Promoting mental health and well-being in schools: examining mindfulness, relaxation and strategies for safety and well-being in English primary and secondary schools-study protocol for a multi-school, cluster randomised controlled trial (INSPIRE).

There are increasing rates of internalising difficulties, particularly anxiety and depression, being reported in children and young people in England. School-based universal prevention programmes are thought to be one way of helping tackle such difficulties. This paper describes an update to a four-arm cluster randomised controlled trial ( http://www.isrctn.com/ISRCTN16386254 ), investigating the effectiveness of three different interventions when compared to usual provision, in English primary and secondary pupils. Due to the COVID-19 pandemic, the trial was put on hold and subsequently prolonged. Data collection will now run until 2024. The key changes to the trial outlined here include clarification of the inclusion and exclusion criteria, an amended timeline reflecting changes to the recruitment period of the trial due to the COVID-19 pandemic and clarification of the data that will be included in the statistical analysis, since the second wave of the trial was disrupted due to COVID-19.Trial registration ISRCTN Registry ISRCTN16386254. Registered on 30 August 2018.

App-based food-specific inhibitory control training as an adjunct to treatment as usual in binge-type eating disorders: A feasibility trial.

Current treatments for binge eating disorder (BED) and bulimia nervosa (BN) only show moderate efficacy, warranting the need for novel interventions. Impairments in food-related inhibitory control contribute to BED/BN and could be targeted by food-specific inhibitory control training (ICT). The aim of this study was to establish the feasibility and acceptability of augmenting treatment for individuals with BN/BED with an ICT app (FoodT), which targets motor inhibition to food stimuli using a go/no-go paradigm. Eighty patients with BED/BN receiving psychological and/or pharmacological treatment were randomly allocated to a treatment-as-usual group (TAU; n = 40) or TAU augmented with the 5-min FoodT app daily (n = 40) for 4 weeks. This mixed-methods study assessed feasibility outcomes, effect sizes of clinical change, and acceptability using self-report measures. Pre-registered cut-offs for recruitment, retention, and adherence were met, with 100% of the targeted sample size (n = 80) recruited within 12 months, 85% of participants retained at 4 weeks, and 80% of the FoodT + TAU group completing ≤8 sessions. The reduction in binge eating did not differ between groups. However, moderate reductions in secondary outcomes (eating disorder psychopathology: SES = -0.57, 95% CI [-1.12, -0.03]; valuation of high energy-dense foods: SES = -0.61, 95% CI [-0.87, -0.05]) were found in the FoodT group compared to TAU. Furthermore, small greater reductions in food addiction (SES = -0.46, 95% CI [-1.14, 0.22]) and lack of premeditation (SES = -0.42, 95% CI [-0.77, -0.07]) were found in the FoodT group when compared to TAU. The focus groups revealed acceptability of FoodT. Participants discussed personal barriers (e.g. distractions) and suggested changes to the app (e.g. adding a meditation exercise). Augmenting treatment for BED/BN with a food-specific ICT app is feasible, acceptable, and may reduce clinical symptomatology with high reach and wide dissemination.

Promoting mental health and wellbeing in schools: examining Mindfulness, Relaxation and Strategies for Safety and Wellbeing in English primary and secondary schools: study protocol for a multi-school, cluster randomised controlled trial (INSPIRE).

BACKGROUND: There are increasing rates of internalising difficulties, particularly anxiety and depression, being reported in children and young people in England. School-based, universal prevention programmes are thought to be one way of helping tackle such difficulties. This protocol describes a four-arm cluster randomised controlled trial, investigating the effectiveness of three different interventions when compared to usual provision, in English primary and secondary pupils. The primary outcome for Mindfulness and Relaxation interventions is a measure of internalising difficulties, while Strategies for Safety and Wellbeing will be examined in relation to intended help-seeking. In addition to the effectiveness analysis, a process and implementation evaluation and a cost-effectiveness evaluation will be undertaken. METHODS AND ANALYSIS: Overall, 160 primary schools and 64 secondary schools will be recruited across England. This corresponds to 17,600 participants. Measures will be collected online at baseline, 3-6 months later, and 9-12 months after the commencement of the intervention. An economic evaluation will assess the cost-effectiveness of the interventions. Moreover, a process and implementation evaluation (including a qualitative research component) will explore several aspects of implementation (fidelity, quality, dosage, reach, participant responsiveness, adaptations), social validity (acceptability, appropriateness and feasibility), and their moderating effects on the outcomes of interest, and perceived impact. DISCUSSION: This trial aims to address important questions about whether schools' practices around the promotion of mental wellbeing and the prevention of mental health problems can: (1) be formalised into feasible and effective models of school-based support and (2) whether these practices and their effects can be sustained over time. Given the focus of these interventions on mirroring popular practice in schools and on prioritising approaches that present low-burden, high-acceptability to schools, if proved effective, and cost-effective, the findings will indicate models that are not only empirically tested but also offer high potential for widespread use and, therefore, potentially widespread benefits beyond the life of the trial. TRIAL REGISTRATION: ISRCTN16386254. Registered on 30 August 2018.