The Work Engagement and Wellbeing Study

Exercise Clinical Trial

— SWELL  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04631302
• Other study ID #: 2020.Vainre_Swell
• Status: Completed
• Phase: N/A
• Start date: February 23, 2021
• Est. completion date: March 31, 2023

Study information

• Verified date: November 2023
• Source: Medical Research Council Cognition and Brain Sciences Unit
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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;

Recruitment information / eligibility

• Status: Completed
• Enrollment: 241
• Est. completion date: March 31, 2023
• Est. primary completion date: March 23, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Exercise
• Mindfulness

Intervention

Behavioral:
• Be Mindful
Be mindful is an online course run by the Mental Health Foundation and Wellmind Media. It was developed together with British mindfulness instructors and offers access to its course materials and instructional videos through a website (http://www.bemindfulonline.com). The course consists of 11 sessions led by two mindfulness teachers, one female, one male. Using a variety of media (videos, assignments, audio tracks and e-mails), participants are taught to use formal as well as informal mindfulness techniques. The course lasts 4 weeks. For each week, participants are asked to do a daily formal mediation practice (up to 30 minutes but it varies from week to week) and one or two informal exercises.
• Light exercise course
The control condition involves light physical exercises aimed at increasing mobility, reducing stiffness, improving circulation, and avoiding pain or repetitive strain injuries that may result from sedentary or repetitive tasks common in office environments. The exercises will include simple whole-body slightly aerobic exercises such as rotation of limbs and stretching. The course was developed by Dr Julieta Galante, a public health doctor, together with an expert in body posture re-education and body techniques. The course is designed to match with the mindfulness intervention condition in duration and media (length of videos, amount of written instructions). It also replicates the encouraged use of short breaks (of seconds or minutes) throughout the workday to focus on wellbeing, as occurs in mindfulness.

Locations

Country	Name	City	State
United Kingdom	MRC Cognition and Brain Sciences Unit	Cambridge

Sponsors (2)

Lead Sponsor	Collaborator
Medical Research Council Cognition and Brain Sciences Unit	University of Cambridge

Country where clinical trial is conducted

United Kingdom, 

References & Publications (30)

