Ethics approval and Consent to Participate
The study is sponsored by Sussex Partnership NHS Foundation Trust. NHS Research Ethics Committee (London – Surrey - reference number 18/LO/ 2091), Health Research Authority and local Research Governance approval was granted before the commencement of the trial (study protocol – version 1, dated 05/11/18 [see Table 1 for approved amendments to protocol]). Participants will provide written informed consent prior to the completion of any study procedures.
Acknowledgements
We would like to acknowledge the significant contribution to the study that is being made by the APs (Emogen Campbell, Sophie Green, Debbie Sheffield, and Sasha Stone) and Research Assistants (Maisha Murshed and Suzanne Neumann). We also appreciate the advice and assistance that is being offered by Becky Whitfield, Peter Garwood, Jake Ellwood, Tina Perry and our Lived Experience Consultants.
Authors’ contributions {31b}
MH is the CI of the study and accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. MH, BC and CB took responsibility for the main drafting of the manuscript. All authors made substantial contributions to conception and design. All authors have been involved in drafting the manuscript or revising it critically for important intellectual content. All authors read and approved the final manuscript.
Funding {4}
This project is funded by the Research for Patient Benefit programme, a National Institute for Health Research grant (ref. number PB-PG-0317-20029). The funding body has not influenced the design, conduct, analysis or dissemination of this study. The views expressed in this publication are those of the author(s) and not necessarily those of the NHS, NIHR or the Department of Health.
Availability of data and materials {29}
Not currently applicable. The fully anonymised datasets generated and/or analysed (and associated statistical code) during the current study will be available from the corresponding author on reasonable request following the publication of results.
Ethics approval and consent to participate {24}
The study is sponsored by Sussex Partnership NHS Foundation Trust who 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.
Competing interests {28}
There is a potential conflict of interest as some members of the research team (MH, CS & 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.
Author details
Mark Hayward (corresponding author)
School of Psychology, University of Sussex, Brighton BN1 9RH & Research & Development Department, Sussex Partnership NHS Foundation Trust, Hove, BN3 7HZ
[email protected]
Clio Berry
School of Psychology, University of Sussex, Brighton BN1 9RH
[email protected]
Ben Cameron
Research & Development Department, Pennine Care NHS Foundation Trust, 225 Old St, Ashton-under-Lyne OL6 7SR
[email protected]
Kate Arnold
Research & Development Department, Sussex Partnership NHS Foundation Trust, Hove, BN3 7HZ
[email protected]
Katherine Berry
Faculty of Biology, Medicine & Health, University of Manchester, M13 9PL
[email protected]
Stephen Bremner
Brighton & Sussex Medical School, University of Sussex, Brighton BN1 9RH
[email protected]
Kate Cavanagh
School of Psychology, University of Sussex, Brighton BN1 9RH
[email protected]
David Fowler
School of Psychology, University of Sussex, Brighton BN1 9RH
[email protected]
Heather Gage
School of Biosciences & Medicine, University of Surrey GU27XH
[email protected]
Kathryn Greenwood
School of Psychology, University of Sussex, Brighton BN1 9RH
[email protected]
Cassie Hazell
Social Sciences Department, University of Westminster, London W1W 6UW
[email protected]
Anna-Marie Jones
Research & Development Department, Sussex Partnership NHS Foundation Trust, Hove, BN3 7HZ
[email protected]
Sam Robertson
Research & Development Department, Sussex Partnership NHS Foundation Trust, Hove, BN3 7HZ
[email protected]
Clara Strauss
University of Sussex & Sussex Partnership NHS Foundation Trust, BN3 7HZ [email protected]