Condition category
Mental and Behavioural Disorders
Date applied
02/11/2020
Date assigned
17/11/2020
Last edited
20/11/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Occupational (work) pressure is recognized as a major source of stress for adults. Long-term stress can contribute to adverse health habits and is a known risk factor in many disease states, increases in absenteeism and a reduction in productivity in the workplace. Because of the prevalence and cost of this problem, an intervention designed to help the stress of staff, which will ultimately lead to the development of emotional well-being, could be beneficial to both employees and employers. Traditionally delivered Mindfulness-Based Stress Reduction (MBSR) programs, which teach core mindfulness concepts, have been well researched with many beneficial healing effects. A potential deterrent to the utilization of a traditionally delivered MBSR program in a workplace setting is the expected participant time commitment. Additional obstacles are a stigma on stress and the absence of a clear link between MBSR content and the workplace. To address these needs, we have created Mindfulness-Based Mental Agility.
The objective of this study is to determine whether Mindfulness-Based Mental Agility training, created for the workplace, is efficacious in decreasing stress of employee while enhancing emotional intelligence, work engagement, resiliency, well-being and mindfulness.

Who can participate?
Participants will be recruited from the WHO EURO and UN City personnel.

What does the study involve?
All participants will complete module 1 of the training (6 weeks). If they wish to continue, they will also complete module 2 (4 weeks).
The intervention is standardized and consists of training built on 2 modules which are delivered online for 1 - 2 hours each week. In order to measure the impact of the full training, follow-up measures for the intervention will be obtained 1 and 6 months after Module 2. In order to measure the impact of Module 1 alone, follow-up measures will be obtained 1 and 6 months after Module 1 if participants don’t register for Module 2 of the training.

What are the possible benefits and risks of participating?
Participants will learn new skills and have the benefits related to the mindfulness-based practice. In addition, participants will receive a personal summary of the evaluations completed during the questionnaires.
Their participation is likely to help us find the impact of the training. Based on these results, the MBMA will be implemented at a larger scale, be offered to a larger population of employees, and integrated into a long-term strategy of Staff Development and Learning.
The researchers do not anticipate any risks from taking part.

Where is the study run from?
World Health Organization, Regional Office for Europe (Denmark)

When is the study starting and how long is it expected to run for?
September 2020 to December 2021

Who is funding the study?
World Health Organization (Switzerland)

Who is the main contact?
Dr Pierre-Olivier Dondoglio
dondogliopi@who.int

Trial website

Contact information

Type

Scientific

Primary contact

Dr Pierre-Olivier Dondoglio

ORCID ID

http://orcid.org/0000-0002-7198-4882

Contact details

World Health Organization
Regional Office for Europe
UN City
Marmorvej 51
Copenhagen
2100
Denmark
+ 45 40 22 14 05
dondogliopi@who.int

Type

Public

Additional contact

Dr Pierre-Olivier Dondoglio

ORCID ID

http://orcid.org/0000-0002-7198-4882

Contact details

World Health Organization
Regional Office for Europe
UN City
Marmorvej 51
Copenhagen
2100
Denmark
+ 45 40 22 14 05
dondogliopi@who.int

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

3462

Study information

Scientific title

Mindfulness-based mental agility: impact of a virtual face to face workplace intervention

Acronym

MBMA

Study hypothesis

The post-intervention evaluations will show a significant decrease in perceived stress as well as increased mindfulness, resiliency, wellbeing, emotional intelligence and work engagement.

Ethics approval

Approved 02/11/2020, World Health Organization Ethic Review Committee (Avenue Appia 20, 1211 Geneva, Switzerland; +41 22 791 1479; guraiibm@who.int), ref: 3462

Study design

Interventional cohort study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Other

Trial type

Quality of life

Patient information sheet

No participant information sheet available

Condition

Emotional intelligence, resiliency, work engagement, perceived stress, mindfulness, wellbeing.

Intervention

The intervention consists of a mindfulness-based approach delivered via live online meetings. This program is significantly modified from traditional Mindfulness-Based Stress Reduction to create a clear link between mindfulness and the 4 domains of Emotional Intelligence. Module 1 is composed of 1 live online training per week for 6 weeks for a total of 8 hours. Module 2 is composed of 1 live online training per week for 4 weeks for a total of 8 hours. The teacher is an MD familiar with Mindfulness-Based training and follows internationally recognized Good Practice Guidelines for Mindfulness-based Approaches.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Measured at baseline and post-intervention (at 1 month and 6 months):
1. Emotional intelligence (S-PEC)
2. Resiliency (BRS)
3. Work engagement (SMVS)
4. Perceived stress (PSS-10 and a single-item measure of stress symptoms)
5. Mindfulness (MAAS)
6. Well-being (WHO-5)

Secondary outcome measures

There are no secondary outcome measures

Overall trial start date

01/09/2020

Overall trial end date

31/12/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Module 1
1. Participation in the information meeting
2. Ensuring commitment towards personal practice
3. Commitment to complete the questionnaires
4. Working for WHO (any office of EURO) or a UN agency based in UN City Copenhagen
5. Greater than 18 years of age

Module 2
1. Completion of Module 1 (minimum 93%)
2. Individual evaluation of medical pre-condition (questionnaire -Annex2- plus individual consultation if one risk factor is identified)
3. Ensuring commitment towards personal practice
4. Commitment to complete the questionnaires for Module 2

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

135

Participant exclusion criteria

There are no exclusion criteria for Module 1

Module 2
1. Medical pre-condition which is a contraindication to the practices taught during Module 2 (e.g. Post-Traumatic Stress Disorder, acute depression).

Participants will be excluded from the study if they end their participation during the training

Recruitment start date

03/11/2020

Recruitment end date

15/03/2021

Locations

Countries of recruitment

Denmark

Trial participating centre

World Health Organization, Regional Office for Europe
UN City Marmorvej 51
Copenhagen
2100
Denmark

Sponsor information

Organisation

World Health Organization Regional Office for Europe

Sponsor details

UN City
Marmorvej 51
Copenhagen
2100
Denmark
+ 45 40 22 14 05
dondogliopi@who.int

Sponsor type

Government

Website

http://www.euro.who.int/en

Funders

Funder type

Research organisation

Funder name

World Health Organization

Alternative name(s)

WHO

Funding Body Type

private sector organisation

Funding Body Subtype

International organizations

Location

Switzerland

Results and Publications

Publication and dissemination plan

Each participant will receive a personal analysis of the evaluation of their different score collected during the research. A personal consultation with the psychologist will be offered to discuss individual evaluations.

Results will also be shared with EURO Learning Committee, EURO Staff Development and Learning, and Global Learning and Development Committee.

The intention is to also publish the results in a peer-reviewed journal. The principal investigator will take the lead in the publication with all researchers involved based on their role in design of the study, field work and writing the manuscript. Potential co-authors include but limited with the members of the Team. This investigators will also make all possible to ensure that each participant becomes familiar with the results of the study within 3 months from the date of the first publication on the study.

IPD sharing statement:
All data generated or analysed during this study will be included in the subsequent results publication.

Intention to publish date

30/11/2022

Participant level data

Other

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

20/11/2020: The ethics approval was added. 13/11/2020: Trial’s existence confirmed by WHO Ethics Review Committee