A randomized controlled trial of mindfulness-based stress reduction (MBSR) in Chilean health workers

ISRCTN	ISRCTN12039804
DOI	https://doi.org/10.1186/ISRCTN12039804
Protocol serial number	204-2017
Sponsor	Pontifical Catholic University of Chile (Pontificia Universidad Catolica de Chile)
Funder	Chilean Safety Association (ACHS)

Submission date: 19/03/2018
Registration date: 26/03/2018
Last edited: 28/10/2022

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
Occupational stress (stress related to job) entails great costs for health workers, employers and patients. A recent study of French workers estimated that 5.3-33.6% of common mental disorders could be attributable to work-related stress. In the United States, it is estimated that the real cost of occupational stress amounts to 300 million dollars per year. The evidence also suggests that occupational stress may increase the prevalence of negative outcomes in patients, including a lower service satisfaction, and a higher rate of medical errors. Previous studies have shown that specific high-demanding conditions within the work context could explain the occurrence of occupational stress, including higher paperwork load, judicialization of medicine, number of "clicks" in electronic medical records, healthcare Fordism (i.e., highly standardized healthcare services), and demands for higher qualifications. One of the interventions that have shown effectiveness in the management of factors related to psychosocial risk is the Mindfulness-Based Stress Reduction program (MBSR ). This study aims to analyze the effectiveness of MBSR to reduce psychological distress in health professionals and determine how it relates to psychosocial risk factors.

Who can participate?
Health care workers of UC Christus Marcoleta Health Complex who are in direct contact with patients.

What does the study involve?
Participants are randomly allocated to one of three groups: Those in the MBSR group participate in a MBSR program, as was originally developed, to complete eight weekly group sessions of 2.5 hours, which they continue to do independently at home. Those in the Stress Management Training group will participate in a 20-hour psychoeducational course on self-care and stress management. The third group will be included in a waiting list and will be offered participation on MBSR or Stress Management Training based on their personal preferences once the trial has ended. Measures of psychological distress, burnout, perceived stress, symptom distress, interpersonal relations and social role, job satisfaction, number of sick leaves in the previous three months, mindfulness skills, job satisfaction and other quality-of-life indicators will be measured at baseline (T0), following the intervention (T1) and after six months (T2).

What are the possible benefits and risks of participating?
Potential benefits: Participants randomized to the MBSR or Stress Management Training may benefit from a significant reduction in psychological distress, burnout, perceived stress and psychosocial risk factors in the workplace. We also expect to see an improvement on participant's health, well-being and job satisfaction.
Potential risks: During Mindfulness practice, it is possible that participants may become more aware of difficult emotions, bodily and mental states such as fear, sadness, irritability, and rumination as a first step in the therapeutic process. There is also a theoretical possibility of observing adverse effects, such as major emotion dysregulation. If that occurred, the trainer in both MBSR will be responsible for referring the cases to a psychiatrist who is a member of the expert committee.

Where is the study run from?
UC Christus Marcoleta Health Complex (Lira Medical Center, Clinical Hospital, and Diagnostic Center) (Santiago, Chile)

When is the study starting and how long is it expected to run for?
August 2017 to August 2019

Who is funding the study?
Chilean Safety Association (ACHS)

