Ethics approval and consent to participate
This study has received full ethical approval from the Health Research Authority (HRA) in the UK (Research Ethics Committee reference: 17/LO/0596) in the UK. Informed consent will be obtained from all participants through completion of a consent form. Important modifications to the trial protocol will be submitted for approval from the trial sponsor and HRA.
Participants will be assigned a unique identification code which will be used to complete assessments and will be used for data files
Consent for publication
Participants will be asked to consent to their anonymised data to be used in research publications.
Availability of data and material
The datasets created for the current study will be available from the corresponding author on reasonable request.
This paper presents independent research funded by the National Institute for Health Research (NIHR) under its Research for Patient Benefit (RfPB) Programme (Grant Reference Number PB-PG-0815-20056). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.
CS is Research Lead for the Sussex Mindfulness Centre and has received NIHR and other funding for research trials evaluating mindfulness-based interventions. KC, FJ, LL, CR and SB have received research funding to evaluate mindfulness-based interventions. All other authors declare that they have no conflicts of interest.
This study was funded by the NIHR Research for Patient Benefit programme, reference number PB-PG-0815-20056. Data collection, data storage, data analysis, interpretation of findings and the decision to publish findings will be conducted independently of the funders.
Brighton & Sussex Clinical Trials Unit will help to manage the study. The Trial Steering Committee (TSC) will compromise of an independent chair, two additional independent members and two lay members. The Chief Investigator (CS), Trial Manager (AA) and Trial Statistician (AMJ) will also attend the TSC. The role of the TSC will be to over the trial and ensuring that it is running in line with the HRA-approved protocol. The Data and Safety Monitoring Board (DSMB) will compromise of an independent chair and two additional independent members, and will comprise of separate membership to the TSC. The DSMB will be independent of the study sponsor. The Chief Investigator (CS), Trial Manager (AA) and Trial Statistician (AMJ) will also attend the TSMB meetings when requested to do so by the chair. The DSMB will have sight of study data and will have the authority to pause or close the trial if it has concerns about participant safety or trial integrity. TSC reports will be shared with members of the DSMB and vice versa. Copies of the DSMB and TSC charters can be requested from the corresponding author. A Lived Experience Advisory Panel (LEAP) will comprise of PPI members and will be chaired by the study PPI Consultant and co-applicant (LL). The LEAP will meet on 7 occasions during the course of the study and their role will be to advise on recruitment and retention strategies, participant experience and they will contribute to dissemination of study findings to participants, patients and the public. The PPI Consultant on the study (LL) will attend weekly operational meetings to oversee the day-to-day running of the study from a PPI perspective and to act as bridge between the research team and LEAP.
CS led on study design with all authors contributing to the design of the study. CS and CR wrote the first draft of the manuscript with all authors contributing to subsequent drafts. All authors read and approved the final manuscript.
Findings will be written up regardless of outcome for publication in peer reviewed journals and an accessible summary of findings will be produced for participants and members of the public with the support of the Lived Experience Advisory Forum (LEAP).
We would like to thank the RfPB stream of NIHR for funding this study (PB-PG-0815-20056) and we would like to thank Brighton & Sussex Clinical Trials Unit for supporting delivery of the study.
This study would not be possible without the hard work and dedication of the study research assistants and we are very grateful to them: Ellie Ball, Peter Beadle, Chloe Burke, Marina Christoforou, Roxanne Denny, Guy Emery, Natalia Fagbemi, Luke Groom, Molly Heeger, Maggie Karanasiou and Amy Pound
We would like to thank the IAPT services for agreeing to take part in this study, the Principal Investigators (PIs) and clinical leads in these sites and the PWPs agreeing to contribute their time to the study. The IAPT services are: Brighton and Hove Wellbeing Service (PI: Juliet Couche, Step 2 Lead: Lizzie Gray), East Riding Emotional Wellbeing Service (PI and Step 2 link: Zoe Lane), Health in Mind in East Sussex (PI: Juliet Couche, Step 2 Lead, Jan Shepherd), Health in Mind in North-East Essex (PI: Maggie Rosairo, Step 2 Lead: John Birsall), italk in Hampshire, Lewisham IAPT service (PI: Janet Wingrove and Kate Rimes, Step 2 Lead: Jackie Ganley), South West Yorkshire Partnership NHS Foundation Trust (PI: Rick Stebbings), Talking Change in Portsmouth (PI: Mahdi Ghomi, Step 2 Lead: Charlotte Hodges), Talking Therapies Southwark (PI: Janet Wingrove and Kate Rimes, Step 2 Lead: Janet Wingrove) and Time to Talk in West Sussex (PI: Claire Taylor, Service Leads: Simon Winter and Siaeda Cullen).
We are extremely grateful to members of the PPI group who contributed to the design, who will support delivery of the study and will contribute to dissemination of findings.