NCT03030040

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 20, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 24, 2017

Completed
2 days until next milestone

Study Start

First participant enrolled

January 26, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 22, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 22, 2018

Completed
Last Updated

March 22, 2019

Status Verified

March 1, 2019

Enrollment Period

1.4 years

First QC Date

January 20, 2017

Last Update Submit

March 20, 2019

Conditions

Psychological Stress

Keywords

mindfulness-based cognitive therapyself-helphealthcare staff

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (16)

  • Stress (follow-up)

    Follow-up (i.e. 21 weeks after baseline)

  • Depression

    Post-intervention (i.e. 9-weeks after baseline)

  • Depression (follow-up)

    Follow-up (i.e. 21 weeks after baseline)

  • Anxiety

    Post-intervention (i.e. 9-weeks after baseline)

  • Anxiety (follow-up)

    Follow-up (i.e. 21 weeks after baseline)

  • +11 more secondary outcomes

Study Arms (2)

MBCT-SH

EXPERIMENTAL

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.

Control

NO INTERVENTION

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.

Interventions

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

MBCT-SH

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Oxleas NHS Foundation Trust

Dartford, Kent, DA2 7WG, United Kingdom

Location

Sussex Partnership NHS Foundation Trust

Hove, Sussex, BN3 7HZ, United Kingdom

Location

MeSH Terms

Conditions

Stress, Psychological

Interventions

Fumigant 93

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Emily C Ironmonger, MSc

    Canterbury Christ Church University

    PRINCIPAL INVESTIGATOR

  • 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 DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
Random allocation of participants to arms will be conducted by a statistician independent of the study.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2017

First Posted

January 24, 2017

Study Start

January 26, 2017

Primary Completion

June 22, 2018

Study Completion

June 22, 2018

Last Updated

March 22, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

GB(2)