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

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.

Study Overview

• Status: Completed
• Conditions: Psychological Stress
• Intervention / Treatment: Behavioral: The self-help book: Williams, M. & Penman, D. (2011). Mindfulness: A practical guide to finding peace in a frantic world. London: Piatkus.

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.

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Kent
    • Dartford, Kent, United Kingdom, DA2 7WG
      • Oxleas NHS foundation trust
  • Sussex
    • Hove, Sussex, United Kingdom, BN3 7HZ
      • Sussex Partnership NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stress	Change from baseline at 9-weeks on the Stress sub-scale of the Depression, Anxiety and Stress Scale-21	Post-intervention (i.e. 9-weeks after baseline)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stress (follow-up)	Change from baseline at 21-weeks on the Stress sub-scale of the Depression, Anxiety and Stress Scale-21	Follow-up (i.e. 21 weeks after baseline)
Depression	Change from baseline at 9-weeks on the Depression sub-scale of the Depression, Anxiety and Stress Scale-21	Post-intervention (i.e. 9-weeks after baseline)
Depression (follow-up)	Change from baseline at 21-weeks on the Depression sub-scale of the Depression, Anxiety and Stress Scale-21	Follow-up (i.e. 21 weeks after baseline)
Anxiety	Change from baseline at 9-weeks on the Anxiety sub-scale of the Depression, Anxiety and Stress Scale-21	Post-intervention (i.e. 9-weeks after baseline)
Anxiety (follow-up)	Change from baseline at 21-weeks on the Anxiety sub-scale of the Depression, Anxiety and Stress Scale-21	Follow-up (i.e. 21 weeks after baseline)
Compassion for others	Change from baseline at 9-weeks on the Compassion Scale	Post-intervention (i.e. 9-weeks after baseline)
Compassion for others (follow-up)	Change from baseline at 21-weeks on the Compassion Scale	Follow-up (i.e. 21 weeks after baseline)
Self-compassion	Change from baseline at 9-weeks on the Self-compassion Scale - Short Form	Post-intervention (i.e. 9-weeks after baseline)
Self-compassion (follow-up)	Change from baseline at 21-weeks on the Self-compassion Scale - Short Form	Follow-up (i.e. 21 weeks after baseline)
Mindfulness	Change from baseline at 9-weeks on the Five-Facet Mindfulness Questionnaire - Short Form	Post-intervention (i.e. 9-weeks after baseline)
Mindfulness (follow-up)	Change from baseline at 21-weeks on the Five-Facet Mindfulness Questionnaire - Short Form	Follow-up (i.e. 21 weeks after baseline)
Burnout	Change from baseline at 9-weeks on the Maslach Burnout Inventory	Post-intervention (i.e. 9-weeks after baseline)
Burnout (follow-up)	Change from baseline at 21-weeks on the Maslach Burnout Inventory	Follow-up (i.e. 21 weeks after baseline)
Mental Wellbeing	Change from baseline at 9-weeks on the Short Warwick-Edinburgh Mental Well-being Scale	Post-intervention (i.e. 9-weeks after baseline)
Mental Wellbeing (follow-up)	Change from baseline at 21-weeks on the Short Warwick-Edinburgh Mental Well-being Scale	Follow-up (i.e. 21 weeks after baseline)
Sickness absence	Change from baseline in the number of days of sickness absence over the previous 12 weeks at 21 weeks.	Follow-up (i.e. 21 weeks after baseline)

Collaborators and Investigators

• Sponsor: Canterbury Christ Church University
• Collaborators: Sussex Partnership NHS Foundation Trust; University of Sussex
• Investigators: 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

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2017
• Primary Completion (Actual): June 22, 2018
• Study Completion (Actual): June 22, 2018

Study Registration Dates

• First Submitted: January 20, 2017
• First Submitted That Met QC Criteria: January 20, 2017
• First Posted (Estimate): January 24, 2017

Study Record Updates

• Last Update Posted (Actual): March 22, 2019
• Last Update Submitted That Met QC Criteria: March 20, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: healthcare staff; self-help; mindfulness-based cognitive therapy
• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological
• Other Study ID Numbers: EmilyIronmongerMRP2016; IRAS ID: 215054 (Other Identifier: UK National Health Service Health Research Authority)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No