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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03030040
Acronym
MindSHINE2
Enrollment
102
Registered
2017-01-24
Start date
2017-01-26
Completion date
2018-06-22
Last updated
2019-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psychological Stress

Keywords

mindfulness-based cognitive therapy, self-help, healthcare staff

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.

Interventions

BEHAVIORALThe 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.

Sponsors

Sussex Partnership NHS Foundation Trust
CollaboratorOTHER
University of Sussex
CollaboratorOTHER
Canterbury Christ Church University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Masking description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
StressPost-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

MeasureTime frameDescription
DepressionPost-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
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
AnxietyPost-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
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
Compassion for othersPost-intervention (i.e. 9-weeks after baseline)Change from baseline at 9-weeks on the Compassion Scale
Compassion for others (follow-up)Follow-up (i.e. 21 weeks after baseline)Change from baseline at 21-weeks on the Compassion Scale
Self-compassionPost-intervention (i.e. 9-weeks after baseline)Change from baseline at 9-weeks on the Self-compassion Scale - Short Form
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
MindfulnessPost-intervention (i.e. 9-weeks after baseline)Change from baseline at 9-weeks on the Five-Facet Mindfulness Questionnaire - Short Form
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
BurnoutPost-intervention (i.e. 9-weeks after baseline)Change from baseline at 9-weeks on the Maslach Burnout Inventory
Burnout (follow-up)Follow-up (i.e. 21 weeks after baseline)Change from baseline at 21-weeks on the Maslach Burnout Inventory
Mental WellbeingPost-intervention (i.e. 9-weeks after baseline)Change from baseline at 9-weeks on the Short Warwick-Edinburgh Mental Well-being Scale
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
Sickness absenceFollow-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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026