Implementing workplace-adapted mindfulness-based stress reduction in private companies

ISRCTN ISRCTN93567471
DOI https://doi.org/10.1186/ISRCTN93567471
Secondary identifying numbers 1715
Submission date
14/02/2022
Registration date
15/02/2022
Last edited
16/03/2023
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Background and study aims
Mindfulness-based interventions (MBIs) are being implemented in many private and public workplaces. Previous research has shown MBIs in workplace settings to be effective in reducing perceived stress, symptoms of anxiety and depression as well as enhancing well-being. Recent research indicates that workplace MBIs facilitate enhanced communication and collaboration within the workplace. Practising mindfulness enables a greater awareness of one’s own patterns of behaviour and can in effect enable individuals to be less reactive in situations of stress. Moreover, practising mindfulness facilitates greater compassion for yourself and others. These parameters may positively affect the psychological work environment. Prevously, the MBIs implemented in workplace settings varied in both the content and the length of the intervention. Therefore, there is a need to investigate the feasibility and impact of a documented effective MBI in workplace settings. One such intervention is the manualized programme, Mindfulness-based Stress Reduction (MBSR). Consequently, the aims of this study are:
1. To systematically develop a workplace-adapted Mindfulness-based Stress Reduction (MBSR) programme
2. To evaluate the feasibility of implementing a workplace-adapted MBSR program in small and medium-sized private companies
3. To evaluate the impact of a workplace-adapted MBSR programme on mental health and psychological work environment

Who can participate?
All employees and managers from small and medium-sized private companies

What does the study involve?
The study involves employees and managers from four small and medium-sized private companies. Each company receives an intervention consisting of three elements:
1. An obligatory 2-hour introductory session on mental health and mindfulness for all employees and managers
2. A 10-week workplace-adapted MBSR-programme for self-selecting employees and managers
3. The offer of participating in a workshop on further implementation of mindfulness in the company for selected managers and employee representatives
All employees and managers receive electronic questionnaires at the start of the study, after the intervention and at 12 months follow-up. Selected employees and managers are asked to participate in focus group interviews at the start of the study and after the intervention.

What are the possible benefits and risks of participating?
Previous research has found MBSR effective in reducing stress, symptoms of depression and anxiety and enhancing well-being. There are indications that mindfulness in a workplace setting may facilitate healthier work environments with more constructive conflict management. There are no known risks of participating.

Where is the study run from?
The study is run from Denmark in a collaboration between the Danish Center for Mindfulness, Department of Clinical Medicine, Aarhus University and Southern University of Denmark

When is the study starting and how long is it expected to run for?
January 2020 to February 2022

Who is funding the study?
The Velliv Association (Denmark)

Who is the main contact:
Lise Juul
lise.juul@clin.au.dk

Contact information

Dr Lise Juul
Principal Investigator

Hack Kampmanns Plads 1-3
4th floor
Aarhus C
8000
Denmark

ORCiD logoORCID ID 0000-0003-3640-7593
Phone + 45 (0)24619664
Email lise.juul@clin.au.dk

Study information

Study designQuasi-experimental interventional trial without control group
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Other
Study typePrevention
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleThe feasibility and impact of implementing workplace-adapted mindfulness-based stress reduction in small and medium-sized private companies on the mental health and psychological work environment: a mixed-methods, quasi-experimental study
Study objectivesHypotheses:
1. The mental health of individuals will improve following participation in a workplace-adapted Mindfulness-based Stress Reduction (MBSR) programme
2. Enhanced awareness through practising mindfulness will improve pro-social behaviour and interpersonal relations
3. Enhancements in pro-social behaviour and interpersonal relations among those choosing to participate in a workplace-adapted MBSR-programme are expected to affect the psychological work environment in the entire company
Ethics approval(s)Approved 24/02/2020, The Danish Data Protection Agency (Carl Jacobsens Vej 35, 2500 Valby, DK; +45 (0)33193200; dt@datatilsynet.dk), ref: 2016-051-000001/1715
Health condition(s) or problem(s) studiedIndividual mental health and psychological work environment promotion and prevention in private companies
InterventionThe intervention is three-fold:
1. 2-hour obligatory introductory sessions for all employees and managers within four small and medium-sized private companies
2. A 10-week workplace-adapted MBSR-programme for self-selected employees and managers within the respective companies
3. A 2-hour workshop for selected managers and employee representatives on further implementation of mindfulness in the companies following the MBSR-programme
A certified MBSR teacher carries out both the two-hour introductory sessions and the workplace-adapted MBSR-programme. The workplace-adapted MBSR-programme is delivered in a live online format with one weekly 1.5-hour session. The workshop is led by an organizational psychologist, a scientific assistant and a certified MBSR teacher and delivered in a live online format.
Intervention typeBehavioural
Primary outcome measurePerceived stress level measured using Cohen's Perceived Stress Scale-10 (PSS-10) at baseline, post-intervention and at 12 months follow-up
Secondary outcome measuresUtilizing mixed methods, both quantitative and qualitative methods are used to evaluate the feasibility and impact of the intervention.

