UNITE: Understanding Neurocognitive Impairment After Trauma Exposure

Sponsor
University of Otago (Other)
Overall Status
Recruiting
CT.gov ID
NCT05090046
Collaborator
(none)
200
1
20.7
9.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Trauma exposure

Study Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Understanding Neurocognitive Impairment After Trauma Exposure
Actual Study Start Date :
Feb 10, 2022
Anticipated Primary Completion Date :
Nov 1, 2023
Anticipated Study Completion Date :
Nov 1, 2023

Arms and Interventions

Arm Intervention/Treatment
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: Trauma exposure
Exposure to the Canterbury earthquake sequence and other relevant psychological trauma

Outcome Measures

Primary Outcome Measures

  1. Subjective cognitive function [Past 6 months]

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

Secondary Outcome Measures

  1. Global cognitive composite [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 [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 [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 [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 [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 [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 [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 [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 [Baseline]

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

  10. Metacognitive beliefs [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 [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 [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 [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 [Past 12 years]

    Assessed with the Post-traumatic Growth Inventory (PTGI)

  15. Mental health diagnoses [Baseline]

    Assessed with the Mini International Neuropsychiatric Interview (MINI)

  16. Metabolic markers [Baseline]

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

  17. Inflammation [Baseline]

    Blood levels of CRP

  18. Sex hormones [Baseline]

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

Other Outcome Measures

  1. Data already obtained [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
44 Years to 46 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Psychological Medicine, University of Otago, Christchurch Christchurch Canterbury New Zealand 8011

Sponsors and Collaborators

  • University of Otago

Investigators

  • Principal Investigator: Katie M Douglas, PhD, University of Otago

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Otago
ClinicalTrials.gov Identifier:
NCT05090046
Other Study ID Numbers:
  • 11896201PQF
First Posted:
Oct 22, 2021
Last Update Posted:
Mar 2, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Otago
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 2, 2022