Clinical trial NCT00461318: The Effectiveness of Supported Employment for People With Severe Mental Illness: an RCT in Six European Countries
Official title: Enhancing the Quality of Life and Independence of Persons Disabled by Severe Mental Illness Through Supported Employment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychosis
Keywords: vocational rehabilitation
psychosis
cross country comparison
Lead sponsor: University of Oxford
Sponsor class: OTHER
First posted: 2007-04-18
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

-

Primary outcomes:
measure: sucessful employment for one day in the open labour market
Secondary outcomes:
measure: duration of employment
measure: psychiatric hospitalisation
measure: well-being
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Division of mental health, St Georges medical school, university of london
Study officials:
affiliation: St Georges Medical School, university of london
name: jocelyn catty, DPhil
role: STUDY_DIRECTOR
References:
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.