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Background and Hypothesis Cognitive remediation (CR) benefits cognition and functioning in psychosis but we do not know the optimal level of therapist contact, so we evaluated the potential benefits of different CR modes. Study Design A multi-arm, multi-center, single-blinded, adaptive trial of therapist-supported CR. Participants from 11 NHS early intervention psychosis services were independently randomized to Independent, Group, One-to-One, or Treatment-as-usual (TAU). The primary outcome was functional recovery (Goal Attainment Scale [GAS]) at 15-weeks post randomization. Independent and TAU arms were closed after an interim analysis, and three informative contrasts tested (Group vs One-to-One, Independent vs TAU, Group + One-to-One vs TAU). Health economic analyses considered the cost per Quality Adjusted Life Year (QALY). All analyses used intention-to-treat principles. Study Results We analyzed 377 participants (65 Independent, 134 Group, 112 One-to-One, 66 TAU). GAS did not differ for Group vs One-to-One: Cohen’s d: 0.07, −0.25 to 0.40 95% CI, P = .655; Independent vs TAU: Cohen’s d: 0.07, −0.41 to 0.55 95% CI, P = .777. GAS and the cognitive score improved for Group + One-to-One vs TAU favoring CR (GAS: Cohen’s d: 0.57, 0.19–0.96 95% CI, P = .003; Cognitive score: Cohens d: 0.28, 0.07–0.48 95% CI, P = .008). The QALY costs were £4306 for Group vs TAU and £3170 for One-to-One vs TAU. Adverse events did not differ between treatment methods and no serious adverse events were related to treatment. Conclusions Both active therapist methods provided cost-effective treatment benefiting functional recovery in early psychosis and should be adopted within services. Some individuals benefited more than others so needs further investigation. Trial registration ISRCTN14678860 https://doi.org/10.1186/ISRCTN14678860Now closed.

Deficits in social and occupational function are widely reported in psychosis, yet no one measure of function is currently agreed upon as a gold standard in psychosis research. The aim of this study was to carry out a systematic review and meta-analysis of functioning measures to determine what measures were associated with largest effect sizes when measuring between-group differences, changes over time, or response to treatment. Literature searches were conducted based on PsycINFO and PubMed to identify studies for inclusion. Cross-sectional and longitudinal observational and intervention studies of early psychosis (≤5 years since diagnosis) that included social and occupational functioning as an outcome measure were considered. A series of meta-analyses were conducted to determine effect size differences for between-group differences, changes over time, or response to treatment. Subgroup analyses and meta-regression were carried out to account for variability in study and participant characteristics. One hundred and sixteen studies were included, 46 studies provided data (N = 13 261) relevant to our meta-analysis. Smallest effect sizes for changes in function over time and in response to treatment were observed for global measures, while more specific measures of social and occupational function showed the largest effect sizes. Differences in effect sizes between functioning measures remained significant after variability in study and participant characteristics were accounted for. Findings suggest that more specific measures of social function are better able to detect changes in function over time and in response to treatment.

Acknowledgements: M.B. and S.P.S are part funded by the National Institute for Health Research through the Applied Research Collaboration West Midlands (ARC-WM). P.B.J. is part funded by the NIHR ARC East of England. The views expressed in this publication are those of the authors and not necessarily those of the NHS, NIHR, or Department of Health. Birmingham and Solihull NHS Foundation Trust acted as study sponsor. We would like to thank the participants of the National EDEN study and the UK Clinical Research Network for study support., Funder: Programme Grants for Applied Research; doi: http://dx.doi.org/10.13039/501100007602, PURPOSE: Psychosis disproportionally affects ethnic minority groups in high-income countries, yet evidence of disparities in outcomes following intensive early intervention service (EIS) for First Episode Psychosis (FEP) is less conclusive. We investigated 5-year clinical and social outcomes of young people with FEP from different racial groups following EIS care. METHOD: Data were analysed from the UK-wide NIHR SUPEREDEN study. The sample at baseline (n = 978) included White (n = 750), Black (n = 71), and Asian (n = 157) individuals, assessed during the 3 years of EIS, and up to 2 years post-discharge (n = 296; Black [n = 23]; Asian [n = 52] and White [n = 221]). Outcome trajectories were modelled for psychosis symptoms (positive, negative, and general), functioning, and depression, using linear mixed effect models (with random intercept and slopes), whilst controlling for social deprivation. Discharge service was also explored across racial groups, 2 years following EIS. RESULTS: Variation in linear growth over time was accounted for by racial group status for psychosis symptoms-positive (95% CI [0.679, 1.235]), negative (95% CI [0.315, 0.783]), and general (95% CI [1.961, 3.428])-as well as for functioning (95% CI [11.212, 17.677]) and depressive symptoms (95% CI [0.261, 0.648]). Social deprivation contributed to this variance. Black individuals experienced greater levels of deprivation (p < 0.001, 95% CI [0.187, 0.624]). Finally, there was a greater likelihood for Asian (OR = 3.04; 95% CI [2.050, 4.498]) and Black individuals (OR = 2.47; 95% CI [1.354, 4.520]) to remain in secondary care by follow-up. CONCLUSION: Findings suggest variations in long-term clinical and social outcomes following EIS across racial groups; social deprivation contributed to this variance. Black and Asian individuals appear to make less improvement in long-term recovery and are less likely to be discharged from mental health services. Replication is needed in large, complete data, to fully understand disparities and blind spots to care.

