NCT05090046

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 22, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 22, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

February 10, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

May 9, 2024

Status Verified

May 1, 2024

Enrollment Period

2 years

First QC Date

September 22, 2021

Last Update Submit

May 7, 2024

Conditions

Keywords

TraumaEarthquakeCognitive impairment

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.

Other: Trauma exposure

Interventions

Exposure to the Canterbury earthquake sequence and other relevant psychological trauma

Christchurch Health and Development Study (CHDS)

Eligibility Criteria

Age44 Years - 46 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
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.

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

Location

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.

Biospecimen

Retention: SAMPLES WITHOUT DNA

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

Psychological TraumaWounds and InjuriesCognitive Dysfunction

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersCognition DisordersNeurocognitive Disorders

Study Officials

  • Katie M Douglas, PhD

    University of Otago

    PRINCIPAL INVESTIGATOR

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

Locations