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Article History

Received: 29 March 2022

Accepted: 13 January 2023

First Online: 10 February 2023

Declarations

:

: This study protocol was approved by the Medical Research Ethics Committee (MREC) Utrecht (now: NedMec) on December 16th, 2021, with reference number NL78891.041.21 / 21–714. The sponsor will inform MREC NedMec of the start of data collection and any amendments to the study protocol. Furthermore, a summary of study progress (e.g., date of first inclusion, number of participants included, serious adverse events, and any problems or delays) will be submitted once a year. The sponsor will notify the MREC within the notification period (24 hours for safety reasons, 15 days for other reasons) in case of suspension or premature end of the study, including the reason. The MREC will be informed within 90 days after the end of the study (defined as completion of the follow-up assessment of the last participant). The study will be performed according to the Declaration of Helsinki [CitationRef removed] and the International Conference on Harmonisation – Good Clinical Practice.Written informed consent is obtained by the researcher overseeing the assessments prior to participation in any study procedures. Participants are informed of the study objective, method, expected benefits and potential hazards, and are given sufficient time to consider their participation and ask questions. Separate informed consent is obtained for collection and use of each data type in the current study and other studies. It is made completely and unambiguously clear to each client that they are free to refuse participation, and that they can withdraw consent at any time, without penalty or effect on their existing treatment. Only clients who are able to give legal consent can participate in the study. Signed informed consent forms are kept on file by the investigator, and are stored in an encrypted digital database.

: Not applicable.

: KopOpOuders Self-Help was developed at and is owned by the Trimbos Institute, but none of the authors affiliated with the Trimbos Institute (MB, AG, JK, and LSZ) derive financial income from KopOpOuders Self-Help or KopOpOuders-PTSD.