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

Not Applicable

Completed

• Conditions: Psychological Stress

• Registration Number: NCT03030040
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2017-01-20
• Study First Submitted QC: 2017-01-20
• Study First Posted: 2017-01-24
• Study Start: 2017-01-26
• Primary Completion: 2018-06-22
• Study Completion: 2018-06-22
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-20
• Last Update Posted: 2019-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Stress	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

Name	Time	Method
Depression (follow-up)	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
Mindfulness	Post-intervention (i.e. 9-weeks after baseline)	Change from baseline at 9-weeks on the Five-Facet Mindfulness Questionnaire - Short Form
Anxiety	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
Compassion for others (follow-up)	Follow-up (i.e. 21 weeks after baseline)	Change from baseline at 21-weeks on the Compassion Scale
Stress (follow-up)	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
Depression	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
Sickness absence	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.
Self-compassion (follow-up)	Follow-up (i.e. 21 weeks after baseline)	Change from baseline at 21-weeks on the Self-compassion Scale - Short Form
Burnout	Post-intervention (i.e. 9-weeks after baseline)	Change from baseline at 9-weeks on the Maslach Burnout Inventory
Mental Wellbeing	Post-intervention (i.e. 9-weeks after baseline)	Change from baseline at 9-weeks on the Short Warwick-Edinburgh Mental Well-being Scale
Compassion for others	Post-intervention (i.e. 9-weeks after baseline)	Change from baseline at 9-weeks on the Compassion Scale
Mindfulness (follow-up)	Follow-up (i.e. 21 weeks after baseline)	Change from baseline at 21-weeks on the Five-Facet Mindfulness Questionnaire - Short Form
Burnout (follow-up)	Follow-up (i.e. 21 weeks after baseline)	Change from baseline at 21-weeks on the Maslach Burnout Inventory
Mental Wellbeing (follow-up)	Follow-up (i.e. 21 weeks after baseline)	Change from baseline at 21-weeks on the Short Warwick-Edinburgh Mental Well-being Scale
Anxiety (follow-up)	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
Self-compassion	Post-intervention (i.e. 9-weeks after baseline)	Change from baseline at 9-weeks on the Self-compassion Scale - Short Form

Trial Locations

Locations (2)

Oxleas NHS Foundation Trust; 🇬🇧 Dartford, Kent, United Kingdom

Sussex Partnership NHS Foundation Trust; 🇬🇧 Hove, Sussex, United Kingdom