9 research outputs found

    Initial development and validation of a dimensional classification system for the emotional disorders

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    Problems with the current categorical approach to classification used by the Diagnostic and Statistical Manual of Mental Disorders (DSM) have led to proposals that classify the emotional disorders (EDs; anxiety and mood disorders) using a dimensional-categorical system based on shared ED vulnerabilities and phenotypes. Such profile-based approaches have yet to be empirically evaluated, in part because a single multidimensional assessment of shared ED vulnerabilities and phenotypes amenable to profile-based classification has not been developed. The present studies aimed to provide an initial examination of a categorical-dimensional approach to ED classification (Study 1) as well as develop and evaluate a multidimensional self-report assessment of shared ED vulnerabilities and phenotypes (the Multidimensional Emotional Disorder Inventory [MEDI], Study 2). The samples consisted of 1,218 (Study 1) and 227 (Study 2) participants who presented for assessment and treatment at an outpatient ED treatment center. All participants were assessed using a semi-structured ED interview and a set of ED self-report questionnaires. The MEDI was completed only by the participants in Study 2. Study 1 used mixture modeling to identify six unobserved groups (classes) of individuals sharing similar profiles across seven dimensional ED vulnerability and phenotype indicators. The external validity of the profiles was supported when related ED covariates were added to the solution. The incremental validity of the profiles was supported using hierarchical regression models; the profiles accounted for unique variance in ED outcomes beyond DSM diagnoses. In Study 2, exploratory structural equation modeling (ESEM) and confirmatory factor analysis were used to evaluate the factor structure of the MEDI. ESEM supported an eight-factor solution of a 47-item version of the MEDI. Differential magnitude of correlation analyses supported the convergent/discriminant validity of seven of the eight MEDI scales. A five-class (profile) solution, consistent with Study 1, was found when mixture modeling was applied to the MEDI scales. Collectively, the present studies provide compelling evidence in support of the development and utility of a hybrid dimensional-categorical profile approach to emotional disorder classification using multidimensional self-report assessment methods such as the MEDI

    The effects of extraverted temperament on agoraphobia in panic disorder

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    Although situational avoidance is viewed as the most disabling aspect of panic disorder, few studies have evaluated how dimensions of neurotic (i.e., neuroticism, behavioral inhibition) and extraverted (i.e., extraversion, behavioral activation) temperament may influence the presence and severity of agoraphobia. Using logistic regression and structural equation modeling, we examined the unique effects of extraverted temperament on situational avoidance in a sample of 274 outpatients with a diagnosis of panic disorder with and without agoraphobia. Results showed low extraverted temperament (i.e., introversion) to be associated with both the presence and the severity of situational avoidance. Findings are discussed in regard to conceptualizations of conditioned avoidance, activity levels, sociability, and positive emotions within the context of panic disorder with agoraphobia

    A Machine Learning Approach to Predicting New‐onset Depression in a Military Population

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    Peer Reviewedhttp://deepblue.lib.umich.edu/bitstream/2027.42/170259/1/rcp21023.pdfhttp://deepblue.lib.umich.edu/bitstream/2027.42/170259/2/rcp21023_am.pd

    Efficacy, safety, and immunogenicity of a booster regimen of Ad26.COV2.S vaccine against COVID-19 (ENSEMBLE2) : results of a randomised, double-blind, placebo-controlled, phase 3 trial

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    Background Despite the availability of effective vaccines against COVID-19, booster vaccinations are needed to maintain vaccine-induced protection against variant strains and breakthrough infections. This study aimed to investigate the efficacy, safety, and immunogenicity of the Ad26.COV2.S vaccine (Janssen) as primary vaccination plus a booster dose. Methods ENSEMBLE2 is a randomised, double-blind, placebo-controlled, phase 3 trial including crossover vaccination after emergency authorisation of COVID-19 vaccines. Adults aged at least 18 years without previous COVID-19 vaccination at public and private medical practices and hospitals in Belgium, Brazil, Colombia, France, Germany, the Philippines, South Africa, Spain, the UK, and the USA were randomly assigned 1:1 via a computer algorithm to receive intramuscularly administered Ad26.COV2.S as a primary dose plus a booster dose at 2 months or two placebo injections 2 months apart. The primary endpoint was vaccine efficacy against the first occurrence of molecularly confirmed moderate to severe-critical COVID-19 with onset at least 14 days after booster vaccination, which was assessed in participants who received two doses of vaccine or placebo, were negative for SARS-CoV-2 by PCR at baseline and on serology at baseline and day 71, had no major protocol deviations, and were at risk of COVID-19 (ie, had no PCR-positive result or discontinued the study before day 71). Safety was assessed in all participants; reactogenicity, in terms of solicited local and systemic adverse events, was assessed as a secondary endpoint in a safety subset (approximately 6000 randomly selected participants). The trial is registered with ClinicalTrials.gov, NCT04614948, and is ongoing. Findings Enrolment began on Nov 16, 2020, and the primary analysis data cutoff was June 25, 2021. From 34 571 participants screened, the double-blind phase enrolled 31 300 participants, 14 492 of whom received two doses (7484 in the Ad26.COV2.S group and 7008 in the placebo group) and 11 639 of whom were eligible for inclusion in the assessment of the primary endpoint (6024 in the Ad26.COV2.S group and 5615 in the placebo group). The median (IQR) follow-up post-booster vaccination was 36 center dot 0 (15 center dot 0-62 center dot 0) days. Vaccine efficacy was 75 center dot 2% (adjusted 95% CI 54 center dot 6-87 center dot 3) against moderate to severe-critical COVID-19 (14 cases in the Ad26.COV2.S group and 52 cases in the placebo group). Most cases were due to the variants alpha (B.1.1.7) and mu (B.1.621); endpoints for the primary analysis accrued from Nov 16, 2020, to June 25, 2021, before the global dominance of delta (B.1.617.2) or omicron (B.1.1.529). The booster vaccine exhibited an acceptable safety profile. The overall frequencies of solicited local and systemic adverse events (evaluated in the safety subset, n=6067) were higher among vaccine recipients than placebo recipients after the primary and booster doses. The frequency of solicited adverse events in the Ad26.COV2.S group were similar following the primary and booster vaccinations (local adverse events, 1676 [55 center dot 6%] of 3015 vs 896 [57 center dot 5%] of 1559, respectively; systemic adverse events, 1764 [58 center dot 5%] of 3015 vs 821 [52 center dot 7%] of 1559, respectively). Solicited adverse events were transient and mostly grade 1-2 in severity. Interpretation A homologous Ad26.COV2.S booster administered 2 months after primary single-dose vaccination in adults had an acceptable safety profile and was efficacious against moderate to severe-critical COVID-19. Studies assessing efficacy against newer variants and with longer follow-up are needed. Funding Janssen Research & Development. Copyright (c) 2022 The Author(s). Published by Elsevier Ltd
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