Testing the effectiveness of an intervention designed to reduce burn-out and improve wellbeing in healthcare professionals

ISRCTN ISRCTN34503872
DOI https://doi.org/10.1186/ISRCTN34503872
IRAS number 268429
Secondary identifying numbers Version 4.1, IRAS 268429
Submission date
03/03/2020
Registration date
14/04/2020
Last edited
30/01/2024
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English Summary

Background and study aims
Occupational burnout refers to a state of job-related emotional exhaustion, depersonalisation and reduced personal accomplishment. Burnout has a negative impact on well-being and physical health. Burnout is also associated with poorer job performance and increased time off work. Burnout in the UK National Health Service (NHS) is a system-wide problem with Public Health England estimating the cost of staff absence due to poor health at £2.4 billion per year. The NHS depends on having a healthy and productive workforce to deliver high-quality patient care and the NHS Long Term Plan acknowledges the need to “support improved health and wellbeing of staff and management of sickness absence”. Interventions that help to remediate occupational burnout and to improve healthcare workers’ wellbeing are greatly needed.
This study aims to assess if access to a group-based intervention based on the Chimp Paradox Model (CPM) may lead to changes in occupational burnout and well-being in healthcare professionals. This will be the first experimental test of this intervention in the NHS. The Chimp Paradox model (CPM) is a “mind management” approach developed by Prof. Steve Peters, a Consultant Psychiatrist. The model is based on developments in neuroscience. It offers practical strategies and skills for the individual to learn how to, gain insight into how their mind is working; understand and recognise their thoughts, behaviours and emotions; and better manage themselves to become the person they would like to be.

Who can participate?
Registered Nurses aged 18 and over, working in the community, who are employed by Rotherham Doncaster and South Humber NHS Foundation Trust.

What does the study involve?
Consenting participants will be randomly assigned to two groups: 1 and 2. If participants are randomly assigned to group 1, they will access an 8-week series of workshops based upon the Chimp Paradox model starting in March. If they are randomly assigned to group 2, they will wait 8 weeks and then access the workshops after group 1 finish their sessions. The workshops completed by both groups will be the same, so everybody will receive the same intervention. Participants will be asked to complete a series of outcome measures (questionnaires) to assess burnout and wellbeing at different time points throughout the study to assess whether the intervention makes any difference to staff well-being and sickness absence levels. The first questionnaire on occupational and personal wellbeing will be completed at the start of the study. This will then be repeated at three further timepoints (8 weeks, 16 weeks, and 40 weeks later). They will also be asked to report the number of sickness and absence days for the 6 month period before the study and for the period of time enrolled in the study.

What are the possible benefits and risks of participating?
Although benefit for individuals cannot be guaranteed, it is hypothesised that taking part in the psychological intervention will reduce occupational burnout levels in a group of nurses. Given the psychoeducational nature of the CPM intervention, the researchers do not envisage any potential for significant distress or adverse events. In the event that a participant is distressed for any reason, they will be provided information about usual sources of psychological and or occupational health support available to employees in RDASH NHS Trust.

Where is the study run from?
1. Rotherham Doncaster and South Humber NHS Foundation Trust (UK)
2. University of Sheffield (UK)

When is the study starting and how long is it expected to run for?
October 2019 to January 2021

Who is funding the study?
1. Chimp Management Ltd (UK)
2. Rotherham Doncaster and South Humber NHS Foundation Trust (UK)

Who is the main contact?
Prof. Michael Barkham
m.barkham@sheffield.ac.uk

Study website

Contact information

Miss Jeannie Mckie
Public

Grounded Research Team
Community Research Hub
Almond Tree Court
Woodfield Park
Doncaster
DN4 8QP
United Kingdom

Phone +44 (0)7818560176
Email j.mckie@nhs.net
Mrs Vikki Laker
Scientific

Grounded Research Team
Community Research Hub
Almond Tree Court
Woodfield Park
Doncaster
DN4 8QP
United Kingdom

Phone +44 (0)7970 049942
Email victoria.laker@nhs.net

Study information

Study designSingle-centre pragmatic stepped-wedge randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeQuality of life
Participant information sheet Not available in web format please use contact details to request a participant information sheet
Scientific titlePragmatic randomised controlled trial of an intervention to reduce burn-out and improve wellbeing in healthcare professionals
Study acronymCHIMP Paradox Model Trial (CPM)
Study hypothesisThis study aims to assess if access to a group-based intervention based on the Chimp Paradox Model (CPM) may lead to changes in occupational burnout and well-being in healthcare professionals. This will be the first experimental test of this intervention in the NHS.
Ethics approval(s)Approved 21/01/2020, NHS Research Ethics Committee (REC) (c/o Public Health Wales, Building 1,
Jobswell Road, St David’s Park, SA31 3HB, UK; +44 (0)1267 61 1164; sue.byng@wales.nhs.uk), REC ref: 20/WA/0029
ConditionOccupational burnout
InterventionThe study will include registered nurses working in community-based services across all four care groups in the Rotherham Doncaster and South Humber NHS Foundation Trust. Consenting participants will be randomly allocated to an immediate intervention group (group 1), or a waitlist control (delayed intervention) group (group 2). Allocation will be carried out by the research team, using randomisation software to apply a 1:1 randomization schedule, and will be communicated directly to study participants via email. Participants in group 1 will first undergo an 8-week, group-based, psychoeducational intervention based on the CPM. Following the completion of this intervention, group 2 will undergo the same intervention.

The planned intervention is the delivery of a standardised series of group-based workshops amongst a cohort of NHS nurses that consent to participate. The workshops will provide these study participants with an understanding of the Chimp Paradox Model (CPM) and help facilitate them in acquiring the skills required to apply the model to themselves in their world. All groups will be delivered at a meeting room based in the NHS to minimise travel time for participants.