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* Note: There are 30 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Retention in the trial	Number of participants completing measures for each time point	Baseline (pre-intervention); 1 week post-intervention (primary outcome measure); 12-week post-intervention
Other	Preferred course	Index of which course the participant would have preferred to be randomised to	1 week post-intervention (primary outcome measure);
Other	Engagement in courses	To index engagement in courses, we will report the number of people accessing each week's practices.	Each of 4 weeks during the intervention.
Other	Regularity in engaging in exercise and mindfulness	Self-rated estimate of the amount of time spent on exercise and on mindfulness, separately.	Baseline (pre-intervention); 1 week post-intervention (primary outcome measure); 12-week post-intervention
Other	Importance of job to participant	1-item self-rated on a Likert scale.	Baseline (pre-intervention); 1 week post-intervention (primary outcome measure); 12-week post-intervention
Primary	Work Role Functioning Questionnaire (WRFQ).	All participants will complete the Work Role Functioning Questionnaire's updated version. It is a 25-item measure to capture the perceived difficulties in meeting work demands. Items are rated on a 5-point scale where 0 is difficult all the time and 5 is difficult none of the time. A 6th option allows participants to denote "does not apply for my job". The subscale and total score are summed, with a minimum score 0 and maximum score 100, with higher scores indicating better work functioning. The questionnaire has not been validated in English but is available in English and validations done in Spain, The Netherlands, Norway, and Brazil have shown good Cronbach alphas (0.7-0.9).; The primary hypothesis will be evaluated with a time (pre, post) x intervention (mindfulness, light exercise) interaction predicting score on the WRFQ.	Baseline (pre-intervention); 1 week post-intervention (primary outcome measure); 12-week post-intervention
Secondary	Work and Social Adjustment Scale	Those who said they have experienced health problems will be asked to fill in the Work and Social Adjustment Scale which is widely used in the National Health Service's psychology services in England. It has high internal reliability and sensitivity to treatment effects, comparable to GAD-7 and PHQ-9.	Baseline (pre-intervention); 1 week post-intervention (primary outcome measure); 12-week post-intervention
Secondary	Daily work engagement	To get a better understanding of daily fluctuations of work engagement that may occur and whether there are any between-group differences, participants will be asked to complete a short questionnaire about their daily work engagement. The link will be sent to participants' e-mail addresses. We will use a short 5-item version of the Work Role Functioning Questionnaire, which features the following items: Start [work] as soon as you arrived (work scheduling demands); Work without mistakes (Output demands); Repeat the same motions (Physical demands); Concentrate on your work (Mental and social demands); Perform multiple tasks (Flexibility demands) Items are rated on a 5-point scale where 0 is difficult all the time and 5 is difficult none of the time. A 6th option allows participants to denote "does not apply for my job".	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.
Secondary	Emotional Stop Signal Task: Reaction times (in both, go and stop trials)	Delivery: Computer-based Stimuli: Images that illustrate negative/neutral social situations are presented. Arrows appear pointing left/right/up.; Typical trial: At the beginning of each trial, a negative/neural image appears. Afterward, a go-signal appears (left/right arrow) toward which participants need to respond (e.g. press left/right key). On a minority of trials, the go-signal is quickly followed by a stop signal (upwards arrow); these stop-signals follow 20% of go-signals. Participants are required to inhibit their go-response when the stop-signal appears.	Baseline (pre-intervention); 1 week post-intervention (primary outcome measure); 12-week post-intervention
Secondary	Emotional Stop Signal Task: response accuracy (failure or success in inhibiting response)	Delivery: Computer-based Stimuli: Images that illustrate negative/neutral social situations are presented. Arrows appear pointing left/right/up.; Typical trial: At the beginning of each trial, a negative/neural image appears. Afterward, a go-signal appears (left/right arrow) toward which participants need to respond (e.g. press left/right key). On a minority of trials, the go-signal is quickly followed by a stop signal (upwards arrow); these stop-signals follow 20% of go-signals. Participants are required to inhibit their go-response when the stop-signal appears.	Baseline (pre-intervention); 1 week post-intervention (primary outcome measure); 12-week post-intervention
Secondary	Emotional Stop Signal Task: variability in reaction time throughout the task (ability to overcome errors).	Delivery: Computer-based Stimuli: Images that illustrate negative/neutral social situations are presented. Arrows appear pointing left/right/up.; Typical trial: At the beginning of each trial, a negative/neural image appears. Afterward, a go-signal appears (left/right arrow) toward which participants need to respond (e.g. press left/right key). On a minority of trials, the go-signal is quickly followed by a stop signal (upwards arrow); these stop-signals follow 20% of go-signals. Participants are required to inhibit their go-response when the stop-signal appears.	Baseline (pre-intervention); 1 week post-intervention (primary outcome measure); 12-week post-intervention
Secondary	Probabilistic reverse learning task: learning performance indexed via the proportion of correct responses	Delivery: Computer-based. Stimuli: Abstract shapes with which participants will have no prior experiences.; Typical trial: At the beginning of each trial, a negative/neural image from the International Affective Picture System appears. Then, the participants are presented with pairs of stimuli (A-B or C-D). One of the stimuli in the pair is more likely to be rewarded than the other (e.g. selecting A or C is reinforced on 80% of trials). Participants must select one of the stimuli (using key-board presses). Through trial-and-error, participants learn which of the two is correct. Feedback is presented after each response. After a certain number of trials, the contingency of reinforcement changes and another stimulus is reinforced (e.g. B is now reinforced on 80% of trials). This task measure participant's ability to track dynamic changes in their environment and alter their response strategies.	Baseline (pre-intervention); 1 week post-intervention (primary outcome measure); 12-week post-intervention
