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The Effectiveness of Supported Employment for People With Severe Mental Illness: an RCT in Six European Countries (EQOLISE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00461318
First Posted: April 18, 2007
Last Update Posted: April 18, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Oxford
  Purpose
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
Psychosis Procedure: Individual placement and support (vocational rehabilitation)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Enhancing the Quality of Life and Independence of Persons Disabled by Severe Mental Illness Through Supported Employment

Resource links provided by NLM:


Further study details as provided by University of Oxford:

Primary Outcome Measures:
  • sucessful employment for one day in the open labour market

Secondary Outcome Measures:
  • duration of employment
  • psychiatric hospitalisation
  • well-being

Estimated Enrollment: 300
Study Start Date: April 2003
Study Completion Date: November 2005
Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • pscychotic illness of at least a years duration
  • unemployed for at least a year

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00461318


Locations
United Kingdom
Division of mental health, St Georges medical school, university of london
London, United Kingdom, SW17 0RE
Sponsors and Collaborators
University of Oxford
Investigators
Study Director: jocelyn catty, DPhil St Georges Medical School, university of london
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00461318     History of Changes
Other Study ID Numbers: QLRT-2001-00683
First Submitted: April 16, 2007
First Posted: April 18, 2007
Last Update Posted: April 18, 2007
Last Verified: April 2007

Keywords provided by University of Oxford:
vocational rehabilitation
psychosis
cross country comparison

Additional relevant MeSH terms:
Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders