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

Psychological Stress Clinical Trial

— MindSHINE2  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03030040
• Other study ID #: EmilyIronmongerMRP2016
• Secondary ID: IRAS ID: 215054
• Status: Completed
• Phase: N/A
• Start date: January 26, 2017
• Est. completion date: June 22, 2018

Study information

• Verified date: March 2019
• Source: Canterbury Christ Church University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: June 22, 2018
• Est. primary completion date: June 22, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Psychological Stress
• Stress, Psychological

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.

Locations

Country	Name	City	State
United Kingdom	Oxleas NHS Foundation Trust	Dartford	Kent
United Kingdom	Sussex Partnership NHS Foundation Trust	Hove	Sussex

Sponsors (3)

Lead Sponsor	Collaborator
Canterbury Christ Church University	Sussex Partnership NHS Foundation Trust, University of Sussex

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Compassion for others	Change from baseline at 9-weeks on the Compassion Scale	Post-intervention (i.e. 9-weeks after baseline)
Secondary	Compassion for others (follow-up)	Change from baseline at 21-weeks on the Compassion Scale	Follow-up (i.e. 21 weeks after baseline)
Secondary	Self-compassion	Change from baseline at 9-weeks on the Self-compassion Scale - Short Form	Post-intervention (i.e. 9-weeks after baseline)
Secondary	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)
Secondary	Mindfulness	Change from baseline at 9-weeks on the Five-Facet Mindfulness Questionnaire - Short Form	Post-intervention (i.e. 9-weeks after baseline)
Secondary	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)
Secondary	Burnout	Change from baseline at 9-weeks on the Maslach Burnout Inventory	Post-intervention (i.e. 9-weeks after baseline)
Secondary	Burnout (follow-up)	Change from baseline at 21-weeks on the Maslach Burnout Inventory	Follow-up (i.e. 21 weeks after baseline)
Secondary	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)
Secondary	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)
Secondary	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)