Condition category
Mental and Behavioural Disorders
Date applied
12/11/2020
Date assigned
13/11/2020
Last edited
13/11/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
This study has been developed as a public health response to the COVID-19 crisis, aiming to support the wellbeing of NHS staff using accessible interventions that combine video-based workshops with app-based self-help materials. The study will compare the effectiveness of two interventions designed to reduce occupational burnout and to improve wellbeing in NHS staff. One intervention has been proven to be effective and is based on cognitive behavioural coping skills; The second intervention is new and has no prior evidence of it's effectiveness.

The study will compare the effects of the new intervention relative to the well-established intervention for occupational burnout in NHS staff.

Who can participate?
NHS staff who have direct contact with patients (including health care and administrative staff) will be eligible to participate

What does the study involve?
Participants will be asked via email to complete a brief electronic questionnaire in relation to their occupational and personal wellbeing, at the start of the study and at three further timepoints (3 weeks, 6 weeks, and 6 months later). This will include basic demographics (age, gender, ethnicity) and self-reported sickness days taken over the last 6 months. After participants complete the initial questionnaire, they will be randomly allocated to one of the two interventions and will receive instructions via email to access their allocated intervention, at a fixed day and time each week, via Microsoft Teams, for a total of six weeks. After the end of each of these hour-long video sessions, participants will have access to online self-help resources through a dedicated app (a website with secure and password protected login). The video sessions will be conducted in a way that participants’
identity is anonymous with no need to show their video or to reveal their full name to other participants.

What are the possible benefits and risks of participating?
Participants are giving up time to complete this study, and this may be seen as a burden. However, it is not expected that taking part in the study would have any disadvantages or risks, given that the tasks and materials are all designed to help NHS staff to cope with stress. Nevertheless, if a participant feels uncomfortable or upset by any aspects of participation in this study, they can contact the research team who can offer support and advice. The research team will also provide participants with a document listing contact details for locally available emotional support services. It is expected that participating in the study will enable participants to learn how to recognise their key signs of occupational burnout and reduced job satisfaction and wellbeing. Participants will also learn about multiple coping skills and will be guided to practice and master them. This is likely to lead to reductions in occupational burnout and improvements in wellbeing.

Where is the study run from?
Rotherham Doncaster and South Humber NHS Foundation Trust (UK)

When is the study starting and how long is it expected to run for?
From May 2020 to November 2021

Who is funding the study?
MindLife UK Ltd (UK)

Who is the main contact?
Miss Jeannie McKie
j.mckie@nhs.net

Trial website

http://uplifttrial.com

Contact information

Type

Scientific

Primary contact

Dr Jaime Delgadillo

ORCID ID

http://orcid.org/0000-0001-5349-230X

Contact details

RDaSH Grounded Research
Almond Tree Court
Woodfield Park
Doncaster
DN4 8QP
United Kingdom
+44 (0)7800747047
j.delgadillo@sheffield.ac.uk

Type

Public

Additional contact

Miss Jeannie McKie

ORCID ID

https://orcid.org/0000-0003-4327-9681

Contact details

RDaSH Grounded Research
Almond Tree Court
Woodfield Park
Doncaster
DN4 8QP
United Kingdom
+44 (0)7818560176
j.mckie@nhs.net

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

CPMS 47066, IRAS 288024

Study information

Scientific title

UpLift: A randomised controlled trial to improve NHS staff wellbeing

Acronym

UpLift

Study hypothesis

1. No significant adjusted mean differences will be found when comparing post-treatment outcomes between the two interventions, across any of the outcome measures. The novel Job Crafting intervention will have comparable effects to an established intervention based on CBT.
2. Moderate within-group, pre-post treatment effect sizes (~d = 0.50) will be observed for both interventions in burnout and wellbeing measures
3. Mean burnout and wellbeing levels at the 6-month follow-up point will be significantly lower than baseline severity (prior to intervention), but not significantly different to end-of-treatment levels, indicating maintenance of gains
4. The network structure of predictors (mechanisms) of change will be different across both interventions. Self-efficacy, autonomy, and neuroticism will be ranked as more important in intervention 1. Organisational stress, over-commitment, and relational factors (professional, client, and family-related stress) will be ranked as more important in intervention 2.

Ethics approval

Approved 15/10/2020, Coventry and Warwick Research Ethics Committee (The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS UK; +44 (0)207 104 8197; coventryandwarwick.rec@hra.nhs.uk), ref: 20/EM/0236

Study design

Pragmatic, multi-site, parallel group, randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Internet

Trial type

Quality of life

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Occupational burnout in health care professionals

Intervention

Consenting NHS staff will be randomly assigned to one of two groups (1:1), by a research assistant using a computerized randomisation algorithm. The randomisation sequence will be based on random blocks of 10 participants, and stratification according to participants’ employing organisation (trial site) and role (administrative; mental health; other health care roles). Participants will take part in one of the two 6-week interventions, either Intervention 1 or Intervention 2, depending on their group assignment.

