ADHD, etc. The chosen questionnaire(s) would be pertinent to the study (less than 2 mins).

How long will the research last and what will I need to do?

If you are answering to the advertisement of using the Behavidence app alone or along with a publicly available wellness app, you will need to download the apps and use it as per your convenience for a period of 30 days. If you are answering to the advertisement of using the Behavidence app only, then you will need to download only this app and use it for a period of 30 days. You will also need to answer in-app questionnaires on the Behavidence app once a week for 4 weeks. This research study collects two types of data: 1. Passive Data The app will passively collect behavioral data from your phone once you have downloaded the app, but will not collect ANY content or any personal information. The data will be automatically collected unless you delete the app from your phone. Passive data means information about when your phone is turned on or off and when your phone is being used or not used. The forms of passive data that we collect are App open and close, digital screen time, digital sleep time and gyroscope. 2. Active Data Collection The app will offer you the questionnaire to answer only once, while onboarding, during the 30 day duration, which you are encouraged to answer. This data will only be collected from the Behavidence App and no data will be collected from the wellness tracking app that you have also downloaded. You are free to stop the app collecting data at any time by deleting the app from your phone. Any data that has been collected before you delete the app will be used for research purposes, but no further or new data will be collected.

Research Procedures

If you qualify to take part in this research study, you will undergo these research procedures: Behavidence App along with a Publicly available mental health app: • You will be asked to download the Behavidence app and the publicly available wellness tracking app mentioned in the advertisement. • You will be required to enter the research code mentioned in the advertisement on the Behavidence App and continue to login using your preferred mode on the wellness tracking app. • The Behavidence app will collect passive data but no personal content data will be tracked or collected. All of the data collected is immediately encrypted on the phone as soon as it is collected. No data will be collected from the Wellness tracking app you download. • You will receive in-app notifications of surveys and standardized questionnaires to answer once a week for 4 weeks on the Behavidence Research App. Only Behavidence App: • At the time you decide to respond to the advertisement, you will be asked to sign up and provide basic demographic details. We will ask you to complete a validated psychological questionnaire to get a baseline assessment. • Sign up can be done securely using your preferred email address and password and enter the research code. • This will take 2–5 mins. You have the choice to log in anonymously. • The app will collect passive data but no personal content data will be tracked or collected. All of the data collected is immediately encrypted on the phone as soon as it is collected. • You are free to use the app according to your convenience.

I am not very technologically inclined; how will I be able to use the app?

The app is very simple to use. It will give you a daily Mental Health Similarity Score to Stress, ADHD, Depression and Anxiety. There is also a journal option. You can simply use the app to monitor your mental health, journal and also to manage your digital use just by opening the app. You can use the Wellness tracking app based on your convenience to meditate, physical activity tracking, monitor your sleep etc based on the simple instructions given in the app.

Is there any way being in this study could be harmful to me?

As a result of your participation in this study, you are at risk for side effects listed in this section. This may or may not happen. There may be other unforeseeable risks. 1. Data Loss It is also possible that although the app has many features to keep your data secure, there is a remote chance that your data or phone could be stolen, although all your data other than the one you see on screen is encrypted. If this were to happen, someone would know all the information the app has been collecting about you including your journal entries. 2. Malfunction of the App or the backend If the app were to malfunction, it could provide misleading information about the mental health condition. This could cause general concerns regarding mental health. Some malfunction could lead to information not being displayed in the app or the app not opening. If the user is relying on the app for insights about their mental health, this may lead to unavailability of timely information. Any malfunction in the backend or in the algorithm could lead to similar condition of either an incorrect information or missing information.

Steps to Ensure Confidentiality

The Behavidence app is HIPAA (Health Insurance Portability and Accountability Act) compliant, which ensures absolute confidentiality for our users. There is also an option to login anonymously where the user has to enter no personal information. Some of the steps that we take to ensure confidentiality are as follows: 1. All the data that we hold for our users is encrypted. We create random IDs when you log in, which can in no way be tracked to your real name/email if you choose to enter. 2. If we give any third parties access to our data, we add another level of encryption. 3. If a user uses their email or any social credential to log in, this information is maintained and managed completely independent of the research data. The user's log in credentials are protected through the highest level of encryption. 4. There is an option to sign in anonymously. This provides the option of using the app without providing any identifiable information including an email address. You will be assigned a unique user ID. As long as you continue to use the app and not delete it, your data will remain persistent and will be associated with the assigned user ID. Upon deletion of the app from the phone, there will be no way to retrieve your past data as there is no way for us to identify an individual user. 5. We have an efficient alert based system for any external threat to our servers, i.e., we are in complete control to protect our information if there is an external interference. 6. As noted above, all data the apps collect are not monitored in real time and no one will be able to respond to that data in real time. If at any time, and for any reason you need help you can email the research coordinator at support@behavidence.com.

Authorization to Use and Disclose Information for Research Purposes

What information may be used and given to others? The physician and the research team associated with the study will have access to your completely de-identified data, and your daily mental health similarity scores from the Behavidence App. The study doctor has no access to your name, or any other personal identifiable information. Who may use and give out information about you? As you are completely de-identified, your data will be shared as part of an anonymous bucket of information to build machine learning algorithms. Who might get this information? The sponsor of this research. "Sponsor" means any persons or companies that are working for or with the sponsor, or owned by the sponsor. In this case, the sponsor is Behavidence. Your information may be given to the following groups. Strict confidentiality is guaranteed as your data is completely de-identified: • The U.S. Food and Drug Administration (FDA) • Department of Health and Human Services (DHHS) agencies • Governmental agencies in other countries • Governmental agencies to whom certain diseases (reportable diseases) must be reported • Pearl IRB Why will this information be used and/or given to others? • To do the research • To study the results • To make sure that the research was done right If the results of this study are made public, information that identifies you cannot be used, as you are completely de-identified.

What if I decide not to give permission to use and give out my health information?

Then you will not be able to be in this research study.

May I review or copy my information?

Yes, but only after the research is over, and if you sign up with an email address. Should you sign up anonymously, we are unable to find your data. You have the right to review any mental health information collected about you and shared with others.

May I withdraw or revoke (cancel) my permission?

Yes, but this permission will not stop automatically. This permission will be good until December 31, 2070. You may withdraw or take away your permission to use and disclose your health information at any time. You do this by sending a written notice to the study doctor. If you withdraw your permission, you will not be able to stay in this study. When you withdraw your permission, no new health information identifying you will be gathered after that date. Information that has already been gathered may still be used and given to others.

Is my health information protected after it has been given to others?

There is NO risk that your information will be given to others without your permission. However, as a result of your participation in this study, you are at risk for less than minimal side effects listed in this section.

Will being in this research help me in any way?

There are no personal benefits to you from taking part in this research. This application is experimental and should not be used to diagnose or monitor mental health conditions. Your participation may help others in the future as a result of knowledge gained from the research. However, if you are also downloading any publicly available wellness tracking app, that may help you with physical fitness, sleep tracking etc. Any relevant research results pertaining to the study in general may be communicated to all participants through in-app notifications. These results would be general findings from the study. No personalized information or findings would be derived from this study and since there is no mechanism to identify an individual, there will be no personalized communications.

What happens if I do not want to be in this research?

Participation in research is completely voluntary. Your alternative is not to be in this study. You can decide to participate or not to participate. If you choose not to take part, or if you leave the study, your decision will not result in any penalty or loss of benefits to which you are otherwise entitled. This research study is not meant to diagnose or treat medical problems. Participation in this research study does not take the place of routine physical examinations or visits to your regular doctor. In addition, you are free to leave this study at any time even if you have already consented to be in the study. Withdrawing from the study or leaving early will have no negative consequences.

Do I have to pay anything for my participation in this study?

You will not be charged for your participation in this research study. You will not be paid for being in this study.

Can I use the application even after the study is over?

Yes, you are welcome to use the app for however long you want to. It will always be available to you free of cost. The anonymized data collected may be used for future research purposes which may be outside of this particular research time frame. No personal information even if provided will be used for any purposes. The user may opt out of using the app and also request their data to be completely deleted by contacting support@behavidence.com. Every user data will always remain anonymized for the life of its existence.

What happens at the end of the study?

Your data will be used as unidentified data to help build more accurate models. You are free to continue using the app or uninstall the app.

How many other participants would be involved in the study?

This study is expected to recruit at least 84 participants.

Undertaking by the Investigator

Your consent to participate in the above study is sought as a user. You have the right to refuse consent or withdraw the same during any part of the study without giving any reason. In such an event, you will not be forced to continue in the study. Behavidence Inc. undertakes to maintain complete confidentiality about the information that you provide us as part of this study. The information/data obtained from you will be stored with coded identification to ensure anonymity and utmost confidentiality and will be used for research only. Data obtained in this research study may be used in other of our research studies in deidentified format. The results of this study may be presented at meetings or in publications; however, your identity will not be disclosed in those presentations or publications. This study will adhere to the ethical principles outlined in the Declaration of Helsinki (2013). Ethical approval will be obtained prior to the study's commencement. Consent forms will prioritize participants' well-being, autonomy, and respect, including strict measures to ensure privacy and confidentiality.

Whom should I contact if I have questions?

If you have any questions, complaints or concerns regarding this study, or if any problems arise during your participation in the study, you may contact us at: Behavidence, Inc. Email: support@behavidence.com Phone: +1 252 486 4519 If you have any questions about your rights as a research subject or if you have concerns or complaints about the research, you may contact Pearl IRB at 317.602.6104. Pearl IRB Monday through Friday, 9–5 EST/EDT 29 East McCarty Street, Suite 100 Indianapolis, IN 46225 support@pearlirb.com 317-899-9341 (main) | 317-602-6554 (fax) https://www.pearlirb.com

Consent for Participating in the Research

I have read this consent form and have been informed about the procedures involved in "Effectiveness of Combined Digital Mental Apps: Evaluating the Impact of Behavidence and Publicly Available Wellness tracking Apps on mental health states measured by standardized questionnaires." I understand that for this study I will use the Behavidence application on the smartphone that I have downloaded. The study duration is 30 days and requires a questionnaire to be filled at one time point. I have understood the types of active and passive data that are being collected through these devices. I understand that the data collected will be processed and summary measures of the anonymized data will be used for data analysis, interpretation and scientific publications where no personal information will be revealed. I understand that I have the right to refuse my consent or withdraw it at any time during the study. I am able to save this consent form on my smartphone and print it should I wish. Furthermore, for participating in this study, I may not stand to benefit directly through my participation in this research project. By consenting to this, I hereby give my consent for participation in this research project and my consent for storage & sharing of my de-identified data as described above.
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