PMID- 29606143 OWN - NLM STAT- MEDLINE DCOM- 20190618 LR - 20190618 IS - 1745-6215 (Electronic) IS - 1745-6215 (Linking) VI - 19 IP - 1 DP - 2018 Apr 2 TI - Evaluation of mindfulness-based cognitive therapy for life and a cognitive behavioural therapy stress-management workshop to improve healthcare staff stress: study protocol for two randomised controlled trials. PG - 209 LID - 10.1186/s13063-018-2547-1 [doi] LID - 209 AB - BACKGROUND: Healthcare workers experience higher levels of work-related stress and higher rates of sickness absence than workers in other sectors. Psychological approaches have potential in providing healthcare workers with the knowledge and skills to recognise stress and to manage stress effectively. The strongest evidence for effectiveness in reducing stress in the workplace is for stress-management courses based on cognitive behavioural therapy (CBT) principles and mindfulness-based interventions (MBIs). However, research examining effects of these interventions on sickness absence (an objective indicator of stress) and compassion for others (an indicator of patient care) is limited, as is research on brief CBT stress-management courses (which may be more widely accessible) and on MBIs adapted for workplace settings. METHODS/DESIGN: This protocol is for two randomised controlled trials with participant preference between the two trials and 1:1 allocation to intervention or wait-list within the preferred choice. The first trial is examining a one-day CBT stress-management workshop and the second trial an 8-session Mindfulness-Based Cognitive Therapy for Life (MBCT-L) course, with both trials comparing intervention to wait-list. The primary outcome for both trials is stress post-intervention with secondary outcomes being sickness absence, compassion for others, depression symptoms, anxiety symptoms, wellbeing, work-related burnout, self-compassion, presenteeism, and mindfulness (MBCT-L only). Both trials aim to recruit 234 staff working in the National Health Service in the UK. DISCUSSION: This trial will examine whether a one-day CBT stress-management workshop and an 8-session MBCT-L course are effective at reducing healthcare staff stress and other mental health outcomes compared to wait-list, and, whether these interventions are effective at reducing sickness absence and presenteeism and at enhancing wellbeing, self-compassion, mindfulness and compassion for others. Findings will help inform approaches offered to reduce healthcare staff stress and other key variables. A note of caution is that individual-level approaches should only be part of the solution to reducing healthcare staff stress within a broader focus on organisational-level interventions and support. TRIAL REGISTRATION: ISRCTN Registry, ISRCTN11723441 . Registered on 16 June 2017. Protocol Version 1: 24 April 2017. Trial Sponsor: Sussex Partnership NHS Foundation Trust (ResearchGovernance@sussexpartnership.nhs.uk). FAU - Strauss, Clara AU - Strauss C AUID- ORCID: 0000-0002-0303-763X AD - School of Psychology, University of Sussex, Pevensey Building, Falmer, BN1 9QH, UK. c.y.strauss@sussex.ac.uk. AD - Sussex Partnership NHS Foundation Trust, R&D Department, Sussex Education Centre, Nevill Avenue, Hove, BN3 7HZ, UK. c.y.strauss@sussex.ac.uk. FAU - Gu, Jenny AU - Gu J AD - School of Psychology, University of Sussex, Pevensey Building, Falmer, BN1 9QH, UK. AD - Sussex Partnership NHS Foundation Trust, R&D Department, Sussex Education Centre, Nevill Avenue, Hove, BN3 7HZ, UK. FAU - Pitman, Nikki AU - Pitman N AD - Sussex Partnership NHS Foundation Trust, R&D Department, Sussex Education Centre, Nevill Avenue, Hove, BN3 7HZ, UK. FAU - Chapman, Cavita AU - Chapman C AD - Sussex Partnership NHS Foundation Trust, R&D Department, Sussex Education Centre, Nevill Avenue, Hove, BN3 7HZ, UK. AD - Health Education England Kent, Surrey and Sussex, Crawley, West Sussex, UK. FAU - Kuyken, Willem AU - Kuyken W AD - Department of Psychiatry, University of Oxford, Warneford Hospital, Headington, Oxford, OX3 7JX, UK. FAU - Whittington, Adrian AU - Whittington A AD - Sussex Partnership NHS Foundation Trust, R&D Department, Sussex Education Centre, Nevill Avenue, Hove, BN3 7HZ, UK. AD - Health Education England Kent, Surrey and Sussex, Crawley, West Sussex, UK. LA - eng GR - ES/J500173/1/Economic and Social Research Council/ PT - Clinical Trial Protocol PT - Journal Article DEP - 20180402 PL - England TA - Trials JT - Trials JID - 101263253 SB - IM MH - Attitude of Health Personnel MH - Burnout, Professional MH - Cognitive Behavioral Therapy/*methods MH - England MH - Health Knowledge, Attitudes, Practice MH - Health Personnel/*psychology MH - Humans MH - *Mental Health MH - *Mindfulness MH - Occupational Stress/diagnosis/psychology/*therapy MH - Randomized Controlled Trials as Topic MH - State Medicine MH - Time Factors MH - Treatment Outcome MH - Workplace/psychology PMC - PMC5879876 OTO - NOTNLM OT - Burnout OT - CBT OT - Cognitive behavioural therapy OT - Compassion OT - Healthcare professional OT - Healthcare staff OT - MBCT OT - MBCT-L OT - Mental health OT - Mindfulness OT - NHS OT - RCT OT - Sickness absence OT - Stress OT - Wellbeing OT - Workplace COIS- ETHICS APPROVAL AND CONSENT TO PARTICIPATE: This study has been granted ethical approval by the Health Research Authority (HRA) in the UK (IRAS ID 224584). Informed consent will be obtained from all participants through completion of an online consent form. Important modifications to the trial protocol will be submitted for approval from the trial sponsor and HRA. CONSENT FOR PUBLICATION: Participants will be asked to consent to their anonymised data to be used in research publications. COMPETING INTERESTS: CS has developed the 1-day CBT workshop and WK has co-authored the MBCT-L course. WK is Director of the Oxford Mindfulness Centre and Principal Investigator of several Wellcome Trust and NIHR funded grants examining mindfulness-based programmes. Any remuneration for public engagement or consultancy is donated in full to the not-for-profit charity the Oxford Mindfulness Foundation. CS is the Research Lead for the Sussex Mindfulness Centre and has received NIHR funding for research trials evaluating mindfulness-based interventions. CC and AW are employed by Health Education England (Kent, Surrey and Sussex) who have funded this study. All other authors declare that they have no conflicts of interest. PUBLISHER'S NOTE: Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. EDAT- 2018/04/03 06:00 MHDA- 2019/06/19 06:00 PMCR- 2018/04/02 CRDT- 2018/04/03 06:00 PHST- 2017/11/02 00:00 [received] PHST- 2018/02/14 00:00 [accepted] PHST- 2018/04/03 06:00 [entrez] PHST- 2018/04/03 06:00 [pubmed] PHST- 2019/06/19 06:00 [medline] PHST- 2018/04/02 00:00 [pmc-release] AID - 10.1186/s13063-018-2547-1 [pii] AID - 2547 [pii] AID - 10.1186/s13063-018-2547-1 [doi] PST - epublish SO - Trials. 2018 Apr 2;19(1):209. doi: 10.1186/s13063-018-2547-1.