|- candidate number||1493|
|- NTR Number||NTR295|
|- Date ISRCTN created||20-dec-2005|
|- date ISRCTN requested||18-okt-2005|
|- Date Registered NTR||9-sep-2005|
|- Secondary IDs||N/A |
|- Public Title||Enhancing the quality of Life for people with Severe mental health problems through Supported Employment.|
|- Scientific Title||A Randomised controlled trial of the cost-effectiveness of Individual Placement and Support in six European countries.|
|- hypothesis||Individual Placement and Supported 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'. |
|- Healt Condition(s) or Problem(s) studied||Mental illness|
|- Inclusion criteria||1. Diagnosis of a serious mental illness: schizophrenia, schzophrenia-like disorders, bipolardisorder 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.
|- Exclusion criteria||Use of the EXP or CC service in the preceding year.|
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jan-2003|
|- planned closingdate||1-jan-2006|
|- Target number of participants||300|
|- Interventions||Individual PLacement and Support (EXP) will be compared to standard vocational rehabilitation (CC).|
|- Primary outcome||1. Achievement of open, paid employment;|
2. Hours of open employment;
3. Time in open employment.
|- Secondary outcome||1. Clinical improvement;|
2. Hospital admissions;
3. (un-met) needs for care;
4. Quality of life.
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||Dr. J.T. Busschbach, van|
|- CONTACT for SCIENTIFIC QUERIES||MD. J.J. Wiersma|
|- Sponsor/Initiator ||University Medical Center Groningen (UMCG), Rob Giel Research Center (RGOc)|
(Source(s) of Monetary or Material Support)
|- Brief summary||A high proportion of people with severe mental health problems are unemployed but would like to work. |
In the US Individual Placement and Support has proved an effective method in establishing people in paid employment.
To investigate the (cost-)effectiveness of IPS outside the US a randomised trail was conducted in six European countries.
Three hunderd people were randomised to receive either IPS or vocational rehabilitation and were followed for 18 months. service data were collected respectively at baseline and over the subsequent 18 months.
Outcome related data were also collected. Costs were calculated using both local and national unit costfigures.
A cost-effectiveness analysis will be conducted with achievement of (open, paid) employment as the primary outcome and other vocational achievements, clinical improvements and hospital admission as secondary outcomes.
Cost-effectiveness acceptability curves will be plotted, distinguishing country effects.
|- Main changes (audit trail)|
|- RECORD||9-sep-2005 - 29-okt-2008|