Association of environmental and socioeconomic indicators with serious mental illness diagnoses identified from general practitioner practice data in England: A spatial Bayesian modelling study.

BACKGROUND: The evidence is sparse regarding the associations between serious mental illnesses (SMIs) prevalence and environmental factors in adulthood as well as the geographic distribution and variability of these associations. In this study, we evaluated the association between availability and proximity of green and blue space with SMI prevalence in England as a whole and in its major conurbations (Greater London, Birmingham, Liverpool and Manchester, Leeds, and Newcastle). METHODS AND FINDINGS: We carried out a retrospective analysis of routinely collected adult population (≥18 years) data at General Practitioner Practice (GPP) level. We used data from the Quality and Outcomes Framework (QOF) on the prevalence of a diagnosis of SMI (schizophrenia, bipolar affective disorder and other psychoses, and other patients on lithium therapy) at the level of GPP over the financial year April 2014 to March 2018. The number of GPPs included ranged between 7,492 (April 2017 to March 2018) to 7,997 (April 2014 to March 2015) and the number of patients ranged from 56,413,719 (April 2014 to March 2015) to 58,270,354 (April 2017 to March 2018). Data at GPP level were converted to the geographic hierarchy unit Lower Layer Super Output Area (LSOA) level for analysis. LSOAs are a geographic unit for reporting small area statistics and have an average population of around 1,500 people. We employed a Bayesian spatial regression model to explore the association of SMI prevalence in England and its major conurbations (greater London, Birmingham, Liverpool and Manchester, Leeds, and Newcastle) with environmental characteristics (green and blue space, flood risk areas, and air and noise pollution) and socioeconomic characteristics (age, ethnicity, and index of multiple deprivation (IMD)). We incorporated spatial random effects in our modelling to account for variation at multiple scales. Across England, the environmental characteristics associated with higher SMI prevalence at LSOA level were distance to public green space with a lake (prevalence ratio [95% credible interval]): 1.002 [1.001 to 1.003]), annual mean concentration of PM2.5 (1.014 [1.01 to 1.019]), and closeness to roads with noise levels above 75 dB (0.993 [0.992 to 0.995]). Higher SMI prevalence was also associated with a higher percentage of people above 24 years old (1.002 [1.002 to 1.003]), a higher percentage of ethnic minorities (1.002 [1.001 to 1.002]), and more deprived areas. Mean SMI prevalence at LSOA level in major conurbations mirrored the national associations with a few exceptions. In Birmingham, higher average SMI prevalence at LSOA level was positively associated with proximity to an urban green space with a lake (0.992 [0.99 to 0.998]). In Liverpool and Manchester, lower SMI prevalence was positively associated with road traffic noise ≥75 dB (1.012 [1.003 to 1.022]). In Birmingham, Liverpool, and Manchester, there was a positive association of SMI prevalence with distance to flood zone 3 (land within flood zone 3 has ≥1% chance of flooding annually from rivers or ≥0.5% chance of flooding annually from the sea, when flood defences are ignored): Birmingham: 1.012 [1.000 to 1.023]; Liverpool and Manchester: 1.016 [1.006 to 1.026]. In contrast, in Leeds, there was a negative association between SMI prevalence and distance to flood zone 3 (0.959 [0.944 to 0.975]). A limitation of this study was because we used a cross-sectional approach, we are unable to make causal inferences about our findings or investigate the temporal relationship between outcome and risk factors. Another limitation was that individuals who are exclusively treated under specialist mental health care and not seen in primary care at all were not included in this analysis. CONCLUSIONS: Our study provides further evidence on the significance of socioeconomic associations in patterns of SMI but emphasises the additional importance of considering environmental characteristics alongside socioeconomic variables in understanding these patterns. In this study, we did not observe a significant association between green space and SMI prevalence, but we did identify an apparent association between green spaces with a lake and SMI prevalence. Deprivation, higher concentrations of air pollution, and higher proportion of ethnic minorities were associated with higher SMI prevalence, supporting a social-ecological approach to public health prevention. It also provides evidence of the significance of spatial analysis in revealing the importance of place and context in influencing area-based patterns of SMI.

Behavioural Activation for Social IsoLation (BASIL+) trial (Behavioural activation to mitigate depression and loneliness among older people with long-term conditions): Protocol for a fully-powered pragmatic randomised controlled trial.

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.

The Cost Effectiveness of Ecotherapy as a Healthcare Intervention, Separating the Wood from the Trees.

Internationally, shifts to more urbanised populations, and resultant reductions in engagements with nature, have been a contributing factor to the mental health crisis facing many developed and developing countries. While the COVID-19 pandemic reinforced recent trends in many countries to give access to green spaces more weight in political decision making, nature-based activities as a form of intervention for those with mental health problems constitute a very small part of patient pathways of care. Nature-based interventions, such as ecotherapy, are increasingly used as therapeutic solutions for people with common mental health problems. However, there is little data about the potential costs and benefits of ecotherapy, making it difficult to offer robust assessments of its cost-effectiveness. This paper explores the capacity for ecotherapy to be cost-effective as a healthcare intervention. Using a pragmatic scoping review of the literature to understand where the potential costs and health benefit lie, we applied value of information methodology to identify what research is needed to inform future cost-effectiveness assessments. We show that there is the potential for ecotherapy for people with mild to moderate common mental health problems to be cost-effective but significant further research is required. Furthermore, nature-based interventions such as ecotherapy also confer potential social and wider returns on investment, strengthening the case for further research to better inform robust commissioning.

Behavioural activation to prevent depression and loneliness among socially isolated older people with long-term conditions: The BASIL COVID-19 pilot randomised controlled trial.

BACKGROUND: Older adults, including those with long-term conditions (LTCs), are vulnerable to social isolation. They are likely to have become more socially isolated during the Coronavirus Disease 2019 (COVID-19) pandemic, often due to advice to "shield" to protect them from infection. This places them at particular risk of depression and loneliness. There is a need for brief scalable psychosocial interventions to mitigate the psychological impacts of social isolation. Behavioural activation (BA) is a credible candidate intervention, but a trial is needed. METHODS AND FINDINGS: We undertook an external pilot parallel randomised trial (ISRCTN94091479) designed to test recruitment, retention and engagement with, and the acceptability and preliminary effects of the intervention. Participants aged ≥65 years with 2 or more LTCs were recruited in primary care and randomised by computer and with concealed allocation between June and October 2020. BA was offered to intervention participants (n = 47), and control participants received usual primary care (n = 49). Assessment of outcome was made blind to treatment allocation. The primary outcome was depression severity (measured using the Patient Health Questionnaire 9 (PHQ-9)). We also measured health-related quality of life (measured by the Short Form (SF)-12v2 mental component scale (MCS) and physical component scale (PCS)), anxiety (measured by the Generalised Anxiety Disorder 7 (GAD-7)), perceived social and emotional loneliness (measured by the De Jong Gierveld Scale: 11-item loneliness scale). Outcome was measured at 1 and 3 months. The mean age of participants was aged 74 years (standard deviation (SD) 5.5) and they were mostly White (n = 92, 95.8%), and approximately two-thirds of the sample were female (n = 59, 61.5%). Remote recruitment was possible, and 45/47 (95.7%) randomised to the intervention completed 1 or more sessions (median 6 sessions) out of 8. A total of 90 (93.8%) completed the 1-month follow-up, and 86 (89.6%) completed the 3-month follow-up, with similar rates for control (1 month: 45/49 and 3 months 44/49) and intervention (1 month: 45/47and 3 months: 42/47) follow-up. Between-group comparisons were made using a confidence interval (CI) approach, and by adjusting for the covariate of interest at baseline. At 1 month (the primary clinical outcome point), the median number of completed sessions for people receiving the BA intervention was 3, and almost all participants were still receiving the BA intervention. The between-group comparison for the primary clinical outcome at 1 month was an adjusted between-group mean difference of -0.50 PHQ-9 points (95% CI -2.01 to 1.01), but only a small number of participants had completed the intervention at this point. At 3 months, the PHQ-9 adjusted mean difference (AMD) was 0.19 (95% CI -1.36 to 1.75). When we examined loneliness, the adjusted between-group difference in the De Jong Gierveld Loneliness Scale at 1 month was 0.28 (95% CI -0.51 to 1.06) and at 3 months -0.87 (95% CI -1.56 to -0.18), suggesting evidence of benefit of the intervention at this time point. For anxiety, the GAD adjusted between-group difference at 1 month was 0.20 (-1.33, 1.73) and at 3 months 0.31 (-1.08, 1.70). For the SF-12 (physical component score), the adjusted between-group difference at 1 month was 0.34 (-4.17, 4.85) and at 3 months 0.11 (-4.46, 4.67). For the SF-12 (mental component score), the adjusted between-group difference at 1 month was 1.91 (-2.64, 5.15) and at 3 months 1.26 (-2.64, 5.15). Participants who withdrew had minimal depressive symptoms at entry. There were no adverse events. The Behavioural Activation in Social Isolation (BASIL) study had 2 main limitations. First, we found that the intervention was still being delivered at the prespecified primary outcome point, and this fed into the design of the main trial where a primary outcome of 3 months is now collected. Second, this was a pilot trial and was not designed to test between-group differences with high levels of statistical power. Type 2 errors are likely to have occurred, and a larger trial is now underway to test for robust effects and replicate signals of effectiveness in important secondary outcomes such as loneliness. CONCLUSIONS: In this study, we observed that BA is a credible intervention to mitigate the psychological impacts of COVID-19 isolation for older adults. We demonstrated that it is feasible to undertake a trial of BA. The intervention can be delivered remotely and at scale, but should be reserved for older adults with evidence of depressive symptoms. The significant reduction in loneliness is unlikely to be a chance finding, and replication will be explored in a fully powered randomised controlled trial (RCT). TRIAL REGISTRATION: ISRCTN94091479.

Interventions for adults with a history of complex traumatic events: the INCiTE mixed-methods systematic review.

