Informed Consent 

 

Participation in: Research to Detect Anxiety through Digital Behavior on a Smartphone.  

 

Introduction:  

You are being invited to take part in research. This research is being carried out by Behavidence Inc. (www.behavidence.com), a commercial company that builds mental health navigation tools to help monitor mental health conditions such as Depression, Anxiety and ADHD 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 research@behavidence.com if you have any questions. Please note that  this research study is not meant to diagnose or treat medical problems.

  

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 anxiety. All participants will be recruited online.  

   

Why is this research being done?  

The purpose of this study is to learn if passive behavioral data, not content, collected through smartphone applications (apps) may be helpful in understanding more about anxiety. This will enable us to create accurate digital behavioral models for anxiety based on this data.  This study involves downloading the Behavidence app to your smartphone and answering a short questionnaire. (<2mins)

 

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

You will need to download the app and use it as per your convenience for a period of 21 days. You will also answer the questionnaire at the beginning of the study when you first download the app using the research code GAD212. 

 

This research study collects two types of data: 

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. 

Active Data:

The app will offer you the GAD (General Anxiety) questionnaire to answer at the beginning of the study, when you first download the app. 

  

 All Data Collected 

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 follow these research procedures:   

  • 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 an anxiety questionnaire to get a baseline assessment.

  • Sign up can be done securely using your preferred email address and password.

  • This will take 2-5 mins. This app will be password protected using a password of your choice, so no one else will be able to access the app.  You have the choice to log in anonymously. This means we will not be able to restore your data should you delete the app and reinstall it again. 

  • The app will collect passive data.

  • All of the data collected is immediately encrypted on the phone as soon as it is collected. When the smartphone is connected to wireless internet, all of the data will be encrypted again and sent to a secure server and stored within the network. 

  • The app will send all information to our server whenever it is connected to wifi. Whenever the app sends data off your phone, it deletes that data from your phone. If there is not a wifi connection, the data will temporarily be stored on your phone in an encrypted manner. As soon you again have a wifi connection, the data will automatically be sent to a safe and secure server.

 

As noted above, all data collected is 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 research@behavidence.com

 

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 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. 

 

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.  

1. Stigma 

It is possible that someone might see you using your  smartphone while on the app. This may lead to some stigmatization on their part that could potentially make you feel uncomfortable. The likelihood of this happening is unknown. However, you should be aware that there are several mobile applications that have a “mental health” connection used across the world by individuals from all walks of life.  

2. 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. 

 

Steps to ensure confidentiality: 

The app is HIPPA (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. 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?  

The app will help you in monitoring your anxiety through the help of Mental Health Similarity Scores. Your participation may help others in the future as a result of knowledge gained from the research. You will not be compensated for participating in this research.

 

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

Participation in research is completely voluntary. 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 in no way affect your treatment or harm your. 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 from my side for my participation in this study? 

You will not be charged for your participation in this research 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 charge. Your data will be used as unidentified data to help build more accurate models

 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. 

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. 

 

If you have any questions or concerns regarding this study, or if any problems arise during your participation in the study, you may contact us at research@behavidence.com

 

Consent for participating in the research:

 I have read this consent form and have been informed about the procedures involved in Research to Detect Anxiety through Digital Behavior on a Smartphone. 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 in. 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 clicking next, I hereby give my consent for participation in this research project.