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

Psychosis Clinical Trial

— EQOLISE  

Official title:

Enhancing the Quality of Life and Independence of Persons Disabled by Severe Mental Illness Through Supported Employment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00461318
• Other study ID #: QLRT-2001-00683
• Status: Completed
• Phase: N/A
• First received: April 16, 2007
• Last updated: April 16, 2007
• Start date: April 2003
• Est. completion date: November 2005

Study information

• Verified date: April 2007
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: November 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• pscychotic illness of at least a years duration

• unemployed for at least a year

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mental Disorders
• Psychosis

Intervention

Procedure:
• Individual placement and support (vocational rehabilitation)

Locations

Country	Name	City	State
United Kingdom	Division of mental health, St Georges medical school, university of london	London

Sponsors (1)

Lead Sponsor	Collaborator
University of Oxford

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sucessful employment for one day in the open labour market
Secondary	duration of employment
Secondary	psychiatric hospitalisation
Secondary	well-being