Condition category
Mental and Behavioural Disorders
Date applied
27/05/2004
Date assigned
21/07/2004
Last edited
03/12/2012
Prospective/Retrospective
Prospectively 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

Prof Graham Thornicroft

ORCID ID

Contact details

Health Services Research
Institute of Psychiatry
De Crespigny Park
London
SE5 8AF
United Kingdom
+44 (0)20 7848 0735
G.Thornicroft@iop.kcl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

071272/Z/03/Z

Study information

Scientific title

Randomised controlled trial of individual placement and support (IPS) to improve the occupational outcomes for people with severe mental illness in South London

Acronym

SWAN - Supported Work And Needs

Study hypothesis

After receiving the supported employment intervention, a significantly greater percentage of individuals in the experimental group will be working at all compared to those in the control group.

Secondary hypotheses are that the individuals in the experimental group will be more likely to be:
1. Working competitively
2. Working more hours each week
3. Earning a higher net income
4. Making greater contributions to the national economy
5. Having a higher quality of life
6. Having more of their needs met

Ethics approval

The Joint South London and Maudsley and the Institute of Psychiatry NHS Research Ethics Committee gave approval on the 26th March 2004 (ref: 319/03)

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Can be found at: http://www.iop.kcl.ac.uk/departments/?locator=342&project=10132

Condition

Unemployed patients with severe mental illness

Intervention

Experimental group:
The experimental condition will be Individual Placement and Support (IPS), a supported employment programme integrated within community mental health teams. The IPS model involves integrating an employment specialist into the community mental health team. This model focuses on rapid placement with continued follow-up support. The IPS model also seeks to find employment opportunities that are consistent with participants' preferences, skills, and abilities. Ongoing supervision and consultation will be provided by local experts in the use of supported employment models (status employment). The duration of the treatment is up to two years.

Control group:
The comparison condition consists of existing psychosocial rehabilitation and day care programmes available in the local area, which use a sheltered vocational rehabilitation approach. Unlike IPS, the comparison services are coordinated with, but not integrated into the community mental health teams. This is therefore a Treatment As Usual (TAU) control, which we have selected after considering options for a control matched for staff intensity of input, but we have ruled this out as current day care and voctional rehabilitation options are multiple and often intensive in the study areas (Croydon and Lambeth).


Further information (as of 23rd January 2007):
An adjunctive qualitative study is due to commence in November 2006. A semi-structured questionnaire will ask clients their views on any support they may have received to help them look for work, barriers to finding work, state benefits, positive and negative aspects of working and disclosure of mental health problems at work. It is planned to interview approximately 20 participants, with the project taking approximately one year to complete.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Work status (all work, competitive work)
2. Total income, net income

Secondary outcome measures

1. Service use, service costs and societal costs
2. Quality of life
3. Unmet needs
4. Mental state

Overall trial start date

17/10/2004

Overall trial end date

01/10/2008

Reason abandoned

Eligibility

Participant inclusion criteria

Amended as of 30/01/2009: point one has been amended as follows:
1. Severe mental illness (duration of illness over two years, Global Assessment of Functioning score of 60 or less, and psychotic or chronic affective disorder)

Initial information at time of registration:
1. Severe mental illness (duration of illness over two years, Global Assessment of Functioning score of 50 or less, and psychotic or chronic affective disorder)
2. Receiving outpatient or community psychiatric care from local mental health services
3. Aged 18 to 65 years, either sex
4. Able to read and speak English
5. Giving informed written consent
6. Unemployed for at least three months before enrolment into the study

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

240

Participant exclusion criteria

1. Relapse in last three months
2. Cannot read or speak English
3. Employed in previous three months

Recruitment start date

17/10/2004

Recruitment end date

01/10/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Health Services Research
London
SE5 8AF
United Kingdom

Sponsor information

Organisation

King's College London (UK)

Sponsor details

Research and Development Office
Room W1.08
Institute of Psychiatry
De Crespigny Park
London
SE5 8AF
United Kingdom
+44 (0)20 7848 0251
G.Dale@iop.kcl.ac.uk

Sponsor type

University/education

Website

http://www.kcl.ac.uk/

Funders

Funder type

Charity

Funder name

The Wellcome Trust (UK) (grant ref: 071272)

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

1. 2009 recruitment difficulties results in http://www.ncbi.nlm.nih.gov/pubmed/18718555
2. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20435968

Publication citations

  1. Recruitment difficulties results

    Howard L, de Salis I, Tomlin Z, Thornicroft G, Donovan J, Why is recruitment to trials difficult? An investigation into recruitment difficulties in an RCT of supported employment in patients with severe mental illness., Contemp Clin Trials, 2009, 30, 1, 40-46, doi: 10.1016/j.cct.2008.07.007.

  2. Results

    Howard LM, Heslin M, Leese M, McCrone P, Rice C, Jarrett M, Spokes T, Huxley P, Thornicroft G, Supported employment: randomised controlled trial., Br J Psychiatry, 2010, 196, 5, 404-411, doi: 10.1192/bjp.bp.108.061465.

Additional files

Editorial Notes