Influence of stigma, sociodemographic and clinical characteristics on mental health-related service use and associated costs among young people in the United Kingdom.

This study examined the influence of stigma, psychopathology, and sociodemographic characteristics on mental health-related service use and costs related to service use in a cohort of young people in the UK. Using data from a community sample of young people aged 9-17 years and their caregivers, we assessed 407 young people's use of services due to mental health problems, young people's psychopathology, demographic characteristics, maternal education and caregivers' stigma-related beliefs. Unit costs related to services were gathered from national annual compendia and other widely used sources. We assessed predictors of service use through logistic regression analysis and developed generalised linear models to identify factors associated with costs of mental health-related service utilisation. Persistent psychopathology, socioeconomic disadvantage, and low caregiver intended stigma-related behaviour were associated with increased likelihood of service use among young people. Older age and socioeconomic disadvantage were associated with increased costs. Different factors influenced contact with services and the cost associated with their use - persistent psychopathology and socioeconomic disadvantage increased, and caregivers' intended stigma-related behaviour decreased the likelihood of using services, whereas socioeconomic disadvantage and older age were associated with increased costs. Social determinants of mental health problems play an important role in the use and costs of different types of mental health-related services for young people. Discordance between drivers of service use and costs implies that young people who are more likely to access services due to mental health problems do not necessarily receive care at the intensity they need.

Clinical effectiveness of the START (STrAtegies for RelaTives) psychological intervention for family carers and the effects on the cost of care for people with dementia: 6-year follow-up of a randomised controlled trial.

BACKGROUND: The START (STrAtegies for RelaTives) intervention reduced depressive and anxiety symptoms of family carers of relatives with dementia at home over 2 years and was cost-effective. AIMS: To assess the clinical effectiveness over 6 years and the impact on costs and care home admission. METHOD: We conducted a randomised, parallel group, superiority trial recruiting from 4 November 2009 to 8 June 2011 with 6-year follow-up (trial registration: ISCTRN 70017938). A total of 260 self-identified family carers of people with dementia were randomised 2:1 to START, an eight-session manual-based coping intervention delivered by supervised psychology graduates, or to treatment as usual (TAU). The primary outcome was affective symptoms (Hospital Anxiety and Depression Scale, total score (HADS-T)). Secondary outcomes included patient and carer service costs and care home admission. RESULTS: In total, 222 (85.4%) of 173 carers randomised to START and 87 to TAU were included in the 6-year clinical efficacy analysis. Over 72 months, compared with TAU, the intervention group had improved scores on HADS-T (adjusted mean difference -2.00 points, 95% CI -3.38 to -0.63). Patient-related costs (START versus TAU, respectively: median £5759 v. £16 964 in the final year; P = 0.07) and carer-related costs (median £377 v. £274 in the final year) were not significantly different between groups nor were group differences in time until care home (intensity ratio START:TAU was 0.88, 95% CI 0.58-1.35). CONCLUSIONS: START is clinically effective and this effect lasts for 6 years without increasing costs. This is the first intervention with such a long-term clinical and possible economic benefit and has potential to make a difference to individual carers. DECLARATIONS OF INTEREST: G.L., Z.W. and C.C. are supported by the UCLH National Institute for Health Research (NIHR) Biomedical Research Centre. G.L. and P.R. were in part supported by the National Institute for Health Research (NIHR) Collaboration for Leadership in Applied Health Research and Care (CLAHRC) North Thames at Bart's Health NHS Trust. The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health. Z.W. reports during the conduct of the study; personal fees from GE Healthcare, grants from GE Healthcare, grants from Lundbeck, other from GE Healthcare, outside the submitted work.

Costing the COVID-19 Pandemic: An Exploratory Economic Evaluation of Hypothetical Suppression Policy in the United Kingdom.

