Understanding Neurocognitive Impairment After Trauma Exposure (UNITE)

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.

Study Overview

• Status: Recruiting
• Conditions: Trauma, Psychological; Earthquake
• Intervention / Treatment: Other: Trauma exposure

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Katie M Douglas, PhD; Phone Number: 0064 3 372 6700; Email: katie.douglas@otago.ac.nz
• Study Contact Backup: Name: Caroline J Bell, MD; Phone Number: 0064 3 372 6700; Email: caroline.bell@otago.ac.nz

Study Locations

• New Zealand
  • Canterbury
    • Christchurch, Canterbury, New Zealand, 8011
      • Recruiting
      • Department of Psychological Medicine, University of Otago, Christchurch
      • Contact: Richard J Porter, MD; Phone Number: 0064 3 372 6700; Email: richard.porter@otago.ac.nz
      • Principal Investigator: Katie M Douglas, PhD
      • Sub-Investigator: Caroline J Bell, MD
      • Sub-Investigator: Richard J Porter, MD
      • Sub-Investigator: Joe Boden, PhD
      • Sub-Investigator: Sandila Tanveer, PhD
      • Sub-Investigator: Kate Eggleston, MBChB

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 44 years to 46 years (Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline
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.	Baseline
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.	Baseline
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.	Baseline
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.	Baseline
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.	Baseline
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.	Baseline
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.	Baseline
Rumination	Assessed with the Ruminative Responses Scale Minimum score = 25, maximum score = 100, higher scores reflect more severe rumination	Baseline
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	Baseline
Psychosocial functioning	Assessed with the Social Adjustment Scale Minimum score = 1, maximum score = 5, higher scores reflect worse psychosocial functioning	Past 2 weeks
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	Past 5 years
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	Past 3 years
Post-traumatic growth	Assessed with the Post-traumatic Growth Inventory (PTGI)	Past 12 years
Mental health diagnoses	Assessed with the Mini International Neuropsychiatric Interview (MINI)	Baseline
Metabolic markers	Blood levels of HbA1C, total cholesterol, HDL cholesterol, LDL cholesterol (calc), triglycerides	Baseline
Inflammation	Blood levels of CRP	Baseline
Sex hormones	Blood levels of progesterone, LH, FSH, testosterone, SHBG (females only)	Baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Data already obtained	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.	1977 to current

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2022
• Primary Completion (Anticipated): November 1, 2023
• Study Completion (Anticipated): November 1, 2023

Study Registration Dates

• First Submitted: September 22, 2021
• First Submitted That Met QC Criteria: October 10, 2021
• First Posted (Actual): October 22, 2021

Study Record Updates

• Last Update Posted (Actual): May 12, 2023
• Last Update Submitted That Met QC Criteria: May 10, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Cognitive impairment; Trauma; Earthquake
• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Wounds and Injuries; Psychological Trauma
• Other Study ID Numbers: 11896201PQF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No