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INTRODUCTION: The prevalence of smoking is high among people living with severe mental illness (SMI). Evidence on feasibility, acceptability and effectiveness of smoking cessation interventions among smokers with SMI is lacking, particularly in low- and middle-income countries. We aim to test the feasibility and acceptability of delivering an evidence-based intervention,i.e., the IMPACT smoking cessation support for people with severe mental illness in South Asia (IMPACT 4S) intervention that is a combination of behavioural support and smoking cessation pharmacotherapies among adult smokers with SMI in India and Pakistan. We will also test the feasibility and acceptability of evaluating the intervention in a randomised controlled trial. METHODS: We will conduct a parallel, open label, randomised controlled feasibility trial among 172 (86 in each country) adult smokers with SMI in India and Pakistan. Participants will be allocated 1:1 to either Brief Advice (BA) or the IMPACT 4S intervention. BA comprises a single five-minute BA session on stopping smoking. The IMPACT 4S intervention comprises behavioural support delivered in upto 15 one-to-one, face-to-face or audio/video, counselling sessions, with each session lasting between 15 and 40 minutes; nicotine gum and/or bupropion; and breath carbon monoxide monitoring and feedback. Outcomes are recruitment rates, reasons for ineligibility/non-participation/non-consent of participants, length of time required to achieve required sample size, retention in study and treatments, intervention fidelity during delivery, smoking cessation pharmacotherapy adherence and data completeness. We will also conduct a process evaluation. RESULTS: Study will address- uncertainty about feasibility and acceptability of delivering smoking cessation interventions, and ability to conduct smoking cessation trials, among adult smokers with SMI in low- and middle-income countries. CONCLUSIONS: This is to inform further intervention adaptation, and the design and conduct of future randomised controlled trials on this topic. Results will be disseminated through peer-review articles, presentations at national, international conferences and policy-engagement forums. TRIAL REGISTRATION: ISRCTN34399445 (Updated 22/03/2021), ISRCTN Registry https://www.isrctn.com/.

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.

Item 10 of the Edinburgh Postnatal Depression Scale (EPDS) is intended to assess thoughts of intentional self-harm but may also elicit concerns about accidental self-harm. It does not specifically address suicide ideation but, nonetheless, is sometimes used as an indicator of suicidality. The 9-item version of the EPDS (EPDS-9), which omits item 10, is sometimes used in research due to concern about positive endorsements of item 10 and necessary follow-up. We assessed the equivalence of total score correlations and screening accuracy to detect major depression using the EPDS-9 versus full EPDS among pregnant and postpartum women. We searched Medline, Medline In-Process and Other Non-Indexed Citations, PsycINFO, and Web of Science from database inception to October 3, 2018 for studies that administered the EPDS and conducted diagnostic classification for major depression based on a validated semi-structured or fully structured interview among women aged 18 or older during pregnancy or within 12 months of giving birth. We conducted an individual participant data meta-analysis. We calculated Pearson correlations with 95% prediction interval (PI) between EPDS-9 and full EPDS total scores using a random effects model. Bivariate random-effects models were fitted to assess screening accuracy. Equivalence tests were done by comparing the confidence intervals (CIs) around the pooled sensitivity and specificity differences to the equivalence margin of δ = 0.05. Individual participant data were obtained from 41 eligible studies (10,906 participants, 1407 major depression cases). The correlation between EPDS-9 and full EPDS scores was 0.998 (95% PI 0.991, 0.999). For sensitivity, the EPDS-9 and full EPDS were equivalent for cut-offs 7–12 (difference range − 0.02, 0.01) and the equivalence was indeterminate for cut-offs 13–15 (all differences − 0.04). For specificity, the EPDS-9 and full EPDS were equivalent for all cut-offs (difference range 0.00, 0.01). The EPDS-9 performs similarly to the full EPDS and can be used when there are concerns about the implications of administering EPDS item 10.Trial registration: The original IPDMA was registered in PROSPERO (CRD42015024785).

