A core outcome set for trials evaluating self-management interventions in people with severe mental illness and coexisting type 2 diabetes.

BACKGROUND: People with severe mental illness (SMI), such as schizophrenia, have higher rates of type 2 diabetes and worse outcomes, compared to those without SMI and it is not known whether diabetes self-management interventions are effective for people who have both conditions. Research in this area has been impeded by a lack of consensus on which outcomes to prioritise in people with co-existing SMI and diabetes. AIMS: To develop a core outcome set (COS) for use in effectiveness trials of diabetes self-management interventions in adults with both type 2 diabetes and SMI. METHODS: The COS was developed in three stages: (i) identification of outcomes from systematic literature review of intervention studies, followed by multi-stakeholder and service user workshops; (ii) rating of outcomes in a two-round online Delphi survey; (iii) agreement of final 'core' outcomes through a stakeholder consensus workshop. RESULTS: Seven outcomes were selected: glucose control, blood pressure, body composition (body weight, BMI, body fat), health-related quality of life, diabetes self-management, diabetes-related distress and medication adherence. CONCLUSIONS: This COS is recommended for future trials of effectiveness of diabetes self-management interventions for people with SMI and type 2 diabetes. Its use will ensure trials capture important outcomes and reduce heterogeneity so findings can be readily synthesised to inform practice and policy.

The Lived Experiences of Family Members and Carers of People with Psychosis: A Bottom-Up Review Co-Written by Experts by Experience and Academics.

Informal caregivers of individuals affected by psychotic disorder can play a key role in the recovery process. However, little research has been conducted on the lived experiences of carers and family members. We conducted a bottom-up (from lived experience to theory) review of first-person accounts, co-written between academics and experts by experience, to identify key experiential themes. First-person accounts of carers, relatives, and individuals with psychosis were screened and discussed in collaborative workshops involving individuals with lived experiences of psychosis, family members, and carers, representing various organizations. The lived experiences of family members and carers were characterized by experiential themes related to dealing with the unexpected news, the search for a reason behind the disorder, living with difficult and negative emotions, dealing with loss, feeling lost in fragmented healthcare systems, feeling invisible and wanting to be active partners in care, struggling to communicate with the affected person, fighting stigma and isolation, dealing with an uncertain future, and learning from one's mistakes and building resilience and hope. Our findings bring forth the voices of relatives and informal carers of people with psychosis, by highlighting some of the common themes of their lived experiences from the time of the initial diagnosis and throughout the different clinical stages of the disorder. Informal carers are key stakeholders who can play a strategic role, and their contributions in the recovery process merit recognition and active support by mental health professionals.

Development of a Supported Self-management Intervention for People With Severe Mental Illness and Type 2 Diabetes: Theory and Evidence-Based Co-design Approach.

BACKGROUND: Type 2 diabetes is 2 to 3 times more common among people with severe mental illness (SMI). Self-management is crucial, with additional challenges faced by people with SMI. Therefore, it is essential that any diabetes self-management program for people with SMI addresses the unique needs of people living with both conditions and the inequalities they experience within health care services. OBJECTIVE: We combined theory, empirical evidence, and co-design approaches to develop a type 2 diabetes self-management intervention for people with SMI. METHODS: The development process encompassed 4 steps: step 1 involved prioritizing the mechanisms of action (MoAs) and behavior change techniques (BCTs) for the intervention. Using findings from primary qualitative research and systematic reviews, we selected candidate MoAs to target in the intervention and candidate BCTs to use. Expert stakeholders then ranked these MoAs and BCTs using a 2-phase survey. The average scores were used to generate a prioritized list of MoAs and BCTs. During step 2, we presented the survey results to an expert consensus workshop to seek expert agreement with the definitive list of MoAs and BCTs for the intervention and identify potential modes of delivery. Step 3 involved the development of trigger films using the evidence from steps 1 and 2. We used animations to present the experiences of people with SMI managing diabetes. These films were used in step 4, where we used a stakeholder co-design approach. This involved a series of structured workshops, where the co-design activities were informed by theory and evidence. RESULTS: Upon the completion of the 4-step process, we developed the DIAMONDS (diabetes and mental illness, improving outcomes and self-management) intervention. It is a tailored self-management intervention based on the synthesis of the outputs from the co-design process. The intervention incorporates a digital app, a paper-based workbook, and one-to-one coaching designed to meet the needs of people with SMI and coexisting type 2 diabetes. CONCLUSIONS: The intervention development work was underpinned by the MoA theoretical framework and incorporated systematic reviews, primary qualitative research, expert stakeholder surveys, and evidence generated during co-design workshops. The intervention will now be tested for feasibility before undergoing a definitive evaluation in a pragmatic randomized controlled trial.

Healthcare resource use and costs for people with type 2 diabetes mellitus with and without severe mental illness in England: longitudinal matched-cohort study using the Clinical Practice Research Datalink.

BACKGROUND: Approximately 60 000 people in England have coexisting type 2 diabetes mellitus (T2DM) and severe mental illness (SMI). They are more likely to have poorer health outcomes and require more complex care pathways compared with those with T2DM alone. Despite increasing prevalence, little is known about the healthcare resource use and costs for people with both conditions. AIMS: To assess the impact of SMI on healthcare resource use and service costs for adults with T2DM, and explore the predictors of healthcare costs and lifetime costs for people with both conditions. METHOD: This was a matched-cohort study using data from the Clinical Practice Research Datalink linked to Hospital Episode Statistics for 1620 people with comorbid SMI and T2DM and 4763 people with T2DM alone. Generalised linear models and the Bang and Tsiatis method were used to explore cost predictors and mean lifetime costs respectively. RESULTS: There were higher average annual costs for people with T2DM and SMI (£1930 higher) than people with T2DM alone, driven primarily by mental health and non-mental health-related hospital admissions. Key predictors of higher total costs were older age, comorbid hypertension, use of antidepressants, use of first-generation antipsychotics, and increased duration of living with both conditions. Expected lifetime costs were approximately £35 000 per person with both SMI and T2DM. Extrapolating nationally, this would generate total annual costs to the National Health Service of around £250 m per year. CONCLUSIONS: Our estimates of resource use and costs for people with both T2DM and SMI will aid policymakers and commissioners in service planning and resource allocation.

The digital divide: amplifying health inequalities for people with severe mental illness in the time of COVID-19.

During COVID-19, health provision and information resources have been increasingly provided via digital means (e.g. websites, apps) and this will become a standard practice beyond the pandemic. People with severe mental illness face profound health inequalities (e.g. a >20-year mortality gap). Digital exclusion puts this population at risk of heightened or compounded inequalities. This has been referred to as the 'digital divide'. For any new digital means introduced in clinical practice to augment healthcare service provision, issues of accessibility, acceptability and usability should be addressed by researchers and developers early in the design phase, and prior to full implementation, to prevent digital exclusion.

Living with diabetes alongside a severe mental illness: A qualitative exploration with people with severe mental illness, family members and healthcare staff.

AIMS: Diabetes is two to three times more prevalent in people with severe mental illness, yet little is known about the challenges of managing both conditions from the perspectives of people living with the co-morbidity, their family members or healthcare staff. Our aim was to understand these challenges and to explore the circumstances that influence access to and receipt of diabetes care for people with severe mental illness. METHODS: Framework analysis of qualitative semi-structured interviews with people with severe mental illness and diabetes, family members, and staff from UK primary care, mental health and diabetes services, selected using a maximum variation sampling strategy between April and December 2018. RESULTS: In all, 39 adults with severe mental illness and diabetes (3 with type 1 diabetes and 36 with type 2 diabetes), nine family members and 30 healthcare staff participated. Five themes were identified: (a) Severe mental illness governs everyday life including diabetes management; (b) mood influences capacity and motivation for diabetes self-management; (c) cumulative burden of managing multiple physical conditions; (d) interacting conditions and overlapping symptoms and (e) support for everyday challenges. People living with the co-morbidity and their family members emphasised the importance of receiving support for the everyday challenges that impact diabetes management, and identified barriers to accessing this from healthcare providers. CONCLUSIONS: More intensive support for diabetes management is needed when people's severe mental illness (including symptoms of depression) or physical health deteriorates. Interventions that help people, including healthcare staff, distinguish between symptoms of diabetes and severe mental illness are also needed.

"I don't think I took her fears seriously": Exploring the experiences of family members of individuals at-risk of developing psychosis over 12 months.

Individuals with an at-risk mental state (ARMS) of psychosis experience high levels of distress, anxiety, low mood, and suicidal ideation. Families of ARMS individuals provide significant support but are often neglected by services. This study is the first of its kind to use a novel longitudinal qualitative methodology to directly compare family/carers' earlier experiences supporting ARMS individuals to 12 months later. This provides a more ecologically valid insight into how perceptions change over time and how family/carers adapt. Semistructured interviews were conducted with 10 family/carers at two points within a 12-month period. This study was embedded within a randomized control trial, the Individual and Family Cognitive Behavioural Therapy trial. Interview transcripts were analysed using thematic analysis, with a focus on how experiences and reactions for family/carers changed over time. Over 12 months, four factors were important for family/carers to facilitate their caring role. These were summarized in the thematic map (LACE model): Looking after your own well-being; Accessing additional support from family intervention; Communicating openly with the individual; and Engaging with services for the individual. All four aspects of the model were important in improving family communication, meeting family/carers' unmet needs, and helping them to feel more confident and less isolated in their carer role. Novel implications suggest that when feasible, services should involve family/carers of ARMS individuals in sessions and explore family/carer support strategies in managing their own distress. The most significant insight was the need to develop family/carer resources to educate, normalize, and validate their own experiences.

Patterns of symptoms before a diagnosis of first episode psychosis: a latent class analysis of UK primary care electronic health records.

BACKGROUND: The nature of symptoms in the prodromal period of first episode psychosis (FEP) remains unclear. The objective was to determine the patterns of symptoms recorded in primary care in the 5 years before FEP diagnosis. METHODS: The study was set within 568 practices contributing to a UK primary care health record database (Clinical Practice Research Datalink). Patients aged 16-45 years with a first coded record of FEP, and no antipsychotic prescription more than 1 year prior to FEP diagnosis (n = 3045) was age, gender, and practice matched to controls without FEP (n = 12,180). Fifty-five symptoms recorded in primary care in the previous 5 years, categorised into 8 groups (mood-related, 'neurotic', behavioural change, volition change, cognitive change, perceptual problem, substance misuse, physical symptoms), were compared between cases and controls. Common patterns of symptoms prior to FEP diagnosis were identified using latent class analysis. RESULTS: Median age at diagnosis was 30 years, 63% were male. Non-affective psychosis (67%) was the most common diagnosis. Mood-related, 'neurotic', and physical symptoms were frequently recorded (> 30% of patients) before diagnosis, and behavioural change, volition change, and substance misuse were also common (> 10%). Prevalence of all symptom groups was higher in FEP patients than in controls (adjusted odds ratios 1.33-112). Median time from the first recorded symptom to FEP diagnosis was 2-2.5 years except for perceptual problem (70 days). The optimal latent class model applied to FEP patients determined three distinct patient clusters: 'no or minimal symptom cluster' (49%) had no or few symptoms recorded; 'affective symptom cluster' (40%) mainly had mood-related and 'neurotic' symptoms; and 'multiple symptom cluster' (11%) consulted for three or more symptom groups before diagnosis. The multiple symptom cluster was more likely to have drug-induced psychosis, female, obese, and have a higher morbidity burden. Affective and multiple symptom clusters showed a good discriminative ability (C-statistic 0.766; sensitivity 51.2% and specificity 86.7%) for FEP, and many patients in these clusters had consulted for their symptoms several years before FEP diagnosis. CONCLUSIONS: Distinctive patterns of prodromal symptoms may help alert general practitioners to those developing psychosis, facilitating earlier identification and referral to specialist care, thereby avoiding potentially detrimental treatment delay.

