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Psychological StressMindSHINE2NCT03030040

A Randomised Controlled Trial of Self-help Mindfulness-based Cognitive Therapy for Health Workers

A study testing The self-help book: Williams, M. & Penman, D. (2011). Mindfulness: A practical guide to finding peace in a frantic world. London: Piatkus. in people with Psychological Stress, run by Canterbury Christ Church University at 2 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study examines whether a mindfulness-based self-help book is effective at reducing healthcare workers' levels of stress and improving their wellbeing. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Psychological Stress
What is being tested?
The self-help book: Williams, M. & Penman, D. (2011). Mindfulness: A practical guide to finding peace in a frantic world. London: Piatkus.
Could I receive a placebo?
No, everyone receives an active treatment
How many people
102 participants
Where
2 sitesUnited Kingdom
Study dates
26 Jan 2017to 22 Jun 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Being currently employed by Sussex Partnership NHS Foundation Trust (in the UK) in a role or roles that involve direct delivery of healthcare.
  • Having at least one day per week of direct contact with UK National Health Service service users.
  • Agreeing to refrain from engaging in another form of psychological therapy during the course of the study.
  • Having self-reported sufficient English language reading ability to read and understand the self-help book

Who cannot join

  • Being currently on leave of absence from work.
  • Having previously received a minimum dose (defined as 50% of a course or more) of a mindfulness-based intervention.

Trial locations and contacts

2 sites in 1 country.

United Kingdom2 sites

  • Oxleas NHS Foundation Trust

    Dartford, Kent, DA2 7WG

  • Sussex Partnership NHS Foundation Trust

    Hove, Sussex, BN3 7HZ

Other trials in United Kingdom

About this study

Official title: A Randomised Controlled Trial of a Mindfulness-based Cognitive Therapy Self-help Intervention for UK National Health Service Employees

This study examines whether a mindfulness-based self-help book is effective at reducing healthcare workers' levels of stress and improving their wellbeing.

Read the detailed description

This study is a randomised controlled trial (RCT) examining the efficacy of a mindfulness-based cognitive therapy self-help book ('Mindfulness: A practice guide to finding peace in a frantic world') relative to a wait-list control, in healthcare staff. It builds on a previous pilot RCT (http://www.isrctn.com/ISRCTN16486066). A battery of measures will be administered at baseline (week 0), post-intervention (week 9) and follow-up (week 21). This trial is designed to test the following hypotheses.

Primary Hypothesis

-Mindfulness-based cognitive therapy self-help (MBCT-SH) participants, in comparison to waitlist control participants, will show a reduction in symptoms of stress by the end of MBCT-SH (week 9).

Secondary Hypotheses

  • The improvement detailed in the primary hypothesis will be maintained at a follow-up 12 weeks after the end of the MBCT-SH (week 21).
  • MBCT-SH participants, in comparison to waitlist control participants, will show improvements in mindfulness, other-compassion, self-compassion, anxiety, depression, burnout and mental well-being by the end of MBCT-SH (week 9), and these improvements will be maintained at a follow-up 12 weeks after the end of the MBCT-SH (week 21).
  • 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.
  • Increases in self-compassion and mindfulness from week 0 to week 9, will mediate the effects of MBCT-SH (relative to waitlist control) on levels of stress, depression, anxiety, wellbeing and burnout.
Being tested
The self-help book: Williams, M. & Penman, D. (2011). Mindfulness: A practical guide to finding peace in a frantic world. London: Piatkus.
Keywords
mindfulness-based cognitive therapy, self-help, healthcare staff
Medical subject headings
Stress, Psychological

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • The self-help book: Williams, M. & Penman, D. (2011). Mindfulness: A practical guide to finding peace in a frantic world. London: Piatkus.Behavioural

    Participants will be provided with a copy of the self-help book, and asked to read it and follow the activities outlined in it, over eight weeks. They will receive weekly standardized emails, to provide information about mindfulness and encouragement to engage with the self-help book.

Study groups in NCT03030040
Study groupRoleWhat they receive
MBCT-SHExperimentalMBCT-SH will be an unguided, mindfulness-based cognitive therapy, book-based self-help intervention.
Receives: Behavioral: The self-help book: Williams, M. & Penman, D. (2011). Mindfulness: A practical guide to finding peace in a frantic world. London: Piatkus.
ControlNo interventionA wait list control group who will receive no intervention during the 21 weeks of the study. Control participants will be provided with the self-help book that the MBCT-SH group received after week 21.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Stress

    Change from baseline at 9-weeks on the Stress sub-scale of the Depression, Anxiety and Stress Scale-21

    Measured: Post-intervention (i.e. 9-weeks after baseline)

Secondary outcomes (16)

  1. Stress (follow-up)

    Change from baseline at 21-weeks on the Stress sub-scale of the Depression, Anxiety and Stress Scale-21

    Measured: Follow-up (i.e. 21 weeks after baseline)

  2. Depression

    Change from baseline at 9-weeks on the Depression sub-scale of the Depression, Anxiety and Stress Scale-21

    Measured: Post-intervention (i.e. 9-weeks after baseline)

  3. Depression (follow-up)

    Change from baseline at 21-weeks on the Depression sub-scale of the Depression, Anxiety and Stress Scale-21

    Measured: Follow-up (i.e. 21 weeks after baseline)

  4. Anxiety

    Change from baseline at 9-weeks on the Anxiety sub-scale of the Depression, Anxiety and Stress Scale-21

    Measured: Post-intervention (i.e. 9-weeks after baseline)

  5. Anxiety (follow-up)

    Change from baseline at 21-weeks on the Anxiety sub-scale of the Depression, Anxiety and Stress Scale-21

    Measured: Follow-up (i.e. 21 weeks after baseline)

  6. Compassion for others

    Change from baseline at 9-weeks on the Compassion Scale

    Measured: Post-intervention (i.e. 9-weeks after baseline)

  7. Compassion for others (follow-up)

    Change from baseline at 21-weeks on the Compassion Scale

    Measured: Follow-up (i.e. 21 weeks after baseline)

  8. Self-compassion

    Change from baseline at 9-weeks on the Self-compassion Scale - Short Form

    Measured: Post-intervention (i.e. 9-weeks after baseline)

  9. Self-compassion (follow-up)

    Change from baseline at 21-weeks on the Self-compassion Scale - Short Form

    Measured: Follow-up (i.e. 21 weeks after baseline)

  10. Mindfulness

    Change from baseline at 9-weeks on the Five-Facet Mindfulness Questionnaire - Short Form

    Measured: Post-intervention (i.e. 9-weeks after baseline)

  11. Mindfulness (follow-up)

    Change from baseline at 21-weeks on the Five-Facet Mindfulness Questionnaire - Short Form

    Measured: Follow-up (i.e. 21 weeks after baseline)

  12. Burnout

    Change from baseline at 9-weeks on the Maslach Burnout Inventory

    Measured: Post-intervention (i.e. 9-weeks after baseline)

  13. Burnout (follow-up)

    Change from baseline at 21-weeks on the Maslach Burnout Inventory

    Measured: Follow-up (i.e. 21 weeks after baseline)

  14. Mental Wellbeing

    Change from baseline at 9-weeks on the Short Warwick-Edinburgh Mental Well-being Scale

    Measured: Post-intervention (i.e. 9-weeks after baseline)

  15. Mental Wellbeing (follow-up)

    Change from baseline at 21-weeks on the Short Warwick-Edinburgh Mental Well-being Scale

    Measured: Follow-up (i.e. 21 weeks after baseline)

  16. Sickness absence

    Change from baseline in the number of days of sickness absence over the previous 12 weeks at 21 weeks.

    Measured: Follow-up (i.e. 21 weeks after baseline)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jan 2017 (estimated)
  2. Study start26 Jan 2017
  3. Primary completion22 Jun 2018
  4. Study completion22 Jun 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
102 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03030040
Sponsor's protocol ID
EmilyIronmongerMRP2016
Other IDs
IRAS ID: 215054
Acronym
MindSHINE2
Status last verified
Mar 2019
First submitted
20 Jan 2017
Last updated
22 Mar 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing The self-help book: Williams, M. & Penman, D. (2011). Mindfulness: A practical guide to finding peace in a frantic world. London: Piatkus. in people with Psychological Stress, run by Canterbury Christ Church University at 2 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Stress (time frame: Post-intervention (i.e. 9-weeks after baseline)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03030040.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2019.

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