Effects of Mindfulness Practice on Healthcare Workers

• Sponsor: Yale-NUS College (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04936893
• Collaborator: Duke-NUS Graduate Medical School (Other)
• Enrollment: 80
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 14.4
• Patients Per Site Per Month: 5.6

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Psychological Burnout	Behavioral: Mindfulness Practice; Behavioral: Cognitive training	N/A

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

• Study Type: Interventional
• Actual Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Supportive Care
• Official Title: Effects of Mindfulness Practice on Healthcare Workers During the COVID-19 (Coronavirus Disease) Pandemic
• Actual Study Start Date: May 19, 2020
• Actual Primary Completion Date: Mar 31, 2021
• Anticipated Study Completion Date: Jul 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Depression [Change from Baseline to Within 7 Days Post intervention]

   Depression subscale of the Depression, Anxiety, and Stress Scales- 21 (DASS)

2. Anxiety [Change from Baseline to Within 7 Days Post intervention]

   Anxiety subscale of the Depression, Anxiety, and Stress Scales- 21 (DASS)

3. Fear of COVID-19 [Change from Baseline to Within 7 Days Post intervention]

   Fear of COVID-19 Scale

4. Burnout, Compassion Satisfaction, and Secondary Traumatic Stress [Change from Baseline to Within 7 Days Post intervention]

   Professional Quality of Life Scale Version 5 (3 subscales respectively)

5. Sleep Quality [Change from Baseline to Within 7 Days Post intervention]

   One item from Pittsburg Sleep Quality Inventory

6. Working Memory [Change from Baseline to Within 7 Days Post intervention]

   Digit span tasks - forward and backward

7. PTSD symptoms [Change from Baseline to Within 7 Days Post intervention]

   Posttraumatic stress disorder Checklist- Civilian Version(higher scores indicate greater PTSD symptoms)

Secondary Outcome Measures

1. Trait Mindfulness [Change from Baseline to Within 7 Days Post intervention]

   Five Facet Mindfulness Questionnaire (higher scores indicate greater trait mindfulness)

2. Self-Compassion [Change from Baseline to Within 7 Days Post intervention]

   Self-Compassion Scale (higher scores indicate greater self-compassion)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yle-NUS College	Singapore		Singapore	129792

Sponsors and Collaborators

• Yale-NUS College
• Duke-NUS Graduate Medical School

Investigators

• Principal Investigator: Shian-Ling Keng, PhD, Yale-NUS College

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yale-NUS College
• ClinicalTrials.gov Identifier: NCT04936893
• Other Study ID Numbers: YaleNUS
• First Posted: Jun 23, 2021
• Last Update Posted: Jun 23, 2021
• Last Verified: Jun 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Burnout, Psychological

Study Results

No Results Posted as of Jun 23, 2021