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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000744358
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
16/04/2026
Date registered
Help: Date registered
22/06/2026
Date last updated
Help: Date last updated
22/06/2026
Date data sharing statement initially provided
Help: Data sharing statement date
22/06/2026
Type of registration
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Retrospectively registered

Titles & IDs
Public title
Translating Cognitive Remediation Therapy into Mental Health Practice: Implementing Computerised Interactive Remediation of Cognition and Thinking Skills (CIRCuiTS) for adults with psychosis in Australian public mental health services
Scientific title
A multi-phase, mixed-methods implementation study evaluating the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) of Computerised Interactive Remediation of Cognition and Thinking Skills (CIRCuiTS) across four Australian public mental health services
Additional trial identifiers [1] 315510 0
Nil known
Universal Trial Number (UTN)
Not applicable
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Psychosis 339096 0
Schizophrenia 342011 0
Condition category
Condition code
Mental Health 335380 335380 0 0
Psychosis and personality disorders
Mental Health 338093 338093 0 0
Schizophrenia

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
This registration covers a multi-phase implementation study of Computerised Interactive Remediation of Cognition and Thinking Skills (CIRCuiTS) across four Australian public mental health services. The total duration of the study is approximately 4.5 years, comprising three sequential phases.

Phase 1 (12 months) involves implementation planning workshops with clinicians, managers, peer workers, administrators, referrers, allied health staff, IT staff, and other stakeholders involved in implementing or supporting CIRCuiTS. One five-hour co-design workshop will be conducted at each site to develop local implementation plans and identify staffing, training, supervision, referral, resource, organisational support, and barriers and enablers to implementation. At the end of the workshops, participants will be asked to complete organisational readiness for implementing change (ORIC) survey. Participants will also prepare a site-specific implementation plan. Therapist training will be initiated during the latter part of Phase 1 and will continue into Phase 2 to accommodate workforce turnover and ensure ongoing service capacity.
Therapists delivering CIRCuiTS will receive online training provided by King’s College London (KCL), consisting of 11 modules (approximately 11–22 hours in total). Additional therapists who join during Phase 2 will also complete this training prior to delivering the intervention.

Phase 2 (30 months) will commence within 4–8 weeks following completion of Phase 1, allowing time for initial therapist training to be completed and for sites to finalise local implementation procedures. Ongoing training will continue throughout Phase 2 as needed to accommodate workforce turnover. Initiation of Phase 2 may be staggered across sites depending on readiness. Phase 2 involves implementation of CIRCuiTS for adults with psychosis. Participants who choose the intervention will receive 20 to 40 CIRCuiTS sessions delivered over approximately 12 to 24 weeks, usually 2 to 3 sessions per week, with each session lasting up to one hour.

CIRCuiTS comprises several core components:

Therapist facilitation: Therapists guide participants throughout sessions, supporting engagement, tailoring task difficulty, providing feedback, and helping participants reflect on cognitive strategies and performance.
Cognitive exercises: Participants complete computer-based tasks targeting cognitive domains such as attention, memory, and executive functioning, with adaptive difficulty based on performance.
Problem-solving strategies: Therapists support participants to develop and apply strategies (e.g., chunking, rehearsal, planning, error monitoring) to improve task performance and cognitive functioning.
Transfer to real-world functioning: A key focus is on linking cognitive skills to everyday activities. Therapists work collaboratively with participants to set personal goals and practise applying strategies to real-life situations (e.g., work, study, social functioning).

The number of sessions (20–40) is individualised and determined collaboratively by the therapist and participant based on clinical need, participant goals, progress, engagement, and service context. Therapists use clinical judgment and participant preference to adjust the duration and intensity of the intervention within this range, consistent with standard CIRCuiTS practice.

Sessions will be delivered by trained therapists face-to-face, via telehealth, or using a hybrid model depending on site resources. CIRCuiTS will be delivered primarily on a one-to-one basis between therapist and participant. However, in some sites, the CIRCuiTS may also be delivered in small groups (typically 2–6 participants), where participants engage in individualised computer-based tasks with therapist facilitation in a shared setting. Group delivery will maintain the same therapeutic principles, including individual goal setting and strategy development, while allowing peer interaction and efficient use of clinical resources.

