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Trial registered on ANZCTR


Registration number
ACTRN12622000192785
Ethics application status
Approved
Date submitted
22/05/2020
Date registered
4/02/2022
Date last updated
12/04/2022
Date data sharing statement initially provided
4/02/2022
Date results provided
4/02/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Is there a synergistic effect of adding social cognition remediation to cognitive remediation therapy versus cognitive remediation alone in young people? A randomised controlled trial
Scientific title
Is there a synergistic effect on the functional outcomes of adding social cognition remediation to cognitive remediation therapy versus cognitive remediation alone in young people with severe mental illness? A randomised controlled trial
Secondary ID [1] 292950 0
Nil Known
Universal Trial Number (UTN)
U1111-1202-5433
Trial acronym
Linked study record
Not linked

Health condition
Health condition(s) or problem(s) studied:
Schizophrenia 304844 0
Bipolar Disorder 304845 0
Major Depression with Psychotic Features 304846 0
Schizoaffective Disorder 304847 0
Condition category
Condition code
Mental Health 304146 304146 0 0
Schizophrenia
Mental Health 304147 304147 0 0
Psychosis and personality disorders
Mental Health 315834 315834 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Cognitive Remediation Therapy (CRT) is a treatment that has been in use for the past 20 years. In our CRT program, we ask people to use computer games sourced from a wide variety of educational and online sources (eg HappyNeuron). The games are assessed using the methodology described in the Neuropsychological Educational Approach to Remediation (NEAR), a widely available manualised therapy, and are selected for individual participants on the basis of their neuropsychological profile. The treatment was provided either individually or in small groups (<5 participants) by trained and supervised therapists (psychologists, Occupational Therapists or psychiatric nurses). The therapy was provided in an community health centre, each session lasting approximately 1 hour, twice a week for 10 weeks.

Social Cognitive Remediation Therapy (SCRT) helps you recognise people’s emotions and trains you to think about how other people think and feel. It also helps you examine your own biases in how you think. The treatment is based upon the Social Cognition and Interaction Therapy (SCIT), a widely available manualised therapy for social cognitive deficits. The therapy is provided in small groups of between 3-8 participants. It was provided by therapists (psychologists, Occupational Therapists and Psychiatric Nurses) who were trained and then supervised in the treatment. The therapy was provided in an community health centre, each session lasting approximately 1 hour, twice a week for 10 weeks.

Attendance at these various groups was confirmed with attendance records at specific therapy and verbally confirmed with both the case managers and the participants.

Participants will receive one of two therapy conditions:
Cognitive Remediation Therapy plus Social Cognitive Remediation Therapy
Cognitive Remediation Therapy plus an additional therapy
Intervention code [1] 299196 0
Rehabilitation
Intervention code [2] 317764 0
Treatment: Other
Comparator / control treatment
The control treatment is Cognitive Remediation Therapy plus AdditionalTherapy as available at the investigation site to balance for therapist exposure.

Additional therapy - this was an additional therapy available at the site where the participant enrolled that was provided for a similar period of time as SCRT as an active control. As the trial was run in multiple sites with differing programs, the type of therapy provided was selected from what was available that could engage the young person twice a week over 10 weeks. This differed from site to site but included exercise groups, social or living skills groups or individual counselling. The additional therapy was provided by a wide range of clinicians which included psychologists, occupational therapists and psychiatric nurses.
Control group
Active

Outcomes
Primary outcome [1] 303472 0
The primary outcome will be real world functioning.
The multiple time points of measurement will assist in the assessment of mediating factors of the outcome. The two arms will be compared across 3 time points (baseline, end of treatment, 3 months follow up) using a repeated measures analysis of variance on measures of real-world outcome (return to work/school, Australian Participation Questionnaire; APQ, Social and Occupational Functioning Assessment Scale; SOFAS).
Timepoint [1] 303472 0
The two arms will be compared across 3 time points: baseline, end of treatment and 3 months follow up. The end of treatment timepoint is considered the primary endpoint.
Secondary outcome [1] 339031 0
The secondary outcome will include measures of neurocognitive functioning, and will be measured by the Repeated Battery for the Assessment of Neuropsychological Status (RBANS).
Timepoint [1] 339031 0
The secondary outcomes will also be assessed and compared across the three timepoints similar to the primary outcome. These are at baseline, at end of treatment, and at 6 months follow-up.
Secondary outcome [2] 404373 0
Quality of life is another secondary outcome and will be measured with the Assessment of Quality of Life (AQoL).
Timepoint [2] 404373 0
Quality of life will be measured at each of the three timepoints: baseline, end of treatment and at the 6-month follow-up.
Secondary outcome [3] 404374 0
Mood and anxiety will be screened using the Depression, Anxiety and Stress Scale (DASS).
Timepoint [3] 404374 0
The Depression, Anxiety and Stress Scale will be measured at each of the three timepoints: baseline, end of treatment and at the 6-month follow-up.
Secondary outcome [4] 404375 0
Neuro-social and -cognitve biases in paranoia will be assessed using the Ambiguous Intentions Hostility Questionnaire (AIHQ).
Timepoint [4] 404375 0
The AIHQ will be assess at each of the three timepoints: baseline, end of treatment and at the 6-month follow-up.