This is a cross-sectional study into the effect of primary schools on the mental health of pupils. Socioeconomic status, ethnicity, and other individual characteristics are associated with mental health outcomes in children and adolescents.[1] Given that schools serve different communities and pupil characteristics vary across schools, it is likely that the average mental health of pupils also varies by school. A small number of studies have already investigated this relationship, and found that a small proportion of variation in mental health or wellbeing is explained at school-level, after adjustment for pupil characteristics. A cross-sectional study of 23,215 year 4 & 5 pupils in 648 primary schools in England found that 4.3% of variation in "high mental health difficulties" (measured using the "Me and My Feelings" self-report questionnaire) was accounted for by schools.[2] Three longitudinal studies of secondary school pupils in England found that 1.4% of variation in mental and emotional health (measured using the "Strengths and Difficulties Questionnaire" and the "Me and My School" questionnaire) was explained at school level.[3] A cross-sectional study of 26,855 pupils at 85 secondary schools in the UK found that schools accounted for 2.4% of variation in ‘psychopathology’ (measured using the "Strengths and Difficulties Questionnaire"); 1.6% of variation in depression (measuring using "CES-D"), and 1.4% of wellbeing (measured using "WEMWEBS").[4] A small number of studies from other countries also suggest that schools account for a small but significant proportion of variation in mental health outcomes. For example, in a cross-sectional analysis of 87,341 secondary school pupils in Finland, schools accounted for 1% of variation in subjective wellbeing.[5] There are many more studies into other contextual and social determinants of young people's mental health. For example, a systematic review of parental factors associated with depression and anxiety in young people identified 181 studies.[6] This study aims to add to evidence of the contribution of schools to pupil's mental health. It also aims to include analysis of crude variation in mental health across schools (ie. whether mental varies before adjusting for pupil characteristics), which could inform prioritisation of school-level interventions to improve pupils' mental health. References: 1. Reiss F. Socioeconomic inequalities and mental health problems in children and adolescents: A systematic review. Soc Sci Med. 2013;90: 24–31. doi:10.1016/j.socscimed.2013.04.026 2. Patalay P, O’Neill E, Deighton J, Fink E. School characteristics and children's mental health: A linked survey-administrative data study. Preventative Medicine. 2020;141; 106292. doi:10.1016/j.ypmed.2020.106292 3. Hale DR, Patalay P, Fitzgerald-Yau N, Hargreaves DS, Bond L, Görzig A, et al. School-Level Variation in Health Outcomes in Adolescence: Analysis of Three Longitudinal Studies in England. Prev Sci. 2014;15: 600–610. doi:10.1007/s11121-013-0414-6 4. Ford T et al. The Role of Schools in Early Adolescents’ Mental Health: Findings From the MYRIAD Study. 2021. J Am Ac Ch Ad Psychiatry. 60,12. 1467-1478.. Doi: 10.1016/j.jaac.2021.02.016 5. Konu AI, Lintonen TP, Autio VJ. Evaluation of Well-Being in Schools ? A Multilevel Analysis of General Subjective Well-Being. Sch Eff Sch Improv. 2002;13: 187–200. doi:10.1076/sesi.13.2.187.3432 6. Yap, M.B., Pilkington, P.D., Ryan, S.M., Jorm, A.F., 2014. Parental factors associated with depression and anxiety in young people: a systematic review and meta-analysis. J. Affect. Disord. 156, 8–23. https://doi.org/10.1016/j.jad.2013.11.007. T. Fukuzaki and S. Takeda

Six months after OWLS was initiated we launched a follow-up to examine the long-term effect of some of the factors examined in OWLS 1, as well as to collect additional information to complement the data collected in the first phase.

The OWLS project is based in University of York and began in April 2020 when a group of researchers who are investigating how to improve the physical health of people with severe mental ill health wanted to explore how the pandemic restrictions were affecting people with severe mental ill health. The researchers worked together with a group of people with lived experience to come up with a series of questions to ask people that would best capture their experiences and concerns. OWLS explored the following domains: - Mental and Physical Health - Service Use - Health behaviours - COVID-19 - Social support -Digital engagement - Employment

The role of animal ownership in severe mental illness for wellbeing and loneliness during the COVID-19 pandemic: Findings from a UK survey study.

A study protocol for the use of individual participant data from randomised controlled trials

The OWLS project is based in University of York and began in April 2020 when a group of researchers who are investigating how to improve the physical health of people with severe mental ill health wanted to explore how the pandemic restrictions were affecting people with severe mental ill health. The researchers worked together with a group of people with lived experience to come up with a series of questions to ask people that would best capture their experiences and concerns. OWLS explored the following domains: - Mental and Physical Health - Service Use - Health behaviours - COVID-19 - Social support -Digital engagement - Employment

Background People with severe mental illness (SMI), such as schizophrenia, have higher rates of physical long-term conditions (LTCs), poorer health outcomes, and shorter life expectancy compared with the general population. Previous research exploring SMI and diabetes highlights that people with SMI experience barriers to self-management, a key component of care in long-term conditions; however, this has not been investigated in the context of other LTCs. The aim of this study was to explore the lived experience of co-existing SMI and LTCs for service users, carers, and healthcare professionals. Methods A qualitative study with people with SMI and LTCs, their carers, and healthcare professionals, using semi-structured interviews, focused observations, and focus groups across the UK. Forty-one interviews and five focus groups were conducted between December 2018 and April 2019. Transcripts were coded by two authors and analysed thematically. Results Three themes were identified, 1) the precarious nature of living with SMI, 2) the circularity of life with SMI and LTCs, and 3) the constellation of support for self-management. People with co-existing SMI and LTCs often experience substantial difficulties with self-management of their health due to the competing demands of their psychiatric symptoms and treatment, social circumstances, and access to support. Multiple long-term conditions add to the burden of self-management. Social support, alongside person-centred professional care, is a key facilitator for managing health. An integrated approach to both mental and physical healthcare was suggested to meet service user and carer needs. Conclusion The demands of living with SMI present a substantial barrier to self-management for multiple co-existing LTCs. It is important that people with SMI can access person-centred, tailored support for their LTCs that takes into consideration individual circumstances and priorities.

Objective: The Maternal Mental Health in Canada, 2018/2019, survey reported that 18% of 7,085 mothers who recently gave birth reported “feelings consistent with postpartum depression” based on scores ≥7 on a 5-item version of the Edinburgh Postpartum Depression Scale (EPDS-5). The EPDS-5 was designed as a screening questionnaire, not to classify disorders or estimate prevalence; the extent to which EPDS-5 results reflect depression prevalence is unknown. We investigated EPDS-5 ≥7 performance relative to major depression prevalence based on a validated diagnostic interview, the Structured Clinical Interview for DSM (SCID). Methods: We searched Medline, Medline In-Process & Other Non-Indexed Citations, PsycINFO, and the Web of Science Core Collection through June 2016 for studies with data sets with item response data to calculate EPDS-5 scores and that used the SCID to ascertain depression status. We conducted an individual participant data meta-analysis to estimate pooled percentage of EPDS-5 ≥7, pooled SCID major depression prevalence, and the pooled difference in prevalence. Results: A total of 3,958 participants from 19 primary studies were included. Pooled prevalence of SCID major depression was 9.2% (95% confidence interval [CI] 6.0% to 13.7%), pooled percentage of participants with EPDS-5 ≥7 was 16.2% (95% CI 10.7% to 23.8%), and pooled difference was 8.0% (95% CI 2.9% to 13.2%). In the 19 included studies, mean and median ratios of EPDS-5 to SCID prevalence were 2.1 and 1.4 times. Conclusions: Prevalence estimated based on EPDS-5 ≥7 appears to be substantially higher than the prevalence of major depression. Validated diagnostic interviews should be used to establish prevalence.

Background\ud \ud 5%–10% children and young people (CYP) experience specific phobias that impact daily functioning. Cognitive Behaviour Therapy (CBT) is recommended but has limitations. One Session Treatment (OST), a briefer alternative incorporating CBT principles, has demonstrated efficacy. The Alleviating Specific Phobias Experienced by Children Trial (ASPECT) investigated the non-inferiority of OST compared to multi-session CBT for treating specific phobias in CYP.\ud \ud \ud \ud Methods\ud \ud ASPECT was a pragmatic, multi-center, non-inferiority randomized controlled trial in 26 CAMHS sites, three voluntary agency services, and one university-based CYP well-being service. CYP aged 7–16 years with specific phobia were randomized to receive OST or CBT. Clinical non-inferiority and a nested cost-effectiveness evaluation was assessed 6-months post-randomization using the Behavioural Avoidance Task (BAT). Secondary outcome measures included the Anxiety Disorder Interview Schedule, Child Anxiety Impact Scale, Revised Children's Anxiety Depression Scale, goal-based outcome measure, and EQ-5DY and CHU-9D, collected blind at baseline and six-months.\ud \ud \ud \ud Results\ud \ud 268 CYPs were randomized to OST (n = 134) or CBT (n = 134). Mean BAT scores at 6 months were similar across groups in both intention-to-treat (ITT) and per-protocol (PP) populations (CBT: 7.1 (ITT, n = 76), 7.4 (PP, n = 57), OST: 7.4 (ITT, n = 73), 7.6 (PP, n = 56), on the standardized scale-adjusted mean difference for CBT compared to OST -0.123, 95% CI −0.449 to 0.202 (ITT), mean difference −0.204, 95% CI −0.579 to 0.171 (PP)). These findings were wholly below the standardized non-inferiority limit of 0.4, suggesting that OST is non-inferior to CBT. No between-group differences were found on secondary outcomes. OST marginally decreased mean service use costs and maintained similar mean Quality Adjusted Life Years compared to CBT.\ud \ud \ud \ud Conclusions\ud \ud One Session Treatment has similar clinical effectiveness to CBT for specific phobias in CYP and may be a cost-saving alternative.

Introduction Depression is a leading mental health problem worldwide. People with long-term conditions are at increased risk of experiencing depression. The COVID-19 pandemic led to strict social restrictions being imposed across the UK population. Social isolation can have negative consequences on the physical and mental wellbeing of older adults. In the Behavioural Activation in Social IsoLation (BASIL+) trial we will test whether a brief psychological intervention (based on Behavioural Activation), delivered remotely, can mitigate depression and loneliness in older adults with long-term conditions during isolation. Methods We will conduct a two-arm, parallel-group, randomised controlled trial across several research sites, to evaluate the clinical and cost-effectiveness of the BASIL+ intervention. Participants will be recruited via participating general practices across England and Wales. Participants must be aged ≥65 with two or more long-term conditions, or a condition that may indicate they are within a ‘clinically extremely vulnerable’ group in relation to COVID-19, and have scored ≥5 on the Patient Health Questionnaire (PHQ9), to be eligible for inclusion. Randomisation will be 1:1, stratified by research site. Intervention participants will receive up to eight intervention sessions delivered remotely by trained BASIL+ Support Workers and supported by a self-help booklet. Control participants will receive usual care, with additional signposting to reputable sources of self-help and information, including advice on keeping mentally and physically well. A qualitative process evaluation will also be undertaken to explore the acceptability of the BASIL+ intervention, as well as barriers and enablers to integrating the intervention into participants’ existing health and care support, and the impact of the intervention on participants’ mood and general wellbeing in the context of the COVID-19 restrictions. Semi-structured interviews will be conducted with intervention participants, participant’s caregivers/supportive others and BASIL+ Support Workers. Outcome data will be collected at one, three, and 12 months post-randomisation. Clinical and cost-effectiveness will be evaluated. The primary outcome is depressive symptoms at the three-month follow up, measured by the PHQ9. Secondary outcomes include loneliness, social isolation, anxiety, quality of life, and a bespoke health services use questionnaire. Discussion This study is the first large-scale trial evaluating a brief Behavioural Activation intervention in this population, and builds upon the results of a successful external pilot trial. Trial registration ClinicalTrials.Gov identifier ISRCTN63034289, registered on 5th February 2021.

