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Background People with severe mental illness (SMI) have worse physical health than the general population. There is evidence that support from volunteers can help the mental health of people with SMI, but little evidence regarding the support they can give for physical health. Aims To evaluate the feasibility of an intervention where volunteer ‘Health Champions’ support people with SMI in managing their physical health. Method A feasibility hybrid randomised controlled trial conducted in mental health teams with people with SMI. Volunteers delivered the Health Champions intervention. We collected data on the feasibility of delivering the intervention, and clinical and cost-effectiveness. Participants were randomised by a statistician independent of the research team, to either having a Health Champion or treatment as usual. Blinding was not done. Results We recruited 48 participants: 27 to the intervention group and 21 to the control group. Data were analysed for 34 participants. No changes were found in clinical effectiveness for either group. Implementation outcomes measures showed high acceptability, feasibility and appropriateness, but with low response rates. No adverse events were identified in either group. Interviews with participants found they identified changes they had made to their physical health. The cost of implementing the intervention was £312 per participant. Conclusions The Health Champion intervention was feasible to implement, but the implementation of the study measures was problematic. Participants found the intervention acceptable, feasible and appropriate, and it led them to make changes in their physical health. A larger trial is recommended, with tailored implementation outcome measures.

Abstract Background Forensic psychiatry is often associated with long admissions and has a high cost of care. There is little known about factors influencing length of stay (LOS), and no previous systematic review has synthesised the available data. This paper aims to identify factors influencing the LOS in forensic psychiatry hospitals to inform care and interventions that may reduce the length of admissions. Methodology A systematic review was conducted by searching major databases, including PubMed, EMBASE and PsycInfo, from inception until May 2022. Observational studies conducted in forensic hospitals that examined associations between variables of interest and LOS were included. Following data extraction, the Newcastle‒Ottawa Scale was used for quality appraisal. No meta-analysis was conducted due to heterogeneity of information; a quantitative measure to assess the strength of evidence was developed and reported. Results A total of 28 studies met the inclusion criteria out of 1606 citations. A detailed quantitative synthesis was performed using robust criteria. Having committed homicide/attempted homicide, a criminal legal status with restrictions, and a diagnosis of schizophrenia-spectrum disorders were all associated with longer LOS. Higher Global Assessment of Functioning (GAF) scores were associated with a shorter LOS. Conclusion High-quality research examining factors associated with LOS in forensic psychiatry is lacking, and studies are heterogeneous. No modifiable characteristics were identified, and thus, practice recommendations were not made. There is an increasing necessity to understand the factors associated with longer admissions to inform care and increase success in reintegration and rehabilitation. This paper provides recommendations for future research.

Severe mental illnesses (SMI) are associated with physical health comorbidities. High intensity interval training (HIIT) may improve cardiometabolic risk and mental wellbeing for people with SMI. This study explores the acceptability and feasibility of implementing HIIT amongst inpatients with SMI. The feasibility study followed a two-part design: a) A randomized controlled trial (RCT) of bicycle-based HIIT versus treatment-as-usual (TAU). TAU comprised provision of details of the relevant hospital gym availability. This RCT was terminated early due to Covid-19 restrictions. b) A naturalistic study of inpatient HIIT. Acceptability and feasibility of the HIIT intervention across both study phases was reported. 32 people were recruited, 19 RCT and 13 naturalistic study participants. The early termination resulted in a maximum of 4 weeks of HIIT per RCT participant. Mean satisfaction with HIIT was 8.52/10. The full length of the HIIT session was completed in 77.3% and 71.9% of instances during the RCT and naturalistic phases respectively. Attendance at HIIT sessions averaged 62.9% in the RCT. HIIT was met with high satisfaction. Attendance to HIIT is comparable to attendance of other exercise regimes. This research supports the development of a large-scale trial of HIIT for inpatients with SMI to determine its health benefits. Trial registration: ClinicalTrials.gov, registration no: NCT03959735.

BackgroundSevere mental illnesses (SMIs), including schizophrenia, bipolar affective disorder, and major depressive disorder, are associated with an increased risk of physical health comorbidities and premature mortality from conditions including cardiovascular disease and diabetes. Digital technologies such as electronic clinical decision support systems (eCDSSs) could play a crucial role in improving the clinician-led management of conditions such as dysglycemia (deranged blood sugar levels) and associated conditions such as diabetes in people with a diagnosis of SMI in mental health settings. ObjectiveWe have developed a real-time eCDSS using CogStack, an information retrieval and extraction platform, to automatically alert clinicians with National Health Service Trust–approved, guideline-based recommendations for dysglycemia monitoring and management in secondary mental health care. This novel system aims to improve the management of dysglycemia and associated conditions, such as diabetes, in SMI. This protocol describes a pilot study to explore the acceptability, feasibility, and evaluation of its implementation in a mental health inpatient setting. MethodsThis will be a pilot hybrid type 3 effectiveness-implementation randomized controlled cluster trial in inpatient mental health wards. A ward will be the unit of recruitment, where it will be randomly allocated to receive either access to the eCDSS plus usual care or usual care alone over a 4-month period. We will measure implementation outcomes, including the feasibility and acceptability of the eCDSS to clinicians, as primary outcomes, alongside secondary outcomes relating to the process of care measures such as dysglycemia screening rates. An evaluation of other implementation outcomes relating to the eCDSS will be conducted, identifying facilitators and barriers based on established implementation science frameworks. ResultsEnrollment of wards began in April 2022, after which clinical staff were recruited to take part in surveys and interviews. The intervention period of the trial began in February 2023, and subsequent data collection was completed in August 2023. Data are currently being analyzed, and results are expected to be available in June 2024. ConclusionsAn eCDSS can have the potential to improve clinician-led management of dysglycemia in inpatient mental health settings. If found to be feasible and acceptable, then, in combination with the results of the implementation evaluation, the system can be refined and improved to support future successful implementation. A larger and more definitive effectiveness trial should then be conducted to assess its impact on clinical outcomes and to inform scalability and application to other conditions in wider mental health care settings. Trial RegistrationClinicalTrials.gov NCT04792268; https://clinicaltrials.gov/study/NCT04792268 International Registered Report Identifier (IRRID)DERR1-10.2196/49548

Background Following the onset of the COVID-19 pandemic, healthcare trusts began to implement remote working arrangements, with little knowledge of their impact on staff well-being. Aims To investigate how remote working of healthcare workers during the pandemic may have been associated with stress, productivity and work satisfaction at that time, and associations between loneliness, workplace isolation, perceived social support and well-being. Method A questionnaire was developed to explore remote working and productivity, stress and work satisfaction during time spent working remotely. Associations between current loneliness, workplace isolation and well-being, and the influence of perceived social support, were explored with perceived social support as a potential moderator. Results A total of 520 participants responded to the study, of whom 112 were men (21.5%) and 406 were women (78.1%), with an age range of 21–77 years (mean 40.0, s.d. = 12.1). Very few (3.1%) worked remotely before the COVID-19 pandemic, and this had increased significantly (96.9%). Those who worked ≥31 h a week remotely reported higher stress and lower workplace satisfaction at that time, compared with office work, yet also felt more productive. Current loneliness, workplace isolation and perceived social support were cross-sectionally associated with lower current well-being. Conclusions Those who worked more hours a week remotely during the pandemic reported increased stress, which may be related to the lack of resources in place to support this change in work.

