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.

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.

Do mindfulness-based programmes improve the cognitive skills, behaviour and mental health of children and adolescents? An updated meta-analysis of randomised controlled trials.

QUESTION: Mindfulness-based programmes (MBPs) are an increasingly popular approach to improving mental health in young people. Our previous meta-analysis suggested that MBPs show promising effectiveness, but highlighted a lack of high-quality, adequately powered randomised controlled trials (RCTs). This updated meta-analysis assesses the-state-of the-art of MBPs for young people in light of new studies. It explores MBP's effectiveness in active vs passive controls; selective versus universal interventions; and studies that included follow-up. STUDY SELECTION AND ANALYSIS: We searched for published and unpublished RCTs of MBPs with young people (<19 years) in PubMed Central, PsycINFO, Web of Science, EMBASE, ICTRP, ClinicalTrials.gov, EThOS, EBSCO and Google Scholar. Random-effects meta-analyses were conducted, and standardised mean differences (Cohen's d) were calculated. FINDINGS: Sixty-six RCTs, involving 20 138 participants (9552 receiving an MBP and 10 586 controls), were identified. Compared with passive controls, MBPs were effective in improving anxiety/stress, attention, executive functioning, and negative and social behaviour (d from 0.12 to 0.35). Compared against active controls, MBPs were more effective in reducing anxiety/stress and improving mindfulness (d=0.11 and 0.24, respectively). In studies with a follow-up, there were no significant positive effects of MBPs. No consistent pattern favoured MBPs as a universal versus selective intervention. CONCLUSIONS: The enthusiasm for MBPs in youth has arguably run ahead of the evidence. While MBPs show promising results for some outcomes, in general, the evidence is of low quality and inconclusive. We discuss a conceptual model and the theory-driven innovation required to realise the potential of MBPs in supporting youth mental health.

The impact of mindfulness training in early adolescence on affective executive control, and on later mental health during the COVID-19 pandemic: a randomised controlled trial.

BACKGROUND: Previous research suggests that mindfulness training (MT) appears effective at improving mental health in young people. MT is proposed to work through improving executive control in affectively laden contexts. However, it is unclear whether MT improves such control in young people. MT appears to mitigate mental health difficulties during periods of stress, but any mitigating effects against COVID-related difficulties remain unexamined. OBJECTIVE: To evaluate whether MT (intervention) versus psychoeducation (Psy-Ed; control), implemented in after-school classes: (1) Improves affective executive control; and/or (2) Mitigates negative mental health impacts from the COVID-19 pandemic. METHODS: A parallel randomised controlled trial (RCT) was conducted (Registration: https://osf.io/d6y9q/; Funding: Wellcome (WT104908/Z/14/Z, WT107496/Z/15/Z)). 460 students aged 11-16 years were recruited and randomised 1:1 to either MT (N=235) or Psy-Ed (N=225) and assessed preintervention and postintervention on experimental tasks and self-report inventories of affective executive control. The RCT was then extended to evaluate protective functions of MT on mental health assessed after the first UK COVID-19 lockdown. FINDINGS: Results provided no evidence that the version of MT used here improved affective executive control after training or mitigated negative consequences on mental health of the COVID-19 pandemic relative to Psy-Ed. No adverse events were reported. CONCLUSIONS: There is no evidence that MT improves affective control or downstream mental health of young people during stressful periods. CLINICAL IMPLICATIONS: We need to identify interventions that can enhance affective control and thereby young people's mental health.

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.

Protocol for a randomised controlled trial investigating an intervention to boost decentering in response to distressing mental experiences during adolescence: the decentering in adolescence study (DECADES).

