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

NCT ID: NCT03030040

Last Updated: 2019-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-26

Study Completion Date

2018-06-22

Brief Summary

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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

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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.

Conditions

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Psychological Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators
Random allocation of participants to arms will be conducted by a statistician independent of the study.

Study Groups

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MBCT-SH

MBCT-SH will be an unguided, mindfulness-based cognitive therapy, book-based self-help intervention.

Group Type EXPERIMENTAL

The self-help book: Williams, M. & Penman, D. (2011). Mindfulness: A practical guide to finding peace in a frantic world. London: Piatkus.

Intervention Type BEHAVIORAL

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sussex Partnership NHS Foundation Trust

OTHER

Sponsor Role collaborator

University of Sussex

OTHER

Sponsor Role collaborator

Canterbury Christ Church University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Emily C Ironmonger, MSc

Role: PRINCIPAL_INVESTIGATOR

Canterbury Christ Church University

Clara Strauss, PhD

Role: STUDY_DIRECTOR

Sussex Partnership NHS Foundation Trust & University of Sussex

Kate Cavanagh, PhD

Role: STUDY_DIRECTOR

University of Sussex

Fergal Jones, PhD

Role: STUDY_DIRECTOR

Canterbury Christ Church University & Sussex Partnership NHS Foundation Trust

Locations

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Oxleas NHS Foundation Trust

Dartford, Kent, United Kingdom

Site Status

Sussex Partnership NHS Foundation Trust

Hove, Sussex, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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IRAS ID: 215054

Identifier Type: OTHER

Identifier Source: secondary_id

EmilyIronmongerMRP2016

Identifier Type: -

Identifier Source: org_study_id

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