Clinical trial NCT04631302: The Work Engagement and Wellbeing Study
Official title: Work Engagement and Well-being Study (SWELL): A Randomised Controlled Feasibility Trial Evaluating the Effects of Mindfulness Versus Light Physical Exercise at Work
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mindfulness
Exercise
Keywords: Mindfulness
physical exercise
wellbeing
workplace
web-based intervention
Lead sponsor: Medical Research Council Cognition and Brain Sciences Unit
Sponsor class: OTHER_GOV
Collaborators: name: University of Cambridge
First posted: 2020-11-17
Enrollment: 241
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Mindfulness and exercise are both widely used to improve mental health and well-being. Some people find that these activities also improve their ability to focus. This study aims to find out whether mindfulness and light exercise could be similarly effective in improving mental wellbeing and engagement at work. The study further investigates the cognitive processes (e.g., memory and attention skills) that might improve as a result of mindfulness and exercise.

Detailed description: Mental illness is a major cause of disability worldwide\[1\]. Much of the adult population is employed and spends 28% of their waking hours doing paid work\[2,3\]. The occupational environment is therefore an opportune location for preventative mental health interventions. A growing number of employers provide programmes to improve well-being and work performance.

Mindfulness is typically defined as "the awareness that emerges through paying attention on purpose, in the present moment, and non-judgmentally to the unfolding of experience moment by moment". Practising such awareness has been linked to reduction in symptoms of anxiety, depression, and stress in community populations. There is also evidence that mindfulness could improve life satisfaction, overall well-being, and quality of life.

It has also been argued that mindfulness may yield workplace benefits beyond well-being. Mindfulness has been suggested to improve work performance, reduce the negative effects of multitasking, and enhance self-regulation of thoughts, emotions and behaviours. Empirical evidence to support these suggestions, however, is scarce. Furthermore, the mechanisms through which mindfulness impacts work performance are not clear. Understanding mechanisms of change (a) would help to design better, more targeted interventions, (b) would improve our attempts to assess MBPs via selection of more stringent control interventions and (c) may promote a personalised medicine approach by informing understanding of what works for whom and in which context.

Current literature suggests that MBPs could improve work performance through increased mental well-being and/or cognitive control over emotional material. A definitive randomised controlled trial is needed to evaluate these potential mechanisms. However, methodological uncertainties need clarification to inform the design of such a trial. We aim to conduct a feasibility trial to clarify these uncertainties and complete a preliminary investigation of the relationships between mindfulness training, workplace performance and the proposed mechanisms of action: mental well-being and cognitive control.

This feasibility trial will:

1. Estimate the between-groups effect size for the effect of mindfulness, relative to a light exercise control condition, on our primary outcome of work performance, in order to inform power calculation for a larger trial;
2. Explore whether improved cognitive control and/or enhanced mental health could be potential mechanisms underlying the effect of mindfulness on work performance;
3. Determine procedural feasibility of a later stage trial by evaluating the willingness of the participants to be randomised and other practical implications of running a randomised controlled trial;

Eligibility criteria: Inclusion Criteria:

* Employee at one of the participating organisations
* Based in the UK

Exclusion Criteria:

* Is currently on a long-term leave
* Is currently suffering from severe periods of anxiety, depression or hypomania/mania;
* Is experiencing other severe mental illnesses;
* Has had a recent bereavement or major loss;
* Has already completed a mindfulness course or have meditated more than 10 hours in the past 10 years.

Primary outcomes:
measure: Work Role Functioning Questionnaire (WRFQ).
timeFrame: Baseline (pre-intervention); 1 week post-intervention (primary outcome measure); 12-week post-intervention
Secondary outcomes:
measure: Work and Social Adjustment Scale
timeFrame: Baseline (pre-intervention); 1 week post-intervention (primary outcome measure); 12-week post-intervention
measure: Daily work engagement
timeFrame: Days which participant works during the 4 weeks of intervention. For example, if working full-time and if Monday is Day 1 of intervention then measurements will take place on Day 1...5, Day 8...12, Day 16...20, Day 23...27.
measure: Emotional Stop Signal Task: Reaction times (in both, go and stop trials)
timeFrame: Baseline (pre-intervention); 1 week post-intervention (primary outcome measure); 12-week post-intervention
measure: Emotional Stop Signal Task: response accuracy (failure or success in inhibiting response)
timeFrame: Baseline (pre-intervention); 1 week post-intervention (primary outcome measure); 12-week post-intervention
measure: Emotional Stop Signal Task: variability in reaction time throughout the task (ability to overcome errors).
timeFrame: Baseline (pre-intervention); 1 week post-intervention (primary outcome measure); 12-week post-intervention
measure: Probabilistic reverse learning task: learning performance indexed via the proportion of correct responses
timeFrame: Baseline (pre-intervention); 1 week post-intervention (primary outcome measure); 12-week post-intervention
measure: Probabilistic reverse learning task: reaction time
timeFrame: Baseline (pre-intervention); 1 week post-intervention (primary outcome measure); 12-week post-intervention
measure: Probabilistic reverse learning task: accuracy, that is whether the chosen stimulus was the one that was correct.
timeFrame: Baseline (pre-intervention); 1 week post-intervention (primary outcome measure); 12-week post-intervention
measure: Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS)
timeFrame: Baseline (pre-intervention); 1 week post-intervention (primary outcome measure); 12-week post-intervention
measure: The Perceived Stress Scale
timeFrame: Baseline (pre-intervention); 1 week post-intervention (primary outcome measure); 12-week post-intervention
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline (pre-intervention); 1 week post-intervention (primary outcome measure); 12-week post-intervention
measure: General Anxiety Disorder 7-item Scale (GAD-7)
timeFrame: Baseline (pre-intervention); 1 week post-intervention (primary outcome measure); 12-week post-intervention
measure: Other health problems
timeFrame: Baseline (pre-intervention); 1 week post-intervention (primary outcome measure); 12-week post-intervention
measure: Decentering
timeFrame: Baseline (pre-intervention); 1 week post-intervention (primary outcome measure); 12-week post-intervention
measure: Mindfulness
timeFrame: Baseline (pre-intervention); 1 week post-intervention (primary outcome measure); 12-week post-intervention
Other outcomes:
measure: Retention in the trial
timeFrame: Baseline (pre-intervention); 1 week post-intervention (primary outcome measure); 12-week post-intervention
measure: Preferred course
timeFrame: 1 week post-intervention (primary outcome measure);
measure: Engagement in courses
timeFrame: Each of 4 weeks during the intervention.
measure: Regularity in engaging in exercise and mindfulness
timeFrame: Baseline (pre-intervention); 1 week post-intervention (primary outcome measure); 12-week post-intervention
measure: Importance of job to participant
timeFrame: Baseline (pre-intervention); 1 week post-intervention (primary outcome measure); 12-week post-intervention
Locations:
city: Cambridge
country: United Kingdom
facility: MRC Cognition and Brain Sciences Unit
Study officials:
affiliation: MRC CBU
name: Maris Vainre, MA
role: PRINCIPAL_INVESTIGATOR
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