Multifaceted ORganizational InterventiONs (M-ORION) project for prevention of depression and anxiety among workers: study protocol for a five-arm cluster randomized controlled trial.

"Declarations Ethics approval and consent to participateInformed consent will be obtained from all participants of the trial. The study protocol has been approved by Kitasato University Medical Ethics Organization (C22-082). The study will be conducted in accordance with the ethical standards of the Declaration of Helsinki (1964) and its subsequent amendments. Consent for publicationNot applicable. Competing interestsKotaro Imamura and Asuka Sakuraya are employed at the Department of Digital Mental Health, an endowment department supported by a grant from 17 enterprises (https://dmh.m.u-tokyo.ac.jp/en), outside the submitted work. Kazuhiro Watanabe, Hiroyuki Hikichi, Toru Yoshikawa, Shuhei Izawa, Hisashi Eguchi, Akiomi Inoue, Kengo Yoshida, Yasushi Orihashi,and Akizumi Tsutsumi declare that there are no conflicts of interest in connection with the paper. Competing interests Kotaro Imamura and Asuka Sakuraya are employed at the Department of Digital Mental Health, an endowment department supported by a grant from 17 enterprises (https://dmh.m.u-tokyo.ac.jp/en), outside the submitted work. Kazuhiro Watanabe, Hiroyuki Hikichi, Toru Yoshikawa, Shuhei Izawa, Hisashi Eguchi, Akiomi Inoue, Kengo Yoshida, Yasushi Orihashi,and Akizumi Tsutsumi declare that there are no conflicts of interest in connection with the paper."

"Funding This study is supported by the Grant-in-Aid for Scientific Research from the Japan Agency for Medical Research and Development (AMED) (JP21de0107006). AMED is a Japanese government agency. The study protocol was specified in the funding application and reviewed by the funder. The funder does not have and will not have any role in the study design, collection, analysis, and interpretation of data, in the writing of the report, or in the decision to submit the article for publication."

"Trial registration number UMIN000050949."