Mindfulness-based training to promote the well-being of NHS staff

ISRCTN ISRCTN13871025
DOI https://doi.org/10.1186/ISRCTN13871025
Secondary identifying numbers G101017
Submission date
11/10/2019
Registration date
14/10/2019
Last edited
04/04/2023
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English Summary

Background and study aims
The purpose of this research is to implement and evaluate mindfulness-based training programs for improving the psychological well-being of healthcare staff in the United Kingdom. Our two primary aims are to: 1) compare the effectiveness of two popular mindfulness interventions for improving staff well-being over a six-month evaluation period; and 2) increase understanding about how these workplace training programs produce their effects.

Who can participate?
Staff aged over 18 working at the host trust who had volunteered for the well-being training and research

What does the study involve?
We compared the effects of two popular mindfulness interventions currently being being delivered in workplace settings: Mindfulness training (MT), and acceptance and commitment therapy (ACT). The MT and ACT programs were delivered to small groups of UK healthcare staff over 4 training sessions, with each session lasting 2 hours. To evaluate the effects of the two programs, we randomly allocated employees to attend MT, ACT, or to a waiting list comparison group. All participants completed a range of well-being questionnaires on five occasions that
were spread across a six month evaluation period. We were particularly interested in
investigating whether the two workplace training programs are equally effective for improving staff well-being, and whether they help to develop the same types of mindfulness and behavioural skills.

What are the possible benefits and risks of participating?
Staff members participating in this training are likely to experience improved well-being. More specifically, following attendance at the MT or ACT programs we expected to see improvements in general mental health, perceived stress, and sleep quality, and a reduction in work limitations due to stress-related difficulties. No significant risks were foreseen. Participation in all training techniques was presented as voluntary and invitational. Participants were informed about additional staff support services should they have felt the need for additional psychological intervention or support.

Where is the study run from?
South London and Maudsley NHS Foundation Trust, UK

When is the study starting and how long is it expected to run for?
November 2011 to May 2013

Who is funding the study?
Guy's and St Thomas' Charity, UK

Who is the main contact?
Dr Paul Flaxman
Paul.Flaxman.1@city.ac.uk

Contact information

Dr Paul Flaxman
Scientific

City, University of London
Psychology Department
Northampton Square
London EC1V 0HB
London
EC1V 0HB
United Kingdom

ORCiD logoORCID ID 0000-0002-6417-2499
Phone +44(0)2070408484
Email Paul.Flaxman.1@city.ac.uk
Dr Vasiliki Christodoulou
Scientific

University of Central Lancashire (Cyprus)
12 – 14 University Avenue Pyla, 7080 Larnaka, Cyprus
Larnaka
7080 Larnaka
Cyprus

Phone +357 24694149
Email Vchristodoulou2@uclan.ac.uk

Study information

Study designA single-centre interventional randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeOther
Participant information sheet Not available in web format. Please use contact details to request a participant information sheet
Scientific titleComparison of two mindfulness interventions in the workplace: A randomised controlled trial
Study hypothesis1. A mindfulness training (MT) program and a program based on acceptance and commitment therapy (ACT) will lead to improvements in employees' well-being over a six month evaluation period
2. The effects of both programs on employees' well-being will be mediated via the cultivation of a mindful (i.e., nonjudgmental or nonreactive) attitude towards difficult internal states
3. The ACT program will show a stronger effect on employees' propensity to engage in values-based action than the MT program
Ethics approval(s)Approved 16/01/2012, King's College London Institute of Psychiatry R&D office (De Crespigny Park, Denmark Hill, London, SE5 8AF, UK; +44 (0)20 78480790; jennifer.liebscher@kcl.ac.uk), ref: R&D2012/003
ConditionOccupational health (promoting staff well-being and mental health)
InterventionA single-centre study. Participants (NHS staff) were randomised to attend a 4 -session group-format MT program, a 4-session group-format ACT program, or to a waiting list control group. Each training session in the MT and ACT programs lasted for 2 hours. Self-report study measures were administered on five occasions spread over a six-month evaluation period.

Mindfulness training: A 4-session group format staff training program based on the principles and practices of mindfulness-based stress reduction.

Acceptance and commitment therapy (ACT): A 4-session group format staff training program based on the principles and practices of acceptance and commitment therapy.

A waiting list control group: Participants allocated to this group were placed on a waiting list to receive either MT or ACT in six months time.

Participants were allocated to one of the three study conditions by a member of the research team using a block randomization procedure (via www.randomisation.com).