OBJECTIVE: This study aims to cost and calculate the relative cost-effectiveness of the hypothetical suppression policies found in the Imperial College COVID-19 Response Team model. METHODS: Key population-level disease projections in deaths, intensive care unit bed days, and non-intensive care unit bed days were taken from the Imperial College COVID-19 Response Team report of March 2020, which influenced the decision to introduce suppression policies in the United Kingdom. National income loss estimates were from a study that estimated the impact of a hypothetical pandemic on the UK economy, with sensitivity analyses based on projections that are more recent. Individual quality-adjusted life-year (QALY) loss and costed resource use inputs were taken from published sources. RESULTS: Imperial model projected suppression polices compared to an unmitigated pandemic, even with the most pessimistic national income loss scenarios under suppression (10%), give incremental cost-effectiveness ratios below £50 000 per QALY. Assuming a maximum reduction in national income of 7.75%, incremental cost-effectiveness ratios for Imperial model projected suppression versus mitigation are below 60 000 per QALY. CONCLUSIONS: Results are uncertain and conditional on the accuracy of the Imperial model projections; they are also sensitive to estimates of national income loss. Nevertheless, it would be difficult to claim that the hypothetical Imperial model-projected suppression policies are obviously cost-ineffective relative to the alternatives available. Despite evolving differences between government policy and Imperial model-projected suppression policy, it is hoped this article will provide some early insight into the trade-offs that are involved.

Childhood bullying victimization, self-labelling, and help-seeking for mental health problems.

PURPOSE: Previous research found sustained high levels of mental health service use among adults who experienced bullying victimization during childhood. This could be due to increased psychopathology among this group, but other factors, such as self-perception as having a mental health problem, might contribute to increased service use. Additionally, the relationship between informal help-seeking for mental health problems and bullying victimization is incompletely understood. METHODS: The present study examined associations between the frequency of bullying victimization and both formal service use and informal help-seeking for mental health problems independent from psychopathology. Data on bullying victimization, service use, informal help-seeking for mental health problems, psychopathology, and self-labelling as a person with mental illness were collected among 422 young people aged 13-22 years. RESULTS: In logistic regression models, controlling for past and current psychopathology and using no bullying victimization as the reference category, we identified a greater likelihood of mental health service use among persons who experienced frequent bullying victimization, as well as a greater likelihood of seeking informal help among persons who experienced occasional victimization. Increased self-identification as a person with mental illness completely mediated the positive association between frequent bullying victimization and mental health service use. CONCLUSIONS: Our findings suggest that services to support persons who experienced frequent bullying victimization should focus on improving empowerment and self-perception. Additionally, there might be unserved need for formal support among those who experienced occasional bullying victimization.

Improving the quality of life of care home residents with dementia: Cost-effectiveness of an optimized intervention for residents with clinically significant agitation in dementia.

INTRODUCTION: To examine whether an optimized intervention is a more cost-effective option than treatment as usual (TAU) for improving agitation and quality of life in nursing home residents with clinically significant agitation and dementia. METHODS: A cost-effectiveness analysis within a cluster-randomized factorial study in 69 care homes with 549 residents was conducted. Each cluster was randomized to receive either the Well-being and Health for people with Dementia (WHELD) intervention or TAU for nine months. Health and social care costs, agitation, and quality of life outcomes were evaluated. RESULTS: Improvements in agitation and quality of life were evident in residents allocated to the WHELD intervention group. The additional cost of the WHELD intervention was offset by the higher health and social care costs incurred by TAU group residents (mean difference, £2103; 95% confidence interval, -13 to 4219). DISCUSSION: The WHELD intervention has clinical and economic benefits when used in residents with clinically significant agitation.

Impact of person-centred care training and person-centred activities on quality of life, agitation, and antipsychotic use in people with dementia living in nursing homes: A cluster-randomised controlled trial.

BACKGROUND: Agitation is a common, challenging symptom affecting large numbers of people with dementia and impacting on quality of life (QoL). There is an urgent need for evidence-based, cost-effective psychosocial interventions to improve these outcomes, particularly in the absence of safe, effective pharmacological therapies. This study aimed to evaluate the efficacy of a person-centred care and psychosocial intervention incorporating an antipsychotic review, WHELD, on QoL, agitation, and antipsychotic use in people with dementia living in nursing homes, and to determine its cost. METHODS AND FINDINGS: This was a randomised controlled cluster trial conducted between 1 January 2013 and 30 September 2015 that compared the WHELD intervention with treatment as usual (TAU) in people with dementia living in 69 UK nursing homes, using an intention to treat analysis. All nursing homes allocated to the intervention received staff training in person-centred care and social interaction and education regarding antipsychotic medications (antipsychotic review), followed by ongoing delivery through a care staff champion model. The primary outcome measure was QoL (DEMQOL-Proxy). Secondary outcomes were agitation (Cohen-Mansfield Agitation Inventory [CMAI]), neuropsychiatric symptoms (Neuropsychiatric Inventory-Nursing Home Version [NPI-NH]), antipsychotic use, global deterioration (Clinical Dementia Rating), mood (Cornell Scale for Depression in Dementia), unmet needs (Camberwell Assessment of Need for the Elderly), mortality, quality of interactions (Quality of Interactions Scale [QUIS]), pain (Abbey Pain Scale), and cost. Costs were calculated using cost function figures compared with usual costs. In all, 847 people were randomised to WHELD or TAU, of whom 553 completed the 9-month randomised controlled trial. The intervention conferred a statistically significant improvement in QoL (DEMQOL-Proxy Z score 2.82, p = 0.0042; mean difference 2.54, SEM 0.88; 95% CI 0.81, 4.28; Cohen's D effect size 0.24). There were also statistically significant benefits in agitation (CMAI Z score 2.68, p = 0.0076; mean difference 4.27, SEM 1.59; 95% CI -7.39, -1.15; Cohen's D 0.23) and overall neuropsychiatric symptoms (NPI-NH Z score 3.52, p < 0.001; mean difference 4.55, SEM 1.28; 95% CI -7.07,-2.02; Cohen's D 0.30). Benefits were greatest in people with moderately severe dementia. There was a statistically significant benefit in positive care interactions as measured by QUIS (19.7% increase, SEM 8.94; 95% CI 2.12, 37.16, p = 0.03; Cohen's D 0.55). There were no statistically significant differences between WHELD and TAU for the other outcomes. A sensitivity analysis using a pre-specified imputation model confirmed statistically significant benefits in DEMQOL-Proxy, CMAI, and NPI-NH outcomes with the WHELD intervention. Antipsychotic drug use was at a low stable level in both treatment groups, and the intervention did not reduce use. The WHELD intervention reduced cost compared to TAU, and the benefits achieved were therefore associated with a cost saving. The main limitation was that antipsychotic review was based on augmenting processes within care homes to trigger medical review and did not in this study involve proactive primary care education. An additional limitation was the inherent challenge of assessing QoL in this patient group. CONCLUSIONS: These findings suggest that the WHELD intervention confers benefits in terms of QoL, agitation, and neuropsychiatric symptoms, albeit with relatively small effect sizes, as well as cost saving in a model that can readily be implemented in nursing homes. Future work should consider how to facilitate sustainability of the intervention in this setting. TRIAL REGISTRATION: ISRCTN Registry ISRCTN62237498.

Feasibility of a staff training and support programme to improve pain assessment and management in people with dementia living in care homes.

OBJECTIVES: The objective of this study was to establish the feasibility and initial effectiveness of training and support intervention for care staff to improve pain management in people with dementia living in care homes (PAIN-Dem). METHODS: PAIN-Dem training was delivered to care staff from three care homes in South London, followed by intervention support and resources to encourage improved pain management by staff over 4 weeks. Feasibility was assessed through fidelity to intervention materials and qualitative approaches. Focus group discussions with staff explored the use of the PAIN-Dem intervention, and interviews were held with six residents and family carers. Pain was assessed in all residents at baseline, 3 and 4 weeks, and goal attainment scaling was assessed at 4 weeks. RESULTS: Delivery of training was a key driver for success and feasibility of the PAIN-Dem intervention. Improvements in pain management behaviour and staff confidence were seen in homes where training was delivered in a care home setting across the care team with good manager buy-in. Family involvement in pain management was highlighted as an area for improvement. Goal attainment in residents was significantly improved across the cohort, although no significant change in pain was seen. CONCLUSIONS: This study shows good initial feasibility of the PAIN-Dem intervention and provides valuable insight into training and support paradigms that deliver successful learning and behaviour change. There is a need for a larger trial of PAIN-Dem to establish its impact on resident pain and quantifiable staff behaviour measures. Copyright © 2017 John Wiley & Sons, Ltd.

