NCT04631302

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
241

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 5, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 17, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

February 23, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 23, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
Last Updated

November 13, 2023

Status Verified

November 1, 2023

Enrollment Period

1.1 years

First QC Date

November 5, 2020

Last Update Submit

November 9, 2023

Conditions

Keywords

Mindfulnessphysical exercisewellbeingworkplaceweb-based intervention

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (15)

  • Work and Social Adjustment Scale

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

  • Daily work engagement

    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.

  • Emotional Stop Signal Task: Reaction times (in both, go and stop trials)

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

  • Emotional Stop Signal Task: response accuracy (failure or success in inhibiting response)

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

  • Emotional Stop Signal Task: variability in reaction time throughout the task (ability to overcome errors).

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

  • +10 more secondary outcomes

Other Outcomes (5)

  • Retention in the trial

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

  • Preferred course

    1 week post-intervention (primary outcome measure);

  • Engagement in courses

    Each of 4 weeks during the intervention.

  • +2 more other outcomes

Study Arms (2)

Mindfulness

EXPERIMENTAL
Behavioral: Be Mindful

Light Physical Exercise

ACTIVE COMPARATOR
Behavioral: Light exercise course

Interventions

Be MindfulBEHAVIORAL

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.

Mindfulness

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.

Also known as: Physical exercise
Light Physical Exercise

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MRC Cognition and Brain Sciences Unit

Cambridge, CB2 7EF, United Kingdom

Location

Related Publications (32)

  • 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.

    PMID: 30253219BACKGROUND
  • 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.

    PMID: 22869455BACKGROUND
  • 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.

    PMID: 11124731BACKGROUND
  • 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.

    PMID: 30714811BACKGROUND
  • 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.

    PMID: 12040063BACKGROUND
  • 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.

    PMID: 28031068BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 17697849BACKGROUND
  • 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.

    PMID: 29422189BACKGROUND
  • 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.

    PMID: 17909949BACKGROUND
  • 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

    BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 29854417BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 27643606BACKGROUND
  • 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.

    PMID: 29733048BACKGROUND
  • 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

    BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 31227212BACKGROUND
  • 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.

    PMID: 25818837BACKGROUND
  • 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.

    PMID: 11556941BACKGROUND
  • 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.

    PMID: 18388841BACKGROUND
  • Marks, I. M., & Bird, J. (1986). Behavioural psychotherapy: Maudsley pocket book of clinical management (6th ed.). Wright.

    BACKGROUND
  • 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.

    PMID: 17132052BACKGROUND
  • 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.

    PMID: 24389721BACKGROUND
  • 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

    BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 16717171BACKGROUND
  • 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.

    PMID: 18042300BACKGROUND
  • 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.

    PMID: 24527886BACKGROUND
  • 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.

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Maris Vainre, MA

    MRC CBU

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcomes assessor will be blind to participant allocation
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2020

First Posted

November 17, 2020

Study Start

February 23, 2021

Primary Completion

March 23, 2022

Study Completion

March 31, 2023

Last Updated

November 13, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will share

Details to be confirmed

Shared Documents
STUDY PROTOCOL

Locations