Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2025-12-30 @ 10:38 PM
Study NCT ID:
NCT01661569
Status:
UNKNOWN
Last Update Posted:
2012-08-09
First Post:
2012-08-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Randomised Controlled Trial to Investigate the Effects of a Mindfulness Smartphone App on Well-being in the Workplace
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073397', 'term': 'Occupational Stress'}], 'ancestors': [{'id': 'D009784', 'term': 'Occupational Diseases'}, {'id': 'D013315', 'term': 'Stress, Psychological'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2013-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-08-07', 'studyFirstSubmitDate': '2012-08-07', 'studyFirstSubmitQcDate': '2012-08-07', 'lastUpdatePostDateStruct': {'date': '2012-08-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Psychological stress', 'timeFrame': '8 weeks', 'description': 'Stress will be measured using the Perceived Stress Scale and measures of job strain, based on Karasek (where job strain is a combination of high demands and low control).'}, {'measure': 'Cortisol', 'timeFrame': '8 weeks', 'description': 'Hair cortisol concentration, as an indicator of activation of the HPA axis'}], 'primaryOutcomes': [{'measure': 'Well-being', 'timeFrame': '8 weeks', 'description': 'Psychological well-being will be assessed using the Warwick Edinburgh Mental Well-Being Scale'}], 'secondaryOutcomes': [{'measure': 'Blood pressure', 'timeFrame': '8 weeks', 'description': 'Blood pressure over the working day will be measured as an indicator of activation of the stress response'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Mindfulness', 'meditation', 'stress', 'well-being', 'work stress', 'blood pressure', 'cortisol'], 'conditions': ['Well-being, Work Stress']}, 'descriptionModule': {'briefSummary': 'We propose a randomised controlled trial in a workplace setting to investigate whether a smartphone-delivered programme of mindfulness meditation influences psychological and biological indicators of well-being.\n\nWe hypothesise that after 8 weeks participants who complete the meditation programme will show increases in psychological well-being and reduced activation of stress-related biological pathways.', 'detailedDescription': 'Mindfulness-based therapies can reduce depressive symptoms in patients and healthy subjects. Therapies such as MBSR (mindfulness-based stress reduction) typically consist of 8 group sessions led by an experienced practitioner, plus home practice and one full day of meditation. In this study we aim to investigate whether a mindfulness programme delivered as a series of podcasts on a mobile phone app could lead to gains in well-being and a reduction in stress.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Employees of a UK high-tech company\n* Raised levels of work stress (overcommitment\\>2) or depression (CESD\\>1)\n\nExclusion Criteria:\n\n* treated for anxiety, depression or hypertension\n* taking medication containing steroids'}, 'identificationModule': {'nctId': 'NCT01661569', 'briefTitle': 'A Randomised Controlled Trial to Investigate the Effects of a Mindfulness Smartphone App on Well-being in the Workplace', 'organization': {'class': 'OTHER', 'fullName': 'University College, London'}, 'officialTitle': 'A Randomised Controlled Trial to Investigate the Effects of the Headspace Mindfulness Smartphone App on Psychological Well-being and Biological Indicators of Stress in the Workplace', 'orgStudyIdInfo': {'id': '3035/002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Headspace On-the-go app', 'description': 'Participants were given access to a 45-day mindfulness meditation programme via the Headspace smartphone app', 'interventionNames': ['Other: Headspace On-the-go app']}, {'type': 'NO_INTERVENTION', 'label': 'Waitlist control', 'description': 'Participants will be asked to wait for 8 weeks before starting the intervention'}], 'interventions': [{'name': 'Headspace On-the-go app', 'type': 'OTHER', 'otherNames': ['Mindfulness meditation smartphone app'], 'description': 'Participants will be given access to a 45-day programme of mindfulness meditation, created and branded by Headspace. They will be encouraged to listen to one meditation podcast each day, or as frequently as possible over 8 weeks.', 'armGroupLabels': ['Headspace On-the-go app']}]}, 'contactsLocationsModule': {'locations': [{'city': 'London', 'country': 'United Kingdom', 'contacts': [{'name': 'Sophie K Bostock, BMedSci, MSc', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UK high-tech company office', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'Sophie K Bostock, BMedSci, MSc', 'role': 'CONTACT', 'email': 'sophie.bostock.09@ucl.ac.uk', 'phone': '+44 (0)7779578733'}], 'overallOfficials': [{'name': 'Andrew Steptoe, DPhil, DSc, FMedSci', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University College, London'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University College, London', 'class': 'OTHER'}, 'collaborators': [{'name': 'British Heart Foundation', 'class': 'OTHER'}, {'name': 'Headspace Meditation Limited', 'class': 'INDUSTRY'}, {'name': 'Technical University Dresden', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}