Ignite Creation Date:
2025-12-24 @ 7:18 PM
Ignite Modification Date:
2025-12-25 @ 4:56 PM
Study NCT ID:
NCT03527303
Status:
COMPLETED
Last Update Posted:
2020-11-19
First Post:
2018-04-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Impact of 8 Weeks of a Digital Meditation Application on Work Stress
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013315', 'term': 'Stress, Psychological'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D000073397', 'term': 'Occupational Stress'}, {'id': 'D000077062', 'term': 'Burnout, Psychological'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D009784', 'term': 'Occupational Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019122', 'term': 'Meditation'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026443', 'term': 'Spiritual Therapies'}, {'id': 'D012064', 'term': 'Relaxation Therapy'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR'], 'maskingDescription': 'Investigator will be blind to condition throughout data accrual.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomization to either digital meditation condition or wait-list control.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1458}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2020-09-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-17', 'studyFirstSubmitDate': '2018-04-25', 'studyFirstSubmitQcDate': '2018-05-15', 'lastUpdatePostDateStruct': {'date': '2020-11-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in perceived stress score, as determined by the total score on the Perceived Stress Scale', 'timeFrame': 'Baseline to post-intervention, an anticipated average of 8 weeks', 'description': 'The Perceived Stress Scale has a total score scale range of 0 to 40, with higher values indicating more perceived stress'}], 'secondaryOutcomes': [{'measure': 'Change in job strain, as determined by Siegrist Job Strain Scale', 'timeFrame': 'Baseline to post-intervention, an anticipated average of 8 weeks', 'description': 'The job strain measure is a comprised of two sub scales, effort (5 items) and reward (11 items), each ranging from 1 to 4. The job strain score is calculated as the ratio of demand to reward, with a higher ratio reflecting more job strain.'}, {'measure': 'Change in job overcommitment, as as determined by Siegrist Job Strain Scale', 'timeFrame': 'Baseline to post-intervention, an anticipated average of 8 weeks', 'description': 'The job overcommitment subscale of the Siegrist Job Strain Scale is comprised of 4 items providing a total score range from 4 to16. A higher total score reflects more job overcommitment.'}, {'measure': 'Change in burnout, as determined by the Bergen Burnout Inventory', 'timeFrame': 'Baseline to post-intervention, an anticipated average of 8 weeks', 'description': 'The Bergen Burnout Inventory is comprised of 9 items, ranging from 1 to 6. The total score range is from 9 to 54 with a higher score reflecting higher burnout.'}, {'measure': 'Change in subjective mindfulness, as determined by total score on Mindful Attention Awareness Scale', 'timeFrame': 'Baseline to post-intervention, an anticipated average of 8 weeks', 'description': 'The Mindful Attention Awareness Scale is a 15-item measure with each item ranging from a score of 1 to 6. To score the scale, we compute the average score across items, with a higher score reflecting higher levels of mindfulness.'}, {'measure': 'Change in work engagement, as determined by the Utrecht Work Engagement Scale', 'timeFrame': 'Baseline to post-intervention, an anticipated average of 8 weeks', 'description': 'The Utrecht Work Engagement scale is comprised of 9 items, with a total score ranging from 0 to 54, with higher scores indicating more work engagement.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['stress', 'health', 'meditation', 'mindfulness', 'employees', 'job strain', 'burnout', 'work', 'mood', 'affect', 'work related stress'], 'conditions': ['Stress, Psychological', 'Behavioral Symptoms']}, 'referencesModule': {'references': [{'pmid': '39808431', 'type': 'DERIVED', 'citation': 'Radin RM, Vacarro J, Fromer E, Ahmadi SE, Guan JY, Fisher SM, Pressman SD, Hunter JF, Sweeny K, Tomiyama AJ, Hofschneider LT, Zawadzki MJ, Gavrilova L, Epel ES, Prather AA. Digital Meditation to Target Employee Stress: A Randomized Clinical Trial. JAMA Netw Open. 2025 Jan 2;8(1):e2454435. doi: 10.1001/jamanetworkopen.2024.54435.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to test the effects of a digital meditation intervention in a sample UCSF employees who report mild to moderate stress. We will randomize UCSF employees to either 8-weeks of a digital meditation intervention (using the commercially available application Headspace) or a waitlist control condition.', 'detailedDescription': 'The aim of this study is to test the effects of a digital meditation intervention in a sample UCSF employees who report moderate to high stress. We will randomize UCSF employees to either 8-weeks of a digital meditation intervention (using the commercially available application Headspace) or a waitlist control condition.\n\nParticipants assigned to the intervention group will be asked to download and use the Headspace mobile application for at least 10 minutes per day for 8 weeks. All study participants will be asked to fill out short (no longer than 25 minutes) questionnaires at baseline, week 4, week 8 (post intervention), and a 4-month follow up period. Among participants who are randomized to the digital meditation intervention, they will also take part in a 1-year follow up. All activities will take place online (via computer or smartphone).\n\nPrior to randomization, participants will go through an eligibility screening and complete the baseline questionnaire battery. The entirety of the study is digital and there are no in-person assessments. Adherence will be tracked remotely. The goal is to recruit as many as 2000 participants (1000 per condition).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nYou may join if you:\n\n* Have access to a smartphone or computer every day\n* Are fluent in English\n* Are a UCSF employee\n* Report mild to moderate levels of stress\n* Consent: demonstrate understanding of the study and willingness to participate as evidenced by voluntary informed consent and has received a signed and dated copy of the informed consent\n* Are at least 18 years of age\n\nExclusion Criteria:\n\n• You may not join if you are an experienced meditator or have participated in a formal meditation practice in the last 3 months (defined as 3 times per week or more for 10 minutes or more at each practice)'}, 'identificationModule': {'nctId': 'NCT03527303', 'briefTitle': 'The Impact of 8 Weeks of a Digital Meditation Application on Work Stress', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'The Impact of 8 Weeks of a Digital Meditation Application on Stress and Job Strain in a Heterogeneous University Employee Cohort', 'orgStudyIdInfo': {'id': '17-23717'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Meditation Group', 'description': 'Participants in the intervention group will assigned to a digitally-based meditation intervention (Headspace app- Basics + Stress packs) and asked to use this for at least 10 minutes a day over the course of 8 weeks', 'interventionNames': ['Behavioral: Meditation']}, {'type': 'NO_INTERVENTION', 'label': 'Waitlist Control Group', 'description': 'Waitlist control group participants will continue their normal activities and not add any form of meditation during the study period.'}], 'interventions': [{'name': 'Meditation', 'type': 'BEHAVIORAL', 'description': '10 minute per day, 8 week digital meditation', 'armGroupLabels': ['Meditation Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94118', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Aric A Prather, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}, {'name': 'Elissa Epel, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Only deidentified aggregated data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': "The University of California's Healthy Campus Network", 'class': 'OTHER'}, {'name': 'Headspace, Inc', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}