- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04936893
Effects of Mindfulness Practice on Healthcare Workers
January 12, 2023 updated by: Yale-NUS College
Effects of Mindfulness Practice on Healthcare Workers During the COVID-19 (Coronavirus Disease) Pandemic
This study aims to examine the effects of mindfulness practice administered using a mobile app on psychological health among health care workers in Singapore.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Research has shown that health workers are particularly at risk of experiencing heightened risks of burnout and psychological symptoms when dealing with a health pandemic, including the current COVID-19 pandemic (Lai et al., 2020; Tan et al., 2020; Wu et al., 2009).
The increased risk reflects an urgent need to develop feasible psychological interventions to mitigate burnout and psychological symptoms among health workers.
The present study aims to examine the effects of a brief mindfulness intervention delivered using a mobile application (HeadSpace) on psychological functioning in the context of coping with the COVID-19 pandemic in a sample of health workers in Singapore.
A total of 80 health workers will be recruited and randomly assigned to using a mindfulness practice app or a cognitive games app daily over a period of 21 days.
They will be assessed at baseline, post-intervention, and at one-month follow-up on depressive symptoms, anxiety, stress, burnout, compassion fatigue, compassion satisfaction, post-traumatic stress symptoms, trait mindfulness, self-compassion, sleep quality, working memory, and fear of COVID-19 infection.
Results of the study will have implications on developing cost-effective interventions to mitigate psychological symptoms among health workers in the context of heightened pandemic-related stress.
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Singapore, Singapore, 129792
- Yle-NUS College
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- aged between 21 and 60
- being a health care worker based in Singapore
- proficient in English
- owns a smartphone (iOS or Android) with Wi-Fi or data access.
Exclusion Criteria:
-Regular mindfulness practice, defined by practicing a minimum of two to three times a week for 10 to 15 minutes each time within the past six months.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: HeadSpace Mobile App
Mindfulness practice
|
10-15 mins of daily mindfulness practice using HeadSpace, for 3 weeks
|
Active Comparator: Lumosity Mobile App
Cognitive games
|
10-15 mins of cognitive games using Lumosity, for 3 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Depression
Time Frame: Change from Baseline to Within 7 Days Post intervention
|
Depression subscale of the Depression, Anxiety, and Stress Scales- 21 (DASS)
|
Change from Baseline to Within 7 Days Post intervention
|
Anxiety
Time Frame: Change from Baseline to Within 7 Days Post intervention
|
Anxiety subscale of the Depression, Anxiety, and Stress Scales- 21 (DASS)
|
Change from Baseline to Within 7 Days Post intervention
|
Fear of COVID-19
Time Frame: Change from Baseline to Within 7 Days Post intervention
|
Fear of COVID-19 Scale
|
Change from Baseline to Within 7 Days Post intervention
|
Burnout, Compassion Satisfaction, and Secondary Traumatic Stress
Time Frame: Change from Baseline to Within 7 Days Post intervention
|
Professional Quality of Life Scale Version 5 (3 subscales respectively)
|
Change from Baseline to Within 7 Days Post intervention
|
Sleep Quality
Time Frame: Change from Baseline to Within 7 Days Post intervention
|
One item from Pittsburg Sleep Quality Inventory
|
Change from Baseline to Within 7 Days Post intervention
|
Working Memory
Time Frame: Change from Baseline to Within 7 Days Post intervention
|
Digit span tasks - forward and backward
|
Change from Baseline to Within 7 Days Post intervention
|
PTSD symptoms
Time Frame: Change from Baseline to Within 7 Days Post intervention
|
Posttraumatic stress disorder Checklist- Civilian Version(higher scores indicate greater PTSD symptoms)
|
Change from Baseline to Within 7 Days Post intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Trait Mindfulness
Time Frame: Change from Baseline to Within 7 Days Post intervention
|
Five Facet Mindfulness Questionnaire (higher scores indicate greater trait mindfulness)
|
Change from Baseline to Within 7 Days Post intervention
|
Self-Compassion
Time Frame: Change from Baseline to Within 7 Days Post intervention
|
Self-Compassion Scale (higher scores indicate greater self-compassion)
|
Change from Baseline to Within 7 Days Post intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Shian-Ling Keng, PhD, Yale-NUS College
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 19, 2020
Primary Completion (Actual)
March 31, 2021
Study Completion (Actual)
July 31, 2021
Study Registration Dates
First Submitted
June 7, 2021
First Submitted That Met QC Criteria
June 15, 2021
First Posted (Actual)
June 23, 2021
Study Record Updates
Last Update Posted (Estimate)
January 13, 2023
Last Update Submitted That Met QC Criteria
January 12, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- YaleNUS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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