Ignite Creation Date:
2025-12-25 @ 12:59 AM
Ignite Modification Date:
2025-12-25 @ 11:12 PM
Study NCT ID:
NCT04936893
Status:
COMPLETED
Last Update Posted:
2023-01-13
First Post:
2021-06-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Mindfulness Practice on Healthcare Workers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077062', 'term': 'Burnout, Psychological'}], 'ancestors': [{'id': 'D013315', 'term': 'Stress, Psychological'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000091942', 'term': 'Cognitive Training'}], 'ancestors': [{'id': 'D000066530', 'term': 'Neurological Rehabilitation'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2021-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-12', 'studyFirstSubmitDate': '2021-06-07', 'studyFirstSubmitQcDate': '2021-06-15', 'lastUpdatePostDateStruct': {'date': '2023-01-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Depression', 'timeFrame': 'Change from Baseline to Within 7 Days Post intervention', 'description': 'Depression subscale of the Depression, Anxiety, and Stress Scales- 21 (DASS)'}, {'measure': 'Anxiety', 'timeFrame': 'Change from Baseline to Within 7 Days Post intervention', 'description': 'Anxiety subscale of the Depression, Anxiety, and Stress Scales- 21 (DASS)'}, {'measure': 'Fear of COVID-19', 'timeFrame': 'Change from Baseline to Within 7 Days Post intervention', 'description': 'Fear of COVID-19 Scale'}, {'measure': 'Burnout, Compassion Satisfaction, and Secondary Traumatic Stress', 'timeFrame': 'Change from Baseline to Within 7 Days Post intervention', 'description': 'Professional Quality of Life Scale Version 5 (3 subscales respectively)'}, {'measure': 'Sleep Quality', 'timeFrame': 'Change from Baseline to Within 7 Days Post intervention', 'description': 'One item from Pittsburg Sleep Quality Inventory'}, {'measure': 'Working Memory', 'timeFrame': 'Change from Baseline to Within 7 Days Post intervention', 'description': 'Digit span tasks - forward and backward'}, {'measure': 'PTSD symptoms', 'timeFrame': 'Change from Baseline to Within 7 Days Post intervention', 'description': 'Posttraumatic stress disorder Checklist- Civilian Version(higher scores indicate greater PTSD symptoms)'}], 'secondaryOutcomes': [{'measure': 'Trait Mindfulness', 'timeFrame': 'Change from Baseline to Within 7 Days Post intervention', 'description': 'Five Facet Mindfulness Questionnaire (higher scores indicate greater trait mindfulness)'}, {'measure': 'Self-Compassion', 'timeFrame': 'Change from Baseline to Within 7 Days Post intervention', 'description': 'Self-Compassion Scale (higher scores indicate greater self-compassion)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Psychological Burnout']}, 'referencesModule': {'references': [{'pmid': '36160038', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to examine the effects of mindfulness practice administered using a mobile app on psychological health among health care workers in Singapore.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aged between 21 and 60\n* being a health care worker based in Singapore\n* proficient in English\n* owns a smartphone (iOS or Android) with Wi-Fi or data access.\n\nExclusion Criteria:\n\n-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.'}, 'identificationModule': {'nctId': 'NCT04936893', 'briefTitle': 'Effects of Mindfulness Practice on Healthcare Workers', 'organization': {'class': 'OTHER', 'fullName': 'Yale-NUS College'}, 'officialTitle': 'Effects of Mindfulness Practice on Healthcare Workers During the COVID-19 (Coronavirus Disease) Pandemic', 'orgStudyIdInfo': {'id': 'YaleNUS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HeadSpace Mobile App', 'description': 'Mindfulness practice', 'interventionNames': ['Behavioral: Mindfulness Practice']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lumosity Mobile App', 'description': 'Cognitive games', 'interventionNames': ['Behavioral: Cognitive training']}], 'interventions': [{'name': 'Mindfulness Practice', 'type': 'BEHAVIORAL', 'description': '10-15 mins of daily mindfulness practice using HeadSpace, for 3 weeks', 'armGroupLabels': ['HeadSpace Mobile App']}, {'name': 'Cognitive training', 'type': 'BEHAVIORAL', 'description': '10-15 mins of cognitive games using Lumosity, for 3 weeks', 'armGroupLabels': ['Lumosity Mobile App']}]}, 'contactsLocationsModule': {'locations': [{'zip': '129792', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'Yle-NUS College', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'overallOfficials': [{'name': 'Shian-Ling Keng, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale-NUS College'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale-NUS College', 'class': 'OTHER'}, 'collaborators': [{'name': 'Duke-NUS Graduate Medical School', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}