Phase 3 (12 months) will commence following the completion of the 26-weeks post-intervention follow-up period for the final participant in Phase 2. This phase will involve data linkage for Phase 2 participants to examine maintenance outcomes, hospital admissions, and health service use over time. It will also include health outcomes, expressed in terms of quality-adjusted life years (QALYs) derived from EQ-5D-3L utility scores. Phase 3 will contribute to the development of guidelines for implementation and evaluation of Computerised Interactive Remediation of Cognition and Thinking Skills (CIRCuiTS) in Australian public mental health services.
Intervention code [1] 332438 0
Behaviour
Intervention code [2] 333312 0
Rehabilitation
Description of the comparator or control
Participants in the treatment-as-usual (TAU) group will continue to receive standard care provided by their existing public mental health services. This may include pharmacological treatment (e.g., antipsychotic medication), routine clinical care from multidisciplinary mental health teams (psychiatry, psychology, nursing and allied health), case management, and rehabilitation services. Depending on the site, services may involve inpatient or community-based care, regular clinician appointments (e.g., weekly or fortnightly), psychosocial support, and access to external supports such as NGOs or NDIS services. No components of the CIRCuiTS cognitive remediation program will be provided to this group.
Control group
Active

Outcomes
Primary outcome [1] 343358 0
1. Proportion of staff who support adopting CIRCuiTS
Timepoint [1] 343358 0
Phase 1: Pre-implementation - at completion of workshop
Primary outcome [2] 344751 0
2. Number and proportion of sites that commence delivery of CIRCuiTS.
Timepoint [2] 344751 0
Phase 2: Baseline and T1 (end of last CIRCuiTS session)
Primary outcome [3] 344752 0
3. Extent to which each site delivers CIRCuiTS as planned
Timepoint [3] 344752 0
Phase 2: Baseline and T1 (end of last CIRCuiTS session)
Secondary outcome [1] 454888 0
1. Change in cognitive function
Timepoint [1] 454888 0
Baseline (pre-intervention), T1(at completion of CIRCuiTS intervention), T2(12 weeks after completion of CIRCuiTS intervention), and T3(26 weeks after completion of CIRCuiTS intervention).
Secondary outcome [2] 461813 0
2. Change in adaptive function
Timepoint [2] 461813 0
Baseline (pre-intervention), T1(at completion of CIRCuiTS intervention), T2(12 weeks after completion of CIRCuiTS intervention), and T3(26 weeks after completion of CIRCuiTS intervention).
Secondary outcome [3] 461814 0
3. Change in goal attainment
Timepoint [3] 461814 0
Baseline (pre-intervention), T1(at completion of CIRCuiTS intervention), T2(12 weeks after completion of CIRCuiTS intervention), and T3(26 weeks after completion of CIRCuiTS intervention).
Secondary outcome [4] 461923 0
4. Participant and staff perceptions of the acceptability and perceived benefit of CIRCuiTS, including willingness to recommend it to others, which will be assessed as a single qualitative outcome.
Timepoint [4] 461923 0
Phase 2: a). Participants - T1(end of CIRCuiTS intervention) and T3(26 weeks after completion of CIRCuiTS intervention) b). Staff - T1(end of CIRCuiTS intervention) and T2(12 weeks after completion of CIRCuiTS intervention)
Secondary outcome [5] 461924 0
5. Number of sites that continue to meet minimum implementation standards at follow-up.
Timepoint [5] 461924 0
Phase 2: T1(end of CIRCuiTS intervention), T2(12 weeks after completion of CIRCuiTS intervention) and T3(26 weeks after completion of CIRCuiTS intervention).
Secondary outcome [6] 461925 0
6. Barriers and enablers influencing implementation of CIRCuiTS across participating sites. This will be assessed as a single qualitative implementation outcome, not as a composite outcome.
Timepoint [6] 461925 0
T1(end of CIRCuiTS intervention), T2(12 weeks after completion of CIRCuiTS intervention) and T3(26 weeks after completion of CIRCuiTS intervention).
Secondary outcome [7] 461926 0
7. Health outcomes, expressed in terms of quality-adjusted life years (QALYs) derived from EQ-5D-3L utility scores.
Timepoint [7] 461926 0
Baseline (pre-intervention), T1(at completion of CIRCuiTS intervention), T2(12 weeks after completion of CIRCuiTS intervention), and T3(26 weeks after completion of CIRCuiTS intervention).
Secondary outcome [8] 461927 0
8. Change in overall clinical severity.
Timepoint [8] 461927 0
Baseline (pre-intervention), T1(at completion of CIRCuiTS intervention), T2(12 weeks after completion of CIRCuiTS intervention), and T3(26 weeks after completion of CIRCuiTS intervention).
Secondary outcome [9] 463104 0
9. Change in psychiatric symptoms
Timepoint [9] 463104 0
Baseline (pre-intervention), T1(at completion of CIRCuiTS intervention), T2(12 weeks after completion of CIRCuiTS intervention), and T3(26 weeks after completion of CIRCuiTS intervention).
Secondary outcome [10] 463105 0
10. Change in impairment
Timepoint [10] 463105 0
Baseline (pre-intervention), T1(at completion of CIRCuiTS intervention), T2(12 weeks after completion of CIRCuiTS intervention), and T3(26 weeks after completion of CIRCuiTS intervention).
Secondary outcome [11] 463106 0
11. Change in social functioning
Timepoint [11] 463106 0
Baseline (pre-intervention), T1(at completion of CIRCuiTS intervention), T2(12 weeks after completion of CIRCuiTS intervention), and T3(26 weeks after completion of CIRCuiTS intervention).
Secondary outcome [12] 463464 0
12. The strength of therapeutic alliance
Timepoint [12] 463464 0
The assessment will be conducted mid-program, approximately 12 weeks after the start of the intervention.
Secondary outcome [13] 463465 0
13. Participants motivation for participating in CIRCuiTS intervention
Timepoint [13] 463465 0
Baseline (pre-intervention), T1(at completion of CIRCuiTS intervention), and T2(12 weeks after completion of CIRCuiTS intervention),
Secondary outcome [14] 463466 0
14. Participants' experience and satisfaction with CIRCuiTS therapy
Timepoint [14] 463466 0
T1(at completion of CIRCuiTS intervention)
Secondary outcome [15] 463473 0
15. Health service use
Timepoint [15] 463473 0
Phase 3: after the completion of the 26-weeks post-intervention follow-up period for the final participant in Phase 2.

