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Demência , Humanos , Demência/epidemiologia , Demência/prevenção & controle , Demência/terapiaRESUMO
Close links exist between vestibular function and cognition. Dual-task (DT) tests may have ecological validity to assess the impact of daily life cognitive-motor demands in people with vestibular dysfunction (PwVD), functional gait and falls risk. The present paper aimed at building predictive models for functional gait under DT conditions, while clarifying the impact of vestibular dysfunction, individual characteristics, varying task types and motor-cognitive demands. Case-controlled observational study with 39 PwVD and 62 healthy participants. The Functional Gait Assessment (FGA), with and without an additional motor, numeracy, or literacy task, was completed. Multiple linear regression was used to fit models to predict FGA under single and DT performance. Dual task cost (DTC, %) was calculated to assess DT interference on FGA performance using the equation: 100*(single task score-dual task score)/single-task score. Following Bonferroni corrections for multiple comparisons (corrected alpha level of 0.003), PwVD had poorer performance than controls for all FGA conditions (p < 0.001), motor (- 3.94%; p = 0.002) and numeracy (- 22.77%; p = 0.001) DTCs and spatial working memory (p = 0.002). The literacy DTC was marginally significant (- 19.39% p = 0.005). FGA single and DT motor, numeracy, and literacy models explained 76%, 76%, 66% and 67% of the variance respectively for PwVD. Sustained attention, visual memory and sex contributed to all models; short-term visual recognition memory, balance confidence, and migraine contributed to some models. Cognitive performance is impaired in PwVD. Motor, numeracy and literacy tasks impair functional gait performance. Cognitive assessment and FGA with a numeracy or literacy cognitive component should be included within assessment protocols and considered in the provision of targeted interventions for PwVD.
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Otopatias , Doenças Vestibulares , Humanos , Marcha , Cognição , Análise e Desempenho de Tarefas , Memória de Curto Prazo , CaminhadaRESUMO
BACKGROUND: midlife hearing loss is a potentially modifiable risk factor for dementia. Addressing comorbid hearing loss and cognitive impairment in services for older adults may offer opportunities to reduce dementia risk. OBJECTIVE: to explore current practice and views amongst UK professionals regarding hearing assessment and care in memory clinics and cognitive assessment and care in hearing aid clinics. METHODS: national survey study. Between July 2021 and March 2022, we distributed the online survey link via email and via QR codes at conferences to professionals working in National Health Service (NHS) memory services and audiologists working in NHS and private adult audiology services. We present descriptive statistics. RESULTS: 135 professionals working in NHS memory services and 156 audiologists (68% NHS, 32% private sector) responded. Of those working in memory services, 79% estimate that >25% of their patients have significant hearing difficulties; 98% think it useful to ask about hearing difficulties and 91% do so; 56% think it useful to perform a hearing test in clinic but only 4% do so. Of audiologists, 36% estimate that >25% of their older adult patients have significant memory problems; 90% think it useful to perform cognitive assessments, but only 4% do so. Main barriers cited are lack of training, time and resources. CONCLUSIONS: although professionals working in memory and audiology services felt addressing this comorbidity would be useful, current practice varies and does not generally address it. These results inform future research into operational solutions to integrating memory and audiology services.
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Audiologia , Disfunção Cognitiva , Demência , Perda Auditiva , Humanos , Idoso , Audiologia/métodos , Medicina Estatal , Perda Auditiva/diagnóstico , Perda Auditiva/epidemiologia , Perda Auditiva/terapia , Disfunção Cognitiva/diagnóstico , Disfunção Cognitiva/epidemiologia , Disfunção Cognitiva/terapia , Comorbidade , Reino Unido/epidemiologiaRESUMO
BACKGROUND: Sleep disturbances affect 38% of care home residents living with dementia. They are often treated with medication, but non-pharmacological interventions may be safer and effective yet more difficult to implement. In the SIESTA study (Sleep problems In dEmentia: interviews with care home STAff) we explored care home staffs' experience of managing sleep disturbances in their residents living with dementia. METHODS: We conducted one-to-one semi-structured interviews in four UK care homes, and purposively recruited a maximum variation sample of 18 nurses and care assistants, who were each interviewed once. We used a topic guide and audio-recorded the interviews. Two researchers independently analysed themes from transcribed interviews. RESULTS: Staff used a range of techniques that often worked in improving or preventing residents' sleep disturbance. During the daytime, staff encouraged residents to eat well, and be physically active and stimulated to limit daytime sleep. In the evening, staff settled residents into dark, quiet, comfortable bedrooms often after a snack. When residents woke at night, they gave them caffeinated tea or food, considered possible pain and discomfort, and reassured residents they were safe. If residents remained unsettled, staff would engage them in activities. They used telecare to monitor night-time risk. Staff found minimising daytime napping difficult, described insufficient staffing at night to attend to reorient and guide awake residents and said residents frequently did not know it was night-time. CONCLUSIONS: Some common techniques, such as caffeinated drinks, may be counterproductive. Future non-pharmacological interventions should consider practical difficulties staff face in managing sleep disturbances, including struggling to limit daytime napping, identifying residents' night-time needs, day-night disorientation, and insufficient night-time staffing.
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Demência , Transtornos do Sono-Vigília , Demência/complicações , Demência/terapia , Humanos , Casas de Saúde , Pesquisa Qualitativa , Sono , Transtornos do Sono-Vigília/etiologia , Transtornos do Sono-Vigília/terapiaRESUMO
INTRODUCTION: People living with dementia in care homes often have sleep disturbances, but little is known about incidence and importance. METHODS: We interviewed 1483 participants in 97 care homes and report prevalence, 1-year incidence, and baseline associations of clinically significant sleep disturbance in people with dementia. RESULTS: Baseline prevalence of clinically significant sleep disturbance was 13.7% (200/1460); 31.3% (457/1462) had them at least once over 16 months. One-year incidence was 25.2%. At baseline, residents with sleep disturbance had lower quality of life (mean difference -4.84; 95% confidence interval [CI] -6.53 to -3.16) and were more frequently prescribed sleep medications (odds ratio 1.75; CI 1.17 to 2.61) than other residents. DISCUSSION: Approximately one-third of care home residents with dementia have or develop sleep disturbances over 1 year. These are associated with lower quality of life and prescription of sedatives, which may have negative outcomes; therefore, it is important to develop effective treatments.
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OBJECTIVES: This research aims to validate a modified visually based Montreal Cognitive Assessment for hearing-aid users (MoCA-HA). This population should be the target of cognitive screening due to high risk of developing dementia. DESIGN: Case-control study. SETTING: The participants were recruited from referral hearing-aid center and memory clinic in central London, United Kingdom. PARTICIPANT: 75 hearing-aid users were recruited. Of these, thirty were cognitively intact controls with hearing impairment (NC-HI); thirty had mild cognitive impairment with hearing impairment (MCI-HI); fifteen had dementia with hearing impairment (D-HI). MEASUREMENTS: The baseline characteristics and analysis of the MoCA-HA for the NC-HI were recorded. The MoCA-HA performance of the MCI-HI cohort and D-HI cohort were also studied. RESULTS: The cutpoint of <26 yields 93.3% sensitivity with 80% specificity in distinguishing MCI-HI from NC-HI. The specificity increased to 95.6% in screening for all cognitive impairment (MCI-HI and D-HI) from NC-HI. CONCLUSION: The MoCA-HA has been validated with a cutpoint which is comparable to the traditional MoCA. This tool may help clinicians to early identify older adult hearing-aid users for appropriate cognitive evaluation.
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AIMS: To identify cognitive tests that best differentiate between Posterior Cortical Atrophy (PCA) and typical Alzheimer's Disease (tAD), as well as PCA and healthy control (HC) participants. METHOD: Medline, PsycInfo and Web of Science were systematically searched using terms related to PCA, tAD, and cognitive testing. Seventeen studies were identified, including 441 PCA, 391 tAD, and 284 HC participants. Standardised effect sizes of mean scores were calculated to measure performance differences on cognitive tests for PCA versus tAD and PCA versus HC groups. Meta-analyses used a random effects model. RESULTS: The most discriminating cognitive tests for PCA and tAD presentations were measures of visuospatial function and verbal memory. Large, significant effect sizes were produced for all measures of visuospatial function, most notably for Rey-Osterrieth Copy (Hedges' g = -2.79), VOSP Fragmented letters (Hedges' g = -1.73), VOSP Dot Counting (Hedges' g = -1.74), and VOSP Cube Analysis (Hedges' g = -1.98). For measures of verbal memory, the RAVLT delay and Digit Span Backwards produced significant medium effects (Hedges' g = .62 and -.56, respectively). CONCLUSION: Establishing a common framework for testing individuals with PCA has important implications for diagnosis and treatment, and forms a practical objective for future research. Findings from this meta-analysis suggest that measures of visuospatial function and verbal memory would form an important part of this framework.
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Doença de Alzheimer , Atrofia , Humanos , Memória , Testes NeuropsicológicosRESUMO
BACKGROUND: A large proportion of older adults assessed for cognitive impairment likely have hearing loss, potentially affecting accuracy of cognitive performance estimations. This study aimed to develop a hearing-impaired version of the Addenbrooke's Cognitive Examination-III (HI-ACE-III) and to assess whether the HI-ACE-III can accurately distinguish people with mild cognitive impairment (MCI) and dementia from cognitively intact controls. METHODS: The HI-ACE-III was developed by converting verbal instructions into a visual, timed PowerPoint presentation. Seventy-four participants over the age of 60 years were classified into three groups: 29 had MCI, 15 had mild to moderate dementia and 30 were cognitively intact controls. Receiver operating characteristic (ROC) curves were graphed to test screening accuracy. Concurrent validity was examined through correlations between HI-ACE-III domain scores and relevant, visually presented standardized neuropsychological measures. RESULTS: ROC analysis for dementia revealed an area under the curve (AUC) of 0.99, achieving excellent sensitivity (100%) and good specificity (93.3%) at an optimum cut-off of <87. The AUC for MCI was 0.86, achieving reasonable sensitivity (75.9%) and good specificity (86.7%) at an optimum cut-off of <92. HI-ACE-III subtests shared anticipated and statistically significant correlations with established measures of cognitive functioning. Internal consistency of the HI-ACE-III was excellent as verified with Cronbach's alpha (α = 0.904). CONCLUSIONS: Preliminarily, the HI-ACE-III showed good reliability, validity and screening utility for MCI and dementia in older adults in a hearing-impairment context. The adapted HI-ACE-III may offer accurate and reliable indication of cognitive performance, supporting timely diagnosis and research examining links between hearing loss and cognitive decline.
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Disfunção Cognitiva , Demência , Idoso , Cognição , Disfunção Cognitiva/diagnóstico , Demência/diagnóstico , Audição , Humanos , Pessoa de Meia-Idade , Testes Neuropsicológicos , Curva ROC , Reprodutibilidade dos TestesRESUMO
BACKGROUND: Patients with dementia commonly have problems processing speech in the presence of competing background speech or noise. This difficulty can be present from the very early stages of dementia, and may be a preclinical feature of Alzheimer's disease. PURPOSE: This study investigates whether people with dementia perform worse on the dichotic digit test (DDT), an experimental probe of speech processing in the presence of competing speech, and whether test performance may predict dementia onset. RESEARCH DESIGN: Systematic review and meta-analysis. DATA COLLECTION AND ANALYSIS: A literature search was conducted in Medline, Embase, Scopus, and Psycinfo. We included (1) studies that included people with a diagnosis of dementia and a healthy control group with no cognitive impairment; (2) studies that reported results from a DDT in a free-recall response task; and (3) studies that had the dichotic digit mean correct percentage score or right-ear advantage, as outcome measurements. RESULTS: People with dementia had a lower DDT total score, with a pooled mean difference of 18.6% (95% confidence interval [CI]: 21.2-15.9). Patients with dementia had an increased right-ear advantage relative to controls with a pooled difference of 24.4% (95% CI: 21.8-27.0). CONCLUSION: The DDT total scores are lower and the right-ear advantage increased in cognitively impaired versus normal control participants. The findings also suggest that the reduction of dichotic digit total score and increase of right-ear advantage progress as cognitive impairment increases. Whether abnormalities in dichotic digit scores could predict subsequent dementia onset should be examined in further longitudinal studies.
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Doença de Alzheimer , Testes com Listas de Dissílabos , Audição , Transtornos da Audição , Humanos , Rememoração MentalAssuntos
Demência/prevenção & controle , Política de Saúde , Estilo de Vida Saudável , Poluição do Ar/efeitos adversos , Poluição do Ar/estatística & dados numéricos , Alcoolismo/epidemiologia , Traumatismos Craniocerebrais/epidemiologia , Demência/epidemiologia , Demência/terapia , Disparidades em Assistência à Saúde , Humanos , Fatores de RiscoRESUMO
OBJECTIVES: Nearly 40% of care home residents who are living with dementia also have symptoms of disturbed sleep. However, the impact of these disturbances is relatively unknown and is needed to indicate whether interventions are warranted; therefore, we aimed to investigate the impact. DESIGN: One-to-one semi-structured interviews. SETTINGS: Four UK care homes. PARTICIPANTS: We interviewed 18 nurses and care assistants about residents with sleep disturbances. MEASUREMENTS: We used a topic guide to explore staff experience of sleep disturbance in residents with dementia. The interviews were audio recorded and transcribed and then analyzed thematically by two researchers independently. RESULTS: Staff described that sleep disturbances in most, but not all, residents impacted negatively on the resident, other residents, staff, and relatives. Residents became more irritable or agitated if they had slept badly. They slept in the daytime after a bad night, which then increased their chances of being awake the following night. For some, being sleepy in the day led to falls, missing medication, drinks, and meals. Staff perceived hypnotics as having low efficacy, but increasing the risk of falls and drowsiness. Other residents were disturbed by noise, and staff described stress when several residents had sleep disturbance. Some of the strategies reported by staff to deal with sleep disturbances such as feeding or providing caffeinated tea at night might be counterproductive. CONCLUSIONS: Sleep disturbances in care home residents living with dementia negatively affect their physical and psychological well-being. These disturbances also disturb other residents and increase stress in staff.
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Cuidadores/psicologia , Demência/psicologia , Pessoal de Saúde , Transtornos do Sono-Vigília/psicologia , Adulto , Instituição de Longa Permanência para Idosos , Humanos , Entrevistas como Assunto , Masculino , Pessoa de Meia-Idade , Casas de Saúde , Pesquisa Qualitativa , Sono/fisiologia , Transtornos do Sono-Vigília/fisiopatologia , Vigília/fisiologiaRESUMO
BACKGROUND: Older adults are at high risk of developing age-related hearing loss (HL) and/or cognitive impairment. However, cognitive screening tools rely on oral administration of instructions and stimuli that may be impacted by HL. This systematic review aims to investigate (a) whether people with HL perform worse than those without HL on the Montreal Cognitive Assessment (MoCA), a widely used screening tool for cognitive impairment, and what the effect size of that difference is (b) whether HL treatment mitigates the impact of HL. METHOD: We conducted a systematic review and meta-analysis including studies that reported mean MoCA scores and SDs for individuals with HL. RESULTS: People with HL performed significantly worse on the MoCA (4 studies, N = 533) with a pooled mean difference of -1.66 points (95% confidence interval CI -2.74 to -0.58). There was no significant difference in MoCA score between the pre- vs post-hearing intervention (3 studies, N = 75). However, sensitivity analysis in the cochlear implant studies (2 studies, N = 33) showed improvement of the MoCA score by 1.73 (95% CI 0.18 to 3.28). CONCLUSION: People with HL score significantly lower than individuals with normal hearing on the standard orally administered MoCA. Clinicians should consider listening conditions when administering the MoCA and report the hearing status of the tested individuals, if known, taking this into account in interpretation or make note of any hearing difficulty during consultations which may warrant onward referral. Cochlear implants may improve the MoCA score of individuals with HL, and more evidence is required on other treatments. J Am Geriatr Soc 68:-, 2020.
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Implantes Cocleares , Disfunção Cognitiva , Perda Auditiva , Idoso , Disfunção Cognitiva/diagnóstico , Audição , Perda Auditiva/diagnóstico , Humanos , Testes de Estado Mental e Demência , Testes NeuropsicológicosRESUMO
OBJECTIVES: Hearing aid usage supports communication and independence; however, many do not use their hearing aids. This study explored the experiences of hearing aid use in adults with mild cognitive impairment or Alzheimer's disease. METHODS: Participants completed semi-structured interviews which were analysed using thematic analysis. Ten people (six males, age range 75-86 years old) with mild cognitive impairment or Alzheimer's disease who had been fitted with hearing aids were recruited to the study. RESULTS: We identified four major themes: (1) memory and other cognitive barriers to using hearing aids, (2) practical aspects of hearing aids, (3) benefits of hearing aids, and (4) ambivalence towards hearing aids. CONCLUSIONS: Participants perceived a significant impact of cognitive impairment on the experience of using hearing aids. This population may benefit from targeted strategies to support use of hearing aids. The findings from this study can inform future research to optimise use of hearing aids in this population.
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BACKGROUND: Brain-derived neurotrophic factor (BDNF) has an essential role in synaptic plasticity and neurogenesis. BDNF mediates amygdala-dependent learning for both aversive and appetitive emotional memories. The expression of BDNF in limbic regions is posited to contribute the development of depression, and amygdala responsivity is a potential marker of depressive state. METHODS: The present study examined the relationship between platelet BDNF levels and amygdala volume and function in major depressive disorder (MDD). Participants were 23 MDD (mean age 38.9 years) and 23 healthy controls (mean age 38.8 years). All participants were recruited from the community. MDD participants were in a current depressive episode of moderate severity and medication-free. Amygdala responses were acquired during a functional MRI task of implicit emotional processing with sad facial expressions. RESULTS: Significant correlation was observed between platelet BDNF levels and left amygdala responses, but no significant correlations were found with right amygdala responses or with amygdala volumes. LIMITATIONS: Interactions with neuroprotective as well as neurotoxic metabolites in the kyneurenine pathway were not examined. CONCLUSIONS: Relationship between BDNF levels and amygdala responsivity to emotionally salient stimuli in MDD could reflect the importance of BDNF in amygdala-dependent learning with clinical implications for potential pathways for treatment.
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Fator Neurotrófico Derivado do Encéfalo , Transtorno Depressivo Maior , Adulto , Tonsila do Cerebelo/diagnóstico por imagem , Emoções , Expressão Facial , Humanos , Imageamento por Ressonância MagnéticaRESUMO
BACKGROUND: The potential economic value of interventions to prevent late-onset dementia is unknown. We modelled this for potentially modifiable risk factors for dementia. METHODS: For this modelling study, we searched PubMed and Web of Science from inception to March 12, 2020, and included interventions that: successfully targeted any of nine prespecified potentially modifiable risk factors (hypertension, diabetes, hearing loss, obesity, physical inactivity, social isolation, depression, cigarette smoking, and less childhood education); had robust evidence that the intervention improved risk or risk behaviour; and are feasible to enact in an adult population. We established when in the life course each intervention would be delivered. We calculated dementia incidence reduction from annual incidence of dementia in people with each risk factor, and population attributable fraction for each risk, corrected for risk factor clustering, and how effectively the intervention controls the risk factor. We calculated the discounted value of lifetime health gain and effect on cost (including NHS, social care and carer costs) per person eligible for treatment. We estimated annual total expenditure on the fully operational intervention programme in England. FINDINGS: We found effective interventions for hypertension, smoking cessation, diabetes prevention, and hearing loss. Treatments for stopping smoking and provision of hearing aids reduced cost. Treatment of hypertension was cost-effective by reference to standard UK thresholds. The three interventions when fully implemented would save £1·863 billion annually in England, reduce dementia prevalence by 8·5%, and produce quality-adjusted life-year gains. The intervention for diabetes was unlikely to be cost-effective in terms of effect on dementia alone. INTERPRETATION: There is a strong case for implementing the three effective interventions on grounds of cost-effectiveness and quality-of-life gains, as well as for improvements in general health. The interventions have the potential to remain cost-saving or cost-effective even with variations in dementia incidence and costs and effectiveness of interventions. FUNDING: Economic and Social Research Council.
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As life expectancy increases, it is imperative that the elderly take advantage of the benefits of technology to remain active and independent. Mobile health applications are widely used nowadays as they promote a healthy lifestyle and self-management of diseases, opening new horizons in the interactive health service delivery. However, adapting these applications to the needs and requirements of the elderly is still a challenge. This article presents a smartphone application that is part of a multifactorial intervention to support older people with balance disorders. The application aims to enable users to self-evaluate their activity and progress, to communicate with each other and, through strategically selected motivational features, to engage with the system with undiminished interest for a long period of time. Mock-up interfaces were evaluated in semi-structured focus groups and interviews that were performed across three European countries. Further evaluation in the form of four pilot studies with 160 participants will be performed and qualitative and quantitative measures will be used to process the feedback about the use of the application.
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Longitudinal neuroimaging studies in major depression have revealed cortico-limbic abnormalities which are modulated by treatment. We performed a systematic review and meta-analysis of psychotherapy treatment studies measuring neural function and metabolism using fMRI, PET, SPECT and MRS. Seventeen studies were included in the systematic review, total of 200 major depression participants (mean age 37.6 years), all medication free, and 116 healthy controls (mean age 36.4 years). Neuroimaging assessments were performed prior to initiation of treatment and following course of treatment. Treatment durations were: 16-30 weeks for CBT, 11 weeks for behavioral activation therapy, and up to 15 months for psychodynamic psychotherapy. The meta-analysis consisted of studies in which both groups had same serial scans and comparable tasks; total of 5 studies with visual presentation tasks of emotional stimuli: 55 patients (mean age: 38.7 years) and 55 healthy controls (mean age: 36.3 years). The meta-analysis revealed a significant group by time effect in left rostral anterior cingulate, in which patients showed increased activity following psychotherapy while healthy controls showed a decrease at follow up. Longitudinal treatment effects revealed reduced left precentral cortical activity in major depression. Findings could be indicative of improvements in emotion responsivity that may be achieved following psychotherapy.
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Transtorno Depressivo Maior/diagnóstico por imagem , Transtorno Depressivo Maior/terapia , Giro do Cíngulo/diagnóstico por imagem , Psicoterapia Psicodinâmica/tendências , Adulto , Cognição/fisiologia , Transtorno Depressivo Maior/psicologia , Emoções/fisiologia , Feminino , Humanos , Imageamento por Ressonância Magnética/tendências , Masculino , Pessoa de Meia-Idade , Neuroimagem/tendências , Psicoterapia Psicodinâmica/métodosRESUMO
OBJECTIVE: The other race effect, also known as own race bias, refers to the enhanced ability to recognize faces belonging to one's own race relative to faces from another race. The other race effect is associated with increased amygdala response in healthy individuals. The amygdala is a key node in emotion processing which shows impaired functioning in depression and has been proposed to be a marker of depressive state. We investigated the impact of the other race effect on amygdala responses in depression. METHODS: Participants were 30 individuals with major depression (mean age 39.4 years) and 23 healthy individuals (mean age: 38.8 years) recruited from the community. Participants were Asian, Black/African American and Caucasian. During a functional MRI scan, participants viewed Caucasian faces which displayed a range of sad expressions. A region of interest analysis of left and right amygdala responses was performed. RESULTS: Increased bilateral amygdala responses were observed in response to the Caucasian face stimuli in participants who were Asian or Black/African American as compared to Caucasian participants in both healthy individuals and individuals with major depression. There was no significant group by race interaction effect. CONCLUSIONS: Increased amygdala responses associated with the other race effect were evident in both individuals with major depression and in healthy participants. Increased amygdala responses with the other race effect is a potential confound of the neural correlates of facial processing in healthy participants and in mental health disorders. The implications of the other race effect on impairments in interpersonal functioning in depression require further investigation.
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Tonsila do Cerebelo/fisiologia , Transtorno Depressivo Maior/fisiopatologia , Reconhecimento Facial/fisiologia , Racismo , Adulto , Feminino , Humanos , Imageamento por Ressonância Magnética , MasculinoRESUMO
Impairments in verbal working memory are evident in major depression. Verbal working memory is comprised of the components of encoding, maintenance and retrieval. Whether the neural impairments are expressed in specific components, and how pharmacological therapy could modify the neural correlates are not well understood. We investigated the neural correlates of verbal working memory components in depression using the Sternberg task in a longitudinal magnetic resonance imaging study. Serial scans were acquired in 23 patients (mean age 39.8 years) during an acute depressive episode and following 12 weeks of pharmacological therapy with duloxetine and in 22 matched healthy controls (mean age 39.1 years) at the same time points. A significant group by time interaction was evident during the long maintenance phase, extending from the left middle frontal to the middle temporal and caudate regions, in which there was reduced activation in healthy participants at the follow -up scan but there were no changes in patients. Persistent neural engagement during the maintenance phase following treatment was revealed in major depression. The findings emphasize that impairments in verbal working memory may be initiated in the maintenance phase in major depression in order to sustain performance. Further research with larger sample size and using randomized, placebo-controlled double-blind studies are required to confirm our results.