Understanding Neurocognitive Impairment After Trauma Exposure
UNITE
1 other identifier
observational
128
1 country
1
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2022
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 22, 2021
CompletedFirst Posted
Study publicly available on registry
October 22, 2021
CompletedStudy Start
First participant enrolled
February 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2024
CompletedMay 9, 2024
May 1, 2024
2 years
September 22, 2021
May 7, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Subjective cognitive function
Assessed with the Cognitive Failures Questionnaire Minimum score = 0, maximum score = 100, higher scores reflect worse subjective cognitive function
Past 6 months
Secondary Outcomes (18)
Global cognitive composite
Baseline
Verbal learning and memory
Baseline
Visuospatial learning and memory
Baseline
Psychomotor speed
Baseline
Executive function
Baseline
- +13 more secondary outcomes
Other Outcomes (1)
Data already obtained
1977 to current
Study Arms (1)
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.
Interventions
Exposure to the Canterbury earthquake sequence and other relevant psychological trauma
Eligibility Criteria
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. At the time of the February 2011 earthquake, 460 participants were in Christchurch and were subject to earthquake-related stresses. This study will recruit people from the CHDS who were exposed to the Canterbury earthquake sequence, based on results of an initial screening using the Cognitive Failures Questionnaire (CFQ): the quartile with the highest scores on the CFQ, and the quartile with the lowest scores will be selected and invited to attend a more comprehensive evaluation.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Psychological Medicine, University of Otago, Christchurch
Christchurch, Canterbury, 8011, New Zealand
Related Publications (1)
Douglas K, Bell C, Tanveer S, Eggleston K, Porter R, Boden J. UNITE Project: understanding neurocognitive impairment after trauma exposure-study protocol of an observational study in Christchurch, New Zealand. BMJ Open. 2023 Aug 7;13(8):e072195. doi: 10.1136/bmjopen-2023-072195.
PMID: 37550025DERIVED
Biospecimen
Blood samples will be collected to assess the following biological markers: * Hormones (females only): progesterone, LH, FSH, testosterone, SHBG * Metabolic markers: total chol, HDL chol, LDL chol (calc), triglycerides, HbA1c * Inflammatory markers: CRP
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Katie M Douglas, PhD
University of Otago
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 22, 2021
First Posted
October 22, 2021
Study Start
February 10, 2022
Primary Completion
February 1, 2024
Study Completion
February 1, 2024
Last Updated
May 9, 2024
Record last verified: 2024-05