Trial Review

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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] 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
Sex
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
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
40
Accrual to date
Final
41
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 834 0
Government body
Name [1] 834 0
NHMRC - Program Grant
Country [1] 834 0
Australia
Funding source category [2] 835 0
Commercial sector/Industry
Name [2] 835 0
BMS
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
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
Trial website
Trial related presentations / publications
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
[email protected]
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
[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
No additional documents have been identified.