Mindfulness-based training to promote the well-being of NHS staff
| ISRCTN | ISRCTN13871025 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13871025 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | G101017 |
| Sponsors | City, University of London, South London and Maudsley NHS Foundation Trust |
| Funder | Guy's and St Thomas' Charity |
- 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
Plain English summary of protocol
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
Scientific
City, University of London
Psychology Department
Northampton Square
London EC1V 0HB
London
EC1V 0HB
United Kingdom
 ORCID ID |
0000-0002-6417-2499 |
|---|---|
| Phone | +44(0)2070408484 |
| Paul.Flaxman.1@city.ac.uk |
Scientific
University of Central Lancashire (Cyprus)
12 – 14 University Avenue Pyla, 7080 Larnaka, Cyprus
Larnaka
7080 Larnaka
Cyprus
| Phone | +357 24694149 |
|---|---|
| Vchristodoulou2@uclan.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | A single-centre interventional randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Comparison of two mindfulness interventions in the workplace: A randomised controlled trial |
| Study objectives | 1. 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 |
| Health condition(s) or problem(s) studied | Occupational health (promoting staff well-being and mental health) |
| Intervention | A 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 type | Other |
| Primary outcome measure(s) |
General health measured using the general health questionnaire at five timepoints between baseline and 6-months |
| Key secondary outcome measure(s) |
The following measures were also administered at all 5 measurement timepoints (baseline to 6-months): |
| Completion date | 03/05/2013 |
Eligibility
| Participant type(s) | Health professional |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 200 |
| Key inclusion criteria | 1. Staff working at the host NHS trust 2. Aged 18 or over, 3. Volunteered for the well-being training and research |
| Key exclusion criteria | Does not meet the inclusion criteria |
| Date of first enrolment | 30/11/2011 |
| Date of final enrolment | 31/05/2012 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Denmark Hill
London
SE5 8AZ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | Current 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
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
