If you enroll in the study, we will collect contact information for you and your healthcare provider, caregiver (if you are under 18 years old), and emergency contact. We will also collect other information from you, including information about your demographics, health, mood, thoughts, and feelings. If you receive the treatment app, we will also collect data on how you use the app and the responses you make in the app.
We will use your study information to determine whether the app is an effective treatment for symptoms of depression.
We will use your contact information to get in touch with you (and your caregiver, if you are under 18 years old) and to ensure your safety while you’re enrolled in the study.
We may publish the results of this research and/or include it in regulatory submissions, including to seek FDA clearance of the study app. We will keep your name and other identifying information confidential in these reports and publications.
Records of your participation in this study will be kept confidential, except when sharing the information is required by law or as described in the consent form that you will be given before enrolling. People who may have access to your study information will include:
- People who work with the research sponsor (Limbix Health, Inc.), such as members of our data and safety monitoring board, who monitor the study and make sure participants are safe.- Government agencies, such as the Food and Drug Administration (FDA), for example, to comply with legal and regulatory reporting requirements.
- The Advarra Institutional Review Board that reviews this research.
- Certain third party vendors who help us operate the study app and study websites. These third parties are required by contract to maintain the confidentiality of your data and to follow applicable data protection laws.