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Clinical Trials/NCT03030040
NCT03030040
Completed
Not Applicable

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

Canterbury Christ Church University2 sites in 1 country102 target enrollmentJanuary 26, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Psychological Stress
Sponsor
Canterbury Christ Church University
Enrollment
102
Locations
2
Primary Endpoint
Stress
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 26, 2017
End Date
June 22, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

  • Depression (follow-up)(Follow-up (i.e. 21 weeks after baseline))
  • Mindfulness(Post-intervention (i.e. 9-weeks after baseline))
  • Stress (follow-up)(Follow-up (i.e. 21 weeks after baseline))
  • Depression(Post-intervention (i.e. 9-weeks after baseline))
  • Anxiety(Post-intervention (i.e. 9-weeks after baseline))
  • Compassion for others (follow-up)(Follow-up (i.e. 21 weeks after baseline))
  • Sickness absence(Follow-up (i.e. 21 weeks after baseline))
  • Self-compassion (follow-up)(Follow-up (i.e. 21 weeks after baseline))
  • Burnout(Post-intervention (i.e. 9-weeks after baseline))
  • Mental Wellbeing(Post-intervention (i.e. 9-weeks after baseline))
  • Compassion for others(Post-intervention (i.e. 9-weeks after baseline))
  • Mindfulness (follow-up)(Follow-up (i.e. 21 weeks after baseline))
  • Burnout (follow-up)(Follow-up (i.e. 21 weeks after baseline))
  • Mental Wellbeing (follow-up)(Follow-up (i.e. 21 weeks after baseline))
  • Anxiety (follow-up)(Follow-up (i.e. 21 weeks after baseline))
  • Self-compassion(Post-intervention (i.e. 9-weeks after baseline))

Study Sites (2)

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