Clinical trial NCT03030040: A Randomised Controlled Trial of Self-help Mindfulness-based Cognitive Therapy for Health Workers
Official title: A Randomised Controlled Trial of a Mindfulness-based Cognitive Therapy Self-help Intervention for UK National Health Service Employees
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychological Stress
Keywords: mindfulness-based cognitive therapy
self-help
healthcare staff
Lead sponsor: Canterbury Christ Church University
Sponsor class: OTHER
Collaborators: name: Sussex Partnership NHS Foundation Trust
name: University of Sussex
First posted: 2017-01-24
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Stress
timeFrame: Post-intervention (i.e. 9-weeks after baseline)
Secondary outcomes:
measure: Stress (follow-up)
timeFrame: Follow-up (i.e. 21 weeks after baseline)
measure: Depression
timeFrame: Post-intervention (i.e. 9-weeks after baseline)
measure: Depression (follow-up)
timeFrame: Follow-up (i.e. 21 weeks after baseline)
measure: Anxiety
timeFrame: Post-intervention (i.e. 9-weeks after baseline)
measure: Anxiety (follow-up)
timeFrame: Follow-up (i.e. 21 weeks after baseline)
measure: Compassion for others
timeFrame: Post-intervention (i.e. 9-weeks after baseline)
measure: Compassion for others (follow-up)
timeFrame: Follow-up (i.e. 21 weeks after baseline)
measure: Self-compassion
timeFrame: Post-intervention (i.e. 9-weeks after baseline)
measure: Self-compassion (follow-up)
timeFrame: Follow-up (i.e. 21 weeks after baseline)
measure: Mindfulness
timeFrame: Post-intervention (i.e. 9-weeks after baseline)
measure: Mindfulness (follow-up)
timeFrame: Follow-up (i.e. 21 weeks after baseline)
measure: Burnout
timeFrame: Post-intervention (i.e. 9-weeks after baseline)
measure: Burnout (follow-up)
timeFrame: Follow-up (i.e. 21 weeks after baseline)
measure: Mental Wellbeing
timeFrame: Post-intervention (i.e. 9-weeks after baseline)
measure: Mental Wellbeing (follow-up)
timeFrame: Follow-up (i.e. 21 weeks after baseline)
measure: Sickness absence
timeFrame: Follow-up (i.e. 21 weeks after baseline)
Other outcomes:
Locations:
city: Dartford
country: United Kingdom
facility: Oxleas NHS Foundation Trust
state: Kent
city: Hove
country: United Kingdom
facility: Sussex Partnership NHS Foundation Trust
state: Sussex
Study officials:
affiliation: Canterbury Christ Church University
name: Emily C Ironmonger, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Sussex Partnership NHS Foundation Trust & University of Sussex
name: Clara Strauss, PhD
role: STUDY_DIRECTOR
affiliation: University of Sussex
name: Kate Cavanagh, PhD
role: STUDY_DIRECTOR
affiliation: Canterbury Christ Church University & Sussex Partnership NHS Foundation Trust
name: Fergal Jones, PhD
role: STUDY_DIRECTOR
References: