Condition category
Mental and Behavioural Disorders
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
14/11/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr J.T. van Busschbach

ORCID ID

Contact details

University Medical Centre Groningen
Rob Giel Research Centre
P.O. Box 30001
Groningen
9700 RB
Netherlands
+31 (0)50 361 2069
j.t.van.busschbach@med.umcg.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR295

Study information

Scientific title

A randomised controlled trial of the cost-effectiveness of individual placement and support in six European countries

Acronym

EQOLISE

Study hypothesis

Individual placement and supported (IPS) will be cost-effective in achieving regular (open, paid) employment. Differences between countries in the effectiveness of IPS can be explained by socio-economic variables like the employment rate and for instance the existence of a 'benefit trap'.

Ethics approval

Received from the local medical ethics committee

Study design

Multicentre, randomised, active controlled, parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Condition

Psychiatric, mental disorders/illness

Intervention

Individual placement and support (EXP) will be compared to standard vocational rehabilitation (CC).

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Achievement of open, paid employment
2. Hours of open employment
3. Time in open employment

Secondary outcome measures

1. Clinical improvement
2. Hospital admissions
3. Unmet needs for care
4. Quality of life

Overall trial start date

01/01/2003

Overall trial end date

01/01/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Diagnosis of a serious mental illness: schizophrenia, schizophrenia-like disorders, bipolar disorder with psychotic features
2. Age 18 - 65 years
3. Living in the community at baseline
4. Not employed for more then a month in the year before the start of the study
5. In mental health care for more then two years
6. Interest in competitive employment
7. Willing to give informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

300

Participant exclusion criteria

Use of the EXP or CC service in the preceding year

Recruitment start date

01/01/2003

Recruitment end date

01/01/2006

Locations

Countries of recruitment

Netherlands

Trial participating centre

University Medical Centre Groningen
Groningen
9700 RB
Netherlands

Sponsor information

Organisation

University Medical Centre Groningen (UMCG) (The Netherlands)

Sponsor details

Department of General Practice
Hanzeplein 1
Groningen
9713 GZ
Netherlands

Sponsor type

Hospital/treatment centre

Website

http://www.umcg.nl/azg/nl/

Funders

Funder type

Government

Funder name

European Community

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes