Mindfulness-based programmes for mental health promotion in adults in nonclinical settings: A systematic review and meta-analysis of randomised controlled trials.

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.

The impact of the COVID-19 pandemic on the mental health of young people: A comparison between China and the United Kingdom.

PURPOSE: As COVID-19 spreads globally and affects people's health, there are concerns that the pandemic and control policies may have psychological effects on young people (age from 17 to 35 years). This psychological impact might vary in different countries, and thus we compared the prevalence of self-reported psychological distress, loneliness and posttraumatic stress symptoms (PTSS) among young people in the United Kingdom (UK) and China at the beginning of the COVID-19 pandemic. METHODS: Data of this study came from two sources. One source was the first wave of COVID-19 study in Understanding Society, a special wave of the UK household longitudinal study, which provided the high-quality, national-wide representative panel data. The sample comprised 1054 young people. The other source was an online survey on the mental health of 1003 young people from Shanghai, a highly developed area in China. The questionnaire included questions on the prevalence of common mental disorders (cut-off score ≥ 4), loneliness and potential PTSS (cut-off ≥ 33). Univariable analyses were conducted to test the differences in the self-reported prevalence of psychological distress and loneliness between the two groups. Multivariable logistic regression analyses were run to explore the predictors of psychological distress and loneliness among all the young people from England and Shanghai. RESULTS: Among the samples with self-reported psychological distress, the UK sample accounted for 34.4% (n=1054) and the Chinese sample accounted for 14.1% (n=1003). The difference between the two groups was statistically significant (p < 0.001). Additionally, 57.1% of people in the UK and 46.7% in China reported that they sometimes or often felt lonely, of which the difference is statistically significant (p < 0.001). Regression analysis of the entire samples showed that nationality, gender, psychotherapy and loneliness were significant predictors of 12-item General Health Questionnaire scores, while the variables of age and living alone were not. Significant predictors of self-reported loneliness were the nationality, gender, age, living alone and psychotherapy. In China, 123 (12.3%) young people, 49 men (11.3%) and 74 women (13.0%), met the criteria of PTSS symptoms (cut-off scores ≥ 33). These scores were only collected in China. CONCLUSION: This evidence suggests that mental health and loneliness reported by young people were lower in China than that in the UK during the studied period. More research is needed to understand these differences. If the differential negative psychological impacts are confirmed, country-specific measures of prevention and intervention should be adopted to improve the mental health of young people under the ongoing impact of the pandemic.

Psychological interventions for people with psychotic experiences: A systematic review and meta-analysis of controlled and uncontrolled effectiveness and economic studies.

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.

The acceptability of repeat Internet-based hybrid diet assessment of previous 24-h dietary intake: administration of the Oxford WebQ in UK Biobank.

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.

Mindfulness Teacher Trainees' Experiences (MTTE): An investigation of intense experiences in mindfulness-based interventions.

With the increasing interest in mindfulness practices within clinical as well as non-clinical settings and the increasing body of research on the positive effects of mindfulness, concerns have been raised that mindfulness might also produce adverse effects including intense experiences and psychosis. The aim of this study was to investigate if intense experiences occur as a natural part of mindfulness practice, and if so to examine the characteristics of such experiences. We conducted a qualitative analysis based on fortnightly meditation reports from 13 mindfulness teacher trainees for 4 months. Intense experiences in meditation were frequently expressed in the reports of most of the practitioners and in some individuals these experiences were similar to psychotic-like experiences. This study presents suggestive evidence that mindfulness practices can produce intense experiences and that for some individuals these intense experiences may resemble psychotic-like experiences.

Prevalence and 20-year trends in meditation, yoga, guided imagery and progressive relaxation use among US adults from 2002 to 2022.

Meditation, yoga, guided imagery, and progressive relaxation are promoted as complementary approaches for health and wellbeing in the United States, but their uptake by different sociodemographic groups is unclear. This study assessed the prevalence and 20 year trends in the use of these practices in US adults between 2002-2022. We examined practice use and associations with sociodemographic and health factors in a population-weighted analysis of n = 134,959 participants across 5 cycles of the National Health Interview Survey. The overall use of meditation (18.3%, 60.53 million), yoga (16.8%, 55.78 million) and guided imagery/progressive relaxation (6.7%, 22.22 million) increased significantly from 2002 to 2022. Growth was consistent across most sociodemographic and health strata, however users of 'Other' race (comprising 54% Indigenous Americans, Odds Ratios; ORs = 1.28-1.70) and users with moderate (ORs = 1.19-1.29) psychological distress were overrepresented across all practices, and those with severe psychological distress were overrepresented in meditation (OR = 1.33) and guided imagery/progressive relaxation (OR = 1.42). Meditation use has accelerated over time for 65 + year olds (OR = 4.22), people not accessing mental health care (OR = 1.39), and less educated (OR = 4.02) groups, potentially reflecting unmet health needs. Health professionals should consider the extensive use of complementary practices in service and treatment planning and consider their risks and benefits.

