ANZCTR - Registration

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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]

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

Bipolar Disorder

Major Depression with Psychotic Features

Schizoaffective Disorder

Condition category

Condition code

Mental Health

Schizophrenia

Mental Health

Psychosis and personality disorders

Mental Health

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]

Rehabilitation

Intervention code [2]

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]

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]

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]

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]

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]

Quality of life is another secondary outcome and will be measured with the Assessment of Quality of Life (AQoL).

Timepoint [2]

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]

Mood and anxiety will be screened using the Depression, Anxiety and Stress Scale (DASS).

Timepoint [3]

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]

Neuro-social and -cognitve biases in paranoia will be assessed using the Ambiguous Intentions Hostility Questionnaire (AIHQ).

Timepoint [4]

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?

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

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Westmead Hospital - Westmead

Recruitment hospital [2]

Cumberland Hospital - Westmead

Recruitment hospital [3]

Headspace Bondi Junction - Bondi Junction

Recruitment hospital [4]

Nepean Hospital - Kingswood

Recruitment hospital [5]

Brookvale Community Health Centre - Brookvale

Recruitment postcode(s) [1]

2145 - Westmead

Recruitment postcode(s) [2]

2148 - Blacktown

Recruitment postcode(s) [3]

2750 - Penrith

Recruitment postcode(s) [4]

2022 - Bondi Junction

Recruitment postcode(s) [5]

2747 - Kingswood

Recruitment postcode(s) [6]

2100 - Brookvale

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Western Sydney Local Health District (WSLHD) Research & Education Network

Address [1]

WSLHD Research and Education Network,
Westmead Hospital,
Hawkesbury Road,
Westmead NSW 2145

Country [1]

Australia

Primary sponsor type

Hospital

Name

Westmead Hospital

Address

Westmead Hospital,
Hawkesbury Road,
Westmead NSW 2145

Country

Australia

Secondary sponsor category [1]

Government body

Name [1]

Health Education and Training Institute

Address [1]

1 Reserve Rd
St Leonards NSW 2065

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Western Sydney Local Health District Human Research Ethics Community (WSLHD HREC)

Ethics committee address [1]

WSLHD Research and Education Network,
Westmead Hospital,
Hawkesbury Road,
Westmead NSW 2145

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

20/09/2017

Approval date [1]

23/02/2018

Ethics approval number [1]

AU RED HREC/17/WMEAD/427

Summary

Brief summary

We have known for some time that serious mental illnesses such as schizophrenia, bipolar disorder or severe depression cause significant problems in thinking skills such as attention, concentration, memory or planning.  Recently we have become aware that they also cause problems in social cognitive skills such as recognising a person’s emotional state from the expression on their face or being able to think in another person’s shoes.  Both of these sets of skills- neurocognition and social cognition – have serious flow on effects upon a person’s ability to function at school, in work or in the community.  Unfortunately medications does not help with these problems, but psychological treatments – cognitive remediation and social cognitive remediation therapy does.  This study will trial different combinations of these treatments to see if they have separate effects upon treatment outcome. The study will be run in frontline mental health services which will mean that the skills and knowledge will be communicated to the clinical teams maximising benefit.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Anthony Harris

Address

Dept. Psychiatry
Westmead Hospital,
Hawkesbury Road,
Westmead NSW 2145

Country

Australia

Phone

+61 2 8890 6688

Fax

[email protected]

Contact person for public queries

Name

Anthony Harris

Address

Dept. Psychiatry
Westmead Hospital,
Hawkesbury Road,
Westmead NSW 2145

Country

Australia

Phone

+612988906688

Fax

[email protected]

Contact person for scientific queries

Name

Anthony Harris

Address

Dept. Psychiatry
Westmead Hospital,
Hawkesbury Road,
Westmead NSW 2145

Country

Australia

Phone

+61 2 8890 6688

Fax

[email protected]

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 - [email protected]

What supporting documents are/will be available?

Doc. No.	Type	Citation	Email	Other Details	Attachment
8041	Study protocol	Advantage Trial Protocol version 4 180718	[email protected]		373695-(Uploaded-23-11-2021-16-40-20)-Study-related document.docx
8042	Ethical approval	Advantage Trial Ethics Submission 20092017		WSLHD HREC documentation	373695-(Uploaded-22-05-2020-14-56-33)-Study-related document.pdf
14197	Informed consent form	ADVANTAGE 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.

Trial Review

Documents added manually

Documents added automatically