Understanding Neurocognitive Impairment After Trauma Exposure

Trauma, Psychological Clinical Trial

— UNITE  

Official title:

Understanding Neurocognitive Impairment After Trauma Exposure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05090046
• Other study ID #: 11896201PQF
• Status: Completed
• Start date: February 10, 2022
• Est. completion date: February 1, 2024

Study information

• Verified date: May 2024
• Source: University of Otago
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: February 1, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 44 Years to 46 Years

Eligibility

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

Related Conditions & MeSH terms

• Psychological Trauma
• Trauma, Psychological
• Wounds and Injuries

Intervention

Other:
• Trauma exposure
Exposure to the Canterbury earthquake sequence and other relevant psychological trauma

Locations

Country	Name	City	State
New Zealand	Department of Psychological Medicine, University of Otago, Christchurch	Christchurch	Canterbury

Sponsors (1)

Lead Sponsor	Collaborator
University of Otago

Country where clinical trial is conducted

New Zealand, 

Outcome

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