Eligibility
Key inclusion criteria
Phase 1: Staff involved in implementing or supporting CIRCuiTS at participating sites, including clinicians, managers, peer-workers, referrers, allied health staff, and IT staff who are active during the implementation planning period.
Phase 2: Adults confirmed with diagnosis of psychosis and treated at the participating study sites and fulfilling the following criteria:
• Able to communicate;
• People who can consent;
• Aged between 18 to 65 years;
• Fluent in English;
• Have approximately a 12–13-year-old reading level;
• Clinically stable as determined by treating clinicians including no recent medication changes (or planned medication changes), or recent acute exacerbation of illness requiring hospitalisation (if in the community setting);
• People with a score of 30 or above on Social and Occupational Functioning Assessment Scale (SOFAS).
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Healthy volunteers
Yes
Key exclusion criteria
Phase 1: staff who are on leave or not active during the implementation planning period.

Phase 2:
1. Primary diagnosis of intellectual disability or acquired brain injury
2. Severe sensory or physical impairments preventing computer use
3. Planned relocation outside participating services during the intervention period

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
Descriptive statistics (means, medians, standard deviations, and percentages) will summarise baseline characteristics. Dropout rates will be calculated and used as a proxy-indicator of the acceptability of CIRCuiTS.

Pre- and post-intervention outcomes will be compared between participants receiving CIRCuiTS and treatment as usual using analysis of covariance (ANCOVA), adjusting for relevant baseline covariates. Goal Attainment Scale (GAS) composite T-scores will be compared between groups at baseline, program completion, and follow-up using ANCOVA. Treatment effects on RBANS, and ABAS-3 outcomes will be examined using ANCOVA and repeated measures analysis where appropriate, with effect sizes estimated using Cohen’s d.

Qualitative data from workshops, implementation meetings, and interviews will be analysed thematically.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
25/06/2025
Date of last participant enrolment
Anticipated
27/11/2026
Actual
Date of last data collection
Anticipated
31/12/2027
Actual
Sample size
Target
300
Accrual to date
44
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD

Funding & Sponsors
Funding source category [1] 320101 0
Government body
Name [1] 320101 0
Australian Commonwealth Government under the Medical Research Future Fund (MRFF)
Country [1] 320101 0
Australia
Primary sponsor type
University
Name
Charles Sturt University
Address
Country
Australia
Secondary sponsor category [1] 322659 0
Government body
Name [1] 322659 0
1. Western NSW Local Health District
Address [1] 322659 0
Country [1] 322659 0
Australia
Secondary sponsor category [2] 324789 0
Government body
Name [2] 324789 0
2. South-Eastern Sydney Local Health District
Address [2] 324789 0
Country [2] 324789 0
Australia
Secondary sponsor category [3] 324790 0
Government body
Name [3] 324790 0
3. Metro South Addiction and Mental health service
Address [3] 324790 0
Country [3] 324790 0
Australia
Secondary sponsor category [4] 324791 0
Government body
Name [4] 324791 0
4. The Illawarra Shoalhaven Local Health District
Address [4] 324791 0
Country [4] 324791 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 318656 0
Greater Western Human Research Ethics Committee
Ethics committee address [1] 318656 0
Ethics committee country [1] 318656 0
Australia
Date submitted for ethics approval [1] 318656 0
24/01/2025
Approval date [1] 318656 0
15/04/2025
Ethics approval number [1] 318656 0
2025/ETH00104
Ethics committee name [2] 320181 0
Metro South Human Research Ethics Committee
Ethics committee address [2] 320181 0
Ethics committee country [2] 320181 0
Australia
Date submitted for ethics approval [2] 320181 0
03/02/2025
Approval date [2] 320181 0
10/02/2025
Ethics approval number [2] 320181 0
HREC/2025/QMS/115911
Ethics committee name [3] 320183 0
Metro South Human Research Ethics Committee
Ethics committee address [3] 320183 0
Ethics committee country [3] 320183 0
Australia
Date submitted for ethics approval [3] 320183 0
03/02/2025
Approval date [3] 320183 0
10/02/2025
Ethics approval number [3] 320183 0
HREC/2025/QMS/116055
Ethics committee name [4] 320184 0
Greater Western Human Research Ethics Committee
Ethics committee address [4] 320184 0
Ethics committee country [4] 320184 0
Australia
Date submitted for ethics approval [4] 320184 0
17/09/2024
Approval date [4] 320184 0
11/10/2024
Ethics approval number [4] 320184 0
2024/ETH02096

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

Contacts
Principal investigator
Name 144822 0
Prof Julaine Allan
Address 144822 0
Building 1008, Rural Health Research Institute, Charles Sturt University, Leeds Pd. Orange, NSW 2800
Country 144822 0
Australia
Phone 144822 0
+610437869033
Fax 144822 0
Email 144822 0
[email protected]
Contact person for public queries
Name 144823 0
Professor Julaine Allan
Address 144823 0
Building 1008, Rural Health Research Institute, Charles Sturt University, Leeds Pd. Orange, NSW 2800
Country 144823 0
Australia
Phone 144823 0
+610437869033
Fax 144823 0
Email 144823 0
[email protected]
Contact person for scientific queries
Name 144824 0
Professor Julaine Allan
Address 144824 0
Building 1008, Rural Health Research Institute, Charles Sturt University, Leeds Pd. Orange, NSW 2800
Country 144824 0
Australia
Phone 144824 0
+610437869033
Fax 144824 0
Email 144824 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.