Enhancing the quality of Life for people with severe mental health problems through supported employment

ISRCTN	ISRCTN15173187
DOI	https://doi.org/10.1186/ISRCTN15173187
Protocol serial number	NTR295
Sponsor	University Medical Centre Groningen (UMCG) (The Netherlands)
Funder	European Community

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr J.T. van Busschbach
Scientific

University Medical Centre Groningen
Rob Giel Research Centre
P.O. Box 30001
Groningen
9700 RB
Netherlands

Phone	+31 (0)50 361 2069
Email	j.t.van.busschbach@med.umcg.nl

Primary study design	Interventional
Study design	Multicentre, randomised, active controlled, parallel group trial
Secondary study design	Randomised controlled trial
Scientific title	A randomised controlled trial of the cost-effectiveness of individual placement and support in six European countries
Study acronym	EQOLISE
Study objectives	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(s)	Received from the local medical ethics committee
Health condition(s) or problem(s) studied	Psychiatric, mental disorders/illness
Intervention	Individual placement and support (EXP) will be compared to standard vocational rehabilitation (CC).
Intervention type	Other
Primary outcome measure(s)	1. Achievement of open, paid employment 2. Hours of open employment 3. Time in open employment
Key secondary outcome measure(s)	1. Clinical improvement 2. Hospital admissions 3. Unmet needs for care 4. Quality of life
Completion date	01/01/2006

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	300
Total final enrolment	312
Key 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
Key exclusion criteria	Use of the EXP or CC service in the preceding year
Date of first enrolment	01/01/2003
Date of final enrolment	01/01/2006

University Medical Centre Groningen

Groningen
9700 RB
Netherlands

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/09/2009	04/07/2019	Yes	No

04/07/2019: Publication reference and total final enrolment added.