Background:Many individuals with first-episode psychosis experience severe and persistent social disability despite receiving specialist early intervention. The SUPEREDEN3 trial assessed whether augmenting early intervention in psychosis services with Social Recovery Therapy (SRT) would lead to better social recovery.Aims:A qualitative process evaluation was conducted to explore implementation and mechanisms of SRT impact from the perspective of SUPEREDEN3 participants.Method:A subsample of SUPEREDEN3 trial participants (n = 19) took part in semi-structured interviews, which were transcribed verbatim and analysed thematically. Trial participants were early intervention service users aged 16–35 years with severe and persistent social disability. Both SRT plus early intervention and early intervention alone arm participants were interviewed to facilitate better understanding of the context in which SRT was delivered and to aid identification of mechanisms specific to SRT.Results:The six themes identified were used to generate an explanatory model of SRT’s enhancement of social recovery. Participant experiences highlight the importance of the therapist cultivating increased self-understanding and assertively encouraging clients to face feared situations in a way that is perceived as supportive, while managing ongoing symptoms. The sense of achievement generated by reaching targets linked to personally meaningful goals promotes increased self-agency, and generates hope and optimism.Conclusions:The findings suggest potentially important processes through which social recovery was enhanced in this trial, which will be valuable in ensuring the benefits observed can be replicated. Participant accounts provide hope that, with the right support, even clients who have persistent symptoms and the most severe disability can make a good social recovery.

Funder: Department of Health (DH); doi: https://doi.org/10.13039/501100000276, Early psychosis is characterised by heterogeneity in illness trajectories, where outcomes remain poor for many. Understanding psychosis symptoms and their relation to illness outcomes, from a novel network perspective, may help to delineate psychopathology within early psychosis and identify pivotal targets for intervention. Using network modelling in first episode psychosis (FEP), this study aimed to identify: (a) key central and bridge symptoms most influential in symptom networks, and (b) examine the structure and stability of the networks at baseline and 12-month follow-up. Data on 1027 participants with FEP were taken from the National EDEN longitudinal study and used to create regularised partial correlation networks using the 'EBICglasso' algorithm for positive, negative, and depressive symptoms at baseline and at 12-months. Centrality and bridge estimations were computed using a permutation-based network comparison test. Depression featured as a central symptom in both the baseline and 12-month networks. Conceptual disorganisation, stereotyped thinking, along with hallucinations and suspiciousness featured as key bridge symptoms across the networks. The network comparison test revealed that the strength and bridge centralities did not differ significantly between the two networks (C = 0.096153; p = 0.22297). However, the network structure and connectedness differed significantly from baseline to follow-up (M = 0.16405, p =

Aim\ud The 0-19 model is an example of a service that has been retransformed in line with UK's recent policies. However, there is limited qualitative research exploring young people's experiences with the accessibility and acceptability of retransformed models through more participatory qualitative approaches. This study aimed to understand service users' experiences of accessibility and acceptability with the 0-19 model and its service provision. In addition, we also aim to outline the process and application of the Lego® Serious Play® methodology to the context of children and young people's mental health research and reflect on the usefulness of this novel approach and its potential for further research use.\ud \ud Methods\ud A qualitative methodology based on the Lego® Serious Play® approach was used to investigate service users' perceptions of the accessibility and acceptability of the 0-19 model. This novel approach is viewed as a facilitator of engagement, which also stimulates critical thinking and reflective practice. All interviews were thematically analysed.\ud \ud Results\ud Seven participants constructed 14 models and provided metaphorical narratives for them besides engaging in group discussions. Thematic analysis of the participants' models and narratives resulted in six identified themes: accessibility, doors into the unknown, let it out, overcoming obstacles, less is sometimes better and satisfaction with the 0-19 model and its provision.\ud \ud Conclusion\ud Participants in this study perceived the 0-19 model as acceptable and, to a degree, accessible. Participants identified a range of barriers to accessibility, such as inconvenient locations, long waiting and inflexible working times.

