Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000849998
Ethics application status
Approved
Date submitted
13/06/2011
Date registered
10/08/2011
Date last updated
28/07/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Does cognitive remediation improve employment prospects for people with a mental illness returning to work?
Scientific title
Does treatment with Cognitive Remediation and Supported Employment as against Supported Employment alone improve employment prospects for people with a severe mental illness returning to work?
Secondary ID [1] 262366 0
Nil
Universal Trial Number (UTN)
U1111-1122-1368
Trial acronym
CogRem
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Schizophrenia 268070 0
Schizophreniform Disorder 268087 0
Bipolar 1 Disorder 268088 0
Psychosis Not Otherwise Stated 268089 0
Schizoaffective disorder 268090 0
Delusional Disorder 268091 0
Major Depressive Disorder with Psychotic features 268092 0
Condition category
Condition code
Mental Health 268215 268215 0 0
Schizophrenia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cognitive Remediation - Internet delivered Cognitive Remediation aiming to improve deficits in attention, concentration, vigilance, memory, speed of processing, planning skills & facial emotion recognition. The treatment will be delivered twice weekly for 45-60 minutes for at least 10 weeks. Treatment can continue for up to 16 weeks. The duration of treatment within that time frame is at the behest of the individual concerned.
Supported Employment - participants will be case managed by vocational employment officers at a ratio of no more than 20 cases per case manager and placed and supported in educational or employment opportunities as it becomes available.
Intervention code [1] 266759 0
Rehabilitation
Intervention code [2] 266776 0
Treatment: Other
Comparator / control treatment
Internet delivered health information will aim to provide access to a broad range of internet available educational and treatment related websites. It will also ask patients to access such popular websites as facebook and email accounts to help balance the number of hours spent "online" between arms.
Supported Employment - participants will be case managed by vocational employment officers at a ratio of no more than 20 cases per case manager and placed and supported in educational or employment opportunities as it becomes available.
Control group
Active

Outcomes
Primary outcome [1] 268953 0
Total number of hours worked - assessed at 6 months by detailed log of work performed including paysheets of participants on the basis of figures reported to DEWR. Assessed at 12 months on the basis of a detailed log of work performed.
Timepoint [1] 268953 0
6 months
12 months
Secondary outcome [1] 276678 0
Total number of days in work over 12 months.
Measured on basis of participant log and report of Supported Employment case manager using all available data including payslips
Timepoint [1] 276678 0
6 months
12 months
Secondary outcome [2] 276719 0
Total number of jobs over 12 months
Measured on basis of participant log and report of Supported Employment case manager using all available data including payslips
Timepoint [2] 276719 0
6 months
12 months
Secondary outcome [3] 276720 0
Total wages over 12 months
Measured on basis of participant log and report of Supported Employment case manager using all available data including payslips
Timepoint [3] 276720 0
12 months
Secondary outcome [4] 276721 0
Change in cognition will be measured using web-based neuropsychiatric testing. Each cognitive domain listed below will be tested and any improvement in cognition measured via web-delivered neuropsychiatric testing will include the following:-
Emotion Identification - Explicit Emotion Identification
Emotion Recognition - Implicit Emotion Recognition
Response Speed - Motor Tapping
Impulsivity - Go-NoGo
Attention-Concentration - Continuous Performance Test
Information Processing Efficiency - Switching of Attention, Verbal Interference, Choice Reaction Time
Memory - Digit Span, Memory Recognition
Executive Function - Maze
Timepoint [4] 276721 0
6 months
12 months
Secondary outcome [5] 276722 0
Number of readmissions to hospital - On the basis of participant report
Timepoint [5] 276722 0
12 months
Secondary outcome [6] 276723 0
Role Functioning Scale score - on the basis of supported employment officer reports
Timepoint [6] 276723 0
6 months
12 months
Secondary outcome [7] 276724 0
Number of contacts with Supported Employment service over 12 months
On the basis of Contacts register and notes at Disability Employment Service Office
Timepoint [7] 276724 0
6 months
12 months

Eligibility
Key inclusion criteria
1. Eligible for the employment program
2. Had given consent to take part in the program
3. a diagnosis of a severe mental illness as defined as schizophrenia, schizophreniform disorder, bipolar disorder, psychotic depression
4. age between 18 and 65 years
5. not developmentally delayed
6. no current substance dependence other than nicotine and caffeine
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Current Substance abuse or dependence
2. Mental Retardation
3. Unable to give consent

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)
Subjects will be recruited at the Supported Employment site by staff independent to the study.
Subjects will log on to study website and after finishing registration will be randomly allocated to a treatment condition. Randomisation is concealed as workers at the individual sites are unable to unmask the randomisation key.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation code has been computer generated by statistician independent to the trial.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
5/09/2011
Actual
7/09/2011
Date of last participant enrolment
Anticipated
Actual
31/10/2013
Date of last data collection
Anticipated
Actual
18/10/2014
Sample size
Target
150
Accrual to date
Final
89
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 4103 0
2093
Recruitment postcode(s) [2] 4104 0
2560
Recruitment postcode(s) [3] 4105 0
2134
Recruitment postcode(s) [4] 4106 0
2103
Recruitment postcode(s) [5] 4107 0
2576
Recruitment postcode(s) [6] 4108 0
2650

Funding & Sponsors
Funding source category [1] 267242 0
Charities/Societies/Foundations
Name [1] 267242 0
Australian Rotary Health
Country [1] 267242 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
The University of Sydney
NSW 2006
Country
Australia
Secondary sponsor category [1] 266307 0
Charities/Societies/Foundations
Name [1] 266307 0
Schizophrenia Fellowship of NSW
Address [1] 266307 0
Locked Bag 5014,
Gladesville NSW 1675
Country [1] 266307 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269233 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 269233 0
Ethics committee country [1] 269233 0
Australia
Date submitted for ethics approval [1] 269233 0
Approval date [1] 269233 0
31/03/2011
Ethics approval number [1] 269233 0
13424

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32736 0
A/Prof Anthony Harris
Address 32736 0
Discipline of Psychiatry
University of Sydney
NSW 2006
Australia
Country 32736 0
Australia
Phone 32736 0
+61 2 9845 6688
Fax 32736 0
Email 32736 0
[email protected]
Contact person for public queries
Name 15983 0
Associate Professor Anthony Harris
Address 15983 0
Department of Psychiatry
Westmead Hospital
PO Box 533
Wentworthville NSW 2145
Country 15983 0
Australia
Phone 15983 0
+61 2 9845 6688
Fax 15983 0
+61 2 9635 7734
Email 15983 0
[email protected]
Contact person for scientific queries
Name 6911 0
Associate Professor Anthony Harris
Address 6911 0
Department of Psychiatry
Westmead Hospital
PO Box 533
Wentworthville NSW 2145
Country 6911 0
Australia
Phone 6911 0
+61 2 9845 6688
Fax 6911 0
Email 6911 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.