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Background Resilience Hubs provide mental health screening, facilitation of access and direct provision of psychosocial support for health and social care keyworkers in England affected by the coronavirus disease 2019 pandemic. Aim To explore implementation of the Hubs, including characteristics of staff using the services, support accessed, costing data and a range of stakeholder perspectives on the barriers and enablers to Hub use and implementation of staff well-being support within the context of the pandemic. Design Mixed-methods evaluation. Setting Four Resilience Hubs. Methods Findings were integrated via mixed-method case studies, including: analyses of Hub mental health screening (N = 1973); follow-up questionnaire data (N = 299) on service use and health status of Hub clients; economic information provided by the Hubs; 63 interviews with Hub staff, wider stakeholders, Hub clients and keyworkers who did not use the Hubs. Results Findings were consistent across Hubs and workstreams. Most Hub clients were NHS staff. Under-represented groups included men, keyworkers from minority ethnic communities, care homes and emergency services staff. Clients reported comorbid mental health needs across multiple domains (anxiety; depression; post-traumatic stress; alcohol use; functioning). Their health status was lower than population norms and relevant pre-pandemic data. Several factors predicted higher needs, but having pre-pandemic emotional well-being concerns was one of the most robust predictors of higher need. Sixty per cent of participants who completed follow-up questionnaires reported receiving mental health support since Hub screening, most of which was directly or indirectly due to Hub support. High levels of satisfaction were reported. As in many services, staffing was the central component of Hub cost. Hubs were predominantly staffed by senior clinicians; this staffing model was consistent with the generally severe difficulties experienced by clients and the need for systemic/team-based working. Costs associated with health and social care use for Hub clients were low, which may be due to barriers to accessing support in general. Enablers to accessing Hubs included: a clear understanding of the Hubs, how to self-refer, and managerial support. Barriers included confusion between Hubs and other support; unhelpful beliefs about job roles, unsupportive managers, negative workplace cultures and difficulties caused by systemic issues. Some keyworkers highlighted a perceived need for further diversity and cultural competency training to improve reach to under-represented communities. Other barriers for these groups included prior negative experiences of services, structural inequalities and stigma. Some wider stakeholders had concerns around growing waiting times for Hub-provided therapy, and insufficient data on Hub usage and outcomes. Feedback was otherwise very positive. Limitations Main limitations included lack of comparative and pre-pandemic/baseline data, small numbers from under-represented groups limiting fine-grained analysis, and participant self-selection. Conclusions Findings highlighted the value of the Hub model of outreach, screening, support navigation and provision of direct support during the coronavirus disease 2019 pandemic, and as a potential model to respond to future crises. The research provided recommendations to improve Hub promotion, equality/diversity/inclusion access issues, management of specialist resources and collection of relevant data on Hub outcomes and activities. Broader recommendations for the primary prevention of mental health difficulties across the health and care system are made, as individual support offers should be an adjunct to, not a replacement for, resolutions to systemic challenges. Research recommendations are made to conduct more robust evaluations of the clinical and cost-effectiveness of the Hubs, using larger data sets and comparative data. Study registration This study is registered as researchregistry6303. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme (NIHR award ref: NIHR132269) and is published in full in Health and Social Care Delivery Research; Vol. 12, No. 29. See the NIHR Funding and Awards website for further award information. Plain language summary Many health and social care staff struggled with mental health difficulties during the coronavirus disease 2019 pandemic. The study evaluated new National Health Service services (‘Resilience Hubs’) that were set up to help these keyworkers. We worked with four Hubs to: (1) look at who accessed the Hubs and what difficulties they had; (2) ask Hub ‘clients’ which support they used, and how helpful they found the Hubs; (3) look at what resources are needed to run the Hubs, to understand their ‘value for money’; (4) interview people who worked with or used the Hubs (e.g. Hub staff, Hub clients, but also keyworkers who did not use the Hubs) to have their feedback. We used this information to make recommendations for the Hubs and the organisations that work with them. We found that Hub clients were mainly National Health Service staff. Many had several mental health difficulties, including anxiety, depression and post-traumatic stress disorder. Few men, staff from minority ethnic communities, care home workers and emergency service staff used the Hubs. People were generally happy with the support they had from the Hubs; clients who completed a follow-up questionnaire rated the helpfulness of support provided by Hubs as 92 out of 100 on average. Staffing was the main cost, as Hubs were mainly staffed by experienced clinicians. Things that made it easier for people to use the Hubs were clear understandings of Hub support and how to access it, and the support of their managers/employers. Some keyworkers from minority ethnic communities wanted greater diversity in the Hub teams. Some had concerns around waiting times and about not knowing enough about how well these services worked. Feedback was otherwise very positive. Our recommendations included how to: better promote the Hubs; improve inclusion of and support for individuals from minority groups; get better data on how well and for whom they work; and for employers to pay more attention to the mental health and well-being of keyworkers beyond the coronavirus disease 2019 pandemic. Scientific summary Background The Resilience Hub model was developed in Greater Manchester to provide large-scale mental health screening and facilitate access to evidence-based mental health support for those affected by the 2017 Manchester Arena bombing. In response to the coronavirus disease 2019 (COVID-19) pandemic, the approach was adapted to provide mental health screening and facilitation of access to psychosocial support for NHS, social care and emergency response keyworkers affected by the pandemic. Since 2020, the model has been replicated in 40 UK regions. Objectives While over time the offers of the Hubs expanded to include further team-based support (e.g. well-being workshops for teams), the overarching aim of this mixed-method project was to evaluate and provide key recommendations in relation to two central functions of the individual support of the Resilience Hubs that were either already operational or at an advanced stage of set-up in the early phases of the pandemic that is the provision of mental health screening to in-scope keyworkers from NHS, social care, and emergency response services; and the facilitation of access to psychosocial support. Data were collected from four Resilience Hubs in the North of England to address the following objectives: Objective 1: To conduct a quantitative analysis of routine demographic, occupational and mental health screening data, to provide findings to model service demand and guide future adaptations to the Hub approach to suit contextual needs and inform evidence-based commissioning. Objective 2: To conduct a health economic analysis to explore the cost and health benefits associated with the set-up, use and management of Resilience Hubs. Objective 3: To conduct qualitative interviews with multiple stakeholder groups to identify the barriers and enablers to the implementation/scaling of the Hub model. Objective 4: To produce mixed-method case studies, integrating findings from the above qualitative and quantitative components and produce key recommendations. Methods To address Objective 1, we analysed data from routine mental health screening data collected by the Hubs on a combined sample of 1973 Hub clients, and service use data from a subsample of 299 Hub clients who completed a follow-up survey deployed 5–8 months after the completion of the Hub screening. Statistical analyses were conducted to examine the demographic and occupational characteristics of Hub clients, the incidence of clinically significant mental health difficulties in the sample, potential predictors of higher mental health needs, and summarise the level of mental health service access and overall satisfaction following Hub support and advice. To address Objective 2, we (1) analysed costing data provided by the Hub teams to estimate the set-up and ongoing cost of Hub service delivery per keyworker supported; (2) costed health and social care service use data obtained from the abovementioned follow-up survey using nationally published unit costs; (3) calculated EQ-5D values for participants in the follow-up survey using the crosswalk algorithm recommended by the National Institute for Health and Care Excellence at the time of data collection, which were then compared to published population norms and to a pre-pandemic sample of keyworkers. A logic model was also developed to illustrate the potential benefits associated with Hub support. To address Objective 3, we conducted 63 qualitative interviews with key stakeholder groups at three Hubs, including Hub staff (n = 14), Hub clients (n = 19), keyworkers eligible for Hub support but who had not accessed these services (n = 20), wider stakeholders who had involvement in the provision of staff support within the health and care system (e.g. occupational health leads; HR leads; n = 10). Efforts were made to interview keyworkers from under-represented groups (e.g. keyworkers from ethnic minority communities). Topic guides and data analysis were informed by well-established analytic frameworks (normalisation process theory and Sekhon’s Acceptability Framework) to explore the barriers and enablers to implementation of the Resilience Hub model. To address Objective 4, key findings from Objectives 1–3 were integrated via mixed-methods case studies. Hub-level cross-case analyses were used to integrate data at a site level, and subgroup-level cross-case analyses were used to explore low uptake by certain demographic and occupational groups. Data were triangulated across work packages to demonstrate how they supported conclusions. Results Most keyworkers who completed the screening offer of the Hubs were NHS employees (44–87%), identified as women (83–86%), and from a White British background (89–92%). Considerably smaller proportions identified as men (13–16%), members of minority ethnic groups (5–7%), social care staff (4–8%). Likewise, emergency services staff were a smaller group accessing the Hubs (1–12%), although not all emergency services were in scope at all Hubs. Most keyworkers had considerable and often co-occurring mental health needs across all domains assessed (anxiety as assessed by the generalised anxiety disorder 7-item questionnaire; depression, patient health questionnaire 9-item questionnaire; post-traumatic stress, post-traumatic stress disorder checklist for DSM-5 or ITQ; problematic alcohol use, alcohol use disorders identification test; and impaired functioning as assessed by the work and social adjustment scale), with 60% meeting criteria for clinically significant difficulties on at least three different screening measures. Approximately 80% of Hub clients reported clinically significant impairments in functioning. Only 10% of clients had subclinical scores across all measures. Regression analyses to identify candidate predictors of higher mental health need in this sample found that several demographic characteristics (e.g. having a disability; identifying as any sexual orientation excluding heterosexual) were associated with higher likelihood for clinically significant mental health concerns. Several work-related circumstances during the pandemic were associated with higher need on specific mental health domains, including working in intensive care units or emergency care environments, moving to new work locations and undertaking new tasks during the pandemic. Experiencing stressful life circumstances brought about by the pandemic (e.g. being ill or hospitalised with COVID, bereavements during the pandemic) was similarly associated with higher need. The two most consistent predictors of higher need were suffering a household financial loss during the pandemic and having a history of mental health/emotional well-being concerns prior to the pandemic. Service use data for the 299 Hub clients who completed the follow-up survey indicated that most respondents (73%) had some form of contact with Hub staff following screening. Fifty-seven per cent reported receiving some form of mental health support since screening, and 11% were on a waiting list for mental health support. Approximately 75% of respondents accessed support that was provided directly by Hub staff or other services that were first accessed as a result of Hub support and advice. Participants reported high levels of satisfaction with the support they received from the Hubs. The median rating of perceived helpfulness of the support provided by the Hubs was 92 (on a 0–100 scale). A large proportion of participants (46%) reported that the Hubs fully met their needs, with only a small minority reporting that the support provided did not meet their needs (4%). Approximately a third of participants reported they did not require support from services other than the Hubs, either because they received all the support they needed from their local Hub or because no further mental health support was required from the Hubs or other services. A further 28% reported that the Hubs helped them to access other beneficial services. Only 5% of participants reported they did not receive help to access the support they believed they needed. The results of the health economic analyses indicated that set-up and ongoing annual costs were variable across Hubs, depending on design. Staff costs accounted for the majority of ongoing costs. Analysis of service use data demonstrated that mental health support was the greatest contributor to total NHS and social care cost, with a mean cost of £376 [95% confidence interval (CI) £294 to £459] versus a mean cost of £138 (95% CI £73 to £202) for wider health and social care use. Services delivered or accessed as a result of Hub support made up over half of the total health and social care service costs. This demonstrates an important component of service costs resulting from Hub support, in a group with minimal contact from other services. Mental health care costs were associated with the Hub accessed and concerns about mental health prior to the pandemic. Hub clients’ mean EQ-5D value was 0.755 (95% CI 0.731 to 0.779), indicating a lower health status compared with population norms and a pre-pandemic sample of health and social care workers. Being from an ethnic minority group was found to be associated with lower health status, as was having higher need at screening, a disability, a bereavement or having had a COVID-related hospitalisation. An economic evaluation was determined not to be possible with the current evidence base and subsequently conclusions around cost-effectiveness could not be made. Work to inform the logic model to guide future evaluations identified a number of potential benefits associated with Hub support, including improved mental health and well-being, reduced risk of burnout and potential economic benefits not only keyworkers but wider groups (services, colleagues, family members, patients). Qualitative data indicated that Hub staff clearly perceived Hub support as distinct from other forms of staff support, but described some challenges in helping the health and care system to understand the value of Hub support. Wider stakeholders tended to see Hubs as a resource for people with more complex or severe difficulties, a finding that resonates with the quantitative findings above. Keyworkers were more likely to access Hub support when they understood it, differentiated it from other types of support, and felt supported by managers to access it. However, some keyworkers felt overwhelmed by different support offers during the pandemic, creating confusion about how the Hubs could support them. Some keyworkers had wider concerns around accessing mental health support (e.g. beliefs about needing to be strong due to their job role; not wanting to take up a resource from which others may have benefitted more). Other barriers included perceptions that employers did not genuinely support help-seeking, negative workplace culture and wider systemic issues that were perceived as the cause of distress. Some keyworkers who specifically wanted support around the impact of racism and discrimination felt that diverse staff representation within Hub clinical was lacking, which was also acknowledged by some Hub staff. Other barriers for these groups included previous negative experiences of health and social care services, structural inequalities and community stigma. Wider stakeholders shared some concerns around growing waiting times for Hub-provided therapy, and insufficient data on Hub usage and outcomes being presented back to the system. With the exception of the above concerns, appraisal of the Hubs was very positive. The responsiveness of the Hubs to local needs was strongly valued by all groups interviewed. Participants felt that the Hubs should continue to evolve according to local and national needs, including the continuation of staff support, and response to traumatic incidents. Hub-level integration of data revealed that findings were consistent across the Hubs, despite differences in model implementation. The finding that most keyworkers accessing the Hubs had clinically significant mental health difficulties is potentially explained by the fact that wider stakeholders viewed the Hubs as resource for keyworkers with more severe or complex mental health difficulties, and that keyworkers typically waited until things were very difficult before seeking support. The demographic and occupational groups accessing services were broadly consistent. Low uptake from keyworkers from minority ethnic groups may be explained by interview findings, whereby some participants described wanting Hub teams to have greater diversity, cultural competency training and experience in supporting people with the impact of racism. Service use data demonstrated that some keyworkers from these communities accessed alternative sources of support, such as faith organisations. Data from other under-represented groups were limited, however stigma was identified frequently as a barrier for keyworkers identifying as men. Wider stakeholders suggested that low uptake of care home staff may have been a consequence of less formalised routes of occupational support, leading to a different culture of help-seeking, which could add to other practical barriers that may not have been experienced within the NHS (e.g. less flexibility of shifts to attend appointments). Interview findings suggested that shift work may also have affected low uptake from emergency services staff. Other barriers for emergency staff included beliefs around job role, such as keyworkers feeling that they should be able to handle stressful or traumatic experiences as a routine part of their job. Keyworkers also described wanting support from someone who understood their job, and so reported often seeking support through work. Conclusions The research demonstrates a need for ongoing mental health and well-being support for health and care staff beyond the pandemic, and highlighted the value of the Hub model of outreach, screening, support navigation and provision of direct support. The model has been shown to be sufficiently adaptable to different contexts (e.g. a new target population; different regional settings), and as a potential system to be repurposed for future response to other large-scale crises. Key recommendations for the Hubs include the continued provision of outreach, mental health screening and direct and indirect support to keyworkers; implementation of suggested strategies to maximise Hub promotion; actions to address equality, diversity and inclusion access issues and guide the strategic allocation of the Hubs’ specialist resources and team-based support; and information flow between Hubs and partner organisations. Broader recommendations for the primary prevention of mental health difficulties across the health and care system are made, as individual and reactive support offers should be an adjunct to, not a replacement for, resolutions to systemic challenges that might underpin or exacerbate the well-being difficulties of the health and social care workforce. Recommendations for future research and evaluation of the Hub approach include larger-scale national service mapping exercises of Hub services (to better understand differentiation in how Hub offers and key functions are operationalised across the country), the standardisation and generation of routine screening and outcome data across Hubs for evaluation purposes, and more robust clinical and cost-effectiveness evaluations of the Resilience Hubs using comparative data in the context of natural experiment studies. Study registration This study is registered as researchregistry6303. Funding This award was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme (NIHR award ref: NIHR132269) and is published in full in Health and Social Care Delivery Research; Vol. 12, No. 29. See the NIHR Funding and Awards website for further award information.

Abstract Background NHS England funded 40 Mental Health and Wellbeing Hubs to support health and social care staff affected by the COVID-19 pandemic. We aimed to document variations in how national guidance was adapted to the local contexts of four Hubs in the North of England. Methods We used a modified version of Price’s (2019) service mapping methodology. Service level data were used to inform the analysis. A mapping template was adapted from a range of tools, including the European Service Mapping Schedule, and reviewed by Hub leads. Key data included service model; staffing; and interventions. Data were collected between March 2021 – March 2022 by site research assistants. Findings were accuracy-checked by Hub leads, and a logic model developed to theorise how the Hubs may effect change. Results Hub goals and service models closely reflected guidance; offering: proactive outreach; team-based support; clinical assessment; onward referral, and rapid access to mental health support (in-house and external). Implementation reflected a service context of a client group with high mental health need, and high waiting times at external mental health services. Hubs were predominantly staffed by experienced clinicians, to manage these mental health presentations and organisational working. Formulation-based psychological assessment and the provision of direct therapy were not core functions of the NHS England model, however all Hubs incorporated these adaptations into their service models in response to local contexts, such as extensive waiting lists within external services, and/or client presentations falling between gaps in existing service provision. Finally, a standalone clinical records system was seen as important to reassure Hub users of confidentiality. Other more nuanced variation depended on localised contexts. Conclusion This study provides a map for setting up services, emphasising early understandings of how new services will integrate within existing systems. Local and regional contexts led to variation in service configuration. Whilst additional Hub functions are supported by available literature, further research is needed to determine whether these functions should comprise essential components of staff wellbeing services moving forward. Future research should also determine the comparative effectiveness of service components, and the limits of permissible variation. Study registration researchregistry6303.

ABSTRACT Introduction Oral diseases are more prevalent in people with severe mental illness (SMI) compared to those without mental illnees. A greater focus on oral health is needed to reverse unacceptable but often neglected oral health inequality in people with SMI. This provided the impetus for developing ‘The Right to Smile’ consensus statement. We aimed to develop and disseminate a consensus statement to address oral health inequality, highlighting the main areas for concern and recommending an evidence‐based 5‐year action plan to improve oral health in people with SMI. Methods The Right to Smile consensus statement was developed by experts from several professional disciplines and practice settings (mental, dental and public health) and people with lived experience, including carers. Stakeholders participated in a series of online workshops to develop a rights‐based consensus statement. Subsequent dissemination activities were conducted to maximise its reach and impact. Results The consensus statement was developed to focus on how oral health inequalities could be addressed through a set of 5‐year improvement targets for practice, policy and training. The consensus was reached on three 5‐year action plans: ‘Any assessment of physical health in people experiencing SMI must include consideration of oral health’, ‘Access to dental services for people with SMI needs to improve’ and ‘The importance of oral health for people experiencing SMI should be recognised in healthcare training, systems, and structures’. Conclusion This consensus statement urges researchers, services and policymakers to embrace a 5‐year action plan to improve oral health for people with SMI. Patient or Public Contribution The team included people with lived experience of SMI, their carers/family members and mental and dental health service providers. They were involved in every stage of developing the consensus statement, from conception to development and dissemination.

Abstract Background People with severe mental illness (e.g. psychosis, bipolar disorder) experience poor oral health compared to the general population as shown by more decayed, missing and filled teeth and a higher prevalence of periodontal disease. Attending dental services allows treatment of oral health problems and support for prevention. However, people with severe mental illness face multiple barriers to attending routine dental appointments and often struggle to access care. Link work interventions use non-clinical support staff to afford vulnerable populations the capacity, opportunity, and motivation to navigate use of services. The authors have co-developed with service users a link work intervention for supporting people with severe mental illness to access routine dental appointments. The Mouth Matters in Mental Health Study aims to explore the feasibility and acceptability of this intervention within the context of a feasibility randomised controlled trial (RCT) measuring outcomes related to the recruitment of participants, completion of assessments, and adherence to the intervention. The trial will closely monitor the safety of the intervention and trial procedures. Methods A feasibility RCT with 1:1 allocation to two arms: treatment as usual (control) or treatment as usual plus a link work intervention (treatment). The intervention consists of six sessions with a link worker over 9 months. Participants will be adults with severe mental illness receiving clinical input from secondary care mental health service and who have not attended a planned dental appointment in the past 3 years. Assessments will take place at baseline and after 9 months. The target recruitment total is 84 participants from across three NHS Trusts. A subset of participants and key stakeholders will complete qualitative interviews to explore the acceptability of the intervention and trial procedures. Discussion The link work intervention aims to improve dental access and reduce oral health inequalities in people with severe mental illness. There is a dearth of research relating to interventions that attempt to improve oral health outcomes in people with mental illness and the collected feasibility data will offer insights into this important area. Trial registration The trial was preregistered on ISRCTN (ISRCTN13650779) and ClinicalTrials.gov (NCT05545228).

BackgroundPsychotic disorders are severe and prevalent mental health conditions associated with long-term disability, reduced quality of life, and substantial economic costs. Early Intervention in Psychosis (EIP) services aim to provide timely and comprehensive treatment for psychotic disorders, and EIP service input is associated with improved outcomes. However, there is limited understanding of the specific components of EIP care that contribute to these improvements. There is significant nationwide variability in the commissioning and delivery of EIP, with individuals receiving different packages of components from different services. In this study, we seek to explore associations between EIP components and clinically significant outcomes, in order to understand the mechanisms underlying improved psychosis care.MethodsThis national retrospective cohort study will utilize data from the 2019 National Clinical Audit of Psychosis (NCAP), examining the care received by 10,560 individuals treated by EIP services in England. Exposure data from the NCAP, capturing the components of care delivered by EIP services, will be linked with outcome data from routine NHS Digital datasets over a three-year follow-up period. This will be the first study to use this method to examine this population in England. The primary outcomes will be surrogate measures of relapse of psychosis (hospital admission and referral to community-based crisis intervention services). Secondary outcomes include duration of admissions, emergency hospital attendances, episodes of detention under the Mental Health Act, and all-cause mortality. We will use multilevel regression to examine associations between exposures and outcome events. We will handle missing data using appropriate imputation techniques.DiscussionThis study aims to provide valuable insights into the long-term effects of variations in EIP service delivery. The study involves a large, diverse cohort including individuals treated by every EIP service in England. While there are limitations inherent in the observational nature of the study, any associations identified will be of great relevance to clinicians, researchers, and policymakers seeking to optimize EIP care. The results will enable more targeted treatment planning, resource allocation, and potential innovations in EIP care, ultimately leading to improved prognoses for people experiencing psychosis.

Background The components of care delivered by Early Intervention in Psychosis (EIP) services vary, but the impact on patient experience is unknown.Objective To investigate associations between components of care provided by EIP services in England and patient-reported outcomes.Methods 2374 patients from EIP services in England were surveyed during the National Clinical Audit of Psychosis. Participants were asked about the care they received, and completed the ‘Patient Global Impressions’ Scale (rating whether their mental health had improved), and ‘Friends and Family Test’ (rating whether they would recommend their service). Information about service structure was obtained from service providers. We analysed associations between outcomes and components of care using multilevel regression.Findings The majority of participants were likely to recommend the treatment they had received (89.8%), and felt that their mental health had improved (89.0%). Participants from services where care coordinators had larger case loads were less likely to recommend their care. Participants were more likely to recommend their care if they had been offered cognitive behavioural therapy for psychosis, family therapy or targeted interventions for carers. Participants were more likely to report that their mental health had improved if they had been offered cognitive behavioural therapy for psychosis or targeted interventions for carers.Conclusions Specific components of EIP care were associated with improved patient reported outcomes. Psychosocial interventions and carer support may be particularly important in optimising outcomes for patients.Clinical implications These findings emphasise the need for small case load sizes and comprehensive packages of treatment in EIP services.

Background Terrorist incidents lead to a range of mental health outcomes for people affected, sometimes extending years after the event. Secondary stressors can exacerbate them, and social support can provide mitigation and aid recovery. There is a need to better understand distress and mitigating factors among survivors of the Manchester Arena attack in 2017. Aims We explored three questions. First, what experiences of distress did participants report? Second, how might secondary stressors have influenced participants’ psychosocial recoveries? Third, what part has social support played in the relationships between distress and participants’ recovery trajectories? Method We conducted a cross-sectional online survey of a convenience sample of survivors of the Manchester Arena bombing (N = 84) in January 2021 (3 years 8 months post-incident), and a longitudinal study of the same participants’ scores on mental health measures over 3 years from September 2017. Results Survivors’ mental well-being scores in early 2021 were significantly lower than general population norms. Longitudinal follow-up provided evidence of enduring distress. Secondary stressors, specifically disruptions to close relationships, were associated with greater post-event distress and slower recovery. We found an indirect relationship between identifying with, and receiving support from, others present at the event and mental well-being >3 years later. Conclusions The Arena attack has had an enduring impact on mental health, even in survivors who had a mild response to the event. The quality of close relationships is pivotal to long-term outcome. Constructive support from family and friends, and people with shared experiences, are key to social cure processes that facilitate coping and recovery.

