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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05090046




Registration number
NCT05090046
Ethics application status
Date submitted
22/09/2021
Date registered
22/10/2021
Date last updated
9/05/2024

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
Timepoint [1] 0 0
Past 6 months
Secondary outcome [1] 0 0
Global cognitive composite
Timepoint [1] 0 0
Baseline
Secondary outcome [2] 0 0
Verbal learning and memory
Timepoint [2] 0 0
Baseline
Secondary outcome [3] 0 0
Visuospatial learning and memory
Timepoint [3] 0 0
Baseline
Secondary outcome [4] 0 0
Psychomotor speed
Timepoint [4] 0 0
Baseline
Secondary outcome [5] 0 0
Executive function
Timepoint [5] 0 0
Baseline
Secondary outcome [6] 0 0
Working memory
Timepoint [6] 0 0
Baseline
Secondary outcome [7] 0 0
Sustained attention
Timepoint [7] 0 0
Baseline
Secondary outcome [8] 0 0
Facial emotion processing
Timepoint [8] 0 0
Baseline
Secondary outcome [9] 0 0
Rumination
Timepoint [9] 0 0
Baseline
Secondary outcome [10] 0 0
Metacognitive beliefs
Timepoint [10] 0 0
Baseline
Secondary outcome [11] 0 0
Psychosocial functioning
Timepoint [11] 0 0
Past 2 weeks
Secondary outcome [12] 0 0
Stressful life events
Timepoint [12] 0 0
Past 5 years
Secondary outcome [13] 0 0
COVID-19 impact
Timepoint [13] 0 0
Past 3 years
Secondary outcome [14] 0 0
Post-traumatic growth
Timepoint [14] 0 0
Past 12 years
Secondary outcome [15] 0 0
Mental health diagnoses
Timepoint [15] 0 0
Baseline
Secondary outcome [16] 0 0
Metabolic markers
Timepoint [16] 0 0
Baseline
Secondary outcome [17] 0 0
Inflammation
Timepoint [17] 0 0
Baseline
Secondary outcome [18] 0 0
Sex hormones
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
Cross-sectional
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
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Individuals living in Canterbury (New Zealand) have experienced significant stress related to
the Canterbury earthquake sequence. Previous research conducted at the Department of
Psychological Medicine (Christchurch, New Zealand) has shown significant cognitive
difficulties in a group of Cantabrians exposed to high levels of earthquake trauma. A high
proportion (30%) perceive themselves to have significant cognitive difficulties, even seven
years post-earthquake. People who perceive that they have cognitive difficulties find this
distressing and tend to function less well in work and parenting. Understanding pathways
underlying cognitive difficulties in the population is vital for developing appropriate
treatments and strategies to help with this.

This will be the first study to investigate rates of, and factors contributing to, perceived
cognitive difficulties in a large population exposed to multiple stressors and is important
for the population of Canterbury, and populations affected by natural and man-made disasters
worldwide.

Four hundred and sixty people who were exposed to the Canterbury earthquake sequence will be
recruited from the Christchurch Health and Development Study (CHDS). Psychological,
cognitive, functional and biological factors will be compared between those with the greatest
levels of perceived cognitive difficulty and those with the lowest levels of difficulty. This
will determine what factors relate most strongly to perceived cognitive difficulties, which
will in turn be used to develop treatments for this population.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05090046
Trial related presentations / publications
Public notes

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