Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000092493p
Ethics application status
Submitted, not yet approved
Date submitted
13/01/2016
Date registered
28/01/2016
Date last updated
28/01/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Occupational and symptom outcomes of combining vocational rehabilitation and cognitive remediation in people with schizophrenia
Scientific title
Effectiveness of integrating cognitive training and individual placement and support programmes on occupational, cognitive and healthcare outcomes in people with schizophrenia
Secondary ID [1] 288291 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Schizophrenia 297251 0
Condition category
Condition code
Mental Health 297456 297456 0 0
Schizophrenia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BrainHQ developed by PositScience Corporation, which is a neuroplasticity based computerised cognitive training programme designed to enhance and restore auditory perceptual and working memory processes, will be used for cognitive training in the intervention group (40 participants). The neuroscience informed approach facilitates training induced neuroplasticity through neuro-adaptive drill and practice exercises which are engaging, rewarding and uses a hierarchical approach to exercise structures.

Selected participants in the intervention group will engage in 40 hours of cognitive training at the rate of one hour daily, four to five times weekly, over a period of 8-10 weeks using the Posit Science BrainHQ programme. Laptops and internet connection with access to BrainHQ will be provided for the duration of the study and participants can do the cognitive training at their residence. Once participants engage in 40 hours of BrainHQ training they will be considered as having completed training.
Project Officer/s (PO) who are qualified occupational therapists or mental health nurses or clinical psychologists and who have experience with cognitive training will be recruited for the purpose of this research project. The PO will assist participants to familiarise with the BrainHQ programme, set up the training package and problem solve any issues for the first 3 sessions face to face. Subsequently the PO will provide telephone support (and face to face support, if required) 2- 3 times a week for the duration of the training. The PO will have access to the participants’ progress and amount of training carried out as an administrator of the BrainHQ. PO will contact the participant to discuss progress, encourage participation, and resolve any training issues. If any clinical concern is observed by the PO or raised by the participant it will be brought to the attention of the treating team. Participant or the treating psychiatrist can take a decision to withdraw the participant from the cognitive training at any stage.
For this study we will be recruiting only people with schizophrenia who are involved in the Individual Placement and Support (IPS) Programme. Participants in both the intervention and control group will be enrolled in the IPS. IPS is an evidence based model of providing vocational rehabilitation that integrates mental health services and employment services. It has been demonstrated through evidence around the world that IPS services are obtaining better outcomes for mental health consumers in employment rates, time to commencement of first job and number of hours worked. The IPS approach has eight key principals - focus on competitive employment, integration of employment specialists with mental health treatment teams, zero exclusion, individualised job search based on consumer preferences, rapid job search, benefits counselling, systematic job development and time unlimited and individualised support. In Western Australia, in the past few years, many public mental health services have entered into partnership with Disability Employment Providers to establish IPS Programmes as part of clinical services for people with severe mental illness.
Intervention code [1] 293587 0
Treatment: Other
Comparator / control treatment
People with schizophrenia drawn from the same setting involved with the Individual Placement and Support Programme (IPS) and receiving other treatments as usual
Control group
Active

Outcomes
Primary outcome [1] 297018 0
Number of people who obtained jobs. Information will be collected through interviewing the participants and from the employment consultant working with the IPS Programme
Timepoint [1] 297018 0
Twelve months from completion of the intervention and a similar period in the control group
Primary outcome [2] 297078 0
Number of days worked in any job. Information will be collected through interviewing the participants and from the employment consultant working with the IPS Programme.
Timepoint [2] 297078 0
Twelve months from completion of the intervention and a similar period in the control group
Primary outcome [3] 297082 0
Number of days hospitalised for a psychiatric illness. Information will be collected by interviewing the participants and participants' care co-ordinators of the treating clinical teams, and from the medical records.
Timepoint [3] 297082 0
Twelve months from completion of the intervention and a similar period in the control group
Secondary outcome [1] 319856 0
Positive and negative symptom of schizophrenia measured using The Scale for Assessment of Positive Smptoms and The Scale for Assessment of Negative Symptoms
Timepoint [1] 319856 0
on completion of intervention and 12 months after completion of intervention and similar periods in the control group
Secondary outcome [2] 319857 0
cognitive functions measured utilising components of CANTAB Schizophrenia Battery
Timepoint [2] 319857 0
on completion of intervention and 12 months after completion of intervention and similar periods in the control group
Secondary outcome [3] 319992 0
Functional capacity measured using the University of California San Diego Performance Skills Assessment (Brief) UPSA -B
Timepoint [3] 319992 0
on completion of intervention and 12 months after completion of intervention and similar periods in the control group
Secondary outcome [4] 319993 0
Community functioning measured using the Specific Level of Function Scale (SLOF)
Timepoint [4] 319993 0
on completion of intervention and 12 months after completion of intervention and similar periods in the control group
Secondary outcome [5] 319994 0
depression severity measured using Zung Depression Rating Scale
Timepoint [5] 319994 0
on completion of intervention and 12 months after completion of intervention and similar periods in the control group
Secondary outcome [6] 319995 0
anxiety symptoms measured using Zung Anxiety Rating Scale
Timepoint [6] 319995 0
on completion of intervention and 12 months after completion of intervention and a similar period in the control group