Objectives Evaluate the implementation of Hubs providing access to psychological support for health and social care keyworkers affected by the COVID-19 pandemic.Design Qualitative interviews informed by normalisation process theory to understand how the Hub model became embedded into normal practice, and factors that disrupted normalisation of this approach.Setting Three Resilience Hubs in the North of England.Participants Hub staff, keyworkers who accessed Hub support (Hub clients), keyworkers who had not accessed a Hub, and wider stakeholders involved in the provision of staff support within the health and care system (N=63).Results Hubs were generally seen as an effective way of supporting keyworkers, and Hub clients typically described very positive experiences. Flexibility and adaptability to local needs were strongly valued. Keyworkers accessed support when they understood the offer, valuing a confidential service that was separate from their organisation. Confusion about how Hubs differed from other support prevented some from enrolling. Beliefs about job roles, unsupportive managers, negative workplace cultures and systemic issues prevented keyworkers from valuing mental health support. Lack of support from managers discouraged keyworker engagement with Hubs. Black, Asian and minority ethnic keyworkers impacted by racism felt that the Hubs did not always meet their needs.Conclusions Hubs were seen as a valuable, responsive and distinct part of the health and care system. Findings highlight the importance of improving promotion and accessibility of Hubs, and continuation of confidential Hub support. Policy implications for the wider health and care sector include the central importance of genuine promotion of and value placed on mental health support by health and social care management, and the creation of psychologically safe work environments. Diversity and cultural competency training is needed to better reach under-represented communities. Findings are consistent with the international literature, therefore, likely to have applicability outside of the current context.

Abstract Background Early Intervention in Psychosis (EIP) services improve health outcomes for young people with psychosis in the medium–long term, but 25% of young people disengage in the first 12 months with costs to their mental health, families, society and the NHS. This study will evaluate the effectiveness, cost-effectiveness and implementation of a team-based motivational Early Youth Engagement (EYE-2) intervention. Method The study design is a cluster randomised controlled trial (RCT) with economic evaluation, comparing the EYE-2 intervention + standardised EIP service to standardised EIP service alone, with randomisation at the team level. A process evaluation will evaluate the delivery of the intervention qualitatively and quantitatively across contexts. The setting is 20 EIP teams in 5 sites: Manchester, South London, East Anglia, Thames Valley and Hampshire. Participants are young people (14–35 years) with first episode psychosis, and EIP staff. The intervention is the team-based motivational engagement (EYE-2) intervention, delivered alongside standardised EIP services, and supported by additional training, website, booklets and social groups. The comparator is the standardised EIP service. Both interventions are delivered by EIP clinicians. The primary outcome is time to disengagement (time in days from date of allocation to care coordinator to date of last contact following refusal to engage with EIP service, or lack of response to EIP contact for a consecutive 3-month period). Secondary outcomes include mental and physical health, deaths, social and occupational function, recovery, satisfaction and service use at 6, 12, 18 and 24 months. A 12-month within-trial economic evaluation will investigate cost-effectiveness from a societal perspective and from an NHS perspective. Discussion The trial will provide the first test of an engagement intervention in standardised care, with the potential for significant impact on the mental health and wellbeing of young people and their families, and economic benefits for services. The intervention will be highly scalable, supported by the toolkit including manuals, commissioning guide, training and resources, adapted to meet the needs of the diverse EIP population, and based on an in-depth process evaluation. Trial registration ISRCTN 51629746 prospectively registered 7th May 2019. Date assigned 10th May 2019.

Abstract Background A 2017 terrorist attack in Manchester, UK, affected large numbers of adults and young people. During the response phase (first seven weeks), a multi-sector collaborative co-ordinated a decentralised response. In the subsequent recovery phase they implemented a centralised assertive outreach programme, ‘The Resilience Hub’, to screen and refer those affected. We present a process evaluation conducted after 1 year. Methods Case study, involving a logic modelling approach, aggregate routine data, and semi-structured interviews topic guides based on the Inter-Agency Collaboration Framework and May’s Normalisation Process Theory. Leaders from health, education and voluntary sectors (n = 21) and frontline Resilience Hub workers (n = 6) were sampled for maximum variation or theoretically, then consented and interviewed. Framework analysis of transcripts was undertaken by two researchers. Results Devolved government, a collaborative culture, and existing clinical networks meant that, in the response phase, a collaboration was quickly established between health and education. All but one leader evaluated the response positively, although they were not involved in pre-disaster statutory planning. However, despite overwhelming positive feedback there were clear difficulties. (1) Some voluntary sector colleagues felt that it took some time for them to be involved. (2) Other VCSE organisations were accused of inappropriate, harmful use of early intervention. (3) The health sector were accused of overlooking those below the threshold for clinical treatment. (4) There was a perception that there were barriers to information sharing across organisations, which was particularly evident in relation to attempts to outreach to first responders and other professionals who may have been affected by the incident. (5) Hub workers encountered barriers to referring people who live outside of Greater Manchester. After 1 year of the recovery phase, 877 children and young people and 2375 adults had completed screening via the Resilience Hub, 79% of whom lived outside Greater Manchester. Conclusions The psychosocial response to terrorist attacks and other contingencies should be planned and practiced before the event, including reviews of communications, protocols, data sharing procedures and workforce capacity. Further research is needed to understand how the health and voluntary sectors can best collaborate in the wake of future incidents.