The workshop series will consist of eight, 90-minute interactive sessions, one week apart. Each standardised workshop will be delivered and facilitated by a member of the Chimp Management team. Each workshop will be structured and delivered using a standardised presentation describing the principles of the model within that session. At specified stages of the presentation, participants will be encouraged to engage in facilitated small group discussions consisting of 6-8 people per table.

In addition to attendance at the workshops, study participants will all be given a copy of The Chimp Paradox book as a reference source. They will be requested to read particular chapters between the sessions and asked to spend some time contemplating key areas covered that week. This is to allow for continuous learning; specifically, the development of insight, acquisition of skills and application of these skills to themselves. Sessions 1-4 will introduce the basic principles of the CPM and sessions 5-8 will cover: communication, success, happiness and leadership.

At different timepoints (weeks 0, 8, 16, 40), outcome measures will be conducted via Qualtrics. This will automatically send email reminders regarding the completion of the outcome measures.

Analysis on the trial data will be based on comparing mean outcome measures between groups at week 8 using analysis of covariance (ANCOVA), controlling for baseline severity. The researchers will also carry out an exploratory analysis of sickness absence, this within-group comparison will be carried out using a paired-samples t-test (or an appropriate non-parametric test depending on the distribution of the data).
Intervention typeBehavioural
Primary outcome measureOccupational burnout measured using the Oldenburg Burnout Inventory (OLBI) at baseline, 8 weeks, 16 weeks, and 6 months’ follow-up
Secondary outcome measures1. Eudaimonic and hedonic mental wellbeing measured using the Warwick-Edinburgh Mental Well-being Scale (WEMWBS) at baseline (week 0), week 8, week 16 and week 40 (after 6 months)
2. Sickness absence days taken, self-reported via online survey during the active study and observation period at week 8, 16 and 6 months
3. Intervention completion/dropout rates: attendance measured using a register for each session and calculated at week 8 and week 16 for groups 1 and 2, respectively. If the participants do not complete all of the measures (point 1) they will also be classed as a dropout, so this will be measured at these points
Overall study start date01/10/2019
Overall study end date21/01/2021

Eligibility

Participant type(s)Health professional
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants192
Total final enrolment198
Participant inclusion criteria1. The study participants will be nursing staff currently working in Rotherham Doncaster and South Humber NHS Foundation Trust (RDaSH), either full-time or part-time
2. All participants will be RDaSH employees and hold an active professional registration with the Nursing and Midwifery Council (NMC)
3. Aged 18+
Participant exclusion criteria1. Currently accessing or referred to any concurrent psychological intervention delivered by a professional
2. Nurses that are currently not in active service at the time of recruitment (e.g., on sick leave, maternity leave or suspended for any reason)
Recruitment start date03/02/2020
Recruitment end date28/02/2020

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Rotherham Doncaster and South Humber (RDaSH) NHS Foundation Trust
Grounded Research
Almond Tree Court
Tickhill Road Hospital
Balby
Doncaster
DN4 8QP
United Kingdom

Sponsor information

Rotherham Doncaster and South Humber NHS Foundation Trust
Hospital/treatment centre

Grounded Research Team
Community Research Hub
Almond Tree Court
Woodfield Park
Doncaster
DN4 8QP
England
United Kingdom

Phone +44 (0)1302 798456
Email rdash.groundedresearch@nhs.net
Website https://www.rdash.nhs.uk/about-us/grounded-research/

Funders

Funder type

Industry

Chimp Management Ltd

No information available

Results and Publications

Intention to publish date31/07/2023
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot expected to be made available
Publication and dissemination planStudy findings will be presented at national conferences and published in appropriate peer-reviewed journals.
IPD sharing planParticipant level data will not be publicly available, in accordance with NHS ethical and governance approvals. A fully anonymised dataset will be available for future analyses, after the primary research manuscript has been published in a scientific journal. Data access requests are to be addressed to the chief investigator in writing, and access will be subject to obtaining ethical approval and pre-registration of intended analyses.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol file version v6 18/03/2020 16/04/2020 No No
HRA research summary 26/07/2023 No No
Results article 16/03/2023 30/01/2024 Yes No

Additional files

ISRCTN34503872_PROTOCOL_v6_18Mar20 (2).pdf
Uploaded 16/04/2020

Editorial Notes

30/01/2024: Publication reference added.
05/07/2023: The intention to publish date was changed from 30/06/2023 to 31/07/2023.
19/12/2022: The intention to publish date was changed from 31/12/2022 to 30/06/2023.
05/10/2022: The following changes were made to the trial record:
1. The overall end date was changed from 31/07/2022 to 21/01/2021.
2. The total final enrolment was changed from 436 to 198.
07/06/2022: The following changes were made to the trial record:
1. The overall end date was changed from 30/05/2022 to 31/07/2022.
2. The intention to publish date was changed from 31/07/2022 to 31/12/2022.
3. The plain English summary was updated to reflect these changes.
23/08/2021: The total final enrolment was changed from 296 to 436 following a second round of enrolment in 2021.
20/08/2021: The following changes were made to the trial record:
1. The overall end date was changed from 29/12/2020 to 30/05/2022.
2. The intention to publish date was changed from 31/07/2021 to 31/07/2022.
3. The plain English summary was updated to reflect these changes.
22/06/2021: The intention to publish date was changed from 01/06/2021 to 31/07/2021.
22/12/2020: Total final enrolment added.
16/04/2020: Internal review.
14/04/2020: Trial's existence confirmed by the NIHR. Uploaded protocol Version 6, 18 March 2020 (not peer reviewed).