Work Engagement and Well-being Study (SWELL): a randomised controlled feasibility trial evaluating the effects of mindfulness versus light physical exercise at work.

BACKGROUND: Mindfulness-based programmes (MBPs) are increasingly offered at work, often in online self-guided format. However, the evidence on MBPs' effect on work performance (WP) is inconsistent. OBJECTIVE: This pragmatic randomised controlled feasibility trial assessed procedural uncertainties, intervention acceptability and preliminary effect sizes of an MBP on WP, relative to an alternative intervention. METHODS: 241 employees from eight employers were randomised (1:1) to complete a 4-week, self-guided, online MBP or a light physical exercise programme (LE)(active control). Feasibility and acceptability measures were of primary interest. WP at postintervention (PostInt) was the primary outcome for preliminary assessment of effect sizes. Secondary outcomes assessed mental health (MH) and cognitive processes hypothesised to be targeted by the MBP. Outcomes were collected at baseline, PostInt and 12-week follow-up (12wFUP). Prospective trial protocol: NCT04631302. FINDINGS: 87% of randomised participants started the course. Courses had high acceptability. Retention rates were typical for online trials (64% PostInt; 30% 12wFUP). MBP, compared with the LE control, offered negligible benefits for WP (PostInt (d=0.06, 95% CI -0.19 to 0.32); 12wFUP (d=0.02, 95% CI -0.30 to 0.26)). Both interventions improved MH outcomes (ds=-0.40 to 0.58, 95% CI -0.32 to 0.18); between-group differences were small (ds=-0.09 to 0.04, 95% CI -0.15 to 0.17). CONCLUSION: The trial is feasible; interventions are acceptable. Results provide little support for a later phase trial comparing an MBP to a light exercise control. To inform future trials, we summarise procedural challenges. CLINICAL IMPLICATIONS: Results suggest MBPs are unlikely to improve WP relative to light physical exercise. Although the MBP improved MH, other active interventions may be just as efficacious. TRIAL REGISTRATION NUMBER: NCT04631302.

A cost-effectiveness analysis of a 10-valent pneumococcal conjugate vaccine in children in six Latin American countries.

BACKGROUND: A recently developed 10-valent pneumococcal non-typeable H influenzae protein D-conjugate vaccine (PHiD-CV) is expected to afford protection against more than two thirds of isolates causing IPD in children in Latin America, and also against acute otitis media caused by both Spn and NTHi. The objective of this study is to assess the cost-effectiveness of PHiD-CV in comparison to non-vaccination in children under 10 years of age in Argentina, Brazil, Chile, Colombia, Mexico and Peru. METHODS: We used a static, deterministic, compartmental simulation model. The dosing regimen considered included three vaccine doses (at 2 months, 4 months and 6 months) and a booster dose (at 13 months) (3 + 1 schedule). Model outcomes included number of cases prevented, deaths averted, quality-adjusted life-years (QALYs) gained and costs. Discount for costs and benefits of long term sequelae was done at 3.5%, and currency reported in 2008-2009 U$S varying between countries. RESULTS: The largest effect in case prevention was observed in pneumococcal meningitis (from 27% in Peru to 47% in Colombia), neurologic sequelae after meningitis (from 38% in Peru to 65% in Brazil) and bacteremia (from 42% in Argentina to 49% in Colombia). The proportion of predicted deaths averted annually ranged from 18% in Peru to 33% in Brazil. Overall, the health benefits achieved with PHiD-CV vaccination resulted in a lower QALY loss (from 15% lower in Peru to 26% in Brazil). At a cost of USD 20 per vaccine dose, vaccination was cost-effective in all countries, from being cost saving in Chile to a maximum Incremental Cost-effectiveness Ratio of 7,088 US$ Dollars per QALY gained. Results were robust in the sensitivity analysis, and scenarios with indirect costs affected results more than those with herd immunity. CONCLUSIONS: The incorporation of the 10-valent pneumococcal conjugate vaccine into routine infant immunization programs in Latin American countries could be a cost-effective strategy to improve infant population health in the region.

Feasibility and Acceptability of an Online Mindfulness-Based Intervention for Stress Reduction and Psychological Wellbeing of University Students in Pakistan: A Pilot Randomized Controlled Trial.

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.

Individual participant data systematic review and meta-analysis of randomised controlled trials assessing adult mindfulness-based programmes for mental health promotion in non-clinical settings.

Introduction: Mindfulness-based programmes (MBPs) are widely used to prevent mental ill-health that is becoming the leading global cause of morbidity. Evidence suggests beneficial average effects but wide variability. We aimed to confirm the effect of MBPs on psychological distress, and to understand whether and how baseline distress, gender, age, education, and dispositional mindfulness modify the effect of MBPs on distress among adults in non-clinical settings. Methods: We conducted a pre-registered systematic review and individual participant data (IPD) meta-analysis (PROSPERO CRD42020200117). Thirteen databases were searched in December 2020 for randomised controlled trials satisfying a quality threshold and comparing in-person, expert-defined MBPs in non-clinical settings with passive control groups. Two researchers independently selected, extracted, and appraised trials using the revised Cochrane Risk-of-Bias Tool (RoB2). Anonymised IPD of eligible trials were sought from collaborating authors. The primary outcome was psychological distress (unpleasant mental or emotional experiences including anxiety and depression) at 1 to 6 months after programme completion. Data were checked and imputed if missing. Pairwise, random-effects, two-stage IPD meta-analyses were conducted. Effect modification analyses followed a within-studies approach. Public and professional stakeholders were involved in the planning, conduct and dissemination of this study. Results: Fifteen trials were eligible, 13 trialists shared IPD (2,371 participants representing 8 countries, median age 34 years-old, 71% women, moderately distressed on average, 20% missing outcome data). In comparison with passive control groups, MBPs reduced average distress between one- and six-months post-intervention with a small to moderate effect size (standardised mean difference (SMD) -0.32; 95% confidence interval (CI) -0.41 to -0.24; p-value < 0.001; 95% prediction interval (PI) -0.41 to -0.24 (no heterogeneity)). Results were robust to sensitivity analyses, and similar for the other psychological distress time point ranges. Confidence in the primary outcome result is high. We found no clear indication that this effect is modified by baseline psychological distress, gender, age, education level, or dispositional mindfulness. Conclusions: Group-based teacher-led MBPs generally reduce psychological distress among community adults who volunteer to receive this type of intervention. More research is needed to identify sources of variability in outcomes at an individual level.

Cost-effectiveness of providing university students with a mindfulness-based intervention to reduce psychological distress: economic evaluation of a pragmatic randomised controlled trial.

OBJECTIVE: Increasing numbers of young people attending university has raised concerns about the capacity of student mental health services to support them. We conducted a randomised controlled trial (RCT) to explore whether provision of an 8 week mindfulness course adapted for university students (Mindfulness Skills for Students-MSS), compared with university mental health support as usual (SAU), reduced psychological distress during the examination period. Here, we conduct an economic evaluation of MSS+SAU compared with SAU. DESIGN AND SETTING: Economic evaluation conducted alongside a pragmatic, parallel, single-blinded RCT comparing provision of MSS+SAU to SAU. PARTICIPANTS: 616 university students randomised. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary economic evaluation assessed the cost per quality-adjusted life year (QALY) gained from the perspective of the university counselling service. Costs relate to staff time required to deliver counselling service offerings. QALYs were derived from the Clinical Outcomes in Routine Evaluation Dimension 6 Dimension (CORE-6D) preference based tool, which uses responses to six items of the Clinical Outcomes in Routine Evaluation Outcome Measure (CORE-OM; primary clinical outcome measure). Primary follow-up duration was 5 and 7 months for the two recruitment cohorts. RESULTS: It was estimated to cost £1584 (2022 prices) to deliver an MSS course to 30 students, £52.82 per student. Both costs (adjusted mean difference: £48, 95% CI £40-£56) and QALYs (adjusted mean difference: 0.014, 95% CI 0.008 to 0.021) were significantly higher in the MSS arm compared with SAU. The incremental cost-effectiveness ratio (ICER) was £3355, with a very high (99.99%) probability of being cost-effective at a willingness-to-pay threshold of £20 000 per QALY. CONCLUSIONS: MSS leads to significantly improved outcomes at a moderate additional cost. The ICER of £3355 per QALY suggests that MSS is cost-effective when compared with the UK's National Institute for Health and Care Excellence thresholds of £20 000 per QALY. TRIAL REGISTRATION NUMBER: Australian and New Zealand Clinical Trials Registry, ACTRN12615001160527.

Sequential multiple assignment randomised controlled trial protocol for developing an adaptive intervention to improve depressive symptoms among family caregivers of people with dementia.

OBJECTIVES: Family caregivers of people with dementia (FC-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 behavioural 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 prespecified 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 randomised trial 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 BA and MP of different sequences and dosages (eg, 8 weeks of BA followed by booster sessions for responders and 8 weeks of MP for non-responders) will be assigned to the participants following a set of decision rules. The primary outcomes will be depressive symptoms (measured using the Patient Health Questionnaire-9), assessed after the second stage of the intervention. Other outcomes, such as positive aspects of caregiving (measured using the Positive Aspects of Caregiving Scale), sleep quality (measured using the Pittsburgh Sleep Quality Index) and time points will also be assessed. The analyses will follow the intention-to-treat principle. Several process indicators (eg, engagement in meaningful activities and level of mindfulness) will also be assessed. The findings will have strong implications for the further development of psychosocial adaptive interventions to reduce depressive symptoms among FC-of-PWD. ETHICS AND DISSEMINATION: This study has received ethical approval from the Human Research Ethics Committee at The Hong Kong Polytechnic University (HSEARS20211223001). The findings will be presented at academic conferences and submitted to peer-reviewed journals for publication. TRIAL REGISTRATION NUMBER: NCT05634317.

Protocol for the Work Engagement and Well-being Study (SWELL): a randomised controlled feasibility trial evaluating the effects of mindfulness versus light physical exercise at work.

INTRODUCTION: Mental 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 ANALYSIS: 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, postintervention and 12-week follow-up. ETHICS AND DISSEMINATION: Approval 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 NUMBER: NCT04631302.

Mindfulness-based programmes for mental health promotion in adults in non-clinical settings: protocol of an individual participant data meta-analysis of randomised controlled trials.

INTRODUCTION: With mental ill health listed as a top cause of global disease burden, there is an urgent need to prioritise mental health promotion programmes. Mindfulness-based programmes (MBPs) are being widely implemented to reduce stress in non-clinical settings. In a recent aggregate-level meta-analysis we found that, compared with no intervention, these MBPs reduce average psychological distress. However, heterogeneity between studies impedes generalisation of effects across every setting. Study-level effect modifiers were insufficient to reduce heterogeneity; studying individual-level effect modifiers is warranted. This requires individual participant data (IPD) and larger samples than those found in existing individual trials. METHODS AND ANALYSIS: We propose an IPD meta-analysis. Our primary aim is to see if, and how, baseline psychological distress, gender, age, education and dispositional mindfulness moderate the effect of MBPs on distress. We will search 13 databases for good-quality randomised controlled trials comparing in-person, expert-defined MBPs in non-clinical settings with passive controls. Two researchers will independently select, extract and appraise trials using the revised Cochrane risk-of-bias tool. Anonymised IPD of eligible trials will be sought from authors, who will be invited to collaborate.The primary outcome will be psychological distress measured using psychometrically validated questionnaires at 1-6 months after programme completion. Pairwise random-effects two-stage IPD meta-analyses will be conducted. Moderator analyses will follow a 'deft' approach. We will estimate subgroup-specific intervention effects. Secondary outcomes and sensitivity analyses are prespecified. Multiple imputation strategies will be applied to missing data. ETHICS AND DISSEMINATION: The findings will refine our knowledge on the effectiveness of MBPs and help improve the targeting of MBPs in non-clinical settings. They will be shared in accessible formats with a range of stakeholders. Public and professional stakeholders are being involved in the planning, conduct and dissemination of this project. PROSPERO REGISTRATION NUMBER: CRD42020200117.

Estimation and comparison of EQ-5D health states' utility weights for pneumococcal and human papillomavirus diseases in Argentina, Chile, and the United Kingdom.

OBJECTIVES: To estimate and compare EuroQol instrument (EQ-5D) health states' values for pneumococcal and human papillomavirus (HPV) diseases in Argentina, Chile, and the United Kingdom. METHODS: Twelve 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. RESULTS: Seventy-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. CONCLUSIONS: Utility 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.

Effectiveness of providing university students with a mindfulness-based intervention to increase resilience to stress: 1-year follow-up of a pragmatic randomised controlled trial.

BACKGROUND: There 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. METHODS: University 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). RESULTS: We 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 (p<0.001). Effects were smaller than during the examination period. No significant differences between arms were detected in the use of University Counselling Service and other support resources, but there was a trend for MSS participants having milder needs. There were no differences in students' workload management; MSS participants made more donations. Home practice had positive dose-response effects; few participants meditated. No adverse effects related to self-harm, suicidality or harm to others were detected. CONCLUSION: Loss 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 NUMBER: ACTRN12615001160527.

Aspirin and cancer survival: a systematic review and meta-analyses of 118 observational studies of aspirin and 18 cancers.

BACKGROUND: Despite 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. AIMS: In 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. RESULTS: Three 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. CONCLUSIONS: There 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.

Interventions to reduce social isolation and loneliness during COVID-19 physical distancing measures: A rapid systematic review.

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.

Establishing a Theory-Based Multi-Level Approach for Primary Prevention of Mental Disorders in Young People.

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.