Background: Relapse is a major determinant of outcome for people with a diagnosis of schizophrenia. Early warning signs frequently precede relapse. A recent Cochrane Review found low-quality evidence to suggest a positive effect of early warning signs interventions on hospitalisation and relapse. Objective: How feasible is a study to investigate the clinical effectiveness and cost-effectiveness of a digital intervention to recognise and promptly manage early warning signs of relapse in schizophrenia with the aim of preventing relapse? Design: A multicentre, two-arm, parallel-group cluster randomised controlled trial involving eight community mental health services, with 12-month follow-up. Settings: Glasgow, UK, and Melbourne, Australia. Participants: Service users were aged > 16 years and had a schizophrenia spectrum disorder with evidence of a relapse within the previous 2 years. Carers were eligible for inclusion if they were nominated by an eligible service user. Interventions: The Early signs Monitoring to Prevent relapse in psychosis and prOmote Wellbeing, Engagement, and Recovery (EMPOWER) intervention was designed to enable participants to monitor changes in their well-being daily using a mobile phone, blended with peer support. Clinical triage of changes in well-being that were suggestive of early signs of relapse was enabled through an algorithm that triggered a check-in prompt that informed a relapse prevention pathway, if warranted. Main outcome measures: The main outcomes were feasibility of the trial and feasibility, acceptability and usability of the intervention, as well as safety and performance. Candidate co-primary outcomes were relapse and fear of relapse. Results: We recruited 86 service users, of whom 73 were randomised (42 to EMPOWER and 31 to treatment as usual). Primary outcome data were collected for 84% of participants at 12 months. Feasibility data for people using the smartphone application (app) suggested that the app was easy to use and had a positive impact on motivations and intentions in relation to mental health. Actual app usage was high, with 91% of users who completed the baseline period meeting our a priori criterion of acceptable engagement (> 33%). The median time to discontinuation of > 33% app usage was 32 weeks (95% confidence interval 14 weeks to ∞). There were 8 out of 33 (24%) relapses in the EMPOWER arm and 13 out of 28 (46%) in the treatment-as-usual arm. Fewer participants in the EMPOWER arm had a relapse (relative risk 0.50, 95% confidence interval 0.26 to 0.98), and time to first relapse (hazard ratio 0.32, 95% confidence interval 0.14 to 0.74) was longer in the EMPOWER arm than in the treatment-as-usual group. At 12 months, EMPOWER participants were less fearful of having a relapse than those in the treatment-as-usual arm (mean difference –4.29, 95% confidence interval –7.29 to –1.28). EMPOWER was more costly and more effective, resulting in an incremental cost-effectiveness ratio of £3041. This incremental cost-effectiveness ratio would be considered cost-effective when using the National Institute for Health and Care Excellence threshold of £20,000 per quality-adjusted life-year gained. Limitations: This was a feasibility study and the outcomes detected cannot be taken as evidence of efficacy or effectiveness. Conclusions: A trial of digital technology to monitor early warning signs that blended with peer support and clinical triage to detect and prevent relapse is feasible. Future work: A main trial with a sample size of 500 (assuming 90% power and 20% dropout) would detect a clinically meaningful reduction in relapse (relative risk 0.7) and improvement in other variables (effect sizes 0.3–0.4). Trial registration: This trial is registered as ISRCTN99559262. Funding: This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 26, No. 27. See the NIHR Journals Library website for further project information. Funding in Australia was provided by the National Health and Medical Research Council (APP1095879).

Background Distress after major incidents is widespread among survivors. The great majority do not meet the criteria for mental health disorders and rely on psychosocial care provided by their informal networks and official response services. There is a need to better understand their experiences of distress and psychosocial care needs. Aims The aims of our study were to enhance understanding of the experience of distress among people present at the Manchester Arena bombing in 2017, identify their experiences of psychosocial care after the incident and learn how to better deliver and target effective psychosocial care following major incidents. Method We conducted a thematic analysis of semi-structured interviews with 18 physically non-injured survivors of the Manchester Arena attack, who registered with the NHS Manchester Resilience Hub. Results Distress was ubiquitous, with long-lasting health and social consequences. Initial reluctance to seek help from services was also common. Early and open access to authoritative sources of information and emotional support, and organised events for survivors, were viewed as helpful interventions. Inappropriate forms of psychosocial and mental healthcare were common and potent stressors that affected coping and recovery. Conclusions This paper extends our understanding of how people react to major events. Provision for the large group of people who are distressed and require psychosocial care may be inadequate after many incidents. There is a substantial agenda for developing awareness of people's needs for psychosocial interventions, and training practitioners to deliver them. The findings have substantial implications for policy and service design.

Background: Young people with social disability and non-psychotic severe and complex mental health problems are an important group. Without intervention, their social problems can persist and have large economic and personal costs. Thus, more effective evidence-based interventions are needed. Social recovery therapy is an individual therapy incorporating cognitive–behavioural techniques to increase structured activity as guided by the participant’s goals. Objective: This trial aimed to test whether or not social recovery therapy provided as an adjunct to enhanced standard care over 9 months is superior to enhanced standard care alone. Enhanced standard care aimed to provide an optimal combination of existing evidence-based interventions. Design: A pragmatic, single-blind, superiority randomised controlled trial was conducted in three UK centres: Sussex, Manchester and East Anglia. Participants were aged 16–25 years with persistent social disability, defined as

Abstract Background Adolescent-onset psychosis is associated with more severe symptoms and poorer outcomes than adult-onset psychosis. The National Institute for Clinical Excellence (NICE) recommend that adolescents with first episode psychosis (FEP) should be offered a combination of antipsychotic medication (APs), cognitive behavioural therapy (CBT) and family intervention (FI). The evidence for APs in treating psychosis is limited in adolescents compared to adults. Nevertheless, it indicates that APs can reduce overall symptoms in adolescents but may cause more severe side effects, including cardiovascular and metabolic effects, than in adults. CBT and FI can improve outcomes in adults, but there are no studies of psychological interventions (PI) in patients under 18 years old. Given this limited evidence base, NICE made a specific research recommendation for determining the clinical and cost effectiveness of APs versus PI versus both treatments for adolescent FEP. Methods/design The current study aimed to establish the feasibility and acceptability of conducting such a trial by recruiting 14–18-year-olds with a first episode of psychosis into a feasibility prospective randomised open blinded evaluation (PROBE) design, three-arm, randomised controlled trial of APs alone versus PI alone versus a combination of both treatments. We aimed to recruit 90 participants from Early Intervention and Child and Adolescent Mental Health Teams in seven UK sites. APs were prescribed by participants’ usual psychiatrists. PI comprised standardised cognitive behavioural therapy and family intervention sessions. Discussion This is the first study to compare APs to PI in an adolescent population with FEP. Recruitment finished on 31 October 2018. The study faced difficulties with recruitment across most sites due to factors including clinician and service-user treatment preferences. Trial registration Current controlled trial with ISRCTN, ISRCTN80567433. Registered on 27 February 2017.

Abstract 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

Abstract Background Obesity is twice as common in people with schizophrenia as the general population and associated with significantly worsened psychiatric and physical health. Despite National Institute for Health and Care Excellence guidelines for the management of psychosis recommending that mental health services offer lifestyle programmes to people with schizophrenia to improve physical health, this is not currently occurring. The aim of the STEPWISE research programme was to develop a lifestyle intervention addressing obesity and preventing weight gain in people with schizophrenia, schizoaffective disorder, or first episode psychosis taking antipsychotic medication, through an approach and fundamental principles drawn from existing diabetes and diabetes prevention interventions. This paper describes the often under-reported process of developing such an intervention from first principles. Methods Following an extensive literature review, an iterative cycle of development with input from people with schizophrenia, mental healthcare professionals, facilitators, and other stakeholders, a new weight management intervention for the target group was developed. A set of four core weekly sessions was piloted in Sheffield, followed at 3-monthly intervals by three booster sessions and telephone support contact once every 2 weeks, to form an intervention lasting 12 months. Facilitators were provided with a 4-day training package to support delivery of the intervention. Results This paper reports the process of development, including challenges and how these were addressed. It describes how user input influenced the structure, topics, and approach of the intervention. The outcome of this process was a feasible and acceptable lifestyle intervention to support people with schizophrenia, schizoaffective disorder, or first episode psychosis to manage their weight. This pilot provided opportunities for refinement of the intervention and facilitator training prior to testing in a multi-centre randomised controlled trial. Key findings from the pilot were linked to accessibility, focus, uptake, and retention, which influenced session length, travel arrangements, refreshment, breaks, and supporting tools to incentivise participants. Conclusions The STEPWISE intervention has been evaluated in a randomised controlled trial in 10 mental health trusts in England, and the results will be published in the British Journal of Psychiatry and the NIHR Journals Library. Trial registration ISRCTN19447796. Date registered: 20/03/2014

The engagement of DNA-binding drugs to their target is difficult to study, particularly in vivo. Here the authors develop an in vivo fluorescence lifetime imaging confocal laparo/endomicroscope to show intra- and inter-tumor heterogeneity in doxorubicin binding to peritoneal metastases, which depends on the route of administration.

Abstract Background Young people who have social disability associated with severe and complex mental health problems are an important group in need of early intervention. Their problems often date back to childhood and become chronic at an early age. Without intervention, the long-term prognosis is often poor and the economic costs very large. There is a major gap in the provision of evidence-based interventions for this group, and therefore new approaches to detection and intervention are needed. This trial provides a definitive evaluation of a new approach to early intervention with young people with social disability and severe and complex mental health problems using social recovery therapy (SRT) over a period of 9 months to improve mental health and social recovery outcomes. Methods This is a pragmatic, multi-centre, single blind, superiority randomised controlled trial. It is conducted in three sites in the UK: Sussex, Manchester and East Anglia. Participants are aged 16 to 25 and have both persistent and severe social disability (defined as engaged in less than 30 hours per week of structured activity) and severe and complex mental health problems. The target sample size is 270 participants, providing 135 participants in each trial arm. Participants are randomised 1:1 using a web-based randomisation system and allocated to either SRT plus optimised treatment as usual (enhanced standard care) or enhanced standard care alone. The primary outcome is time use, namely hours spent in structured activity per week at 15 months post-randomisation. Secondary outcomes assess typical mental health problems of the group, including subthreshold psychotic symptoms, negative symptoms, depression and anxiety. Time use, secondary outcomes and health economic measures are assessed at 9, 15 and 24 months post-randomisation. Discussion This definitive trial will be the first to evaluate a novel psychological treatment for social disability and mental health problems in young people presenting with social disability and severe and complex non-psychotic mental health problems. The results will have important implications for policy and practice in the detection and early intervention for this group in mental health services. Trial registration Trial Registry: International Standard Randomised Controlled Trial Number (ISRCTN) Registry. Trial Registration Number: ISRCTN47998710 (registered 29/11/2012).

BackgroundTerrorist attacks have increased globally since the late 1990s with clear evidence of psychological distress across both adults and children and young people (CYP). After the Manchester Arena terrorist attack, the Resilience Hub was established to identify people in need of psychological and psychosocial support.AimsTo examine the severity of symptoms and impact of the programme.MethodThe hub offers outreach, screening, clinical telephone triage and facilitation to access evidenced treatments. People were screened for trauma, depression, generalised anxiety and functioning who registered at 3, 6 and 9 months post-incident. Baseline scores were compared between screening groups (first screen at 3, 6 or 9 months) in each cohort (adult, CYP), and within groups to compare scores at 9 months.ResultsThere were significant differences in adults' baseline scores across screening groups on trauma, depression, anxiety and functioning. There were significant differences in the baseline scores of CYP across screening groups on trauma, depression, generalised anxiety and separation anxiety. Paired samples t-tests demonstrated significant differences between baseline and follow-up scores on all measures for adults in the 3-month screening group, and only depression and functioning measures for adults in the 6-month screening group. Data about CYP in the 3-month screening group, demonstrated significant differences between baseline and follow-up scores on trauma, generalised anxiety and separation anxiety.ConclusionsThese findings suggest people who register earlier are less symptomatic and demonstrate greater improvement across a range of psychological measures. Further longitudinal research is necessary to understand changes over time.Declaration of interestNone.