Secondary	Probabilistic reverse learning task: reaction time	Delivery: Computer-based. Stimuli: Abstract shapes with which participants will have no prior experiences.; Typical trial: At the beginning of each trial, a negative/neural image from the International Affective Picture System appears. Then, the participants are presented with pairs of stimuli (A-B or C-D). One of the stimuli in the pair is more likely to be rewarded than the other (e.g. selecting A or C is reinforced on 80% of trials). Participants must select one of the stimuli (using key-board presses). Through trial-and-error, participants learn which of the two is correct. Feedback is presented after each response. After a certain number of trials, the contingency of reinforcement changes and another stimulus is reinforced (e.g. B is now reinforced on 80% of trials). This task measure participant's ability to track dynamic changes in their environment and alter their response strategies.	Baseline (pre-intervention); 1 week post-intervention (primary outcome measure); 12-week post-intervention
Secondary	Probabilistic reverse learning task: accuracy, that is whether the chosen stimulus was the one that was correct.	Delivery: Computer-based. Stimuli: Abstract shapes with which participants will have no prior experiences.; Typical trial: At the beginning of each trial, a negative/neural image from the International Affective Picture System appears. Then, the participants are presented with pairs of stimuli (A-B or C-D). One of the stimuli in the pair is more likely to be rewarded than the other (e.g. selecting A or C is reinforced on 80% of trials). Participants must select one of the stimuli (using key-board presses). Through trial-and-error, participants learn which of the two is correct. Feedback is presented after each response. After a certain number of trials, the contingency of reinforcement changes and another stimulus is reinforced (e.g. B is now reinforced on 80% of trials). This task measure participant's ability to track dynamic changes in their environment and alter their response strategies.	Baseline (pre-intervention); 1 week post-intervention (primary outcome measure); 12-week post-intervention
Secondary	Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS)	Subjective well-being will be measured with the Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS), a questionnaire designed to capture a broad concept of well-being. In SWEMWBS, each item scored on a five-point scale ranging from 1 (none of the time) to 5 (all of the time). The SWEMWBS internal consistency was a =0.84 in a study in the UK general population (n=27,169).	Baseline (pre-intervention); 1 week post-intervention (primary outcome measure); 12-week post-intervention
Secondary	The Perceived Stress Scale	The Perceived Stress Scale (PSS) measures the extent to which the individual has perceived events as uncontrollable and overwhelming in the previous month. Validity and reliability of the PSS have good reports. The PSS consists of 10 items, each answered on a five-point scale ranging from 0 to 4. Higher scores indicate higher stress levels.	Baseline (pre-intervention); 1 week post-intervention (primary outcome measure); 12-week post-intervention
Secondary	Patient Health Questionnaire (PHQ-9)	The Patient Health Questionnaire (PHQ-9) is used to assess depression severity during the preceding 2 weeks. The PHQ-9 consists of 9 items answered using a four-point scale, ranging from 0 to 3, and a further item asking about the level of difficulty associated with any checked off items. Scores range from 0 to 27 with cut-off points for depression at 5, 10, 15 and 20 for mild, moderate, moderately severe and severe depression, respectively.	Baseline (pre-intervention); 1 week post-intervention (primary outcome measure); 12-week post-intervention
Secondary	General Anxiety Disorder 7-item Scale (GAD-7)	The General Anxiety Disorder 7-item Scale (GAD-7) assesses anxiety during the preceding 2 weeks and has been shown to have good reliability and validity. The items are answered using a four-point scale, ranging from 0 to 3 with total scores ranging from 0 to 21. Higher scores indicate increasing functional impairment with cut-offs at 5, 10 and 15 for mild, moderate and severe anxiety, respectively.	Baseline (pre-intervention); 1 week post-intervention (primary outcome measure); 12-week post-intervention
Secondary	Other health problems	Single item: "Have you had any health problems in the last 7 days that have affected your ability to work?", with options to pick one or several of the following: physical health problems, mental health problems, other health problems, no problems or prefer not to say. If a participant selects one of the first three options (i.e., they have had problems), they will be asked to briefly describe these problems.	Baseline (pre-intervention); 1 week post-intervention (primary outcome measure); 12-week post-intervention
Secondary	Decentering	Experiences Questionnaire (EQ) is an 11-item measure of decentering. he items were generated to represent the changes believed to occur as a result of mindfulness practice, including lack of identification with one's thoughts, nonreactivity to negative experiences, and self-compassion. Statements are rated on a 5-point scale (never to all the time). The EQ test scores have an acceptable reliability (alphas .81-.84).	Baseline (pre-intervention); 1 week post-intervention (primary outcome measure); 12-week post-intervention
Secondary	Mindfulness	Mindful Attention Awareness Scale is a self-report questionnaire consisting of 15 items designed to assess a core characteristic of mindfulness - a receptive state of mind in which attention simply observes what is taking place. Internal consistency is good (a = .82), with good test-retest reliability and convergent validity.	Baseline (pre-intervention); 1 week post-intervention (primary outcome measure); 12-week post-intervention