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Trauma, PsychologicalUNITENCT05090046

Understanding Neurocognitive Impairment After Trauma Exposure

An observational study of Trauma, Psychological and Earthquake, run by University of Otago at 1 site in New Zealand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 44 to 46 years
Conditions the study is for
Trauma, Psychological, Earthquake
What is being tested?
Trauma exposure
How many people
128 participants
Where
1 siteNew Zealand
Study dates
10 Feb 2022to 1 Feb 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 44 to 46 years
  • All sexes
  • No healthy volunteers
  • Adult

Study population: 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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

New Zealand1 site

  • Department of Psychological Medicine, University of Otago, Christchurch

    Christchurch, Canterbury, 8011

Other trials in New Zealand

About this study

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.

Being tested
Trauma exposure
Keywords
Trauma, Earthquake, Cognitive impairment
Medical subject headings
Psychological Trauma, Wounds and Injuries, Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Trauma exposureOther

    Exposure to the Canterbury earthquake sequence and other relevant psychological trauma

Study groups in NCT05090046
Study groupRoleWhat they receive
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.
Receives: Other: Trauma exposure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Subjective cognitive function

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

    Measured: Past 6 months

Secondary outcomes (18)

  1. Global cognitive composite

    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.

    Measured: Baseline

  2. Verbal learning and memory

    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.

    Measured: Baseline

  3. Visuospatial learning and memory

    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.

    Measured: Baseline

  4. Psychomotor speed

    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.

    Measured: Baseline

  5. Executive function

    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.

    Measured: Baseline

  6. Working memory

    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.

    Measured: Baseline

  7. Sustained attention

    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.

    Measured: Baseline

  8. Facial emotion processing

    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.

    Measured: Baseline

  9. Rumination

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

    Measured: Baseline

  10. Metacognitive beliefs

    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

    Measured: Baseline

  11. Psychosocial functioning

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

    Measured: Past 2 weeks

  12. Stressful life events

    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

    Measured: Past 5 years

  13. COVID-19 impact

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

    Measured: Past 3 years

  14. Post-traumatic growth

    Assessed with the Post-traumatic Growth Inventory (PTGI)

    Measured: Past 12 years

  15. Mental health diagnoses

    Assessed with the Mini International Neuropsychiatric Interview (MINI)

    Measured: Baseline

  16. Metabolic markers

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

    Measured: Baseline

  17. Inflammation

    Blood levels of CRP

    Measured: Baseline

  18. Sex hormones

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

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Oct 2021
  2. Study start10 Feb 2022
  3. Primary completion1 Feb 2024
  4. Study completion1 Feb 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
128 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05090046
Sponsor's protocol ID
11896201PQF
Acronym
UNITE
Status last verified
May 2024
First submitted
22 Sep 2021
Last updated
9 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 37550025

Questions about this trial

What is this clinical trial studying?

An observational study of Trauma, Psychological and Earthquake, run by University of Otago at 1 site in New Zealand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Subjective cognitive function (time frame: Past 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05090046, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2024.

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