Importance: Socioeconomic factors are associated with the prevalence of depression, but their associations with prognosis are unknown. Understanding this association would aid in the clinical management of depression.Objective: To determine whether employment status, financial strain, housing status, and educational attainment inform prognosis for adults treated for depression in primary care, independent of treatment and after accounting for clinical prognostic factors.Data Sources: The Embase, International Pharmaceutical Abstracts, MEDLINE, PsycINFO, and Cochrane (CENTRAL) databases were searched from database inception to October 8, 2021.Study Selection: Inclusion criteria were as follows: randomized clinical trials that used the Revised Clinical Interview Schedule (CIS-R; the most common comprehensive screening and diagnostic measure of depressive and anxiety symptoms in primary care randomized clinical trials), measured socioeconomic factors at baseline, and sampled patients with unipolar depression who sought treatment for depression from general physicians/practitioners or who scored 12 or more points on the CIS-R. Exclusion criteria included patients with depression secondary to a personality or psychotic disorder or neurologic condition, studies of bipolar or psychotic depression, studies that included children or adolescents, and feasibility studies. Studies were independently assessed against inclusion and exclusion criteria by 2 reviewers.Data Extraction and Synthesis: Data were extracted and cleaned by data managers for each included study, further cleaned by multiple reviewers, and cross-checked by study chief investigators. Risk of bias and quality were assessed using the Quality in Prognosis Studies (QUIPS) and Grading of Recommendations, Assessment, Development and Evaluation (GRADE) tools, respectively. This study followed the Preferred Reporting Items for Systematic Reviews and Meta-analyses-Individual Participant Data (PRISMA-IPD) reporting guidelines.Main Outcomes and Measures: Depressive symptoms at 3 to 4 months after baseline.Results: This systematic review and individual patient data meta-analysis identified 9 eligible studies that provided individual patient data for 4864 patients (mean [SD] age, 42.5 (14.0) years; 3279 women [67.4%]). The 2-stage random-effects meta-analysis end point depressive symptom scale scores were 28% (95% CI, 20%-36%) higher for unemployed patients than for employed patients and 18% (95% CI, 6%-30%) lower for patients who were homeowners than for patients living with family or friends, in hostels, or homeless, which were equivalent to 4.2 points (95% CI, 3.6-6.2 points) and 2.9 points (95% CI, 1.1-4.9 points) on the Beck Depression Inventory II, respectively. Financial strain and educational attainment were associated with prognosis independent of treatment, but unlike employment and housing status, there was little evidence of associations after adjusting for clinical prognostic factors.Conclusions and Relevance: Results of this systematic review and meta-analysis revealed that unemployment was associated with a poor prognosis whereas home ownership was associated with improved prognosis. These differences were clinically important and independent of the type of treatment received. Interventions that address employment or housing difficulties could improve outcomes for patients with depression.

AimsTo explore: how satisfied people with severe mental illness (SMI) are with the support received during the pandemic; understand any difficulties encountered when accessing both mental health and primary care services; consider ways to mitigate these difficulties; and assess the perceived need for future support from mental health services.Materials and MethodsA representative sample was drawn from a large transdiagnostic clinical cohort of people with SMI, which was recruited between April 2016 and March 2020. The sample was re-surveyed a few months after the beginning of the restrictions. Descriptive frequency statistics were used to analyze the quantitative data. The free text responses were analyzed thematically.Results367 participants responded to the survey. Two thirds were receiving support from mental health services with the rest supported in primary care or self-managing. A quarter thought they would need more mental health support in the coming year. Half had needed to used community mental health services during the pandemic and the majority had been able to get support. A minority reported that their mental health had deteriorated but they had either not got the supported they wanted or had not sought help. The biggest service change was the reduction in face-to-face appointments and increasing use of phone and video call support. Nearly half of those using mental health services found this change acceptable or even preferred it. However, acceptability was influenced by several factors, and participants were more likely to report that they had received all the support they needed, when seen in person.DiscussionAlthough most participants were satisfied with the mental health support they had received, a minority were not. This, couple with findings on future need for mental health support has implications for post pandemic demand on services. Remote care has brought benefits but also risks that it could increase inequalities in access to services.

Additional file 1.

BackgroundThe COVID-19 pandemic has amplified pre-existing health inequalities and people with severe mental ill health (SMI) are one of the groups at greatest risk. In this study, we explored the effects of the pandemic and pandemic restrictions on people with SMI during the first year of the pandemic.MethodsWe conducted a longitudinal study in a sample of people with SMI. The inception survey was carried out between July and December 2020. Participants were then re-surveyed between January and March 2021. People were contacted by telephone and invited to take part in the study over the phone, online or by postal questionnaire. Across both waves we asked participants about their physical and mental health, health risk behaviors, well-being, loneliness, and employment status.ResultsThree hundred and sixty-seven people with SMI completed the inception survey and 249 people completed the follow up. Whilst some people reported no change in their physical (77, 31%) or mental health (60, 24%) over the course of the pandemic 53 (21%) reported a continuing decline in physical health and 52 (21%) reported a continuing decline in mental health. Participants who maintained a daily routine or reported no decline in physical health were found to be associated with no deterioration in mental health (Daily routine OR 2.27, 95% CI 1.11–4.64; no reported physical health decline OR 0.54, 95% CI 0.17–0.70). Participants were less likely to be occupationally active in the first phase of the pandemic compared to before the pandemic and in the second phase of the pandemic. However, there was no one single experience of people with SMI and similar to studies in the general populations a range of different scenarios was experienced.ConclusionsWe observed a series of factors that might amplify pre-existing health inequalities. Health systems should be mindful of this, and should redouble efforts to set in place changes to practice and policy, which can mitigate these inequalities. Examples might include; raising awareness of the importance of ensuring that people with SMI receive an annual physical health check and supporting people to maintain a daily routine.

Objective: to investigate associations between major life events and prognosis independent of treatment type: (1) after adjusting for clinical prognostic factors and socio-demographics; (2) amongst patients with depressive episodes at least six-months long; and (3) patients with a first life-time depressive episode.Methods: six RCTs of adults seeking treatment for depression in primary care met eligibility criteria, individual patient data (IPD) were collated from all six (n = 2858). Participants were randomized to any treatment and completed the same baseline assessment of life events, demographics and clinical prognostic factors. Two-stage random effects meta-analyses were conducted.Results: reporting any major life events was associated with poorer prognosis regardless of treatment type. Controlling for baseline clinical factors, socio-demographics and social support resulted in minimal residual evidence of associations between life events and treatment prognosis. However, removing factors that might mediate the relationships between life events and outcomes reporting: arguments/disputes, problem debt, violent crime, losing one's job, and three or more life events were associated with considerably worse prognoses (percentage difference in 3-4 months depressive symptoms compared to no reported life events =30.3%(95%CI: 18.4-43.3)).Conclusions: assessing for clinical prognostic factors, social support, and socio-demographics is likely to be more informative for prognosis than assessing self-reported recent major life events. However, clinicians might find it useful to ask about such events, and if they are still affecting the patient, consider interventions to tackle problems related to those events (e.g. employment support, mediation, or debt advice). Further investigations of the efficacy of such interventions will be important.

ObjectiveTo update a previous individual participant data meta-analysis and determine the accuracy of the Patient Health Questionnaire-9 (PHQ-9), the most commonly used depression screening tool in general practice, for detecting major depression overall and by study or participant subgroups.DesignSystematic review and individual participant data meta-analysis.Data sourcesMedline, Medline In-Process, and Other Non-Indexed Citations via Ovid, PsycINFO, Web of Science searched through 9 May 2018.Review methodsEligible studies administered the PHQ-9 and classified current major depression status using a validated semistructured diagnostic interview (designed for clinician administration), fully structured interview (designed for lay administration), or the Mini International Neuropsychiatric Interview (MINI; a brief interview designed for lay administration). A bivariate random effects meta-analytic model was used to obtain point and interval estimates of pooled PHQ-9 sensitivity and specificity at cut-off values 5-15, separately, among studies that used semistructured diagnostic interviews (eg, Structured Clinical Interview for Diagnostic and Statistical Manual), fully structured interviews (eg, Composite International Diagnostic Interview), and the MINI. Meta-regression was used to investigate whether PHQ-9 accuracy correlated with reference standard categories and participant characteristics.ResultsData from 44 503 total participants (27 146 additional from the update) were obtained from 100 of 127 eligible studies (42 additional studies; 79% eligible studies; 86% eligible participants). Among studies with a semistructured interview reference standard, pooled PHQ-9 sensitivity and specificity (95% confidence interval) at the standard cut-off value of ≥10, which maximised combined sensitivity and specificity, were 0.85 (0.79 to 0.89) and 0.85 (0.82 to 0.87), respectively. Specificity was similar across reference standards, but sensitivity in studies with semistructured interviews was 7-24% (median 21%) higher than with fully structured reference standards and 2-14% (median 11%) higher than with the MINI across cut-off values. Across reference standards and cut-off values, specificity was 0-10% (median 3%) higher for men and 0-12 (median 5%) higher for people aged 60 or older.ConclusionsResearchers and clinicians could use results to determine outcomes, such as total number of positive screens and false positive screens, at different PHQ-9 cut-off values for different clinical settings using the knowledge translation tool atwww.depressionscreening100.com/phq.Study registrationPROSPERO CRD42014010673.

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 to 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 Matched cohort study using data from Clinical Practice Research Datalink (CPRD) linked to Hospital Episode Statistics (HES) for 1,620 people with comorbid SMI and T2DM and 4,763 people with T2DM alone. Generalised linear models (GLMs) and the Bang and Tsiatis method were used to explore cost predictors and mean lifetime costs respectively. Results People with T2DM and SMI had higher average annual costs (£1,930) than people with T2DM alone, driven primarily by mental health and non-mental health-related hospitalisations. Key predictors of higher total costs were older age, comorbid hypertension, use of antidepressants and 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 NHS of around £250m per year. Conclusions Our estimates of resource use and costs for people with both T2DM and SMI will aid policy makers and commissioners in service planning and resource allocation.

MSc1,2; , PhD1-3; , MSc1,2; , PhD4, , MD1,2,5; , PhD1,2,6-10,*; , PhD1,2,6,*; and the 11

Background: People with severe mental illnesses (SMI) have reduced life expectancy compared with the general population. Diabetes is a major contributor to this disparity with higher prevalence and poorer outcomes in people with SMI. Aim: To determine the impact of SMI on healthcare processes and outcomes for diabetes. Design and setting: Retrospective observational matched nested case-control study using patient records from the Clinical Practice Research Datalink linked to Hospital Episode Statistics. Methods: We compared a range of healthcare processes (primary care consultations, physical health checks, metabolic measurements) and outcomes (prevalence and hospitalisation for cardiovascular disease (CVD), and mortality risk) for 2,192 people with SMI and type 2 diabetes (cases) with 7,773 people with diabetes alone (controls). Socio-demographics, comorbidity and medication prescription were covariates in regression models. Results: SMI was associated with increased risk of all-cause mortality (Hazard Ratio [HR]: 1.92; 95% CI: 1.60 to 2.30) and CVD-specific mortality (HR: 2.24; 1.55 to 3.25); higher physician consultation rates (Incidence Rate Ratio [IRR]: 1.15; 1.11 to 1.19); more frequent checks of blood pressure (IRR: 1.02; 1.00 to 1.05) and cholesterol (IRR: 1.04; 1.02 to 1.06); lower prevalence of angina (Odds Ratio [OR]: 0.67; 0.45 to 1.00); higher emergency admissions for angina (IRR: 1.53; 1.07 to 2.20) and lower elective admissions for ischaemic heart disease (IRR: 0.68; 0.51 to 0.92). Conclusion: Monitoring of metabolic measurements was comparable for people with diabetes with and without SMI. Increased mortality rates observed in SMI may be attributable to under-diagnosis of CVD and delays in treatment.

