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Background: Severe mental ill health (SMI) includes schizophrenia, bipolar disorder and schizoaffective disorder and is associated with premature deaths when compared to people without SMI. Over 70% of those deaths are attributed to preventable health conditions, which have the potential to be positively affected by the adoption of healthy behaviours, such as physical activity. People with SMI are generally less active than those without and face unique barriers to being physically active. Physical activity interventions for those with SMI demonstrate promise, however, there are important questions remaining about the potential feasibility and acceptability of a physical activity intervention embedded within existing NHS pathways. Method: This is a two-arm multi-site randomised controlled feasibility trial, assessing the feasibility and acceptability of a co-produced physical activity intervention for a full-scale trial across geographically dispersed NHS mental health trusts in England. Participants will be randomly allocated via block, 1:1 randomisation, into either the intervention arm or the usual care arm. The usual care arm will continue to receive usual care throughout the trial, whilst the intervention arm will receive usual care plus the offer of a weekly, 18-week, physical activity intervention comprising walking and indoor activity sessions and community taster sessions. Another main component of the intervention includes one-to-one support. The primary outcome is to investigate the feasibility and acceptability of the intervention and to scale it up to a full-scale trial, using a short proforma provided to all intervention participants at follow-up, qualitative interviews with approximately 15 intervention participants and 5 interventions delivery staff, and data on intervention uptake, attendance, and attrition. Usual care data will also include recruitment and follow-up retention. Secondary outcome measures include physical activity and sedentary behaviours, body mass index, depression, anxiety, health-related quality of life, healthcare resource use, and adverse events. Outcome measures will be taken at baseline, three, and six-months post randomisation. Discussion: This study will determine if the physical activity intervention is feasible and acceptable to both participants receiving the intervention and NHS staff who deliver it. Results will inform the design of a larger randomised controlled trial assessing the clinical and cost effectiveness of the intervention. Trial registration: ISRCTN: ISRCTN83877229. Registered on 09.09.2022. [ABSTRACT FROM AUTHOR]

Mental health problems bring substantial individual, community and societal costs and the need for innovation to promote good mental health and to prevent and treat mental health problems has never been greater. However, we know that research findings can take up to 20 years to implement. One way to push the pace is to focus researchers and funders on shared, specific goals and targets. We describe a consultation process organised by the Department of Health and Social Care and convened by the Chief Medical Officer to consider high level goals for future research efforts and to begin to identify UK-specific targets to measure research impact. The process took account of new scientific methods and evidence, the UK context with a universal health care system (the NHS) and the embedded research support from the National Institute for Health Research Clinical Research Network, as well as the views of individual service users and service user organisations. The result of the consultation is a set of four overarching goals with the potential to be measured at intervals of three, five or ten years. [ABSTRACT FROM AUTHOR]

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

Objective: This study aimed to quantify the incidence rates of common mental and physical health conditions in mothers of children with a life-limiting condition.Methods: Comparative national longitudinal cohort study using linked primary and secondary care data from the Clinical Practice Research Datalink in England. Maternal-child dyads were identified in these data. Maternal physical and mental health outcomes were identified in the primary and secondary care datasets using previously developed diagnostic coding frameworks. Incidence rates of the outcomes were modelled using Poisson regression, adjusting for deprivation, ethnicity and age and accounting for time at risk.Results: A total of 35 683 mothers; 8950 had a child with a life-limiting condition, 8868 had a child with a chronic condition and 17 865 had a child with no long-term condition.The adjusted incidence rates of all of the physical and mental health conditions were significantly higher in the mothers of children with a life-limiting condition when compared with those mothers with a child with no long-term condition (eg, depression: incidence rate ratio (IRR) 1.21, 95% CI 1.13 to 1.30; cardiovascular disease: IRR 1.73, 95% CI 1.27 to 2.36; death in mothers: IRR 1.59, 95% CI 1.16 to 2.18).Conclusion: This study clearly demonstrates the higher incidence rates of common and serious physical and mental health problems and death in mothers of children with a life-limiting condition. Further research is required to understand how best to support these mothers, but healthcare providers should consider how they can target this population to provide preventative and treatment services. [ABSTRACT FROM AUTHOR]

Background: People with severe mental illnesses (SMIs) have reduced life expectancy compared with the general population. Diabetes is a 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 people with type 2 diabetes (T2DM).Design and Setting: Retrospective, observational, matched, nested, case-control study conducted in England using patient records from the Clinical Practice Research Datalink, linked to Hospital Episode Statistics.Method: A range of healthcare processes (primary care consultations, physical health checks, and metabolic measurements) and outcomes (prevalence and hospitalisation for cardiovascular disease [CVD], and mortality risk) were compared for 2192 people with SMI and T2DM (cases) with 7773 people who had diabetes alone (controls). Sociodemographics, comorbidity, and medication prescription were covariates in regression models.Results: When compared with results for participants with T2DM only, SMI was associated with increased risk of all-cause mortality (hazard ratio [HR] 1.919, 95% confidence interval [CI] = 1.602 to 2.300) and CVD-specific mortality (HR 2.242, 95% CI = 1.547 to 3.250), higher primary care physician consultation rates (incidence rate ratio [IRR] 1.149, 95% CI = 1.111 to 1.188), more-frequent checks of blood pressure (IRR 1.024, 95% CI = 1.003 to 1.046) and cholesterol (IRR 1.038, 95% CI = 1.019 to 1.058), lower prevalence of angina (odds ratio 0.671, 95% CI = 0.450 to 1.001), more emergency admissions for angina (IRR 1.532, 95% CI = 1.069 to 2.195), and fewer elective admissions for ischaemic heart disease (IRR 0.682, 95% CI = 0.508 to 0.915).Conclusion: Monitoring of metabolic measurements was comparable for people with T2DM who did, and did not, have SMI. Increased mortality rates observed in people with SMI may be attributable to underdiagnosis of CVD and delays in treatment. [ABSTRACT FROM AUTHOR]