Impact of secondary care financial incentives on the quality of physical healthcare for people with psychosis: a longitudinal controlled study.

BACKGROUND: Concerns have repeatedly been expressed about the quality of physical healthcare that people with psychosis receive. AIMS: To examine whether the introduction of a financial incentive for secondary care services led to improvements in the quality of physical healthcare for people with psychosis. METHOD: Longitudinal data were collected over an 8-year period on the quality of physical healthcare that people with psychosis received from 56 trusts in England before and after the introduction of the financial incentive. Control data were also collected from six health boards in Wales where a financial incentive was not introduced. We calculated the proportion of patients whose clinical records indicated that they had been screened for seven key aspects of physical health and whether they were offered interventions for problems identified during screening. RESULTS: Data from 17 947 people collected prior to (2011 and 2013) and following (2017) the introduction of the financial incentive in 2014 showed that the proportion of patients who received high-quality physical healthcare in England rose from 12.85% to 31.65% (difference 18.80, 95% CI 17.37-20.21). The proportion of patients who received high-quality physical healthcare in Wales during this period rose from 8.40% to 13.96% (difference 5.56, 95% CI 1.33-10.10). CONCLUSIONS: The results of this study suggest that financial incentives for secondary care mental health services are associated with marked improvements in the quality of care that patients receive. Further research is needed to examine their impact on aspects of care that are not incentivised.

Structured lifestyle education for people with schizophrenia, schizoaffective disorder and first-episode psychosis (STEPWISE): randomised controlled trial.

BACKGROUND: Obesity is a major challenge for people with schizophrenia.AimsWe assessed whether STEPWISE, a theory-based, group structured lifestyle education programme could support weight reduction in people with schizophrenia. METHOD: In this randomised controlled trial (study registration: ISRCTN19447796), we recruited adults with schizophrenia, schizoaffective disorder or first-episode psychosis from ten mental health organisations in England. Participants were randomly allocated to the STEPWISE intervention or treatment as usual. The 12-month intervention comprised four 2.5 h weekly group sessions, followed by 2-weekly maintenance contact and group sessions at 4, 7 and 10 months. The primary outcome was weight change after 12 months. Key secondary outcomes included diet, physical activity, biomedical measures and patient-related outcome measures. Cost-effectiveness was assessed and a mixed-methods process evaluation was included. RESULTS: Between 10 March 2015 and 31 March 2016, we recruited 414 people (intervention 208, usual care 206) with 341 (84.4%) participants completing the trial. At 12 months, weight reduction did not differ between groups (mean difference 0.0 kg, 95% CI -1.6 to 1.7, P = 0.963); physical activity, dietary intake and biochemical measures were unchanged. STEPWISE was well-received by participants and facilitators. The healthcare perspective incremental cost-effectiveness ratio was £246 921 per quality-adjusted life-year gained. CONCLUSIONS: Participants were successfully recruited and retained, indicating a strong interest in weight interventions; however, the STEPWISE intervention was neither clinically nor cost-effective. Further research is needed to determine how to manage overweight and obesity in people with schizophrenia.Declaration of interestR.I.G.H. received fees for lecturing, consultancy work and attendance at conferences from the following: Boehringer Ingelheim, Eli Lilly, Janssen, Lundbeck, Novo Nordisk, Novartis, Otsuka, Sanofi, Sunovion, Takeda, MSD. M.J.D. reports personal fees from Novo Nordisk, Sanofi-Aventis, Lilly, Merck Sharp & Dohme, Boehringer Ingelheim, AstraZeneca, Janssen, Servier, Mitsubishi Tanabe Pharma Corporation, Takeda Pharmaceuticals International Inc.; and, grants from Novo Nordisk, Sanofi-Aventis, Lilly, Boehringer Ingelheim, Janssen. K.K. has received fees for consultancy and speaker for Novartis, Novo Nordisk, Sanofi-Aventis, Lilly, Servier and Merck Sharp & Dohme. He has received grants in support of investigator and investigator-initiated trials from Novartis, Novo Nordisk, Sanofi-Aventis, Lilly, Pfizer, Boehringer Ingelheim and Merck Sharp & Dohme. K.K. has received funds for research, honoraria for speaking at meetings and has served on advisory boards for Lilly, Sanofi-Aventis, Merck Sharp & Dohme and Novo Nordisk. D.Sh. is expert advisor to the NICE Centre for guidelines; board member of the National Collaborating Centre for Mental Health (NCCMH); clinical advisor (paid consultancy basis) to National Clinical Audit of Psychosis (NCAP); views are personal and not those of NICE, NCCMH or NCAP. J.P. received personal fees for involvement in the study from a National Institute for Health Research (NIHR) grant. M.E.C. and Y.D. report grants from NIHR Health Technology Assessment, during the conduct of the study; and The Leicester Diabetes Centre, an organisation (employer) jointly hosted by an NHS Hospital Trust and the University of Leicester and who is holder (through the University of Leicester) of the copyright of the STEPWISE programme and of the DESMOND suite of programmes, training and intervention fidelity framework that were used in this study. S.R. has received honorarium from Lundbeck for lecturing. F.G. reports personal fees from Otsuka and Lundbeck, personal fees and non-financial support from Sunovion, outside the submitted work; and has a family member with professional links to Lilly and GSK, including shares. F.G. is in part funded by the National Institute for Health Research Collaboration for Leadership in Applied Health Research & Care Funding scheme, by the Maudsley Charity and by the Stanley Medical Research Institute and is supported by the by the Biomedical Research Centre at South London and Maudsley NHS Foundation Trust and King's College London.

