Condition category
Mental and Behavioural Disorders
Date applied
11/03/2018
Date assigned
19/04/2018
Last edited
04/04/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Doctors and nurses report having high burnout. It can not only damage their own well-being, but also quality of patient care and teamwork in providing the healthcare services. A recent study confirmed that a mindfulness-based intervention program developed in the United States, called Mindful Practice (MP), was useful to reduce burnout of healthcare workers in Hong Kong (HK). This lead to a localized MP program being developed in Chinese.
This study aims to examine the effectiveness of the Chinese MP program to reduce burnout, perceived stress and number of sick leave days, improve job engagement, quality of life, well-being and interpersonal communication skills of healthcare workers in Hong Kong.

Who can participate?
Adult hospital staff experiencing burnout or perceived stress

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group receive an eight week Mindful Practice program, with a total of 27 contact hours. Participants are also encouraged to complete home-based mindful exercise or stretching each day as well as apply mindfulness at work. Participants are assessed using different inventories and scales before and after the program and after three months.
Those in the second group are invited to undertake the program after the first group have finished follow up.

What are the possible benefits and risks of participating?
Participants may benefit from a reduction in burnout and perceived stress, improving quality of life. There are no direct risks for participants.

Where is the study run from?
Oasis- Center for Personal Growth and Crisis Intervention (Hong Kong)

When is the study starting and how long is it expected to run for?
January 2014 – August 2017

Who is funding the study?
Oasis - Center for Personal Growth and Crisis Intervention (Hong Kong)

Who is the main contact?
Ms Wacy Wai Sze Lui (Scientific)

Trial website

Contact information

Type

Scientific

Primary contact

Ms Wacy Wai Sze Lui

ORCID ID

Contact details

Oasis 1/F Centre for Health Protection
147 C Argyle Street
Hong Kong
000
Hong Kong

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MP210

Study information

Scientific title

RCT on Mindful Practice to alleviate burnout and perceived stress of health care workers

Acronym

Study hypothesis

Mindful practice (MP) can alleviate burnout and perceived stress. It can also improve job engagement, quality of life, wellbeing, interpersonal communication and number of sick leave days.

Ethics approval

Hospital Authority Hong Kong Kowloon East/Kowloon Central Cluster Research Ethics Committee, 25/08/2014, ref: LC/KE-14-0-0160/ER-2

Study design

Randomised single centre waitlist controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format

Condition

Burnout and perceived stress

Intervention

All enrolled participants are invited to fill in the screening tools on burnout and perceived stress to assess their eligibility for the program. Those with burnout or perceived stress are then randomly assigned to the experimental and control groups, using the computer-generated procedures. Participants are informed of the assignment by the executive assistant and they are blinded of the research hypothesis.

All participants (both experimental and control groups) attend briefing sessions. Then, the participants of the experimental groups first join the 8-week manual Mindful Practice (MP) intervention (total 27 contact hours). Apart from the class-based learning, participants of the experimental groups are invited to do home practice during the program, which involves around 1 hour of formal mindful exercise or stretching per day, as well as application of mindfulness at work.
Participants in the control group do not undertake this program during this time, but upon completion of 3-month follow-up, participants in the waitlist control groups are also invited to join the MP program.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Burnout (emotional exhaustion, depersonalization, and personal accomplishment) is measured using the Chinese Maslach Burnout Inventory pre-intervention, post-intervention and at 3 month follow up.

Secondary outcome measures

1. Stress is measured using the Perceived Stress Scale
2. Work engagement is measured using the Utrecht Work Engagement Scale (UWES)
3. Health status is assessed using the Short term Health Survey (SF-12)
4. Current mental wellbeing is assessed using the World Health Organization Well-being Index
5. Communication competency is measured using the Interpersonal Communication Assessment Scale (ICAS)
All outcomes are assessed pre-intervention, post-intervention and at 3 month follow up.

Overall trial start date

01/01/2014

Overall trial end date

01/08/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Existing staff of Hospital Authority
2. Aged 18-65 years
3. Report having burnout or perceived stress
4. Committed to attend all MP classes and have mindful practice an hour a day between classes
5. No previous mindfulness experience

Participant type

Health professional

Age group

Adult

Gender

Both

Target number of participants

114

Participant exclusion criteria

1. No burnout or perceived stress
2. Not able to attend both treatment and control groups for randomization
3. Currently havepsychosis, substance abuse, active suicidal ideation and plan
4. Receiving any active psychological and psychiatric treatment

Recruitment start date

01/09/2014

Recruitment end date

01/01/2017

Locations

Countries of recruitment

Hong Kong

Trial participating centre

Oasis Center for Personal Growth and Crisis Intervention
Hospital Authority Hong Kong
000
Hong Kong

Sponsor information

Organisation

Oasis - Center for Personal Growth and Crisis Intervention

Sponsor details

Oasis 1/F Centre for Heath Protection
Hospital Authority Hong Kong
Hong Kong
000
Hong Kong

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Oasis - Center for Personal Growth and Crisis Intervention

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

IPS sharing statement:
The data sharing plans for the current study are unknown and will be made available at a later date

Intention to publish date

01/10/2018

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes