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Trial registered on ANZCTR


Registration number
ACTRN12616001476426
Ethics application status
Approved
Date submitted
17/10/2016
Date registered
24/10/2016
Date last updated
6/05/2019
Date data sharing statement initially provided
6/05/2019
Date results information initially provided
6/05/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
The impact of cognitive remediation on cognitive and self-reported psychosocial outcomes in individuals with schizophrenia or schizoaffective disorder
Scientific title
The impact of cognitive remediation on cognitive and self-reported psychosocial outcomes in individuals with schizophrenia or schizoaffective disorder
Secondary ID [1] 290300 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Schizophrenia 300559 0
Schizoaffective disorder 300560 0
Condition category
Condition code
Mental Health 300415 300415 0 0
Schizophrenia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The current study is examining the relative benefits of a 10-week computer-based cognitive remediation (CR) intervention delivered in the community with participants with schizophrenia or schizoaffective disorder, when compared with an active control. Participants will be randomised into one of the study groups: CR or control. Primary outcomes will include a range of cognitive and self-report psychosocial measures.

The CR intervention will involve the delivery of twenty 1-hour face-to-face intervention sessions over the 10 weeks (2 sessions/week). Intervention sessions will be delivered in groups of 2-4 people. The intervention will be delivered across a range of locations including MAPrc, supported residential services and other community-based locations.

The program that will be used to facilitate the CR intervention is COGPACK; a commercially available training program that has been found to be effective in improving cognitive test performance in populations with schizophrenia. The intervention will involve a 'drill-and-practice' training paradigm supplemented with internal compensation strategies provided by the group leader. The group leader will be doctoral-level neuropsychology student with experience in working with cognitively-impaired individuals.

The laptop computers (and related equipment) used in the intervention will be provided by the research lab. The intervention will follow a standardised training protocol (with some flexibility with the specific exercises based on the cognitive domain being targeted) that was developed by the research team. Adherence to specific training exercises in-session will be reviewed by the group leader during delivery of the CR sessions.

All participants will be asked to complete a baseline assessment prior to group randomisation, as well as immediately post-intervention and at three-months following the completion of the intervention.
Intervention code [1] 296115 0
Rehabilitation
Intervention code [2] 296117 0
Treatment: Devices
Intervention code [3] 296191 0
Treatment: Other
Comparator / control treatment
The control group will involve readily available computer games of similar style to those in the CR intervention. The control group will be used to control for non-specific therapeutic factors including social contact; cognitive stimulation from computer based tasks; and the structure and intensity of a 10-week intervention.
Control group
Active