Intervention 1 integrates concepts from cognitive behavioural therapy and positive psychology.
Intervention 2 integrates concepts from key theories in the field of occupational burnout: the job demands-resources model, the effort-reward imbalance model, and the job crafting model.

All participants will complete outcome measures using an online survey at a baseline assessment after they provide informed consent. All participants will then take part in one of the two 6-week interventions, depending on their group assignment. Outcome measures using an online survey will be assessed again following week 3, week 6, and finally at a 6-month follow-up. All measures will be completed online using an industry-standard survey system which automatically sends email reminders to consenting participants.

In both groups, participants will have access to one of two “blended care” interventions which have been developed by the research team with reference to the current evidence-base in the field of occupational burnout. These interventions will involve weekly 1 h online workshops delivered by psychological professionals, for a total of 6 weeks, using video-conferencing software that can involve large groups of participants (Microsoft Teams). These sessions will be supported by a mobile app that integrates educational and self-help tools that are based on the content of each session. The app includes interactive media such as videos, animations and practical exercises that guide participants to apply and practice coping skills covered in each of the 6 sessions. Each session will be delivered in such a way that participants will learn about key concepts in an interactive way (including group discussions and participation), and will be guided to practice two specific coping skills each week. At the end of each session, participants will be encouraged to use the app, which will guide them to practice key coping skills that will be covered each week. In this way, learning will be followed by practical exercises, increasing the chances of behaviour change and integration of coping skills into daily life. Each of these interventions is based on a different underpinning evidence-base and theory. We expect that both interventions will lead to changes in burnout and wellbeing, but they will do so through different mechanisms, which is consistent with literature in the field that points to multiple interrelated risk factors.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

1. Occupational burnout will be measured using the Oldenburg Burnout Inventory (OLBI) at baseline, 3 and 6 weeks, and 6 months

Secondary outcome measures

1. Demographic information, including age, gender, ethnicity, job role, and hours worked (full-time or part-time) by participant self-report at baseline
2. Number of sickness absence days they have had during the 1-month period preceding the start of the study by participant self-report at baseline, and self-report of any sickness absence days taken during the active study and observation period
3. Mental wellbeing measured using the Warwick-Edinburgh Mental Well-being Scale (WEMWBS) at baseline, 3 and 6 weeks, and 6 months
4. Turnover intention measured using the Job Diagnostic Survey turnover intent single-item at baseline, 3 and 6 weeks, and 6 months

Overall trial start date

26/05/2020

Overall trial end date

01/11/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Any staff currently working in the NHS either full-time or part-time
2. Direct patient contact as part of their role in the NHS, either in a clinical capacity or an administrative capacity (such as receptionists and administrators)

Participant type

Health professional

Age group

Adult

Gender

Both

Target number of participants

240

Participant exclusion criteria

1. Currently not in active service at the time of recruitment (on sick leave, maternity leave, or suspended for any reason)
2. Temporary (bank or agency) contract
3. Participant in the recent CPM Trial which is in a 6 month follow-up period during recruitment to this trial

Recruitment start date

01/11/2020

Recruitment end date

01/05/2021

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Rotherham Doncaster and South Humber NHS Foundation Trust
St. Catherine's House St. Catherine's Hospital Tickhill Road
Doncaster
DN4 8QN
United Kingdom

Trial participating centre

North East London NHS Foundation Trust
West Wing C E M E Centre Marsh Way
Rainham
RM13 8GQ
United Kingdom

Trial participating centre

Lincolnshire Partnership NHS Foundation Trust
St George's Long Leys Road
Lincoln
LN1 1FS
United Kingdom

Sponsor information

Organisation

Rotherham, Doncaster and South Humber NHS Foundation Trust

Sponsor details

RDaSH Grounded Research
Almond Tree Court
Woodfield Park
Doncaster
DN4 8QP
United Kingdom
+44 (0)7818560176
j.mckie@nhs.net

Sponsor type

Hospital/treatment centre

Website

https://www.rdash.nhs.uk/about-us/grounded-research/

Funders

Funder type

Industry

Funder name

MindLife UK LTD

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement:
The datasets generated during and/or analysed during the current study will be available upon request from the data custodian (j.delgadillo@sheffield.ac.uk). Only de-identified participant data can be made available, along with a data dictionary, to suitably qualified researchers who obtain ethical approval for their proposed analysis; pre-register their statistical analysis plan; and provide a signed data-sharing contract which enables data storage and analysis for a time-limited period of 12 months.

Intention to publish date

31/12/2021

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

13/11/2020: Uploaded protocol version 3.3, 11 November 2020 (not peer reviewed). 12/11/2020: Trial’s existence confirmed by the National Institute for Health Research (NIHR).