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A Randomised Controlled Trial of Self-help Mindfulness-based Cognitive Therapy for Health Workers (MindSHINE2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03030040
Recruitment Status : Completed
First Posted : January 24, 2017
Last Update Posted : March 22, 2019
Sponsor:
Collaborators:
Sussex Partnership NHS Foundation Trust
University of Sussex
Information provided by (Responsible Party):
Canterbury Christ Church University

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

Condition or disease Intervention/treatment Phase
Psychological Stress Behavioral: The self-help book: Williams, M. & Penman, D. (2011). Mindfulness: A practical guide to finding peace in a frantic world. London: Piatkus. Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Masking Description: Random allocation of participants to arms will be conducted by a statistician independent of the study.
Primary Purpose: Treatment
Official Title: A Randomised Controlled Trial of a Mindfulness-based Cognitive Therapy Self-help Intervention for UK National Health Service Employees
Actual Study Start Date : January 26, 2017
Actual Primary Completion Date : June 22, 2018
Actual Study Completion Date : June 22, 2018

Arm Intervention/treatment
Experimental: MBCT-SH
MBCT-SH will be an unguided, mindfulness-based cognitive therapy, book-based self-help intervention.
Behavioral: The self-help book: Williams, M. & Penman, D. (2011). Mindfulness: A practical guide to finding peace in a frantic world. London: Piatkus.
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.

No Intervention: Control
A 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.



Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03030040


Locations
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United Kingdom
Oxleas NHS Foundation Trust
Dartford, Kent, United Kingdom, DA2 7WG
Sussex Partnership NHS Foundation Trust
Hove, Sussex, United Kingdom, BN3 7HZ
Sponsors and Collaborators
Canterbury Christ Church University
Sussex Partnership NHS Foundation Trust
University of Sussex
Investigators
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Principal Investigator: Emily C Ironmonger, MSc Canterbury Christ Church University
Study Director: Clara Strauss, PhD Sussex Partnership NHS Foundation Trust & University of Sussex
Study Director: Kate Cavanagh, PhD University of Sussex
Study Director: Fergal Jones, PhD Canterbury Christ Church University & Sussex Partnership NHS Foundation Trust
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Responsible Party: Canterbury Christ Church University
ClinicalTrials.gov Identifier: NCT03030040    
Other Study ID Numbers: EmilyIronmongerMRP2016
IRAS ID: 215054 ( Other Identifier: UK National Health Service Health Research Authority )
First Posted: January 24, 2017    Key Record Dates
Last Update Posted: March 22, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Canterbury Christ Church University:
mindfulness-based cognitive therapy
self-help
healthcare staff
Additional relevant MeSH terms:
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Stress, Psychological
Behavioral Symptoms