INTRODUCTION: Decentering describes the ability to voluntarily adopt an objective self-perspective from which to notice internal, typically distressing, stressors (eg, difficult thoughts, memories and feelings). The reinforcement of this skill may be an active ingredient through which different psychological interventions accrue reductions in anxiety and/or depression. However, it is unclear if decentering can be selectively trained at a young age and if this might reduce psychological distress. The aim of the current trial is to address this research gap. METHODS AND ANALYSIS: Adolescents, recruited from schools in the UK and Ireland (n=57 per group, age range=16-19 years), will be randomised to complete 5 weeks of decentering training, or an active control group that will take part in a combination of light physical exercise and cognitive training. The coprimary training outcomes include a self-reported decentering inventory (ie, the Experiences Questionnaire) and the momentary use of decentering in response to psychological stressors, using experience sampling. The secondary mental health outcomes will include self-reported inventories of depression and anxiety symptoms, as well as psychological well-being. Initial statistical analysis will use between-group analysis of covariance to estimate the effect of training condition on self-rated inventories, adjusted for baseline scores. Additionally, experience sampling data will be examined using hierarchical linear models. ETHICS AND DISSEMINATION: This study was approved by the Cambridge Psychology Research Ethics Committee, University of Cambridge (PRE.2019.109). Findings will be disseminated through typical academic routes including poster/paper presentations at (inter)national conferences, academic institutes and through publication in peer-reviewed journals. TRIAL REGISTRATION NUMBER: ISRCTN14329613.

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.

Evaluating the CYP-IAPT transformation of child and adolescent mental health services in Cambridgeshire, UK: a qualitative implementation study.

BACKGROUND: The Children and Young People's Improving Access to Psychological Therapies (CYP-IAPT) programme was introduced to transform Child and Adolescent Mental Health Services (CAMHS) across England. The programme comprised a set of principles that local CAMHS partnerships were expected to operationalise and embed with the aim of increasing access to services and improving the quality of care. This study explored how the implementation of the CYP-IAPT programme was executed and experienced by CAMHS professionals in the county of Cambridgeshire (UK), and the extent to which the CYP-IAPT principles were perceived to be successfully embedded into everyday practice. METHODS: We analysed 275 documents relating to the CYP-IAPT programme issued between 2011 and 2015. We also conducted a thematic analysis of 20 qualitative interviews, undertaken at two time points, with professionals from three CAMHS teams in Cambridgeshire. Analysis was informed by implementation science frameworks. RESULTS: Document analysis suggested that the CYP-IAPT programme was initially not clearly defined and lacked guidance on how to operationalise key programme principles and apply them in everyday practice. There was also a degree of programme evolution over time, which made it difficult for local stakeholders to understand the scope and aims of CYP-IAPT. Interviews with staff showed low coherent understanding of the programme, variable levels of investment among stakeholders and difficulties in collaborative working. Barriers and facilitators to programme implementation were identified at individual, service and strategic levels. These in turn impacted the local implementation efforts and sustainability of the programme in Cambridgeshire. CONCLUSIONS: We identified factors relating to programme design and national and local implementation planning, as well as features of inner and outer context, which impacted on the delivery and sustainability of the programme. These findings can be drawn upon to inform the development and delivery of other local and national quality improvement (QI) initiatives relating to children and young people's mental health.

Advancing methodology for scoping reviews: recommendations arising from a scoping literature review (SLR) to inform transformation of Children and Adolescent Mental Health Services.

BACKGROUND: There is consensus that health services commissioning and clinical practice should be driven by scientific evidence. However, workload pressures, accessibility of peer reviewed publications and skills to find, appraise, and synthesise relevant evidence are often cited as barriers to uptake of research evidence by practitioners and commissioners alike. In recent years a growing requirement for rapid evidence synthesis to inform commissioning decisions about healthcare service delivery and provision of care contributed to an increasing popularity of scoping literature reviews (SLRs). Yet, comprehensive guidelines for conducting and reporting SLRs are still relatively scarce. METHODS: The exemplar review used as a worked example aimed to provide a readily available, comprehensive, and user-friendly repository of research evidence for local commissioners to help them make evidence-informed decisions about redesigning East of England Children and Adolescent Mental Health Services. In conducting the review, we were broadly guided by Arksey and O'Malley's framework, however some modifications were made at different stages to better reflect the largely pragmatic objective of this review. This paper compares the methodology used with existing methodological frameworks for scoping studies, to add to the existing knowledge base. RESULTS: We proposed the following advancements to the existing SLR frameworks: (i) Assemble a research team with complementary skills and expertise; (ii); Draw on expertise of external partners, particularly practitioners, decision-makers and commissioners who will be translating findings into practice; (iii) Pre-register the review protocol. Keep a detailed record of all steps and decisions and consider how they would impact on generalisability and utility of review findings; (iv) Use systematic procedures for literature searchers, selection of studies, data extraction and analysis; (v) If feasible, appraise the quality of included evidence; (vi) Be transparent about limitations of findings. CONCLUSIONS: Despite some methodological limitations, scoping literature reviews are a useful method of rapidly synthesising a large body of evidence to inform commissioning and transformation of CAMHS. SLRs allow researchers to start with a broader questions, to explore the issue from different perspectives and perhaps find more comprehensive solutions that are not only effective, but also accounted for their feasibility and acceptability to key stakeholders.

