Experience-based Investigation and Co-design of Psychosis Centred Integrated Care Services for Ethnically Diverse People with Multimorbidity (CoPICS): study protocol.

INTRODUCTION: Ethnic minorities (also called racialised groups) are more likely to experience severe mental illness (SMI). People with SMI are more likely to experience multimorbidity (MM), making psychosis among racialised groups more likely to lead to MM, poor outcomes, disability and premature mortality. METHODS AND ANALYSIS: This National Institute for Health and Care Research-funded study (151887) seeks to use innovative participatory methods including photovoice and biographical narrative interviews in urban and rural areas of England to assemble experience data. These data will be subjected to polytextual thematic analysis, and alongside pictures and captions, will inform an experienced-based co-design of interventions, the implementation of which will be evaluated. There will be an economic analysis and a process evaluation of the implementation. ETHICS AND DISSEMINATION: This programme of work has received ethical (IRAS 322421; Newcastle North Tyneside Research Ethics Committee 23/NE/0143) and sponsor approval. The findings will be disseminated in galleries showing the creative work, as lay and academic summaries and infographics; as practice briefings for practitioners, commissioners and policy makers; peer-reviewed publications. TRIAL REGISTRATION NUMBER: https://www.researchregistry.com/browse-the-registry%23home/registrationdetails/649c08111c037d0027b17d17/.

Behavioural activation to mitigate the psychological impacts of COVID-19 restrictions on older people in England and Wales (BASIL+): a pragmatic randomised controlled trial.

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.

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

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

Acceptability of a behavioural intervention to mitigate the psychological impacts of COVID-19 restrictions in older people with long-term conditions: a qualitative study.

OBJECTIVES: The COVID-19 pandemic heightened the need to address loneliness, social isolation and associated incidence of depression among older adults. Between June and October 2020, the Behavioural Activation in Social IsoLation (BASIL) pilot study investigated the acceptability and feasibility of a remotely delivered brief psychological intervention (behavioural cctivation) to prevent and reduce loneliness and depression in older people with long-term conditions during the COVID-19 pandemic. DESIGN: An embedded qualitative study was conducted. Semi-structured interviews generated data that was analysed inductively using thematic analysis and then deductively using the theoretical framework of acceptability (TFA). SETTING: NHS and third sector organisations in England. PARTICIPANTS: Sixteen older adults and nine support workers participating in the BASIL pilot study. RESULTS: Acceptability of the intervention was high across all constructs of the TFA: Older adults and BASIL Support Workers described a positive Affective Attitude towards the intervention linked to altruism, however the activity planning aspect of the intervention was limited due to COVID-19 restrictions. A manageable Burden was involved with delivering and participating in the intervention. For Ethicality, older adults valued social contact and making changes, support workers valued being able to observe those changes. The intervention was understood by older adults and support workers, although less understanding in older adults without low mood (Intervention Coherence). Opportunity Cost was low for support workers and older adults. Behavioural Activation was perceived to be useful in the pandemic and likely to achieve its aims (Perceived Effectiveness), especially if tailored to people with both low mood and long-term conditions. Self-efficacy developed over time and with experience for both support workers and older adults. CONCLUSIONS: Overall, BASIL pilot study processes and the intervention were acceptable. Use of the TFA provided valuable insights into how the intervention was experienced and how the acceptability of study processes and the intervention could be enhanced ahead of the larger definitive trial (BASIL+).

Promoting and Maintaining Changes in Smoking Behavior for Patients Following Discharge from a Smoke-free Mental Health Inpatient Stay: Development of a Complex Intervention Using the Behavior Change Wheel.

INTRODUCTION: Evidence suggests that smokers can successfully quit, remain abstinent or reduce smoking during a smoke-free mental health inpatient stay, provided behavioral/pharmacological support are offered. However, few evidence-based strategies to prevent the return to prehospital smoking behaviors post-discharge exist. AIMS AND METHODS: We report the development of an intervention designed to support smoking-related behavior change following discharge from a smoke-free mental health stay. We followed the Behavior Change Wheel (BCW) intervention development process. The target behavior was supporting patients to change their smoking behaviors following discharge from a smoke-free mental health stay. Using systematic reviews, we identified the barriers and enablers, classified according to the Theoretical Domains Framework (TDF). Potential intervention functions to address key influences were identified by consulting the BCW and Behavior Change Technique (BCT) taxonomy. Another systematic review identified effectiveness of BCTs in this context. Stakeholder consultations were conducted to prioritize and refine intervention content. RESULTS: Barriers and enablers to supporting smoking cessation were identified within the domains of environmental context and resources (lack of staff time); knowledge (ill-informed interactions about smoking); social influences, and intentions (lack of intention to deliver support). Potential strategies to address these influences included goal setting, problem-solving, feedback, social support, and information on health consequences. A strategy for operationalizing these techniques into intervention components was agreed upon: Pre-discharge evaluation sessions, a personalized resource folder, tailored behavioral and text message support post-discharge, and a peer interaction group, delivered by a trained mental health worker. CONCLUSIONS: The intervention includes targeted resources to support smoking-related behavior change in patients following discharge from a smoke-free mental health setting. IMPLICATIONS: Using the BCW and TDF supported a theoretically and empirically informed process to define and develop a tailored intervention that acknowledges barriers and enablers to supporting smoking cessation in mental health settings. The result is a novel complex theory- and evidence-based intervention that will be formally tested in a randomized controlled feasibility study.

Acceptability and feasibility of continuous glucose monitoring in people with diabetes: protocol for a mixed-methods systematic review of quantitative and qualitative evidence.

BACKGROUND: Good glycaemic control is a crucial part of diabetes management. Traditional assessment methods, including HbA1c checks and self-monitoring of blood glucose, can be unreliable and inaccurate. Continuous glucose monitoring (CGM) offers a non-invasive and more detailed alternative. Availability of this technology is increasing worldwide. However, there is no current comprehensive evidence on the acceptability and feasibility of these devices. This is a protocol for a mixed-methods systematic review of qualitative and quantitative evidence about acceptability and feasibility of CGM in people with diabetes. METHODS: We will search MEDLINE, Embase, CINAHL, and CENTRAL for qualitative and quantitative evidence about the feasibility and acceptability of CGM in all populations with diabetes (any type) using search terms for "continuous glucose monitoring" and "diabetes". We will not apply any study-type filters. Searches will be restricted to studies conducted in humans and those published from 2011 onwards. We will not restrict the search by language. Study selection and data extraction will be carried out by two reviewers independently using Rayyan and Eppi-Reviewer, respectively, with disagreements resolved by discussion. Data extraction will include key information about each study, as well as qualitative evidence in the form of participant quotes from primary studies and themes and subthemes based on the authors' analysis. Quantitative data relating to acceptability and feasibility including data loss, adherence, and quantitative ratings of acceptability will be extracted as means and standard deviations or n/N as appropriate. Qualitative evidence will be analysed using framework analysis informed by the Theoretical Framework of Acceptability. Where possible, quantitative evidence will be combined using random-effects meta-analysis; otherwise, a narrative synthesis will be performed. The most appropriate method for integrating qualitative and quantitative findings will be selected based on the data available. DISCUSSION: Ongoing assessment of the acceptability of interventions has been identified as crucially important to scale-up and implementation. This review will provide new knowledge with the potential to inform a programme theory of CGM as well as future roll-out to potentially vulnerable populations, including those with severe mental illness. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42021255141.

Can we mitigate the psychological impacts of social isolation using behavioural activation? Long-term results of the UK BASIL urgent public health COVID-19 pilot randomised controlled trial and living systematic review.

BACKGROUND: Behavioural and cognitive interventions remain credible approaches in addressing loneliness and depression. There was a need to rapidly generate and assimilate trial-based data during COVID-19. OBJECTIVES: We undertook a parallel pilot RCT of behavioural activation (a brief behavioural intervention) for depression and loneliness (Behavioural Activation in Social Isolation, the BASIL-C19 trial ISRCTN94091479). We also assimilate these data in a living systematic review (PROSPERO CRD42021298788) of cognitive and/or behavioural interventions. METHODS: Participants (≥65 years) with long-term conditions were computer randomised to behavioural activation (n=47) versus care as usual (n=49). Primary outcome was PHQ-9. Secondary outcomes included loneliness (De Jong Scale). Data from the BASIL-C19 trial were included in a metanalysis of depression and loneliness. FINDINGS: The 12 months adjusted mean difference for PHQ-9 was -0.70 (95% CI -2.61 to 1.20) and for loneliness was -0.39 (95% CI -1.43 to 0.65).The BASIL-C19 living systematic review (12 trials) found short-term reductions in depression (standardised mean difference (SMD)=-0.31, 95% CI -0.51 to -0.11) and loneliness (SMD=-0.48, 95% CI -0.70 to -0.27). There were few long-term trials, but there was evidence of some benefit (loneliness SMD=-0.20, 95% CI -0.40 to -0.01; depression SMD=-0.20, 95% CI -0.47 to 0.07). DISCUSSION: We delivered a pilot trial of a behavioural intervention targeting loneliness and depression; achieving long-term follow-up. Living meta-analysis provides strong evidence of short-term benefit for loneliness and depression for cognitive and/or behavioural approaches. A fully powered BASIL trial is underway. CLINICAL IMPLICATIONS: Scalable behavioural and cognitive approaches should be considered as population-level strategies for depression and loneliness on the basis of a living systematic review.

Co-production of a nature-based intervention for children with ADHD study (CONIFAS): Protocol for co-production phases.