STructured lifestyle education for people WIth SchizophrEnia (STEPWISE): mixed methods process evaluation of a group-based lifestyle education programme to support weight loss in people with schizophrenia.

BACKGROUND: STEPWISE is a theory-informed self-management education programme that was co-produced with service users, healthcare professionals and interventionists to support weight loss for people with schizophrenia. We report the process evaluation to inform understanding about the intervention and its effectiveness in a randomised controlled trial (RCT) that evaluated its efficacy. METHODS: Following the UK Medical Research Council (MRC) Guidelines for developing and evaluating complex interventions, we explored implementation quality. We considered causal mechanisms, unanticipated consequences and contextual factors associated with variation in actual and intended outcomes, and integrated treatment fidelity, using the programme theory and a pipeline logic model. We followed a modified version of Linnan and Steckler's framework and single case design. Qualitative data from semi-structured telephone interviews with service-users (n = 24), healthcare professionals delivering the intervention (n = 20) and interventionists (n = 7) were triangulated with quantitative process and RCT outcome data and with observations by interventionists, to examine convergence within logic model components. RESULTS: Training and course materials were available although lacked co-ordination in some trusts. Healthcare professionals gained knowledge and some contemplated changing their practice to reflect the (facilitative) 'style' of delivery. They were often responsible for administrative activities increasing the burden of delivery. Healthcare professionals recognised the need to address antipsychotic-induced weight gain and reported potential value from the intervention (subject to the RCT results). However, some doubted senior management commitment and sustainability post-trial. Service-users found the intervention highly acceptable, especially being in a group of people with similar experiences. Service-users perceived weight loss and lifestyle benefits; however, session attendance varied with 23% (n = 47) attending all group-sessions and 17% (n = 36) attending none. Service-users who lost weight wanted closer monitoring and many healthcare professionals wanted to monitor outcomes (e.g. weight) but it was outside the intervention design. No clinical or cost benefit was demonstrated from the intermediate outcomes (RCT) and any changes in RCT outcomes were not due to the intervention. CONCLUSIONS: This process evaluation provides a greater understanding of why STEPWISE was unsuccessful in promoting weight loss during the clinical trial. Further research is required to evaluate whether different levels of contact and objective monitoring can support people with schizophrenia to lose weight. TRIAL REGISTRATION: ISRCTN, ISRCTN19447796. Registered 20 March 2014.