Objectives To investigate factors associated with the recording of glycated haemoglobin (HbA1c) in people with first diagnoses of serious mental illness (SMI) in a large mental healthcare provider, and factors associated with HbA1c levels, when recorded. To our knowledge this is the first such investigation, although attention to dysglycaemia in SMI is an increasing priority in mental healthcare.Design The study was primarily descriptive in nature, seeking to ascertain the frequency of HbA1c recording in the mental healthcare sector for people following first SMI diagnosis.Settings A large mental healthcare provider, the South London and Maudsley National Health Service Trust.Participants Using electronic mental health records data, we ascertained patients with first SMI diagnoses (schizophrenia, schizoaffective disorder, bipolar disorder) from 2008 to 2018.Outcome measures Recording or not of HbA1c level was ascertained from routine local laboratory data and supplemented by a natural language processing (NLP) algorithm for extracting recorded values in text fields (precision 0.89%, recall 0.93%). Age, gender, ethnic group, year of diagnosis, and SMI diagnosis were investigated as covariates in relation to recording or not of HbA1c and first recorded levels.Results Of 21 462 patients in the sample (6546 bipolar disorder; 14 916 schizophrenia or schizoaffective disorder; mean age 38.8 years, 49% female), 4106 (19.1%) had at least one HbA1c result recorded from laboratory data, increasing to 6901 (32.2%) following NLP. HbA1c recording was independently more likely in non-white ethnic groups (black compared with white: OR 2.45, 95% CI 2.29 to 2.62), and was negatively associated with age (OR per year increase 0.93, 0.92–0.95), female gender (0.83, 0.78–0.88) and bipolar disorder (0.49, 0.45–0.52).Conclusions Over a 10-year period, relatively low level of recording of HbA1c was observed, although this has increased over time and ascertainment was increased with text extraction. It remains important to improve the routine monitoring of dysglycaemia in these at-risk disorders.

Background There are few data on the profile of those with serious mental illness (SMI) admitted to hospital for physical health reasons. Aims To compare outcomes for patients with and without an SMI admitted to hospital in England where the primary reason for admission was chronic obstructive pulmonary disease (COPD). Method This was a retrospective, observational analysis of the English Hospital Episodes Statistics data-set for the period from 1 April 2018 to 31 March 2019, for patients aged 18–74 years with COPD as the dominant reason for admission. Patient with an SMI (psychosis spectrum disorder, bipolar disorder) were identified. Results Data were available for 54 578 patients, of whom 2096 (3.8%) had an SMI. Patients with an SMI were younger, more likely to be female and more likely to live in deprived areas than those without an SMI. The burden of comorbidity was similar between the two groups. After adjusting for covariates, SMI was associated with significantly greater risk of length of stay than the median (odds ratio 1.24, 95% CI 1.12–1.37, P ≤ 0.001) and with 30-day emergency readmission (odds ratio 1.51, 95% confidence interval 1.34–1.69, P ≤ 0.001) but not with in-hospital mortality. Conclusion Clinicians should be aware of the potential for poorer outcomes in patients with an SMI even when the SMI is not the primary reason for admission. Collaborative working across mental and physical healthcare provision may facilitate improved outcomes for people with SMI.

Background: Treatment-resistant schizophrenia (TRS) affects approximately 30% of people with schizophrenia. Clozapine is the gold standard treatment for TRS but is not always suitable, with a proportion of individuals intolerant of side effects or unable to engage in necessary blood monitoring. Given the profound impact TRS can have on those affected, alternative pharmacological approaches to care are needed. Objectives: To review the literature on the efficacy and tolerability of high-dose olanzapine (>20 mg daily) in adults with TRS. Design: This is a systematic review. Data Sources and Methods: We searched for eligible trials published prior to April 2022 in PubMed/MEDLINE, Scopus and Google Scholar. Ten studies met the inclusion criteria [five randomised controlled trials (RCTs), one randomised crossover trial and four open label studies]. Data were extracted for predefined primary outcomes (efficacy, tolerability). Results: Compared with standard treatment, high-dose olanzapine was non-inferior in four RCTs, three of which used clozapine as the comparator. Clozapine was superior to high-dose olanzapine in a double-blind crossover trial. Open-label studies demonstrated tentative evidence in support of high-dose olanzapine use. It was better tolerated than clozapine and chlorpromazine in two respective RCTs, and was generally well tolerated in open-label studies. Conclusion: This evidence suggests high-dose olanzapine is superior for TRS when compared with other commonly used first- and second-generation antipsychotics, including haloperidol and risperidone. In comparison with clozapine, the data are encouraging for the use of high-dose olanzapine where clozapine use is problematic, but larger, better designed trials are needed to assess the comparative efficacy of both treatments. There is insufficient evidence to consider high-dose olanzapine equivalent to clozapine when clozapine is not contraindicated. Overall, high-dose olanzapine was well tolerated, with no serious side effects. Registration: This systematic review was preregistered with PROSPERO [CRD42022312817].

Objectives Fatigue is a pervasive clinical symptom in coronaviruses and may continue beyond the acute phase, lasting for several months or years. This systematic review and meta-analysis aimed to incorporate the current evidence for postinfection fatigue among survivors of SARS-CoV-2 and investigate associated factors.Methods Embase, PsyINFO, Medline, CINAHL, CDSR, Open Grey, BioRxiv and MedRxiv were systematically searched from January 2019 to December 2021. Eligible records included all study designs in English. Outcomes were fatigue or vitality in adults with a confirmed diagnosis of SARS-CoV-2 measured at >30 days post infection. Non-confirmed cases were excluded. JBI risk of bias was assessed by three reviewers. Random effects model was used for the pooled proportion with 95% CIs. A mixed effects meta-regression of 35 prospective articles calculated change in fatigue overtime. Subgroup analyses explored specific group characteristics of study methodology. Heterogeneity was assessed using Cochran’s Q and I2 statistic. Egger’s tests for publication bias.Results Database searches returned 14 262 records. Following deduplication and screening, 178 records were identified. 147 (n=48 466 participants) were included for the meta-analyses. Pooled prevalence was 41% (95% CI: 37% to 45%, k=147, I2=98%). Fatigue significantly reduced over time (−0.057, 95% CI: −107 to −0.008, k=35, I2=99.3%, p=0.05). A higher proportion of fatigue was found in studies using a valid scale (51%, 95% CI: 43% to 58%, k=36, I2=96.2%, p=0.004). No significant difference was found for fatigue by study design (p=0.272). Egger’s test indicated publication bias for all analyses except valid scales. Quality assessments indicated 4% at low risk of bias, 78% at moderate risk and 18% at high risk. Frequently reported associations were female gender, age, physical functioning, breathlessness and psychological distress.Conclusion This study revealed that a significant proportion of survivors experienced fatigue following SARS-CoV-2 and their fatigue reduced overtime. Non-modifiable factors and psychological morbidity may contribute to ongoing fatigue and impede recovery.PROSPERO registration number CRD42020201247.

Abstract Background Improvements to the primary prevention of physical health illnesses like diabetes in the general population have not been mirrored to the same extent in people with serious mental illness (SMI). This work evaluates the technical feasibility of implementing an electronic clinical decision support system (eCDSS) for supporting the management of dysglycaemia and diabetes in patients with serious mental illness in a secondary mental healthcare setting. Methods A stepwise approach was taken as an overarching and guiding framework for this work. Participatory methods were employed to design and deploy a monitoring and alerting eCDSS. The eCDSS was evaluated for its technical feasibility. The initial part of the feasibility evaluation was conducted in an outpatient community mental health team. Thereafter, the evaluation of the eCDSS progressed to a more in-depth in silico validation. Results A digital health intervention that enables monitoring and alerting of at-risk patients based on an approved diabetes management guideline was developed. The eCDSS generated alerts according to expected standards and in line with clinical guideline recommendations. Conclusions It is feasible to design and deploy a functional monitoring and alerting eCDSS in secondary mental healthcare. Further work is required in order to fully evaluate the integration of the eCDSS into routine clinical workflows. By describing and sharing the steps that were and will be taken from concept to clinical testing, useful insights could be provided to teams that are interested in building similar digital health interventions.

Abstract Observational evidence has implicated vitamin D levels as a risk factor in major depressive disorder (MDD). Confounding or reverse causation may be driving these observed associations, with studies using genetics indicating little evidence of an effect. However, genetic studies have relied on broad definitions of depression. The genetic architecture of different depression subtypes may vary since MDD is a highly heterogenous condition, implying potentially diverging requirements in therapeutic approaches. We explored the associations between vitamin D and two subtypes of MDD, for which evidence of a causal link could have the greatest clinical benefits: treatment-resistant depression (TRD) and atypical depression (AD). We used a dual approach, combining observational data with genetic evidence from polygenic risk scores (PRS) and two-sample Mendelian randomization (MR), in the UK Biobank. There was some evidence of a weak association between vitamin D and both incident TRD (Ncases = 830) and AD (Ncases = 2366) in observational analyses, which largely attenuated when adjusting for confounders. Genetic evidence from PRS and two-sample MR, did not support a causal link between vitamin D and either TRD (Ncases = 1891, OR = 1.01 [95%CI 0.78, 1.31]) or AD (Ncases = 2101, OR = 1.04 [95%CI 0.80, 1.36]). Our comprehensive investigations indicated some evidence of an association between vitamin D and TRD/AD observationally, but little evidence of association when using PRS and MR, mirroring findings of genetic studies of vitamin D on broad depression phenotypes. Results do not support further clinical trials of vitamin D in these MDD subtypes but do not rule out that small effects may exist that require larger samples to detect.

Abstract Background Severe mental illnesses (SMI), including schizophrenia spectrum disorder, bipolar disorder and major depressive disorder, are associated with physical health comorbidities and premature mortality. Physical activity and structured exercise have a beneficial impact on cardiometabolic risk and ameliorate mental health symptomology and cognition. This protocol describes a feasibility study for a high-intensity interval training (HIIT) intervention among inpatients with SMI, to improve their physical and mental health. Methods The feasibility study follows a two-part design owing to COVID-19-related adaptations to project design: (a) a non-blinded randomised controlled trial (RCT) of 12 weeks of bicycle-based HIIT, delivered twice weekly in a face-to-face, one-to-one setting, compared to treatment as usual (TAU) and (b) a naturalistic study of inpatient HIIT; eligible participants will be invited to two sessions of HIIT per week, delivered by the research team remotely or in person. Additionally, participants in the naturalistic study may use the bike to conduct self-directed sessions of their chosen length and intensity. We will measure the feasibility and acceptability of the HIIT intervention as primary outcomes, alongside secondary and tertiary outcomes evaluating the physical, mental and cognitive effects of HIIT. The study aims to recruit 40 patients to the RCT and 6–8 patients to the naturalistic design. Discussion Exercise is a modifiable lifestyle barrier that can reverse cardiometabolic disease risk. If HIIT is found to be feasible and acceptable in inpatients with SMI, there would be scope for large-scale work to evaluate the clinical, cost and implementation effectiveness of HIIT in inpatient mental health settings. Trial registration ClinicalTrials.gov NCT03959735 . Registered June 22, 2019.

Severe mental illnesses, such as schizophrenia or bipolar disorder, affect ≈1% of the population who, as a group, experience significant disadvantage in terms of physical health and reduced life expectancy. In this review, we explore the interaction between race, ethnicity, severe mental illness, and cardiovascular disease, with a focus on cardiovascular care pathways. Finally, we discuss strategies to investigate and address disparities in cardiovascular care for patients with severe mental illness.

Abstract Background People with serious mental illnesses (SMI) such as schizophrenia often also have physical health illnesses and interventions are needed to address the resultant multimorbidity and reduced life expectancy. Research has shown that volunteers can support people with SMI. This protocol describes a feasibility randomised controlled trial (RCT) of a novel intervention involving volunteer ‘Health Champions’ supporting people with SMI to manage and improve their physical health. Methods This is a feasibility hybrid II randomised effectiveness-implementation controlled trial. The intervention involves training volunteers to be ‘Health Champions’ to support individual people with SMI using mental health services. This face-to-face or remote support will take place weekly and last for up to 9 months following initial introduction. This study will recruit 120 participants to compare Health Champions to treatment as usual for people with SMI using secondary community mental health services in South London, UK. We will measure the clinical and cost effectiveness including quality of life. We will measure the implementation outcomes of acceptability, feasibility, appropriateness, fidelity, barriers and enablers, unintended consequences, adoption and sustainability. Discussion There is a need for interventions to support people with SMI with their physical health. If this feasibility trial is successful, a definitive trial will follow to fully evaluate the clinical, cost and implementation effectiveness of Health Champions supporting people with SMI. Trial registration ClinicalTrials.gov, registration no: NCT04124744 .

