2 research outputs found
Teachers and Mindful Colouring to Tackle Burnout and Increase Mindfulness, Resiliency and Wellbeing
The number of teachers leaving the profession continues to increase at a worrying rate. Factors contributing to this include burnout, heightened levels of stress, anxiety and depression. The current study tested whether the use of mindful colouring would translate to improvements in wellbeing. Teachers from the UK (nâ=â35) were randomly assigned to a colouring mindfulness-based intervention or waitlist group. Participants completed four scales (burnout, wellbeing, resilience and mindfulness) and participated in a 5-day intervention of daily mindfulness colouring or continued their working week as usual. Results of repeated-measures ANOVA showed statistically significant lower levels of burnout, stress, depressive symptoms and anxiety in the mindfulness colouring condition, as well as increased levels of resilience and mindfulness. Findings from the current study support the use of mindfulness colouring to significantly enhance levels of wellbeing in teachers. The study also presents an inexpensive, highly accessible and effective self-help tool for this targeted non-clinical population
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
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 severeâcritical 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 34â571 participants screened, the double-blind phase enrolled 31â300 participants, 14â492 of whom received two doses (7484 in the Ad26.COV2.S group and 7008 in the placebo group) and 11â639 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 36·0 (15·0â62·0) days. Vaccine efficacy was 75·2% (adjusted 95% CI 54·6â87·3) against moderate to severeâcritical 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 [55·6%] of 3015 vs 896 [57·5%] of 1559, respectively; systemic adverse events, 1764 [58·5%] of 3015 vs 821 [52·7%] of 1559, respectively). Solicited adverse events were transient and mostly grade 1â2 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 severeâcritical COVID-19. Studies assessing efficacy against newer variants and with longer follow-up are needed