A Randomised Controlled Trial of Self-help Mindfulness-based Cognitive Therapy for Health Workers (MindSHINE2)
Primary Purpose
Psychological Stress
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
The self-help book: Williams, M. & Penman, D. (2011). Mindfulness: A practical guide to finding peace in a frantic world. London: Piatkus.
Sponsored by
About this trial
This is an interventional treatment trial for Psychological Stress focused on measuring mindfulness-based cognitive therapy, self-help, healthcare staff
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.
Sites / Locations
- Oxleas NHS Foundation Trust
- Sussex Partnership NHS Foundation Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
MBCT-SH
Control
Arm Description
MBCT-SH will be an unguided, mindfulness-based cognitive therapy, book-based self-help 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.
Outcomes
Primary Outcome Measures
Stress
Change from baseline at 9-weeks on the Stress sub-scale of the Depression, Anxiety and Stress Scale-21
Secondary Outcome Measures
Stress (follow-up)
Change from baseline at 21-weeks on the Stress sub-scale of the Depression, Anxiety and Stress Scale-21
Depression
Change from baseline at 9-weeks on the Depression sub-scale of the Depression, Anxiety and Stress Scale-21
Depression (follow-up)
Change from baseline at 21-weeks on the Depression sub-scale of the Depression, Anxiety and Stress Scale-21
Anxiety
Change from baseline at 9-weeks on the Anxiety sub-scale of the Depression, Anxiety and Stress Scale-21
Anxiety (follow-up)
Change from baseline at 21-weeks on the Anxiety sub-scale of the Depression, Anxiety and Stress Scale-21
Compassion for others
Change from baseline at 9-weeks on the Compassion Scale
Compassion for others (follow-up)
Change from baseline at 21-weeks on the Compassion Scale
Self-compassion
Change from baseline at 9-weeks on the Self-compassion Scale - Short Form
Self-compassion (follow-up)
Change from baseline at 21-weeks on the Self-compassion Scale - Short Form
Mindfulness
Change from baseline at 9-weeks on the Five-Facet Mindfulness Questionnaire - Short Form
Mindfulness (follow-up)
Change from baseline at 21-weeks on the Five-Facet Mindfulness Questionnaire - Short Form
Burnout
Change from baseline at 9-weeks on the Maslach Burnout Inventory
Burnout (follow-up)
Change from baseline at 21-weeks on the Maslach Burnout Inventory
Mental Wellbeing
Change from baseline at 9-weeks on the Short Warwick-Edinburgh Mental Well-being Scale
Mental Wellbeing (follow-up)
Change from baseline at 21-weeks on the Short Warwick-Edinburgh Mental Well-being Scale
Sickness absence
Change from baseline in the number of days of sickness absence over the previous 12 weeks at 21 weeks.
Full Information
NCT ID
NCT03030040
First Posted
January 20, 2017
Last Updated
March 20, 2019
Sponsor
Canterbury Christ Church University
Collaborators
Sussex Partnership NHS Foundation Trust, University of Sussex
1. Study Identification
Unique Protocol Identification Number
NCT03030040
Brief Title
A Randomised Controlled Trial of Self-help Mindfulness-based Cognitive Therapy for Health Workers
Acronym
MindSHINE2
Official Title
A Randomised Controlled Trial of a Mindfulness-based Cognitive Therapy Self-help Intervention for UK National Health Service Employees
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
January 26, 2017 (Actual)
Primary Completion Date
June 22, 2018 (Actual)
Study Completion Date
June 22, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Canterbury Christ Church University
Collaborators
Sussex Partnership NHS Foundation Trust, University of Sussex
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychological Stress
Keywords
mindfulness-based cognitive therapy, self-help, healthcare staff
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Masking Description
Random allocation of participants to arms will be conducted by a statistician independent of the study.
Allocation
Randomized
Enrollment
102 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MBCT-SH
Arm Type
Experimental
Arm Description
MBCT-SH will be an unguided, mindfulness-based cognitive therapy, book-based self-help intervention.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
The self-help book: Williams, M. & Penman, D. (2011). Mindfulness: A practical guide to finding peace in a frantic world. London: Piatkus.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Stress
Description
Change from baseline at 9-weeks on the Stress sub-scale of the Depression, Anxiety and Stress Scale-21
Time Frame
Post-intervention (i.e. 9-weeks after baseline)
Secondary Outcome Measure Information:
Title
Stress (follow-up)
Description
Change from baseline at 21-weeks on the Stress sub-scale of the Depression, Anxiety and Stress Scale-21
Time Frame
Follow-up (i.e. 21 weeks after baseline)
Title
Depression
Description
Change from baseline at 9-weeks on the Depression sub-scale of the Depression, Anxiety and Stress Scale-21
Time Frame
Post-intervention (i.e. 9-weeks after baseline)
Title
Depression (follow-up)
Description
Change from baseline at 21-weeks on the Depression sub-scale of the Depression, Anxiety and Stress Scale-21
Time Frame
Follow-up (i.e. 21 weeks after baseline)
Title
Anxiety
Description
Change from baseline at 9-weeks on the Anxiety sub-scale of the Depression, Anxiety and Stress Scale-21
Time Frame
Post-intervention (i.e. 9-weeks after baseline)
Title
Anxiety (follow-up)
Description
Change from baseline at 21-weeks on the Anxiety sub-scale of the Depression, Anxiety and Stress Scale-21
Time Frame
Follow-up (i.e. 21 weeks after baseline)
Title
Compassion for others
Description
Change from baseline at 9-weeks on the Compassion Scale
Time Frame
Post-intervention (i.e. 9-weeks after baseline)
Title
Compassion for others (follow-up)
Description
Change from baseline at 21-weeks on the Compassion Scale
Time Frame
Follow-up (i.e. 21 weeks after baseline)
Title
Self-compassion
Description
Change from baseline at 9-weeks on the Self-compassion Scale - Short Form
Time Frame
Post-intervention (i.e. 9-weeks after baseline)
Title
Self-compassion (follow-up)
Description
Change from baseline at 21-weeks on the Self-compassion Scale - Short Form
Time Frame
Follow-up (i.e. 21 weeks after baseline)
Title
Mindfulness
Description
Change from baseline at 9-weeks on the Five-Facet Mindfulness Questionnaire - Short Form
Time Frame
Post-intervention (i.e. 9-weeks after baseline)
Title
Mindfulness (follow-up)
Description
Change from baseline at 21-weeks on the Five-Facet Mindfulness Questionnaire - Short Form
Time Frame
Follow-up (i.e. 21 weeks after baseline)
Title
Burnout
Description
Change from baseline at 9-weeks on the Maslach Burnout Inventory
Time Frame
Post-intervention (i.e. 9-weeks after baseline)
Title
Burnout (follow-up)
Description
Change from baseline at 21-weeks on the Maslach Burnout Inventory
Time Frame
Follow-up (i.e. 21 weeks after baseline)
Title
Mental Wellbeing
Description
Change from baseline at 9-weeks on the Short Warwick-Edinburgh Mental Well-being Scale
Time Frame
Post-intervention (i.e. 9-weeks after baseline)
Title
Mental Wellbeing (follow-up)
Description
Change from baseline at 21-weeks on the Short Warwick-Edinburgh Mental Well-being Scale
Time Frame
Follow-up (i.e. 21 weeks after baseline)
Title
Sickness absence
Description
Change from baseline in the number of days of sickness absence over the previous 12 weeks at 21 weeks.
Time Frame
Follow-up (i.e. 21 weeks after baseline)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emily C Ironmonger, MSc
Organizational Affiliation
Canterbury Christ Church University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Clara Strauss, PhD
Organizational Affiliation
Sussex Partnership NHS Foundation Trust & University of Sussex
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Kate Cavanagh, PhD
Organizational Affiliation
University of Sussex
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Fergal Jones, PhD
Organizational Affiliation
Canterbury Christ Church University & Sussex Partnership NHS Foundation Trust
Official's Role
Study Director
Facility Information:
Facility Name
Oxleas NHS Foundation Trust
City
Dartford
State/Province
Kent
ZIP/Postal Code
DA2 7WG
Country
United Kingdom
Facility Name
Sussex Partnership NHS Foundation Trust
City
Hove
State/Province
Sussex
ZIP/Postal Code
BN3 7HZ
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
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A Randomised Controlled Trial of Self-help Mindfulness-based Cognitive Therapy for Health Workers
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