Abstract Background People diagnosed with a serious mental illness have worse physical health and lower life expectancy than the general population. Integration of mental and physical health services is seen as one service development that could better support this. This protocol describes the evaluation of the provision of a Virtual Physical Health Clinic (VPHC) and Consultant Connect (CC) services to one UK-based mental health Trust. Methods Prospective, formative, pragmatic evaluation using both quantitative and qualitative techniques and driven by implementation science theoretical frameworks. The VPHC and CC are described along with the methodology being used to rapidly evaluate their implementation, effectiveness and potential economic impact in order to inform future roll out. We will assess the implementation process through quantitative data on uptake and reach and through self-reported data to be collected from interviews and the use of validated implementation outcome assessment measures. We will assess implementation strategies using the Expert Recommendations for Implementing Change (ERIC) strategies as a framework. We will assess the health economic impact of both services using established health economic methods including cost comparison scenarios and health service utilisation analyses. Discussion Supporting the physical health management of people in psychiatric inpatient units is important in improving the physical health of this population. Integration of mental and physical health can help this to happen effectively. This initiative provides one of the first service evaluation protocols of its kind to be reported in the UK at the time of the COVID-19 pandemic.

Abstract Background Antipsychotic drug-induced weight gain puts individuals with schizophrenia at increased cardiometabolic risk. As a potential intervention for this problem, we describe the theoretical background and a protocol for a feasibility randomised controlled trial (RCT) of approach bias modification (ABM) training combined with real versus sham (placebo) transcranial direct current stimulation (tDCS). The primary aim of this trial is to obtain information that will guide decision making and protocol development in relation to a future large-scale RCT of ABM and tDCS in this group of participants. Second, the study will assess the preliminary efficacy of ABM + tDCS in reducing food cravings in people who take antipsychotic medication. Methods Thirty adults with a DSM-V diagnosis of schizophrenia or schizoaffective disorder treated with anti-psychotic medication will be randomly allocated to receive five sessions that will combine ABM and real or sham tDCS, in a parallel group design. In this feasibility study, a broad range of outcome variables will be examined. Measures will include food craving, psychopathology (e.g. symptoms of schizophrenia and depression), neuropsychological processes (such as attentional bias and impulsiveness), and the tolerability and acceptability of tDCS. The feasibility of conducting a large-scale RCT of ABM + tDCS and appropriateness of tDCS as a treatment for antipsychotic drug-induced weight gain will be evaluated by assessment of recruitment and retention rates, acceptability of random allocation, blinding success (allocation concealment), completion of treatment sessions and research assessments (baseline, post-treatment and follow-up). Discussion The effect sizes generated and other findings from this trial will inform a future large-scale RCT with respect to decisions on primary outcome measures and other aspects of protocol development. In addition, results from this study will provide a preliminary indication of the efficacy of ABM + tDCS treatment for antipsychotic drug-induced weight gain. Trial registration ISRCTN Registry, ISRCTN13280178 . Registered on 16 October 2018.

Abstract Background People experiencing their first episode of psychosis are often deficient in vitamin D. Observational studies have reported an association between low vitamin D concentrations and poorer subsequent health outcomes in psychosis. A vitamin D deficiency in neonates and children has been linked to a later increased risk of schizophrenia and psychotic-like experiences. This trial aims to examine the effect of high-dose vitamin D supplementation on outcomes in early psychosis. We hypothesise that vitamin D supplementation will be associated with better mental health outcomes. Methods/design The DFEND study is a multicentre double-blind placebo-controlled parallel-group trial of vitamin D supplementation in people with early psychosis. Patients with an ICD-10 diagnosis of functional psychosis will be randomised in a 1:1 ratio to receive either 120,000 IU/month of vitamin D (cholecalciferol) or a matched placebo for 6 months. The primary outcome is the total Positive and Negative Syndrome Scale (PANSS) score at the 6-month follow-up for all patients. Secondary outcomes include assessment of mood (Calgary Depression Scale), general function (Global Assessment of Functioning), cardiovascular risk (body mass index, waist circumference, C-reactive protein, cholesterol and HbA1c) and vitamin D levels at the 6-month follow-up. Additionally, 3- and 6-month total PANSS scores will be analysed for those with inadequate vitamin D levels at the baseline. Discussion The DFEND study is the first trial to examine whether vitamin D supplementation in early psychosis is associated with better mental health outcomes. The findings of this study may help to resolve the clinical equipoise regarding the benefits and cost-effectiveness of routine vitamin D supplementation in people with psychosis. Trial registration ISRCTN, ISRCTN12424842. Registered on 25 February 2015.

BackgroundEarly in 2020, mental health services had to rapidly shift from face-to-face models of care to delivering the majority of treatments remotely (by video or phone call or occasionally messaging) due to the COVID-19 pandemic. This resulted in several challenges for staff and patients, but also in benefits such as convenience or increased access for people with impaired mobility or in rural areas. There is a need to understand the extent and impacts of telemental health implementation, and barriers and facilitators to its effective and acceptable use. This is relevant both to future emergency adoption of telemental health and to debates on its future use in routine mental health care. ObjectiveTo investigate the adoption and impacts of telemental health approaches during the COVID-19 pandemic, and facilitators and barriers to optimal implementation. MethodsFour databases (PubMed, PsycINFO, CINAHL, and Web of Science) were searched for primary research relating to remote working, mental health care, and the COVID-19 pandemic. Preprint servers were also searched. Results of studies were synthesized using framework synthesis. ResultsA total of 77 papers met our inclusion criteria. In most studies, the majority of contacts could be transferred to a remote form during the pandemic, and good acceptability to service users and clinicians tended to be reported, at least where the alternative to remote contacts was interrupting care. However, a range of impediments to dealing optimal care by this means were also identified. ConclusionsImplementation of telemental health allowed some continuing support to the majority of service users during the COVID-19 pandemic and has value in an emergency situation. However, not all service users can be reached by this means, and better evidence is now needed on long-term impacts on therapeutic relationships and quality of care, and on impacts on groups at risk of digital exclusion and how to mitigate these. Trial RegistrationPROSPERO International prospective register of systematic reviews CRD42021211025; https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42021211025

