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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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, 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: HeadSpace Mobile App
Mindfulness practice
Behavioral: Mindfulness Practice
10-15 mins of daily mindfulness practice using HeadSpace, for 3 weeks
Active Comparator: Lumosity Mobile App
Cognitive games
Behavioral: Cognitive training
10-15 mins of cognitive games using Lumosity, for 3 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yale-NUS College

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Duke-NUS Graduate Medical School

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 19, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 7, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 23, 2021

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 13, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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