Funding for this research was provided by:
Stichting Steunfonds Joodse Geestelijke Gezondheidszorg
Received: 21 May 2019
Accepted: 4 June 2020
First Online: 6 August 2020
Ethics approval and consent to participate
: This study will be performed according to the declaration of Helsinki (64th WMA general assembly; October 2013) and the International Conference on Harmonisation – Good Clinical Practice (ICH-GCP). The study protocol has been approved by the medical ethics committee (METC – case number A2018.428 (2017.335), version 7) was informed about the start of the study and will be informed about any amendments. A summary of the study progress will be submitted once a year to the accredited Ethical Review Board (ERB), including the date of inclusion of the first client, the number of clients included, serious adverse events, other problems, and amendments. The investigator will notify the accredited ERB of the end of the study within a period of 90 days. The end of the study is defined as the last patient’s visit. The investigator will notify the accredited METC immediately in case of temporary or prematurely halt of the study, including the reason of such an action. In order to evaluate whether the study is performed in compliance with the quality standards of the Good Clinical Practise guidelines, an independent researcher may conduct audits of all aspects of this study either during the study or after the study has been completed.Informed consent is obtained before any study-specific procedures take place. After explanation of the aims, methods, benefits and potential hazards of the study, the investigator obtains written informed consent from each client participating in the study. It is made completely and unambiguously clear to each client that they are free to refuse to participate in the study, or that they can withdraw their consent at any time and for any reason, without incurring any penalty or withholding of treatment on the part of the investigator. Only clients who are able to give legal consent will be entered into the study. Signed informed consents are kept on file by the investigator, and are documented in a database management system (i.e. Microsoft Access).
: Study results will be published in accordance to the CCMO statement on publication policy. Results will therefore be published in international scientific peer-reviewed journals only.
: The authors have declared that no competing interests exist.