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Effects of Mindfulness Practice on Healthcare Workers

Primary Purpose

Psychological Burnout

Status

Completed

Phase

Not Applicable

Locations

Singapore

Study Type

Interventional

Intervention

Mindfulness Practice

Cognitive training

About this trial

This is an interventional supportive care trial for Psychological Burnout

Eligibility Criteria

21 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Yle-NUS College

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

HeadSpace Mobile App

Lumosity Mobile App

Arm Description

Mindfulness practice

Cognitive games

Outcomes

Primary Outcome Measures

Depression

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

Anxiety

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

Fear of COVID-19

Fear of COVID-19 Scale

Burnout, Compassion Satisfaction, and Secondary Traumatic Stress

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

Sleep Quality

One item from Pittsburg Sleep Quality Inventory

Working Memory

Digit span tasks - forward and backward

PTSD symptoms

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

Secondary Outcome Measures

Trait Mindfulness

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

Self-Compassion

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

Full Information

NCT ID

NCT04936893

First Posted

June 7, 2021

Last Updated

January 12, 2023

Sponsor

Yale-NUS College

Collaborators

Duke-NUS Graduate Medical School

1. Study Identification

Unique Protocol Identification Number

NCT04936893

Brief Title

Effects of Mindfulness Practice on Healthcare Workers

Official Title

Effects of Mindfulness Practice on Healthcare Workers During the COVID-19 (Coronavirus Disease) Pandemic

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Completed

Study Start Date

May 19, 2020 (Actual)

Primary Completion Date

March 31, 2021 (Actual)

Study Completion Date

July 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yale-NUS College

Collaborators

Duke-NUS Graduate Medical School

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Psychological Burnout

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

HeadSpace Mobile App

Arm Type

Experimental

Arm Description

Mindfulness practice

Arm Title

Lumosity Mobile App

Arm Type

Active Comparator

Arm Description

Cognitive games

Intervention Type

Behavioral

Intervention Name(s)

Mindfulness Practice

Intervention Description

10-15 mins of daily mindfulness practice using HeadSpace, for 3 weeks

Intervention Type

Behavioral

Intervention Name(s)

Cognitive training

Intervention Description

10-15 mins of cognitive games using Lumosity, for 3 weeks

Primary Outcome Measure Information:

Title

Depression

Description

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

Time Frame

Change from Baseline to Within 7 Days Post intervention

Title

Anxiety

Description

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

Time Frame

Change from Baseline to Within 7 Days Post intervention

Title

Fear of COVID-19

Description

Fear of COVID-19 Scale

Time Frame

Change from Baseline to Within 7 Days Post intervention

Title

Burnout, Compassion Satisfaction, and Secondary Traumatic Stress

Description

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

Time Frame

Change from Baseline to Within 7 Days Post intervention

Title

Sleep Quality

Description

One item from Pittsburg Sleep Quality Inventory

Time Frame

Change from Baseline to Within 7 Days Post intervention

Title

Working Memory

Description

Digit span tasks - forward and backward

Time Frame

Change from Baseline to Within 7 Days Post intervention

Title

PTSD symptoms

Description

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

Time Frame

Change from Baseline to Within 7 Days Post intervention

Secondary Outcome Measure Information:

Title

Trait Mindfulness

Description

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

Time Frame

Change from Baseline to Within 7 Days Post intervention

Title

Self-Compassion

Description

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

Time Frame

Change from Baseline to Within 7 Days Post intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shian-Ling Keng, PhD

Organizational Affiliation

Yale-NUS College

Official's Role

Principal Investigator

Facility Information:

Facility Name

Yle-NUS College

City

Singapore

ZIP/Postal Code

129792

Country

Singapore

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

36160038

Citation

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.

Results Reference

derived

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Effects of Mindfulness Practice on Healthcare Workers

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