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
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
-
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.
-
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.