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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05090046




Registration number
NCT05090046
Ethics application status
Date submitted
22/09/2021
Date registered
22/10/2021

Titles & IDs
Public title
Understanding Neurocognitive Impairment After Trauma Exposure
Scientific title
Understanding Neurocognitive Impairment After Trauma Exposure
Secondary ID [1] 0 0
11896201PQF
Universal Trial Number (UTN)
Trial acronym
UNITE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Trauma, Psychological 0 0
Earthquake 0 0
Condition category
Condition code
Skin 0 0 0 0
Other skin conditions
Mental Health 0 0 0 0
Other mental health disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - Trauma exposure

Christchurch Health and Development Study (CHDS) - The Christchurch Health and Development Study (CHDS) is a birth cohort study comprising 1265 people born in Christchurch in 1977. Participants have been followed to age 40, with 75-80% retention at data collection points.


Other interventions: Trauma exposure
Exposure to the Canterbury earthquake sequence and other relevant psychological trauma
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Subjective cognitive function
Assessment method [1] 0 0
Assessed with the Cognitive Failures Questionnaire Minimum score = 0, maximum score = 100, higher scores reflect worse subjective cognitive function
Timepoint [1] 0 0
Past 6 months
Secondary outcome [1] 0 0
Global cognitive composite
Assessment method [1] 0 0
Global cognitive composite will average Z-scores across the cognitive domains of (i) verbal learning and memory, (ii) visuospatial learning and memory, (iii) psychomotor speed, (iv) executive function, (v) working memory, (vi) sustained attention, and (vii) emotion processing. The Global cognitive composite score will be a single, averaged Z-value score, with a higher score reflecting better objective cognitive performance.
Timepoint [1] 0 0
Baseline
Secondary outcome [2] 0 0
Verbal learning and memory
Assessment method [2] 0 0
Z-scores from variables of the Rey Auditory Verbal Learning Test will be averaged to create a singe Z-score for the domain of 'Verbal Learning and Memory', with higher scores reflecting better performance.
Timepoint [2] 0 0
Baseline
Secondary outcome [3] 0 0
Visuospatial learning and memory
Assessment method [3] 0 0
Z-scores from variables of the Groton Maze Learning Test (CogState) will be averaged to create a singe Z-score for the domain of 'Visuospatial Learning and Memory', with higher scores reflecting better performance.
Timepoint [3] 0 0
Baseline
Secondary outcome [4] 0 0
Psychomotor speed
Assessment method [4] 0 0
Z-scores from variables of the Timed Chase Test (CogState), Trail Making Test - Part A, and Digit Symbol Coding Test will be averaged to create a singe Z-score for the domain of 'Psychomotor speed', with higher scores reflecting better performance.
Timepoint [4] 0 0
Baseline
Secondary outcome [5] 0 0
Executive function
Assessment method [5] 0 0
Z-scores from variables of the Trail Making Test - Part B and Category Fluency will be averaged to create a singe Z-score for the domain of 'Executive function', with higher scores reflecting better performance.
Timepoint [5] 0 0
Baseline
Secondary outcome [6] 0 0
Working memory
Assessment method [6] 0 0
Z-scores from variables of the Digit Span Test will be averaged to create a singe Z-score for the domain of 'Working memory', with higher scores reflecting better performance.
Timepoint [6] 0 0
Baseline
Secondary outcome [7] 0 0
Sustained attention
Assessment method [7] 0 0
Z-scores from variables of the Continuous Performance Test will be averaged to create a singe Z-score for the domain of 'Sustained attention', with higher scores reflecting better performance.
Timepoint [7] 0 0
Baseline
Secondary outcome [8] 0 0
Facial emotion processing
Assessment method [8] 0 0
Z-scores from variables of the Facial Expression Recognition Test and the Reading the Mind in the Eyes Test will be averaged to create a singe Z-score for the domain of 'Facial emotion processing', with higher scores reflecting better performance.
Timepoint [8] 0 0
Baseline
Secondary outcome [9] 0 0
Rumination
Assessment method [9] 0 0
Assessed with the Ruminative Responses Scale Minimum score = 25, maximum score = 100, higher scores reflect more severe rumination
Timepoint [9] 0 0
Baseline
Secondary outcome [10] 0 0
Metacognitive beliefs
Assessment method [10] 0 0
Assessed with the Metacognitions Questionnaire - 30-item version Minimum score = 30, maximum score = 120, higher scores reflect more problematic metacognitive beliefs Minimum score = 25, maximum score = 100, higher scores reflect more severe rumination
Timepoint [10] 0 0
Baseline
Secondary outcome [11] 0 0
Psychosocial functioning
Assessment method [11] 0 0
Assessed with the Social Adjustment Scale Minimum score = 1, maximum score = 5, higher scores reflect worse psychosocial functioning
Timepoint [11] 0 0
Past 2 weeks
Secondary outcome [12] 0 0
Stressful life events
Assessment method [12] 0 0
Number of stressful life events is assessed with the Life Events Scale (adapted from the Crisis in Family Systems - Revised Questionnaire) Minimum score = 0, higher score reflects more stressful life events
Timepoint [12] 0 0
Past 5 years
Secondary outcome [13] 0 0
COVID-19 impact
Assessment method [13] 0 0
Assessed with the COVID Psychosocial Impacts Scale (CPIS) Minimum score = 0, maximum score = 135, higher scores reflect more severe impact of COVID
Timepoint [13] 0 0
Past 3 years
Secondary outcome [14] 0 0
Post-traumatic growth
Assessment method [14] 0 0
Assessed with the Post-traumatic Growth Inventory (PTGI)
Timepoint [14] 0 0
Past 12 years
Secondary outcome [15] 0 0
Mental health diagnoses
Assessment method [15] 0 0
Assessed with the Mini International Neuropsychiatric Interview (MINI)
Timepoint [15] 0 0
Baseline
Secondary outcome [16] 0 0
Metabolic markers
Assessment method [16] 0 0
Blood levels of HbA1C, total cholesterol, HDL cholesterol, LDL cholesterol (calc), triglycerides
Timepoint [16] 0 0
Baseline
Secondary outcome [17] 0 0
Inflammation
Assessment method [17] 0 0
Blood levels of CRP
Timepoint [17] 0 0
Baseline
Secondary outcome [18] 0 0
Sex hormones
Assessment method [18] 0 0
Blood levels of progesterone, LH, FSH, testosterone, SHBG (females only)
Timepoint [18] 0 0
Baseline

Eligibility
Key inclusion criteria
* Cohort member of the Christchurch Health and Development Study (born in 1977)
* Exposed to the Canterbury earthquake sequence
* In the highest or lowest quartile with regards to score on the Cognitive Failures Questionnaire
Minimum age
44 Years
Maximum age
46 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* lifetime diagnosed psychotic disorder
* previous moderate to severe head injury (> 30 minutes loss of consciousness)
* current pregnancy
* intellectual disability (IQ < 80)
* residing outside of Canterbury

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/02/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/02/2024
Sample size
Target
Accrual to date
Final
128
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Canterbury

Funding & Sponsors
Primary sponsor type
Other
Name
University of Otago
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Katie M Douglas, PhD
Address 0 0
University of Otago
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05090046