The MT and ACT programs were delivered by Dr.Vasilki Christodoulou, a counselling psychologist and cognitive-behavioral therapist registered with the British Psychological Society and the UK’s Health and Care Professions Council (HCPC). Dr. Christodoulou had previous experience of delivering both MT and ACT in clinical and non-clinical settings. Throughout the training delivery period, the trainer attended regular supervision with two clinical psychologists involved in the study
Intervention typeOther
Primary outcome measureGeneral health measured using the general health questionnaire at five timepoints between baseline and 6-months
Secondary outcome measuresThe following measures were also administered at all 5 measurement timepoints (baseline to 6-months):
1. Perceived stress scale
2. Abbreviated version of the Work Limitations Questionnaire
3. Sleep disturbance (subscale of the Physical Health Questionnaire)
4. Activity and circumstances change questionnaire
5. Behavioural activation for depression scale (BADS-10)
6. Three facets from the five facet mindfulness questionnaire (FFMQ)
7. The valuing questionnaire (VQ)
8. The acceptance and action questionnaire II (AAQ II)
Overall study start date03/09/2010
Overall study end date03/05/2013

Eligibility

Participant type(s)Health professional
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants200
Participant inclusion criteria1. Staff working at the host NHS trust
2. Aged 18 or over,
3. Volunteered for the well-being training and research
Participant exclusion criteriaDoes not meet the inclusion criteria
Recruitment start date30/11/2011
Recruitment end date31/05/2012

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

South London and Maudsley NHS Foundation Trust
Maudsley Hospital
Denmark Hill
London
SE5 8AZ
United Kingdom

Sponsor information

City, University of London
University/education

Psychology Department
Northampton Square
London
EC1V0HB
England
United Kingdom

Phone +44 (0)20 7040 5060
Email Paul.Flaxman.1@city.ac.uk
Website http://www.city.ac.uk
ROR logo "ROR" https://ror.org/04489at23
South London and Maudsley NHS Foundation Trust
Hospital/treatment centre

Bethlem Royal Hospital
Monks Orchard Road
Beckenham
BR3 3BX
England
United Kingdom

Phone +44(0) 20 3228 6000.
Email vasochrist@hotmail.com
Website https://www.slam.nhs.uk/
ROR logo "ROR" https://ror.org/015803449

Funders

Funder type

Hospital/treatment centre

Guy's and St Thomas' Charity
Private sector organisation / Trusts, charities, foundations (both public and private)
Alternative name(s)
Guy's and St Thomas' Charity, Guy's and St Thomas' Foundation, GSTTFoundation
Location
United Kingdom

Results and Publications

Intention to publish date01/12/2022
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planCurrent publication and dissemination plan as of 21/01/2022:
A first paper is being prepared to report comparison of the effects of MT and ACT on the primary outcome measure (GHQ-12); this study will also assess whether the effects of the programs on employees' general mental health are mediated via the same mindfulness skills. A second paper will examine effects of the two interventions on the trial's secondary outcomes, namely sleep quality, perceived stress, and work limitations.

A second planned paper will report on the effects of the two programs on secondary (non-clinical) outcome measures, particularly perceived stress, sleep quality, and work limitations.


Previous publication and dissemination plan:
A first paper is being prepared to report comparison of the effects of MT and ACT on the primary outcome measure (GHQ-12); this study will also assess whether the effects of the programs on employees' general mental health are mediated via the same mindfulness skills.

A second planned paper will report on the effects of the two programs on secondary (non-clinical) outcome measures, particularly perceived stress, sleep quality, and work limitations.
IPD sharing planCurrent individual participant data (IPD) sharing statement as of 21/01/2022:
The datasets generated during and/or analysed during the current study will be available upon request from: Dr. Paul Flaxman, City, University of London. Email: Paul.Flaxman.1@city.ac.uk. The raw data are in a SPSS file, saved on Dr. Flaxman’s password protected University computer. The data will be available from January 2020 for a proposed period of 10 years, to support publication. Once we have published the main outcome and mediation findings, we are happy to respond to requests to share the full dataset with fellow researchers/ journal reviewers who wish to check our analyses, or for meta-analytic review purposes. Participants were informed at the study’s outset of the team’s intention to publish results of the study in scientific journals and through various NHS outlets. Participants were informed that they would not be personally identified in any reports of the findings. In the raw dataset, all job titles, tenure, and other person- and organisation-identifiable data will have been removed.


Previous individual participant data (IPD) sharing statement:
The datasets generated during and/or analysed during the current study will be available upon request from: Dr. Paul Flaxman, City, University of London. Email: Paul.Flaxman.1@city.ac.uk. The raw data are in a SPSS file, saved on Dr. Flaxman’s password protected University computer. The data will be available from January 2020 for a proposed period of 10 years, to support publication. We are happy to respond to requests to share the full dataset with fellow researchers/ journal reviewers who wish to check our analyses, or for meta-analytic review purposes. Participants were informed at the study’s outset of the team’s intention to publish results of the study in scientific journals and through various NHS outlets. Participants were informed that they would not be personally identified in any reports of the findings. In the raw dataset, all job titles, tenure, and other person- and organisation-identifiable data will have been removed.

Editorial Notes

04/04/2023: Internal review.
21/01/2022: The following changes have been made:
1. The intention to publish date has been changed from 05/02/2021 to 01/12/2022.
2. The publication and dissemination plan has been updated.
3. The individual participant data (IPD) sharing statement has been updated.
19/06/2020: The intention to publish date has been changed from 01/11/2019 to 05/02/2021.
14/10/2019: Trial’s existence confirmed by King's College London