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.

A Hybrid Ecological Momentary Compassion-Focused Intervention for Enhancing Resilience in Help-Seeking Young People: Prospective Study of Baseline Characteristics in the EMIcompass Trial.

BACKGROUND: Young people are a target population for mental health-related early intervention and prevention. Although evidence for early intervention is promising, availability of and access to youth mental health services remain limited. Therefore, the development of an evidence-based hybrid intervention is urgently needed. OBJECTIVE: This study aimed to present a manual for a hybrid intervention, combining an ecological momentary intervention and face-to-face sessions aimed for enhancing resilience in help-seeking young people based on compassion-focused interventions, and explore whether participants' baseline characteristics are associated with putative mechanisms and outcomes of the EMIcompass intervention. Specifically, we aimed to explore initial signals as to whether participants' sociodemographic, clinical, and functional characteristics at baseline are associated with putative mechanisms (ie, change in self-compassion, change in emotion regulation, working alliance, training frequency); and whether participants' sociodemographic, clinical, and functional characteristics, self-compassion, and emotion regulation at baseline are associated with clinical outcomes (ie, psychological distress and general psychopathology at postintervention and 4-week follow-ups) in the experimental condition and obtain first parameter estimates. METHODS: We recruited young people aged 14 to 25 years, with psychological distress, Clinical High At-Risk Mental State, or first episodes of severe mental disorder for an exploratory randomized controlled trial with assessments at baseline and postintervention and 4-week follow-ups. A structured manual was developed and optimized based on a pilot study's manual, a scoping review of existing literature and manuals, exchange with experts, the team's clinical experience of working with compassion-focused interventions, and the principles of ecological momentary interventions. This analysis focuses on the experimental condition receiving the EMIcompass intervention. RESULTS: A total of 46 young individuals were randomized to the experimental condition. There was evidence for initial signals of effects of age (B=0.11, 95% CI 0.00-0.22), general psychopathology (B=0.08, 95% CI -0.01 to 0.16), and clinical stage (B=1.50, 95% CI 0.06-2.93) on change in momentary self-compassion and change in emotion regulation from baseline to postintervention assessments. There was no evidence for associations of other baseline characteristics (eg, gender, minority status, and level of functioning) and putative mechanisms (eg, overall self-compassion, working alliance, and training frequency). In addition, except for an initial signal for an association of momentary self-compassion at baseline and psychological distress (B=-2.83, 95% CI -5.66 to 0.00), we found no evidence that baseline characteristics related to clinical outcomes. CONCLUSIONS: The findings indicated the reach of participants by the intervention largely independent of sociodemographic, clinical, and functional baseline characteristics. The findings need to be confirmed in a definitive trial. TRIAL REGISTRATION: German Clinical Trials Register NDRKS00017265; https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00017265. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.2196/27462.

Prevalence of physical health conditions and health risk behaviours in people with severe mental illness in South Asia: protocol for a cross-sectional study (IMPACT SMI survey).

INTRODUCTION: People with severe mental illness (SMI) die on average 10-20 years earlier than the general population. Most of these deaths are due to physical health conditions. The aim of this cross-sectional study is to determine the prevalence of physical health conditions and their associations with health-risk behaviours, health-related quality of life and various demographic, behavioural, cognitive, psychological and social variables in people with SMI attending specialist mental health facilities in South Asia. METHODS AND ANALYSIS: We will conduct a survey of patients with SMI attending specialist mental health facilities in Bangladesh, India and Pakistan (n=4500). Diagnosis of SMI will be confirmed using the Mini-international neuropsychiatric interview V.6.0. We will collect information about physical health and related health-risk behaviours (WHO STEPwise approach to Surveillance (STEPS)); severity of common mental disorders (Patient Health Questionnaire-9 (PHQ-9) and General Anxiety Disorder scale (GAD-7)) and health-related quality of life (EQ-5D-5L). We will measure blood pressure, height, weight and waist circumference according to WHO guidelines. We will also measure glycated haemoglobin, lipid profile, thyroid function, liver function, creatinine and haemoglobin. Prevalence rates of physical health conditions and health-risk behaviours will be presented and compared with the WHO STEPS survey findings in the general population. Regression analyses will explore the association between health-risk behaviours, mental and physical health conditions. ETHICS AND DISSEMINATION: The study has been approved by the ethics committees of the Department of Health Sciences University of York (UK), Centre for Injury Prevention and Rehabilitation (Bangladesh), Health Ministry Screening Committee and Indian Council of Medical Research (India) and National Bioethics Committee (Pakistan). Findings will be disseminated in peer-reviewed articles, in local and international conferences and as reports for policymakers and stakeholders in the countries involved. TRIAL REGISTRATION NUMBER: ISRCTN88485933; 3 June 2019.

School-based intervention study examining approaches for well-being and mental health literacy of pupils in Year 9 in England: study protocol for a multischool, parallel group cluster randomised controlled trial (AWARE).

INTRODUCTION: The prevalence of emotional difficulties in young people is increasing. This upward trend is largely accounted for by escalating symptoms of anxiety and depression. As part of a public health response, there is increasing emphasis on universal prevention programmes delivered in school settings. This protocol describes a three-arm, parallel group cluster randomised controlled trial, investigating the effectiveness and cost-effectiveness of two interventions, alongside a process and implementation evaluation, to improve mental health and well-being of Year 9 pupils in English secondary schools. METHOD: A three-arm, parallel group cluster randomised controlled trial comparing two different interventions, the Youth Aware of Mental Health (YAM) or the Mental Health and High School Curriculum Guide (The Guide), to Usual Provision. Overall, 144 secondary schools in England will be recruited, involving 8600 Year 9 pupils. The primary outcome for YAM is depressive symptoms, and for The Guide it is intended help-seeking. These will be measured at baseline, 3-6 months and 9-12 months after the intervention commenced. Secondary outcomes measured concurrently include changes to: positive well-being, behavioural difficulties, support from school staff, stigma-related knowledge, attitudes and behaviours, and mental health first aid. An economic evaluation will assess the cost-effectiveness of the interventions, and 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, feasibility, utility), and their moderating effects on the outcomes of interest, and perceived impact. ETHICS AND DISSEMINATION: This trial has been approved by the University College London Research Ethics Committee. Findings will be published in a report to the Department for Education, in peer-reviewed journals and at conferences. TRIAL REGISTRATION NUMBER: ISRCTN17631228. PROTOCOL: V1 3 January 2019. Substantial changes to the protocol will be communicated to the trials manager to relevant parties (eg, ISRCTN).

Associations between active travel and diet: cross-sectional evidence on healthy, low-carbon behaviours from UK Biobank.

OBJECTIVES: To examine whether there are associations between active travel and markers of a healthy, low-carbon (HLC) diet (increased consumption of fruit and vegetables (FV), reduced consumption of red and processed meat (RPM)). DESIGN: Cross-sectional analysis of a cohort study. SETTINGS: Population cohort of over 500 000 people recruited from 22 centres across the UK. Participants aged between 40 and 69 years were recruited between 2006 and 2010. PARTICIPANTS: 412 299 adults with complete data on travel mode use, consumption of FV and RPM, and sociodemographic covariates were included in the analysis. EXPOSURE MEASURES: Mutually exclusive mode or mode combinations of travel (car, public transport, walking, cycling) for non-work and commuting journeys. OUTCOME MEASURES: Consumption of FV measured as portions per day and RPM measured as frequency per week. RESULTS: Engaging in all types of active travel was positively associated with higher FV consumption and negatively associated with more frequent RPM consumption. Cycling exclusively or in combination with walking was most strongly associated with increased dietary consumption of FV and reduced consumption of RPM for both non-work and commuting journeys. Overall, the strongest associations were between non-work cycling and FV consumption (males: adjusted OR=2.18, 95% CI 2.06 to 2.30; females: adjusted OR=2.50, 95% CI 2.31 to 2.71) and non-work cycling and RPM consumption (males: adjusted OR=0.57, 95% CI 0.54 to 0.60; females: adjusted OR=0.54, 95% CI 0.50 to 0.59). Associations were generally similar for both commuting and non-work travel, and were robust to adjustment with sociodemographic and behavioural factors. CONCLUSIONS: There are strong associations between engaging in active travel, particularly cycling, and HLC dietary consumption, suggesting that these HLC behaviours are related. Further research is needed to better understand the drivers and dynamics between these behaviours within individuals, and whether they share common underlying causes.

Are there researcher allegiance effects in diagnostic validation studies of the PHQ-9? A systematic review and meta-analysis.

OBJECTIVES: To investigate whether an authorship effect is found that leads to better performance in studies conducted by the original developers of the Patient Health Questionnaire (PHQ-9) (allegiant studies). DESIGN: Systematic review with random effects bivariate diagnostic meta-analysis. Search strategies included electronic databases, examination of reference lists and forward citation searches. INCLUSION CRITERIA: Included studies provided sufficient data to calculate the diagnostic accuracy of the PHQ-9 against a gold standard diagnosis of major depression using the algorithm or the summed item scoring method at cut-off point 10. DATA EXTRACTION: Descriptive information, methodological quality criteria and 2×2 contingency tables. RESULTS: Seven allegiant and 20 independent studies reported the diagnostic performance of the PHQ-9 using the algorithm scoring method. Pooled diagnostic OR (DOR) for the allegiant group was 64.40, and 15.05 for non-allegiant studies group. The allegiance status was a significant predictor of DOR variation (p<0.0001).Five allegiant studies and 26 non-allegiant studies reported the performance of the PHQ-9 at recommended cut-off point of 10. Pooled DOR for the allegiant group was 49.31, and 24.96 for the non-allegiant studies. The allegiance status was a significant predictor of DOR variation (p=0.015).Some potential alternative explanations for the observed authorship effect including differences in study characteristics and quality were found, although it is not clear how some of them account for the observed differences. CONCLUSIONS: Allegiant studies reported better performance of the PHQ-9. Allegiance status was predictive of variation in the DOR. Based on the observed differences between independent and non-independent studies, we were unable to conclude or exclude that allegiance effects are present in studies examining the diagnostic performance of the PHQ-9. This study highlights the need for future meta-analyses of diagnostic validation studies of psychological measures to evaluate the impact of researcher allegiance in the primary studies.