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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05090046
Registration number
NCT05090046
Ethics application status
Date submitted
22/09/2021
Date registered
22/10/2021
Titles & IDs
Public title
Understanding Neurocognitive Impairment After Trauma Exposure
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Scientific title
Understanding Neurocognitive Impairment After Trauma Exposure
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Secondary ID [1]
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11896201PQF
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Universal Trial Number (UTN)
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Trial acronym
UNITE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Trauma, Psychological
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Earthquake
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Condition category
Condition code
Skin
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Other skin conditions
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Mental Health
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Other mental health disorders
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Other interventions - Trauma exposure
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 interventions: Trauma exposure
Exposure to the Canterbury earthquake sequence and other relevant psychological trauma
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Subjective cognitive function
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Assessment method [1]
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Assessed with the Cognitive Failures Questionnaire Minimum score = 0, maximum score = 100, higher scores reflect worse subjective cognitive function
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Timepoint [1]
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Past 6 months
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Secondary outcome [1]
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Global cognitive composite
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline
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Secondary outcome [2]
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Verbal learning and memory
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Assessment method [2]
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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.
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Timepoint [2]
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Baseline
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Secondary outcome [3]
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Visuospatial learning and memory
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Assessment method [3]
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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.
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Timepoint [3]
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Baseline
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Secondary outcome [4]
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Psychomotor speed
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Assessment method [4]
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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.
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Timepoint [4]
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Baseline
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Secondary outcome [5]
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Executive function
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Assessment method [5]
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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.
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Timepoint [5]
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Baseline
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Secondary outcome [6]
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Working memory
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Assessment method [6]
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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.
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Timepoint [6]
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Baseline
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Secondary outcome [7]
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Sustained attention
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Assessment method [7]
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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.
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Timepoint [7]
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Baseline
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Secondary outcome [8]
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Facial emotion processing
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Assessment method [8]
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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.
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Timepoint [8]
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Baseline
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Secondary outcome [9]
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Rumination
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Assessment method [9]
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Assessed with the Ruminative Responses Scale Minimum score = 25, maximum score = 100, higher scores reflect more severe rumination
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Timepoint [9]
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Baseline
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Secondary outcome [10]
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Metacognitive beliefs
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Assessment method [10]
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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
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Timepoint [10]
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Baseline
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Secondary outcome [11]
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Psychosocial functioning
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Assessment method [11]
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Assessed with the Social Adjustment Scale Minimum score = 1, maximum score = 5, higher scores reflect worse psychosocial functioning
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Timepoint [11]
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Past 2 weeks
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Secondary outcome [12]
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Stressful life events
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Assessment method [12]
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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
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Timepoint [12]
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Past 5 years
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Secondary outcome [13]
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COVID-19 impact
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Assessment method [13]
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Assessed with the COVID Psychosocial Impacts Scale (CPIS) Minimum score = 0, maximum score = 135, higher scores reflect more severe impact of COVID
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Timepoint [13]
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Past 3 years
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Secondary outcome [14]
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Post-traumatic growth
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Assessment method [14]
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Assessed with the Post-traumatic Growth Inventory (PTGI)
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Timepoint [14]
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Past 12 years
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Secondary outcome [15]
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Mental health diagnoses
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Assessment method [15]
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Assessed with the Mini International Neuropsychiatric Interview (MINI)
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Timepoint [15]
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Baseline
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Secondary outcome [16]
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Metabolic markers
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Assessment method [16]
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Blood levels of HbA1C, total cholesterol, HDL cholesterol, LDL cholesterol (calc), triglycerides
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Timepoint [16]
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Baseline
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Secondary outcome [17]
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Inflammation
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Assessment method [17]
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Blood levels of CRP
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Timepoint [17]
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Baseline
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Secondary outcome [18]
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Sex hormones
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Assessment method [18]
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Blood levels of progesterone, LH, FSH, testosterone, SHBG (females only)
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Timepoint [18]
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Baseline
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Eligibility
Key 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
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Minimum age
44
Years
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Maximum age
46
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose
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Duration
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Selection
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Timing
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
10/02/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/02/2024
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Sample size
Target
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Accrual to date
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Final
128
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Canterbury
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of Otago
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT05090046
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Katie M Douglas, PhD
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Address
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University of Otago
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05090046