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Sponsored by: |
University of Oxford |
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Information provided by: | University of Oxford |
ClinicalTrials.gov Identifier: | NCT00461318 |
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.
Condition | Intervention |
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Psychosis |
Procedure: Individual placement and support (vocational rehabilitation) |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study |
Official Title: | Enhancing the Quality of Life and Independence of Persons Disabled by Severe Mental Illness Through Supported Employment |
Estimated Enrollment: | 300 |
Study Start Date: | April 2003 |
Study Completion Date: | November 2005 |
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.
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
-
United Kingdom | |
Division of mental health, St Georges medical school, university of london | |
London, United Kingdom, SW17 0RE |
Study Director: | jocelyn catty, DPhil | St Georges Medical School, university of london |
Study ID Numbers: | QLRT-2001-00683 |
Study First Received: | April 16, 2007 |
Last Updated: | April 16, 2007 |
ClinicalTrials.gov Identifier: | NCT00461318 |
Health Authority: | United Kingdom: Research Ethics Committee |
vocational rehabilitation psychosis cross country comparison |
Schizophrenia Mental Disorders Quality of Life Psychotic Disorders Schizophrenia and Disorders with Psychotic Features |