Background: Clozapine is the only medication licenced for treating patients with treatment-refractory schizophrenia. However, there are no evidence-based guidelines as to the optimal plasma level of clozapine to aim for, and their association with clinical and functional outcome. Objective: We assessed the relationship between clinical and functional outcome measures and blood concentrations of clozapine among patients with treatment-refractory psychosis. Methods: Data were reviewed in 82 patients with treatment-refractory psychosis admitted to a specialised tertiary-level service and treated with clozapine. Analysis focussed on the relationship between clozapine and norclozapine plasma concentrations and the patient’s clinical symptoms and functional status. Results: Clinical symptom improvement was positively correlated with norclozapine plasma concentrations and inversely correlated with clozapine to norclozapine plasma concentrations ratio. Clozapine concentrations showed a bimodal association with clinical improvement (peaks around 350 and 660 ng/ml). Clinical symptom improvement correlated with functional outcomes, although there was no significant correlation between the latter and clozapine or norclozapine plasma concentrations. Conclusion: Clozapine treatment was associated with optimal clinical improvement at two different peak plasma concentrations around 350 and 650 ng/ml. Clinical improvement was associated with functional outcome; however, functionality was not directly associated with clozapine concentrations. A subset of patients may require higher clozapine plasma concentrations to achieve clinical improvement.

BackgroundTelemental health care has been rapidly adopted for maintaining services during the COVID-19 pandemic, and a substantial interest is now being devoted in its future role. Service planning and policy making for recovery from the pandemic and beyond should draw on both COVID-19 experiences and the substantial research evidence accumulated before this pandemic. ObjectiveWe aim to conduct an umbrella review of systematic reviews available on the literature and evidence-based guidance on telemental health, including both qualitative and quantitative literature. MethodsThree databases were searched between January 2010 and August 2020 for systematic reviews meeting the predefined criteria. The retrieved reviews were independently screened, and those meeting the inclusion criteria were synthesized and assessed for risk of bias. Narrative synthesis was used to report these findings. ResultsIn total, 19 systematic reviews met the inclusion criteria. A total of 15 reviews examined clinical effectiveness, 8 reported on the aspects of telemental health implementation, 10 reported on acceptability to service users and clinicians, 2 reported on cost-effectiveness, and 1 reported on guidance. Most reviews were assessed to be of low quality. The findings suggested that video-based communication could be as effective and acceptable as face-to-face formats, at least in the short term. Evidence on the extent of digital exclusion and how it can be overcome and that on some significant contexts, such as children and young people’s services and inpatient settings, was found to be lacking. ConclusionsThis umbrella review suggests that telemental health has the potential to be an effective and acceptable form of service delivery. However, we found limited evidence on the impact of its large-scale implementation across catchment areas. Combining previous evidence and COVID-19 experiences may allow realistic planning for the future implementation of telemental health.

Individuals with serious mental disorders (SMD) may have a higher risk of vitamin D (VIT-D) deficiency. They also experience higher mortality because of coronavirus disease 2019 (COVID-19) infection. Therefore, we have conducted a comprehensive review to examine the significance of VIT-D for public health and public mental health during the ongoing COVID-19 pandemic. This review had three specific aims, from a global perspective to (a) create a profile of VIT-D and review the epidemiology of VIT-D deficiency, (b) explore VIT-D deficiency as risk factor for SMD and COVID-19 infections and (c) examine the effectiveness of VIT-D supplementation for both conditions. We found that, in terms of SMD, the evidence from laboratory and observational studies points towards some association between VIT-D deficiency and depression or schizophrenia. Mendelian randomisation studies, however, suggest no, or reverse, causality. The evidence from intervention studies is conflicting. Concerning COVID-19 infection, on proof of principle, VIT-D could provide a plausible defence against the infection itself and against an adverse clinical course. But data from observational studies and the first preliminary intervention studies remain conflicting, with stronger evidence that VIT-D may mitigate the clinical course of COVID-19 infection rather than the risk of infection in the first place. From a public health and public mental health point of view, based on the currently limited knowledge, for individuals with SMD, the benefits of VIT-D optimisation through supplementation seem to outweigh the risks. VIT-D supplementation, however, should not substitute for vaccination or medical care for COVID-19 infection.

Background: Despite the growing number of studies on the use of non-invasive brain stimulation in people with schizophrenia, there is limited research on participant views of such treatment methods.Aim: Explore participant experiences and perceptions of transcranial direct current stimulation (tDCS).Methods: Twelve people with schizophrenia took part in semi-structured interviews after having completed 5 sessions of tDCS. Thematic analysis was used to identify codes and themes.Results: Five themes were identified: (1) motivation for study enrolment; (2) concerns about tDCS; (3) factors reducing the fear of tDCS; (4) experience of tDCS; (5) perceived effects of tDCS.Conclusions: The study provides insight into the perceptions and experiences of each individual. Participants were concerned about the safety of tDCS and associated it with invasive procedures such as electroconvulsive therapy and lobotomy. Educational materials and a good relationship with the researcher played an important role in reducing the fear of brain stimulation. All participants described tDCS as uncomfortable, however, agreed that unpleasant sensations only lasted for a short while (20 s−5 min). After the first session, participants no longer felt anxious about the remaining ones. Strategies to improve treatment experience and study recruitment have been identified.

Abstract Background Cardiovascular disease (CVD) is the leading cause of premature death among people with serious mental illness (SMI). Sedentary behaviour (SB) is an independent risk factor for CVD and mortality and people with SMI are highly sedentary. We developed a health coaching intervention called ‘Walk this Way’ to reduce SB and increase physical activity (PA) in people with SMI and conducted a pilot randomised controlled trial (RCT) to test its feasibility and acceptability. Methods We randomised people with SMI from three community mental health teams into either the WTW intervention or treatment as usual. The WTW intervention lasted 17 weeks and included an initial education session, fortnightly coaching, provision of pedometers and access to a weekly walking group. Objective SB and PA were measured with accelerometers. Cardiometabolic risk factors and wellbeing measures were collected. Results We recruited 40 people of whom 33 (82.5%) were followed up. 13/20 (65%) of participants allocated to the coaching intervention completed it. In the intervention group SB decreased by 56 min and total PA increased by 32 min per day on average which was sustained 6 months later. There was no change in PA or SB in the control group. When interviewed, participants in the intervention found the intervention helpful and acceptable. No adverse events were reported from the intervention. Conclusions The intervention was feasible and acceptable to participants. Preliminary results were encouraging with improvement seen in both SB and PA. A larger study is needed to assess the effectiveness of the intervention and address any implementation challenges. Trial registration ISRCTN Registry identifier: ISRCTN37724980, retrospectively registered 25 September 2015.

