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Article History

Received: 26 July 2019

Accepted: 4 November 2020

First Online: 26 November 2020

Ethics approval and consent to participate

: All study procedures have been approved by the ethics committee of the Ulm University (application no. 47/18). Significant changes in the study protocol will be reported to the ethics committee, whereas additional meetings are not considered necessary due to the low-risk nature of the examined intervention. Participants will receive written information on study conditions, data security, publication of anonymized results, voluntariness of participation, and the right to leave the study at all times. They will also be informed that in case of study withdrawal, they will be able to decide whether they want their data to be included in the analysis or to be deleted. Additionally, participants will be asked for permission for the research team to share relevant data with people from regulatory authorities, where necessary. To confirm understanding of the above, written consent is obtained from all participants prior to study entry. This trial will only involve the collection and storage of self-report data, not of biological specimens. Data collection will be pseudonymized and data will only be accessed by authorized study personnel obliged to secrecy. After data collection is completed, personalized information will be deleted and all data will be completely anonymized. According to German law, data will only be shared with parties outside the project team in anonymized form. As there is no anticipated harm for participants of the trial, no compensation will be necessary.

: Not applicable.

: AK, DS, and HB were involved in the development of StudiCare-M or its predecessor versions. AK has received fees for lectures/workshops from chambers of psychotherapists and health insurance companies. HB reports to have received consultancy fees and fees for lectures/workshops from chambers of psychotherapists and training institutes for psychotherapists in the e-mental-health context. AK has received fees for lectures/workshops from chambers of psychotherapists and health insurance companies. DDE reports to have received consultancy fees/served in the scientific advisory board from several companies such as Minddistrict, Lantern, Schoen Kliniken, and German health insurance companies. He is stakeholder of the Institute for health training online (GET.ON), which aims to implement scientific findings related to digital health interventions into routine care.