Edge, Daniel
Newbold, Alexandra
Ehring, Thomas
Rosenkranz, Tabea
Frost, Mads
Watkins, Edward R. http://orcid.org/0000-0002-2432-5577
Funding for this research was provided by:
Horizon 2020 (754657)
Article History
Received: 17 September 2021
Accepted: 12 October 2021
First Online: 21 October 2021
Declarations
:
: 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 University of Exeter, (10th February 2021, reference number eCLESPsy001977 v5.1). The trial is being conducted as part of a doctoral thesis project for a trainee clinical psychologist at the University of Exeter. The study is currently using trial protocol version 1.5 dated 7th September 2021.The trial sponsor is the University of Exeter, Exeter, UK. Protocol modifications are recorded and communicated to the University of Exeter and the ethics committee. Adverse events and other unintended effects of trial interventions or trial conduct will be self-reported by participants on the website through open questions asking about any problems arising from participation, standardized questions about self-harm and symptoms at each follow up at 6 and 12 weeks, plus spontaneously reported feedback from participants. If any of the participants indicate the trial is causing unnecessary harm, a Data Monitoring Committee (DMC) will be formed to review adverse events. Interim analyses will only be conducted at request of the DMC if there is a concern about harmful effects of the intervention under investigation; based on these analyses, the DMC will decide if the trial should be discontinued on the basis of participant well-being and safety. All serious adverse events will be reported to the University of Exeter ethics committee within 2 working days for review.The study 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 the research team.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, whose solution delivered the app.