Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000094370
Ethics application status
Approved
Date submitted
12/11/2007
Date registered
20/02/2008
Date last updated
27/07/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Vocational Recovery in Young People With First Episode Psychosis.
Scientific title
A Randomised Controlled Trial of Individual Placement and Support versus treatment as usual in young people with first episode psychosis. Predictors of outcome and health, social, employment and economic outcomes.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Unemployment in first episode psychosis 2541 0
Condition category
Condition code
Mental Health 2641 2641 0 0
Schizophrenia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will be an employment intervention called Individual Placement and Support which is a well defined version of Supported Employment. Individual Placement and Support has six key principles: it is focussed on competitive employment (i.e. jobs which are not set aside but open to anyone with the appropriate skills or qualifications to apply for) as an outcome; IPS is open to any person with mental illness who chooses to look for work and that acceptance into the program is not determined by measures of work-readiness or illness variables; job searching commences directly on entry into the program; the IPS program is integrated with the mental health treatment team; potential jobs are chosen based on consumer preference; and the support provided in the program is time-unlimited, continuing after employment is obtained, and is adapted to the needs of the individual. A seventh principle is also sometimes considered as part of the model of IPS which is benefits counselling as there are often disincentives to be negotiated in transitioning from a welfare benefit to paid employment. These can include loss of concessions for transport and utilities, high effective marginal tax rates and loss of public health access (especially in USA). Those in the intervention group will receive service from one of two employment consultants who will follow the principles of the IPS model described above. These consultants are people who have worked in and are familiar with the Department of Employment and Workplace Relations (DEWR) system, but are not subject to the contractual conditions of DEWR services in their current role. Their job will be to meet with participants as required, begin job searching immediately, support the job seeking process and support those who find work in their position for the duration of the intervention. They may also work with participants to achieve an educational outcome such as enrolment in a course where this is the most appropriate outcome for the individual. Those in the intervention group will have access to all normal Early Psychosis Prevention and Intervention Centre (EPPIC) services. In intervention the consultant liaises with the participant’s case manager, and clinical care is continued throughout. The intervention will last for a period of 6 months. The employment sought will be in the open labour market.
Intervention code [1] 2273 0
Rehabilitation
Comparator / control treatment
The comparator will be treatment as usual which in the case of employment consists of case manager determined referral to external employment agencies.
Control group
Active

Outcomes
Primary outcome [1] 3551 0
Employment
Timepoint [1] 3551 0
6 months (end of intervention) 12 & 18 months
Secondary outcome [1] 6495 0
Symptomotology
Timepoint [1] 6495 0
6 months (end of intervention) 12 & 18 months
Secondary outcome [2] 6496 0
Social participation
Timepoint [2] 6496 0
6 months (end of intervention) 12 & 18 months
Secondary outcome [3] 6497 0
Economic participation
Timepoint [3] 6497 0
6 months (end of intervention) 12 & 18 months
Secondary outcome [4] 6498 0
Economic evaluation of intervention
Timepoint [4] 6498 0
6 months (end of intervention) 12 & 18 months
Secondary outcome [5] 6499 0
Self-reported health service usage
Timepoint [5] 6499 0
6 months (end of intervention) 12 & 18 months

Eligibility
Key inclusion criteria
Patrients of a first episode psychosis service aged between 15 and 25 years who have a stated desire to seek employment
Minimum age
15 Years
Maximum age
25 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Lack of sufficient english fluency to participate in assessments