Quantitative evaluation:
1. Self-reported symptoms of depression and anxiety measured using Hopkins Symptom Check List-5 (SCL-5) at baseline, post-intervention and at 12 months follow-up
2. Self-reported well-being measured using Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS) at baseline, post-intervention and at 12 months follow-up
3. Self-reported resilience measured using Brief Resilience Scale (BRS) at baseline, post-intervention and at 12 months follow-up
4. Self-reported mindfulness practice measured using questions related to mindfulness practice at post-intervention and 12 months follow-up
5. Self-reported sleep measured using 6 items of the Karolinska Sleep Questionnaire at baseline, post-intervention and at 12 months follow-up
6. Social capital in the workplace measured using a questionnaire developed by the Danish National Institute of Occupational Health at baseline, post-intervention and at 12 months follow-up
7. Negative acts in the workplace measured using Negative Act Questionnaire-short (NAQ-S) at baseline, post-intervention and at 12 months follow-up
8. Self-reported dispositional mindfulness measured using Five Facet Mindfulness Questionnaire-15 (FFMQ-15) at baseline, post-intervention and at 12 months follow-up
9. Organizational conditions relating to the psychological work environment, such as social support and work-life balance, measured using questions from a questionnaire on psychological work environment developed by the Danish National Institute of Occupational Health at baseline, post-intervention and at 12 months follow-up

Qualitative evaluation:
1. Data on participants' knowledge of mindfulness, perceived stress and stress management, organizational conditions for psychological work environment and knowledge of facilitators and barriers to implementation, collected using semi-structured focus group interviews with both employees and managers in each company at baseline and post-intervention
2. Team psychological safety measured using the 7-item scale developed by Amy Edmundson at baseline, post-intervention and at 12 months follow-up
Overall study start date01/01/2020
Completion date01/02/2022

Eligibility

Participant type(s)Other
Age groupAll
SexBoth
Target number of participantsAccording to power calculations, a number of 150 participants are required to detect a mean change of 1.5 point on the PSS-score
Total final enrolment250
Key inclusion criteria1. For companies to enroll in this trial, they have to be a small or medium-sized private company (10-250 employees and managers)
2. All employees and managers within the enrolled companies are eligible for inclusion
Key exclusion criteriaCompanies with more than 250 employees
Date of first enrolment28/02/2020
Date of final enrolment04/12/2020

Locations

Countries of recruitment

  • Denmark

Study participating centres

Aarhus University
Danish Center for Mindfulness
Hack Kampmanns Plads 1-3
4th floor
Aarhus
8000
Denmark
Southern University of Denmark
Campusvej 55
Odense
5230
Denmark

Sponsor information

Aarhus University
University/education

Nordre Ringgade 1
Aarhus
8000
Denmark

Phone +45 (0)87150000
Email mindfulness@clin.au.dk
Website http://www.au.dk/en/
ROR logo "ROR" https://ror.org/01aj84f44

Funders

Funder type

Other

The Velliv Association

No information available

Results and Publications

Intention to publish date01/02/2023
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination plan1. Planned publications in high-impact peer-reviewed journals
2. Planned dissemination at international conferences regarding mental health and psychological work environment
IPD sharing planAnonymized data will be available upon reasonable request from the Principal Investigator, Associate Professor Lise Juul (lise.juul@clin.au.dk). The quantitative data will be available for researchers following the publication of the results of the trial until 01/03/2025. The quantitative data can be used for replication of the analyses performed. Participants provided consent by completing baseline questionnaires, this being the standard protocol in Denmark when performing non-biological research. The qualitative data will not be made freely available but we encourage interested researchers to contact us, should questions arise.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol file In Danish 01/09/2019 05/09/2022 No No
Results article 06/12/2022 16/03/2023 Yes No
Results article 07/03/2023 16/03/2023 Yes No

Additional files

ISRCTN93567471_Protocol_in Danish_01Sep2019.pdf
In Danish

Editorial Notes

16/03/2023: Publication references added.
05/09/2022: Protocol file uploaded.
01/03/2022: The sponsor email address was updated.
15/02/2022: Trial's existence confirmed by the Danish Data Protection Agency.