Condition category
Mental and Behavioural Disorders
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
20/02/2015
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 H. Michon

ORCID ID

Contact details

Trimbos Institute - Netherlands Institute for Mental Health and Addiction
P.O. Box 725
Utrecht
3500 AS
Netherlands
+31 (0)30 295 9217
hmichon@trimbos.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR292

Study information

Scientific title

Effects and costs of the individual placement and support program for people with severe mental illness: a multi-site randomised clinical trial

Acronym

SCION

Study hypothesis

1. Clients in individual placement and support (IPS) will get more competitive jobs, work more hours, and earn more wages than clients in standard services
2. IPS will be more cost-effective than standard services in terms of combined medical and non-medical costs

Ethics approval

Received from the local medical ethics committee

Study design

Multicentre randomised single-blind 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

The study is located at four mental health agencies.

IPS (experimental condition) is integrated within case management teams. These teams (staff patient ratio of 1:20 to 30) deliver comprehensive treatment and care for severely mentally ill clients in their respective catchment areas. An employment specialist (or IPS worker) is added to the team to offer IPS. The employment specialist assists people in getting jobs, offers follow-along support after job placement, and spends most of the time in the community. The employment specialist works in close collaboration with the other team members and attends team meetings.

Clients in the control condition use the same treatment and care facilities. In this condition the mental health staff or a counsellor links eligible clients to separate vocational services, based on individual competencies and preferences.

These services range from vocational services offered by the mental health agency (in a separate rehabilitation center), a sheltered workshop and/or reintegration companies. In general these services focus more on getting people ready for competitive employment (by assessment, training, prevocational activities and voluntary jobs) instead of the rapid job search of IPS. The primary difference with IPS is that staff from the these control rehabilitation services are not part of the case management teams.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

1. Proportion entering competitive employment during the follow-up period. Competitive employment is defined as part or full-time work in competitive job market at prevailing wages with supervision provided by personnel employed by the business and in integrated work settings.
2. In a secondary analysis we will also include subsidised work in regular job settings (including temporary competitive work without loss of benefits rights

Secondary outcome measures

1. Vocational:
1.1. Hours in competitive employment
1.2. Jobs held
1.3. Duration of each job in days
1.4. Days from baseline to entering first job
1.5. Total earnings
1.6. Job satisfaction (Indiana Job Satisfaction Scale)
1.7. Generic work behaviour (Generic Work Behaviour Questionnaire)
2. Hospitalisation:
2.1. Admissions
2.2. Days in hospital
3. Clinical:
3.1. Psychiatric symptoms
3.2. Global functioning (Global Assessment of Functioning Scale S-D)
3.3. Self-esteem
3.4. Quality of life
4. Costs: based on Client Socio-demographic and Service Receipt Inventory

Overall trial start date

01/09/2005

Overall trial end date

01/10/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Clients of mental health teams specifically focused at people with severe mental illness (e.g., diagnosis of a serious mental illness (schizophrenia and schizophrenia-like disorders, bipolar disorder, depression with psychotic features)
2. Aged 18 - 65 years (i.e., age of retirement)
3. Living in the community at baseline (i.e. not hospitalised)
4. Clear interest in competitive; employment as a short- or long-term goal
5. No competitive work at inclusion
6. Willing to give informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

150

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/09/2005

Recruitment end date

01/10/2008

Locations

Countries of recruitment

Netherlands

Trial participating centre

Trimbos Institute - Netherlands Institute for Mental Health and Addiction
Utrecht
3500 AS
Netherlands

Sponsor information

Organisation

Trimbos Institute - Netherlands Institute of Mental Health and Addiction (Netherlands)

Sponsor details

Da Costakade 45
P.O. Box 725
Utrecht
3500 AS
Netherlands
+31 (0)30 297 1100
info@trimbos.nl

Sponsor type

Research organisation

Website

http://www.trimbos.nl/default2.html

Funders

Funder type

Research organisation

Funder name

Rob Giel Research Centre (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Trimbos Institute - Netherlands Institute of Mental Health and Addiction (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

UWV (Workers Insurance Authority) (Netherlands)

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

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24912062

Publication citations

Additional files

Editorial Notes