Objectives Estimates of depression prevalence in pregnancy and postpartum are based on the Edinburgh Postnatal Depression Scale (EPDS) more than on any other method. We aimed to determine if any EPDS cutoff can accurately and consistently estimate depression prevalence in individual studies. Methods We analyzed datasets that compared EPDS scores to Structured Clinical Interview for DSM (SCID) major depression status. Random-effects meta-analysis was used to compare prevalence with EPDS cutoffs versus the SCID. Results Seven thousand three hundred and fifteen participants (1017 SCID major depression) from 29 primary studies were included. For EPDS cutoffs used to estimate prevalence in recent studies (>= 9 to >= 14), pooled prevalence estimates ranged from 27.8% (95% CI: 22.0%-34.5%) for EPDS >= 9 to 9.0% (95% CI: 6.8%-11.9%) for EPDS >= 14; pooled SCID major depression prevalence was 9.0% (95% CI: 6.5%-12.3%). EPDS >= 14 provided pooled prevalence closest to SCID-based prevalence but differed from SCID prevalence in individual studies by a mean absolute difference of 5.1% (95% prediction interval: -13.7%, 12.3%). Conclusion EPDS >= 14 approximated SCID-based prevalence overall, but considerable heterogeneity in individual studies is a barrier to using it for prevalence estimation.

Aims: This study used a large database to develop a reliable and valid shortened form of the Edinburgh Postnatal Depression Scale (EPDS), a self-report questionnaire used for depression screening in pregnancy and postpartum, based on objective criteria. Methods: Item responses from the 10-item EPDS were obtained from 5157 participants (765 major depression cases) from 22 primary screening accuracy studies that compared the EPDS to the Structured Clinical Interview for DSM (SCID). Unidimensionality of the EPDS latent construct was verified using confirmatory factor analysis, and an item response theory model was fit. Optimal test assembly (OTA) methods identified a maximally informative shortened form for each possible scale length between 1 and 9 items. The final shortened form was selected based on prespecified validity and reliability criteria and non-inferiority of screening accuracy of the EPDS as compared to the SCID. Results: A 5-item short form of the EPDS (EPDS-Dep-5) was selected. The EPDSDep-5 had a Cronbach's alpha of 0.82. Sensitivity and specificity of the EPDS-Dep-5 for a cutoff of 4 or greater were 0.83 (95% CI, 0.73, 0.89) and 0.86 (95% CI, 0.80, 0.90) and were statistically non-inferior to the EPDS. The correlation of total scores with the full EPDS was high (r = 0.91). Conclusion: The EPDS-Dep-5 is a valid short form with minimal loss of information when compared to the full-length EPDS. The EPDS-Dep-5 was developed with OTA methods using objective, pre-specified criteria, but the approach is data-driven and exploratory. Thus, there is a need to replicate results of this study in different populations., This study was funded by the Canadian Institutes of Health Research (CIHR, KRS-140994). Dr. Levis was supported by a Fonds de recherche du QuébecSanté (FRQS) Postdoctoral Training Fellowship. Drs. Thombs and Benedetti were supported by FRQS researcher salary awards. Dr. Wu was supported by a FRQS Postdoctoral Training Fellowship. Mr. Bhandari was supported by a studentship from the Research Institute of the McGill University Health Centre. Ms. Neupane was supported by G.R. Caverhill Fellowship from the Faculty of Medicine, McGill University. Ms. Rice was supported by a Vanier Canada Graduate Scholarship. Ms. Azar was supported by a FRQS Masters Training Award. The primary study by Barnes et al was supported by a grant from the Health Foundation (1665/608). The primary study by Beck et al was supported by the Patrick and Catherine Weldon Donaghue Medical Research Foundation and the University of Connecticut Research Foundation. The primary study by Helle et al was supported by the Werner Otto Foundation, the Kroschke Foundation, and the Feindt Foundation. The primary study by de Figueiredo et al was supported by Fundação de Amparo à Pesquisa do Estado de São Paulo. The primary study by Tendais et al was supported under the project POCI/SAU-ESP/56397/2004 by the Operational Program Science and Innovation 2010 (POCI 2010) of the Community Support Board III and by the European Community Fund FEDER. This primary study by Green et al was supported by a grant from the Duke Global Health Institute (453- 0751). The primary study by Kettunen et al was supported with an Annual EVO Financing (Special government subsidies from the Ministry of Health and Welfare, Finland) by North Karelia Central Hospital and Päijät-Häme Central Hospital. The primary study by Phillips et al was supported by a scholarship from the National Health and Medical and Research Council (NHMRC). The primary study by Nakić Radoš et al was supported by the Croatian Ministry of Science, Education, and Sports (134- 0000000-2421). The primary study by Rochat et al was supported by grants from the University of Oxford (HQ5035), the Tuixen Foundation (9940), the Wellcome Trust (082384/Z/07/Z and 071571), and the American Psychological Association. Dr. Rochat receives salary support from a Wellcome Trust Intermediate Fellowship (211374/Z/18/Z). The primary study by Smith-Nielsen et al was supported by a grant from the charitable foundation Tryg Foundation (Grant ID no 107616). The primary study by Prenoveau et al was supported by The Wellcome Trust (grant number 071571). The primary study by Stewart et al was supported by Professor Francis Creed's Journal of Psychosomatic Research Editorship fund (BA00457) administered through University of Manchester. The primary study by Tandon et al was funded by the Thomas Wilson Sanitarium. The primary study by Tran et al was supported by the Myer Foundation who funded the study under its Beyond Australia scheme. Dr. Tran was supported by an early career fellowship from the Australian National Health and Medical Research Council. The primary study by Vega-Dienstmaier et al was supported by Tejada Family Foundation, Inc, and Peruvian-American Endowment, Inc.

Background Given, smoking results in poor physical and mental health, reducing tobacco harm is of high importance. Recommendations published by National Institute for Health and Care Excellence to reduce smoking harms included provision of support, use of nicotine containing products and commissioning of smoking cessation services. Aims This report explores the difficulties in obtaining such support, as observed in a recently conducted randomised controlled trial in patients with severe mental ill health, and outlines suggestions to improve facilitation of provision. Methods Data collected during the Smoking Cessation Intervention for severe Mental Ill Health Trial (SCIMITAR+) trial, was reviewed to identify the difficulties experienced, across the trial, with regards to access and provision of NRT. Actions taken to facilitate access and provision of NRT were collated to outline how provision could be better facilitated. Results Access to nicotine replacements therapy (NRT) varied across study settings and in some instances proved impossible for patients to access. Difficulty in access was irrespective of a diagnosis of severe mental ill health. Where NRT was provided, this was not always provided in accordance with NICE guidelines. Conclusions Availability of smoking cessation support, and NRT provision would benefit from being made clearer, simpler and more easily accessible so as to enhance smoking cessation rates.

There is increasing academic and clinical interest in how “lifestyle factors” traditionally associated with physical health may also relate to mental health and psychological well‐being. In response, international and national health bodies are producing guidelines to address health behaviors in the prevention and treatment of mental illness. However, the current evidence for the causal role of lifestyle factors in the onset and prognosis of mental disorders is unclear. We performed a systematic meta‐review of the top‐tier evidence examining how physical activity, sleep, dietary patterns and tobacco smoking impact on the risk and treatment outcomes across a range of mental disorders. Results from 29 meta‐analyses of prospective/cohort studies, 12 Mendelian randomization studies, two meta‐reviews, and two meta‐analyses of randomized controlled trials were synthesized to generate overviews of the evidence for targeting each of the specific lifestyle factors in the prevention and treatment of depression, anxiety and stress‐related disorders, schizophrenia, bipolar disorder, and attention‐deficit/hyperactivity disorder. Standout findings include: a) convergent evidence indicating the use of physical activity in primary prevention and clinical treatment across a spectrum of mental disorders; b) emerging evidence implicating tobacco smoking as a causal factor in onset of both common and severe mental illness; c) the need to clearly establish causal relations between dietary patterns and risk of mental illness, and how diet should be best addressed within mental health care; and d) poor sleep as a risk factor for mental illness, although with further research required to understand the complex, bidirectional relations and the benefits of non‐pharmacological sleep‐focused interventions. The potentially shared neurobiological pathways between multiple lifestyle factors and mental health are discussed, along with directions for future research, and recommendations for the implementation of these findings at public health and clinical service levels.

Researchers increasingly use meta-analysis to synthesize the results of several studies in order to estimate a common effect. When the outcome variable is continuous, standard meta-analytic approaches assume that the primary studies report the sample mean and standard deviation of the outcome. However, when the outcome is skewed, authors sometimes summarize the data by reporting the sample median and one or both of (i) the minimum and maximum values and (ii) the first and third quartiles, but do not report the mean or standard deviation. To include these studies in meta-analysis, several methods have been developed to estimate the sample mean and standard deviation from the reported summary data. A major limitation of these widely used methods is that they assume that the outcome distribution is normal, which is unlikely to be tenable for studies reporting medians. We propose two novel approaches to estimate the sample mean and standard deviation when data are suspected to be non-normal. Our simulation results and empirical assessments show that the proposed methods often perform better than the existing methods when applied to non-normal data.

Background Serious mental illness (SMI), including schizophrenia, bipolar disorder and other psychoses, is linked with high disease burden, poor outcomes, high treatment costs and lower life expectancy. In the UK, most people with SMI are treated in primary care by general practitioners (GPs), who are financially incentivised to meet quality targets for patients with chronic conditions, including SMI, under the Quality and Outcomes Framework (QOF). The QOF, however, omits important aspects of quality. Objective(s) We examined whether better quality of primary care for people with SMI improved a range of outcomes. Design and setting We used administrative data from English primary care practices that contribute to the Clinical Practice Research Datalink GOLD database, linked to Hospital Episode Statistics, Accident & Emergency (A&E) attendances, Office for National Statistics mortality data, and community mental health records in the Mental Health Minimum Dataset. We used survival analysis to estimate whether selected quality indicators affect the time until patients experience an outcome. Participants Four cohorts of people with SMI depending on the outcomes examined and inclusion criteria. Interventions Quality of care was measured with: i) QOF indicators: care plans and annual physical reviews ;and ii) non-QOF indicators identified through a systematic review (antipsychotic polypharmacy and continuity of care provided by GPs). Main outcome measures Several outcomes were examined: emergency admissions for i) SMI and ii) ambulatory care sensitive conditions (ACSCs); iii) all unplanned admissions; iv) A&E attendances; v) mortality; vi) re-entry into specialist mental health services; vii) costs attributed to primary, secondary and community mental healthcare. Results Care plans were associated with lower risk of A&E attendance (Hazard ratio (HR) 0.74, 95%CI 0.69-0.80), SMI admission (HR 0.67, 95%CI 0.59-0.75), ACSC admission (HR 0.73, 95%CI 0.64-0.83), and lower overall healthcare (£53), primary care (£9), hospital (£26), and mental healthcare costs (£12). Annual reviews were associated with reduced risk of A&E attendance (HR 0.80, 95%CI 0.76-0.85), SMI admission (HR 0.75, 95%CI 0.67-0.84), ACSC admission (HR 0.76, 95%CI 0.67-0.87), and lower overall healthcare (£34), primary care (£9), and mental healthcare costs (£30). Higher GP continuity was associated with lower risk of A&E presentation (HR 0.89, 95%CI 0.83-0.97), ACSC admission (HR 0.77, 95%CI 0.65-0.92), but not SMI admission. High continuity was associated with lower primary care costs (£3). Antipsychotic polypharmacy was not statistically significantly associated with the risk of unplanned admission, death or A&E presentation. None of the quality measures were statistically significantly associated with risk of re-entry into specialist mental healthcare. Limitations There is risk of bias from unobserved factors. To mitigate this, we controlled for observed patient characteristics at baseline and adjusted for the influence of time-invariant unobserved patient differences. Conclusions Better performance on QOF measures and continuity of care are associated with better outcomes and lower resource utilisation and could generate moderate cost savings. Future work Future research should examine the impact of primary care quality on measures that capture broader aspects of health and functioning.

BACKGROUND: Around one in ten adults take antidepressants for depression in England, and their long-term use is increasing. Some need them to prevent relapse, but 30-50% could possibly stop them without relapsing and avoid adverse effects and complications of long-term use. However, stopping is not always easy due to withdrawal symptoms and a fear of relapse of depression. When general practitioners review patients on long-term antidepressants and recommend to those who are suitable to stop the medication, only 6-8% are able to stop. The Reviewing long-term antidepressant use by careful monitoring in everyday practice (REDUCE) research programme aims to identify safe and cost-effective ways of helping patients taking long-term antidepressants taper off treatment when appropriate.METHODS: Design: REDUCE is a two-arm, 1:1 parallel group randomised controlled trial, with randomisation clustered by participating family practices.SETTING: England and north Wales.POPULATION: patients taking antidepressants for longer than 1 year for a first episode of depression or longer than 2 years for repeated episodes of depression who are no longer depressed and want to try to taper off their antidepressant use.INTERVENTION: provision of 'ADvisor' internet programmes to general practitioners or nurse practitioners and to patients designed to support antidepressant withdrawal, plus three patient telephone calls from a psychological wellbeing practitioner. The control arm receives usual care. Blinding of patients, practitioners and researchers is not possible in an open pragmatic trial, but statistical and health economic data analysts will remain blind to allocation.OUTCOME MEASURES: the primary outcome is self-reported nine-item Patient Health Questionnaire at 6 months for depressive symptoms.SECONDARY OUTCOMES: depressive symptoms at other follow-up time points, anxiety, discontinuation of antidepressants, social functioning, wellbeing, enablement, quality of life, satisfaction, and use of health services for costs.SAMPLE SIZE: 402 patients (201 intervention and 201 controls) from 134 general practices recruited over 15-18 months, and followed-up at 3, 6, 9 and 12 months. A qualitative process evaluation will be conducted through interviews with 15-20 patients and 15-20 practitioners in each arm to explore why the interventions were effective or not, depending on the results.DISCUSSION: Helping patients reduce and stop antidepressants is often challenging for practitioners and time-consuming for very busy primary care practices. If REDUCE provides evidence showing that access to internet and telephone support enables more patients to stop treatment without increasing depression we will try to implement the intervention throughout the National Health Service, publishing practical guidance for professionals and advice for patients to follow, publicised through patient support groups.TRIAL REGISTRATION: ISRCTN:12417565. Registered on 7 October 2019.

Objective: The Maternal Mental Health in Canada, 2018/2019, survey reported that 18% of 7,085 mothers who recently gave birth reported “feelings consistent with postpartum depression” based on scores >= 7 on a 5-item version of the Edinburgh Postpartum Depression Scale (EPDS-5). The EPDS-5 was designed as a screening questionnaire, not to classify disorders or estimate prevalence; the extent to which EPDS-5 results reflect depression prevalence is unknown. We investigated EPDS-5 >= 7 performance relative to major depression prevalence based on a validated diagnostic interview, the Structured Clinical Interview for DSM (SCID). Methods: We searched Medline, Medline In-Process & Other Non-Indexed Citations, PsycINFO, and the Web of Science Core Collection through June 2016 for studies with data sets with item response data to calculate EPDS-5 scores and that used the SCID to ascertain depression status. We conducted an individual participant data meta-analysis to estimate pooled percentage of EPDS-5 >= 7, pooled SCID major depression prevalence, and the pooled difference in prevalence. Results: A total of 3,958 participants from 19 primary studies were included. Pooled prevalence of SCID major depression was 9.2% (95% confidence interval [CI] 6.0% to 13.7%), pooled percentage of participants with EPDS-5 >= 7 was 16.2% (95% CI 10.7% to 23.8%), and pooled difference was 8.0% (95% CI 2.9% to 13.2%). In the 19 included studies, mean and median ratios of EPDS-5 to SCID prevalence were 2.1 and 1.4 times. Conclusions: Prevalence estimated based on EPDS-5 >= 7 appears to be substantially higher than the prevalence of major depression. Validated diagnostic interviews should be used to establish prevalence.