Many individuals with early psychosis experience impairments in social and occupational function. Identification of modifiable predictors of function such as cognitive performance has the potential to inform effective treatments. Our aim was to estimate the strength of the relationship between psychosocial function in early psychosis and different domains of cognitive and social cognitive performance. We conducted a systematic review and meta-analysis of peer-reviewed, cross-sectional, and longitudinal studies examining cognitive predictors of psychosocial function. Literature searches were conducted in PsycINFO, PubMed, and reference lists of relevant articles to identify studies for inclusion. Of the 2565 identified, 46 studies comprising 3767 participants met inclusion criteria. Separate meta-analyses were conducted for 9 cognitive domains. Pearson correlation values between cognitive variables and function were extracted. All cognitive domains were related to psychosocial function both cross-sectionally and longitudinally. Importantly, these associations remained significant even after the effects of symptom severity, duration of untreated psychosis, and length of illness were accounted for. Overall, general cognitive ability and social cognition were most strongly associated with both concurrent and long-term function. Associations demonstrated medium effect sizes. These findings suggest that treatments targeting cognitive deficits, in particular those focusing on social cognition, are likely to be important for improving functional outcomes in early psychosis. [Abstract copyright: © The Author(s) 2021. Published by Oxford University Press on behalf of the Maryland Psychiatric Research Center.All rights reserved. For permissions, please email: journals.permissions@oup.com.]

BACKGROUND: Poor functioning is common in psychosis, with predictors of poor outcome including negative symptoms and deficits in neurocognition (NC) and social cognition (SC). The extent to which these variables contribute unique variance in social and role trajectories remains inconclusive. Identifying robust predictors of outcome will inform targeted interventions in early psychosis, where functional trajectories are being set. METHOD: Prospective 12-month follow-up study investigating the predictive values of NC and SC on social and role functioning in individuals with first-episode psychosis (FEP), within the context of clinical variables. 98 individuals with FEP (mean age = 24; male = 77) were assessed within the first year of diagnosis on functioning (social and role), cognition (SC and NC) and psychosis symptoms. RESULTS: Negative symptoms were the only significant predictor of 12-month social (χ2 = 9.59, P = .002, OR = 1.12) and role (χ2 = 10.86, P

Aim:\ud Existing children and adolescent mental health services in the United Kingdom have many gaps, such as reduced access to community‐based services, and a lack of early intervention, prevention, and 24/7 crisis care. These gaps prevent timely access to appropriate levels of care, decrease children and young people's engagement with providers, and lead to increased pressures on urgent and emergency care. In this paper, we outline a newly created 0‐19 model and its crisis service, which have been transformed into a fully integrated, “joint partnership” service, in line with the recommendations from the recent UK policies that aim to meet the aforementioned challenges.\ud \ud Method:\ud The “Solar” service is described as a case study of a 0‐19 service model. We cover the national and local contexts of the service, in addition to its rationale, aims, organizational structure, strengths and limitations.\ud \ud Results:\ud The presented model is a fully integrated and innovative example of a service model that operates without tiers, and helps to create an inclusive, compassionate, stigma‐free and youth‐friendly environment. Additionally, the model aims to prioritize recovery, early intervention, prevention and the development of resilience.\ud \ud Conclusion:\ud The 0‐19 model is a result of the recent transformation of children and youth mental health services in the United Kingdom. The ongoing evaluation of the 0‐19 model and its crisis component will investigate the model's effectiveness, accessibility and acceptability, as well as understanding the potential of the model to contribute towards solving numerous gaps in the existing mental health service provision within the United Kingdom.

IntroductionThe primary aim of the National Institute of Health Research-funded global health research group, Warwick-India-Canada (WIC), is to reduce the burden of psychotic disorders in India. India has a large pool of undetected and untreated patients with psychosis and a treatment gap exceeding 75%. Evidence-based packages of care have been piloted, but delivery of treatments still remains a challenge. Even when patients access treatment, there is minimal to no continuity of care. The overarching ambition of WIC programme is to improve patient outcomes through (1) developing culturally tailored clinical interventions, (2) early identification and timely treatment of individuals with mental illness and (3) improving access to care by exploiting the potential of digital technologies.Methods and analysisThis multicentre, multicomponent research programme, comprising five work packages and two cross-cutting themes, is being conducted at two sites in India: Schizophrenia Research Foundation, Chennai (South India) and All India Institute of Medical Sciences, New Delhi (North India). WIC will (1) develop and evaluate evidence-informed interventions for early and first-episode psychosis; (2) determine pathways of care for early psychosis; (3) investigate the efficacy and cost-effectiveness of community care models, including digital and mobile technologies; (4) develop strategies to reduce the burden of mental illnesses among youth; (5) assess the economic burden of psychosis on patients and their carers; and (6) determine the feasibility of an early intervention in psychosis programme in India.Ethics and disseminationThis study was approved by the University of Warwick’s Biomedical and Scientific Research Ethics Committee (reference: REGO-2018-2208), Coventry, UK and research ethics committees of all participating organisations. Research findings will be disseminated through peer-reviewed scientific publications, presentations at learnt societies and visual media.

Background\ud \ud Many people diagnosed with schizophrenia, bipolar or other psychoses in England receive the majority of their healthcare from primary care. Primary care practitioners may not be well equipped to meet their needs and there is often poor communication with secondary care. Collaborative care is a promising alternative model but has not been trialled specifically with this service user group in England. Collaborative care for other mental health conditions has not been widely implemented despite evidence of its effectiveness. We carried out a formative evaluation of the PARTNERS model of collaborative care, with the aim of establishing barriers and facilitators to delivery, identifying implementation support requirements and testing the initial programme theory. \ud \ud Methods\ud \ud The PARTNERS intervention was delivered on a small scale in three sites. Qualitative data was collected from primary and secondary care practitioners, service users and family carers, using se mi-structured interviews, session recordings and tape-assisted recall. Deductive and inductive thematic analysis was carried out; themes were compared to the programme theory and used to inform an implementation support strategy. \ud \ud Results\ud \ud Key components of the intervention that were not consistently delivered as intended were: interaction with primary care teams, the use of coaching, and supervision. Barriers and facilitators identified were related to service commitment, care partner skills, supervisor understanding and service user motivation. An implementation support strategy was developed, with researcher facilitation of communication and supervision and additional training for practitioners. Some components of the intervention were not experienced as intended; this appeared to reflect difficulties with operationalising the intervention. Analysis of data relating to the intended outcomes of the intervention indicated that the mechanisms proposed in the programme theory had operated as expected. \ud \ud Conclusions\ud \ud Additional implementation support is likely to be required for the PARTNERS model to be delivered; the effectiveness of such support may be affected by practitioner and service user readiness to change. There is also a need to test the programme theory more fully. These issues will be addressed in the process evaluation of our full trial. \ud \ud Trial registration: ISRCTN95702682 , 26 October 2017 \ud

Objective\ud The extant literature is inconsistent over whether manic symptoms in first‐episode psychosis (FEP) impact on its development and trajectory. This study addressed the following: (1) Does Duration of Untreated Illness (DUI) and Duration of Untreated Psychosis (DUP) differ between FEP patients with and without manic symptoms? (2) Do manic symptoms in FEP have an impact on time to remission over 1 year?\ud \ud Methods\ud We used data from the National EDEN study, a longitudinal cohort of patients with FEP accessing early intervention services (EIS) in England, which measured manic, positive and negative psychotic symptoms, depression and functioning at service entry and 1 year. Data from 913 patients with FEP (639 without manic symptoms, 237 with manic symptoms) were analysed using both general linear modelling and survival analysis.\ud \ud Results\ud Compared to FEP patients without manic symptoms, those with manic symptoms had a significantly longer DUI, though no difference in DUP. At baseline, people with manic symptoms had higher levels of positive and negative psychotic symptoms, depression and worse functioning. At 12 months, people with manic symptoms had significantly poorer functioning and more positive psychotic symptoms. The presence of manic symptoms delayed time to remission over 1 year. There was a 19% reduced rate of remission for people with manic symptoms compared to those without.\ud \ud Conclusions\ud Manic symptoms in FEP are associated with delays to treatment. This poorer trajectory persists over 1 year. They appear to be a vulnerable and under‐recognised group for poor outcome and need more focussed early intervention treatment.

Background There is global interest in the reconfiguration of community mental health services, including primary care, to improve clinical and cost effectiveness. Aims This study seeks to describe patterns of service use, continuity of care, health risks, physical healthcare monitoring and the balance between primary and secondary mental healthcare for people with severe mental illness in receipt of secondary mental healthcare in the UK. Method We conducted an epidemiological medical records review in three UK sites. We identified 297 cases randomly selected from the three participating mental health services. Data were manually extracted from electronic patient medical records from both secondary and primary care, for a 2-year period (2012–2014). Continuous data were summarised by mean and s.d. or median and interquartile range (IQR). Categorical data were summarised as percentages. Results The majority of care was from secondary care practitioners: of the 18 210 direct contacts recorded, 76% were from secondary care (median, 36.5; IQR, 14–68) and 24% were from primary care (median, 10; IQR, 5–20). There was evidence of poor longitudinal continuity: in primary care, 31% of people had poor longitudinal continuity (Modified Modified Continuity Index ≤0.5), and 43% had a single named care coordinator in secondary care services over the 2 years. Conclusions The study indicates scope for improvement in supporting mental health service delivery in primary care. Greater knowledge of how care is organised presents an opportunity to ensure some rebalancing of the care that all people with severe mental illness receive, when they need it. A future publication will examine differences between the three sites that participated in this study.

Psychosis is a major mental illness with first onset in young adults. The prognosis is poor in around half of the people affected, and difficult to predict. The few tools available to predict prognosis have major weaknesses which limit their use in clinical practice. We aimed to develop and validate a risk prediction model of symptom nonremission in first-episode psychosis. Our development cohort consisted of 1027 patients with first-episode psychosis recruited between 2005 and 2010 from 14 early intervention services across the National Health Service in England. Our validation cohort consisted of 399 patients with first-episode psychosis recruited between 2006 and 2009 from a further 11 English early intervention services. The one-year nonremission rate was 52% and 54% in the development and validation cohorts, respectively. Multivariable logistic regression was used to develop a risk prediction model for nonremission, which was externally validated. The prediction model showed good discrimination C-statistic of 0.73 (0.64, 0.81) and adequate calibration with intercept alpha of –0.014 (–0.34, 0.31) and slope beta of 0.85 (0.42, 1.27). Our model improved the net-benefit by 16% at a risk threshold of 50% compared to the strategy of treating all, equivalent to 16 more detected nonremitted first-episode psychosis individuals per 100 without incorrectly classifying remitted cases. Once prospectively validated, our first episode psychosis prediction model could help identify patients at increased risk of nonremission at initial clinical contact.

Treatment resistance is prevalent in early intervention in psychosis services, and causes a significant burden for the individual. A wide range of variables are shown to contribute to treatment resistance in first episode psychosis (FEP). Heterogeneity in illness course and the complex, multidimensional nature of the concept of recovery calls for an evidence base to better inform practice at an individual level. Current gold standard treatments, adopting a ‘one-size fits all’ approach, may not be addressing the needs of many individuals. This following review will provide an update and critical appraisal of current clinical practices and methodological approaches for understanding, identifying, and managing early treatment resistance in early psychosis. Potential new treatments along with new avenues for research will be discussed. Finally, we will discuss and critique the application and translation of machine learning approaches to aid progression in this area. The move towards ‘big data’ and machine learning holds some prospect for stratifying intervention-based subgroups of individuals. Moving forward, better recognition of early treatment resistance is needed, along with greater sophistication and precision in predicting outcomes, so that effective evidence-based treatments can be appropriately tailored to the individual. Understanding the antecedents and the early trajectory of one’s illness may also be key to understanding the factors that drive illness course.

Background Treatment resistance causes significant burden in psychosis. Clozapine is the only evidence-based pharmacologic intervention available for people with treatment-resistant schizophrenia; current guidelines recommend commencement after two unsuccessful trials of standard antipsychotics. Aims This paper aims to explore the prevalence of treatment resistance and pathways to commencement of clozapine in UK early intervention in psychosis (EIP) services. Method Data were taken from the National Evaluation of the Development and Impact of Early Intervention Services study (N = 1027) and included demographics, medication history and psychosis symptoms measured by the Positive and Negative Syndrome Scale (PANSS) at baseline, 6 months and 12 months. Prescribing patterns and pathways to clozapine were examined. We adopted a strict criterion for treatment resistance, defined as persistent elevated positive symptoms (a PANSS positive score ≥16, equating to at least two items of at least moderate severity), across three time points. Results A total of 143 (18.1%) participants met the definition of treatment resistance of having continuous positive symptoms over 12 months, despite treatment in EIP services. Sixty-one (7.7%) participants were treatment resistant and eligible for clozapine, having had two trials of standard antipsychotics; however, only 25 (2.4%) were prescribed clozapine over the 12-month study period. Treatment-resistant participants were more likely to be prescribed additional antipsychotic medication and polypharmacy, instead of clozapine. Conclusions Prevalent treatment resistance was observed in UK EIP services, but prescription of polypharmacy was much more common than clozapine. Significant delays in the commencement of clozapine may reflect a missed opportunity to promote recovery in this critical period.