Aims: To evaluate the cost‐effectiveness of a specialist smoking cessation package for people with severe mental illness Design Incremental cost‐effectiveness analysis was undertaken from the UK National Health Service and Personal Social Services perspective over a 12‐month time horizon. Total costs, including smoking cessation, health‐care and social services costs and quality‐adjusted life years (QALYs), derived from the five‐level EuroQol 5‐dimension (EQ‐5D‐5 L), collected from a randomized controlled trial, were used as outcome measures. The bootstrap technique was employed to assess the uncertainty. Setting: Sixteen primary care and 21 secondary care mental health sites in England. Participants: Adult smokers with bipolar affective disorder, schizoaffective disorder or schizophrenia and related illnesses (n = 526). Intervention and comparator: A bespoke smoking cessation (BSC) package for people with severe mental illness offered up to 12 individual sessions with a mental health smoking cessation practitioner versus usual care (UC). Of the participants who were randomized, 261 were in UC group and 265 were in BSC group. Measurements BSC intervention cost was estimated from the treatment log. Costs of UC, health‐care and social services and EQ‐5D‐5 L were collected at baseline, 6‐ and 12‐month follow‐ups. Incremental costs and incremental QLAYs were estimated using regression adjusting for respective baseline values and other baseline covariates. Findings The mean total cost in the BSC group was £270 [95% confidence interval (CI) = –£1690 to £1424] lower than in the UC group, while the mean QALYs were 0.013 (95% CI = –0.008 to 0.045) higher, leading to BSC dominating UC (76% probability of cost‐effective at £20 000/QALY). Conclusions: A bespoke smoking cessation package for people with severe mental illness is likely to be cost‐effective over 12 months compared with usual care provided by the UK's National Health Service and personal social services. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Objective: To investigate whether continuity of care in family practice reduces unplanned hospital use for people with serious mental illness (SMI).Data Sources: Linked administrative data on family practice and hospital utilization by people with SMI in England, 2007-2014.Study Design: This observational cohort study used discrete-time survival analysis to investigate the relationship between continuity of care in family practice and unplanned hospital use: emergency department (ED) presentations, and unplanned admissions for SMI and ambulatory care-sensitive conditions (ACSC). The analysis distinguishes between relational continuity and management/ informational continuity (as captured by care plans) and accounts for unobserved confounding by examining deviation from long-term averages.Data Collection/extraction Methods: Individual-level family practice administrative data linked to hospital administrative data.Principal Findings: Higher relational continuity was associated with 8-11 percent lower risk of ED presentation and 23-27 percent lower risk of ACSC admissions. Care plans were associated with 29 percent lower risk of ED presentation, 39 percent lower risk of SMI admissions, and 32 percent lower risk of ACSC admissions.Conclusions: Family practice continuity of care can reduce unplanned hospital use for physical and mental health of people with SMI. [ABSTRACT FROM AUTHOR]

Objective: Although U.K. and international guidelines recommend monotherapy, antipsychotic polypharmacy among patients with serious mental illness is common in clinical practice. However, empirical evidence on its effectiveness is scarce. Therefore, the authors estimated the effectiveness of antipsychotic polypharmacy relative to monotherapy in terms of health care utilization and mortality.Methods: Primary care data from Clinical Practice Research Datalink, hospital data from Hospital Episode Statistics, and mortality data from the Office of National Statistics were linked to compile a cohort of patients with serious mental illness in England from 2000 to 2014. The antipsychotic prescribing profile of 17,255 adults who had at least one antipsychotic drug record during the period of observation was constructed from primary care medication records. Survival analysis models were estimated to identify the effect of antipsychotic polypharmacy on the time to first occurrence of each of three outcomes: unplanned hospital admissions (all cause), emergency department (ED) visits, and mortality.Results: Relative to monotherapy, antipsychotic polypharmacy was not associated with increased risk of unplanned hospital admission (hazard ratio [HR]=1.14; 95% confidence interval [CI]=0.98-1.32), ED visit (HR=0.95; 95% CI=0.80-1.14), or death (HR=1.02; 95% CI=0.76-1.37). Relative to not receiving antipsychotic medication, monotherapy was associated with a reduced hazard of unplanned admissions to the hospital and ED visits, but it had no effect on mortality.Conclusions: The study results support current guidelines for antipsychotic monotherapy in routine clinical practice. However, they also suggest that when clinicians have deemed antipsychotic polypharmacy necessary, health care utilization and mortality are not affected. [ABSTRACT FROM AUTHOR]

Rationale, aims and objectives Our aim was to evaluate the effectiveness of a Post-it® note to increase response rates and shorten response times to a 4-month postal follow-up questionnaire sent to participants taking part in the Collaborative Care in Screen-Positive Elders (CASPER) trials. Method Our trial was a two-arm randomized controlled trial comparing response rates to questionnaires with a printed Post-it® note (intervention) and without (control), nested in multi centred randomized controlled trials of older people with varying levels of depressive symptoms; the CASPER+ and CASPER Self Help for those At Risk of Depression (SHARD) trials. A total of 611 participants were eligible and randomized. The primary outcome was response rates, secondary outcomes were time to response and need for a reminder. Results Of 297 participants, 266 (89.6%) returned their 4-month questionnaire in the post-it note arm, compared with 282 of 314 participants (89.8%) in the control arm (OR = 0.97, 95% CI: 0.57, 1.65, P = 0.913). There were no statistically significant differences in time to respond or the need to be sent a reminder. Patients with a major depressive episode were more likely to return questionnaires with post-it notes ( P of interaction = .019). Conclusion There was no significant difference in response rates, time to response, or the need for a reminder between the intervention and control at 4-month follow up for older people with depressive symptoms. However, there was a significant interaction between the Post-it® note group and level of depression. [ABSTRACT FROM AUTHOR]

Background: Long-term conditions often coexist with depression and anxiety.Aims: To assess the effectiveness of stepped-care psychological therapies for patients with long-term conditions.Method: Data from 28 498 patients were analysed using regression to model depression (Patient Health Questionnaire (PHQ-9)) and anxiety (Generalised Anxiety Disorder scale (GAD-7)) outcomes. Post-treatment symptoms and effect sizes (d) were estimated for individuals with and without long-term conditions, controlling for covariates. The likelihood of access and response to intensive psychological interventions was also examined.Results: Higher post-treatment symptoms were predicted for patients with musculoskeletal problems (d = 0.22-0.27), chronic obstructive pulmonary disease (d = 0.26-0.33), diabetes (d = 0.05-0.13) and psychotic disorders (d = 0.50-0.58). Most long-term conditions were associated with greater odds of accessing high-intensity therapies, yet individuals who accessed these continued to have higher average post-treatment symptoms.Conclusions: Some long-term conditions are associated with greater intensity of care and poorer outcomes after therapy. [ABSTRACT FROM AUTHOR]

Background: Serious mental illness (SMI), which encompasses a set of chronic conditions such as schizophrenia, bipolar disorder and other psychoses, accounts for 3.4 m (7 %) total bed days in the English NHS. The introduction of prospective payment to reimburse hospitals makes an understanding of the key drivers of length of stay (LOS) imperative. Existing evidence, based on mainly small scale and cross-sectional studies, is mixed. Our study is the first to use large-scale national routine data to track English hospitals' LOS for patients with a main diagnosis of SMI over time to examine the patient and local area factors influencing LOS and quantify the provider level effects to draw out the implications for payment systems.Methods: We analysed variation in LOS for all SMI admissions to English hospitals from 2006 to 2010 using Hospital Episodes Statistics (HES). We considered patients with a LOS of up to 180 days and estimated Poisson regression models with hospital fixed effects, separately for admissions with one of three main diagnoses: schizophrenia; psychotic and schizoaffective disorder; and bipolar affective disorder. We analysed the independent contribution of potential determinants of LOS including clinical and socioeconomic characteristics of the patient, access to and quality of primary care, and local area characteristics. We examined the degree of unexplained variation in provider LOS.Results: Most risk factors did not have a differential effect on LOS for different diagnostic sub-groups, however we did find some heterogeneity in the effects. Shorter LOS in the pooled model was associated with co-morbid substance or alcohol misuse (4 days), and personality disorder (8 days). Longer LOS was associated with older age (up to 19 days), black ethnicity (4 days), and formal detention (16 days). Gender was not a significant predictor. Patients who self-discharged had shorter LOS (20 days). No association was found between higher primary care quality and LOS. We found large differences between providers in unexplained variation in LOS.Conclusions: By identifying key determinants of LOS our results contribute to a better understanding of the implications of case-mix to ensure prospective payment systems reflect accurately the resource use within sub-groups of patients with SMI. [ABSTRACT FROM AUTHOR]

Background: Guidance from the National Institute for Health and Care Excellence advocates the use of two case-finding questions about depressed mood and loss of interest in activities to identify perinatal depression. However, there are no studies of their acceptability when administered in the antenatal and postnatal period. Methods: The study was an intra-mixed methods cohort study set in an antenatal clinic in an inner-city hospital in the North of England. Pregnant women attending a routine antenatal appointment at approximately 26 weeks' gestation completed a self-report survey at a routine hospital antenatal appointment and a postal survey between 5 and 13 weeks postnatal. Survey responses and free-text commentaries of women's views were analysed using descriptive statistics and qualitative content analysis. Results: Ninety-three percent of participants felt it was desirable to ask about perinatal mental wellbeing, and 97% felt comfortable answering the questions. Free-text comments revealed depressed and non-depressed women found the questions easy, simple and straightforward to answer . Conclusions: Case-finding questions to identify perinatal depression were generally acceptable to depressed and non-depressed pregnant and newly delivered mothers. Health professionals should consider the acceptability and appropriateness of this strategy in order to facilitate identification of perinatal mental health issues in routine maternity care practice. [ABSTRACT FROM AUTHOR]

Objectives To investigate if early symptom changes in brief low intensity psychological interventions (guided self-help and psycho-education using cognitive behavioural therapy principles) are predictive of final treatment outcome. Design Retrospective cohort data analysis. Method Clinical records for 1,850 patients who screened positive for depression and/or an anxiety disorder were analysed. Reliable and clinically significant improvement ( RCSI) on depression (Patient Health Questionnaire-9: PHQ-9) or anxiety (generalized anxiety disorder-7: GAD-7) outcome measures after treatment was the primary outcome. Change scores ≥6 on PHQ-9 and ≥5 on GAD-7 were taken as indicative of reliable improvement ( RI). The model assumed that RI in the earliest treatment sessions would be predictive of RCSI post-treatment. Predictive accuracy was assessed by calculating the area under the curve ( AUC), as well as positive and negative predictive values. Diagnostic odds ratios were also estimated, adjusting for confounders such as baseline severity, use of medication, and pre-treatment symptom change. Results The AUC estimates for session-to-session change scores ranged between .62 and .88, indicative of modest to high predictive reliability. Predictive accuracy was higher for patients who had four or more treatment sessions, with more than 70% of patients with RCSI being accurately identified as early as sessions 1-3. Attrition rates were significantly associated with poor outcomes. Results suggest that at least four therapy sessions are necessary to achieve more than 50% RCSI rates, and the dose-response effect appears to decline in treatments longer than six sessions. Conclusions Patients showing RI early in treatment were at least twice as likely to fully recover compared to those without early RI. Practitioner points Patients showing early response to low intensity therapy are at least twice as likely to recover at the end of treatment., Dropout from treatment is associated with poor clinical outcomes., Optimal recovery rates were observed for treatments with a total length of between four and six sessions; the dose-response declined in lengthier treatments., Randomization to different treatment lengths is necessary to confirm this dose-response effect with greater certainty. [ABSTRACT FROM AUTHOR]

The article discusses a study focusing on the relapse and recurrence rates of mental health problems in people who were treated using low intensity cognitive behavioural therapy (LiCBT). Topics discussed include the patients with depression and anxiety disorders, who were part of the study; the criteria for risk event in the study; and the diagnosis of acute symptoms of depression and anxiety in the patients.