Background: Clozapine (clozaril, Mylan Products Ltd) is a first-choice treatment for people with schizophrenia who have a poor response to standard antipsychotic medication. However, a significant number of patients who trial clozapine have an inadequate response and experience persistent symptoms, called clozapine-resistant schizophrenia (CRS). There is little evidence regarding the clinical effectiveness of pharmacological or psychological interventions for this population. Objectives: To evaluate the clinical effectiveness and cost-effectiveness of cognitive–behavioural therapy (CBT) for people with CRS and to identify factors predicting outcome. Design: The Focusing on Clozapine Unresponsive Symptoms (FOCUS) trial was a parallel-group, randomised, outcome-blinded evaluation trial. Randomisation was undertaken using permuted blocks of random size via a web-based platform. Data were analysed on an intention-to-treat (ITT) basis, using random-effects regression adjusted for site, age, sex and baseline symptoms. Cost-effectiveness analyses were carried out to determine whether or not CBT was associated with a greater number of quality-adjusted life-years (QALYs) and higher costs than treatment as usual (TAU). Setting: Secondary care mental health services in five cities in the UK. Participants: People with CRS aged ≥ 16 years, with an International Classification of Diseases, Tenth Revision (ICD-10) schizophrenia spectrum diagnoses and who are experiencing psychotic symptoms. Interventions: Individual CBT included up to 30 hours of therapy delivered over 9 months. The comparator was TAU, which included care co-ordination from secondary care mental health services. Main outcome measures: The primary outcome was the Positive and Negative Syndrome Scale (PANSS) total score at 21 months and the primary secondary outcome was PANSS total score at the end of treatment (9 months post randomisation). The health benefit measure for the economic evaluation was the QALY, estimated from the EuroQol-5 Dimensions, five-level version (EQ-5D-5L), health status measure. Service use was measured to estimate costs. Results: Participants were allocated to CBT (n = 242) or TAU (n = 245). There was no significant difference between groups on the prespecified primary outcome [PANSS total score at 21 months was 0.89 points lower in the CBT arm than in the TAU arm, 95% confidence interval (CI) –3.32 to 1.55 points; p = 0.475], although PANSS total score at the end of treatment (9 months) was significantly lower in the CBT arm (–2.40 points, 95% CI –4.79 to –0.02 points; p = 0.049). CBT was associated with a net cost of £5378 (95% CI –£13,010 to £23,766) and a net QALY gain of 0.052 (95% CI 0.003 to 0.103 QALYs) compared with TAU. The cost-effectiveness acceptability analysis indicated a low likelihood that CBT was cost-effective, in the primary and sensitivity analyses (probability

Peer victimization increases the risk of experiencing psychotic symptoms among clinical and general populations, but the mechanism underlying this association remains unclear. Dissociation, which is related to peer victimization and hallucinatory experiences, has been demonstrated as a significant mediator in the relation between childhood victimization and hallucinatory experience among adult patients with psychosis. However, no studies have examined the mediating effect of dissociation in a general early adolescent population. We examined whether dissociation mediates the relationship between peer victimization and hallucinatory experiences among 10-year-old adolescents using a population-based cross-sectional survey of early adolescents and their main parent (Tokyo Early Adolescence Survey; N = 4478). We examined the mediating effect of dissociation, as well as external locus of control and depressive symptoms, on the relationship between peer victimization and hallucinatory experiences using path analysis. The model assuming mediation effects indicated good model fit (comparative fit index = .999; root mean square error of approximation = .015). The mediation effect between peer victimization and hallucination via dissociation (standardized indirect effect = .038, p

Background: Obesity is twice as common in people with schizophrenia as in the general population. The National Institute for Health and Care Excellence guidance recommends that people with psychosis or schizophrenia, especially those taking antipsychotics, be offered a healthy eating and physical activity programme by their mental health care provider. There is insufficient evidence to inform how these lifestyle services should be commissioned. Objectives: To develop a lifestyle intervention for people with first episode psychosis or schizophrenia and to evaluate its clinical effectiveness, cost-effectiveness, delivery and acceptability. Design: A two-arm, analyst-blind, parallel-group, randomised controlled trial, with a 1 : 1 allocation ratio, using web-based randomisation; a mixed-methods process evaluation, including qualitative case study methods and logic modelling; and a cost–utility analysis. Setting: Ten community mental health trusts in England. Participants: People with first episode psychosis, schizophrenia or schizoaffective disorder. Interventions: Intervention group: (1) four 2.5-hour group-based structured lifestyle self-management education sessions, 1 week apart; (2) multimodal fortnightly support contacts; (3) three 2.5-hour group booster sessions at 3-monthly intervals, post core sessions. Control group: usual care assessed through a longitudinal survey. All participants received standard written lifestyle information. Main outcome measures: The primary outcome was change in weight (kg) at 12 months post randomisation. The key secondary outcomes measured at 3 and 12 months included self-reported nutrition (measured with the Dietary Instrument for Nutrition Education questionnaire), objectively measured physical activity measured by accelerometry [GENEActiv (Activinsights, Kimbolton, UK)], biomedical measures, adverse events, patient-reported outcome measures and a health economic assessment. Results: The trial recruited 414 participants (intervention arm: 208 participants; usual care: 206 participants) between 10 March 2015 and 31 March 2016. A total of 341 participants (81.6%) completed the trial. A total of 412 participants were analysed. After 12 months, weight change did not differ between the groups (mean difference 0.0 kg, 95% confidence interval –1.59 to 1.67 kg; p = 0.964); physical activity, dietary intake and biochemical measures were unchanged. Glycated haemoglobin, fasting glucose and lipid profile were unchanged by the intervention. Quality of life, psychiatric symptoms and illness perception did not change during the trial. There were three deaths, but none was related to the intervention. Most adverse events were expected and related to the psychiatric illness. The process evaluation showed that the intervention was acceptable, with participants valuing the opportunity to interact with others facing similar challenges. Session feedback indicated that 87.2% of participants agreed that the sessions had met their needs. Some indicated the desire for more ongoing support. Professionals felt that the intervention was under-resourced and questioned the long-term sustainability within current NHS settings. Professionals would have preferred greater access to participants’ behaviour data to tailor the intervention better. The incremental cost-effectiveness ratio from the health-care perspective is £246,921 per quality-adjusted life-year (QALY) gained and the incremental cost-effectiveness ratio from the societal perspective is £367,543 per QALY gained. Conclusions: Despite the challenges of undertaking clinical research in this population, the trial successfully recruited and retained participants, indicating a high level of interest in weight management interventions; however, the STEPWISE intervention was neither clinically effective nor cost-effective. Further research will be required to define how overweight and obesity in people with schizophrenia should be managed. The trial results suggest that lifestyle programmes for people with schizophrenia may need greater resourcing than for other populations, and interventions that have been shown to be effective in other populations, such as people with diabetes mellitus, are not necessarily effective in people with schizophrenia. Trial registration: Current Controlled Trials ISRCTN19447796. Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 22, No. 65. See the NIHR Journals Library website for further project information.