Eligibility
Key inclusion criteria
Voluntary patients who are registered as community outpatients of Bentley, PaRK, Osborne Park or Midland Mental Health Services, WA, Australia and participating in the Individual Placement and Support Programme at these sites.
Diagnosis of schizophrenia according to ICD -10 criteria, diagnosed by the treating psychiatrist
Fluent in English
Able to provide consent to participate in research as determined by the treating psychiatrist or treating doctor or care coordinator within the treating team
Written consent provided by participant
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Involuntary status under the Mental Health Act
History of head injury, epilepsy, pre-existing intellectual disability or dependence on alcohol or illicit drugs.
Current in-patient
Not able to provide informed consent as determined by the treating psychiatrist / or his /her delegate from the treating team.
Clinically deemed to be not suitable to participate by the treating psychiatrist / Psychiatry Registrar/ Medical Officer or Care Coordinator..
Has received ECT in the past 6 month or had any neuroplasticity based treatments in the past such as CT, trans-cranial magnetic stimulation or deep brain stimulation.
Questionable fluency or lack of fluency with spoken and written English

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)
Participants will draw sealed opaque envelopes from the project officer for allocation to either intervention or control group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
By drawing lots blindly and allocating to treatment and control group (simple randomisation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical analyses
Statistical analyses will be conducted using IBM SPSS Statistics version 22. Between groups differences for continuously distributed variables will be assessed using independent samples t-test. Ordinal and nominal data will be treated using non-parametric procedures. p values less than 0.05 will be considered as significant.

Power calculations
Power calculations were conducted using GPower (version 3.1.9.2). Since our study involves multiple outcome measures we have modelled various scenarios in order to find out the optimal total sample size which will provide a reasonable balance of power and expected effect sizes. . Modelling has taken into account two parameters: total sample size (from 40 to 80 with equal groups) and effect size (% difference between groups in range from 15% to 40%). For example, with the total size of 60 (30 subjects in each group) 30-35% observed difference in employment rate will have enough statistical power. If effect size (% difference) is expected to be lower (e.g., 25%), then 40 subjects in each group is a minimum to attain the required statistical power greater than 70%.


We expect the difference in number of days employed to be 25-30% between the groups. On the basis of this modelling, we conclude that our study should involve a minimum of 80 subjects, ideally 40 in each group. This total sample size will survive a slight subject’s attrition during study life.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2016
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 292667 0
Government body
Name [1] 292667 0
STATE HEALTH RESEARCH ADVISORY COUNCIL (SHRAC) WA
Country [1] 292667 0
Australia
Primary sponsor type
University
Name
Office of Research Enterprise, University of Western Australia
Address
35 Stirling Hwy, Perth Western Australia 6009

Country
Australia
Secondary sponsor category [1] 291388 0
None
Name [1] 291388 0
Address [1] 291388 0
Country [1] 291388 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 294139 0
South Metropolitan Health Service Human Research Ethics Committee
Ethics committee address [1] 294139 0
Ethics committee country [1] 294139 0
Australia
Date submitted for ethics approval [1] 294139 0
03/11/2015
Approval date [1] 294139 0
Ethics approval number [1] 294139 0

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

Contacts
Principal investigator
Name 62662 0
Prof Alexander John
Address 62662 0
School of Psychiatry, University of Western Australia
Bentley Health Service, Mills Street
Bentley 6102
WA
Country 62662 0
Australia
Phone 62662 0
+61894163666
Fax 62662 0
Email 62662 0
[email protected]
Contact person for public queries
Name 62663 0
Helen Ayres
Address 62663 0
John Milne Centre
Bentley Health Service
Mills Street
Bentley 6102, WA
Country 62663 0
Australia
Phone 62663 0
+61894163666
Fax 62663 0
Email 62663 0
[email protected]
Contact person for scientific queries
Name 62664 0
Alexander John
Address 62664 0
School of Psychiatry, University of Western Australia
Bentley Health Service, Mills Street
Bentley 6102
WA
Country 62664 0
Australia
Phone 62664 0
+61894163666
Fax 62664 0
Email 62664 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.