Background Evidence for the effectiveness of treatments in early-onset psychosis is sparse. Current guidance for the treatment of early-onset psychosis is mostly extrapolated from trials in adult populations. The UK National Institute for Health and Care Excellence has recommended evaluation of the clinical effectiveness and cost-effectiveness of antipsychotic drugs versus psychological intervention (cognitive behavioural therapy [CBT] and family intervention) versus the combination of these treatments for early-onset psychosis. The aim of this study was to establish the feasibility of a randomised controlled trial of antipsychotic monotherapy, psychological intervention monotherapy, and antipsychotics plus psychological intervention in adolescents with first-episode psychosis. Methods We did a multicentre pilot and feasibility trial according to a randomised, single-blind, three-arm, controlled design. We recruited participants from seven UK National Health Service Trust sites. Participants were aged 14–18 years; help-seeking; had presented with first-episode psychosis in the past year; were under the care of a psychiatrist; were showing current psychotic symptoms; and met ICD-10 criteria for schizophrenia, schizoaffective disorder, or delusional disorder, or met the entry criteria for an early intervention for psychosis service. Participants were assigned (1:1:1) to antipsychotics, psychological intervention (CBT with optional family intervention), or antipsychotics plus psychological intervention. Randomisation was via a web-based randomisation system, with permuted blocks of random size, stratified by centre and family contact. CBT incorporated up to 26 sessions over 6 months plus up to four booster sessions, and family intervention incorporated up to six sessions over 6 months. Choice and dose of antipsychotic were at the discretion of the treating consultant psychiatrist. Participants were followed up for a maximum of 12 months. The primary outcome was feasibility (ie, data on trial referral and recruitment, session attendance or medication adherence, retention, and treatment acceptability) and the proposed primary efficacy outcome was total score on the Positive and Negative Syndrome Scale (PANSS) at 6 months. Primary outcomes were analysed by intention to treat. Safety outcomes were reported according to as-treated status, for all patients who had received at least one session of CBT or family intervention, or at least one dose of antipsychotics. The study was prospectively registered with ISRCTN, ISRCTN80567433. Findings Of 101 patients referred to the study, 61 patients (mean age 16·3 years [SD 1·3]) were recruited from April 10, 2017, to Oct 31, 2018, 18 of whom were randomly assigned to psychological intervention, 22 to antipsychotics, and 21 to antipsychotics plus psychological intervention. The trial recruitment rate was 68% of our target sample size of 90 participants. The study had a low referral to recruitment ratio (around 2:1), a high rate of retention (51 [84%] participants retained at the 6-month primary endpoint), a high rate of adherence to psychological intervention (defined as six or more sessions of CBT; in 32 [82%] of 39 participants in the monotherapy and combined groups), and a moderate rate of adherence to antipsychotic medication (defined as at least 6 consecutive weeks of exposure to antipsychotics; in 28 [65%] of 43 participants in the monotherapy and combined groups). Mean scores for PANSS total at the 6-month primary endpoint were 68·6 (SD 17·3) for antipsychotic monotherapy (6·2 points lower than at randomisation), 59·8 (13·7) for psychological intervention (13·1 points lower than at randomisation), and 62·0 (15·9) for antipsychotics plus psychological intervention (13·9 points lower than at randomisation). A good clinical response at 6 months (defined as ≥50% improvement in PANSS total score) was achieved in four (22%) of 18 patients receiving antipsychotic monotherapy, five (31%) of 16 receiving psychological intervention, and five (29%) of 17 receiving antipsychotics plus psychological intervention. In as-treated groups, serious adverse events occurred in eight [35%] of 23 patients in the combined group, two [13%] of 15 in the antipsychotics group, four [24%] of 17 in the psychological intervention group, and four [80%] of five who did not receive any treatment. No serious adverse events were considered to be related to participation in the trial. Interpretation This trial is the first to show that a head-to-head clinical trial comparing psychological intervention, antipsychotics, and their combination is safe in young people with first-episode psychosis. However, the feasibility of a larger trial is unclear because of site-specific recruitment challenges, and amendments to trial design would be needed for an adequately powered clinical and cost-effectiveness trial that provides robust evidence. Funding National Institute for Health Research.

Background: Delayed treatment for first episodes of psychosis predicts worse outcomes. We hypothesised that delaying treatment makes all symptoms more refractory, with harm worsening first quickly, then more slowly. We also hypothesised that although delay impairs treatment response, worse symptoms hasten treatment, which at presentation mitigates the detrimental effect of treatment delay on symptoms. Methods: In this longitudinal analysis and modelling study, we included two longitudinal cohorts of patients with first-episode psychosis presenting to English early intervention services from defined catchments: NEDEN (recruiting 1003 patients aged 14–35 years from 14 services between Aug 1, 2005, and April 1, 2009) and Outlook (recruiting 399 patients aged 16–35 years from 11 services between April 1, 2006, and Feb 28, 2009). Patients were assessed at baseline, 6 months, and 12 months with the Positive and Negative Symptom Scale (PANSS), Calgary Depression Scale for Schizophrenia, Mania Rating Scale, Insight Scale, and Social and Occupational Functioning Assessment Scale. Regression was used to compare different models of the relationship between duration of untreated psychosis (DUP) and total symptoms at 6 months. Growth curve models of symptom subscales tested predictions arising from our hypotheses. Findings: We included 948 patients from the NEDEN study and 332 patients from the Outlook study who completed baseline assessments and were prescribed dopamine antagonist antipsychotics. For both cohorts, the best-fitting models were logarithmic, describing a curvilinear relationship of DUP to symptom severity: longer DUP predicted reduced treatment response, but response worsened more slowly as DUP lengthened. Increasing DUP by ten times predicted reduced improvement in total symptoms (ie, PANSS total) by 7·339 (95% CI 5·762 to 8·916; p

