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MindfulnessSWELLNCT04631302

The Work Engagement and Wellbeing Study

A study testing Be Mindful and Light exercise course in people with Mindfulness and Exercise, run by Medical Research Council Cognition and Brain Sciences Unit at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Mindfulness, Exercise
What is being tested?
Be Mindful and Light exercise course
Could I receive a placebo?
No, everyone receives an active treatment
How many people
241 participants
Where
1 siteUnited Kingdom
Study dates
23 Feb 2021to 31 Mar 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • MRC Cognition and Brain Sciences Unit

    Cambridge, CB2 7EF

Other trials in United Kingdom

About this 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

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.

Read the 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;
Being tested
Be Mindful, Light exercise course
Keywords
Mindfulness, physical exercise, wellbeing, workplace, web-based intervention
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Be MindfulBehavioural

    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 courseBehavioural

    Also called Physical exercise

    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.

Study groups in NCT04631302
Study groupRoleWhat they receive
MindfulnessExperimentalNot described
Receives: Behavioral: Be Mindful
Light Physical ExerciseActive comparatorNot described
Receives: Behavioral: Light exercise course

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline (pre-intervention); 1 week post-intervention (primary outcome measure); 12-week post-intervention

Secondary outcomes (15)

  1. 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.

    Measured: Baseline (pre-intervention); 1 week post-intervention (primary outcome measure); 12-week post-intervention

  2. 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".

    Measured: 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.

  3. 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.

    Measured: Baseline (pre-intervention); 1 week post-intervention (primary outcome measure); 12-week post-intervention

  4. 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.

    Measured: Baseline (pre-intervention); 1 week post-intervention (primary outcome measure); 12-week post-intervention

  5. 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.

    Measured: Baseline (pre-intervention); 1 week post-intervention (primary outcome measure); 12-week post-intervention

  6. 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.

    Measured: Baseline (pre-intervention); 1 week post-intervention (primary outcome measure); 12-week post-intervention

  7. 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.

    Measured: Baseline (pre-intervention); 1 week post-intervention (primary outcome measure); 12-week post-intervention

  8. 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.

    Measured: Baseline (pre-intervention); 1 week post-intervention (primary outcome measure); 12-week post-intervention

  9. 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 α =0.84 in a study in the UK general population (n=27,169).

    Measured: Baseline (pre-intervention); 1 week post-intervention (primary outcome measure); 12-week post-intervention

  10. 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.

    Measured: Baseline (pre-intervention); 1 week post-intervention (primary outcome measure); 12-week post-intervention

  11. 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.

    Measured: Baseline (pre-intervention); 1 week post-intervention (primary outcome measure); 12-week post-intervention

  12. 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.

    Measured: Baseline (pre-intervention); 1 week post-intervention (primary outcome measure); 12-week post-intervention

  13. 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.

    Measured: Baseline (pre-intervention); 1 week post-intervention (primary outcome measure); 12-week post-intervention

  14. 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).

    Measured: Baseline (pre-intervention); 1 week post-intervention (primary outcome measure); 12-week post-intervention

  15. 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 (α = .82), with good test-retest reliability and convergent validity.

    Measured: Baseline (pre-intervention); 1 week post-intervention (primary outcome measure); 12-week post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Nov 2020
  2. Study start23 Feb 2021
  3. Primary completion23 Mar 2022
  4. Study completion31 Mar 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
241 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04631302
Sponsor's protocol ID
2020.Vainre_Swell
Acronym
SWELL
Status last verified
Nov 2023
First submitted
5 Nov 2020
Last updated
13 Nov 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Details to be confirmed

Publications

  • Abma F, Bjorner JB, Amick BC 3rd, Bultmann U. Two valid and reliable work role functioning questionnaire short versions were developed: WRFQ 5 and WRFQ 10. J Clin Epidemiol. 2019 Jan;105:101-111. doi: 10.1016/j.jclinepi.2018.09.005. Epub 2018 Sep 22.

    PubMed 30253219

  • Abma FI, van der Klink JJ, Bultmann U. The work role functioning questionnaire 2.0 (Dutch version): examination of its reliability, validity and responsiveness in the general working population. J Occup Rehabil. 2013 Mar;23(1):135-47. doi: 10.1007/s10926-012-9379-8.

    PubMed 22869455

  • Amick BC 3rd, Lerner D, Rogers WH, Rooney T, Katz JN. A review of health-related work outcome measures and their uses, and recommended measures. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3152-60. doi: 10.1097/00007632-200012150-00010. No abstract available.

    PubMed 11124731

  • Bartlett L, Martin A, Neil AL, Memish K, Otahal P, Kilpatrick M, Sanderson K. A systematic review and meta-analysis of workplace mindfulness training randomized controlled trials. J Occup Health Psychol. 2019 Feb;24(1):108-126. doi: 10.1037/ocp0000146.

    PubMed 30714811

  • Cools R, Clark L, Owen AM, Robbins TW. Defining the neural mechanisms of probabilistic reversal learning using event-related functional magnetic resonance imaging. J Neurosci. 2002 Jun 1;22(11):4563-7. doi: 10.1523/JNEUROSCI.22-11-04563.2002.

    PubMed 12040063

  • Crane RS, Brewer J, Feldman C, Kabat-Zinn J, Santorelli S, Williams JM, Kuyken W. What defines mindfulness-based programs? The warp and the weft. Psychol Med. 2017 Apr;47(6):990-999. doi: 10.1017/S0033291716003317. Epub 2016 Dec 29.

    PubMed 28031068

  • Dane, E. (2011). Paying Attention to Mindfulness and Its Effects on Task Performance in the Workplace. Journal of Management, 37(4), 997-1018. https://doi.org/10.1177/0149206310367948

  • Fresco DM, Moore MT, van Dulmen MH, Segal ZV, Ma SH, Teasdale JD, Williams JM. Initial psychometric properties of the experiences questionnaire: validation of a self-report measure of decentering. Behav Ther. 2007 Sep;38(3):234-46. doi: 10.1016/j.beth.2006.08.003. Epub 2007 Apr 24.

    PubMed 17697849

  • Galante J, Dufour G, Vainre M, Wagner AP, Stochl J, Benton A, Lathia N, Howarth E, Jones PB. A mindfulness-based intervention to increase resilience to stress in university students (the Mindful Student Study): a pragmatic randomised controlled trial. Lancet Public Health. 2018 Feb;3(2):e72-e81. doi: 10.1016/S2468-2667(17)30231-1. Epub 2017 Dec 19.

    PubMed 29422189

  • Gallasch CH, Alexandre NM, Amick B 3rd. Cross-cultural adaptation, reliability, and validity of the work role functioning questionnaire to Brazilian Portuguese. J Occup Rehabil. 2007 Dec;17(4):701-11. doi: 10.1007/s10926-007-9103-2. Epub 2007 Oct 2.

    PubMed 17909949

  • Glomb, T. M., Duffy, M. K., Bono, J. E., & Yang, T. (2011). Mindfulness at Work. In A. Joshi, H. Liao, & J. J. Martocchio (Eds.), Research in Personnel and Human Resources Management (Vol. 30, pp. 115-157). Emerald Group Publishing Limited. https://doi.org/10.1108/S0742-7301(2011)0000030005

  • Good, D. J., Lyddy, C. J., Glomb, T. M., Bono, J. E., Brown, K. W., Duffy, M. K., Baer, R. A., Brewer, J. A., & Lazar, S. W. (2016). Contemplating Mindfulness at Work: An Integrative Review. Journal of Management, 42(1), 114-142. https://doi.org/10.1177/0149206315617003

  • Hallingberg B, Turley R, Segrott J, Wight D, Craig P, Moore L, Murphy S, Robling M, Simpson SA, Moore G. Exploratory studies to decide whether and how to proceed with full-scale evaluations of public health interventions: a systematic review of guidance. Pilot Feasibility Stud. 2018 May 28;4:104. doi: 10.1186/s40814-018-0290-8. eCollection 2018.

    PubMed 29854417

  • Health and Safety Executive. (2019). Work-related stress, anxiety or depression statistics in Great Britain, 2019 (Annual Statistics). Health and Safety Executive. https://www.hse.gov.uk/statistics/causdis/stress.pdf

  • Jamieson SD, Tuckey MR. Mindfulness interventions in the workplace: A critique of the current state of the literature. J Occup Health Psychol. 2017 Apr;22(2):180-193. doi: 10.1037/ocp0000048. Epub 2016 Sep 19.

    PubMed 27643606

Questions about this trial

What is this clinical trial studying?

A study testing Be Mindful and Light exercise course in people with Mindfulness and Exercise, run by Medical Research Council Cognition and Brain Sciences Unit at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Work Role Functioning Questionnaire (WRFQ). (time frame: Baseline (pre-intervention); 1 week post-intervention (primary outcome measure); 12-week post-intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04631302, which also lists 32 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2023.

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