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Millions of people globally have learned mindfulness meditation with the goal of improving health and well-being outcomes in both clinical and non-clinical contexts. An estimated half of these practitioners follow mindfulness teachers’ recommendations to continue regular meditation after completion of initial instruction, but it is unclear whether benefits are strengthened by regular practice and whether harm can occur. Increasing evidence shows a wide range of experiences that can arise with regular mindfulness meditation, from profoundly positive to challenging and potentially harmful. Initial research suggests that complex interactions and temporal sequences may explain these experiential phenomena and their relations to health and well-being. We believe further study of the effects of mindfulness meditation is urgently needed to better understand the benefits and challenges of continued practice after initial instructions. Effects may vary systematically over time due to factors such as initial dosage, accumulation of ongoing practice, developing skill of the meditator, and complex interactions with the subjects’ past experiences and present environment. We propose that framing mindfulness meditation experiences and any associated health and well-being benefits within integrated longitudinal models may be more illuminating than treating them as discrete, unrelated events. We call for ontologically agnostic, collaborative, and interdisciplinary research to study the effects of continued mindfulness meditation and their contexts, advancing the view that practical information found within religious and spiritual contemplative traditions can serve to develop initial theories and scientifically falsifiable hypotheses. Such investigation could inform safer and more effective applications of mindfulness meditation training for improving health and well-being.

The rise in mental health concerns of university students is causing a serious hinderance to their wellbeing, impeding their functioning. The socio-economic and political friction in low- and middle-income countries adds to their vulnerability and calls for a cost-effective indigenous intervention. Consequently, this study aimed to inform a large definitive trial by assessing the feasibility and acceptability of a randomized controlled trial (RCT) design evaluating a culturally adapted online Mindfulness Training Course (MTC) used to improve stress and wellbeing among Pakistani university students. A two-arm pilot randomized controlled trial was conducted. University students (n = 156) were randomly assigned to either the MTC group (n = 80) or Wait-list (WL) control group (n = 76) and completed baseline and post-intervention self-report measures for mindfulness, stress and psychological wellbeing. Additionally, semi-structured interviews were conducted with consenting MTC group participants (n = 18) to explore their views about MTC, employing reflexive thematic analysis. Of 80 participants randomized to the MTC group, 32 completed the course, whereas, from the 156 randomized participants, 102 completed assessment surveys. Feasibility and acceptability indicators showed high recruitment, compliance, and adherence to MTC, with practical steps for randomization and online data collection. Further results showed higher levels of mindfulness and psychological wellbeing and lowered stress levels in the MTC group compared to the control group. The attrition and dropout rates were high; however, the feedback from participants who completed the MTC was highly positive and encouraging. In conclusion, if the trial proceeds with increased outreach in a large-scale RCT, the recruitment might be revised to reduce attrition rates. Further recommendations are discussed.

BackgroundMindfulness-based programmes (MBPs) have shown beneficial mental health effects. There is emerging evidence that MBPs may also be associated with marked deviations in the subjective experience of waking consciousness. We aimed to assess whether MBPs can have a causal role in different types of such states. MethodsWe conducted a pragmatic randomised controlled trial (ACTRN12615001160527). University of Cambridge students without severe mental illness were randomised to an 8-week MBP plus mental health support as usual (SAU), or to SAU alone. We adapted the Altered States of Consciousness Rating Scale (OAV) to assess spontaneous experiences in daily life, and included it as a post-hoc secondary outcome at the end of the one-year follow-up questionnaire. ResultsWe randomised 670 participants; 205 (33%) completed the OAV. In comparison with SAU, MBP participants had more intense experiences of unity, (adjusted partial eta squared (n2) 0.04, p=0.001) and disembodiment (n2 0.04, p=0.006). Meditation predicted reports of unity, blissful state, insightfulness, disembodiment, and changed meanings. Findings were robust to corrections for multiple comparisons.ConclusionsResults provide a novel suggestion of causal links between mindfulness practice and specific altered states of consciousness. Practitioners need to anticipate and handle them appropriately. Future studies need to confirm findings.

Background: Family caregivers of people with dementia (FG-of-PWD) suffer from a high level of stress and depressive symptoms, which usually require different interventions at different stages. Although some standalone interventions such as behavioral activation (BA) and mindfulness practice (MP) have been shown to be potentially effective at reducing depressive symptoms, the best sequence and combination of these interventions for caregivers are unknown. This study aims to develop and identify a two-stage adaptive intervention with pre-specified rules guiding whether, how, or when to offer different interventions initially/over time to reduce depressive symptoms in FG-of-PWD. Methods: A sequential multiple assignment randomized trial (SMART) design will be adopted. 272 FG-of-PWD with mild to moderate depressive symptoms will be recruited from the community. Four two-stage embedded adaptive interventions involving behavioral activation and mindfulness practice with different sequences and dosages (e.g., 8 weeks of Behavioral Activation followed by booster sessions for responders, and 8 weeks of mindfulness practice for non-responders) will be assigned to the participants following a set of decision rules. The primary outcomes will be depressive symptoms, assessed after the second stage of the intervention. Other outcomes (e.g., positive aspect of caregiving and sleep quality) and time-points will also be assessed. The analyses will follow the intention-to-treat principle. In addition, several process indicators (e.g. engagement in meaningful activities and level of mindfulness) will also be assessed. Discussion: The traditional RCT design allows for the effectiveness of an intervention to be rigorously tested but provides limited data to develop “treatment strategies” that may involve a number of different interventions, dosages, or components. We propose using the SMART design to provide evidence of which intervention to provide initially, how to determine whether the first stage of the intervention is working or not, and which intervention to provide next if the first stage of the intervention is not working. The findings will have strong implications for the further development of psycho-social adaptive intervention in reducing the depressive symptoms among FC-of-PWD. Trial registration: ClinicalTrials.gov, NCT05634317

Mindfulness-based programmes (MBPs) are suggested to improve work performance despite scarcity of evidence. We synthesised randomised controlled trials (RCTs) assessing the impact of MBPs on adults’ work performance. The primary outcome was task performance. Secondary outcomes were contextual performance, adaptive performance, and counter-productive behaviour. In March 2021 we searched ASSIA, EMBASE, ERIC, MEDLINE, PsycINFO, Scopus, Web of Science, and the Cochrane Central Register of Controlled Trials (CENTRAL). Cochrane Risk of Bias tool 2 was used. We conducted pairwise random-effects meta-analyses to calculate Hedges’ gs. A total of 47 studies (N = 5041) were included, all of them with high risk of bias. MBPs were not found to improve task performance (k = 7, n = 454, Hedges’ g = 0.52, 95% CI -0.03 to 1.07, p = 0.059) up to 4 weeks post-intervention compared to passive control groups. However, MBPs improved adaptive performance and contextual performance. The number of studies was insufficient for comparisons with active control groups. Confidence in the review results, per Grading of Recommendations Assessment, Development and Evaluation (GRADE), is low to very low. Future trials need to improve their quality to confirm effects on work performance and use active as well as passive control groups.

IntroductionMental ill health is a major cause of disability. Workplaces are attractive for preventative interventions since most adults work; meanwhile, employers are interested in improving employees’ well-being and productivity. Mindfulness-based programmes are increasingly popular in occupational settings. However, there is inconsistent evidence whether mindfulness interventions improve work performance and how effective mindfulness-based programmes are, compared with other interventions, in preventing mental ill health.Methods and analysisIn this online randomised controlled feasibility trial, an anticipated 240 employees will be randomised to either a 4-week light physical exercise course or a mindfulness course of the same duration (1:1 allocation). The primary outcome is work performance, measured using the Work Role Functioning Questionnaire. We aim to evaluate the acceptability, feasibility and procedural uncertainties of a randomised controlled trial in a workplace, calculate an effect size estimate to inform power calculations for a larger trial, and explore whether improved executive function and/or enhanced mental health could be potential mechanisms underlying the effect of mindfulness on work performance. Outcomes will be collected at baseline, postintervention and 12-week follow-up.Ethics and disseminationApproval has been obtained from Cambridge Psychology Research Ethics Committee. (PRE.2020072). Results will be published in peer-reviewed journals. A lay summary will be disseminated to a wider audience including participating employers.Trial registration numberNCT04631302.

Objectives: Mindfulness research in education has focused on its potential to support student well-being. There is a paucity of research on the interaction between mindfulness and academic performance (AP). This qualitative study builds on results of the largest randomised control trial of mindfulness in education to date which suggested mindfulness can have mixed effects on academic performance. A more in-depth understanding of the relationship between mindfulness and academic performance is therefore needed to ascertain if, how and for which students mindfulness facilitates academic performance. The objective of the study was to capture students’ perceptions of the impact of mindfulness on their academic performance. Methods: Thematic analysis was applied to data obtained by six in-depth interviews from three higher and three lower performing undergraduate participants in the mindfulness intervention arm of the Mindful Student Study randomised control trial. Results: Three themes emerged, whereby five students described mindfulness having a positive impact on their academic performance. One student felt mindfulness had an initial negative impact on academic performance. All students felt mindfulness enhanced self-awareness and self-regulation of their thinking, feelings and behaviours, and our analysis suggests students perceived these processes underpinned the effect of mindfulness on academic performance. Conclusion: Differences in students’ psychological distress and study habits may determine the differing initial impact of mindfulness on academic performance.

BackgroundDespite the accumulation of research papers on aspirin and cancer, there is doubt as to whether or not aspirin is an acceptable and effective adjunct treatment of cancer. The results of several randomised trials are awaited, and these should give clear evidence on three common cancers: colon, breast and prostate. The biological effects of aspirin appear likely however to be of relevance to cancer generally, and to metastatic spread, rather than just to one or a few cancers, and there is already a lot of evidence, mainly from observational studies, on the association between aspirin and survival in a wide range of cancers.AimsIn order to test the hypothesis that aspirin taking is associated with an increase in the survival of patients with cancer, we conducted a series of systematic literature searches to identify clinical studies of patients with cancer, some of whom took aspirin after having received a diagnosis of cancer.ResultsThree literature searches identified 118 published observational studies in patients with 18 different cancers. Eighty-one studies report on aspirin and cancer mortality and 63 studies report on all-cause mortality. Within a total of about a quarter of a million patients with cancer who reported taking aspirin, representing 20%-25% of the total cohort, we found aspirin to be associated with a reduction of about 20% in cancer deaths (pooled hazard ratio (HR): 0.79; 95% confidence intervals: 0.73, 0.84 in 70 reports and a pooled odds ratio (OR): 0.67; 0.45, 1.00 in 11 reports) with similar reductions in all-cause mortality (HR: 0.80; 0.74, 0.86 in 56 studies and OR: 0.57; 0.36, 0.89 in seven studies). The relative safety of aspirin taking was examined in the studies and the corresponding author of every paper was written to asking for additional information on bleeding. As expected, the frequency of bleeding increased in the patients taking aspirin, but fatal bleeding was rare and no author reported a significant excess in fatal bleeds associated with aspirin. No author mentioned cerebral bleeding in the patients they had followed.ConclusionsThere is a considerable body of evidence suggestive of about a 20% reduction in mortality in patients with cancer who take aspirin, and the benefit appears not to be restricted to one or a few cancers. Aspirin, therefore, appears to deserve serious consideration as an adjuvant treatment of cancer, and patients with cancer, and their carers, have a right to be informed of the available evidence.

Background Many people who have common mental disorders, such as depression and anxiety, also have some psychotic experiences. These experiences are associated with higher clinical complexity, poor treatment response, and negative clinical outcomes. Psychological interventions have the potential to improve outcomes for people with psychotic experiences. The aims of this systematic review are to (1) synthesise the evidence on the effectiveness and cost-effectiveness of psychological interventions to reduce psychotic experiences and their associated distress and (2) identify key components of effective interventions. Methods Our search strategy will combine terms for (1) psychological interventions, (2) psychotic experiences, and (3) symptoms associated with psychotic experiences. We will search the following online databases: MEDLINE, Embase, PsycINFO, all Cochrane databases, British Nursing Index (BNI), Cumulative Index to Nursing and Allied Health Literature (CINAHL), Health Management Information Consortium (HMIC), Education Resources Information Center (ERIC), and EconLit. Our primary outcome is the proportion of people who recovered or remitted from psychotic experiences after the intervention. Our secondary outcomes are changes in positive psychotic symptoms, negative psychotic symptoms, depression, anxiety, functioning (including social, occupational, and academic), quality of life, and cost-effectiveness. Two independent reviewers will judge each study against pre-specified inclusion and exclusion criteria and will extract study characteristics, outcome data, and intervention components. Risk of bias and methodological quality will be assessed using the Effective Public Health Practice Project Quality Assessment Tool for Quantitative Studies and the Drummond Checklist. Results will be synthesised using random-effects meta-analysis and narrative synthesis. Discussion The identification of effective psychological interventions and of specific components associated with intervention effectiveness will augment existing evidence that can inform the development of a new, tailored intervention to improve outcomes related to psychotic symptoms, anxiety and depression, distress, functioning, and quality of life. Systematic review registration PROSPERO CRD42016033869

Mental ill health is a major cause of disability. Workplaces are attractive for preventative interventions since most adults work while employers are interested in improving employees’ well-being and productivity. Mindfulness-based programmes are increasingly popular in occupational settings. However, there is inconsistent evidence whether mindfulness interventions improve work performance and how effective mindfulness-based programmes are, compared to other interventions, in preventing mental ill health.In this online randomised controlled feasibility trial, an anticipated 240 employees will be randomised to either a 4-week light physical exercise course or a mindfulness course of the same duration (1:1 allocation). The primary outcome is work performance, measured using the Work Role Functioning Questionnaire. We aim to evaluate the acceptability, feasibility, and procedural uncertainties of a randomised controlled trial in a workplace, calculate an effect size estimate to inform power calculations for a larger trial, and explore whether improved executive function and/or enhanced mental health could be potential mechanisms underlying the effect of mindfulness on work performance. Outcomes will be collected at baseline, post-intervention and 12-week follow-up.

Background There is an urgent need for mental health promotion in nonclinical settings. Mindfulness–based programmes (MBPs) are being widely implemented to reduce stress, but a comprehensive evidence synthesis is lacking. We reviewed trials to assess whether MBPs promote mental health relative to no intervention or comparator interventions. Methods and findings Following a detailed preregistered protocol (PROSPERO CRD42018105213) developed with public and professional stakeholders, 13 databases were searched to August 2020 for randomised controlled trials (RCTs) examining in–person, expert–defined MBPs in nonclinical settings. Two researchers independently selected, extracted, and appraised trials using the Cochrane Risk–of–Bias Tool 2.0. Primary outcomes were psychometrically validated anxiety, depression, psychological distress, and mental well–being questionnaires at 1 to 6 months after programme completion. Multiple testing was performed using p < 0.0125 (Bonferroni) for statistical significance. Secondary outcomes, meta–regression and sensitivity analyses were prespecified. Pairwise random–effects multivariate meta–analyses and prediction intervals (PIs) were calculated. A total of 11,605 participants in 136 trials were included (29 countries, 77% women, age range 18 to 73 years). Compared with no intervention, in most but not all scenarios MBPs improved average anxiety (8 trials; standardised mean difference (SMD) = −0.56; 95% confidence interval (CI) −0.80 to −0.33; p–value < 0.001; 95% PI −1.19 to 0.06), depression (14 trials; SMD = −0.53; 95% CI −0.72 to −0.34; p–value < 0.001; 95% PI −1.14 to 0.07), distress (27 trials; SMD = −0.45; 95% CI −0.58 to −0.31; p–value < 0.001; 95% PI −1.04 to 0.14), and well–being (9 trials; SMD = 0.33; 95% CI 0.11 to 0.54; p–value = 0.003; 95% PI −0.29 to 0.94). Compared with nonspecific active control conditions, in most but not all scenarios MBPs improved average depression (6 trials; SMD = −0.46; 95% CI −0.81 to −0.10; p–value = 0.012, 95% PI −1.57 to 0.66), with no statistically significant evidence for improving anxiety or distress and no reliable data on well–being. Compared with specific active control conditions, there is no statistically significant evidence of MBPs’ superiority. Only effects on distress remained when higher–risk trials were excluded. USA–based trials reported smaller effects. MBPs targeted at higher–risk populations had larger effects than universal MBPs. The main limitation of this review is that confidence according to the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach is moderate to very low, mainly due to inconsistency and high risk of bias in many trials. Conclusions Compared with taking no action, MBPs of the included studies promote mental health in nonclinical settings, but given the heterogeneity between studies, the findings do not support generalisation of MBP effects across every setting. MBPs may have specific effects on some common mental health symptoms. Other preventative interventions may be equally effective. Implementation of MBPs in nonclinical settings should be partnered with thorough research to confirm findings and learn which settings are most likely to benefit., In a systematic review and meta-analysis, Julieta Galante and colleagues investigate whether mindfulness-based programs improve mental health outcomes in randomized controlled trials in non-clinical settings., Author summary Why was this study done? Mindfulness courses to increase well–being and reduce stress have become very popular; most are in community settings. Many randomised controlled trials (RCTs) tested whether mindfulness courses show benefit, but results are varied and, to our knowledge, there are no reviews combining the data from these studies to show an overall effect. What did the researchers do and find? Worldwide, we identified 136 RCTs on mindfulness training for mental health promotion in community settings. We reviewed them all, assessed their quality, and calculated their combined effects. We showed that, compared with doing nothing, mindfulness reduces anxiety, depression, and stress, and increases well–being, but we cannot be sure that this will happen in every community setting. In these RCTs, mindfulness is neither better nor worse than other feel–good practices such as physical exercise, and RCTs in this field tend to be of poor quality, so we cannot be sure that our combined results represent the true effects. What do these findings mean? Mindfulness courses in the community need to be implemented with care, because we cannot assume that they work for everyone, everywhere. We need good quality collaborative research to find out which types of communities benefit from the different types of mindfulness courses available. The courses that work best may be those aimed at people who are most stressed or in stressful situations.

The increasing prevalence of mental health disorders and psychosocial distress among young people exceeds the capacity of mental health services. Social and systemic factors determine mental health as much as individual factors. To determine how best to address multi-level risk factors, we must first understand the distribution of risk. Previously, we have used psychometric methods applied to two epidemiologically-principled samples of people aged 14–24 to establish a robust, latent common mental distress (CMD) factor of depression and anxiety normally distributed across the population. This was linearly associated with suicidal thoughts and non-suicidal self-harm such that effective interventions to reduce CMD across the whole population could have a greater total benefit than those that focus on the minority with the most severe scores. In a randomised trial of mindfulness interventions in university students (the Mindful Student Study), we demonstrated a population-shift effect whereby the intervention group appeared resilient to a universal stressor. Given these findings, and in light of the COVID-19 pandemic, we argue that population-based interventions to reduce CMD are urgently required. To target all types of mental health determinants, these interventions must be multi-level. Careful design and evaluation, interdisciplinary work, and extensive local stakeholder involvement are crucial for these interventions to be effective.

BackgroundThere is concern that increasing demand for student mental health services reflects deteriorating student well-being. We designed a pragmatic, parallel, single-blinded randomised controlled trial hypothesising that providing mindfulness courses to university students would promote their resilience to stress up to a year later. Here we present 1-year follow-up outcomes.MethodsUniversity of Cambridge students without severe mental illness or crisis were randomised (1:1, remote software-generated random numbers), to join an 8-week mindfulness course adapted for university students (Mindfulness Skills for Students (MSS)), or to mental health support as usual (SAU).ResultsWe randomised 616 students; 53% completed the 1-year follow-up questionnaire. Self-reported psychological distress and mental well-being improved in the MSS arm for up to 1 year compared to SAU (pConclusionLoss to follow-up is a limitation, but evidence suggests beneficial effects on students’ average psychological distress that last for at least a year. Effects are on average larger at stressful times, consistent with the hypothesis that this type of mindfulness training increases resilience to stress.Trial registration numberACTRN12615001160527.

Objective: Many people with psychotic experiences do not develop psychotic disorders, yet those who seek help demonstrate high clinical complexity and poor outcomes. In this systematic review and meta-analysis, we evaluated the effectiveness and cost-effectiveness of psychological interventions for people with psychotic experiences. Method: We searched 13 databases for studies of psychological interventions for adults with psychotic experiences, but not psychotic disorders. Our outcomes were the proportion of participants remitting from psychotic experiences (primary); changes in positive and negative psychotic symptoms, depression, anxiety, functioning, distress, and quality of life; and economic outcomes (secondary). We analysed results using multilevel random-effects meta-analysis and narrative synthesis. Results: A total of 27 reports met inclusion criteria. In general, there was no strong evidence for the superiority of any one intervention. Five studies reported on our primary outcome, though only two reports provided randomised controlled trial evidence that psychological intervention (specifically, cognitive behavioural therapy) promoted remission from psychotic experiences. For secondary outcomes, we could only meta-analyse trials of cognitive behavioural therapy. We found that cognitive behavioural therapy was more effective than treatment as usual for reducing distress (pooled standardised mean difference: −0.24; 95% confidence interval = [−0.37, −0.10]), but no more effective than the control treatment for improving any other outcome. Individual reports indicated that cognitive behavioural therapy, mindfulness-based cognitive therapy, sleep cognitive behavioural therapy, systemic therapy, cognitive remediation therapy, and supportive treatments improved at least one clinical or functional outcome. Four reports included economic evaluations, which suggested cognitive behavioural therapy may be cost-effective compared with treatment as usual. Conclusion: Our meta-analytic findings were primarily null, with the exception that cognitive behavioural therapy may reduce the distress associated with psychotic experiences. Our analyses were limited by scarcity of studies, small samples and variable study quality. Several intervention frameworks showed preliminary evidence of positive outcomes; however, the paucity of consistent evidence for clinical and functional improvement highlights a need for further research into psychological treatments for psychotic experiences. PROSPERO protocol registration number: CRD42016033869

Background People with Borderline Personality Disorder (BPD) have limited access to long term psychological therapies. Briefer interventions have been developed but trial evidence to support their use has not been reviewed. Aims To examine whether psychological interventions for adults with BPD of six months duration or less improve symptoms, mood, self-harm, suicidal behaviour, and service use. Methods The protocol was prospectively registered (PROSPERO CRD42017063777). Database searches were conducted up to April 2020. Inclusion, data extraction and risk of bias were assessed in duplicate. We identified 27 randomised controlled trials. We conducted random-effects meta-analyses sub-grouping data into delivery method, additional support, and comparison type. Results High levels of bias were found for attrition and reporting. Heterogeneity was high in some pooled data. Borderline symptom reductions were greatest for interventions including additional support (SMD. -1.23, 95% C.I. -2.13, −0.33). Planned generic support may be as effective as specialist interventions for borderline symptoms (SMD = −0.11, 95% C.I. -0.51, 0.29) and social functioning (SMD = −0.16., 95% C.I. -0.65, 0.33). Follow-up was limited and direct comparison with post-intervention results was unreliable. Conclusions Short-term interventions may be effective. Access to additional support has an impact on outcomes. It is unclear if symptomatic change is sustained.

Psychological distress persisting for weeks or more promotes pro-inflammatory immune dysregulation, a risk factor for a range of chronic diseases. We have recently shown that mindfulness training reduces distress among university students. Here we present an exploratory trial to study immune dysregulation in a cohort of students who were exposed to progressively greater stress as the exam period approached, and to explore whether mindfulness training mitigated this dysregulation. Healthy University of Cambridge students were randomised to join an 8-week mindfulness course (N = 27), or to mental health support as usual (N = 27). Psychological distress, immune cell proportions, cytokines, CRP and serum cortisol were measured at baseline and during the exam period. Increased distress was associated with statistically significant increases in the proportion of B cells, regardless of trial arm (*p = 0.027). There were no other associations between any of the measured parameters, distress or mindfulness. Our finding that the proportion of B cells increases with psychological distress supports the findings of other studies. However, we found no evidence that mindfulness training is able to buffer the effects of psychological distress on healthy participants’ immune system. In order to detect these effects, should they exist, larger randomised trials will be required.

Background The measurement of health benefits is a key issue in health economic evaluations. There is very scarce empirical literature exploring the differences of using quality-adjusted life years (QALYs) or disability-adjusted life years (DALYs) as benefit metrics and their potential impact in decision-making. Methods Two previously published models delivering outputs in QALYs, were adapted to estimate DALYs: a Markov model for human papilloma virus (HPV) vaccination, and a pneumococcal vaccination deterministic model (PNEUMO). Argentina, Chile, and the United Kingdom studies were used, where local EQ-5D social value weights were available to provide local QALY weights. A primary study with descriptive vignettes was done (n = 73) to obtain EQ-5D data for all health states included in both models. Several scenario analyses were carried-out to evaluate the relative importance of using different metrics (DALYS or QALYs) to estimate health benefits on these economic evaluations. Results QALY gains were larger than DALYs avoided in all countries for HPV, leading to more favorable decisions using the former. With discounting and age-weighting – scenario with greatest differences in all countries – incremental DALYs avoided represented the 75%, 68%, and 43% of the QALYs gained in Argentina, Chile, and United Kingdom respectively. Differences using QALYs or DALYs were less consistent and sometimes in the opposite direction for PNEUMO. These differences, similar to other widely used assumptions, could directly influence decision-making using usual gross domestic products (GDPs) per capita per DALY or QALY thresholds. Conclusion We did not find evidence that contradicts current practice of many researchers and decision-makers of using QALYs or DALYs interchangeably. Differences attributed to the choice of metric could influence final decisions, but similarly to other frequently used assumptions. Fil: Augustovski, Federico Ariel. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Pque. Centenario. Centro de Investigaciones En Epidemiología y Salud Publica. Instituto de Efectividad Clinica y Sanitaria. Centro de Investigaciones En Epidemiología y Salud Publica.; Argentina Fil: Colantonio, Lisandro Damián. University of Alabama at Birmingahm; Estados Unidos Fil: Galante, Julieta. Cardiff University; Reino Unido Fil: Bardach, Ariel Esteban. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Pque. Centenario. Centro de Investigaciones En Epidemiología y Salud Publica. Instituto de Efectividad Clinica y Sanitaria. Centro de Investigaciones En Epidemiología y Salud Publica.; Argentina Fil: Caporale, Joaquín E.. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Pque. Centenario. Centro de Investigaciones En Epidemiología y Salud Publica. Instituto de Efectividad Clinica y Sanitaria. Centro de Investigaciones En Epidemiología y Salud Publica.; Argentina Fil: Zárate, Víctor. Universidad San Sebastian; Chile Fil: Chuang, Ling Hsiang. Pharmerit; Países Bajos Fil: Pichón-Riviere, Andrés. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Pque. Centenario. Centro de Investigaciones En Epidemiología y Salud Publica. Instituto de Efectividad Clinica y Sanitaria. Centro de Investigaciones En Epidemiología y Salud Publica.; Argentina Fil: Kind, Paul. University of Leeds; Reino Unido

Background: Many people with psychotic experiences who seek help do not develop psychotic disorders, yet still demonstrate higher clinical complexity, suboptimal treatment response, and poor clinical and functional outcomes. Methods: We searched thirteen databases for studies concerning psychological interventions for adults with psychotic experiences, but not psychotic disorders. Our outcomes were the proportion of participants remitting/recovering from psychotic experiences (primary); changes in positive and negative psychotic symptoms, depression, anxiety, functioning, distress, or quality of life; and economic outcomes (secondary). We analysed results using random-effects meta-analysis and narrative synthesis. Findings: Twenty-seven reports from 21 studies met inclusion criteria. Five reported the proportion of participants remitting from psychotic experiences. Non-meta-analytic evidence suggested that cognitive behavioural therapy (CBT) may promote symptomatic recovery. For secondary outcomes, CBT demonstrated effectiveness over treatment as usual (TAU) and supportive treatments (ST) in improving distress (pooled standardised mean difference: -0.23 [-0.36 to -0.10]), but no other outcome. Individual reports indicated that CBT, mindfulness, sleep CBT, systemic therapy, cognitive remediation therapy, and supportive treatments improved some clinical and/or functional outcomes. Only four reports, using data from two studies, included economic evaluations, which suggested CBT may be cost-effective compared with TAU. Interpretation: Initial evidence suggests that CBT may promote recovery from psychotic experiences and reduce associated distress, although scarcity of studies, small sample sizes, and variable study quality limit our ability to make definitive conclusions. The paucity of consistent evidence for improving other non-psychotic clinical and functional outcomes highlights a need for further research into psychological treatments for this population. Funding: This paper presents independent research funded by the National Institute for Health Research (NIHR) under its Programme Grants for Applied Research Programme (Reference Number RP-PG-0616-20003). Declaration of Interest: The authors declare no competing interests. Ethical Approval: Not applicable.

Background University students are expressing an increased need for mental health support. Mindfulness-based interventions (MBIs) are being integrated into university stress-reduction programmes globally. We conducted a comprehensive systematic review and meta-analysis of randomised controlled trials (RCTs) assessing MBI effects on university students' mental and physical health. Methods We searched nine databases, including grey literature and trial registries. Two independent reviewers extracted data following a prospective public protocol. Results Fifty-one RCTs were included. In comparison with passive controls, and when measured shortly after intervention completion, MBIs improve distress, anxiety, depression, well-being, rumination, and mindfulness with small to moderate effect sizes, with no benefit found for blood pressure, sleep, life satisfaction, resilience, worry, and thought suppression. Evidence for self-compassion is inconclusive. Effects last beyond three months for distress and mindfulness, with no data on other outcomes. Compared with active control groups, MBIs significantly improve distress and state anxiety, but not mindfulness, depression, well-being, affect, trait anxiety, or emotion regulation. Results were robust to adjustment for multiple testing, but RCTs' risk of bias is generally high. Moderator analyses did not find differential intervention effects according to intervention duration, delivery mode, or sub-populations. Conclusions MBIs may be helpful to students but higher-quality research is needed.

Background A significant proportion of the worldwide population is at risk of social isolation and loneliness as a result of the COVID-19 pandemic. We aimed to identify effective interventions to reduce social isolation and loneliness that are compatible with COVID-19 shielding and social distancing measures. Methods and findings In this rapid systematic review, we searched six electronic databases (Medline, Embase, Web of Science, PsycINFO, Cochrane Database of Systematic Reviews and SCOPUS) from inception to April 2020 for systematic reviews appraising interventions for loneliness and/or social isolation. Primary studies from those reviews were eligible if they included: 1) participants in a non-hospital setting; 2) interventions to reduce social isolation and/or loneliness that would be feasible during COVID-19 shielding measures; 3) a relevant control group; and 4) quantitative measures of social isolation, social support or loneliness. At least two authors independently screened studies, extracted data, and assessed risk of bias using the Downs and Black checklist. Study registration: PROSPERO CRD42020178654. We identified 45 RCTs and 13 non-randomised controlled trials; none were conducted during the COVID-19 pandemic. The nature, type, and potential effectiveness of interventions varied greatly. Effective interventions for loneliness include psychological therapies such as mindfulness, lessons on friendship, robotic pets, and social facilitation software. Few interventions improved social isolation. Overall, 37 of 58 studies were of “Fair” quality, as measured by the Downs & Black checklist. The main study limitations identified were the inclusion of studies of variable quality; the applicability of our findings to the entire population; and the current poor understanding of the types of loneliness and isolation experienced by different groups affected by the COVID-19 pandemic. Conclusions Many effective interventions involved cognitive or educational components, or facilitated communication between peers. These interventions may require minor modifications to align with COVID-19 shielding/social distancing measures. Future high-quality randomised controlled trials conducted under shielding/social distancing constraints are urgently needed.

Background: The rising number of young people going to university has led to concerns about an increasing demand for student mental health services. We aimed to assess whether provision of mindfulness courses to university students would improve their resilience to stress. Methods: We did this pragmatic randomised controlled trial at the University of Cambridge, UK. Students aged 18 years or older with no severe mental illness or crisis (self-assessed) were randomly assigned (1:1), via remote survey software using computer-generated random numbers, to receive either an 8 week mindfulness course adapted for university students (Mindfulness Skills for Students [MSS]) plus mental health support as usual, or mental health support as usual alone. Participants and the study management team were aware of group allocation, but allocation was concealed from the researchers, outcome assessors, and study statistician. The primary outcome was self-reported psychological distress during the examination period, as measured with the Clinical Outcomes in Routine Evaluation Outcome Measure (CORE–OM), with higher scores indicating more distress. The primary analysis was by intention to treat. This trial is registered with the Australia and New Zealand Clinical Trials Registry, number ACTRN12615001160527. Findings: Between Sept 28, 2015, and Jan 15, 2016, we randomly assigned 616 students to the MSS group (n=309) or the support as usual group (n=307). 453 (74%) participants completed the CORE–OM during the examination period and 182 (59%) MSS participants completed at least half of the course. MSS reduced distress scores during the examination period compared with support as usual, with mean CORE–OM scores of 0·87 (SD 0·50) in 237 MSS participants versus 1·11 (0·57) in 216 support as usual participants (adjusted mean difference −0·14, 95% CI −0·22 to −0·06; p=0·001), showing a moderate effect size (β −0·44, 95% CI −0·60 to −0·29; p

Background Evidence suggests that facilitating empathy could improve individuals’ well-being. Loving-kindness meditation (LKM) could be a facilitator, and online delivery a cost-effective format. Methods We conducted an internet-based randomised controlled trial recruiting 809 adults to test whether an LKM course improves well-being through evoking pleasant emotions, psychological resources, and altruism compared to a light physical exercise course (LE). Participants in both arms followed video-based instructions, completed post-intervention questionnaires, and used online diaries and forums. To measure altruism 10 GBP/10 USD were offered to participants with a choice of donating all/half to charity. Thematic analysis was applied to diary/forum entries. Results Both courses increased well-being without significant differences. LKM participants were less anxious than LE participants (ß = -0.22, 95% confidence interval (CI) [-0.43, -0.02], p = .03), and more likely to donate 5 GBP/5 USD (Relative Risk = 3.57, 95%CI [0.82, 15.50], p = .09). Attrition was high (82%). Participants engaged in diary/forum usage. LKM was an emotionally intense experience, generating deep reflections and increased connectedness but difficult for some to process. LE led to gentle increases in relaxation, generating a sense of achievement. Conclusion Future research needs to confirm findings and devise ways of delivering online LKM effectively to diverse populations.

Context UK Biobank is a prospective study of half a million subjects, almost all aged 40–69 years, identified in 22 centres across the UK during 2006–2010. Objective A healthy lifestyle has been described as ‘better than any pill, and no side effects [5]. We therefore examined the relationships between healthy behaviours: low alcohol intake, non-smoking, healthy BMI, physical activity and a healthy diet, and the risk of all cancers, colon, breast and prostate cancers in a large dataset. Method Data on lifestyle behaviours were provided by 343,150 subjects, and height and weight were measured at recruitment. 14,285 subjects were diagnosed with cancer during a median of 5.1 years of follow-up. Results Compared with subjects who followed none or a single healthy behaviour, a healthy lifestyle based on all five behaviours was associated with a reduction of about one-third in incident cancer (hazard ratio [HR] 0.68; 95% confidence intervals [CI] 0.63–0.74). Colorectal cancer was reduced in subjects following the five behaviours by about one-quarter (HR 0.75; 95% CI 0.58–0.97), and breast cancer by about one-third (HR 0.65; 95% CI 0.52–0.83). The association between a healthy lifestyle and prostate cancer suggested a significant increase in risk, but this can be attributed to bias consequent on inequalities in the uptake of the prostate specific antigen screening test. Conclusions Taken together with reported reductions in diabetes, vascular disease and dementia, it is clearly important that every effort is taken to promote healthy lifestyles throughout the population, and it is pointed out that cancer and other screening clinics afford ‘teachable moments’ for the promotion of a healthy lifestyle.

BACKGROUND: Aspirin has been shown to lower the incidence and the mortality of vascular disease and cancer but its wider adoption appears to be seriously impeded by concerns about gastrointestinal (GI) bleeding. Unlike heart attacks, stroke and cancer, GI bleeding is an acute event, usually followed by complete recovery. We propose therefore that a more appropriate evaluation of the risk-benefit balance would be based on fatal adverse events, rather than on the incidence of bleeding. We therefore present a literature search and meta-analysis to ascertain fatal events attributable to low-dose aspirin. METHODS: In a systematic literature review we identified reports of randomised controlled trials of aspirin in which both total GI bleeding events and bleeds that led to death had been reported. Principal investigators of studies in which fatal events had not been adequately described were contacted via email and asked for further details. A meta-analyses was then performed to estimate the risk of fatal gastrointestinal bleeding attributable to low-dose aspirin. RESULTS: Eleven randomised trials were identified in the literature search. In these the relative risk (RR) of 'major' incident GI bleeding in subjects who had been randomised to low-dose aspirin was 1.55 (95% CI 1.33, 1.83), and the risk of a bleed attributable to aspirin being fatal was 0.45 (95% CI 0.25, 0.80). In all the subjects randomised to aspirin, compared with those randomised not to receive aspirin, there was no significant increase in the risk of a fatal bleed (RR 0.77; 95% CI 0.41, 1.43). CONCLUSIONS: The majority of the adverse events caused by aspirin are GI bleeds, and there appears to be no valid evidence that the overall frequency of fatal GI bleeds is increased by aspirin. The substantive risk for prophylactic aspirin is therefore cerebral haemorrhage which can be fatal or severely disabling, with an estimated risk of one death and one disabling stroke for every 1,000 people taking aspirin for ten years. These adverse effects of aspirin should be weighed against the reductions in vascular disease and cancer.

Introduction Levels of stress in UK university students are high, with an increase in the proportion of students seeking help in recent years. Academic pressure is reported as a major trigger. Mindfulness training has been shown to reduce stress and is popular among students, but its effectiveness in this context needs to be ascertained. In this pragmatic randomised controlled trial, we hypothesise that the provision of a preventative mindfulness intervention in universities could reduce students' psychological distress during the examination period (primary outcome), improve their resilience to stress up to at least 1 year later, reduce their use of mental health support services and improve academic performance. Methods and analysis At least 550 University of Cambridge students free from active crises or severe mental illness will be randomised to joining an 8-week mindfulness course or to mental health provision as usual (one-to-one allocation rate). Psychological distress will be measured using the Clinical Outcomes in Routine Evaluation Outcome Measure at baseline, postintervention, examination term and 1-year follow-up. Other outcomes are use of mental health services, inability to sit examinations or special circumstance requests, examination grades, well-being, altruism and coping measured with ecological momentary assessment. Outcome assessment and intention-to-treat primary analysis using linear mixed models adjusted for baseline scores will be blind to intervention allocation. We will also conduct per-protocol, subgroup and secondary outcome analyses. An Independent Data Monitoring and Ethics Committee will be set up. We will systematically monitor for, and react to, possible adverse events. An advisory reference group will comprise student representatives, members of the University Counselling Service and other student welfare staff. Ethics and dissemination Approval has been obtained from Cambridge Psychology Research Ethics Committee (PRE.2015.060). Results will be published in peer-reviewed journals. A lay summary will be disseminated to a wider audience including other universities. Trial registration number [ACTRN12615001160527][1]; pre-results. [1]: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12615001160527

SUMMARY Colon cancer is the third most common cancer worldwide. Sigmoidoscopy and colonoscopy, with the removal of rectal and colon polyps, are proven strategies for the prevention of colon cancer, and testing for fecal occult blood helps to identify subjects suitable for endoscopy. Evidence that low-dose aspirin is associated with a substantial reduction in colon cancer risk and reduces the number and growth of colon polyps is accumulating from randomized trials and observational studies. Advantages and disadvantages of endoscopy and aspirin prophylaxis are discussed extensively in this review. The reduction in cancer incidence by the two approaches together is considerably enhanced as they complement each other. Expenditure could become more cost effective if the two were promoted together.

Although dietary intake over a single 24-h period may be atypical of an individual’s habitual pattern, multiple 24-h dietary assessments can be representative of habitual intake and help in assessing seasonal variation. Web-based questionnaires are convenient for the participant and result in automatic data capture for study investigators. This study reports on the acceptability of repeated web-based administration of the Oxford WebQ – a 24-h recall of frequency from a set food list suitable for self-completion from which energy and nutrient values can be automatically generated. As part of the UK Biobank study, four invitations to complete the Oxford WebQ were sent by email over a 16-month period. Overall, 176 012 (53 % of those invited) participants completed the online version of the Oxford WebQ at least once and 66 % completed it more than once, although only 16 % completed it on all four occasions. The response rate for any one round of invitations varied between 34 and 26 %. On most occasions, the Oxford WebQ was completed on the same day that they received the invitation, although this was less likely if sent on a weekend. Participants who completed the Oxford WebQ tended to be white, female, slightly older, less deprived and more educated, which is typical of health-conscious volunteer-based studies. These findings provide preliminary evidence to suggest that repeated 24-h dietary assessment via the Internet is acceptable to the public and a feasible strategy for large population-based studies.

ObjectivesTo estimate and compare EuroQol instrument (EQ-5D) health states' values for pneumoccocal and human papillomavirus (HPV) diseases in Argentina, Chile, and the United Kingdom.MethodsTwelve vignettes were designed, pilot-tested, and administered to a convenience sample in a cross-sectional design to elicit descriptive EQ-5D state data. Country-specific EQ-5D time-trade-off-based weights were used to map these descriptive health states into local country preference weights. Descriptive analysis is reported and intercountry differences for each condition were compared using repeated measures analysis of variance.ResultsSeventy-three subjects completed the survey. Pneumococcal disease-related health states mean values ranged from −0.331 (sepsis, Chile) to 0.727 (auditive sequelae, Argentina). HPV-related conditions ranged from 0.152 (cervical cancer, United Kingdom) to 0.848 (cervical intraepithelial neoplasia 1, Argentina). Chile had consistently the lowest mean values in pneumococcal states and in one HPV state, whereas those of the United Kingdom were the lowest in most HPV states. Argentina had the highest mean values in both diseases. Differences in country-specific values for each health state were statistically (P < 0.001) significant except for six health states in which differences between Chilean and United Kingdom weights were nonsignificant.ConclusionsUtility values for most conditions differed statistically relevantly among analyzed countries, even though the same health states′ descriptive set was valued for each. These results reflect the difference in social weights among different countries, which could be attributed to either different population values or valuation study methodologies. They stress the importance of using local preference weights for context-specific decision making.