Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001081808
Ethics application status
Approved
Date submitted
16/06/2021
Date registered
16/08/2021
Date last updated
8/03/2023
Date data sharing statement initially provided
16/08/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Reward learning and Cognitive Remediation
Scientific title
The effect of cognitive remediation on reward learning in adults with schizophrenia spectrum disorder
Secondary ID [1] 304499 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Schizophrenia spectrum disorder 322349 0
Condition category
Condition code
Mental Health 320026 320026 0 0
Schizophrenia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This pilot examines whether reward learning is the mechanism of effect for people with schizophrenia spectrum disorder receiving a evidence based therapy, cognitive remediation (CR) that aims to improve cognition
What is CR
CR involves a range of cognitive tasks that focus on attention, memory and planning via drill and practice and strategy based interventions
What is involved in participating in CR
The CR program is twice a week for 1 hour of a computer based program
The first session is face to face with subsequent sessions online with remote facilitation via team software
The program is 20 sessions with the time taken to complete 20 sessions usually taking 12 weeks.
CR is delivered by trained CR therapists of a range of disciplines
The program notes progress and sessions completed as well as therapist keeping a record of attendance
Intervention code [1] 320860 0
Behaviour
Intervention code [2] 321359 0
Rehabilitation
Comparator / control treatment
This study also includes a treatment as usual (TAU) group. This group will continue to receive standard care through the Metro South Addiction and Mental Health Services via a multidisciplinary team with the only exception being they cannot engage in CR therapy while they are enrolled in the trial. For the purposes of this study the definition of standard care includes usual medication, usual supports including NDIS and case management, and able to engage in psychosocial groups that do not focus on neurocognition. In addition, this study includes a group of healthy volunteers without a history of a Schizophrenia Spectrum Disorder. The healthy participants will complete one fMRI task only. They will not participate in CR.
Control group
Active

Outcomes
Primary outcome [1] 327888 0

Change in reward processing as measured via the BIS/BAS
Timepoint [1] 327888 0
baseline( pre intervention) and post completion of 20 session
Primary outcome [2] 328139 0
Changes in reward processing as measured by fMRI task
Timepoint [2] 328139 0
Post completion of CR 20 sessions
Primary outcome [3] 328328 0
Changes in Behavioural Inhibition Scale BIS/Behavioural Activation Scale BAS
Timepoint [3] 328328 0
On assessment after completing 20 sessions
Secondary outcome [1] 396894 0
Changes in working memory post CR intervention as measured by a composite of:
Brief Assessment of Cognition in Schizophrenia (BACS)
Schizophrenia Cognition Rating Scale (SCoRS)
Timepoint [1] 396894 0
Baseline and 12 weeks at the end of therapy
Secondary outcome [2] 397800 0
Changes in negative symptoms as measured by Clinical Assessment Interview for Negative symptoms (CAINS)
Timepoint [2] 397800 0
Baseline and 12 weeks at completion of CR program
Secondary outcome [3] 419351 0
Validation of the novel fMRI task. Construct validity will be examine comparing the results of the novel task in HC to previous reports of the reward fMRI tasks both social and non-social. Convergent validity will be explored based on the correlation of the fMRI tasks with the psychological measures of the reward system (BIS/BAS) in HC. Divergent validity will be explored using correlation analysis of the psychological measures and the fMRI data.
Timepoint [3] 419351 0
Baseline

Eligibility
Key inclusion criteria
Inclusion criteria for the intervention group:
Patients of the Metro South Addiction and Mental Health Service
Primary diagnosis of schizophrenia spectrum disorder
Basic competence in written and spoken English
Capacity to consent as advised by the treating team
Aged between 18-35
No history of neurological disorders or acquired brain injury.
Estimated intelligence quotient >70

Inclusion criteria for healthy control group:
No history of a diagnosis of schizophrenia spectrum disorder
Basic competence in written and spoken English
Capacity to consent as advised by a member of the research team
Aged between 18-35
No history of neurological disorders or acquired brain injury.
Estimated intelligence quotient >70
Minimum age
18 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Participants known or have any suspicion that you may have a metallic object in your body. This includes things such as a cardiac pacemaker, cochlear implant, metal IUD (hormonal IUD’s made of plastic are fine), neuro-stimulator, aneurysm clips, non-removable body piercing, history of shrapnel or metal fragments in the eye.
• Are pregnant or possibly pregnant (unprotected sex since last menstrual period).
• History of claustrophobia.
• Have permanent metal braces or a molar retainer.
weigh more than 120kg

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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)
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
For the fMRI analysis the General Linear Model approach for event-related designs will be conducted using SPM8 (http://www.fil.ion.ucl.ac.uk).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/09/2021
Actual
12/05/2022
Date of last participant enrolment
Anticipated
1/09/2023
Actual
Date of last data collection
Anticipated
1/12/2023
Actual
Sample size
Target
60
Accrual to date
10
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 20144 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 34869 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 308860 0
Hospital
Name [1] 308860 0
Princess Alexandra Hospital and health service
Country [1] 308860 0
Australia
Primary sponsor type
Hospital
Name
Princess Alexandra Hospital and health service
Address
199 Ipswich Rd
Woolloongabba
Brisbane 4102
Queensland
Country
Australia
Secondary sponsor category [1] 309779 0
Other
Name [1] 309779 0
Translational Research Institute
Address [1] 309779 0
37 Kent St
Woolloongabba
Brisbane 4102
Queensland
Country [1] 309779 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308770 0
Metro South HREC
Ethics committee address [1] 308770 0
Ethics committee country [1] 308770 0
Australia
Date submitted for ethics approval [1] 308770 0
09/11/2020
Approval date [1] 308770 0
10/03/2021
Ethics approval number [1] 308770 0
HREC/2021/QMS/67093

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

Contacts
Principal investigator
Name 111822 0
A/Prof Frances Dark
Address 111822 0
Princess Alexandra Hospital and Health Service Addiction and Mental health service
199 Ipswich Rd
Woolloongabba
Brisbane 4102
Queenlsand
Country 111822 0
Australia
Phone 111822 0
+61 488412054
Fax 111822 0
Email 111822 0
[email protected]
Contact person for public queries
Name 111823 0
Frances Dark
Address 111823 0
Princess Alexandra Hospital and Health Service Addiction and Mental health service
199 Ipswich Rd
Woolloongabba
Brisbane 4102
Queensland
Country 111823 0
Australia
Phone 111823 0
+61 7 31762111
Fax 111823 0
Email 111823 0
[email protected]
Contact person for scientific queries
Name 111824 0
Frances Dark
Address 111824 0
Princess Alexandra Hospital and Health Service Addiction and Mental health service
199 Ipswich Rd
Woolloongabba
Brisbane 4102
Queensland
Country 111824 0
Australia
Phone 111824 0
+61 7 31762111
Fax 111824 0
Email 111824 0
[email protected]

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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
12099Study protocol  [email protected] 382191-(Uploaded-02-12-2022-16-54-05)-Study-related document.pdf



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.