The Effectiveness of Supported Employment for People With Severe Mental Illness: an RCT in Six European Countries (EQOLISE)
April 16, 2007 updated by: University of Oxford
Enhancing the Quality of Life and Independence of Persons Disabled by Severe Mental Illness Through Supported Employment
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment
300
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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London, United Kingdom, SW17 0RE
- Division of mental health, St Georges medical school, university of london
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- pscychotic illness of at least a years duration
- unemployed for at least a year
Exclusion Criteria:
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Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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sucessful employment for one day in the open labour market
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Secondary Outcome Measures
Outcome Measure |
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duration of employment
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psychiatric hospitalisation
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well-being
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: jocelyn catty, DPhil, St Georges Medical School, university of london
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2003
Study Completion (Actual)
November 1, 2005
Study Registration Dates
First Submitted
April 16, 2007
First Submitted That Met QC Criteria
April 16, 2007
First Posted (Estimate)
April 18, 2007
Study Record Updates
Last Update Posted (Estimate)
April 18, 2007
Last Update Submitted That Met QC Criteria
April 16, 2007
Last Verified
April 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- QLRT-2001-00683
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