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Completed

NCT Number: NCT03030040

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

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

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Key information

Conditions

Psychological Stress Behavior Behavioral Symptoms Stress, Psychological

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oxleas NHS Foundation Trust, Dartford, Kent, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

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

Behavioral

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.

Primary outcomes

  1. Stress

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

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

Secondary outcomes

  1. Stress (follow-up)

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

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

  2. Depression

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

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

  3. Depression (follow-up)

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

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

  4. Anxiety

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

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

  5. Anxiety (follow-up)

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

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

  6. Compassion for others

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

    Change from baseline at 9-weeks on the Compassion Scale

  7. Compassion for others (follow-up)

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

    Change from baseline at 21-weeks on the Compassion Scale

  8. Self-compassion

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

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

  9. Self-compassion (follow-up)

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

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

  10. Mindfulness

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

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

  11. Mindfulness (follow-up)

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

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

  12. Burnout

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

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

  13. Burnout (follow-up)

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

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

  14. Mental Wellbeing

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

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

  15. Mental Wellbeing (follow-up)

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

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

  16. Sickness absence

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

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

Sponsors and collaborators

Lead sponsor

Canterbury Christ Church University

Other

Collaborators

  • Sussex Partnership NHS Foundation Trust
  • University of Sussex

Registry information

Official study title

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

Acronym: MindSHINE2

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 24, 2017
Registry last updated
Mar 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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