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      UNITE Project: understanding neurocognitive impairment after trauma exposure–study protocol of an observational study in Christchurch, New Zealand

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          Abstract

          Introduction

          Our previous research has demonstrated significant cognitive effects of earthquake exposure 2–3 years following the Canterbury earthquake sequence of 2011. Such impairment has major implications for a population trying to recover, and to rebuild, a devastated city. This study aims to examine psychological, cognitive and biological factors that may contribute to subjective cognitive difficulties in a large group of individuals exposed to the Canterbury earthquake sequence.

          Methods and analysis

          Two-hundred earthquake-exposed participants from an existing large cohort study (Christchurch Health and Development Study, CHDS) will be recruited. Inclusion is based on results of online screening of the CHDS cohort, using the Cognitive Failures Questionnaire. Individuals scoring the highest (n=100) and lowest (n=100), representing the highest and lowest levels of subjective cognitive impairment, are selected. Exclusions are: psychotic/bipolar disorders, serious substance/alcohol dependence, chronic medical conditions, pregnancy and previous serious head injury. Participants will undergo a half-day assessment including clinician-rated interviews, self-report measures, objective and subjective cognitive assessments, blood sample collection and physical measurements. The primary analysis will compare cognitive, psychological and biological measures in ‘high’ and ‘low’ subjective cognitive impairment groups. The study will have power (p<0.05, α=0.8) to show a difference between groups of 0.4 SD on any variable.

          Ethics and dissemination

          Ethical approval for this study was granted by the New Zealand Health and Disability Ethics Committee. The online screening component of the study received ethical approval on 1 April 2021 (16/STH/188, PAF 7), and the main study (subsequent to screening) received approval on 16 August 2021 (Northern A 21/NTA/68). All participants provide written informed consent. Findings will be disseminated initially to the CHDS cohort members, the wider Canterbury community, and then by publication in scientific journals and conference presentations.

          Trial registration number

          ClinicalTrials.gov Registry (NCT05090046).

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          Most cited references62

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          Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies.

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            Effects of stress throughout the lifespan on the brain, behaviour and cognition.

            Chronic exposure to stress hormones, whether it occurs during the prenatal period, infancy, childhood, adolescence, adulthood or aging, has an impact on brain structures involved in cognition and mental health. However, the specific effects on the brain, behaviour and cognition emerge as a function of the timing and the duration of the exposure, and some also depend on the interaction between gene effects and previous exposure to environmental adversity. Advances in animal and human studies have made it possible to synthesize these findings, and in this Review a model is developed to explain why different disorders emerge in individuals exposed to stress at different times in their lives.
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              The MATRICS Consensus Cognitive Battery, part 1: test selection, reliability, and validity.

              The lack of an accepted standard for measuring cognitive change in schizophrenia has been a major obstacle to regulatory approval of cognition-enhancing treatments. A primary mandate of the National Institute of Mental Health's Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) initiative was to develop a consensus cognitive battery for clinical trials of cognition-enhancing treatments for schizophrenia through a broadly based scientific evaluation of measures. The MATRICS Neurocognition Committee evaluated more than 90 tests in seven cognitive domains to identify the 36 most promising measures. A separate expert panel evaluated the degree to which each test met specific selection criteria. Twenty tests were selected as a beta battery. The beta battery was administered to 176 individuals with schizophrenia and readministered to 167 of them 4 weeks later so that the 20 tests could be compared directly. The expert panel ratings are presented for the initially selected 36 tests. For the beta battery tests, data on test-retest reliability, practice effects, relationships to functional status, practicality, and tolerability are presented. Based on these data, 10 tests were selected to represent seven cognitive domains in the MATRICS Consensus Cognitive Battery. The structured consensus method was a feasible and fair mechanism for choosing candidate tests, and direct comparison of beta battery tests in a common sample allowed selection of a final consensus battery. The MATRICS Consensus Cognitive Battery is expected to be the standard tool for assessing cognitive change in clinical trials of cognition-enhancing drugs for schizophrenia. It may also aid evaluation of cognitive remediation strategies.
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                Author and article information

                Journal
                BMJ Open
                BMJ Open
                bmjopen
                bmjopen
                BMJ Open
                BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                2044-6055
                2023
                7 August 2023
                : 13
                : 8
                : e072195
                Affiliations
                [1 ]departmentDepartment of Psychological Medicine , Ringgold_2495University of Otago , Christchurch, New Zealand
                [2 ]departmentSpecialist Mental Health Services , Ringgold_63588Te Whatu Ora Waitaha , Christchurch, New Zealand
                Author notes
                [Correspondence to ] Dr Katie Douglas; katie.douglas@ 123456otago.ac.nz
                Author information
                http://orcid.org/0000-0002-5344-2959
                http://orcid.org/0000-0002-0648-5382
                Article
                bmjopen-2023-072195
                10.1136/bmjopen-2023-072195
                10407410
                37550025
                04406588-5b84-4934-970d-6f74a7e5aa95
                © Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

                This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See:  http://creativecommons.org/licenses/by-nc/4.0/.

                History
                : 25 January 2023
                : 21 July 2023
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/501100001530, Canterbury Medical Research Foundation;
                Award ID: N/A
                Funded by: FundRef http://dx.doi.org/10.13039/501100001505, Health Research Council of New Zealand;
                Award ID: 16/600
                Award ID: 19/082
                Categories
                Mental Health
                1506
                1712
                Protocol
                Custom metadata
                unlocked

                Medicine
                life change events,mental health,adult psychiatry,risk factors
                Medicine
                life change events, mental health, adult psychiatry, risk factors

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