Eligibility
Key inclusion criteria
Inclusion criteria: 1. A diagnosis of a severe mental illness and neurocognitive or social cognitive deficits; 2. Are aged 16 – 30 years; 3. Able to provide consent (and parent/guardian if required; 4. Have reasonable English skills.
Minimum age
16 Years
Maximum age
30 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria: 1.Developmental delay (IQ < 75); 2.Current substance abuse or substance dependence other than caffeine or nicotine; 3. History of head injury (> 10 minutes unconsciousness). 4. Electroconvulsive Therapy in last six months.

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)
Allocation involved contacting the holder of the allocation schedule who was "off-site" and at a central administration site and was concealed from the researcher doing all assessments. . Allocation was not concealed from the participant or clinicians treating the participants.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Generated using an online randomisation generator (Sealed Envelope) by a statistician independent to the research team
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Not Applicable
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Participants were assessed on the battery of neurocognitive and functional measures at baseline, post-treatment, and follow-up at three months after the treatment. Repeated measures analysis of variance (ANOVA) was used to assess any potential interactions across time and between treatment groups. A chi-squared analysis was conducted to compare the demographics between the treatment and control groups inclusive of the diagnosed SMI and medication. Statistical analyses were conducted using SPSS Statistical Packaging for the Social Sciences.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
Other reasons/comments
Other reasons
Covid-19 forced cessation of recruitment
Date of first participant enrolment
Anticipated
Actual
5/10/2018
Date of last participant enrolment
Anticipated
Actual
15/11/2019
Date of last data collection
Anticipated
Actual
14/08/2020
Sample size
Target
120
Accrual to date
Final
64
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 9092 0
Westmead Hospital - Westmead
Recruitment hospital [2] 21438 0
Cumberland Hospital - Westmead
Recruitment hospital [3] 21439 0
Headspace Bondi Junction - Bondi Junction
Recruitment hospital [4] 21440 0
Nepean Hospital - Kingswood
Recruitment hospital [5] 21513 0
Brookvale Community Health Centre - Brookvale
Recruitment postcode(s) [1] 17586 0
2145 - Westmead
Recruitment postcode(s) [2] 17588 0
2148 - Blacktown
Recruitment postcode(s) [3] 17590 0
2750 - Penrith
Recruitment postcode(s) [4] 36340 0
2022 - Bondi Junction
Recruitment postcode(s) [5] 36341 0
2747 - Kingswood
Recruitment postcode(s) [6] 36420 0
2100 - Brookvale

Funding & Sponsors
Funding source category [1] 297576 0
Government body
Name [1] 297576 0
Western Sydney Local Health District (WSLHD) Research & Education Network
Country [1] 297576 0
Australia
Primary sponsor type
Hospital
Name
Westmead Hospital
Address
Westmead Hospital,
Hawkesbury Road,
Westmead NSW 2145
Country
Australia
Secondary sponsor category [1] 296598 0
Government body
Name [1] 296598 0
Health Education and Training Institute
Address [1] 296598 0
1 Reserve Rd
St Leonards NSW 2065
Country [1] 296598 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298669 0
Western Sydney Local Health District Human Research Ethics Community (WSLHD HREC)
Ethics committee address [1] 298669 0
Ethics committee country [1] 298669 0
Australia
Date submitted for ethics approval [1] 298669 0
20/09/2017
Approval date [1] 298669 0
23/02/2018
Ethics approval number [1] 298669 0
AU RED HREC/17/WMEAD/427

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

Contacts
Principal investigator
Name 77838 0
Prof Anthony Harris
Address 77838 0
Dept. Psychiatry
Westmead Hospital,
Hawkesbury Road,
Westmead NSW 2145
Country 77838 0
Australia
Phone 77838 0
+61 2 8890 6688
Fax 77838 0
Email 77838 0
anthony.harris@sydney.edu.au
Contact person for public queries
Name 77839 0
Anthony Harris
Address 77839 0
Dept. Psychiatry
Westmead Hospital,
Hawkesbury Road,
Westmead NSW 2145
Country 77839 0
Australia
Phone 77839 0
+612988906688
Fax 77839 0
Email 77839 0
anthony.harris@sydney.edu.au
Contact person for scientific queries
Name 77840 0
Anthony Harris
Address 77840 0
Dept. Psychiatry
Westmead Hospital,
Hawkesbury Road,
Westmead NSW 2145
Country 77840 0
Australia
Phone 77840 0
+61 2 8890 6688
Fax 77840 0
Email 77840 0
anthony.harris@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified data
All results
When will data be available (start and end dates)?
Start 01/01/21
Finish 31/12/27
Available to whom?
All accredited academic researchers who provide a methodologically sound proposal.
Available for what types of analyses?
review or meta-analysis
How or where can data be obtained?
From Chief Investigator - anthony.harris@sydney.edu.au


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
8041Study protocolAdvantage Trial Protocol version 4 180718 anthony.harris@sydney.edu.au 373695-(Uploaded-23-11-2021-16-40-20)-Study-related document.docx
8042Ethical approvalAdvantage Trial Ethics Submission 20092017   WSLHD HREC documentation 373695-(Uploaded-22-05-2020-14-56-33)-Study-related document.pdf
14197Informed consent formADVANTAGE Master PICF Adult V5 23rd April 19 clean   373695-(Uploaded-23-11-2021-16-40-48)-Study-related document.docx



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.