Background:\ud India has a large youth population whose mental health needs must be addressed. This includes promotion of positive mental health, with early detection and effective intervention for mental health disorders. Understanding the perspectives of community stakeholders working with youth is pivotal to this effort. Current study aimed to bring together a group of community stakeholders (eg, parents, teachers, policy makers) to understand their perspectives on youth mental health problems, challenges in provision of care, and to provide recommendations to address these concerns at national level.\ud \ud Materials and methods:\ud The study was conducted across two sites in India: Chennai and New Delhi. Three group meetings were conducted involving 52 participants, including governmental, non‐governmental and community representatives working with youth. The proceedings were manually recorded, transcribed, and analyzed using thematic analysis method.\ud \ud Results:\ud Many youth mental health problems were similar across the two sites. The commonest drivers of mental health problems were reported to be academic pressure, substance use and problematic internet/social media use. Stigma and lack of awareness were identified as the most important challenges acting as barriers to seeking mental health help by youth. Prioritizing youth mental health as a national programmes along with strong political will were the major recommendations suggested by the stakeholders.\ud \ud Conclusion:\ud Initial findings suggest that prioritizing youth mental health programmes in India would be advantageous. Inclusive and collaborative approach, involving community stakeholders working with youth in providing services that promote mental health and early access to care will help in developing healthy young citizens.

AimsCo‐design implies genuine partnership in the generation of knowledge between service users and researchers. Service user involvement in research has been encouraged in government policy, but it is rarely achieved, especially at trial initial stages. Co‐designed with service users, we adapted existing manualised social cognition intervention for people with a first episode of psychosis to a virtual world environment.MethodsWe invited a group of young people who have used mental health services to co‐design a virtual environment to deliver an accessible social cognition intervention to a hard to engage service user group. We used an iterative process with young service users and the design team that included developing initial ideas, creating a prototype and testing the virtual world.ResultsTwenty young service users of local mental healthcare services provided feedback on the design and delivery of the intervention. Reflecting the demographic of the sample, young people felt the virtual environment should be familiar, urban spaces, akin to therapy rooms or classrooms they have used in real‐life situations rather than non‐traditional therapy spaces that were initially proposed.ConclusionThe co‐design process led to the development of a specific design, approach and protocol to be tested in a proof‐of‐concept trial. Young service users were integral to an agile and iterative design. Technological innovations should be routinely co‐designed and co‐produced if they are to realise their potential to deliver acceptable and affordable mental health interventions.

There is a need to develop and refine psychosocial interventions to improve functioning in First Episode Psychosis (FEP). Social cognition and neurocognition are closely linked to functioning in psychosis; examinations of cognition pre- and post- psychosocial intervention may provide insights into the mechanisms of these interventions, and identify which individuals are most likely to benefit.\ud \ud Method:\ud Cognition was assessed within a multi-site trial of Social Recovery Therapy (SRT) for individuals with FEP experiencing poor functioning (

BackgroundRelapse in schizophrenia is a major cause of distress and disability and is predicted by changes in symptoms such as anxiety, depression, and suspiciousness (early warning signs [EWSs]). These can be used as the basis for timely interventions to prevent relapse. However, there is considerable uncertainty regarding the implementation of EWS interventions.ObjectiveThis study was designed to establish the feasibility of conducting a definitive cluster randomized controlled trial comparing Early signs Monitoring to Prevent relapse in psychosis and prOmote Well-being, Engagement, and Recovery (EMPOWER) against treatment as usual (TAU). Our primary outcomes are establishing parameters of feasibility, acceptability, usability, safety, and outcome signals of a digital health intervention as an adjunct to usual care that is deliverable in the UK National Health Service and Australian community mental health service (CMHS) settings. We will assess the feasibility of candidate primary outcomes, candidate secondary outcomes, and candidate mechanisms for a definitive trial.MethodsWe will randomize CMHSs to EMPOWER or TAU. We aim to recruit up to 120 service user participants from 8 CMHSs and follow them for 12 months. Eligible service users will (1) be aged 16 years and above, (2) be in contact with local CMHSs, (3) have either been admitted to a psychiatric inpatient service or received crisis intervention at least once in the previous 2 years for a relapse, and (4) have an International Classification of Diseases-10 diagnosis of a schizophrenia-related disorder. Service users will also be invited to nominate a carer to participate. We will identify the feasibility of the main trial in terms of recruitment and retention to the study and the acceptability, usability, safety, and outcome signals of the EMPOWER intervention. EMPOWER is a mobile phone app that enables the monitoring of well-being and possible EWSs of relapse on a daily basis. An algorithm calculates changes in well-being based on participants’ own baseline to enable tailoring of well-being messaging and clinical triage of possible EWSs. Use of the app is blended with ongoing peer support.ResultsRecruitment to the trial began September 2018, and follow-up of participants was completed in July 2019. Data collection is continuing. The database was locked in July 2019, followed by analysis and disclosing of group allocation.ConclusionsThe knowledge gained from the study will inform the design of a definitive trial including finalizing the delivery of our digital health intervention, sample size estimation, methods to ensure successful identification, consent, randomization, and follow-up of participants, and the primary and secondary outcomes. The trial will also inform the final health economic model to be applied in the main trial.Trial RegistrationInternational Standard Randomized Controlled Trial Number (ISRCTN): 99559262; http://isrctn.com/ISRCTN99559262International Registered Report Identifier (IRRID)DERR1-10.2196/15058

