PsychosisEQOLISENCT00461318
The Effectiveness of Supported Employment for People With Severe Mental Illness: an RCT in Six European Countries
A study testing Individual placement and support (vocational rehabilitation) in people with Psychosis, run by University of Oxford at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Psychosis
- What is being tested?
- Individual placement and support (vocational rehabilitation)
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2003to Nov 2005
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- pscychotic illness of at least a years duration
- unemployed for at least a year
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Division of mental health, St Georges medical school, university of london
London, SW17 0RE
About this study
Official title: 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.
Read the 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.
- Conditions
- Psychosis
- Being tested
- Individual placement and support (vocational rehabilitation)
- Keywords
- vocational rehabilitation, psychosis, cross country comparison
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individual placement and support (vocational rehabilitation)Procedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
sucessful employment for one day in the open labour market
Secondary outcomes (3)
duration of employment
psychiatric hospitalisation
well-being
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2007 (estimated)
- Study startApr 2003
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PsychosisStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Investigators
- jocelyn catty, DPhil, Study director, St Georges Medical School, university of london
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00461318
- Sponsor's protocol ID
- QLRT-2001-00683
- Acronym
- EQOLISE
- Status last verified
- Apr 2007
- First submitted
- 16 Apr 2007
- Last updated
- 18 Apr 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 17905167