Ignite Creation Date:
2025-12-24 @ 5:28 PM
Ignite Modification Date:
2026-02-20 @ 10:42 PM
Study NCT ID:
NCT01039168
Status:
COMPLETED
Last Update Posted:
2024-03-15
First Post:
2009-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Return to Work After a Workplace-oriented Intervention for Patients on Sick Leave Due to Burnout
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002055', 'term': 'Burnout, Professional'}, {'id': 'D000077062', 'term': 'Burnout, Psychological'}], 'ancestors': [{'id': 'D000073397', 'term': 'Occupational Stress'}, {'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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 76}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-13', 'studyFirstSubmitDate': '2009-12-22', 'studyFirstSubmitQcDate': '2009-12-22', 'lastUpdatePostDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-12-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Return to work from sick leave', 'timeFrame': 'Up to 1,5 years post intervention completion'}], 'secondaryOutcomes': [{'measure': 'Self-rated health measures (only in the intervention group)', 'timeFrame': 'Up to 1,5 years post intervention completion'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Burnout', 'Sick leave', 'Intervention study', 'Prospective study', 'Work'], 'conditions': ['Professional Burnout']}, 'referencesModule': {'references': [{'pmid': '20515510', 'type': 'DERIVED', 'citation': 'Karlson B, Jonsson P, Palsson B, Abjornsson G, Malmberg B, Larsson B, Osterberg K. Return to work after a workplace-oriented intervention for patients on sick-leave for burnout--a prospective controlled study. BMC Public Health. 2010 Jun 2;10:301. doi: 10.1186/1471-2458-10-301.'}]}, 'descriptionModule': {'briefSummary': 'The study aims to evaluate the effect on return to work of a workplace intervention with patients being treated for burnout. The intervention intends to reduce job-person mismatch through patient-supervisor communication.The hypothesis is that the intervention group will show a more favourable outcome than a control group with respect to return to work.', 'detailedDescription': "Participants are consecutively recruited in co-operation with regional social insurance offices (RSIOs) in the two southern counties of Sweden. Persons accepting participation are clinically examined and interviewed of the course of events leading up to the burnout and the patient's expectations of changes necessary to facilitate return to work are recorded. The patient´s supervisor is then interviewed at the workplace, responding to the same questions on perceived main causes of the subordinate's sick leave and changes necessary to facilitate return to work. Finally, the core intervention takes place, namely a dialogue being initiated between the patient and the supervisor to find solutions to facilitate return to work. Out of those who do not want to participate, without giving any specific reason for that, a control group is matched by length and degree of sick leave at the time of the intervention."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '63 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* employment\n* sick leave at lest half time 2-6 months due to work related burnout\n* previously healthy\n\nExclusion Criteria:\n\n* other somatic or psychiatric disease explaining the symptoms'}, 'identificationModule': {'nctId': 'NCT01039168', 'acronym': 'ADA model', 'briefTitle': 'Return to Work After a Workplace-oriented Intervention for Patients on Sick Leave Due to Burnout', 'organization': {'class': 'OTHER', 'fullName': 'Region Skane'}, 'officialTitle': 'Reduction of Person-job Mismatch to Increase Work Capacity, by Education of, and Dialogue Between Involved Parties - Evaluation of an Intervention Program', 'orgStudyIdInfo': {'id': 'FAS 2003-0765'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Workplace dialogue', 'description': 'Clinical examination and dialogue with supervisor to find solutions to reduce job-person mismatch and facilitate return to work', 'interventionNames': ['Behavioral: Workplace dialogue']}, {'type': 'SHAM_COMPARATOR', 'label': 'Care as usual', 'description': 'No intervention besides of the care as usual being available for the patient', 'interventionNames': ['Other: Care as usual']}], 'interventions': [{'name': 'Workplace dialogue', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Workplace dialogue']}, {'name': 'Care as usual', 'type': 'OTHER', 'armGroupLabels': ['Care as usual']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22185', 'city': 'Lund', 'country': 'Sweden', 'facility': 'Occupational and Environmental Medicine, Lund University Hospital', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}], 'overallOfficials': [{'name': 'Björn Karlson, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Occupational and Environmental Medicine, Lund University Hospital and Lund University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Region Skane', 'class': 'OTHER'}, 'collaborators': [{'name': 'Swedish Council for Working Life and Social Research', 'class': 'OTHER'}, {'name': 'Lund University', 'class': 'OTHER'}, {'name': 'County Councils of Southern Sweden', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}