Abstract Background People with serious mental illness (SMI) have poorer physical health and reduced lifespans compared to the general population. Reasons for this are complex, but one important area is the identification and treatment of physical health conditions. In England, services are structured into primary and secondary care; physical and mental secondary health services are separate. This often leads to a lack of co-ordination of care, with people missing the screening and treatment they need. People with SMI may find accessing physical health services more difficult due to the impact of their symptoms and/or a lack of social support. When they do access physical care, there may be ‘diagnostic overshadowing’ where physical health concerns are put down to a mental health diagnosis. Creating tools to support people with SMI to assume more control of their physical health may help to ameliorate some of these problems. The aim of this study is to evaluate the use of a service user-held Physical health plan (PHP) for secondary mental health service users to determine whether its use increases uptake of physical health services. Methods We will undertake a pilot quality improvement (QI) study to test the use of the PHP. The development of the PHP is described. A Theory of Change (ToC) has been developed which we will test to understand how the PHP is used, using focus groups at the beginning of the study. We will then pilot the use of the PHP for 6 months in two community mental health teams to find out how people use it, what actions are taken, and if it increases uptake of physical health care. We will use the RE-AIM implementation framework to guide the evaluation. After the pilot, we will undertake interviews with service users and clinical staff to elicit their views on using the PHP. Discussion This study uses QI methodology and an implementation framework to test a novel intervention for people with SMI. If successful, the intervention will support people with SMI to access physical health services. The study will inform the design of a larger-scale definitive RCT. Trial registration ClinicalTrials.gov Identifier: NCT03178279. Registered date: 05/06/2017

We performed a systematic analysis of blood DNA methylation profiles from 4483 participants from seven independent cohorts identifying differentially methylated positions (DMPs) associated with psychosis, schizophrenia, and treatment-resistant schizophrenia. Psychosis cases were characterized by significant differences in measures of blood cell proportions and elevated smoking exposure derived from the DNA methylation data, with the largest differences seen in treatment-resistant schizophrenia patients. We implemented a stringent pipeline to meta-analyze epigenome-wide association study (EWAS) results across datasets, identifying 95 DMPs associated with psychosis and 1048 DMPs associated with schizophrenia, with evidence of colocalization to regions nominated by genetic association studies of disease. Many schizophrenia-associated DNA methylation differences were only present in patients with treatment-resistant schizophrenia, potentially reflecting exposure to the atypical antipsychotic clozapine. Our results highlight how DNA methylation data can be leveraged to identify physiological (e.g., differential cell counts) and environmental (e.g., smoking) factors associated with psychosis and molecular biomarkers of treatment-resistant schizophrenia.

BackgroundTreatment-resistant schizophrenia is a major disabling illness which often proves challenging to manage in a secondary care setting. The National Psychosis Unit (NPU) is a specialised tertiary in-patient facility that provides evidence-based, personalised, multidisciplinary interventions for complex treatment-resistant psychosis, in order to reduce the risk of readmission and long-term care costs.AimsThis study aimed to assess the long-term effectiveness of treatment at the NPU by considering naturalistic outcome measures.MethodUsing a mirror image design, we compared the numbers of psychiatric and general hospital admissions, in-patient days, acuity of placement, number of psychotropic medications and dose of antipsychotic medication prescribed before and following NPU admission. Data were obtained from the Clinical Records Interactive Search system, an anonymised database sourced from the South London and Maudsley NHS Trust electronic records, and by means of anonymous linkage to the Hospital Episode Statistics system.ResultsCompared with the 2 years before NPU admission, patients had fewer mental health admissions (1.65 ± 1.44 v. 0.87 ± 0.99, z = 5.594, P < 0.0001) and less mental health bed usage (335.31 ± 272.67 v. 199.42 ± 261.96, z = 5.195 P < 0.0001) after NPU admission. Total in-patient days in physical health hospitals and total number of in-patient days were also significantly reduced (16.51 ± 85.77 v. 2.83 ± 17.38, z = 2.046, P = 0.0408; 351.82 ± 269.09 v. 202.25 ± 261.05, z = 5.621, P < 0.0001). The reduction in level of support required after treatment at the NPU was statistically significant (z = −8.099, P < 0.0001).ConclusionsThis study demonstrates the long-term effectiveness of a tertiary service specialising in treatment-resistant psychosis.

Clozapine is the only available treatment for refractory schizophrenia but its use involves frequent physical contact with healthcare workers for the purpose of mandatory blood monitoring. During the COVID-19 pandemic, patients taking clozapine will be self-isolating to reduce the risk of infection, not least because these patients are at high risk of serious illness and fatality because of high rates of diabetes, obesity and pulmonary disease and an increased risk of pneumonia. Problems may also arise because both clozapine-induced myocarditis and neutropenic sepsis share signs and symptoms with COVID-19 (fever, chest pain, dyspnoea, etc.). We recommend decreasing the frequency of physical contacts by extending the blood monitoring interval to 12 weeks in those patients taking clozapine for more than 1 year. To distinguish COVID-19 from clozapine-related physical adverse effects, we suggest an urgent antigen test alongside a full blood count. In those taking clozapine who develop COVID-19, we suggest continuing with clozapine whenever possible (even during ventilation), reducing the dose if necessary in line with blood assay results. Blood monitoring should continue but clozapine should only cease if there is a significant fall in neutrophils (COVID-19 is linked to lymphopenia but not neutropenia). To protect against the likelihood and severity of respiratory infection, we recommend the use of vitamin D in all clozapine patients. Initiation of clozapine is likely to remain problematic while the risk of infection remains, given the degree of physical contact required to assure safety.

BackgroundTo estimate the potential gain in life expectancy from addressing modifiable risk factors for all-cause mortality (excluding suicide and deaths from accidents or violence) across specific serious mental illness (SMI) subgroups, namely schizophrenia, schizoaffective disorders, and bipolar disorders in a Western population.MethodsWe have used relative risks from recent meta-analyses to estimate the population attribution fraction (PAF) due to specific modifiable risk factors known to be associated with all-cause mortality within SMI. The potential gain in life expectancy at birth, age 50 and age 65 years were assessed by estimating the combined effect of modifiable risk factors from different contextual levels (behavioural, healthcare, social) and accounting for the effectiveness of existing interventions tackling these factors. Projections for annual gain in life expectancy at birth during a two-decade was estimated using the Annual Percentage Change (APC) formula. The predicted estimates were based on mortality rates for year 2014-2015.ResultsBased on the effectiveness of existing interventions targeting these modifiable risk factors, we estimated potential gain in life expectancy at birth of four (bipolar disorders), six (schizoaffective disorders), or seven years (schizophrenia). The gain in life expectancy at age 50 years was three (bipolar disorders) or five (schizophrenia and schizoaffective disorders) years. The projected gain in life expectancy at age 65 years was three (bipolar disorders) or four (schizophrenia and schizoaffective disorders) years.ConclusionsThe implementation of existing interventions targeting modifiable risk factors could narrow the current mortality gap between the general and the SMI populations by 24% (men) to 28% (women). These projections represent ideal circumstances and without the limitation of overestimation which often comes with PAFs.

Background: People with psychotic disorders have reduced life expectancy largely because of physical health problems, especially cardiovascular disease, that are complicated by the use of tobacco and cannabis. Objectives: We set out to (1) chart lifestyle and substance use choices and the emergence of cardiometabolic risk from the earliest presentation with psychosis, (2) develop a pragmatic health promotion intervention integrated within the clinical teams to improve the lifestyle choices and health outcomes of people with psychosis and (3) evaluate the clinical effectiveness and cost-effectiveness of that health promotion intervention. Design: We performed a longitudinal cohort study of people presenting with their first episode of psychosis in three mental health trusts and followed up participants for 1 year [work package 1, physical health and substance use measures in first episode of psychosis (PUMP)]. We used an iterative Delphi methodology to develop and refine a modular health promotion intervention, improving physical health and reducing substance use in psychosis (IMPaCT) therapy, which was to be delivered by the patient’s usual care co-ordinator and used motivational interviewing techniques and cognitive–behavioural therapy to improve health choices of people with psychosis (work package 2). We then conducted a multicentre, two-arm, parallel-cluster, randomised controlled trial to determine the clinical effectiveness and cost-effectiveness of using the intervention with people with established psychosis (work package 3: IMPaCT randomised controlled trial) in five UK mental health trusts. The work took place between 2008 and 2014. Participants: All people aged between 16 and 65 years within 6 months of their first presentation with a non-organic psychosis and who were proficient in English were eligible for inclusion in the PUMP study. Participants in the work package 2 training development were staff selected from a range of settings, working with psychosis. Participants in the phase 3 Delphi consensus and manual development comprised three expert groups of (1) therapists/researchers recruited from the local and national community, (2) clinicians and (3) service users, each of whom took part in two iterative review and feedback sessions. For work package 3, IMPaCT randomised controlled trial, care co-ordinators in participating community mental health teams who were permanently employed and had a minimum of four eligible patients (i.e. aged between 18 and 65 years with a diagnosis of a psychotic disorder) on their caseload were eligible to participate. In studies 1 and 3, patient participants were ineligible if they were pregnant or had a major illness that would have had an impact on their metabolic status or if they had a significant learning disability. All participants were included in the study only after giving written confirmed consent. Main outcome measures: Cardiometabolic risk markers, including rates of obesity and central obesity, and levels of glycated haemoglobin (HbA1c) and lipids, were the main outcomes in work package 1 (PUMP), with descriptive data presented on substance use. Our primary outcome measure for the IMPaCT randomised controlled trial was the physical or mental health component Short Form questionnaire-36 items quality-of-life scores at 12 months. Results: Obesity rates rose from 18% at first presentation with psychosis to 24% by 1 year, but cardiometabolic risk was not associated with baseline lifestyle and substance use choices. Patterns of increase in the levels of HbA1c over the year following first presentation showed variation by ethnic group. We recruited 104 care co-ordinators, of whom 52 (with 213 patients) were randomised to deliver IMPaCT therapy and 52 (with 193 patients) were randomised to deliver treatment as usual, in keeping with our power calculations. Of these 406 participants with established psychosis, 318 (78%) and 301 (74%) participants, respectively, attended the 12- and 15-month follow-ups. We found no significant effect of IMPaCT therapy compared with treatment as usual on the physical or mental health component Short Form questionnaire-36 items scores at either time point in an intention-to-treat analysis [physical health score (‘d’) –0.17 at 12 months and –0.09 at 15 months; mental health score (‘d’) 0.03 at 12 months and –0.05 at 15 months] or on costs. Nor did we find an effect on other cardiovascular risk indicators, including diabetes, except in the case of high-density lipoprotein cholesterol, which showed a trend for greater benefit with IMPaCT therapy than with treatment as usual (treatment effect 0.085, 95% confidence interval 0.007 to 0.16; p = 0.034). Limitations: Follow-up in work package 1 was challenging, with 127 out of 293 participants attending; however, there was no difference in cardiometabolic measures or demographic factors at baseline between those who attended for follow-up and those who did not. In work package 3, the IMPaCT randomised controlled trial, care co-ordinators struggled to provide additional time to their patients that was devoted to the health promotion intervention on top of their usual clinical care contact with them. Conclusions: Cardiometabolic risk is prominent even soon after first presentation with psychosis and increases over time. Lifestyle choices and substance use habits at first presentation do not predict those who will be most cardiometabolically compromised 1 year later. Training and supervising care co-ordinators to deliver a health promotion intervention to their own patients on top of routine care is not effective in the NHS for improving quality of life or reducing cardiometabolic risk. Future work: Further work is needed to develop and evaluate effective, cost-effective and affordable ways of preventing the emergence of and reversing existing cardiometabolic risk indicators in people with psychosis. Trial registration: Current Controlled Trials ISRCTN58667926. Funding: This project was funded by the National Institute for Health Research (NIHR) Programme Grants for Applied Research programme and will be published in full in Programme Grants for Applied Research; Vol. 8, No. 1. See the NIHR Journals Library website for further project information.

Abstract Background There is mounting evidence that people with severe mental illness have unhealthy lifestyles, high rates of cardiovascular and metabolic diseases, and greater risk of early mortality. This study aimed to assess the cost-effectiveness of a health promotion intervention seeking to improve physical health and reduce substance use in people with psychosis. Methods Participants with a psychotic disorder, aged 18-65 years old and registered on an enhanced care approach programme or equivalent were recruited from community mental health teams in six mental health trusts in England. Participants were randomisation to either standard community mental health team care (treatment as usual) or treatment as usual with an integrated health promotion intervention (IMPaCT). Cost-effectiveness and cost-utility analyses from health and social care and societal perspectives were conducted alongside a cluster randomised controlled trial. Total health and social care costs and total societal costs at 12 and 15 months were calculated as well as cost-effectiveness (incremental cost-effectiveness ratios and cost-effectiveness acceptability curves) at 15 months based on quality of life (SF-36 mental and physical health components, primary outcome measures) and quality adjusted life years (QALYs) using two measures, EQ-5D-3 L and SF-36. Data were analysed using bootstrapped regressions with covariates for relevant baseline variables. Results At 12-15 months 301 participants had full data needed to be included in the economic evaluation. There were no differences in adjusted health and social care costs (£95, 95% CI -£1410 to £1599) or societal costs (£675, 95% CI -£1039 to £2388) between the intervention and control arms. Similarly, there were no differences between the groups in the SF-36 mental component (−0.80, 95% CI -3.66 to 2.06), SF-36 physical component (−0.68, 95% CI -3.01 to 1.65), QALYs estimated from the SF-36 (−0.00, −0.01 to 0.00) or QALYs estimated from the EQ-5D-3 L (0.00, 95% CI -0.01 to 0.02). Cost-effectiveness acceptability curves for all four outcomes and from both cost perspectives indicate that the probability of the health promotion intervention being cost-effective does not exceed 0.4 for willingness to pay thresholds ranging from £0-£50,000. Conclusions Alongside no evidence of additional quality of life/clinical benefit, there is also no evidence of cost-effectiveness. Trial registration ISRCTN58667926 . Date retrospectively registered: 23/04/2010. Recruitment start date: 01/03/2010.

