Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12625001294448
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
24/09/2025
Date registered
Help: Date registered
20/11/2025
Date last updated
Help: Date last updated
9/06/2026
Date data sharing statement initially provided
Help: Data sharing statement date
20/11/2025
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Cognitive Screening in First-Episode Psychosis in Aotearoa New Zealand
Scientific title
Assessing the feasibility, user experience and cultural appropriateness of a brief cognitive screening tool in First-Episode Psychosis in Aotearoa New Zealand
Additional trial identifiers [1] 315376 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Psychosis 338870 0
Bipolar Disorder 339690 0
Condition category
Condition code
Mental Health 335165 335165 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Psychosis occurs where a person has a break from reality, characterised by hallucinations and delusions, often accompanied by disorganized thinking and speech. The first episode of psychosis (FEP), as part of a psychotic or bipolar disorder, is usually experienced before age 25 and can significantly disrupt a young person’s transition into adulthood. FEP often affects education, employment, relationships, and independent living.

Cognitive impairment, such as problems with memory, attention and problem-solving, is a core feature of FEP, affecting up to 75% of people with the disorder. Cognitive impairment often continues after psychosis resolves, which contributes to longer-term poor functioning, reduced self-confidence, and relapse. Addressing cognitive impairment is therefore a high priority for young adults with FEP. To effectively target cognitive impairment in treatment, assessment is required.

In Canterbury, the early intervention service for FEP (Totara House, Te Whatu Ora Waitaha) faces barriers to cognitive assessment, including high caseloads and limited data on suitable cognitive assessment tools and how cognitive assessment may inform treatment planning. A suitable, brief cognitive screening tool is a significant unmet need in FEP services.

This project addresses these issues by examining the feasibility, user experience, and cultural appropriateness of the Screen for Cognitive Impairment in Psychiatry (SCIP), for young adults with FEP. Participants will only receive access to the SCIP screening tool because they have enrolled in this study, as no cognitive screening is currently taking place at Totara House.

Participants will complete the SCIP, a brief, standardised cognitive assessment administered by the principal investigator or another trained member of the research team. The tool involves a series of short verbal and written tasks assessing immediate and delayed recall, working memory, verbal fluency, and processing speed. Each task is delivered face-to-face using simple materials (paper, pencil, and a stopwatch). The assessment takes approximately 10–15 minutes per participant to complete.

The SCIP will be administered at 6 weeks after entry to the service (baseline), and on discharge (typically between 18-24 months after admission). A survey assessing the suitability of the SCIP will be administered to all participants immediately after the first time the SCIP has been administered. A small number (n = 20) will also take part in a qualitative interview about their experience. The interview will be undertaken with the first 10 Maori and first 10 non-Maori participants who opt-in. The interview will take place between the same day to two weeks after the SCIP testing, depending on patient preference and interviewer availability.

Training for the researcher administering the SCIP will take place via a video workshop from the SCIP developer, and in person training with a clinical psychologist with expertise in neuropsychology, and who has had direct training with the SCIP developer. Additionally, there will be fortnightly supervision with this same clinical psychologist.
Intervention code [1] 331982 0
Early detection / Screening
Description of the comparator or control
NA
Control group
Uncontrolled

Outcomes
Primary outcome [1] 342870 0
SCIP feasibility
Timepoint [1] 342870 0
Recruitment numbers and completion numbers will be tallied at the end of the study.
Primary outcome [2] 342970 0
SCIP user experience
Timepoint [2] 342970 0
Baseline (~6 weeks after entry to the service), immediately after administration of the SCIP.
Primary outcome [3] 342971 0
SCIP user experience
Timepoint [3] 342971 0
Between same day as SCIP testing to two weeks after, depending on patient preference and interviewer availability.
Secondary outcome [1] 452474 0
SCIP cultural appropriateness
Timepoint [1] 452474 0
Between same day as SCIP testing to two weeks after, depending on patient preference and interviewer availability.
Secondary outcome [2] 452475 0
Prevalence of cognitive impairment
Timepoint [2] 452475 0
Baseline (~6 weeks after entry to the service) and discharge from service (around 18-24 months)
Secondary outcome [3] 452476 0
Subjective cognitive difficulties
Timepoint [3] 452476 0
Baseline (~6 weeks after entry to the service) and discharge from service (around 18-24 months)
Secondary outcome [4] 452477 0
Hauora health and wellness
Timepoint [4] 452477 0
Baseline (~6 weeks after entry to the service) and discharge from service (around 18-24 months)
Secondary outcome [5] 452969 0
Depressive symptoms
Timepoint [5] 452969 0
Baseline (~6 weeks after entry to the service) and discharge from service (around 18-24 months)
Secondary outcome [6] 452975 0
Psychotic symptoms
Timepoint [6] 452975 0
Baseline (~6 weeks after entry to the service) and discharge from service (around 18-24 months)