No abstract available.

Aim\ud Duration of untreated psychosis (DUP) is considered a key prognostic variable in psychosis. Yet it is unclear whether a longer DUP causes worse outcomes or whether reported associations have alternative explanations. \ud Methods\ud Data from two cohorts of patients with first episode psychosis were used (n=2134). Measures of DUP were assessed at baseline and outcomes at 12 months. Regression models were used to investigate associations between DUP and outcomes. We also investigated whether any associations were replicated using instrumental variables analysis to reduce the effect of residual confounding and measurement bias.\ud Results\ud There were associations between DUP per 1 year increase and positive psychotic symptoms (7.0% in symptom score increase 95% CI 4.0%,10.0% p

Background Cognitive problems in people with schizophrenia predict poor functional recovery even with the best possible rehabilitation opportunities and optimal medication. A psychological treatment known as cognitive remediation therapy (CRT) aims to improve cognition in neuropsychiatric disorders, with the ultimate goal of improving functional recovery. Studies suggest that intervening early in the course of the disorder will have the most benefit, so this study will be based in early intervention services, which treat individuals in the first few years following the onset of the disorder. The overall aim is to investigate different methods of CRT. Methods This is a multicentre, randomised, single-blinded, controlled trial based in early intervention services in National Health Service Mental Health Trusts in six English research sites. Three different methods of providing CRT (intensive, group, and independent) will be compared with treatment as usual. We will recruit 720 service users aged between 16 and 45 over 3 years who have a research diagnosis of non-affective psychosis and will be at least 3 months from the onset of the first episode of psychosis. The primary outcome measure will be the degree to which participants have achieved their stated goals using the Goal Attainment Scale. Secondary outcome measures will include improvements in cognitive function, social function, self-esteem, and clinical symptoms. Discussion It has already been established that cognitive remediation improves cognitive function in people with schizophrenia. Successful implementation in mental health services has the potential to change the recovery trajectory of individuals with schizophrenia-spectrum disorders. However, the best mode of implementation, in terms of efficacy, service user and team preference, and cost-effectiveness is still unclear. The CIRCuiTS trial will provide guidance for a large-scale roll-out of CRT to mental health services where cognitive difficulties impact recovery and resilience. Trial registration ISRCTN, ISRCTN14678860, Registered on 6 June 2016. Electronic supplementary material The online version of this article (10.1186/s13063-018-2553-3) contains supplementary material, which is available to authorized users.

Hospital admissions provide a “teachable moment”. Many patients admitted to mental health hospitals have co-existing substance misuse. As acute symptoms decline, a window of increased insight into factors that contributed to becoming unwell and admission may present. This study used this “teachable” opportunity to assess the acceptability of delivering a brief integrated motivational intervention (BIMI) to inpatients and the feasibility of delivery by inpatient staff. Qualitative interviews were completed with 21 inpatients experiencing co-occurring schizophrenia-related or bipolar disorder diagnoses and substance misuse who received the BIMI. Twelve staff members completed either individual interviews or a focus group. Four themes were identified from the qualitative interviews with participants; these were openness/readiness to talk about substance use, feeling valued, understanding substance use and helpful skills and processes; each with a number of subthemes. Participants appeared to find the intervention useful; although, felt they did not always have the “headspace”. One theme emerged from the staff data, the acceptability of the approach for inpatient ward staff, which had four subthemes; training in the intervention; delivering the intervention; joint working; and feasibility. Staff considered the targeted style of the BIMI useful. Delivery considerations included “timing” and competing ward duties. Hospital admission presents a natural window of opportunity for staff to start conversations with inpatients about substance misuse.