Hayward, Mark http://orcid.org/0000-0001-6567-7723
Berry, Clio
Cameron, Ben
Arnold, Kate
Berry, Katherine
Bremner, Stephen
Cavanagh, Kate
Fowler, David
Gage, Heather
Greenwood, Kathryn
Hazell, Cassie
Jones, Anna-Marie
Robertson, Sam
Strauss, Clara
Funding for this research was provided by:
Research for Patient Benefit Programme (PB-PG-0317-20029)
Article History
Received: 4 January 2020
Accepted: 18 February 2020
First Online: 1 April 2020
Ethics approval and consent to participate {24}
: The study is sponsored by Sussex Partnership NHS Foundation Trust which will provide at least annual monitoring and audit of the trial and governance procedures. NHS Research Ethics Committee (London – Surrey, reference number 18/LO/ 2091), Health Research Authority and local Research Governance (at both sites) approval were granted before the commencement of the trial (study protocol – version 1, dated 5 November 2018 (see Table InternalRef removed for approved amendments to protocol)). Participants will provide written informed consent prior to the completion of any study procedures. The sponsor played no part in study design; collection, management, analysis and interpretation of data; writing of the report; and the decision to submit the report for publication.
: There is a potential conflict of interest as some members of the research team (MH, CS and CH) are also authors on the self-help book and/or published workbook being used within the GiVE intervention. Therefore, the research team agrees to publish the results of this feasibility trial, irrespective of the findings.