Abstract Background People with psychosis have a reduced life expectancy of 10–20 years, largely due to cardiovascular disease. This trial aimed to determine the effectiveness of a modular health promotion intervention (IMPaCT Therapy) in improving health and reducing cardiovascular risk in psychosis. Methods A multicentre, two arm, parallel cluster RCT was conducted across five UK mental health NHS trusts. Community care coordinators (CC) were randomly assigned to training and supervision in delivering IMPaCT Therapy or treatment as usual (TAU) to current patients with psychosis (cluster). The primary outcome was the physical and mental health subscales of the Short form-36 (SF-36) questionnaire. Results Of 104 care coordinators recruited, 52 (with 213 patients) were randomised to deliver IMPaCT therapy and 52 (with 193 patients) randomised to TAU. Of 406 patients, 318 (78%) and 301 (74%) attended 12- and 15-month follow-up respectively. IMPaCT therapy showed no significant effect on the physical or mental health component SF-36 scores versus TAU at 12 or 15 months. No effect was observed for cardiovascular risk indicators, except for HDL cholesterol, which improved more with IMPACT therapy than TAU (Treatment effect (95% CI); 0.085 (0.007 to 0.16); p = 0.034). The 22% of patients who received >180 min of IMPACT Therapy in addition to usual care achieved a greater reduction in waist circumference than did controls, which was clinically significant. Conclusion Training and supervising community care coordinators to use IMPaCT therapy in patients with psychosis is insufficient to significantly improve physical or mental health quality of life. The search for effective, pragmatic interventions deliverable in health care services continues. Trial registration The trial was retrospectively registered with ISRCTN registry on 23/4/2010 at ISRCTN58667926 ; recruitment started on 01/03/2010 with first randomization on 09.08.2010 ISRCTN58667926 .

BackgroundPatients with serious mental disorders have poorer healthcare outcomes at the end of life and are at greater risk of dying from unnatural causes.AimsTo explore place of death and demographic and clinical correlates of unnatural causes of death in patients with serious mental disorders.MethodRoutinely collected patient data were used to explore bivariate and adjusted associations between covariates and natural/unnatural cause of death.ResultsIn multivariable analysis (n = 1029), dying at home (odds ratio (OR) = 1.87, 95% CI 1.03–3.40), ‘other’ locations (OR = 16.50, 95% CI 7.57–36.00), younger age (OR = 17.26, 95% CI 8.28–36.00) and a diagnosis other than schizophrenia spectrum disorder (OR = 1.69, 95% CI 1.04–2.73) were correlates of unnatural cause of death.ConclusionsDeaths from unnatural causes were high and more likely to occur at home and non-healthcare settings. Unnatural causes of death were higher in younger patients with non-schizophrenia spectrum disorder diagnoses.Declaration of interestF.G. has received support or honoraria for CME, advisory work and lectures from Bristol-Myers Squibb, Janssen, Lundbeck, Otsuka, Roche, and Sunovion, and has a family member with professional links to Lilly and GSK, including shares.

Introduction: Cardiovascular morbidity and mortality are increased in severe mental illnesses (SMI). Trials of psychosocial health interventions to improve physical health in SMI, including in treatment-resistant schizophrenia, have shown some benefit. However, the representativeness of participants in such trials has not been determined.Method: We utilized an anonymised case register to determine if participants in a randomized controlled trial (RCT) of a novel psychosocial health intervention aiming to improve physical health in SMI had similar severity of illness to eligible non-participants. A retrospective database analysis was performed, using Health of the Nation Outcome Scale (HoNOS) data from the sample of patients participating in the IMPaCT (Improving Physical health and reducing substance use in Psychosis) RCT (n = 293) compared to all eligible participants with a psychotic illness (n = 774).Results: The mean total HoNOS score in the eligible comparator population (Mean = 9.09, SD = 5.8, range = 0–30) was significantly greater than that of the IMPaCT RCT participants (Mean = 7.16, SD = 4.7, range = 0–26), (t = 3.810, p = 0.006), as was the degree of overall illness severity and functional impairment, as measured by HoNOS.Conclusion: This study shows for the first time that the patient population participating in an RCT of a lifestyle intervention for those with SMI had a better mental health status at entry to the trial, than the total eligible population, although there was no difference in physical health needs. This has relevance to the applicability of RCTs of lifestyle interventions in service planning and suggests that when people are more unwell, greater effort may be needed to include them in psychosocial interventions. A more careful and focused recruitment approach should be followed to improve the participation of the more severely ill patients in psychosocial interventions in order to enhance the external validity of such studies.

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.

Progress in personalised psychiatry is dependent on researchers having access to systematic and accurately acquired symptom data across clinical diagnoses. We have developed a structured psychiatric assessment tool, OPCRIT+, that is being introduced into the electronic medical records system of the South London and Maudsley NHS Foundation Trust which can help to achieve this. In this report we examine the utility of the symptom data being collected with the tool. Cross-sectional mental state data from a mixed-diagnostic cohort of 876 inpatients was subjected to a principal components analysis (PCA). Six components, explaining 46% of the variance in recorded symptoms, were extracted. The components represented dimensions of mania, depression, positive symptoms, anxiety, negative symptoms and disorganization. As indicated by component scores, different clinical diagnoses demonstrated distinct symptom profiles characterized by wide-ranging levels of severity. When comparing the predictive value of symptoms against diagnosis for a variety of clinical outcome measures (e.g. 'Overactive, aggressive behaviour'), symptoms proved superior in five instances (R(2) range: 0.06-0.28) whereas diagnosis was best just once (R(2):0.25). This report demonstrates that symptom data being routinely gathered in an NHS trust, when documented on the appropriate tool, have considerable potential for onward use in a variety of clinical and research applications via representation as dimensions of psychopathology.