Immune dysregulation among students exposed to exam stress and its mitigation by mindfulness training: findings from an exploratory randomised trial.

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.

Delphi study to identify key features of community-based child and adolescent mental health services in the East of England.

OBJECTIVE: To identify priorities for the delivery of community-based Child and Adolescent Mental health Services (CAMHS). DESIGN: (1) Qualitative methods to gather public and professional opinions regarding the key principles and components of effective service delivery. (2) Two-round, two-panel adapted Delphi study. The Delphi method was adapted so professionals received additional feedback about the public panel scores. Descriptive statistics were computed. Items rated 8-10 on a scale of importance by ≥80% of both panels were identified as shared priorities. SETTING: Eastern region of England. PARTICIPANTS: (1) 53 members of the public; 95 professionals from the children's workforce. (2) Two panels. Public panel: round 1,n=23; round 2,n=16. Professional panel: round 1,n=44; round 2,n=33. RESULTS: 51 items met the criterion for between group consensus. Thematic grouping of these items revealed three key findings: the perceived importance of schools in mental health promotion and prevention of mental illness; an emphasis on how specialist mental health services are delivered rather than what is delivered (ie, specific treatments/programmes), and the need to monitor and evaluate service impact against shared outcomes that reflect well-being and function, in addition to the mere absence of mental health symptoms or disorders. CONCLUSIONS: Areas of consensus represent shared priorities for service provision in the East of England. These findings help to operationalise high level plans for service transformation in line with the goals and needs of those using and working in the local system and may be particularly useful for identifying gaps in ongoing transformation efforts. More broadly, the method used here offers a blueprint that could be replicated by other areas to support the ongoing transformation of CAMHS.

A mindfulness-based intervention to increase resilience to stress in university students (the Mindful Student Study): a pragmatic randomised controlled trial.

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 (ß -0·44, 95% CI -0·60 to -0·29; p<0·0001). 123 (57%) of 214 participants in the support as usual group had distress scores above an accepted clinical threshold compared with 88 (37%) of 235 participants in the MSS group. On average, six students (95% CI four to ten) needed to be offered the MSS course to prevent one from experiencing clinical levels of distress. No participants had adverse reactions related to self-harm, suicidality, or harm to others. INTERPRETATION: Our findings show that provision of mindfulness training could be an effective component of a wider student mental health strategy. Further comparative effectiveness research with inclusion of controls for non-specific effects is needed to define a range of additional, effective interventions to increase resilience to stress in university students. FUNDING: University of Cambridge and National Institute for Health Research Collaboration for Leadership in Applied Health Research and Care East of England.

Protocol for the Mindful Student Study: a randomised controlled trial of the provision of a mindfulness intervention to support university students' well-being and resilience to stress.

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; pre-results.

Values and helping behavior: A study in four cultures.

Values are important factors in determining individuals' behaviours. Previous studies have examined the relations between values and helping behaviour, but usually in the context of a single culture. The current study examines the relations between personal value types and helping behaviour among university students (N = 722) in four cultures (Germany, Scotland-UK, Israel and Turkey). Across cultures, the value types of self-transcendence versus self-enhancement and conservation versus openness to change were positively related to helping. Specifically, self-transcendence values were positively related, and self-enhancement and openness to change values negatively related, to helping behaviour. The correlations pattern did not differ significantly between cultures.