The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12605000554662
Ethics application status
Approved
Date submitted
26/09/2005
Date registered
29/09/2005
Date last updated
27/07/2016
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
Nil
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

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

Outcomes
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.

Eligibility
Key inclusion criteria
Stated desire to seek employment.
Minimum age
15 Years
Maximum age
25 Years
Gender
Both males and females
Can healthy volunteers participate?
No
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
Parallel
Other design features
Phase
Phase 2 / Phase 3
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
Australia
Funding source category [2] 835 0
Commercial sector/Industry
Name [2] 835 0
BMS
Address [2] 835 0
Bristol-Myers Squibb
556 Princess Highway
NOBLE PARK NORTH, VICTORIA 3174
Country [2] 835 0
United States of America
Primary sponsor type
Other
Name
ORYGEN Research Centre
Address
Country
Australia
Secondary sponsor category [1] 702 0
University
Name [1] 702 0
The UNiversity of Melbourne
Address [1] 702 0
The University of Melbourne
Victoria 3010
Australia
Country [1] 702 0
Australia

Ethics approval
Ethics application status
Approved
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
Australia
Date submitted for ethics approval [1] 287775 0
15/08/2005
Approval date [1] 287775 0
15/09/2005
Ethics approval number [1] 287775 0
New ethics HREC. Please modify.

Summary
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

Contacts
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
Australia
Phone 9865 0
+61 3 93422900
Fax 9865 0
Email 9865 0
eoin@unimelb.edu.au
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
Australia
Phone 793 0
+61 3 93422900
Fax 793 0
Email 793 0
eoin@unimelb.edu.au

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