BACKGROUND: People with a history of complex traumatic events typically experience trauma and stressor disorders and additional mental comorbidities. It is not known if existing evidence-based treatments are effective and acceptable for this group of people. OBJECTIVE: To identify candidate psychological and non-pharmacological treatments for future research. DESIGN: Mixed-methods systematic review. PARTICIPANTS: Adults aged ≥ 18 years with a history of complex traumatic events. INTERVENTIONS: Psychological interventions versus control or active control; pharmacological interventions versus placebo. MAIN OUTCOME MEASURES: Post-traumatic stress disorder symptoms, common mental health problems and attrition. DATA SOURCES: Cumulative Index to Nursing and Allied Health Literature (CINAHL) (1937 onwards); Cochrane Central Register of Controlled Trials (CENTRAL) (from inception); EMBASE (1974 to 2017 week 16); International Pharmaceutical Abstracts (1970 onwards); MEDLINE and MEDLINE Epub Ahead of Print and In-Process & Other Non-Indexed Citations (1946 to present); Published International Literature on Traumatic Stress (PILOTS) (1987 onwards); PsycINFO (1806 to April week 2 2017); and Science Citation Index (1900 onwards). Searches were conducted between April and August 2017. REVIEW METHODS: Eligible studies were singly screened and disagreements were resolved at consensus meetings. The risk of bias was assessed using the Cochrane risk-of-bias tool and a bespoke version of a quality appraisal checklist used by the National Institute for Health and Care Excellence. A meta-analysis was conducted across all populations for each intervention category and for population subgroups. Moderators of effectiveness were assessed using metaregression and a component network meta-analysis. A qualitative synthesis was undertaken to summarise the acceptability of interventions with the relevance of findings assessed by the GRADE-CERQual checklist. RESULTS: One hundred and four randomised controlled trials and nine non-randomised controlled trials were included. For the qualitative acceptability review, 4324 records were identified and nine studies were included. The population subgroups were veterans, childhood sexual abuse victims, war affected, refugees and domestic violence victims. Psychological interventions were superior to the control post treatment for reducing post-traumatic stress disorder symptoms (standardised mean difference -0.90, 95% confidence interval -1.14 to -0.66; number of trials = 39) and also for associated symptoms of depression, but not anxiety. Trauma-focused therapies were the most effective interventions across all populations for post-traumatic stress disorder and depression. Multicomponent and trauma-focused interventions were effective for negative self-concept. Phase-based approaches were also superior to the control for post-traumatic stress disorder and depression and showed the most benefit for managing emotional dysregulation and interpersonal problems. Only antipsychotic medication was effective for reducing post-traumatic stress disorder symptoms; medications were not effective for mental comorbidities. Eight qualitative studies were included. Interventions were more acceptable if service users could identify benefits and if they were delivered in ways that accommodated their personal and social needs. LIMITATIONS: Assessments about long-term effectiveness of interventions were not possible. Studies that included outcomes related to comorbid psychiatric states, such as borderline personality disorder, and populations from prisons and humanitarian crises were under-represented. CONCLUSIONS: Evidence-based psychological interventions are effective and acceptable post treatment for reducing post-traumatic stress disorder symptoms and depression and anxiety in people with complex trauma. These interventions were less effective in veterans and had less of an impact on symptoms associated with complex post-traumatic stress disorder. FUTURE WORK: Definitive trials of phase-based versus non-phase-based interventions with long-term follow-up for post-traumatic stress disorder and associated mental comorbidities. STUDY REGISTRATION: This study is registered as PROSPERO CRD42017055523. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 43. See the NIHR Journals Library website for further project information.

Traumatic events that happen often and that are difficult to escape from, such as childhood abuse, are sometimes known as complex traumatic events. People who have a history of complex traumatic events can develop post-traumatic stress disorder and can also suffer from other mental health problems. It is not known if people who experience complex traumatic events can benefit from existing psychological treatments or medications, or if these treatments are acceptable. This review aimed to find out which treatments are most effective and acceptable for mental health problems in people with complex trauma histories, and to identify the frontrunners for future research. We searched electronic databases for evidence about treatment effectiveness and acceptability in adults with a history of complex traumatic events. We found 104 randomised controlled trials and nine non-randomised controlled trials that tested the effectiveness of psychological and/or medications, as well as nine studies that used interviews and focus groups to describe the acceptability of psychological treatments. The studies were split across different populations that included veterans, refugees, people who had experienced childhood sexual abuse and domestic violence, and civilians affected by war. We found that psychological treatments that focused on improving symptoms associated with trauma were effective for reducing post-traumatic stress disorder symptoms and depression across all populations and fewer people dropped out of these treatments, suggesting that they are acceptable. However, trauma-focused treatments were less effective among veterans than among other groups and less effective for reducing other psychological symptoms commonly experienced by people with complex trauma histories. Phased treatments that first start with helping people to feel safe before focusing on trauma symptoms might be beneficial for both post-traumatic stress disorder and additional psychological symptoms. There was little evidence that medications, other than antipsychotics, were effective for post-traumatic stress disorder symptoms. Future work should test if phased treatments are more effective than non-phased treatments over the long term.

Impact of telephone delivered case-management on the effectiveness of collaborative care for depression and anti-depressant use: A systematic review and meta-regression.

BACKGROUND: The health service delivery framework collaborative care is an effective intervention for depression. However, uncertainties remain about how to optimise its delivery at scale. Structured case management is a core component of collaborative care; its delivery via the telephone may improve access. AIMS: To examine using meta-regression if telephone delivered case management diminishes the clinical effectiveness of collaborative care on depressive symptoms and anti-depressant use relative to face-to-face delivery methods. METHODS: Randomised controlled trials were eligible if they included collaborative care interventions for adults with depression identified using self-report measures or diagnostic interviews and reported depression outcomes. Sociodemographics, intervention characteristics, depressive symptoms, and anti-depressant use were extracted. Random effects univariable and multivariable meta-regression analyses were used to examine the moderating effect of telephone delivered case-management on outcomes. RESULTS: Ninety-four trials were identified comprising of 103 comparisons across 24, 132 participants with depression outcomes and 67 comparisons from 15,367 participants with anti-depressant use outcomes. Telephone delivered case management did not diminish the effects of collaborative care on depressive symptoms (ß = -0.01, 95% CI -0.12 to 0.10; p = 0.86). Telephone delivered case management decreased anti-depressant medication use (relative risk 0.76, 95% CI 0.63 to 0.92; p = 0.005); this effect remained when assessed simultaneously alongside other study-level moderators of collaborative care. CONCLUSION: Using remote platforms such as the telephone to deliver case management may be a feasible way to implement collaborative care with no loss of effectiveness on depressive symptoms. However, adherence to anti-depressant medication may decrease when telephone case management is used.

Is telephone health coaching a useful population health strategy for supporting older people with multimorbidity? An evaluation of reach, effectiveness and cost-effectiveness using a 'trial within a cohort'.

BACKGROUND: Innovative ways of delivering care are needed to improve outcomes for older people with multimorbidity. Health coaching involves 'a regular series of phone calls between patient and health professional to provide support and encouragement to promote healthy behaviours'. This intervention is promising, but evidence is insufficient to support a wider role in multimorbidity care. We evaluated health coaching in older people with multimorbidity. METHODS: We used the innovative 'Trials within Cohorts' design. A cohort was recruited, and a trial was conducted using a 'patient-centred' consent model. A randomly selected group within the cohort were offered the intervention and were analysed as the intervention group whether they accepted the offer or not. The intervention sought to improve the skills of patients with multimorbidity to deal with a range of long-term conditions, through health coaching, social prescribing and low-intensity support for low mood. RESULTS: We recruited 4377 older people, and 1306 met the eligibility criteria (two or more long-term conditions and moderate 'patient activation'). We selected 504 for health coaching, and 41% consented. More than 80% of consenters received the defined 'dose' of 4+ sessions. In an intention-to-treat analysis, those selected for health coaching did not improve on any outcome (patient activation, quality of life, depression or self-care) compared to usual care. We examined health care utilisation using hospital administrative and self-report data. Patients selected for health coaching demonstrated lower levels of emergency care use, but an increase in the use of planned services and higher overall costs, as well as a quality-adjusted life year (QALY) gain. The incremental cost per QALY was £8049, with a 70-79% probability of being cost-effective at conventional levels of willingness to pay. CONCLUSIONS: Health coaching did not lead to significant benefits on the primary measures of patient-reported outcome. This is likely related to relatively low levels of uptake amongst those selected for the intervention. Demonstrating effectiveness in this design is challenging, as it estimates the effect of being selected for treatment, regardless of whether treatment is adopted. We argue that the treatment effect estimated is appropriate for health coaching, a proactive model relevant to many patients in the community, not just those seeking care. TRIAL REGISTRATION: International Standard Randomised Controlled Trial Number ( ISRCTN12286422 ).

Long-term clinical and cost-effectiveness of collaborative care (versus usual care) for people with mental-physical multimorbidity: cluster-randomised trial.

BACKGROUND: Collaborative care can support the treatment of depression in people with long-term conditions, but long-term benefits and costs are unknown.AimsTo explore the long-term (24-month) effectiveness and cost-effectiveness of collaborative care in people with mental-physical multimorbidity. METHOD: A cluster randomised trial compared collaborative care (integrated physical and mental healthcare) with usual care for depression alongside diabetes and/or coronary heart disease. Depression symptoms were measured by the symptom checklist-depression scale (SCL-D13). The economic evaluation was from the perspective of the English National Health Service. RESULTS: 191 participants were allocated to collaborative care and 196 to usual care. At 24 months, the mean SCL-D13 score was 0.27 (95% CI, -0.48 to -0.06) lower in the collaborative care group alongside a gain of 0.14 (95% CI, 0.06-0.21) quality-adjusted life-years (QALYs). The cost per QALY gained was £13 069. CONCLUSIONS: In the long term, collaborative care reduces depression and is potentially cost-effective at internationally accepted willingness-to-pay thresholds.Declaration of interestNone.

Long-term cost-effectiveness of collaborative care (vs usual care) for people with depression and comorbid diabetes or cardiovascular disease: a Markov model informed by the COINCIDE randomised controlled trial.

OBJECTIVES: To evaluate the long-term cost-effectiveness of collaborative care (vs usual care) for treating depression in patients with diabetes and/or coronary heart disease (CHD). SETTING: 36 primary care general practices in North West England. PARTICIPANTS: 387 participants completed baseline assessment (collaborative care: 191; usual care: 196) and full or partial 4-month follow-up data were captured for 350 (collaborative care: 170; usual care: 180). 62% of participants were male, 14% were non-white. Participants were aged ≥18 years, listed on a Quality and Outcomes Framework register for CHD and/or type 1 or 2 diabetes mellitus, with persistent depressive symptoms. Patients with psychosis or type I/II bipolar disorder, actively suicidal, in receipt of services for substance misuse, or already in receipt of psychological therapy for depression were excluded. INTERVENTION: Collaborative care consisted of evidence-based low-intensity psychological treatments, delivered over 3 months and case management by a practice nurse and a Psychological Well Being Practitioner. OUTCOME MEASURES: As planned, the primary measure of cost-effectiveness was the incremental cost-effectiveness ratio (cost per quality-adjusted life year (QALY)). A Markov model was constructed to extrapolate the trial results from short-term to long-term (24 months). RESULTS: The mean cost per participant of collaborative care was £317 (95% CI 284 to 350). Over 24 months, it was estimated that collaborative care was associated with greater healthcare usage costs (net cost £674 (95% CI -30 953 to 38 853)) and QALYs (net QALY gain 0.04 (95% CI -0.46 to 0.54)) than usual care, resulting in a cost per QALY gained of £16 123, and a likelihood of being cost-effective of 0.54 (willingness to pay threshold of £20 000). CONCLUSIONS: Collaborative care is a potentially cost-effective long-term treatment for depression in patients with comorbid physical and mental illness. The estimated cost per QALY gained was below the threshold recommended by English decision-makers. Further, long-term primary research is needed to address uncertainty associated with estimates of cost-effectiveness. TRIAL REGISTRATION NUMBER: ISRCTN80309252; Post-results.

Comparison of active treatments for impaired glucose regulation: a Salford Royal Foundation Trust and Hitachi collaboration (CATFISH): study protocol for a randomized controlled trial.

BACKGROUND: Diabetes is highly prevalent and contributes to significant morbidity and mortality worldwide. Behaviour change interventions that target health and lifestyle factors associated with the onset of diabetes can delay progression to diabetes, but many approaches rely on intensive one-to-one contact by specialists. Health coaching is an approach based on motivational interviewing that can potentially deliver behaviour change interventions by non-specialists at a larger scale. This trial protocol describes a randomized controlled trial (CATFISH) that tests whether a web-enhanced telephone health coaching intervention (IGR3) is more acceptable and efficient than a telephone-only health coaching intervention (IGR2) for people with prediabetes (impaired glucose regulation). METHODS: CATFISH is a two-parallel group, single-centre individually randomized controlled trial. Eligible participants are patients aged ≥18 years with impaired glucose regulation (HbA1c concentration between 42 and 47 mmol/mol), have access to a telephone and home internet and have been referred to an existing telephone health coaching service at Salford Royal NHS Foundation Trust, Salford, UK. Participants who give written informed consent will be randomized remotely (via a clinical trials unit) to either the existing pathway (IGR2) or the new web-enhanced pathway (IGR3) for 9 months. The primary outcome measure is patient acceptability at 9 months, determined using the Client Satisfaction Questionnaire. Secondary outcome measures at 9 months are: cost of delivery of IGR2 and IGR3, mental health, quality of life, patient activation, self-management, weight (kg), HbA1c concentration, and body mass index. All outcome measures will be analyzed on an intention-to-treat basis. A qualitative process evaluation will explore the experiences of participants and providers with a focus on understanding usability of interventions, mechanisms of behaviour change, and impact of context on delivery and user acceptability. Qualitative data will be analyzed using Framework. DISCUSSION: The CATFISH trial will provide a pragmatic assessment of whether a web-based information technology platform can enhance acceptability of a telephone health coaching intervention for people with prediabetes. The data will prove critical in understanding the role of web applications to improve engagement with evidence-based approaches to preventing diabetes. TRIAL REGISTRATION: ISRCTN16534814 . Registered on 7 February 2016.

What are the core predictors of 'hassles' among patients with multimorbidity in primary care? A cross sectional study.

BACKGROUND: A limitation of service delivery in primary care in the United Kingdom is that services are often organised to manage discrete long-term conditions, using guidelines related to single conditions, and managed in clinics organised around single conditions. However, many older patients have more than one condition (so called multimorbidity). Qualitative research suggests that these patients experience 'hassles' in their care, including multiple appointments, poor co-ordination, and conflicting recommendations. However, there is limited quantitative evidence on the 'hassles' that patients with multimorbidity experience, or factors predicting 'hassles' in patients with multimorbidity. METHODS: We conducted a cross sectional study, mailing questionnaires to 1460 patients with multimorbidity identified from the disease registers of four general practices in the UK. Patients were asked to complete a range of self-report measures including measures of multimorbidity, measures of their experience of multimorbidity and service delivery. Data were analysed using regression modelling to assess the factors predicting 'hassles' in patients with multimorbidity. RESULTS: In total 33% (n = 486) of patients responded to the baseline survey. The 'hassles' most often reported by patients related to lack of information about conditions and treatment options, poor communication among health professionals, and poor access to specialist care. There was a significant relationship between numbers of conditions, and reports of 'hassles'. In multivariate analysis, 5 variables predicted more 'hassles': more long-term conditions, symptoms of anxiety and depression, younger age, being in paid employment, and not having a discussion with their GP in the last 12 months. CONCLUSION: Hassles are frequently reported by patients with multimorbidity in primary care. A priority for future research should be on the development of new models of care that better cater for these patients. This research highlights core hassles that need to be addressed, and the patient groups that are most at risk, which may aid in the design of these new models.

Capacity, responsibility, and motivation: a critical qualitative evaluation of patient and practitioner views about barriers to self-management in people with multimorbidity.

BACKGROUND: Primary care is increasingly focussed on the care of people with two or more long-term conditions (multimorbidity). The UK Department of Health strategy for long term conditions is to use self-management support for the majority of patients but there is evidence of limited engagement among primary care professionals and patients with multimorbidity. Furthermore, multimorbidity is more common in areas of socioeconomic deprivation but deprivation may act as a barrier to patient engagement in self-management practices. BACKGROUND: Effective self-management is considered critical to meet the needs of people living with long term conditions but achieving this is a significant challenge in patients with multimorbidity. This study aimed to explore patient and practitioner views on factors influencing engagement in self-management in the context of multimorbidity. METHODS: A qualitative study using individual semi-structured interviews with 20 patients and 20 practitioners drawn from four general practices in Greater Manchester situated in areas of high and low social deprivation. RESULTS: Three main factors were identified as influencing patient engagement in self-management: capacity (access and availability of socio-economic resources and time; knowledge; and emotional and physical energy), responsibility (the degree to which patients and practitioners agreed about the division of labour about chronic disease management, including self-management) and motivation (willingness to take-up types of self-management practices). Socioeconomic deprivation negatively impacted on all three factors. Motivation was especially reduced in the presence of mental and physical multimorbidity. CONCLUSION: Full engagement in self-management practices in multimorbidity was only present where patients' articulated a sense of capacity, responsibility, and motivation. Patient 'know-how' or interpretive capacity to self-manage multimorbidity is potentially an important precursor to responsibility and motivation, and might be a critical target for intervention. However, individual and social resources are needed to generate capacity, responsibility, and motivation for self-management, pointing to a balanced role for health services and wider enabling networks.

Overview of the prevalence, impact, and management of depression and anxiety in chronic obstructive pulmonary disease.

More than one third of individuals with chronic obstructive pulmonary disease (COPD) experience comorbid symptoms of depression and anxiety. This review aims to provide an overview of the burden of depression and anxiety in those with COPD and to outline the contemporary advances and challenges in the management of depression and anxiety in COPD. Symptoms of depression and anxiety in COPD lead to worse health outcomes, including impaired health-related quality of life and increased mortality risk. Depression and anxiety also increase health care utilization rates and costs. Although the quality of the data varies considerably, the cumulative evidence shows that complex interventions consisting of pulmonary rehabilitation interventions with or without psychological components improve symptoms of depression and anxiety in COPD. Cognitive behavioral therapy is also an effective intervention for managing depression in COPD, but treatment effects are small. Cognitive behavioral therapy could potentially lead to greater benefits in depression and anxiety in people with COPD if embedded in multidisciplinary collaborative care frameworks, but this hypothesis has not yet been empirically assessed. Mindfulness-based treatments are an alternative option for the management of depression and anxiety in people with long-term conditions, but their efficacy is unproven in COPD. Beyond pulmonary rehabilitation, the evidence about optimal approaches for managing depression and anxiety in COPD remains unclear and largely speculative. Future research to evaluate the effectiveness of novel and integrated care approaches for the management of depression and anxiety in COPD is warranted.

Self-management interventions in patients with long-term conditions: a structured review of approaches to reporting inclusion, assessment, and outcomes in multimorbidity.

BACKGROUND: Multimorbidity has many potential implications for healthcare delivery, but a particularly important impact concerns the validity of trial evidence underpinning clinical guidelines for individual conditions. OBJECTIVE: To review how authors of published trials of self-management interventions reported inclusion criteria, sample descriptions, and consideration of the impact of multimorbidity on trial outcomes. METHODS: We restricted our analysis to a small number of exemplar long-term conditions: type 2 diabetes mellitus, coronary heart disease, and chronic obstructive pulmonary disease. We focussed our search on published Cochrane reviews. Data were extracted from the trials on inclusion/exclusion, sample description, and impact on outcomes. RESULTS: Eleven reviews consisting of 164 unique trials were identified. Sixty percent of trials reported excluding patients with forms of multimorbidity. Reasons for exclusion were poorly described or defined. Reporting of multimorbidity within the trials was poor, with only 35% of trials reporting on multimorbidity in their patient samples. Secondary analyses, exploring the impact of multimorbidity, were very rare. CONCLUSIONS: The importance of multimorbidity in trials is only going to become more important over time, but trials often exclude patients with multimorbidity, and reporting of multimorbidity in trials including such patients is generally poor. This limits judgements about the external validity of the results for clinical populations. A consistent approach to the conduct and reporting of secondary analyses of the effects of multimorbidity on outcomes, using current best-practice guidance, could lead to a rapid development of the evidence base.

Is treatment of depression cost-effective in people with diabetes? A systematic review of the economic evidence.

OBJECTIVES: Depression is common in diabetes and linked to a wide range of adverse outcomes. UK policy indicates that depression should be treated using conventional psychological treatments in a stepped care framework. This review aimed to identify current economic evidence of psychological treatments for depression among people with diabetes. METHOD: Electronic search strategies (conducted in MEDLINE, EMBASE, PsycINFO, CINAHL, NHS EED) combined clinical and economic search terms to identify full economic evaluations of the relevant interventions. Prespecified screening and inclusion criteria were used. Standardized data extraction and critical appraisal were conducted and the results summarized qualitatively. RESULTS: Excluding duplicates, 1,516 studies for co-morbid depression and diabetes were screened. Four economic evaluations were identified. The studies found that the interventions improved health status, reduced depression and were cost-effective compared with usual care. The studies were all U.S.-based and evaluated collaborative care programs that included psychological therapies. Critical appraisal indicated limitations with the study designs, analysis and results for all studies. CONCLUSIONS: The review highlighted the paucity of evidence in this area. The four studies indicated the potential of interventions to reduce depression and be cost-effective compared with usual care. Two studies reported costs per QALY gained of USD 267 to USD 4,317, whilst two studies reported the intervention dominated usual care, with net savings of USD 440 to USD 612 and net gains in patient free days or QALYs.

Collaborative Interventions for Circulation and Depression (COINCIDE): study protocol for a cluster randomized controlled trial of collaborative care for depression in people with diabetes and/or coronary heart disease.

BACKGROUND: Depression is up to two to three times as common in people with long-term conditions. It negatively affects medical management of disease and self-care behaviors, and leads to poorer quality of life and high costs in primary care. Screening and treatment of depression is increasingly prioritized, but despite initiatives to improve access and quality of care, depression remains under-detected and under-treated, especially in people with long-term conditions. Collaborative care is known to positively affect the process and outcome of care for people with depression and long-term conditions, but its effectiveness outside the USA is still relatively unknown. Furthermore, collaborative care has yet to be tested in settings that resemble more naturalistic settings that include patient choice and the usual care providers. The aim of this study was to test the effectiveness of a collaborative-care intervention, for people with depression and diabetes/coronary heart disease in National Health Service (NHS) primary care, in which low-intensity psychological treatment services are delivered by the usual care provider - Increasing Access to Psychological Therapies (IAPT) services. The study also aimed to evaluate the cost-effectiveness of the intervention over 6 months, and to assess qualitatively the extent to which collaborative care was implemented in the intervention general practices. METHODS: This is a cluster randomized controlled trial of 30 general practices allocated to either collaborative care or usual care. Fifteen patients per practice will be recruited after a screening exercise to detect patients with recognized depression (≥10 on the nine-symptom Patient Health Questionnaire; PHQ-9). Patients in the collaborative-care arm with recognized depression will be offered a choice of evidence-based low-intensity psychological treatments based on cognitive and behavioral approaches. Patients will be case managed by psychological well-being practitioners employed by IAPT in partnership with a practice nurse and/or general practitioner. The primary outcome will be change in depressive symptoms at 6 months on the 90-item Symptoms Checklist (SCL-90). Secondary outcomes include change in health status, self-care behaviors, and self-efficacy. A qualitative process evaluation will be undertaken with patients and health practitioners to gauge the extent to which the collaborative-care model is implemented, and to explore sustainability beyond the clinical trial. DISCUSSION: COINCIDE will assess whether collaborative care can improve patient-centered outcomes, and evaluate access to and quality of care of co-morbid depression of varying intensity in people with diabetes/coronary heart disease. Additionally, by working with usual care providers such as IAPT, and by identifying and evaluating interventions that are effective and appropriate for routine use in the NHS, the COINCIDE trial offers opportunities to address translational gaps between research and implementation. TRIAL REGISTRATION NUMBER: ISRCTN80309252 TRIAL STATUS: Open.

Counselling for mental health and psychosocial problems in primary care.

BACKGROUND: The prevalence of mental health and psychosocial problems in primary care is high. Counselling is a potential treatment for these patients, but there is a lack of consensus over the effectiveness of this treatment in primary care. OBJECTIVES: To assess the effectiveness and cost effectiveness of counselling for patients with mental health and psychosocial problems in primary care. SEARCH STRATEGY: To update the review, the following electronic databases were searched: the Cochrane Collaboration Depression, Anxiety and Neurosis (CCDAN) trials registers (to December 2010), MEDLINE, EMBASE, PsycINFO and the Cochrane Central Register of Controlled Trials (to May 2011). SELECTION CRITERIA: Randomised controlled trials of counselling for mental health and psychosocial problems in primary care. DATA COLLECTION AND ANALYSIS: Data were extracted using a standardised data extraction sheet by two reviewers. Trials were rated for quality by two reviewers using Cochrane risk of bias criteria, to assess the extent to which their design and conduct were likely to have prevented systematic error. Continuous measures of outcome were combined using standardised mean differences. An overall effect size was calculated for each outcome with 95% confidence intervals (CI). Continuous data from different measuring instruments were transformed into a standard effect size by dividing mean values by standard deviations. Sensitivity analyses were undertaken to test the robustness of the results. Economic analyses were summarised in narrative form. There was no assessment of adverse events. MAIN RESULTS: Nine trials were included in the review, involving 1384 randomised participants. Studies varied in risk of bias, although two studies were identified as being at high risk of selection bias because of problems with concealment of allocation. All studies were from primary care in the United Kingdom and thus comparability was high. The analysis found significantly greater clinical effectiveness in the counselling group compared with usual care in terms of mental health outcomes in the short-term (standardised mean difference -0.28, 95% CI -0.43 to -0.13, n = 772, 6 trials) but not in the long-term (standardised mean difference -0.09, 95% CI -0.27 to 0.10, n = 475, 4 trials), nor on measures of social function (standardised mean difference -0.09, 95% CI -0.29 to 0.11, n = 386, 3 trials). Levels of satisfaction with counselling were high. There was some evidence that the overall costs of counselling and usual care were similar. There were limited comparisons between counselling and other psychological therapies, medication, or other psychosocial interventions. AUTHORS' CONCLUSIONS: Counselling is associated with significantly greater clinical effectiveness in short-term mental health outcomes compared to usual care, but provides no additional advantages in the long-term. Participants were satisfied with counselling. Although some types of health care utilisation may be reduced, counselling does not seem to reduce overall healthcare costs. The generalisability of these findings to settings outside the United Kingdom is unclear.

Validation and psychometric assessment of a short clinical scale to measure chemotherapy-induced nausea and vomiting: the MASCC antiemesis tool.

There is a lack of clinical tools to facilitate communication between clinicians and patients about chemotherapy-induced nausea and vomiting (CINV). The Multinational Association of Supportive Care in Cancer (MASCC) has developed such a tool, which is an eight-item scale for the assessment of acute and delayed nausea and vomiting, and is completed once per cycle of chemotherapy. The aim of the current study was to assess its psychometric properties, specifically reliability and validity, cultural transferability and equivalence, and congruence with proxy assessments, as well as to determine if accuracy of recall of CINV events using the MASCC Antiemesis Tool (MAT) differed over time from chemotherapy. A prospective study was carried out with adult cancer patients and their informal carers from two hospitals, one each in the United Kingdom (UK) and United States of America (U.S.). Patients completed the Rhodes Index for nausea, vomiting and retching (INVR) daily for the first five days after chemotherapy and were then asked to complete the MAT at one week, two weeks, or three weeks after chemotherapy. Carers completed an adapted MAT concurrently with patients. The sample consisted of 87 patients and 22 informal carers. The internal consistency reliability of the scale was high, with Cronbach alphas of 0.77 (patient sample) and 0.82 (carer sample). Responses were similar between the UK and U.S. samples in terms of nausea and vomiting, and both samples found the scale easy to use. Contrasted-groups validity (using age as a grouping variable) and concurrent validity (MAT compared with INVR) suggested that the scale is sensitive to detect the different dimensions of CINV and performed well against a daily assessment of nausea/vomiting (total score correlation r=0.86, P<0.001). Recall of events was high even three weeks after chemotherapy (correlations with INVR of 0.44-0.99, all P<0.01). Factor analysis clearly identified three factors, namely vomiting, acute nausea, and delayed nausea. Proxy assessments by carers were congruent with the patients' responses, especially in relation to vomiting. The MAT is a reliable, valid, clear, and easy-to-use clinical tool that could facilitate discussion between clinicians and patients about their nausea and vomiting experience, thereby potentially aiding treatment decisions. Regular assessment of nausea and vomiting after chemotherapy has the potential to significantly improve CINV management.

Prediction of appropriate timing of palliative care for older adults with non-malignant life-threatening disease: a systematic review.

BACKGROUND: most people in contemporary western society die of the chronic diseases of old age. Whilst palliative care is appropriate for elderly patients with chronic, non-malignant disease, few of these patients access such care compared with cancer patients. Objective referral criteria based on accurate estimation of survival may facilitate more timely referral of non-cancer patients most appropriate for specialist palliative care. OBJECTIVE: to identify tools and predictor variables that might aid clinicians estimate survival and assess palliative status in non-cancer patients aged 65 years and older. METHODS: systematic review and quality assessment using criteria modified from the literature. RESULTS: 11 studies that evaluated prognoses in hospitalised and community-based older adults with non-malignant disease were identified. Key generic predictors of survival were increased dependency of activities of daily living, presence of comorbidities, poor nutritional status and weight loss, and abnormal vital signs and laboratory values. Disease-specific predictors of survival were identified for dementia, chronic obstructive pulmonary disorder and congestive heart failure. No study evaluated the relationship between survival and palliative status. CONCLUSION: prognostic models that attempt to estimate survival of < or = 6 months in non-cancer patients have generally poor discrimination, reflecting the unpredictable nature of most non-malignant disease. However, a number of generic and disease-specific predictor variables were identified that may help clinicians identify older, non-cancer patients with poor prognoses and palliative care needs. Simple, well-validated prognostic models that provide clinicians with objective measures of palliative status in non-cancer patients are needed. Additionally, research that evaluates the effect of general and specialist palliative care on psychosocial outcomes in non-cancer patients and their carers is needed.