Eligibility
Key inclusion criteria
All new patients referred to Totara House from the point of study commencement will be eligible. These people will be aged 18 to 28 years and have a working DSM-5 (Diagnostic and Statistical Manual of Mental Disorders – 5th Edition) diagnosis of a psychotic disorder or bipolar disorder.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Significant previous brain injury (loss of consciousness for >1 hour)
Intellectual disability
Pregnancy
Chronic neurological condition (e.g., epilepsy)
Unable to communicate in English.

Study design
Purpose of the study
Diagnosis
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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Feasibility outcomes will include rate of recruitment (number of people consenting to the SCIP), rate of completion of the SCIP, and the custom-made questionnaire evaluating individuals’ experience of the assessment and cognitive difficulties. Rate of cognitive impairment according to established cut-offs on the SCIP will be determined. Associations between cognitive impairment and clinical/health factors (e.g., mood and psychotic symptoms) will use one-way ANOVA and chi-squared analyses.

Qualitative analysis of interviews will use thematic analysis, supervised by an experienced qualitative methodology and equity researcher at the Department of Psychological Medicine (Dr Jenni Manuel).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
19/01/2026
Actual
Date of last participant enrolment
Anticipated
19/01/2028
Actual
Date of last data collection
Anticipated
19/01/2030
Actual
Sample size
Target
100
Accrual to date
0
Final
Recruitment outside Australia
Country [1] 27377 0
New Zealand
State/province [1] 27377 0

Funding & Sponsors
Funding source category [1] 319964 0
Charities/Societies/Foundations
Name [1] 319964 0
Canterbury Medical Research Foundation
Country [1] 319964 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
Country
New Zealand
Secondary sponsor category [1] 322579 0
None
Name [1] 322579 0
Address [1] 322579 0
Country [1] 322579 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 318504 0
Northern A Health and Disability Ethics Committee 
Ethics committee address [1] 318504 0
Ethics committee country [1] 318504 0
New Zealand
Date submitted for ethics approval [1] 318504 0
15/09/2025
Approval date [1] 318504 0
02/03/2026
Ethics approval number [1] 318504 0
ACTRN12625001294448p

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

Contacts
Principal investigator
Name 144394 0
Dr Zoe Odering
Address 144394 0
Department of Psychological Medicine, University of Otago - Christchurch, PO Box 4345, Christchurch 8140
Country 144394 0
New Zealand
Phone 144394 0
+64 3 3726739
Fax 144394 0
Email 144394 0
[email protected]
Contact person for public queries
Name 144395 0
Katie Douglas
Address 144395 0
Department of Psychological Medicine, University of Otago - Christchurch, PO Box 4345, Christchurch 8140
Country 144395 0
New Zealand
Phone 144395 0
+64 3 3726739
Fax 144395 0
Email 144395 0
[email protected]
Contact person for scientific queries
Name 144396 0
Zoe Odering
Address 144396 0
Department of Psychological Medicine, University of Otago - Christchurch, PO Box 4345, Christchurch 8140
Country 144396 0
New Zealand
Phone 144396 0
+64 3 3726739
Fax 144396 0
Email 144396 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• No requirements
What individual participant data might be shared?
• De-identified individual participant data:
• Published results
What types of analyses could be done with individual participant data?
• Systematic reviews and meta-analyses
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: By email to the principal investigator [email protected]

Are there extra considerations when requesting access to 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.