Clinical trial of an intervention to support medical doctors with occupational burnout
| ISRCTN | ISRCTN14947225 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14947225 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 326365 |
| Protocol serial number | CPMS 56864, IRAS 326365 |
| Sponsor | Rotherham Doncaster and South Humber NHS Foundation Trust |
| Funders | Health Education England, Chimp Management Ltd. |
- Submission date
- 24/09/2023
- Registration date
- 28/02/2024
- Last edited
- 14/11/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Occupational burnout and associated mental health symptoms are known to affect around 44% of UK doctors. Previous studies show that burnout has a negative impact upon psychological well-being and physical health, as well as being associated with poorer job performance. Burnout is also associated with poorer patient treatment outcomes. The purpose of this study is to assess the effects of a psychological intervention called Mind Management Skills for Life Programme on NHS Doctors' health and wellbeing.
Who can participate?
Doctors working in the English National Health Service.
What does the study involve?
Participating doctors will access an 8-session, internet-enabled, psychological intervention delivered by experienced facilitators using videocall software. Half of the consenting participants will access this intervention immediately, while the other half wait to access the intervention ten weeks later. Participants will complete online surveys at four time-points (baseline, after 10 weeks, after 20 weeks, after 6 months) including measures of occupational burnout, psychological wellbeing, and job satisfaction. We will compare mean levels of severity across all of these measures at multiple timepoints. We expect that there will be no differences between groups at baseline. After group 1 completes the intervention, we expect their measures will indicate better occupational health and wellbeing than group 2 (who did not yet receive the intervention). After group 2 completes the intervention, we expect to find no significant differences in outcome measures, nor do we expect to find significant differences between groups at 6 months' follow-up.
What are the possible benefits and risks of participating?
We expect that participants will experience improvements in occupational burnout, wellbeing and job satisfaction. We do not foresee any risks or adverse effects, based on prior research examining the impact of this intervention.
Where is the study run from?
This study is led by the Psychological Health Observatory, part of the Grounded Research Team at Rotherham Doncaster and South Humber NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
September 2023 to September 2025
Who is funding the study?
The study has been partly funded by a grant from Health Education England, and partly supported by in-kind funding (specifically to cover the cost of intervention delivery) from Chimp Management Ltd. (UK)
Who is the main contact?
rdash.research-gov@nhs.net
Contact information
Principal investigator
Grounded Research Hub, No 2 St Catherine’s Close, Tickhill Road Hospital, Balby
Doncaster
DN4 8QN
United Kingdom
 ORCID ID |
0000-0002-6009-2440 |
|---|---|
| Phone | +44 (0)3000 212 456 |
| victoria.laker@nhs.net |
Scientific
Rotherham Doncaster and South Humber NHS FT
Grounded Research
2 St Catherine’s Close
Tickhill Road Hospital
Doncaster
DN4 8QN
United Kingdom
| Phone | +44 3000 212 456 |
|---|---|
| rdash.research-gov@nhs.net |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Pragmatic delayed intervention randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Pragmatic randomised controlled trial of an intervention to reduce burnout and improve well-being in NHS doctors |
| Study acronym | CPM Trial 2 |
| Study objectives | Exposure to the "Mind Management Skills for Life Programme" will be associated with significantly lower mean burnout severity by comparison to a waitlist (delayed intervention) control group. |
| Ethics approval(s) |
Approved 14/09/2023, South West - Frenchay Research Ethics Committee (Ground Floor, Temple Quay House, 2 The Square, Bristol, BS1 6PN, United Kingdom; +44 207 1048106; frenchay.rec@hra.nhs.uk), ref: 23/SW/0075 |
| Health condition(s) or problem(s) studied | Occupational burnout |
| Intervention | Consenting participants will be randomly assigned to one of two groups using an electronic random sequence generator. Participants allocated to group 1 will have immediate access to the Mind Management Skills for Life Programme, which is an eight-session, group-based psychological intervention delivered online (video conference) by trained mentors. The intervention lasts for 10 weeks (4 weekly consecutive sessions, followed by a two-week break, followed by another 4 consecutive weekly sessions). Participants allocated to group 2 are part of a waitlist (no intervention) control group during the first 10 weeks of the study. After week 10, participants in group 2 access the same intervention that was completed by group 1. All study participants will be asked to complete online surveys including primary (occupational burnout) and secondary (job satisfaction, psychological well-being) at four time-points: [1] Baseline; [2] after 10 weeks; [3] after 20 weeks; [4] 6 months after the third measurement point. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
Occupational burnout, measured by the Oldenburg Burnout Inventory (OLBI), at baseline, 10 weeks, 20 weeks, and 6 months follow-up. |
| Key secondary outcome measure(s) |
1. The Warwick-Edinburgh Mental Well-being Scale (WEMWBS), measured at baseline, 10 weeks, 20 weeks, and 6 months follow-up. |
| Completion date | 25/09/2025 |
Eligibility
| Participant type(s) | Health professional |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 99 Years |
| Sex | All |
| Target sample size at registration | 180 |
| Total final enrolment | 347 |
| Key inclusion criteria | 1. GMC registered doctors from any areas of specialty and NHS healthcare services. 2. Trainee doctors in medical school, who have already started clinical rotations. 3. Working either part-time or full-time in a clinical role. |
| Key exclusion criteria | 1. Currently accessing or referred to any concurrent psychological intervention delivered by a mental health professional (this specifically refers to talking therapies for mental health problems). 2. Doctors that are currently not in active clinical service at the time of recruitment (e.g., on sick leave, maternity leave or suspended for any reason). 3. Doctors that work in a purely managerial, supervisory or educational role (e.g., not in clinical practice at the time of recruitment). 4. Medical students in the early phase of training, who are not yet in clinical practice. |
| Date of first enrolment | 26/09/2023 |
| Date of final enrolment | 17/11/2023 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Tickhill Road
Doncaster
DN4 8QN
England
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Dr Victoria Laker, victoria.laker@nhs.net. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 8 | 19/04/2024 | 14/11/2025 | No | No |
| Statistical Analysis Plan | 14/11/2025 | No | No |
Additional files
- ISRCTN14947225 CPM_Trial2_Protocol_v8_19.04.2024_Clean.pdf
- Protocol file
- ISRCTN14947225 CPM_Trial2_Stats_Plan.pdf
- Statistical Analysis Plan
Editorial Notes
14/11/2025: The following changes were made to the trial record:
1. Uploaded protocol (not peer-reviewed) as an additional file.
2. The statistical analysis plan was uploaded as an additional file.
11/09/2025: Total final enrolment added.
09/05/2025: The PI contact was updated.
11/04/2024: A scientific contact was added.
01/03/2024: Sponsor details updated.
25/09/2023: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