Outcomes
Primary outcome [1] 299858 0
Change in objective cognitive functioning is measured using the MATRICS Consensus Cognitive Battery (MCCB).
Timepoint [1] 299858 0
Administered at baseline (prior to randomisation); immediately post-intervention (within 1 week post-intervention); and three-months post-intervention.
Primary outcome [2] 299859 0
Independent living skills are measured using global and composite subscale scores on the Independent Living Skills Survey - Self-report (ILSS-SR).
Timepoint [2] 299859 0
Administered at baseline (prior to randomisation); immediately post-intervention (within 1 week post-intervention); and three-months post-intervention.
Primary outcome [3] 299860 0
Self efficacy measured using global and composite subscale scores on the Revised Self Efficacy Scale (RSES).
Timepoint [3] 299860 0
Administered at baseline (prior to randomisation); immediately post-intervention (within 1 week post-intervention); and three-months post-intervention.
Secondary outcome [1] 328327 0
Quality of life measured using global scores on the European Health Interview Survey - Quality of Life (EUROHIS-QOL).
Timepoint [1] 328327 0
Administered at baseline (prior to randomisation); immediately post-intervention (within 1 week post-intervention); and three-months post-intervention.
Secondary outcome [2] 328328 0
Intrinsic motivation are measured using global and composite subscale scores on the Intrinsic Motivation Inventory for Schizophrenia Research (IMI-SR).
Timepoint [2] 328328 0
Administered at the completion of a participants second group session (i.e. baseline intrinsic motivation) and in the last week of the intervention (i.e. end intrinsic motivation).
Secondary outcome [3] 328329 0
Psychiatric symptoms measured total and subscale (i.e. positive, negative and general psychopathology) scores using the Positive and Negative Symptom Scale (PANSS).
Timepoint [3] 328329 0
Administered at baseline (prior to randomisation); immediately post-intervention (within 1 week post-intervention); and three-months post-intervention.
Secondary outcome [4] 328331 0
Total score from the four subtests (Word reading, Colour Naming, Interference & Interference/switching) of the Colour Word Interference task from the Delis-Kaplan Executive Function System (D-KEFS).
Timepoint [4] 328331 0
Administered at baseline (prior to randomisation); immediately post-intervention (within 1 week post-intervention); and three-months post-intervention.
Secondary outcome [5] 328365 0
Subjective participant experience of involvement in the CR or control group as measured using an open-ended survey and structured rating scales designed by the research team.
Timepoint [5] 328365 0
Administered at the end of the intervention (completed at the end of the last session)
Secondary outcome [6] 328610 0
Total score on Digit Span from the Wechsler Adult Intelligence Scale - Third edition
Timepoint [6] 328610 0
Administered at baseline (prior to randomisation); immediately post-intervention (within 1 week post-intervention); and three-months post-intervention.
Secondary outcome [7] 328611 0
Total score on delayed recall from the Hopkins Verbal Learning Test-Revised (HVLT-R)
Timepoint [7] 328611 0
Administered at baseline (prior to randomisation); immediately post-intervention (within 1 week post-intervention); and three-months post-intervention.
Secondary outcome [8] 328612 0
Total score on delayed recall from the Brief Visuospatial Memory Test-Revised (BVMT-R).
Timepoint [8] 328612 0
Administered at baseline (prior to randomisation); immediately post-intervention (within 1 week post-intervention); and three-months post-intervention.
Secondary outcome [9] 328613 0
Total score on phonemic fluency (FAS)
Timepoint [9] 328613 0
Administered at baseline (prior to randomisation); immediately post-intervention (within 1 week post-intervention); and three-months post-intervention.
Secondary outcome [10] 328614 0
Trail Making Test - Part B (TMT-B)
Timepoint [10] 328614 0
Administered at baseline (prior to randomisation); immediately post-intervention (within 1 week post-intervention); and three-months post-intervention.

Eligibility
Key inclusion criteria
- Diagnosis of schizophrenia or schizoaffective disorder
- Aged between 18-65
- Participants clinically stable with no acute psychosis requiring hospitalisation within the last 8 weeks
- Fluency in English with an ability to comprehend research material
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Estimated intelligence quotient (IQ) of less than 80 (i.e. Borderline IQ or lower)
- History of any significant neurological injury or neurodegenerative disease known to impact cognition.
- Currently pregnant
- Substance dependence in the past 6 months
- Electroconvulsive therapy in the past 6 months
- Participation in any cognitively-enhancing research trial or intervention
- Significant sensory or motor impairments that may impact ability to use computers

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)
The allocation sequence will be generated and concealed by a research member who is independent of participant recruitment and screening, intervention delivery, or statistical analysis.

Treatment allocation will be revealed to the group leader prior to the start of a given group by email correspondence once all assessments have been completed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A block randomization will be used to create the random order for the allocation of study groups. Participant will be recruited and sequentially assigned to the next group in the sequence. The treatment sequence will be created through a computer-based random sequence generator.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
None
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 6804 0
The Alfred - Prahran
Recruitment hospital [2] 6805 0
Monash Alfred Psychiatry Research Centre - Melbourne
Recruitment postcode(s) [1] 14462 0
3004 - Prahran
Recruitment postcode(s) [2] 14463 0
3004 - Melbourne
Recruitment postcode(s) [3] 14465 0
3182 - St Kilda
Recruitment postcode(s) [4] 14466 0
3141 - South Yarra
Recruitment postcode(s) [5] 14467 0
3072 - Preston
Recruitment postcode(s) [6] 14468 0
3181 - Prahran

