Clinical trial NCT05090046: Understanding Neurocognitive Impairment After Trauma Exposure
Official title: Understanding Neurocognitive Impairment After Trauma Exposure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Trauma, Psychological
Earthquake
Keywords: Trauma
Earthquake
Cognitive impairment
Lead sponsor: University of Otago
Sponsor class: OTHER
First posted: 2021-10-22
Enrollment: 128
Sex: ALL
Minimum age (years): 44
Maximum age (years): 46
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Subjective cognitive function
timeFrame: Past 6 months
Secondary outcomes:
measure: Global cognitive composite
timeFrame: Baseline
measure: Verbal learning and memory
timeFrame: Baseline
measure: Visuospatial learning and memory
timeFrame: Baseline
measure: Psychomotor speed
timeFrame: Baseline
measure: Executive function
timeFrame: Baseline
measure: Working memory
timeFrame: Baseline
measure: Sustained attention
timeFrame: Baseline
measure: Facial emotion processing
timeFrame: Baseline
measure: Rumination
timeFrame: Baseline
measure: Metacognitive beliefs
timeFrame: Baseline
measure: Psychosocial functioning
timeFrame: Past 2 weeks
measure: Stressful life events
timeFrame: Past 5 years
measure: COVID-19 impact
timeFrame: Past 3 years
measure: Post-traumatic growth
timeFrame: Past 12 years
measure: Mental health diagnoses
timeFrame: Baseline
measure: Metabolic markers
timeFrame: Baseline
measure: Inflammation
timeFrame: Baseline
measure: Sex hormones
timeFrame: Baseline
Other outcomes:
measure: Data already obtained
timeFrame: 1977 to current
Locations:
city: Christchurch
country: New Zealand
facility: Department of Psychological Medicine, University of Otago, Christchurch
state: Canterbury
Study officials:
affiliation: University of Otago
name: Katie M Douglas, PhD
role: PRINCIPAL_INVESTIGATOR
References: