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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
Type of registration
Prospectively registered

Titles & IDs
Public title
Vocational rehabilitation in first episode psychosis
Scientific title
The effect of vocational rehabilitation on employment and health outcomes in first episode psychosis: A randomised controlled pilot study
Secondary ID [1] 280981 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
First-episode psychosis 679 0
Condition category
Condition code
Mental Health 754 754 0 0
Psychosis and personality disorders

Study type
Description of intervention(s) / exposure
6 month intervention with Youth Employment Specialist.
Intervention code [1] 676 0
Comparator / control treatment
Treatment as Usual.
Control group

Primary outcome [1] 942 0
Vocational status.
Timepoint [1] 942 0
Measured at baseline and at the end of the 6 month intervention in the intervention group and at 6 months post baseline assessment in the control group.
Secondary outcome [1] 1798 0
Symptom severity
Timepoint [1] 1798 0
Measured at baseline and at the end of the 6 month intervention in the intervention group and at 6 months post baseline assessment in the control group.
Secondary outcome [2] 1799 0
Quality of life
Timepoint [2] 1799 0
Measured at baseline and at the end of the 6 month intervention in the intervention group and at 6 months post baseline assessment in the control group.

Key inclusion criteria
Stated desire to seek employment.
Minimum age
15 Years
Maximum age
25 Years
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
Intellectual disability.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer randomisation carried out by independent party
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?

Intervention assignment
Other design features
Phase 2 / Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 834 0
Government body
Name [1] 834 0
NHMRC - Program Grant
Address [1] 834 0
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Country [1] 834 0
Funding source category [2] 835 0
Commercial sector/Industry
Name [2] 835 0
Address [2] 835 0
Bristol-Myers Squibb
556 Princess Highway
Country [2] 835 0
United States of America
Primary sponsor type
ORYGEN Research Centre
Secondary sponsor category [1] 702 0
Name [1] 702 0
The UNiversity of Melbourne
Address [1] 702 0
The University of Melbourne
Victoria 3010
Country [1] 702 0

Ethics approval
Ethics application status
Ethics committee name [1] 287775 0
Melbourne Health Mental Health Research and Ethics Committee
Ethics committee address [1] 287775 0
Royal Melbourne Hospital
Ethics committee country [1] 287775 0
Date submitted for ethics approval [1] 287775 0
Approval date [1] 287775 0
Ethics approval number [1] 287775 0
New ethics HREC. Please modify.

Brief summary
The aim of this project is to examine the acceptability and effectiveness of introducing a vocational specialist into the clinical program of a service providing clinical interventions for people aged between 15 and 25 experiencing a first episode of psychosis in the north and west regions of Melbourne. In the project a person with expertise in the rehabilitation employment sector will be employed to provide specialist input with clients of the Early Psychosis, Prevention and Intervention Centre (EPPIC). The proposed intervention is based upon a model called supported employment (sometimes called individual placement and support). This model has been found to be the most effective model of vocational rehabilitation for people with chronic mental illnesses. However, to date only one published pilot study has examined the usefulness of this model in people in the early phase of their illnesses. This study, conducted in England, and another, unpublished from America, suggests that this model may be successfully applied to helping young people with mental illness return to work and study. Unemployment and withdrawal from training and study are often sequelae of psychosis, and for the group who go on to develop schizophrenia, unemployment rates of 80% and above have been reported both in Australia and other comparable countries. Unemployment, leads to social isolation, and lower socio-economic status, both of which, along with unemployment itself, are risk factors for further psychotic episodes. This intervention seeks to prevent this sequence of events from beginning by actively supporting young people who wish to work. Supported employment works by having a specialist who collaborates with the young person to help them identify competitive work (i.e. work opportunities that are open to the public as opposed to sheltered work opportunities available only to particular groups) that they would like to do, prepare for interviews and crucially, supports the person in the role after they have obtained the job. This support is often not at the workplace, but consists of meetings outside work. In all of the interventions the vocational specialist liaises with the clientÿ¢ÿ¿ÿ¿s case manager, and clinical care is continued throughout. The study will be conducted by recruiting clients of the EPPIC service who have expressed an interest in working. They will be randomised to either a group that will work with the vocational specialist or to a group that will receive EPPIC treatment as usual. Participants will be assessed at the time of coming into the study and six months later. The assessment battery will include demographic questions, measures of psychopathology, symptomatology and quality of life. There will also be a questionnaire examining work history in the previous six months. This information will be collected by a trained research assistant.
Trial website
Trial related presentations / publications
Baksheev, G. N., et al. (2012). "Predictors of vocational recovery among patients with first-episode psychosis: findings from a randomised controlled trial." Psychiatric rehabilitation journal 35(6): 421-427.
Public notes

Principal investigator
Name 36294 0
Address 36294 0
Country 36294 0
Phone 36294 0
Fax 36294 0
Email 36294 0
Contact person for public queries
Name 9865 0
Dr Eoin Killackey
Address 9865 0
University of Melbourne
35 Poplar Road
Parkville VIC 3052
Country 9865 0
Phone 9865 0
+61 3 93422900
Fax 9865 0
Email 9865 0
Contact person for scientific queries
Name 793 0
Dr Eoin Killackey
Address 793 0
University of Melbourne
35 Poplar Road
Parkville VIC 3052
Country 793 0
Phone 793 0
+61 3 93422900
Fax 793 0
Email 793 0

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary