Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2026-01-07 @ 4:13 AM
Study NCT ID:
NCT02867657
Status:
COMPLETED
Last Update Posted:
2025-03-28
First Post:
2016-08-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bringing the Practice of Mindfulness Into Nature - Preventing Mental Fatigue in Healthcare Professionals.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013315', 'term': 'Stress, Psychological'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D064866', 'term': 'Mindfulness'}, {'id': 'D000099024', 'term': 'Mindfulness-Based Stress Reduction'}], 'ancestors': [{'id': 'D015928', 'term': 'Cognitive Behavioral 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', 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 93}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2018-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-24', 'studyFirstSubmitDate': '2016-08-10', 'studyFirstSubmitQcDate': '2016-08-10', 'lastUpdatePostDateStruct': {'date': '2025-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Perceived Stress Scale', 'timeFrame': 'At the end of five days retreat', 'description': 'PSS'}, {'measure': 'Self-compassion', 'timeFrame': 'At the end of five days retreat', 'description': 'S-C-S Neff2'}], 'secondaryOutcomes': [{'measure': 'Five Facet Mindfulness Questionnaire', 'timeFrame': 'At the end of five days retreat'}, {'measure': 'Breath Counting', 'timeFrame': 'At the end of five days retreat', 'description': 'Behavioral measurement of attention'}, {'measure': 'NF-kB gene expression', 'timeFrame': 'At the end of five days retreat'}, {'measure': 'IL-1 gene expression', 'timeFrame': 'At the end of five days retreat'}, {'measure': 'IL-6 gene expression', 'timeFrame': 'At the end of five days retreat'}, {'measure': 'cRP expression', 'timeFrame': 'At the end of five days retreat', 'description': 'c reactive protein'}, {'measure': 'Heart Rate Variability', 'timeFrame': 'At the end of five days retreat', 'description': 'HRV'}, {'measure': 'Blood pressure', 'timeFrame': 'At the end of five days retreat'}, {'measure': 'Connectedness to Nature Scale', 'timeFrame': 'At the end of five days retreat'}, {'measure': 'GR gene expression', 'timeFrame': 'At the end of five days retreat'}, {'measure': 'RIPK2 gene expression', 'timeFrame': 'At the end of five days retreat'}, {'measure': 'TNF-α gene expression', 'timeFrame': 'At the end of five days retreat'}, {'measure': 'CCL5 gene expression', 'timeFrame': 'At the end of five days retreat'}, {'measure': 'IL-8 gene expression', 'timeFrame': 'At the end of five days retreat'}, {'measure': 'TERT gene expression', 'timeFrame': 'At the end of five days retreat'}, {'measure': 'TERC gene expression', 'timeFrame': 'At the end of five days retreat'}, {'measure': 'IL-1β protein expression', 'timeFrame': 'At the end of five days retreat'}, {'measure': 'IL-2 protein expression', 'timeFrame': 'At the end of five days retreat'}, {'measure': 'IL-4 protein expression', 'timeFrame': 'At the end of five days retreat'}, {'measure': 'IL-6 protein expression', 'timeFrame': 'At the end of five days retreat'}, {'measure': 'IL-8 protein expression', 'timeFrame': 'At the end of five days retreat'}, {'measure': 'IL-10 protein expression', 'timeFrame': 'At the end of five days retreat'}, {'measure': 'IL-12p70 protein expression', 'timeFrame': 'At the end of five days retreat'}, {'measure': 'IL-13 protein expression', 'timeFrame': 'At the end of five days retreat'}, {'measure': 'TNF-α protein expression', 'timeFrame': 'At the end of five days retreat'}, {'measure': 'IFN-γ protein expression', 'timeFrame': 'At the end of five days retreat'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Stress, Psychological', 'Inflammation', 'Stress, Physiological']}, 'referencesModule': {'references': [{'pmid': '32691879', 'type': 'DERIVED', 'citation': 'Kunzler AM, Helmreich I, Konig J, Chmitorz A, Wessa M, Binder H, Lieb K. Psychological interventions to foster resilience in healthcare students. Cochrane Database Syst Rev. 2020 Jul 20;7(7):CD013684. doi: 10.1002/14651858.CD013684.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine whether a five day mindfulness retreat in nature can increase measures of attention and self-compassion, and reduce stress among bachelor students at Danish Universities and University Colleges. Secondary whether the expression of inflammatory markers can be reduced .\n\nIt is the hypothesis that perceived stress is reduced and the expression of genetic markers of inflammation is reduced after a five day mindfulness retreat.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Bachelor student at a Danish University or University College\n* A score of 16 or above on the Perceived Stress Scale (PSS)\n\nExclusion Criteria:\n\n* Smoking\n* Psychiatric diagnosis (depression, anxiety, adjustment disorder, PTSD, personality disorder, psychosis).\n* Untreated ADHD, autism, abuse and risk of suicide'}, 'identificationModule': {'nctId': 'NCT02867657', 'briefTitle': 'Bringing the Practice of Mindfulness Into Nature - Preventing Mental Fatigue in Healthcare Professionals.', 'organization': {'class': 'OTHER', 'fullName': 'VIA University College'}, 'officialTitle': 'Enhancement of Presence, Compassion and Resilience Bringing the Practice of Mindfulness Into Nature - Preventing Mental Fatigue in Healthcare Professionals.', 'orgStudyIdInfo': {'id': 'H-15010925'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mindfulness in nature', 'description': 'A five day mindfulness retreat in nature', 'interventionNames': ['Behavioral: Mindfulness']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Mindfulness indoor', 'description': 'A five day mindfulness retreat indoor', 'interventionNames': ['Behavioral: Mindfulness']}, {'type': 'NO_INTERVENTION', 'label': 'Wait list control', 'description': 'A wait list control group, that 6 months later is offered a two-day mindfulness retreat in nature'}], 'interventions': [{'name': 'Mindfulness', 'type': 'BEHAVIORAL', 'otherNames': ['Mindfulness Based Stress Reduction', 'MBSR'], 'description': 'Five days MBSR curriculum with meditation and yoga', 'armGroupLabels': ['Mindfulness in nature', 'Mindfulness indoor']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'DK-8200', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'VIA University College', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}, {'zip': '2970', 'city': 'Hoersholm', 'country': 'Denmark', 'facility': 'Nacadia, University of Copenhagen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VIA University College', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Copenhagen', 'class': 'OTHER'}, {'name': 'University of Aarhus', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}