Is self-help mindfulness-based cognitive therapy beneficial for healthcare staff? A pilot randomised controlled trial
| ISRCTN | ISRCTN16486066 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16486066 |
| Protocol serial number | N/A |
| Sponsor | Sussex Partnership NHS Foundation Trust |
| Funder | Sussex Partnership NHS Foundation Trust (UK) |
- Submission date
- 07/11/2014
- Registration date
- 25/11/2014
- Last edited
- 21/12/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Stress and other mental health difficulties are among the most common reasons for staff sickness absence in the National Health Service (NHS) in the UK and cultivating greater compassionate care has been identified as vital within the NHS. Providing more psychological support for NHS staff has the potential to reduce stress, improve well-being, reduce the number of working days lost to sickness absence and improve job satisfaction. It may also result in greater retention of staff and an improvement in the quality of patient care. Mindfulness is a mind-body approach to well-being. It is designed to help people change how they feel about experiences and reduce levels of stress and anxiety. Evidence suggests that group mindfulness-based interventions (treatments) can help a wide range of people, including healthcare staff. Self-help mindfulness-based interventions (MBIs) have the potential to provide this treatment in a low-cost, accessible and acceptable way and there is growing evidence that self-help MBIs can lead to lower levels of stress, anxiety and depression for a number of different groups of people. However, little is known about the potential of self-help MBIs for healthcare staff. This study is a small-scale, or pilot, study that will help in the development of a larger, full-scale one.
Who can participate?
Healthcare workers aged at least 18 that work in a particular mental health NHS trust, that have not previously completed a mindfulness-based programme, are happy to not use any other form of psychological treatment during the course of the study and have English language reading skills good enough to read and understand a self-help book.
What does the study involve?
Participants are randomly allocated into one of two groups. Those in group 1 are given an unguided 8-week MBI (MBCT-SH) intervention and those in group 2 are placed in a wait-list (control). The MBCT-SH intervention uses a self-help book with a CD of audio-guided mindfulness practices ‘Mindfulness: a practical guide to finding peace in a frantic world’ (Williams & Penman, 2011). Staff levels of stress, compassion for others, and sickness absence alongside with depression, anxiety, self-compassion, burnout and well-being are assessed before the study begins, when the study ends and 3 months later.
What are the possible benefits and risks of participating?
Potential benefits of taking part include contributing to research on how to support healthcare staff well-being as well as directly benefiting from the self-help course. The self-help course teaches participants to bring non-judgmental awareness to current experiences, allowing them to come and go without trying to control them. This can mean becoming more aware of difficult thoughts and feelings that are present which some people can find troubling, and this presents a risk in the study. In order to address this, participants are signposted to sources of support, including contacting the study Chief Investigator who is a clinical psychologist and mindfulness teacher.
Where is the study run from?
Sussex Partnership NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
November 2014 to June 2015
Who is funding the study?
Sussex Partnership NHS Foundation Trust (UK)
Who is the main contact?
Dr Clara Strauss
clara.strauss@nhs.net
Contact information
Scientific
Sussex Education Centre
Mill View Hospital
Nevill Avenue
Hove
BN3 7HZ
United Kingdom
| Phone | +44 (0)778 691 4010 |
|---|---|
| clara.strauss@nhs.net |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Pilot randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A pilot randomised controlled trial of self-help Mindfulness-Based Cognitive Therapy (MBCT) for healthcare staff |
| Study acronym | MindSHINE (Mindfulness Self-Help Intervention for NHS Employees) |
| Study objectives | It is not appropriate to conduct hypothesis testing in a pilot study as, by definition, the study is likely to be underpowered. Rather, this pilot RCT aims to establish if trial procedures are successful and the study also aims to calculate the between-group effect size for Mindfulness-Based Cognitive Therapy self-help (MBCT-SH) in comparison to the waitlist control condition for primary outcome measures. These effect sizes will be used to conduct a sample size calculation for a definitive trial. If the effect sizes are in favour of MBCT-SH then funding for a full trial will be sought. There are three specific main aims of this pilot study: 1. To establish if trial procedures are successful prior to a definitive trial 2. To investigate whether MBCT-SH appears to be beneficial for participants in reducing stress and in improving psychological wellbeing (i.e. if effect sizes are in the direction hypothesised for the definitive trial) 3. To investigate