Health inequalities and psychosis: time for action.

People with psychosis face a life-restricting and life-shortening epidemic of obesity, diabetes and cardiovascular disease. This can be predicted by the associated antecedent risk factors evident from early in psychosis, yet remain largely ignored. Greater coordination between primary care, secondary care and public health to systematically prevent and intervene earlier for these physical illnesses offers a realistic solution to reduce this health inequality.

Interventions to improve the experience of caring for people with severe mental illness: systematic review and meta-analysis.

BACKGROUND: Informal caregiving is an integral part of the care of people with severe mental illness, but the support needs of those providing such care are not often met. AIMS: To determine whether interventions provided to people caring for those with severe mental illness improve the experience of caring and reduce caregiver burden. METHOD: We conducted a systematic review and meta-analyses of randomised controlled trials (RCTs) of interventions delivered by health and social care services to informal carers (i.e. family or friends who provide support to someone with severe mental illness). RESULTS: Twenty-one RCTs with 1589 carers were included in the review. There was evidence suggesting that the carers' experience of care was improved at the end of the intervention by psychoeducation (standardised mean difference -1.03, 95% CI -1.69 to -0.36) and support groups (SMD = -1.16, 95% CI -1.96 to -0.36). Psychoeducation had a benefit on psychological distress more than 6 months later (SMD = -1.79, 95% CI -3.01 to -0.56) but not immediately post-intervention. Support interventions had a beneficial effect on psychological distress at the end of the intervention (SMD = -0.99, 95% CI -1.48 to -0.49) as did problem-solving bibliotherapy (SMD = -1.57, 95% CI -1.79 to -1.35); these effects were maintained at follow-up. The quality of the evidence was mainly low and very low. Evidence for combining these interventions and for self-help and self-management was inconclusive. CONCLUSIONS: Carer-focused interventions appear to improve the experience of caring and quality of life and reduce psychological distress of those caring for people with severe mental illness, and these benefits may be gained in first-episode psychosis. Interventions for carers should be considered as part of integrated services for people with severe mental health problems.

Assessment and treatment of physical health problems among people with schizophrenia: national cross-sectional study.

BACKGROUND: In the UK and other high-income countries, life expectancy in people with schizophrenia is 20% lower than in the general population. AIMS: To examine the quality of assessment and treatment of physical health problems in people with schizophrenia. Method Retrospective audit of records of people with schizophrenia or schizoaffective disorder aged ⩾18. We collected data on nine key aspects of physical health for 5091 patients and combined these with a cross-sectional patient survey. RESULTS: Body mass index was recorded in 2599 (51.1%) patients during the previous 12 months and 1102 (21.6%) had evidence of assessment of all nine key measures. Among those with high blood sugar, there was recorded evidence of 53.5% receiving an appropriate intervention. Among those with dyslipidaemia, this was 19.9%. Despite this, most patients reported that they were satisfied with the physical healthcare they received. CONCLUSIONS: Assessment and treatment of common physical health problems in people with schizophrenia falls well below acceptable standards. Cooperation and communication between primary and secondary care services needs to improve if premature mortality in this group is to be reduced.

Supporting people in Early Intervention in Psychosis services: the role of primary care.

BACKGROUND: Early Intervention in Psychosis (EIP) services offer treatment to people experiencing a first episode of psychosis. Service users may be referred from primary care and discharged directly back at the end of their time in an EIP service. AIM: To explore the role of primary care in supporting EIP service users (SUs) and to understand how to improve collaboration between primary and specialist care. METHOD: Qualitative study comprising semi-structured interviews with SUs, carers, healthcare professionals (HCPs), managers, and commissioners. Interviews were conducted either online or by telephone. Thematic analysis was carried out using principles of constant comparison. Patient and public involvement were key to all stages, including data analysis. RESULTS: In total, 55 interviews were conducted with SUs (n = 13), carers (n = 10), and GPs, EIP HCPs, managers, and commissioners (n = 33). GPs reported difficulties in referring people into EIP services and little contact with SUs while in EIP services, even about physical health. GPs suggested they were not included in planning discharge from EIP to primary care. SUs and carers reported that transition from EIP can lead to uncertainty, distress, and exacerbation of symptoms. GPs reported only being made aware of patients on or after discharge, with no contact for 3 years. GPs described difficulty managing complex medication regimes, and barriers to re-referral to mental health services. CONCLUSION: GPs have a key role in supporting people within EIP services, specifically monitoring and managing physical health. Inclusion of GPs in planning discharge from EIP services is vital.