The cost of care homes for people with dementia in England: a modelling approach.

OBJECTIVES: To examine the cost of care for people with dementia in institutional care settings, to understand the major cost drivers and to highlight opportunities for service development. METHODS: Data on 277 residents with dementia in 16 UK residential or nursing homes were collected. We estimated care and support costs and fitted models to the data. Sensitivity analyses were also conducted. RESULTS: Care home residents cost £792 weekly: 95% of the costs accounted for by direct fees. Hospital contacts contributed the largest proportion of the additional costs. Having an established diagnosis of dementia (b = 0.070; p < 0.05) was associated with higher costs. No association was found between cost and needs (b = -0.002; p = 0.818). CONCLUSION: The absence of an association between cost and needs emphasizes the importance of a more needs-based costing system which could result in clinical and economic advantages. Copyright © 2016 John Wiley & Sons, Ltd.

Cost-effectiveness of donepezil and memantine in moderate to severe Alzheimer's disease (the DOMINO-AD trial).

OBJECTIVE: Most investigations of pharmacotherapy for treating Alzheimer's disease focus on patients with mild-to-moderate symptoms, with little evidence to guide clinical decisions when symptoms become severe. We examined whether continuing donepezil, or commencing memantine, is cost-effective for community-dwelling, moderate-to-severe Alzheimer's disease patients. METHODS: Cost-effectiveness analysis was based on a 52-week, multicentre, double-blind, placebo-controlled, factorial clinical trial. A total of 295 community-dwelling patients with moderate/severe Alzheimer's disease, already treated with donepezil, were randomised to: (i) continue donepezil; (ii) discontinue donepezil; (iii) discontinue donepezil and start memantine; or (iv) continue donepezil and start memantine. RESULTS: Continuing donepezil for 52 weeks was more cost-effective than discontinuation, considering cognition, activities of daily living and health-related quality of life. Starting memantine was more cost-effective than donepezil discontinuation. Donepezil-memantine combined is not more cost-effective than donepezil alone. CONCLUSIONS: Robust evidence is now available to inform clinical decisions and commissioning strategies so as to improve patients' lives whilst making efficient use of available resources. Clinical guidelines for treating moderate/severe Alzheimer's disease, such as those issued by NICE in England and Wales, should be revisited. © 2016 The Authors. International Journal of Geriatric Psychiatry published by John Wiley & Sons Ltd.

Quality-of-life assessment in dementia: the use of DEMQOL and DEMQOL-Proxy total scores.

PURPOSE: There is a need to determine whether health-related quality-of-life (HRQL) assessments in dementia capture what is important, to form a coherent basis for guiding research and clinical and policy decisions. This study investigated structural validity of HRQL assessments made using the DEMQOL system, with particular interest in studying domains that might be central to HRQL, and the external validity of these HRQL measurements. METHODS: HRQL of people with dementia was evaluated by 868 self-reports (DEMQOL) and 909 proxy reports (DEMQOL-Proxy) at a community memory service. Exploratory and confirmatory factor analyses (EFA and CFA) were conducted using bifactor models to investigate domains that might be central to general HRQL. Reliability of the general and specific factors measured by the bifactor models was examined using omega (ω) and omega hierarchical (ω h) coefficients. Multiple-indicators multiple-causes models were used to explore the external validity of these HRQL measurements in terms of their associations with other clinical assessments. RESULTS: Bifactor models showed adequate goodness of fit, supporting HRQL in dementia as a general construct that underlies a diverse range of health indicators. At the same time, additional factors were necessary to explain residual covariation of items within specific health domains identified from the literature. Based on these models, DEMQOL and DEMQOL-Proxy overall total scores showed excellent reliability (ω h > 0.8). After accounting for common variance due to a general factor, subscale scores were less reliable (ω h < 0.7) for informing on individual differences in specific HRQL domains. Depression was more strongly associated with general HRQL based on DEMQOL than on DEMQOL-Proxy (-0.55 vs -0.22). Cognitive impairment had no reliable association with general HRQL based on DEMQOL or DEMQOL-Proxy. CONCLUSIONS: The tenability of a bifactor model of HRQL in dementia suggests that it is possible to retain theoretical focus on the assessment of a general phenomenon, while exploring variation in specific HRQL domains for insights on what may lie at the 'heart' of HRQL for people with dementia. These data suggest that DEMQOL and DEMQOL-Proxy total scores are likely to be accurate measures of individual differences in HRQL, but that subscale scores should not be used. No specific domain was solely responsible for general HRQL at dementia diagnosis. Better HRQL was moderately associated with less depressive symptoms, but this was less apparent based on informant reports. HRQL was not associated with severity of cognitive impairment.

Dependence in Alzheimer's disease and service use costs, quality of life, and caregiver burden: the DADE study.

BACKGROUND: Most models determining how patient and caregiver characteristics and costs change with Alzheimer's disease (AD) progression focus on one aspect, for example, cognition. AD is inadequately defined by a single domain; tracking progression by focusing on a single aspect may mean other important aspects are insufficiently addressed. Dependence has been proposed as a better marker for following disease progression. METHODS: This was a cross-sectional observational study (18 UK sites). Two hundred forty-nine community or institutionalized patients, with possible/probable AD, Mini-Mental State Examination (3-26), and a knowledgeable informant participated. RESULTS: Significant associations noted between dependence (Dependence Scale [DS]) and clinical measures of severity (cognition, function, and behavior). Bivariate and multivariate models demonstrated significant associations between DS and service use cost, patient quality of life, and caregiver perceived burden. CONCLUSION: The construct of dependence may help to translate the combined impact of changes in cognition, function, and behavior into a more readily interpretable form. The DS is useful for assessing patients with AD in clinical trials/research.

Development and evaluation of a manualised mental health awareness and stigma reduction intervention for Black faith communities: study protocol for the ON TRAC feasibility study.

INTRODUCTION: This paper presents the study protocol for a feasibility study of a manualised mental health awareness and stigma reduction intervention for Black faith communities, as part of the Outcomes and Needs of Traditional Religious And Complementary practitioners (ON TRAC) project. The primary objective is to assess the feasibility and acceptability of the intervention and the secondary objectives include assessment of the feasibility of: recruiting participants to take part in the intervention, delivering the intervention, and conducting qualitative assessments, and use of the selected scales. The findings from this study will be used to inform the development of a subsequent trial which will focus on exploring the potential impact of the intervention on stigma-related knowledge, attitudes, and behaviour. METHODS AND ANALYSIS: The study uses a mixed-methods approach. A total of 80 participants from four Black Majority Churches in South London will be recruited. Randomisation of the participants will be at an individual level to either the intervention group (who will participate in the 10 week Mental Health Awareness Course intervention) or to the waiting list control group (who will receive the same intervention, 8 weeks after the intervention group). Outcomes for both arms will be collected at baseline, postintervention, and at 4 week follow-up. In addition, focus group discussions will be conducted with participants in the intervention group, a week following the end of the 10 week session course, to investigate the feasibility and acceptability of the mental health awareness course. ETHICS AND DISSEMINATION: The results of this research will be disseminated at local, national, and international levels. TRIAL REGISTRATION NUMBER: ISRCTN12253092.

Cost-effectiveness analyses for mirtazapine and sertraline in dementia: randomised controlled trial.

BACKGROUND: Depression is a common and costly comorbidity in dementia. There are very few data on the cost-effectiveness of antidepressants for depression in dementia and their effects on carer outcomes. AIMS: To evaluate the cost-effectiveness of sertraline and mirtazapine compared with placebo for depression in dementia. METHOD: A pragmatic, multicentre, randomised placebo-controlled trial with a parallel cost-effectiveness analysis (trial registration: ISRCTN88882979 and EudraCT 2006-000105-38). The primary cost-effectiveness analysis compared differences in treatment costs for patients receiving sertraline, mirtazapine or placebo with differences in effectiveness measured by the primary outcome, total Cornell Scale for Depression in Dementia (CSDD) score, over two time periods: 0-13 weeks and 0-39 weeks. The secondary evaluation was a cost-utility analysis using quality-adjusted life years (QALYs) computed from the Euro-Qual (EQ-5D) and societal weights over those same periods. RESULTS: There were 339 participants randomised and 326 with costs data (111 placebo, 107 sertraline, 108 mirtazapine). For the primary outcome, decrease in depression, mirtazapine and sertraline were not cost-effective compared with placebo. However, examining secondary outcomes, the time spent by unpaid carers caring for participants in the mirtazapine group was almost half that for patients receiving placebo (6.74 v. 12.27 hours per week) or sertraline (6.74 v. 12.32 hours per week). Informal care costs over 39 weeks were £1510 and £1522 less for the mirtazapine group compared with placebo and sertraline respectively. CONCLUSIONS: In terms of reducing depression, mirtazapine and sertraline were not cost-effective for treating depression in dementia. However, mirtazapine does appear likely to have been cost-effective if costing includes the impact on unpaid carers and with quality of life included in the outcome. Unpaid (family) carer costs were lower with mirtazapine than sertraline or placebo. This may have been mediated via the putative ability of mirtazapine to ameliorate sleep disturbances and anxiety. Given the priority and the potential value of supporting family carers of people with dementia, further research is warranted to investigate the potential of mirtazapine to help with behavioural and psychological symptoms in dementia and in supporting carers.

Dementia care costs and outcomes: a systematic review.

OBJECTIVE: We reviewed evidence on the cost-effectiveness of prevention, care and treatment strategies in relation to dementia. METHODS: We performed a systematic review of available literature on economic evaluations of dementia care, searching key databases and websites in medicine, social care and economics. Literature reviews were privileged, and other study designs were included only to fill gaps in the evidence base. Narrative analysis was used to synthesise the results. RESULTS: We identified 56 literature reviews and 29 single studies offering economic evidence on dementia care. There is more cost-effectiveness evidence on pharmacological therapies than other interventions. Acetylcholinesterase inhibitors for mild-to-moderate disease and memantine for moderate-to-severe disease were found to be cost-effective. Regarding non-pharmacological treatments, cognitive stimulation therapy, tailored activity programme and occupational therapy were found to be more cost-effective than usual care. There was some evidence to suggest that respite care in day settings and psychosocial interventions for carers could be cost-effective. Coordinated care management and personal budgets held by carers have also demonstrated cost-effectiveness in some studies. CONCLUSION: Five barriers to achieving better value for money in dementia care were identified: the scarcity and low methodological quality of available studies, the difficulty of generalising from available evidence, the narrowness of cost measures, a reluctance to implement evidence and the poor coordination of health and social care provision and financing.

Clinical and cost evaluation of two models of specialist intensive support teams for adults with intellectual disabilities who display behaviours that challenge: the IST-ID mixed-methods study.

BACKGROUND: Intensive support teams (ISTs) are recommended for individuals with intellectual disabilities who display behaviours that challenge. However, there is currently little evidence about the clinical and cost-effectiveness of IST models operating in England. AIMS: To investigate the clinical and cost-effectiveness of IST models. METHOD: We carried out a cohort study to evaluate the clinical and cost-effectiveness of two previously identified IST models (independent and enhanced) in England. Adult participants (n = 226) from 21 ISTs (ten independent and 11 enhanced) were enrolled. The primary outcome was change in challenging behaviour between baseline and 9 months as measured by the Aberrant Behaviour Checklist-Community version 2. RESULTS: We found no statistically significant differences between models for the primary outcome (adjusted ß = 4.27; 95% CI -6.34 to 14.87; P = 0.430) or any secondary outcomes. Quality-adjusted life-years (0.0158; 95% CI: -0.0088 to 0.0508) and costs (£3409.95; 95% CI -£9957.92 to £4039.89) of the two models were comparable. CONCLUSIONS: The study provides evidence that both models were associated with clinical improvement for similar costs at follow-up. We recommend that the choice of service model should rest with local services. Further research should investigate the critical components of IST care to inform the development of fidelity criteria, and policy makers should consider whether roll out of such teams should be mandated.

Toward a multi-level strategy to reduce stigma in global mental health: overview protocol of the Indigo Partnership to develop and test interventions in low- and middle-income countries.

There is increasing attention to the impacts of stigma and discrimination related to mental health on quality of life and access to and quality of healthcare. Effective strategies for stigma reduction exist, but most evidence comes from high-income settings. Recent reviews of stigma research have identified gaps in the field, including limited cultural and contextual adaptation of interventions, a lack of contextual psychometric information on evaluation tools, and, most notably, a lack of multi-level strategies for stigma reduction. The Indigo Partnership research programme will address these knowledge gaps through a multi-country, multi-site collaboration for anti-stigma interventions in low- and middle-income countries (LMICs) (China, Ethiopia, India, Nepal, and Tunisia). The Indigo Partnership aims to: (1) carry out research to strengthen the understanding of mechanisms of stigma processes and reduce stigma and discrimination against people with mental health conditions in LMICs; and (2) establish a strong collaborative research consortium through the conduct of this programme. Specifically, the Indigo Partnership involves developing and pilot testing anti-stigma interventions at the community, primary care, and mental health specialist care levels, with a systematic approach to cultural and contextual adaptation across the sites. This work also involves transcultural translation and adaptation of stigma and discrimination measurement tools. The Indigo Partnership operates with the key principle of partnering with people with lived experience of mental health conditions for the development and implementation of the pilot interventions, as well as capacity building and cross-site learning to actively develop a more globally representative and equitable mental health research community. This work is envisioned to have a long-lasting impact, both in terms of the capacity building provided to participating institutions and researchers, and the foundation it provides for future research to extend the evidence base of what works to reduce and ultimately end stigma and discrimination in mental health.

Sertraline or mirtazapine for depression in dementia (HTA-SADD): a randomised, multicentre, double-blind, placebo-controlled trial.

BACKGROUND: Depression is common in dementia but the evidence base for appropriate drug treatment is sparse and equivocal. We aimed to assess efficacy and safety of two of the most commonly prescribed drugs, sertraline and mirtazapine, compared with placebo. METHODS: We undertook the parallel-group, double-blind, placebo-controlled, Health Technology Assessment Study of the Use of Antidepressants for Depression in Dementia (HTA-SADD) trial in participants from old-age psychiatry services in nine centres in England. Participants were eligible if they had probable or possible Alzheimer's disease, depression (lasting ≥4 weeks), and a Cornell scale for depression in dementia (CSDD) score of 8 or more. Participants were ineligible if they were clinically critical (eg, suicide risk), contraindicated to study drugs, on antidepressants, in another trial, or had no carer. The clinical trials unit at King's College London (UK) randomly allocated participants with a computer-generated block randomisation sequence, stratified by centre, with varying block sizes, in a 1:1:1 ratio to receive sertraline (target dose 150 mg per day), mirtazapine (45 mg), or placebo (control group), all with standard care. The primary outcome was reduction in depression (CSDD score) at 13 weeks (outcomes to 39 weeks were also assessed), assessed with a mixed linear-regression model adjusted for baseline CSDD, time, and treatment centre. This study is registered, number ISRCTN88882979 and EudraCT 2006-000105-38. FINDINGS: Decreases in depression scores at 13 weeks did not differ between 111 controls and 107 participants allocated to receive sertraline (mean difference 1·17, 95% CI -0·23 to 2·58; p=0·10) or mirtazapine (0·01, -1·37 to 1·38; p=0·99), or between participants in the mirtazapine and sertraline groups (1·16, -0·25 to 2·57; p=0·11); these findings persisted to 39 weeks. Fewer controls had adverse reactions (29 of 111 [26%]) than did participants in the sertraline group (46 of 107, 43%; p=0·010) or mirtazapine group (44 of 108, 41%; p=0·031), and fewer serious adverse events rated as severe (p=0·003). Five patients in every group died by week 39. INTERPRETATION: Because of the absence of benefit compared with placebo and increased risk of adverse events, the present practice of use of these antidepressants, with usual care, for first-line treatment of depression in Alzheimer's disease should be reconsidered. FUNDING: UK National Institute of Health Research HTA Programme.

An integrated primary care-based programme of PRE-Pregnancy cARE to improve pregnancy outcomes in women with type 2 Diabetes (The PREPARED study): protocol for a multi-method study of implementation, system adaptation and performance.

BACKGROUND: The number of women of childbearing age with Type 2 diabetes(T2DM) is increasing, and they now account for > 50% of pregnancies in women with pre-existing diabetes. Diabetes pregnancies without adequate pre-pregnancy care have higher risk for poor outcomes (miscarriages, birth-defects, stillbirths) and are associated with increased complications (caesarean deliveries, macrosomic babies, neonatal intensive-care admissions). The risks and costs of these pregnancies can be reduced with pregnancy preparation (HbA1c, ≤ 6.5%, 5 mg folic acid and stopping potentially harmful medicines). However, 90% of women with T2DM, most of whom are based in primary care, are not adequately prepared for pregnancy. This study will evaluate a programme of primary care-based interventions (decision-support systems; pre-pregnancy care-pathways; pregnancy-awareness resources; professional training; and performance monitoring) to improve pregnancy preparation in women with T2DM. METHODS: The study aims to optimise the programme interventions and estimate their impact on pregnancy preparation, pre-pregnancy care uptake and pregnancy outcomes. To evaluate this multimodal intervention, we will use a multi-method research design following Complex Adaptive Systems (CAS) theory, refining the interventions iteratively during the study. Thirty GP practices with ≥ 25 women with T2DM of reproductive age (18-45 years) from two South London boroughs will be exposed to the intervention. This will provide > 750 women with an estimated pregnancy incidence of 80-100 to study. The research involves: a clinical audit of processes and outcomes; a process evaluation informing intervention feasibility, implementation, and behaviour change; and a cost-consequences analysis informing future economic evaluation. Performance data will be collected via audits of GP systems, hospital antenatal clinics and pregnancy outcomes. Following CAS theory, we will use repeated measurements to monitor intervention impact on pregnancy preparation markers at 4-monthly intervals over 18-months. We will use performance and feasibility data to optimise intervention effects iteratively. The target performance for the intervention is a 30% increase in the proportion of women meeting pre-pregnancy care criteria. DISCUSSION: The primary output will be development of an integrated programme of interventions to improve pregnancy preparation, pre-pregnancy care uptake, and reduce adverse pregnancy outcomes in women with T2DM. We will also develop an implementation plan to support the introduction of the interventions across the NHS. TRIAL REGISTRATION: ISRCTN47576591 ; February 8, 2022.

Utilisation and costs of mental health-related service use among adolescents.

BACKGROUND: The high level of care needs for adolescents with mental health conditions represents a challenge to the public sector, especially in low and middle-income countries. We estimated the costs to the public purse of health, education, criminal justice and social care service use associated with psychiatric conditions among adolescents in Brazil; and examined whether the trajectory of psychopathology and its impact on daily life, and parental stigma towards mental illness, was associated with service utilisation and costs. METHODS: Data on reported service use among adolescents from a prospective community cohort (n = 1,400) were combined with Brazilian unit costs. Logistic regression and generalised linear models were used to examine factors associated with service use and associated costs, respectively. RESULTS: Twenty-two percent of those who presented with a psychiatric disorder used some type of service for their mental health in the previous twelve months. Higher odds of service use were associated with having a diagnosed mental disorder (either incident, [OR = 2.49, 95%CI = 1.44-4.30, p = 0.001], remittent [OR = 2.16, 95%CI = 1.27-3.69, p = 0.005] or persistent [OR = 3.01, 95%CI = 1.69-5.36, p<0.001]), higher impact of symptoms on adolescent's life (OR = 1.32, 95%CI = 1.19-1.47, p<0.001) and lower parental stigma toward mental illness (OR = 1.12, 95%CI = 1.05-1.20, p = 0.001). Average annual cost of service use was 527.14 USD (s.d. = 908.10). Higher cost was associated with higher disorder impact (ß = 0.25, 95%CI = 0.12-0.39, p<0.001), lower parental stigma (ß = 0.12, 95%CI = 0.02-0.23, p = 0.020) and white ethnicity (ß = 0.55, 95%CI = 0.04-1.07, p = 0.036). CONCLUSION: The impact of mental health problems on adolescents' daily lives and parental stigmatising attitudes toward mental illness were the main predictors of both service use and costs.