Who is the main contact?
Dr Antonia Errázuriz
anerrazuriz@uc.cl

Contact information

Dr Antonia Errázuriz Concha
Scientific

Diagonal Paraguay 362, piso 5
Santiago
8330077
Chile

Phone	+56 (0)953631333
Email	anerrazuriz@uc.cl

Study information

Primary study design	Interventional
Study design	Interventional single-center three-arm parallel-group randomized controlled trial.
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Mindfulness based stress reduction (MBSR) for psychological distress reduction in Chilean health workers: a randomized controlled trial
Study objectives	Health workers participating in a Mindfulness Based Stress Reduction (MBSR) intervention will show lower levels of 1) psychological distress, 2) burnout, 3) perceived stress, 4) depressive symptoms, 5) psychosocial risk factors at work and 6) salivary cortisol (a stress biomarker), and an improvement in quality of life compared with (i) health workers participating in a Stress Education and Self-Management Workshop (active controls) (ii) health workers assigned to a waiting list (i.e., passive controls), as measured in the short-term (8 weeks) and long-term (6 months).
Ethics approval(s)	Ethical Scientific Committee of the Medical School of the Pontifical Catholic University of Chile [CEC MED UC], 11/16/2017, ref: Project ID: 170710014.
Health condition(s) or problem(s) studied	Psychological distress/occupational stress (i.e. quality of life, perceived stress, burnout, depressive symptoms).
Intervention	Participants in the trial are full-time health workers employed by the UC Christus Health Network working at the "UC Christus Marcoleta Health Complex" in Santiago, Chile. All health workers will be invited via e-mail, leaflet, brochure, and oral communication to participate in the study. Those interested will be asked to respond a questionnaire used to determine participant's eligibility based on a predefined set of inclusion/exclusion criteria (details below). Those selected to participate in the trial will be randomly assigned to one of three arms: Arm 1. Mindfulness Based Stress Reduction (MBSR) (Experimental): The group will participate in a MBSR program, as was originally developed by Dr. Kabat-Zinn at the University of Massachusetts, consisting of eight weekly group sessions of 2.5 hours combining experiential exercises and meditation. The MBSR program will be conducted by a MBSR-certified psychologist with vast teaching experience. Arm 2. Stress Education and Self-Management Workshop (active control): The group will participate in an educational stress management intervention consisting in eight weekly group sessions of 2.5 hours about self-care and stress management techniques for effective work development. Arm 3. Waiting list (passive control): The group will not participate in either the MBSR program or the Stress Education and Self-Management Workshop during the trial, but will be offered the opportunity to participate in either course once the trial has ended (i.e. 6 months following the intervention).
Intervention type	Behavioural
Primary outcome measure(s)	Current primary outcome measure as of 20/07/2020: 1. Psychological distress measured using the 12-item General Health Questionnaire (GHQ-12) 2. Perceived stress, as measured by the Perceives Stress Scale (PSS) 3. Symptoms of distress (SD), interpersonal relations (IR) and social role (SR) performance, as measured by the Outcome Questionnaire (OQ 45) All primary outcomes will be measured at baseline (T0), at week 8 immediately after the intervention (T1) and 6 months after baseline (T2) in all participants. Previous primary outcome measure: 1. Psychological distress measured using the 12-item General Health Questionnaire (GHQ-12) 2. Burnout, as measured by the Maslach Burnout Inventory (MBI) 3. Perceived stress, as measured by the Perceives Stress Scale (PSS) 4. Symptoms of distress (SD), interpersonal relations (IR) and social role (SR) performance, as measured by the Outcome Questionnaire (OQ 45) 5. Circadian excursions of salivary cortisol concentrations, as measured by LC/MS-MS. Salivary samples for cortisol measurements will be collected at 3 time points/day (at awakening, 30 min after awakening and at bedtime or around 10 pm) prior to intervention (1 day = 3 measurements/person) and post intervention (1 day = 3 measurements/ person). Saliva samples will be collected using a Salivette Cortisol (Sarsted, Germany) device. All primary outcomes except cortisol concentration will be measured at baseline (T0), at week 8 immediately after the intervention (T1) and 6 months after baseline (T2) in all participants. Cortisol concentration will only be measured at T0 and T1 and only in participants receiving MBSR or passive controls Updated 10/08/2018: Cortisol concentration will only be measured at T0 and T1
Key secondary outcome measure(s)	Current secondary outcome measures as of 20/07/2020: 1. Job satisfaction, as measured by the Job Satisfaction Scale (JSS) 2. Number of sick leaves in the previous three months 3. Mindfulness skills, as measured by the Five Facet Mindfulness Questionnaire (FFMQ) 4. Other quality-of-life indicators (e.g. comorbidity, sleep quality) 5. Circadian excursions of salivary cortisol concentrations, as measured by LC/MS-MS. Salivary samples for cortisol measurements will be collected at 3 time points/day (at awakening, 30 min after awakening and at bedtime or around 10 pm) prior to intervention (1 day = 3 measurements/person) and post intervention (1 day = 3 measurements/ person). Saliva samples will be collected using a Salivette Cortisol (Sarsted, Germany) device. All secondary outcomes will be measured at T0, T1, and T2 in all participants, bar cortisol concentration, which will only be measured at T0 and T1. Previous secondary outcome measures: 1. Job satisfaction, as measured by the Job Satisfaction Scale (JSS) 2. Number of sick leaves in the previous three months 3. Mindfulness skills, as measured by the Five Facet Mindfulness Questionnaire (FFMQ) 4. Other quality-of-life indicators (e.g. comorbidity, sleep quality) All secondary outcomes will be measured at T0, T1, and T2 in all participants.
Completion date	31/07/2019

Eligibility

Participant type(s)	Health professional
Age group	Adult
Sex	All
Target sample size at registration	150
Total final enrolment	105
Key inclusion criteria	1. Health worker at UC Christus Marcoleta Health Complex 2. Has direct patient contact 3. Gives consent
Key exclusion criteria	1. Working under a fixed-term contract 2. Not in direct contact with patient 3. Reporting severe depression symptoms (OQ-45 score >= 47) 4. Reporting suicidal ideation (OQ-45 item 8 "almost always") 5. Reporting problematic alcohol consumption (OQ-45 item 11 "almost always") 6. Not available to attend to all 8 sessions of an MBSR course/Stress Education and Self-Management Workshop
Date of first enrolment	20/03/2018
Date of final enrolment	30/04/2018

Locations

Countries of recruitment

Chile

Study participating centre

UC Christus Marcoleta Health Complex

Marcoleta 367
Santiago
8330024
Chile

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Stored in publicly available repository
IPD sharing plan	The raw data is available in two publicly available repositories: Dataverse and Mendeley Data.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/11/2020	24/11/2020	Yes	No
Basic results		13/08/2020	13/08/2020	No	No
Dataset		26/05/2020	28/10/2022	No	No
Dataset		11/08/2020	28/10/2022	No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Additional files

ISRCTN12039804_BasicResults_13Aug20.pdf: Uploaded 13/08/2020

Editorial Notes

28/10/2022: Publication reference, IPD sharing statement and datasets added.
24/11/2020: Publication reference added.
13/08/2020: The following changes have been made:
1. The basic results of this trial have been uploaded as an additional file.
2. The total final enrolment number has been added.
20/07/2020: The primary outcome measure and secondary outcome measures have been updated.
12/03/2020: The intention to publish date has been changed from 01/09/2019 to 31/07/2020.
13/05/2019: Internal review.
10/08/2018: The following changes were made to the trial record:
1. The recruitment end date was changed from 06/04/2018 to 30/04/2018.
2. The funder was changed from Scientific and Technological Foundation (FUCYT) to Chilean Safety Association (ACHS).
3. The primary outcome measure was amended.