Background: Depression accounts for the greatest disease burden of all mental health disorders, contributes heavily to healthcare costs, and by 2020 is set to become the second largest cause of global disability. Although 10% to 16% of people aged 65 years and over are likely to experience depressive symptoms, the condition is under-diagnosed and often inadequately treated in primary care. Later-life depression is associated with chronic illness and disability, cognitive impairment and social isolation. With a progressively ageing population it becomes increasingly important to refine strategies to identity and manage depression in older people. Currently, management may be limited to the prescription of antidepressants where there may be poor concordance; older people may lack awareness of psychosocial interventions and general practitioners may neglect to offer this treatment option.Methods/design: CASPER Plus is a multi-centre, randomised controlled trial of a collaborative care intervention for individuals aged 65 years and over experiencing moderate to severe depression. Selected practices in the North of England identify potentially eligible patients and invite them to participate in the study. A diagnostic interview is carried out and participants with major depressive disorder are randomised to either collaborative care or usual care. The recruitment target is 450 participants. The intervention, behavioural activation and medication management in a collaborative care framework, has been adapted to meet the complex needs of older people. It is delivered over eight to 10 weekly sessions by a case manager liaising with general practitioners. The trial aims to evaluate the clinical and cost effectiveness of collaborative care in addition to usual GP care versus usual GP care alone. The primary clinical outcome, depression severity, will be measured with the Patient Health Questionnaire-9 (PHQ-9) at baseline, 4, 12 and 18 months. Cost effectiveness analysis will assess health-related quality of life using the SF-12 and EQ-5D and will examine cost-consequences of collaborative care. A qualitative process evaluation will be undertaken to explore acceptability, gauge the extent to which the intervention is implemented and to explore sustainability beyond the clinical trial.Discussion: Results will add to existing evidence and a positive outcome may lead to the commissioning of this model of service in primary care.Trial Registration: ISRCTN45842879 (24 July 2012). [ABSTRACT FROM AUTHOR]

Background: Cognitive behaviour therapy (CBT) is an effective treatment for depression. However, CBT is a complex therapy that requires highly trained and qualified practitioners, and its scalability is therefore limited by the costs of training and employing sufficient therapists to meet demand. Behavioural activation (BA) is a psychological treatment for depression that may be an effective alternative to CBT and, because it is simpler, might also be delivered by less highly trained and specialised mental health workers.Methods/design: COBRA is a two-arm, non-inferiority, patient-level randomised controlled trial, including clinical, economic, and process evaluations comparing CBT delivered by highly trained professional therapists to BA delivered by junior professional or para-professional mental health workers to establish whether the clinical effectiveness of BA is non-inferior to CBT and if BA is cost effective compared to CBT. Four hundred and forty patients with major depressive disorder will be recruited through screening in primary care. We will analyse for non-inferiority in per-protocol and intention-to-treat populations. Our primary outcome will be severity of depression symptoms (Patient Health Questionnaire-9) at 12 months follow-up. Secondary outcomes will be clinically significant change and severity of depression at 18 months, and anxiety (General Anxiety Disorder-7 questionnaire) and health-related quality of life (Short-Form Health Survey-36) at 12 and 18 months. Our economic evaluation will take the United Kingdom National Health Service/Personal Social Services perspective to include costs of the interventions, health and social care services used, plus productivity losses. Cost-effectiveness will explored in terms of quality-adjusted life years using the EuroQol-5D measure of health-related quality of life.Discussion: The clinical and economic outcomes of this trial will provide the evidence to help policy makers, clinicians and guideline developers decide on the merits of including BA as a first-line treatment of depression.Trial Registration: Current Controlled Trials ISRCTN27473954. [ABSTRACT FROM AUTHOR]

Background: Older adults were more likely to be socially isolated during the COVID-19 pandemic, with increased risk of depression and loneliness. We aimed to investigate whether a behavioural activation intervention delivered via telephone could mitigate depression and loneliness in at-risk older people during the COVID-19 pandemic., Methods: BASIL+ (Behavioural Activation in Social Isolation) was a pragmatic randomised controlled trial conducted among patients recruited from general practices in England and Wales, and was designed to assess the effectiveness of behavioural activation in mitigating depression and loneliness among older people during the COVID-19 pandemic. Eligible participants were aged 65 years and older, socially isolated, with a score of 5 or higher on the Patient Health Questionnaire-9 (PHQ-9), and had multiple long-term conditions. Participants were allocated in a 1:1 ratio to the intervention (behavioural activation) or control groups by use of simple randomisation without stratification. Behavioural activation was delivered by telephone; participants were offered up to eight weekly sessions with trained BASIL+ Support Workers. Behavioural activation was adapted to maintain social connections and encourage socially reinforcing activities. Participants in the control group received usual care with existing COVID-19 wellbeing resources. The primary clinical outcome was self-reported depression severity, assessed by the PHQ-9, at 3 months. Outcomes were assessed masked to allocation and analysis was by treatment allocation. This trial is registered with the ISRCTN registry (ISRCTN63034289)., Findings: Between Feb 8, 2021, and Feb 28, 2022, 449 eligible participants were identified and 435 from 26 general practices were recruited and randomly assigned (1:1) to the behavioural activation intervention (n=218) or to the control group (usual care with signposting; n=217). The mean age of participants was 75·7 years (SD 6·7); 270 (62·1%) of 435 participants were female, and 418 (96·1%) were White. Participants in the intervention group attended an average of 5·2 (SD 2·9) of eight remote behavioural activation sessions. The adjusted mean difference in PHQ-9 scores between the control and intervention groups at 3 months was -1·65 (95% CI -2·54 to -0·75, p=0·0003). No adverse events were reported that were attributable to the behavioural activation intervention., Interpretation: Behavioural activation is an effective and potentially scalable intervention that can reduce symptoms of depression and emotional loneliness in at-risk groups in the short term. The findings of this trial add to the range of strategies to improve the mental health of older adults with multiple long-term conditions. These results can be helpful to policy makers beyond the pandemic in reducing the global burden of depression and addressing the health impacts of loneliness, particularly in at-risk groups., Funding: UK National Institute for Health and Care Research., Competing Interests: Declaration of interests SG and DE are members of the NICE Depression Guideline (update) Development Group. CAC-G declares royalties from Cambridge University Press Primary Care Mental Health, honoraria as Editor-in-Chief of Health Expectations and for organisation of the Royal College of General Practitioners (RCGP) One Day Essential learning event, and is Chair of the Society for Academic Primary Care awards panel and the RCGP Research Paper of the Year. All other authors declare no competing interests., (Copyright © 2024 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY-NC-ND 4.0 license. Published by Elsevier Ltd.. All rights reserved.)

Background: Social skills interventions are commonly recommended to help children and young people with autism spectrum disorder develop social skills, but some struggle to engage in these interventions. LEGO ® (LEGO System A/S, Billund, Denmark) based therapy, a group social skills intervention, aims to be more interesting and engaging., Objective: To evaluate the clinical effectiveness of LEGO ® based therapy on the social and emotional skills of children and young people with autism spectrum disorder in school settings compared with usual support. Secondary objectives included evaluations of cost-effectiveness, acceptability and treatment fidelity., Design: A cluster randomised controlled trial randomly allocating participating schools to either LEGO ® based therapy and usual support or usual support only., Setting: Mainstream schools in the north of England., Participants: Children and young people (aged 7-15 years) with autism spectrum disorder, their parent/guardian, an associated teacher/teaching assistant and a facilitator teacher/teaching assistant (intervention schools only)., Intervention: Schools randomised to the intervention arm delivered 12 weekly sessions of LEGO ® based therapy, which promotes collaborative play and encourages social problem-solving in groups of three children and young people with a facilitator (trained teacher or teaching assistant). Participants received usual support from school and community services. Participants in the control arm received usual support only. Research assistants and statisticians were blind to treatment allocation., Main Outcome Measure: The social skills subscale of the Social Skills Improvement System (SSIS), completed by the children and young people's unblinded teacher pre randomisation and 20 weeks post randomisation. The SSIS social skills subscale measures social skills including social communication, co-operation, empathy, assertion, responsibility and self-control. Participants completed a number of other pre- and post-randomisation measures of emotional health, quality of life, loneliness, problem behaviours, academic competence, service resource utilisation and adverse events., Results: A total of 250 children and young people from 98 schools were randomised: 127 to the intervention arm and 123 to the control arm. Intention-to-treat analysis of the main outcome measure showed a modest positive difference of 3.74 points (95% confidence interval -0.16 to 7.63 points, standardised effect size 0.18; p  = 0.06) in favour of the intervention arm. Statistical significance increased in per-protocol analysis, with a modest positive difference (standardised effect size 0.21; p  = 0.036). Cost-effectiveness of the intervention was found in reduced service use costs and a small increase in quality-adjusted life-years. Intervention fidelity and acceptability were positive. No intervention-related adverse events or effects were reported., Conclusions: The primary and pre-planned sensitivity analysis of the primary outcome consistently showed a positive clinical difference, with modest standardised effect sizes of between 0.15 and 0.21. There were positive health economics and qualitative findings, corroborated by the difference between arms for the majority of secondary outcomes, which were not statistically significant but favoured the intervention arm. Post hoc additional analysis was exploratory and was not used in drawing this conclusion. Given the small positive change, LEGO ® based therapy for children and young people with autism spectrum disorder in schools should be considered., Limitations: The primary outcome measure was completed by an unblinded teacher (rather than by the facilitator)., Future Work: The study team recommends future research into LEGO ® based therapy, particularly in school environments., Trial Registration: This trial is registered as ISRCTN64852382., Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Public Health Research programme (NIHR award ref: 15/49/32) and is published in full in Public Health Research ; Vol. 11, No. 12. See the NIHR Funding and Awards website for further award information.

Background: Depression is a common mental health condition with considerable negative impact on health and well-being. Although antidepressants are recommended as first-line treatment, there is limited evidence regarding the cost effectiveness of long-term maintenance antidepressants for preventing relapse., Objectives: Our objective was to calculate the mean incremental costs and quality-adjusted life-years (QALYs) over 12 months of discontinuing long-term antidepressant medication in well patients compared with maintenance, using patient-level trial data., Methods: We conducted a cost-utility analysis of 478 participants from 150 UK general practices recruited to a randomised, double-blind trial (ANTLER). QALYs were calculated from EQ-5D-5L and 12-Item Short Form survey (SF-12) results, with primary analysis using the EQ-5D-5L value set for England. Resource use was collected from primary care patient electronic medical records and self-completed questionnaires capturing mental-health-related resource use. Costs were calculated by applying standard UK unit costs to resource use. Adjustments were made for baseline variables., Results: Participants randomised to discontinuation had significantly worse utility scores at 3 months (- 0.032; 95% confidence interval [CI] - 0.053 to - 0.011) but no significant difference in QALYs (- 0.011; 95% CI - 0.026 to 0.003) or costs (£3.11; 95% CI - 41.28 to 47.50) at 12 months. The probability that discontinuation was cost effective compared with maintenance was 12.9% at a threshold of £20,000 per QALY gained., Conclusions: Discontinuation of antidepressants was unlikely to be cost effective compared with maintenance for currently well patients on long-term antidepressants. However, this analysis provides no information on the wider impact of antidepressants. Our findings provide information on the potential impact of discontinuing long-term maintenance antidepressants and facilitate improving guidance for shared patient-clinician decision making., Trial Registration: EudraCT number 2015-004210-26; ISRCTN number ISRCTN15969819., (© 2021. The Author(s).)

Objective: To investigate whether two primary care activities that are framed as indicators of primary care quality (comprehensive care plans and annual reviews of physical health) influence unplanned utilisation of hospital services for people with serious mental illness (SMI)., Design, Setting, Participants: Retrospective observational cohort study using linked primary care and hospital records (Hospital Episode Statistics) for 5158 patients diagnosed with SMI between April 2006 and March 2014, who attended 213 primary care practices in England that contribute to the Clinical Practice Research Datalink GOLD database., Outcomes and Analysis: Cox survival models were used to estimate the associations between two primary care quality indicators (care plans and annual reviews of physical health) and the hazards of three types of unplanned hospital utilisation: presentation to accident and emergency departments (A&E), admission for SMI and admission for ambulatory care sensitive conditions (ACSC)., Results: Risk of A&E presentation was 13% lower (HR 0.87, 95% CI 0.77 to 0.98) and risk of admission to hospital for ACSC was 23% lower (HR 0.77, 95% CI 0.60 to 0.99) for patients with a care plan documented in the previous year compared with those without a care plan. Risk of A&E presentation was 19% lower for those who had a care plan documented earlier but not updated in the previous year (HR: 0.81, 95% CI 0.67 to 0.97) compared with those without a care plan. Risks of hospital admission for SMI were not associated with care plans, and none of the outcomes were associated with annual reviews., Conclusions: Care plans documented in primary care for people with SMI are associated with reduced risk of A&E attendance and reduced risk of unplanned admission to hospital for physical health problems, but not with risk of admission for mental health problems. Annual reviews of physical health are not associated with risk of unplanned hospital utilisation., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY. Published by BMJ.)

Background: Previous research suggests that the use of outcome feedback technology can enable psychological therapists to identify and resolve obstacles to clinical improvement. We aimed to assess the effectiveness of an outcome feedback quality assurance system applied in stepped care psychological services., Methods: This multisite, open-label, cluster randomised controlled trial was done at eight National Health Service (NHS) Trusts in England, involving therapists who were qualified to deliver evidence-based low-intensity or high-intensity psychological interventions. Adult patients (18 years or older) who accessed individual therapy with participating therapists were eligible for inclusion, except patients who accessed group therapies and those who attended less than two individual therapy sessions. Therapists were randomly assigned (1:1) to an outcome feedback intervention group or a treatment-as-usual control group by use of a computer-generated randomisation algorithm. The allocation of patients to therapists was quasi-random, whereby patients on waiting lists were allocated sequentially on the basis of therapist availability. All patients received low-intensity (less than eight sessions) or high-intensity (up to 20 sessions) psychological therapies for the duration of the 1-year study period. An automated computer algorithm alerted therapists in the outcome feedback group to patients who were not on track, and primed them to review these patients in clinical supervision. The primary outcome was symptom severity on validated depression (Patient Health Questionnaire-9 [PHQ-9]) and anxiety (Generalised Anxiety Disorder-7 [GAD-7]) measures after treatment of varying durations, which were compared between groups with multilevel modelling, controlling for cluster (therapist) effects. We used an intention-to-treat approach. This trial was prospectively registered with ISRCTN, number ISRCTN12459454., Findings: In total, 79 therapists were recruited to the study between Jan 8, 2016, and July 15, 2016, but two did not participate. Of these participants, 39 (51%) were randomly assigned to the outcome feedback group and 38 (49%) to the control group. Overall, 2233 patients were included in the trial (1176 [53%] were treated by therapists in the outcome feedback group, and 1057 [47%] by therapists in the control group). Patients classified as not on track had less severe symptoms after treatment if they were allocated to the outcome feedback group than those in the control group (PHQ-9 d=0·23, B=-1·03 [95% CI -1·84 to -0·23], p=0·012; GAD-7 d=0·19, B=-0·85 [-1·56 to -0·14], p=0·019)., Interpretation: Supplementing psychological therapy with low-cost feedback technology can reduce symptom severity in patients at risk of poor response to treatment. This evidence supports the implementation of outcome feedback in stepped care psychological services., Funding: English NHS and Department of Health Sciences, University of York, York, UK., (Copyright © 2018 Elsevier Ltd. All rights reserved.)

Background: Randomised controlled trials (RCT) can struggle to recruit to target on time. This is especially the case with hard to reach populations such as those with severe mental ill health. The SCIMITAR+ trial, a trial of a bespoke smoking cessation intervention for people with severe mental ill health achieved their recruitment ahead of time and target. This article reports strategies that helped us to achieve this with the aim of aiding others recruiting from similar populations., Methods: SCIMITAR+ is a multi-centre pragmatic two-arm parallel-group RCT, which aimed to recruit 400 participants with severe mental ill health who smoke and would like to cut down or quit. The study recruited primarily in secondary care through community mental health teams and psychiatrists with a smaller number of participants recruited through primary care. Recruitment opened in October 2015 and closed in December 2016, by which point 526 participants had been recruited. We gathered information from recruiting sites on strategies which led to the successful recruitment in SCIMITAR+ and in this article present our approach to trial management along with the strategies employed by the recruiting sites., Results: Alongside having a dedicated trial manager and trial management team, we identified three main themes that led to successful recruitment. These were: clinicians with a positive attitude to research; researchers and clinicians working together; and the use of NHS targets. The overriding theme was the importance of relationships between both the researchers and the recruiting clinicians and the recruiting clinicians and the participants., Conclusions: This study makes a significant contribution to the limited evidence base of real-world cases of successful recruitment to RCTs and offers practical guidance to those planning and conducting trials. Building positive relationships between clinicians, researchers and participants is crucial to successful recruitment.

Background: Common mental disorders (CMD) such as anxiety and depression during the maternal period can cause significant morbidity to the mother in addition to disrupting biological, attachment and parenting processes that affect child development. Pharmacological treatment is a first-line option for moderate to severe episodes. Many women prescribed pharmacological treatments cease them during pregnancy but it is unclear to what extent non-pharmacological options are offered as replacement. There are also concerns that treatments offered may not be proportionate to need in minority ethnic groups, but few data exist on treatment disparities in the maternal period. We examined these questions in a multi-ethnic cohort of women with CMD living in Bradford, England before, during and up to one year after pregnancy., Methods: We searched the primary care records of women enrolled in the Born in Bradford cohort for diagnoses, symptoms, signs ('identification'), referrals for treatment, non-pharmacological and pharmacological treatment and monitoring ('treatment') related to CMD. Records were linked with maternity data to classify women identified with a CMD as treated prior to, and one year after, delivery. We examined rates and types of treatment during pregnancy, and analysed potential ethnic group differences using adjusted Poisson and multinomial logistic regression models., Results: We analysed data on 2,234 women with indicators of CMD. Most women were discontinued from pharmacological treatment early in pregnancy, but this was accompanied by recorded access to non-drug treatments in only 15 % at the time of delivery. Fewer minority ethnic women accessed treatments compared to White British women despite minority ethnic women being 55-70 % more likely than White British women to have been identified with anxiety in their medical record., Conclusions: Very few women who discontinued pharmacological treatment early in their pregnancy were offered other non-pharmacological treatments as replacement, and most appeared to complete their pregnancy untreated. Further investigation is warranted to replicate the finding that minority ethnic women are more likely to be identified as being anxious or having anxiety and understand what causes the variation in access to treatments.

Purpose of Research: To validate the Whooley questions as a screening tool for depression amongst a population of older adults in UK primary care., Objective: To assess the diagnostic performance of the Whooley questions as a screening tool for depression amongst older adults in UK primary care., Participants: A cross-sectional validation study was conducted with 766 patients aged ≥75 from UK primary care, recruited via 17 general practices based in the North of England during the pilot phase of a randomized controlled trial., Main Outcome Measures: Sensitivity, specificity and likelihood ratios comparing the index test (two Whooley questions) with a diagnosis of major depressive disorder (MDD) ascertained by the reference standard Mini International Neuropsychiatric Interview (MINI)., Results: The two screening questions had a sensitivity of 94.3% (95% confidence interval, 80.8-99.3%) and specificity of 62.7% (95% confidence interval, 59.0-66.2%). The likelihood ratio for a positive test was 2.5 (95% confidence interval, 2.2-2.9) and the likelihood ratio for a negative test was 0.09 (95% confidence interval, 0.02-0.35)., Conclusion: The two Whooley questions missed few cases of depression. However, they were responsible for a high rate of false positives. This creates additional burden on general practitioners, to conduct more detailed investigation on patients who screen positive, but many of whom turn out not to have MDD., (Copyright © 2015 Elsevier B.V. All rights reserved.)

Background: The Quality and Outcomes Framework (QOF) incentivises general practices in England to provide proactive care for people with serious mental illness (SMI) including schizophrenia, bipolar disorder and other psychoses. Better proactive primary care may reduce the risk of psychiatric admissions to hospital, but this has never been tested empirically., Methods: The QOF data set included 8234 general practices in England from 2006/2007 to 2010/2011. Rates of hospital admissions with primary diagnoses of SMI or bipolar disorder were estimated from national routine hospital data and aggregated to practice level. Poisson regression was used to analyse associations., Results: Practices with higher achievement on the annual review for SMI patients (MH9), or that performed better on either of the two lithium indicators for bipolar patients (MH4 or MH5), had more psychiatric admissions. An additional 1% in achievement rates for MH9 was associated with an average increase in the annual practice admission rate of 0.19% (95% CI 0.10% to 0.28%) or 0.007 patients (95% CI 0.003 to 0.01)., Conclusions: The positive association was contrary to expectation, but there are several possible explanations: better quality primary care may identify unmet need for secondary care; higher QOF achievement may not prevent the need for secondary care; individuals may receive their QOF checks postdischarge rather than prior to admission; individuals with more severe SMI may be more likely to be registered with practices with better QOF performance; and QOF may be a poor measure of the quality of care for people with SMI., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.)

Background: There is a high prevalence of smoking among people who experience severe mental ill health (SMI). Helping people with disorders such as bipolar illness and schizophrenia to quit smoking would help improve their health, increase longevity and also reduce health inequalities. Around half of people with SMI who smoke express an interest in cutting down or quitting smoking. There is limited evidence that smoking cessation can be achieved for people with SMI. Those with SMI rarely access routine NHS smoking cessation services. This suggests the need to develop and evaluate a behavioural support and medication package tailored to the needs of people with SMI., Objective: The objective in this project was to conduct a pilot trial to establish acceptability of the intervention and to ensure the feasibility of recruitment, randomisation and follow-up. We also sought preliminary estimates of effect size in order to design a fully powered trial of clinical effectiveness and cost-effectiveness. The pilot should inform a fully powered trial to compare the clinical effectiveness and cost-effectiveness of a bespoke smoking cessation (BSC) intervention with usual general practitioner (GP) care for people with SMI., Design: A pilot pragmatic two-arm individually randomised controlled trial (RCT). Simple randomisation was used following a computer-generated random number sequence. Participants and practitioners were not blinded to allocation., Setting: Primary care and secondary care mental health services in England., Participants: Smokers aged > 18 years with a severe mental illness who would like to cut down or quit smoking., Interventions: A BSC intervention delivered by mental health specialists trained to deliver evidence-supported smoking cessation interventions compared with usual GP care., Main Outcome Measures: The primary outcome was carbon monoxide-verified smoking cessation at 12 months. Smoking-related secondary outcomes were reduction of number of cigarettes smoked, Fagerstrom test of nicotine dependence and motivation to quit (MTQ). Other secondary outcomes were Patient Health Questionnaire-9 items and Short Form Questionnaire-12 items to assess whether there were improvements or deterioration in mental health and quality of life. We also measured body mass index to assess whether or not smoking cessation was associated with weight gain. These were measured at 1, 6 and 12 months post randomisation., Results: The trial recruited 97 people aged 19-73 years who smoked between 5 and 60 cigarettes per day (mean 25 cigarettes). Participants were recruited from four mental health trusts and 45 GP surgeries. Forty-six people were randomised to the BSC intervention and 51 people were randomised to usual GP care. The odds of quitting at 12 months was higher in the BSC intervention (36% vs. 23%) but did not reach statistical significance (odds ratio 2.9; 95% confidence interval 0.8% to 10.5%). At 3 and 6 months there was no evidence of difference in self-reported smoking cessation. There was a non-significant reduction in the number of cigarettes smoked and nicotine dependence. MTQ and number of quit attempts all increased in the BSC group compared with usual care. There was no difference in terms of quality of life at any time point, but there was evidence of an increase in depression scores at 12 months for the BSC group. There were no serious adverse events thought likely to be related to the trial interventions. The pilot economic analysis demonstrated that it was feasible to carry out a full economic analysis., Conclusions: It was possible to recruit people with SMI from primary and secondary care to a trial of a smoking cessation intervention based around behavioural support and medication. The overall direction of effect was a positive trend in relation to biochemically verified smoking cessation and it was feasible to obtain follow-up in a substantial proportion of participants. A definitive trial of a bespoke cessation intervention has been prioritised by the National Institute for Health Research (NIHR) and the SCIMITAR pilot trial forms a template for a fully powered RCT to examine clinical effectiveness and cost-effectiveness., Trial Registration: Current Controlled Trials ISRCTN79497236., Funding: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment, Vol. 19, No. 25. See the NIHR Journals Library website for further project information.

Background: Self-harm is common among prisoners, particularly female prisoners. In 2007, concerned about the rising incidence, the prison service introduced a care-planning system called Assessment, Care in Custody, and Teamwork (ACCT). To date, it does not incorporate a standardised diagnostic test to estimate the risk of future self-harm., Objective: To identify potential screening instruments, or items from those instruments, to predict the risk of self-harm among prisoners., Participants: Prisoners who had been assigned to an ACCT during the recruitment period., Design: A multistage prospective cohort study. Following a pilot study, instruments were administered to prisoners by interview at baseline, and followed up for 6 months (or until point of release if this was sooner) to ascertain self-harm status. Instruments were assessed for unidimensionality, scalability (Mokken) and quantitative structure (Rasch). Area under the curve (AUC) analysis was used to examine the ability of instruments and/or their items to predict future self-harm. Cox proportional hazards regression models were used to examine the multivariate predictive ability of the scales and various sociodemographic and sentencing factors., Setting: Three prisons (including one women's prison) in northern England., Main Outcome Measures: A set of standardised questionnaires, including the Prison Screening Questionnaire (PriSnQuest), Revised Borderline Symptom List-23 (frequency-based responses) (BSL-23-F), Self-Harm Inventory (SHI), Patient Health Questionnaire (PHQ-9) and the Clinical Outcomes in Routine Evaluation - Outcome Measure (CORE-OM), together with sociodemographic and sentencing data., Results: In total, 450 prisoners consented to participate in the study, of whom 26% were female. The mean age of participants was 31.2 years. Over half of male prisoners recruited were on remand, compared with just over one-fifth (22.6%) of female prisoners. The average tariff of those sentenced was 41 months, of which 14.7 months, on average, had been served. Just over one-third of ACCTs had been initiated because of a known self-harm event, and over one-quarter (27.8%) of participants self-harmed during the follow-up period. Thus, almost half (46.7%) of those entered into the study were reported to have self-harmed, either from their index ACCT, or subsequently, or both. Cutting was the most frequent behaviour (51%). All screening instruments showed some evidence of unidimensionality, and four out of five showed scaling criteria consistent with ordinal scaling, so verifying the validity of the cut points. However, many showed gender bias and failure to fit the Rasch measurement model. While a resolution was made in most cases, both ordinal raw scores and latent interval scale estimates failed to show predictive value when applied within AUC analysis (0.491-0.566) or adjusted Cox proportional hazards models. However, good predictive values were shown for gender-specific sets of items, thus providing easily applied screening indexes., Conclusions: While four out of five potential screening instruments were found to have acceptable psychometric properties within this setting, their predictive validity of all instruments was poor under AUC analysis. Gender-specific item sets were put together to form two screening indexes with formative indicators which gave reasonable AUC values, particularly so for females. The indexes provide identification of low-medium-high risk of self-harm, and so may help to inform potential care pathways and decisions to sign prisoners off from the ACCT. Future work should concentrate on refining a set of predictive screening items among different offender populations and investigating the time point at which this set of items should be administered. Future work may also look at the different magnitudes of risk as indicators for care pathways., Funding: The National Institute for Health Research Health Technology Assessment programme.

Background: Policy developments in recent years have led to important changes in the level of access to evidence-based psychological treatments. Several methods have been used to investigate the effectiveness of these treatments in routine care, with different approaches to outcome definition and data analysis., Aims: To present a review of challenges and methods for the evaluation of evidence-based treatments delivered in routine mental healthcare. This is followed by a case example of a benchmarking method applied in primary care., Method: High, average and poor performance benchmarks were calculated through a meta-analysis of published data from services working under the Improving Access to Psychological Therapies (IAPT) Programme in England. Pre-post treatment effect sizes (ES) and confidence intervals were estimated to illustrate a benchmarking method enabling services to evaluate routine clinical outcomes., Results: High, average and poor performance ES for routine IAPT services were estimated to be 0.91, 0.73 and 0.46 for depression (using PHQ-9) and 1.02, 0.78 and 0.52 for anxiety (using GAD-7). Data from one specific IAPT service exemplify how to evaluate and contextualize routine clinical performance against these benchmarks., Conclusions: The main contribution of this report is to summarize key recommendations for the selection of an adequate set of psychometric measures, the operational definition of outcomes, and the statistical evaluation of clinical performance. A benchmarking method is also presented, which may enable a robust evaluation of clinical performance against national benchmarks. Some limitations concerned significant heterogeneity among data sources, and wide variations in ES and data completeness.