whether MBCT-SH for NHS employees has the potential to improve the quality of patient care (i.e. if effect sizes on the measure or other-compassion are in the direction hypothesised by the definitive trial) Primary hypotheses for the definitive trial will be: 1. MBCT-SH participants in comparison to waitlist control participants will show a reduction in symptoms of stress and this improvement will be maintained at the three months follow-up. 2. MBCT-SH participants in comparison to waitlist control participants will show improvements in other-compassion and this improvement will be maintained at the three months follow-up 3. MBCT-SH participants in comparison to waitlist control participants will show a reduction in the number of sickness absence days from the three months preceding the intervention to the three months following the intervention. Secondary hypotheses for the definitive trial are that MBCT-SH participants, in comparison to waitlist control participants, will show improvements in mindfulness, self-compassion, anxiety, depression, burnout and mental well-being, and these improvements will be maintained at the three-month follow-up. |
| Ethics approval(s) | As this study is for NHS staff it does not require NHS ethics approval. According to NRES, where NHS staff are participants then R&D approval is needed but NRES approval is not needed. The study has R&D approval in the host trust (Sussex Partnership NHS Foundation Trust) with approval number 5043-2014. |
| Health condition(s) or problem(s) studied | Mental health |
| Intervention | Mindfulness-Based Cognitive Therapy (MBCT) is an 8-week group intervention with a wealth of evidence for effectiveness at improving mental health, including for healthcare staff. This study will use a self-help version of MBCT as the tested intervention. Participants in the MBCT-SH condition will be given a copy of the self-help book 'Mindfulness: A practical guide to finding peace in a frantic world' by Mark Williams and Danny Penman (2011), with Mark Williams being one of the people who developed the original MBCT course. This book provides four introductory chapters followed by an 8-week self-guided MBCT course, including mindfulness practices provided on an accompanying CD. Participants will receive a standardised weekly email to encourage them to continue with the self-help course but no specific individualised, tailored support will be given. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
1. Stress: The stress subscale of the Depression Anxiety Stress Scales (DASS-21). The DASS-21 is a short version of the 42-item DASS. The DASS-21 is a set of three 7-item self-report scales designed to measure stress, depression, and anxiety. Each of the 21 items describes a negative state and participants are asked to use a 4-point Likert-type scale to rate the extent they have experienced this state over the past week. The DASS-21 subscales have been found to validly measure stress, anxiety and stress; in non-clinical populations, as well as tapping a more general dimension of psychological distress. The internal consistency and concurrent validity of the scale and subscales have been reported to be in the acceptable to excellent ranges. |
| Key secondary outcome measure(s) |
1. The anxiety and depression subscales of the Depression Anxiety Stress Scales (DASS-21): The anxiety and depression subscales of the DASS-21 will be used as a secondary outcome measure in the pilot and main trial. The internal consistency and concurrent validity of the scale and subscales have been reported to be in the acceptable to excellent ranges. |
| Completion date | 30/06/2015 |
Eligibility
| Participant type(s) | Health professional |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 40 |
| Key inclusion criteria | 1. Adults aged 18 or older 2. Are currently employed by the host mental health NHS trust in a role that involves direct delivery of healthcare, this is operationalised as having at least one day per week of direct contact with patients 3. Are currently in work 4. Are willing to refrain from engaging in another form of psychological intervention during the course of the study 5. Have not previously completed a mindfulness-based intervention where 'completed is defined as having undertaken 50% or more of a face-to-face delivered mindfulness-based intervention 6. Have self-reported sufficient English language reading ability to read and understand the self help book |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 01/12/2014 |
| Date of final enrolment | 26/01/2015 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Hove
BN3 7HZ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The data that support the findings of this study are available from Dr Clara Strauss (c.y.strauss@sussex.ac.uk) upon reasonable request. |
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
21/12/2020: The following changes have been made:
1. The recruitment start date has been changed from 10/11/2014 to 01/12/2014.
2. The recruitment end date has been changed from 30/06/2015 to 26/01/2015.
3. The intention to publish date has been added.
4. The IPD sharing statement has been added.
11/08/2017: No publications found, verifying study status with principal investigator.