Motiv8: a study protocol for a cluster-randomised feasibility trial of a weight management intervention for adults with severe mental illness in secure forensic services.

INTRODUCTION: People with severe mental illness have physical comorbidities which result in significant reductions in quality of life and premature mortality. Effective interventions are required that are suitable for people in secure forensic mental health services. We conducted pilot work of a multidisciplinary weight management intervention (Motiv8) which showed improvements in physical and mental health and high levels of satisfaction. We aim to test the feasibility of Motiv8 under cluster randomised conditions, with an aim to investigate the acceptability, feasibility and potential effectiveness of this intervention to supplement standard secure care. METHODS AND ANALYSIS: A randomised waitlist-controlled feasibility trial of a lifestyle intervention (Motiv8) + TAU compared with TAU (+ Motiv8 waitlist) for adults on secure mental health units will be conducted. Thirty-two people (4 cohorts) will be recruited from secure services in Greater Manchester Mental Health NHS Foundation Trust. Participants will be randomly allocated to Motiv8 or TAU + Motiv8 waitlist. All participants will receive Motiv8 during the trial. Assessor-blinded physical/mental health and lifestyle assessments will be conducted at baseline, 10 weeks (post-intervention/waitlist), and after 12 weeks (post-waitlist intervention/follow-up). Motiv8 is a multidisciplinary intervention including exercise sessions, cooking/nutrition classes, physical health education, psychology sessions, sleep hygiene, peer support and medication review by pharmacy. A nested qualitative study will be conducted with a subsample of participants (n = 10) to explore their experiences of taking part. The analysis will focus on feasibility outcomes and tabulated success indicators of the study (e.g. Recruitment rates, retention rates, follow-up retention and response rates, attendance at sessions, the experience of involvement in the trial and delivery of the intervention, assessment of safety, development of a manualised intervention). Thematic analysis will be conducted through qualitative interviews. The analysis will aim to inform the development of a definitive trial. ETHICS AND DISSEMINATION: The trial has been granted ethical approval from the NHS Health Research Authority and adopted onto the UK Clinical Research Network Portfolio. Findings will be disseminated via peer-reviewed publications, professional and public networks, conferences and clinical services. TRIAL REGISTRATION: ISRCTN13539285.

Collaboration across the primary/specialist interface in early intervention in psychosis services: a qualitative study.

Background People with new psychotic symptoms may be managed within an Early Intervention in Psychosis service (EIP). They may be discharged back to primary care at the end of their time in an EIP service. Aim To explore the role of primary care in supporting people with psychosis in an EIP service. Design and Setting Qualitative study, within a programme of work to explore the optimum duration of management within an EIP service. Methods Semi-structured interviews with people in EIP services, carers, general practitioners (GPs) and EIP practitioners. Findings GPs report difficulties in referring people into EIP services, have little contact with people who are supported by EIP services and are not included in planning discharge from EIP service to primary care. Conclusions This study suggests that GPs should have a role in the support of people within EIP services (in particular monitoring and managing physical health) and their carers. Inclusion of GPs in managing discharge from EIP services is vital. We suggest that a joint consultation with the service user, their carer (if they wish) along with EIP care co-ordinator and GP would make this transition smoother.

Bridging the gap from evidence to policy and practice: reducing the progression to metabolic syndrome for children and adolescents on antipsychotic medication.

OBJECTIVES: For children and adolescents, the adverse effects from antipsychotic medicines exaggerate the already considerable burden of having a serious mental illness. Many of these young people face a future not only limited by stigmatizing psychiatric illness but also a life restricted and shortened by physical ill-health, particularly cardiovascular disease and type-2 diabetes. This review focuses on bridging the current gap between available evidence and practice guidelines and policies. METHOD: Following an extensive literature search, key papers focusing on the evidence of the nature and occurrence of metabolic morbidity in children and adolescents following the use of antipsychotic medication were included. RESULTS: There is growing evidence to suggest that some of the key antecedents of metabolic syndrome occur soon after diagnosis and initiation of antipsychotic medication, and they accumulate over time. CONCLUSION: While guidelines and policies around the monitoring of metabolic syndrome in children and adolescents with mental illness receiving antipsychotic medication are limited, an opportunity lies in altering the trajectory towards cardiovascular disease and type-2 diabetes by early recognition and intervention to reduce cardiometabolic risk rather than waiting until disease end-points are reached later in life.

Periodontal disease in people with a history of psychosis: Results from the UK biobank population-based study.

OBJECTIVES: To test the hypotheses that: (1) Prevalence of periodontal disease would be higher in people with a history of psychosis when compared to the general population and (2) Demographic, life-style related factors and co-morbid medical conditions would predict periodontal disease in people experiencing psychosis. METHODS: The authors performed cross-sectional analysis of baseline data from the UK Biobank study (2007-2010), identifying cases with psychosis using clinical diagnosis, antipsychotic medication, and self-report. Demographic (age, gender, ethnicity, socioeconomic status), lifestyle-related(BMI, blood pressure, smoking and alcohol intake, physical activity) and physical co-morbidities (cancer, cardiovascular, respiratory, inflammatory disease and metabolic conditions) were included as potential risk factors for periodontal disease among people with a history of psychosis using logistic regression analyses. The analysis sample included 502,505 participants. RESULTS: Risk of periodontal disease was higher in people with psychosis, regardless of how cases were identified. Patients with a clinical diagnosis had the highest proportion of periodontal disease compared to the general population (21.3% vs. 14.8%, prevalence ratio 1.40, 95% CI: 1.26-1.56). Older and female cases were more likely to experience periodontal disease. Lifestyle factors (smoking) and comorbidities (cardiovascular, cancer or respiratory disease) were associated with periodontal disease among people with a history of psychosis. CONCLUSIONS: The findings suggest that periodontal disease is more common in people with a history of psychosis, compared to the general population. Prevention and early diagnosis of periodontal disease should be a priority for oral health promotion programmes, which should also address modifiable risk factors like smoking which also contribute to co-morbid systemic disease.

Understanding the relationship between oral health and psychosis: qualitative analysis.

BACKGROUND: Individuals with psychosis have poor oral health compared with the general population. The interaction between oral health and psychosis is likely to be complex and have important ramifications for improving dental and mental health outcomes. However, this relationship is poorly understood and rarely studied using qualitative methods. AIMS: To explore patient perspectives on the relationship between oral health and psychosis. METHOD: The authors recruited 19 people with experiences of psychosis from community mental health teams, early intervention in psychosis services, and rehabilitation units. Participants completed a qualitative interview. Transcripts were analysed with reflexive thematic analysis. RESULTS: The analysis resulted in three themes: theme 1, psychosis creates barriers to good oral health, including a detachment from reality, the threat of unusual experiences and increased use of substances; theme 2, the effects of poor oral health in psychosis, with ramifications for self-identify and social relationships; and theme 3, systems for psychosis influence oral health, with central roles for formal and informal support networks. CONCLUSIONS: Psychosis was perceived to affect adherence to oral health self-care behaviours and overall oral health. Poor oral health negatively affected self-identity and social relationships. Clinical implications include a systemic approach to provide early intervention and prevention of the sequelae of dental disease, which lead to tooth loss and impaired oral function and aesthetics, which in turn affect mental health. Participants felt that mental health services play an important role in supporting people with oral health.