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Enrolling will be conducted by the project manager after referral to the study from case managers of the Early Psychosis Prevention and Intervention Centre (EPPIC). Allocation will be conducted by a statistician independent of the study but located at the same centre who will then inform the employment consultant which clients to see. The research assistant who will conduct assessments will remain blind to the allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation will be conducted by a statistician using a computer programme with random blocks.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2008
Actual
2/04/2008
Date of last participant enrolment
Anticipated
Actual
8/04/2011
Date of last data collection
Anticipated
Actual
7/10/2012
Sample size
Target
360
Accrual to date
Final
146
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2784 0
Charities/Societies/Foundations
Name [1] 2784 0
Australian Rotary Health Research Foundation
Country [1] 2784 0
Australia
Funding source category [2] 2785 0
Commercial sector/Industry
Name [2] 2785 0
ORYGEN Research Centre
Country [2] 2785 0
Australia
Primary sponsor type
Individual
Name
Dr Eoin Killackey
Address
ORYGEN Research Centre
35 Poplar Road
Parkville, 3052
Victoria
Country
Australia
Secondary sponsor category [1] 2516 0
None
Name [1] 2516 0
Address [1] 2516 0
Country [1] 2516 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4703 0
North Western Mental Health Human Research and Ethics Committee
Ethics committee address [1] 4703 0
Ethics committee country [1] 4703 0
Australia
Date submitted for ethics approval [1] 4703 0
19/11/2007
Approval date [1] 4703 0
05/03/2008
Ethics approval number [1] 4703 0
Ethics committee name [2] 5073 0
Ethics committee address [2] 5073 0
Ethics committee country [2] 5073 0
Date submitted for ethics approval [2] 5073 0
10/12/2007
Approval date [2] 5073 0
Ethics approval number [2] 5073 0

Summary
Brief summary
Unemployment is the most significant non-illness disability that people with mental illness face. Despite much effort being put into employment systems in the community, they remain the single most unemployed disability group despite being able to, and wanting to work. In this study we will trial a form of employment intervention known as Individual Placement and Support with a group of young people with first episode psychosis who are interested in finding work. Our primary aim is to see if this intervention is superior to currently normal treatment. Secondly we are interested in seeing if employment has positive effects on symptoms and medication management. Finally we will be examining the economics of this intervention to establish if the benefit (if there is one) exceeds the cost of providing this type of intervention.
Trial website
Trial related presentations / publications
Killackey, E., et al. (2013). "A randomized controlled trial of vocational intervention for young people with first-episode psychosis: method." Early Intervention in Psychiatry 7(3): 329-337.

Arnold, C., et al. (2015). "Neurocognitive and social cognitive predictors of cannabis use in first-episode psychosis." Schizophrenia Research 168: 231-237.

Caruana, E., et al. (2015). "The Relationship between Cognition, Job Complexity and Employment Duration in First-Episode Psychosis." Psychiatric rehabilitation journal 38(3): 210-217.

Reser, M. P., et al. (2015). "Exploring cognitive heterogeneity in first-episode psychosis: What cluster analysis can reveal." Psychiatry Research 229(3): 819-827.

On, Z. X., et al. (In Press). "Relationship between duration of untreated psychosis and neurocognition and social cognition in first-episode psychosi." Schizophrenia Research.
Public notes

Contacts
Principal investigator
Name 28176 0
Address 28176 0
Country 28176 0
Phone 28176 0
Fax 28176 0
Email 28176 0
Contact person for public queries
Name 11333 0
Dr Eoin Killackey
Address 11333 0
ORYGEN Research Centre
35 Poplar Road
Parkville, 3052
Victoria
Country 11333 0
Australia
Phone 11333 0
+61 3 9342 2900
Fax 11333 0
Email 11333 0
[email protected]
Contact person for scientific queries
Name 2261 0
Dr Eoin Killackey
Address 2261 0
ORYGEN Research Centre
35 Poplar Road
Parkville, 3052
Victoria
Country 2261 0
Australia
Phone 2261 0
+61 3 9342 2900
Fax 2261 0
Email 2261 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseRelationship between duration of untreated psychosis and neurocognition and social cognition in first-episode psychosis.2016https://dx.doi.org/10.1016/j.schres.2016.06.018
EmbaseHeterogeneity of quality of life in the later stages of first-episode psychosis recovery.2023https://dx.doi.org/10.1007/s11136-022-03277-x
EmbaseIndividual placement and support for vocational recovery in first-episode psychosis: Randomised controlled trial.2019https://dx.doi.org/10.1192/bjp.2018.191
N.B. These documents automatically identified may not have been verified by the study sponsor.