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Completed

NCT Number: NCT00461318

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

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Division of mental health, St Georges medical school, university of london

London, SW17 0RE, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-

Treatment and study plan

Individual placement and support (vocational rehabilitation)

Procedure

Primary outcomes

  1. sucessful employment for one day in the open labour market

Secondary outcomes

  1. duration of employment

  2. psychiatric hospitalisation

  3. well-being

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Registry information

Official study title

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

Acronym: EQOLISE

Important dates

Study start
2003
Study completion
2005
First posted
Apr 18, 2007
Registry last updated
Apr 18, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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