Psychological BurnoutNCT04936893
Effects of Mindfulness Practice on Healthcare Workers
A study testing Mindfulness Practice and Cognitive training in people with Psychological Burnout, run by Yale-NUS College at 1 site in Singapore.
Trial summary
This study aims to examine the effects of mindfulness practice administered using a mobile app on psychological health among health care workers in Singapore. Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychological Burnout
- What is being tested?
- Mindfulness Practice and Cognitive training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSingapore
- Study dates
- 19 May 2020to 31 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- -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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Psychological Burnout
- Being tested
- Mindfulness Practice, Cognitive training
- Medical subject headings
- Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness PracticeBehavioural
10-15 mins of daily mindfulness practice using HeadSpace, for 3 weeks
Cognitive trainingBehavioural
10-15 mins of cognitive games using Lumosity, for 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| HeadSpace Mobile App | Experimental | Mindfulness practice Receives: Behavioral: Mindfulness Practice |
| Lumosity Mobile App | Active comparator | Cognitive games Receives: Behavioral: Cognitive training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression
Depression subscale of the Depression, Anxiety, and Stress Scales- 21 (DASS)
Measured: Change from Baseline to Within 7 Days Post intervention
Anxiety
Anxiety subscale of the Depression, Anxiety, and Stress Scales- 21 (DASS)
Measured: Change from Baseline to Within 7 Days Post intervention
Fear of COVID-19
Fear of COVID-19 Scale
Measured: Change from Baseline to Within 7 Days Post intervention
Burnout, Compassion Satisfaction, and Secondary Traumatic Stress
Professional Quality of Life Scale Version 5 (3 subscales respectively)
Measured: Change from Baseline to Within 7 Days Post intervention
Sleep Quality
One item from Pittsburg Sleep Quality Inventory
Measured: Change from Baseline to Within 7 Days Post intervention
Working Memory
Digit span tasks - forward and backward
Measured: Change from Baseline to Within 7 Days Post intervention
PTSD symptoms
Posttraumatic stress disorder Checklist- Civilian Version(higher scores indicate greater PTSD symptoms)
Measured: Change from Baseline to Within 7 Days Post intervention
Secondary outcomes (2)
Trait Mindfulness
Five Facet Mindfulness Questionnaire (higher scores indicate greater trait mindfulness)
Measured: Change from Baseline to Within 7 Days Post intervention
Self-Compassion
Self-Compassion Scale (higher scores indicate greater self-compassion)
Measured: Change from Baseline to Within 7 Days Post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2021
- Study start19 May 2020
- Primary completion31 Mar 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Psychological BurnoutStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale-NUS College
- Sponsor type
- University, hospital or other
- Collaborators
- Duke-NUS Graduate Medical School
- Responsible party
- Sponsor
- Investigators
- Shian-Ling Keng, PhD, Principal investigator, Yale-NUS College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04936893
- Sponsor's protocol ID
- YaleNUS
- Status last verified
- Jan 2023
- First submitted
- 7 Jun 2021
- Last updated
- 13 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Keng SL, Chin JWE, Mammadova M, Teo I. Effects of Mobile App-Based Mindfulness Practice on Healthcare Workers: a Randomized Active Controlled Trial. Mindfulness (N Y). 2022;13(11):2691-2704. doi: 10.1007/s12671-022-01975-8. Epub 2022 Sep 16.
PubMed 36160038
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Mindfulness Practice on Healthcare Workers During the COVID-19 (Coronavirus Disease) Pandemic
- ClinicalTrials.gov ID
- NCT04936893
- Acronym / sponsor ID
- YaleNUS
- Conditions
- Psychological Burnout
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Yale-NUS CollegeUniversity, hospital or other
- Collaborators
- Duke-NUS Graduate Medical School
- Study start
- 19 May 2020 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 23 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to examine the effects of mindfulness practice administered using a mobile app on psychological health among health care workers in Singapore.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HeadSpace Mobile App | Experimental | Behavioral: Mindfulness PracticeMindfulness practice |
| Lumosity Mobile App | Active comparator | Behavioral: Cognitive trainingCognitive games |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- -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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness Practice10-15 mins of daily mindfulness practice using HeadSpace, for 3 weeks | Behavioural | HeadSpace Mobile App |
| Cognitive training10-15 mins of cognitive games using Lumosity, for 3 weeks | Behavioural | Lumosity Mobile App |
Primary outcome
Depression
Time frame: Change from Baseline to Within 7 Days Post intervention
Depression subscale of the Depression, Anxiety, and Stress Scales- 21 (DASS)
Anxiety
Time frame: Change from Baseline to Within 7 Days Post intervention
Anxiety subscale of the Depression, Anxiety, and Stress Scales- 21 (DASS)
Fear of COVID-19
Time frame: Change from Baseline to Within 7 Days Post intervention
Fear of COVID-19 Scale
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)
Sleep Quality
Time frame: Change from Baseline to Within 7 Days Post intervention
One item from Pittsburg Sleep Quality Inventory
Working Memory
Time frame: Change from Baseline to Within 7 Days Post intervention
Digit span tasks - forward and backward
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)
2 secondary outcomes
Trait Mindfulness
Time frame: Change from Baseline to Within 7 Days Post intervention
Self-Compassion
Time frame: Change from Baseline to Within 7 Days Post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2023.
- Derived from this study: PubMed 36160038Keng SL, Chin JWE, Mammadova M, Teo I. Effects of Mobile App-Based Mindfulness Practice on Healthcare Workers: a Randomized Active Controlled Trial. Mindfulness (N Y). 2022;13(11):2691-2704. doi: 10.1007/s12671-022-01975-8. Epub 2022 Sep 16.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shian-Ling Keng, PhD principal investigator
Yale-NUS College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Practice and Cognitive training in people with Psychological Burnout, run by Yale-NUS College at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression (time frame: Change from Baseline to Within 7 Days Post intervention). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04936893, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2023.