Version: 1.0
Last update: 2025/03/12
Study full title: Feasibility Study of EmoDtx, a Digital Health Application for Depression: Preliminary Effectiveness and Usability Evaluation
Study ref: EMOTHRIVE-1
Sponsor: EMOBOT – 15 rue des Halles – 75001 PARIS
Principal investigator: Prof. Dr. med. Jan Philipp Klein, Center for Integrative Psychiatry ZiP gGmbH, University of Lübeck
Dear Patient,
In this document, you will find all the essential information about the study.
Please read this information carefully.
The planned participation is 50 people in the study.
This study is planned and conducted by UKSH/UKE.
The study is supported by Emobot, the manufacturer of the evaluated digital health application.
The study has been submitted to the responsible ethics committee.
The ethics committee has raised no objections. Your participation in this study is voluntary. You can end your participation at any time without giving reasons. You will not incur any disadvantages as a result.
People with depressive symptoms often have difficulty noticing changes in their mood and only seek help when they feel significantly worse. Traditional mental health care relies on patients telling their feelings to doctors or therapists, but there are long waiting times or a reluctance to seek professional help.
Our study is testing EmoDTx, a CE-certified Class I medical device available as a web/desktop and mobile app. It helps patients self-monitor and evaluate their emotions and mood. The app provides a dynamic representation of emotional well-being and offers personalized cognitive behavioral therapy (CBT) interventions to support mental health.
Your consent to participate in the study is voluntary and you can revoke it at any time without disadvantages. Exclusion from the study is possible if this is necessary for medical or organizational reasons.
The controller responsible for data processing within the scope of this study is:
Emobot, 15 rue des Halles, 75001, Paris, France
Email: dpo@emobot.fr
Website: https://www.emobot.fr
The data is collected and processed for the purpose of conducting the described study and used in this context. We also plan to use the data beyond the scope of this study for scientific research in the field of psychiatry. Participation in further data usage is voluntary.
The processing of your personal data is based on the following legal grounds:
- Art. 6 (1) (a) GDPR – your explicit consent
- Art. 9 (2) (a) GDPR – your consent to the processing of special categories of personal data (e.g., health data)
Additionally:
The processing of your personal data is also necessary for the conduct of this clinical investigation. It falls under the legal obligation of the sponsor in its role as a medical device manufacturer and allows for the evaluation of the performance, reliability, and safety of its product.
The data controller (sponsor) implements appropriate measures to safeguard your rights and freedoms, in particular by collecting only the data strictly necessary for the investigation.
The following data will be collected, stored, and processed:
Data collected by Emobot (stored on French servers and a certified health data host):
Data from patient questionnaires (processed by a third-party provider):
The data includes personal identifiers such as date of birth and sensitive health data.
Any data that could directly identify you (e.g., name, date of birth) is replaced with an identification code (pseudonymized). This makes re-identification by unauthorized persons virtually impossible. Identification is only possible by authorized study personnel.
For scientific publications or data sharing via research platforms, data will be anonymized to prevent identification of study participants.
The data will be stored in the sponsor’s and study site’s information systems:
Data will be deleted no later than 10 years after the end of the clinical trial or the last commercialization of the software.
Personal data will only be transferred to third parties:
In the context of Emobot’s commercial development, your encrypted data may be transferred to supervisory authorities in third countries, particularly the United States. Since the U.S. does not offer the same data protection level as the EU, the sponsor will ensure appropriate safeguards (e.g., contractual clauses) in accordance with Art. 46 GDPR.
You may request access to these safeguards or copies of the data or transfer location by contacting the Data Protection Officer (DPO).
All data is transmitted in pseudonymized form. This means recipients will only access the data necessary for the research. Identifying data such as names are not disclosed.
The EU has recognized the U.S. as having an adequate level of data protection through the Adequacy Decision.
You may agree to or refuse the use of your coded data for additional health- or medicine-related research projects, carried out exclusively for scientific purposes in psychiatry, by the sponsor or its contracted partners.An overview of ongoing research using your data can be found at: https://www.emobot.fr/recherche/clinique. This website includes all required GDPR information, including:
The publication of research projects on this site serves as notification. No additional individual communication will be provided for each new project.
To opt out of further use of your data, you may send an email to the sponsor's Data Protection Officer at: dpo@emobot.fr.
Your consent decision must be indicated in the consent form (checkbox yes/no).
Your consent to data processing is voluntary. You may withdraw consent at any time without providing reasons and without any disadvantage.
Upon withdrawal, no further data will be collected. The legality of processing carried out up to the point of withdrawal remains unaffected.
Already collected data may still be used if:
Under the General Data Protection Regulation, you have the right to:
If you have questions about data protection or wish to exercise any of your rights, including withdrawal of consent, please contact:
Data Protection Officer (DPO)
Email: dpo@emobot.fr
