Objective: Recent studies suggest mental health in youths is deteriorating. The current policy in the United Kingdom emphasizes the role of schools for mental health promotion and prevention, but little data exist on what aspects of schools influence mental health in pupils. This study explored school-level influences on the mental health of young people in a large school-based sample from the United Kingdom. Method: Baseline data from a large cluster randomized controlled trial collected between 2016 and 2018 from mainstream secondary schools selected to be representative in relation to their quality rating, size, deprivation, mixed or single-sex pupil population, and country were analyzed. Participants were pupils in their first or second year of secondary school. The study assessed whether school-level factors were associated with pupil mental health. Results: The study included 26,885 pupils (response rate ¼ 90%; age range, 11-14 years; 55% female) attending 85 schools in the United Kingdom. Schools accounted for 2.4% (95% CI: 2.0%-2.8%; p < .0001) of the variation in psychopathology, 1.6% (95% CI: 1.2%-2.1%; p < .0001) of depression, and 1.4% (95% CI: 1.0%-1.7%; p < .0001) of well-being. Schools in urban locations, with a higher percentage of free school meals and of White British, were associated with poorer pupil mental health. A more positive school climate was associated with better mental health. Conclusion: School-level variables, primarily related to contextual factors, characteristics of pupil population, and school climate, explain a small but significant amount of variability in mental health of young people. This information might be used to identify schools that are in need of more resources to support mental health of young people.

Background Depression and debt are common in the UK. Debt Counselling for Depression in Primary Care: an adaptive randomised controlled pilot trial (DeCoDer) aimed to assess the clinical effectiveness and cost-effectiveness of the addition of a primary care debt counselling advice service to usual care for patients with depression and debt. However, the study was terminated early during the internal pilot trial phase because of recruitment delays. This report describes the rationale, methods and findings of the pilot study, and implications for future research. Objectives The overarching aim of the internal pilot was to identify and resolve problems, thereby assessing the feasibility of the main trial. The specific objectives were to confirm methods for practice recruitment and the ability to recruit patients via the proposed approaches; to determine the acceptability of the study interventions and outcome measures; to assess contamination; to confirm the randomisation method for main trial and the level of participant attrition; and to check the robustness of data collection systems. Design An adaptive, parallel, two-group multicentre randomised controlled pilot trial with a nested mixed-methods process and economic evaluation. Both individual- and cluster (general practice)-level were was used in the pilot phase to assign participants to intervention or control groups. Setting General practices in England and Wales. Participants Individuals were included who were aged ≥ 18 years, scored ≥ 14 on the Beck Depression Inventory II and self-identified as having debt worries. The main exclusion criteria were being actively suicidal or psychotic and/or severely depressed and unresponsive to treatment; having a severe addiction to alcohol/illicit drugs; being unable/unwilling to give written informed consent; currently participating in other research including follow-up phases; having received Citizens Advice Bureau (CAB) debt advice in the past year; and not wanting debt advice via a general practice. Interventions The participants in the intervention group were given debt advice provided by the CAB and shared biopsychosocial assessment, in addition to treatment as usual (TAU) and two debt advice leaflets. The participants in the control group were given advice leaflets provided by the general practitioner and TAU only. Main outcome measures (1) Outcomes of the pilot trial – the proportion of eligible patients who consented, the number of participants recruited compared with target, assessment of contamination, and assessment of patient satisfaction with intervention and outcome measures. (2) Participant outcomes – primary – Beck Depression Inventory II; secondary – psychological well-being, health and social care utilisation, service satisfaction, substance misuse, record of priority/non-priority debts, life events and difficulties, and explanatory measures. Outcomes were assessed at baseline (pre-randomisation) and at 4 months post randomisation. Other data sources – qualitative interviews were conducted with participants, clinicians and CAB advisors. Results Of the 238 expressions of interest screened, 61 participants (26%) were recruited and randomised (32 in the intervention group and 29 in the control group). All participants provided baseline outcomes and 52 provided the primary outcome at 4 months’ follow-up (14.7% dropout). Seventeen participants allocated to the intervention saw a CAB advisor. Descriptive statistics are reported for participants with complete outcomes at baseline and 4 months’ follow-up. Our qualitative findings suggest that the relationship between debt and depression is complex, and the impact of each on the other is compounded by other psychological, social and contextual influences. Conclusions As a result of low recruitment, this trial was terminated at the internal pilot phase and was too small for inferential statistical analysis. We recommend ways to reduce this risk when conducting complex trials among vulnerable populations recruited in community settings. These cover trial design, the design and delivery of interventions, recruitment strategies and support for sites. Trial registration Current Controlled Trials ISRCTN79705874. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 21, No. 35. See the NIHR Journals Library website for further project information. Mark Gabbay and Adele Ring are part-funded by NIHR Collaborations for Leadership in Applied Health Research and Care (CLAHRC) North West Coast and Richard Byng and Rod S Taylor, Vashti Berry and Elizabeth Shaw part-funded by NIHR CLAHRC South West Peninsula.

Background: Although typically an aggressive disease some patients with Mantle Cell Lymphoma (MCL) follow an indolent course and may not benefit from immediate therapy. Several studies evaluating watch-and-wait (W&W) strategies in MCL show no detriment to patient survival and international guidelines acknowledge the strategy's suitability for a minority of patients. Differences in pathogenetic mechanisms have provided insight into variable clinical behaviour, but there is little clinical evidence to inform patient suitability for W&W. The MCL Biobank Observational Study is a prospective study designed to distinguish indolent from aggressive forms of MCL. Tissue samples and baseline characteristics are collected at enrolment. The study has recruited over 550 patients across the UK and remains open to recruitment. Method: This analysis includes 315 patients from 58 centers in the United Kingdom enrolled between January 2015 and March 2018. All new MCL diagnoses compatible with WHO diagnostic criteria were eligible. Patients were enrolled within 90 days of diagnosis and prior to receiving therapy. Baseline data was recorded including investigator decision to start systemic therapy or enter W&W. Clinical updates were provided at 6 month intervals and patients were followed-up for a minimum of 12 months. Standard statistical methods were used to examine which factors were associated with initial disease management and those remaining on W&W long-term. Time to treatment was measured from date of diagnosis until date of first treatment, patients who had not commenced treatment were censored at the last date of follow-up. Results: Median age of all patients was 71 (range 32-92), 68.9% were male, 53.5% were MIPI high risk and median follow up 26 months. At baseline 67.3% of patients received upfront systemic therapy, 4.1% received localized radiotherapy, 1.0% were palliated and 27.6% were on W&W 90 days beyond diagnosis. Estimated 2-year OS of the whole population was 77.5%. Patients on initial W&W tended to be older than those treated early (median 73 yrs vs. 71 yrs), had similar performance score (ECOG>1 OR 1.16, p=0.68) and no significant difference in WBC (WBC>15 OR 0.55, p=0.07). Although high risk MIPI was equally prevalent between the groups (OR 1.3, p=0.31) it was notable that no patient under 75 years was high risk in the observation group. Presence of measurable disease on CT discriminated between the two groups (OR 0.23, p=<0.001), but 71% of W&W had measurable disease indicating most were not the leukemic subtype. Markers of higher cell turnover, raised LDH and Ki67≥30%, were significantly less common in W&W patients (OR 0.32, p=<0.001; OR 0.3, p=0.001). 40% of women were put on W&W compared to 22% of men (OR 2.6, p=<0.001). Of 87 patients followed on W&W 73.5% remained on observation at 1 year and 50.6% at 2 years, with median follow up 2.4 years. Univariate analysis revealed few baseline characteristics to be predictive for prolonged period of observation, in part relating to the low patient numbers, but key observations are displayed in figure 1. Patients with Ki67≥30% were less likely to remain on observation (HR 2.39, p=0.03), as were patients over 80 years old (HR 3.67, p=0.007), and those MIPI high risk compared to low risk (3.56, p=0.02). Conclusion: This study demonstrates the high prevalence of W&W in UK clinical practice and it provides reassurance to clinicians that half remain on observation beyond 2 yrs. LDH level and Ki67 status reflect the biological nature of disease and it is therefore not unexpected that lower levels predict for a more indolent course. However, with Ki67≥30 in 25% of patients observed beyond 2 years these measures alone are not sufficient to decide treatment. The tendency for older patients to be observed likely reflects a less aggressive clinical approach in patients with co-morbidities, and not the underlying biology. This explains the tendency for shortened observation period in older patients. The high prevalence of female patients in W&W is a striking observation that alludes to pathophysiological differences between the sexes that warrants further investigation. Although the study highlights clinicians are increasingly at ease adopting W&W in MCL, it also demonstrates the need for better predictive markers of indolent disease. This study aims to achieve this with analysis of the collected tissue samples. Disclosures Crosbie: Janssen: Honoraria. Rule:Sunesis: Consultancy, Honoraria; TG Therapeutics: Consultancy, Honoraria; Napp: Consultancy; Kite: Consultancy; Gilead: Consultancy, Honoraria; Pharmacyclics: Consultancy, Honoraria; Celgene: Consultancy, Honoraria; Astra-Zeneca: Consultancy, Honoraria; Roche: Consultancy, Honoraria, Research Funding; Janssen: Consultancy, Honoraria, Research Funding.

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Highlights One-in-five adolescents reported suicidality or pain. Pain was associated with an increased risk of suicidality and vice versa (OR=4.00). Network analysis supported the pain-suicidality association (aOR=1.39). This cross-sectional association was not moderated by depression. Pain should be considered as a key risk correlate of suicidality in adolescents.