Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT00461318
Status:
COMPLETED
Last Update Posted:
2007-04-18
First Post:
2007-04-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effectiveness of Supported Employment for People With Severe Mental Illness: an RCT in Six European Countries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011618', 'term': 'Psychotic Disorders'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010166', 'term': 'Palliative Care'}, {'id': 'D012050', 'term': 'Rehabilitation, Vocational'}], 'ancestors': [{'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-04', 'completionDateStruct': {'date': '2005-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-04-16', 'studyFirstSubmitDate': '2007-04-16', 'studyFirstSubmitQcDate': '2007-04-16', 'lastUpdatePostDateStruct': {'date': '2007-04-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-04-18', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'sucessful employment for one day in the open labour market'}], 'secondaryOutcomes': [{'measure': 'duration of employment'}, {'measure': 'psychiatric hospitalisation'}, {'measure': 'well-being'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['vocational rehabilitation', 'psychosis', 'cross country comparison'], 'conditions': ['Psychosis']}, 'referencesModule': {'references': [{'pmid': '17905167', 'type': 'DERIVED', 'citation': 'Burns T, Catty J, Becker T, Drake RE, Fioritti A, Knapp M, Lauber C, Rossler W, Tomov T, van Busschbach J, White S, Wiersma D; EQOLISE Group. The effectiveness of supported employment for people with severe mental illness: a randomised controlled trial. Lancet. 2007 Sep 29;370(9593):1146-52. doi: 10.1016/S0140-6736(07)61516-5.'}]}, 'descriptionModule': {'briefSummary': "The primary aim of the study was to determine the effectiveness of a form of supported employment, Individual Placement and Support (IPS) compared to existing good quality rehabilitation and vocational services for people with psychotic illnesses in terms of 'open' employment outcomes (in the competitive labour market), and to examine its relative effectiveness in the context of different European welfare systems and labour markets. The primary hypothesis was that IPS patients would be more likely to obtain open employment than control service patients. Secondary hypotheses were that they would be in open employment for longer than the control patients, and that they would not spend more time in hospital.", 'detailedDescription': "An RCT was conducted in six European centres: London (UK), Ulm-Guenzburg (Germany), Rimini (Italy), Zurich (Switzerland), Groningen (the Netherlands) and Sofia (Bulgaria). Patients were included if they had a diagnosis of SMI (psychotic illness including bipolar disorder), were aged 18 to retirement age, had been ill and had major role dysfunction for at least two years, were living in the community at baseline, had not been in competitive employment in the preceding year and expressed the desire to enter competitive employment. They were randomly allocated to receive either IPS or the 'Vocational Service' (control service). Given the need to consider the impact of gender and work history on vocational outcomes (20), service allocation was stratified by centre, gender and work history (more or less than a month's competitive employment in the five years prior to baseline). Randomisation was conducted centrally using MINIM Version 1.5. A researcher at each centre recruited the patients, submitted them to the statistician for randomisation and received the allocation by email. The allocation sequence was concealed until the services had been assigned, but it was not possible for patients, professionals or researchers to be blind to service allocation thereafter."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* pscychotic illness of at least a years duration\n* unemployed for at least a year\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT00461318', 'acronym': 'EQOLISE', 'briefTitle': 'The Effectiveness of Supported Employment for People With Severe Mental Illness: an RCT in Six European Countries', 'organization': {'class': 'OTHER', 'fullName': 'University of Oxford'}, 'officialTitle': 'Enhancing the Quality of Life and Independence of Persons Disabled by Severe Mental Illness Through Supported Employment', 'orgStudyIdInfo': {'id': 'QLRT-2001-00683'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Individual placement and support (vocational rehabilitation)', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SW17 0RE', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Division of mental health, St Georges medical school, university of london', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'jocelyn catty, DPhil', 'role': 'STUDY_DIRECTOR', 'affiliation': 'St Georges Medical School, university of london'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oxford', 'class': 'OTHER'}}}}