Mai, Anna https://orcid.org/0000-0001-5600-8560
Pape, Magdalena
Busse, Theresa Sophie
Kunde, Katharina
Bosompem, Jennifer
Giehl, Chantal
Otte, Ina Carola
Herpertz, Stephan
Juckel, Georg
Haussleiter, Ida
Wirth, Rainer
Vollmar, Horst Christian
Timmesfeld, Nina
Dieris-Hirche, Jan
Funding for this research was provided by:
Medizinische Fakultät, Ruhr-Universität Bochum (IF-025-22)
Ruhr-Universität Bochum
Article History
Received: 23 July 2024
Accepted: 3 March 2025
First Online: 10 April 2025
Declarations
:
: Clinical protocol and written informed consent were approved by the Ethics Committee for the Faculty of Medicine, Ruhr University Bochum (approval number 23-7901). Furthermore, the main ethical approval was confirmed by the ethics committees of all cooperating centers. All procedures described in the clinical trial protocol follow the Good Clinical Practice guidelines and the ethical principles described in the current revision of the Declaration of Helsinki. The study will be carried out in keeping with local legal and regulatory requirements.Consent forms describing in detail the study intervention, study procedures, and risks will be given to the participant and written documentation of informed consent will be completed prior to starting the study intervention. All participants receive a personally signed copy of the patient information and consent form.
: Not applicable.
: The study was funded by Innovation FoRUM, a financial support of the Medical Faculty at Ruhr University Bochum. External companies, in particular pharmaceutical companies or manufacturers of DiGA, had no influence on the study. The authors confirm that there are no conflicts of interest.