Ignite Creation Date:
2025-12-24 @ 8:00 PM
Ignite Modification Date:
2026-02-27 @ 1:09 AM
Study NCT ID:
NCT02825004
Status:
COMPLETED
Last Update Posted:
2018-02-01
First Post:
2016-07-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Recognizing and Preventing Burnout
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': 'D000083626', 'term': 'Psychosocial Intervention'}], 'ancestors': [{'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2018-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-31', 'studyFirstSubmitDate': '2016-07-04', 'studyFirstSubmitQcDate': '2016-07-06', 'lastUpdatePostDateStruct': {'date': '2018-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in burnout, as assessed by the Maslach Burnout Inventory (MBI) (Maslach C., 1981) between baseline (T0), 6 months (T1) and 12 months (T2)', 'timeFrame': 'At the baseline (T0), 6 months (T1) and 12 months (T2)'}], 'secondaryOutcomes': [{'measure': 'Changes in coping strategies as assessed by the Coping Orientation to Problems Experienced (COPE) (Carver et al., 1989) between baseline (T0), 6 months (T1) and 12 months (T2)', 'timeFrame': 'At the baseline (T0), 6 months (T1) and 12 months (T2)'}, {'measure': 'Changes in psychological symptoms as assessed by the Symptom Checklist-90-R (Prunas et al., 2012) between baseline (T0), 6 months (T1) and 12 months (T2)', 'timeFrame': 'At the baseline (T0), 6 months (T1) and 12 months (T2)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Burnout', 'Health Care Workers', 'Coping Skills', 'Clinical Trial'], 'conditions': ['Burnout, Professionals']}, 'referencesModule': {'references': [{'pmid': '21334861', 'type': 'RESULT', 'citation': 'Prunas A, Sarno I, Preti E, Madeddu F, Perugini M. Psychometric properties of the Italian version of the SCL-90-R: a study on a large community sample. Eur Psychiatry. 2012 Nov;27(8):591-7. doi: 10.1016/j.eurpsy.2010.12.006. Epub 2011 Feb 21.'}, {'pmid': '23356679', 'type': 'RESULT', 'citation': 'Kleijweg JH, Verbraak MJ, Van Dijk MK. The clinical utility of the Maslach Burnout Inventory in a clinical population. Psychol Assess. 2013 Jun;25(2):435-41. doi: 10.1037/a0031334. Epub 2013 Jan 28.'}, {'pmid': '2926629', 'type': 'RESULT', 'citation': 'Carver CS, Scheier MF, Weintraub JK. Assessing coping strategies: a theoretically based approach. J Pers Soc Psychol. 1989 Feb;56(2):267-83. doi: 10.1037//0022-3514.56.2.267.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to prevent burnout and offer the hospital staff a space for processing the emotional experiences.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Doctors, physiotherapists, nurses and care workers\n* Be a Professional Worker at the Rehabilitation Respiratory Unit\n* Age \\> 18 years old\n\nExclusion Criteria:\n\n* Refusal at the Informed Consent'}, 'identificationModule': {'nctId': 'NCT02825004', 'briefTitle': 'Recognizing and Preventing Burnout', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Don Carlo Gnocchi Onlus'}, 'officialTitle': 'Recognizing and Preventing Burnout: A Pilot Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'FDG_BURN01_HP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Psychological Intervention', 'description': 'All the professionals workers involved in the experimental group will attend three intensive psychological meetings about emotional exhaustion, depersonalisation, low personal accomplishment and how to improve coping skills.', 'interventionNames': ['Behavioral: Psychological Intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'There is not any intervention.'}], 'interventions': [{'name': 'Psychological Intervention', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Psychological Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20148', 'city': 'Milan', 'country': 'Italy', 'facility': 'Paolo Banfi', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Don Carlo Gnocchi Onlus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'Paolo Banfi', 'investigatorAffiliation': 'Fondazione Don Carlo Gnocchi Onlus'}}}}