Funding & Sponsors
Funding source category [1] 294690 0
University
Name [1] 294690 0
Monash University
Address [1] 294690 0
School of Psychological Sciences, 18 Innovation Walk, Monash University, Clayton, VIC 3800
Country [1] 294690 0
Australia
Primary sponsor type
University
Name
Monash University
Address
School of Psychological Sciences, 18 Innovation Walk, Monash University, Clayton, VIC 3800
Country
Australia
Secondary sponsor category [1] 293535 0
None
Name [1] 293535 0
Address [1] 293535 0
Country [1] 293535 0
Other collaborator category [1] 279264 0
University
Name [1] 279264 0
Swinburne University of Technology
Address [1] 279264 0
Advanced Manufacturing and Design Centre, Corner of Burwood Rd and William St, Hawthorn, Victoria, 3122 Australia.
Country [1] 279264 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296110 0
Alfred Human Research Ethics Committee
Ethics committee address [1] 296110 0
Office of Ethics and Research Governance, Ground Floor, Linay Pavilion, The Alfred, 55 Commercial Road, Melbourne VIC 3004
Ethics committee country [1] 296110 0
Australia
Date submitted for ethics approval [1] 296110 0
20/08/2014
Approval date [1] 296110 0
17/09/2014
Ethics approval number [1] 296110 0
354/14
Ethics committee name [2] 296111 0
Monash University Human Research Ethics Committee
Ethics committee address [2] 296111 0
Monash University, Room 111, Chancellery Building E, 24 Sports Walk, Clayton Campus, Wellington Rd, Clayton VIC 3800, Australia

Ethics committee country [2] 296111 0
Australia
Date submitted for ethics approval [2] 296111 0
13/10/2014
Approval date [2] 296111 0
16/10/2014
Ethics approval number [2] 296111 0
CF14/3094 - 2014001700 & CF15/536 - 2015000253

Summary
Brief summary
Cognitive impairment is a significant cause of psychosocial disability in people with schizophrenia and schizoaffective disorder, and persists even when psychiatric symptoms are well managed. Cognitive remediation has demonstrated much promise as a method of alleviating cognitive symptoms and supporting improvements in real-world functioning. Nevertheless, well-controlled research trials remain a minority in the research literature, particularly those focusing on self-reported psychosocial outcomes that form key components of recovery from mental illness. There is also little consideration of patient related factors that may impact treatment adherence or success.

At Monash University, in affiliation with the Monash Alfred Psychiatry research centre, we are running a randomized controlled trial to explore the unique benefits of CR on cognitive and self-reported psychosocial outcomes when compared to an active control in a population with schizophrenia or schizoaffective disorder. We will also examine the role of patient-related factors in predicting treatment-related outcomes and qualitatively explore the lived experience of participation in a social group based intervention.
Trial website
http://www.maprc.org.au/schizophrenia-trials
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 69574 0
Prof Susan Rossell
Address 69574 0
Monash Alfred Psychiatry research centre (MAPrc), Level 4, 607 St Kilda Road, Melbourne VIC 3004
Country 69574 0
Australia
Phone 69574 0
+61 3 9076 6564
Fax 69574 0
Email 69574 0
SRossell@srossell.com
Contact person for public queries
Name 69575 0
Mr Shayden Bryce
Address 69575 0
Monash Alfred Psychiatry research centre (MAPrc), Level 4, 607 St Kilda Road, Melbourne VIC 3004
Country 69575 0
Australia
Phone 69575 0
+61 3 9076 6564
Fax 69575 0
Email 69575 0
shayden.bryce@monash.edu
Contact person for scientific queries
Name 69576 0
Mr Shayden Bryce
Address 69576 0
Monash Alfred Psychiatry research centre (MAPrc), Level 4, 607 St Kilda Road, Melbourne VIC 3004
Country 69576 0
Australia
Phone 69576 0
+61 3 9076 6564
Fax 69576 0
Email 69576 0
shayden.bryce@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
Yes
Journal publication details
Publication date and citation/details [1] 1990 0
Bryce et al. (2018). Neurocognitive and Self-efficacy Benefits of Cognitive Remediation in Schizophrenia: A Randomized Controlled Trial. Journal of the International Neuropsychological Society. 24(6):549-562.
Attachments [1] 1990 0
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary