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Completed

NCT Number: NCT05090046

Understanding Neurocognitive Impairment After Trauma Exposure

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.

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Key information

Age range

44 year–46 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Psychological Medicine, University of Otago, Christchurch

Christchurch, Canterbury, 8011, New Zealand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Trauma exposure

Other

Exposure to the Canterbury earthquake sequence and other relevant psychological trauma

Primary outcomes

  1. Subjective cognitive function

    Time frame: Past 6 months

    Assessed with the Cognitive Failures Questionnaire Minimum score = 0, maximum score = 100, higher scores reflect worse subjective cognitive function

Secondary outcomes

  1. Global cognitive composite

    Time frame: Baseline

    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.

  2. Verbal learning and memory

    Time frame: Baseline

    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.

  3. Visuospatial learning and memory

    Time frame: Baseline

    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.

  4. Psychomotor speed

    Time frame: Baseline

    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.

  5. Executive function

    Time frame: Baseline

    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.

  6. Working memory

    Time frame: Baseline

    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.

  7. Sustained attention

    Time frame: Baseline

    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.

  8. Facial emotion processing

    Time frame: Baseline

    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.

  9. Rumination

    Time frame: Baseline

    Assessed with the Ruminative Responses Scale Minimum score = 25, maximum score = 100, higher scores reflect more severe rumination

  10. Metacognitive beliefs

    Time frame: Baseline

    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

  11. Psychosocial functioning

    Time frame: Past 2 weeks

    Assessed with the Social Adjustment Scale Minimum score = 1, maximum score = 5, higher scores reflect worse psychosocial functioning

  12. Stressful life events

    Time frame: Past 5 years

    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

  13. COVID-19 impact

    Time frame: Past 3 years

    Assessed with the COVID Psychosocial Impacts Scale (CPIS) Minimum score = 0, maximum score = 135, higher scores reflect more severe impact of COVID

  14. Post-traumatic growth

    Time frame: Past 12 years

    Assessed with the Post-traumatic Growth Inventory (PTGI)

  15. Mental health diagnoses

    Time frame: Baseline

    Assessed with the Mini International Neuropsychiatric Interview (MINI)

  16. Metabolic markers

    Time frame: Baseline

    Blood levels of HbA1C, total cholesterol, HDL cholesterol, LDL cholesterol (calc), triglycerides

  17. Inflammation

    Time frame: Baseline

    Blood levels of CRP

  18. Sex hormones

    Time frame: Baseline

    Blood levels of progesterone, LH, FSH, testosterone, SHBG (females only)

Other outcomes

  1. Data already obtained

    Time frame: 1977 to current

    Data will already be available from the CHDS database from birth to present, on the following relevant factors:

    • Childhood physical and emotional health
    • Childhood physical and sexual abuse
    • Previous stressful life event history
    • Lifetime mental health disorders
    • Traumatic brain injury
    • Environmental toxin exposure
    • Substance use
    • Personality factors (neuroticism, extraversion, novelty-seeking)
    • Educational achievement and IQ
    • Lifestyle factors, including diet and exercise
    • Parental functioning measures in childhood, including parental attachment and overprotection
    • Family functioning measures including parental maladaptive behaviour and illicit drug use, family instability, parental intimate partner violence
    • Trauma exposure in adulthood (including Christchurch earthquakes and Mosque shooting)
    • Menstrual history to identify those in early menopause The exact variables to be used for this study, and how they are to be aggregated, are TBC.

Sponsors and collaborators

Lead sponsor

University of Otago

Other

Registry information

Acronym: UNITE

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Oct 22, 2021
Registry last updated
May 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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