Study Results
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Basic Information
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COMPLETED
NA
241 participants
INTERVENTIONAL
2021-02-23
2023-03-31
Brief Summary
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Detailed Description
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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;
Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
SINGLE
Study Groups
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Mindfulness
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 Physical Exercise
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Based in the UK
Exclusion Criteria
* 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.
18 Years
ALL
Yes
Sponsors
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University of Cambridge
OTHER
Medical Research Council Cognition and Brain Sciences Unit
OTHER_GOV
Responsible Party
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Principal Investigators
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Maris Vainre, MA
Role: PRINCIPAL_INVESTIGATOR
MRC CBU
Locations
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MRC Cognition and Brain Sciences Unit
Cambridge, , United Kingdom
Countries
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References
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Vainre M, Dalgleish T, Watson P, Haag C, Dercon Q, Galante J, Hitchcock C. Work Engagement and Well-being Study (SWELL): a randomised controlled feasibility trial evaluating the effects of mindfulness versus light physical exercise at work. BMJ Ment Health. 2024 Feb 28;27(1):e300885. doi: 10.1136/bmjment-2023-300885.
Vainre M, Galante J, Watson P, Dalgleish T, Hitchcock C. Protocol for the Work Engagement and Well-being Study (SWELL): a randomised controlled feasibility trial evaluating the effects of mindfulness versus light physical exercise at work. BMJ Open. 2022 Apr 12;12(4):e050951. doi: 10.1136/bmjopen-2021-050951.
Shapiro, S. L., Wang, M. C., & Peltason, E. H. (2015). What is mindfulness, and why should organizations care about it? In J. Reb & P. W. B. Atkins (Eds.), Mindfulness in Organizations (pp. 17-41). Cambridge University Press. https://doi.org/10.1017/CBO9781107587793.004
Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
Tennant R, Hiller L, Fishwick R, Platt S, Joseph S, Weich S, Parkinson J, Secker J, Stewart-Brown S. The Warwick-Edinburgh Mental Well-being Scale (WEMWBS): development and UK validation. Health Qual Life Outcomes. 2007 Nov 27;5:63. doi: 10.1186/1477-7525-5-63.
Zahra D, Qureshi A, Henley W, Taylor R, Quinn C, Pooler J, Hardy G, Newbold A, Byng R. The work and social adjustment scale: reliability, sensitivity and value. Int J Psychiatry Clin Pract. 2014 Jun;18(2):131-8. doi: 10.3109/13651501.2014.894072. Epub 2014 Mar 16.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Johansen T, Lund T, Jensen C, Momsen AH, Eftedal M, Oyeflaten I, Braathen TN, Stapelfeldt CM, Amick B, Labriola M. Cross-cultural adaptation of the Work Role Functioning Questionnaire 2.0 to Norwegian and Danish. Work. 2018;59(4):471-478. doi: 10.3233/WOR-182705.
Josefsson, T., Lindwall, M., & Broberg, A. G. (2014). The Effects of a Short-term Mindfulness Based Intervention on Self-reported Mindfulness, Decentering, Executive Attention, Psychological Health, and Coping Style: Examining Unique Mindfulness Effects and Mediators. Mindfulness, 5(1), 18-35. https://doi.org/10.1007/s12671-012-0142-1
Kabat-Zinn, J. (2003). Mindfulness-based interventions in context: Past, present, and future. Clinical Psychology: Science and Practice, 10(2), 144-156. https://doi.org/10.1093/clipsy/bpg016
Kamerade D, Wang S, Burchell B, Balderson SU, Coutts A. A shorter working week for everyone: How much paid work is needed for mental health and well-being? Soc Sci Med. 2019 Nov;241:112353. doi: 10.1016/j.socscimed.2019.06.006. Epub 2019 Jun 18.
Khoury B, Sharma M, Rush SE, Fournier C. Mindfulness-based stress reduction for healthy individuals: A meta-analysis. J Psychosom Res. 2015 Jun;78(6):519-28. doi: 10.1016/j.jpsychores.2015.03.009. Epub 2015 Mar 20.
Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
Lowe B, Decker O, Muller S, Brahler E, Schellberg D, Herzog W, Herzberg PY. Validation and standardization of the Generalized Anxiety Disorder Screener (GAD-7) in the general population. Med Care. 2008 Mar;46(3):266-74. doi: 10.1097/MLR.0b013e318160d093.
Marks, I. M., & Bird, J. (1986). Behavioural psychotherapy: Maudsley pocket book of clinical management (6th ed.). Wright.
Mathers CD, Loncar D. Projections of global mortality and burden of disease from 2002 to 2030. PLoS Med. 2006 Nov;3(11):e442. doi: 10.1371/journal.pmed.0030442.
Ramada JM, Serra C, Amick BC 3rd, Abma FI, Castano JR, Pidemunt G, Bultmann U, Delclos GL. Reliability and validity of the work role functioning questionnaire (Spanish version). J Occup Rehabil. 2014 Dec;24(4):640-9. doi: 10.1007/s10926-013-9495-0.
Shapiro, S. L., Astin, J. A., Bishop, S. R., & Cordova, M. (2005). Mindfulness-Based Stress Reduction for Health Care Professionals: Results From a Randomized Trial. International Journal of Stress Management, 12(2), 164-176. https://doi.org/10.1037/1072-5245.12.2.164
Other Identifiers
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2020.Vainre_Swell
Identifier Type: -
Identifier Source: org_study_id
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