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Article History

Received: 24 July 2020

Accepted: 3 September 2020

First Online: 22 September 2020

Ethics approval and consent to participate

: Ethical and professional guidelines will be followed at all times, in line with Good Clinical Practice guidelines. Institutional review board approval has been obtained from Universitat Jaume I de Castellon, Spain (14th May 2019, Reference number CD/023/2019), Ludwig-Maximiliansuniversitaet Muenchen, Germany, (4th September 2019; reference number 19–468, 19–315), University of Exeter, (23rd July 2019, reference number eCLESPsy000048 v3.0) and University of Ghent, Belgium (17th October 2019, reference number 2019–1069).The study is currently using trial protocol version 1.2. dated 6th April 2020. The trial sponsor is the University of Exeter, Exeter, UK. Protocol modifications are recorded and communicated to trial partners, sponsor, review boards and Trial Steering Committee (TSC).A Trial Steering Committee (TSC) with independent experts in ethics, psychiatry, statistics and a representative from a patient’s association will provide independent oversight of the trial and expert advice, meeting every 6 months, and ensure that it is being conducted in accordance with the principles of Good Clinical Practice and the relevant regulations, including if necessary a subgroup forming a Data Monitoring Committee to review adverse events. Interim analyses will only be conducted at request of the DMC if there is a concern about harmful effects of intervention; based on these analyses, the DMC will decide if the trial or a particular intervention should be discontinued on the basis of participant well-being and safety.Adverse events and other unintended effects of trial interventions or trial conduct will be self-reported on the website through open questions asking about any problems arising from participation, standardized questions about self-harm and symptoms at each follow up, healthcare use (including hospitalisation and emergency care) asked at the 3 and 12 month assessments, plus spontaneously reported feedback from participants. All serious adverse events will be reported to sponsor, ethics board and TSC within 2 working days for review. All adverse events are collated in a report for each TSC/DMC.Each trial site has a risk and safety protocol, which includes action for ancillary care for participants with mental health disorders, including signposting to help, aiding with onward referrals, and contact with a clinician in the team. The sponsor has trial insurance that has provision for compensation for those who suffer harm from trial participation, in the unlikely event it is required.All participants will provide written informed consent prior to baseline assessment. All participants can discontinue allocated interventions at their own choice and request.

: Not applicable.

: The authors declare no competing interests, except for MF, who is a co-founder and shareholder of Monsenso.