The Effectiveness of Supported Employment for People With Severe Mental Illness: an RCT in Six European Countries (EQOLISE)
Primary Purpose
Psychosis
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Individual placement and support (vocational rehabilitation)
Sponsored by
About this trial
This is an interventional treatment trial for Psychosis focused on measuring vocational rehabilitation, psychosis, cross country comparison
Eligibility Criteria
Inclusion Criteria:
- pscychotic illness of at least a years duration
- unemployed for at least a year
Exclusion Criteria:
-
Sites / Locations
- Division of mental health, St Georges medical school, university of london
Outcomes
Primary Outcome Measures
sucessful employment for one day in the open labour market
Secondary Outcome Measures
duration of employment
psychiatric hospitalisation
well-being
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00461318
Brief Title
The Effectiveness of Supported Employment for People With Severe Mental Illness: an RCT in Six European Countries
Acronym
EQOLISE
Official Title
Enhancing the Quality of Life and Independence of Persons Disabled by Severe Mental Illness Through Supported Employment
Study Type
Interventional
2. Study Status
Record Verification Date
April 2007
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Oxford
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychosis
Keywords
vocational rehabilitation, psychosis, cross country comparison
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Individual placement and support (vocational rehabilitation)
Primary Outcome Measure Information:
Title
sucessful employment for one day in the open labour market
Secondary Outcome Measure Information:
Title
duration of employment
Title
psychiatric hospitalisation
Title
well-being
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
pscychotic illness of at least a years duration
unemployed for at least a year
Exclusion Criteria:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
jocelyn catty, DPhil
Organizational Affiliation
St Georges Medical School, university of london
Official's Role
Study Director
Facility Information:
Facility Name
Division of mental health, St Georges medical school, university of london
City
London
ZIP/Postal Code
SW17 0RE
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
17905167
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.
Results Reference
derived
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The Effectiveness of Supported Employment for People With Severe Mental Illness: an RCT in Six European Countries
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