Zero Self-Harm app: a mobile phone application to reduce non-suicidal self-injury-study protocol for a randomized controlled trial.

"Declarations Ethics approval and consent to participateThe trial is approved by the Regional Ethics Committee in the Capital Region of Denmark as H-19024725 and the Danish Data Protection Agency as P-2019-84. The trial is registered under Clinicaltrials.gov as NCT04463654. Potential participants will be informed about the project both verbally and with written information and have the opportunity for consideration or a chat with a next of kin before deciding whether to enrol in the trial. Participants will be informed about confidentiality and anonymity in the trial and encouraged not to e-mail any personal information but only provide this over the phone. Furthermore, to ensure confidentiality and anonymity, informed consent will be obtained through REDCap to the trusted Danish secure platform e-Boks. It will be stressed that participation is voluntary, and participation and written consent can be withdrawn at any time. The withdrawal will not have any consequences for future treatment possibilities. Consent for publicationNot applicable. Competing interestsThe authors declare that they have no competing interests. Competing interests The authors declare that they have no competing interests."

"Funding Open access funding provided by Copenhagen University The study is founded by a grant from the Tryg Foundation ID-127390 in February 2019. Contact information for the trial sponsor is: The Tryg Foundation, Hummeltoftevej 49, 2830 Virum, Denmark. Neither current nor future sponsors of the trial will have any role in the trial design, data collection, management, data analysis, or interpretation of data; writing of the report; or the decision to submit the report for publication."

"Trial registration ClinicalTrials.gov NCT04463654. Registered on 7 June 2020."