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

This study has been completed.
Sponsor:
Information provided by:
University of Oxford
ClinicalTrials.gov Identifier:
NCT00461318
First received: April 16, 2007
Last updated: NA
Last verified: April 2007
History: No changes posted

April 16, 2007
April 16, 2007
April 2003
Not Provided
sucessful employment for one day in the open labour market
Same as current
No Changes Posted
  • duration of employment
  • psychiatric hospitalisation
  • well-being
Same as current
Not Provided
Not Provided
 
The Effectiveness of Supported Employment for People With Severe Mental Illness: an RCT in Six European Countries
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Psychosis
Procedure: Individual placement and support (vocational rehabilitation)
Not Provided
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
November 2005
Not Provided

Inclusion Criteria:

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

Exclusion Criteria:

-

Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00461318
QLRT-2001-00683
No
Not Provided
University of Oxford
Not Provided
Study Director: jocelyn catty, DPhil St Georges Medical School, university of london
University of Oxford
April 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP