ANZCTR - Registration

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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]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

First-episode psychosis

Condition category

Condition code

Mental Health

Psychosis and personality disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

6 month intervention with Youth Employment Specialist.

Intervention code [1]

Rehabilitation

Comparator / control treatment

Treatment as Usual.

Control group

Active

Outcomes

Primary outcome [1]

Vocational status.

Timepoint [1]

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]

Symptom severity

Timepoint [1]

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]

Quality of life

Timepoint [2]

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

Sex

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

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

3/10/2005

Actual

3/10/2005

Date of last participant enrolment

Anticipated

10/04/2006

Actual

10/04/2006

Date of last data collection

Anticipated

10/10/2006

Actual

10/10/2006

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

NHMRC - Program Grant

Address [1]

National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601

Country [1]

Australia

Funding source category [2]

Commercial sector/Industry

Name [2]

BMS

Address [2]

Bristol-Myers Squibb
556 Princess Highway
NOBLE PARK NORTH, VICTORIA 3174

Country [2]

United States of America

Primary sponsor type

Other

Name

ORYGEN Research Centre

Address

Country

Australia

Secondary sponsor category [1]

University

Name [1]

The UNiversity of Melbourne

Address [1]

The University of Melbourne
Victoria 3010
Australia

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Melbourne Health Mental Health Research and Ethics Committee

Ethics committee address [1]

Royal Melbourne Hospital

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

15/08/2005

Approval date [1]

15/09/2005

Ethics approval number [1]

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 clientÃ¿Â¢Ã¿Â¿Ã¿Â¿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

Address

Country

Phone

Fax

Contact person for public queries

Name

Dr Eoin Killackey

Address

University of Melbourne
35 Poplar Road
Parkville VIC 3052

Country

Australia

Phone

+61 3 93422900

Fax

eoin@unimelb.edu.au

Contact person for scientific queries

Name

Dr Eoin Killackey

Address

University of Melbourne
35 Poplar Road
Parkville VIC 3052

Country

Australia

Phone

+61 3 93422900

Fax

eoin@unimelb.edu.au

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

No additional documents have been identified.

Trial Review

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