Children with Attention Deficit Hyperactivity Disorder can face difficulties with inattention, hyperactivity, and impulsivity, which can impact many areas of their lives, including their educational attainment and social and emotional wellbeing. Involvement in nature-based activities can reduce these difficulties and improve wellbeing, but there are limited resources for supporting children with this diagnosis to access these approaches and no nature-based interventions designed with and for this group. This protocol describes a co-production study in which children diagnosed with Attention Deficit Hyperactivity Disorder aged 5-11 years old, their parents/guardians, and professionals will attend a series of workshops to share their knowledge to co-produce a new nature-based intervention for this population of children. We aim to understand how the children's' experiences of Attention Deficit Hyperactivity Disorder may affect their interactions with nature, identify how activity in and with nature may help with symptom reduction and general wellbeing, and co-produce an intervention for families which applies our learning. The result of this study will be the designed intervention and insights into how children and young people with Attention Deficit Hyperactivity Disorder interact with nature. The prototype intervention will then undergo feasibility testing in a future study. Trail registration: NIHR203043; ISRCTN11763460.

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.

Nature-based outdoor activities for mental and physical health: Systematic review and meta-analysis.

Mental health problems are associated with lower quality of life, increased unscheduled care, high economic and social cost, and increased mortality. Nature-based interventions (NBIs) that support people to engage with nature in a structured way are asset-based solutions to improve mental health for community based adults. However, it is unclear which NBIs are most effective, or what format and dose is most efficacious. We systematically reviewed the controlled and uncontrolled evidence for outdoor NBIs. The protocol was registered at PROSPERO (CRD42020163103). Studies that included adults (aged ≥18 years) in community-based settings with or without mental and/or physical health problems were eligible for inclusion. Eligible interventions were structured outdoor activities in green and/or blue space for health and wellbeing. We searched ASSIA, CENTRAL, Embase, Greenfile, MEDLINE, PsycINFO, and Web of Science in October 2019; the search was updated in September 2020. We screened 14,321 records and included 50 studies. Sixteen studies were randomised controlled trials (RCTs); 18 were controlled studies; and 16 were uncontrolled before and after studies. Risk of bias for RCTs was low to moderate; and moderate to high for controlled and uncontrolled studies. Random effects meta-analysis of RCTs showed that NBIs were effective for improving depressive mood -0.64 (95% CI: 1.05 to -0.23), reducing anxiety -0.94 (95% CI: 0.94 to -0.01), improving positive affect 0.95 (95% CI: 0.59 to 1.31), and reducing negative affect -0.52 (95% CI: 0.77 to -0.26). Results from controlled and uncontrolled studies largely reflected findings from RCTs. There was less evidence that NBIs improved physical health. The most effective interventions were offered for between 8 and 12 weeks, and the optimal dose ranged from 20 to 90 min. NBIs, specifically gardening, green exercise and nature-based therapy, are effective for improving mental health outcomes in adults, including those with pre-existing mental health problems.

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.

Exploring the facilitators, barriers, and strategies for self-management in adults living with severe mental illness, with and without long-term conditions: A qualitative evidence synthesis.

BACKGROUND: People living with severe mental illness (SMI) have a reduced life expectancy by around 15-20 years, in part due to higher rates of long-term conditions (LTCs) such as diabetes and heart disease. Evidence suggests that people with SMI experience difficulties managing their physical health. Little is known, however, about the barriers, facilitators and strategies for self-management of LTCs for people with SMI. AIM: To systematically review and synthesise the qualitative evidence exploring facilitators, barriers and strategies for self-management of physical health in adults with SMI, both with and without long-term conditions. METHODS: CINAHL, Conference Proceedings Citation Index- Science, HMIC, Medline, NICE Evidence and PsycInfo were searched to identify qualitative studies that explored barriers, facilitators and strategies for self-management in adults with SMI (with or without co-morbid LTCs). Articles were screened independently by two independent reviewers. Eligible studies were purposively sampled for synthesis according to the richness and relevance of data, and thematically synthesised. RESULTS: Seventy-four articles met the inclusion criteria for the review; 25 articles, reporting findings from 21 studies, were included in the synthesis. Seven studies focused on co-morbid LTC self-management for people with SMI, with the remaining articles exploring self-management in general. Six analytic themes and 28 sub-themes were identified from the synthesis. The themes included: the burden of SMI; living with co-morbidities; beliefs and attitudes about self-management; support from others for self-management; social and environmental factors; and routine, structure and planning. CONCLUSIONS: The synthesis identified a range of barriers and facilitators to self-management, including the burden of living with SMI, social support, attitudes towards self-management and access to resources. To adequately support people with SMI with co-morbid LTCs, healthcare professionals need to account for how barriers and facilitators to self-management are influenced by SMI, and meet the unique needs of this population.

Determinants of Physical Health Self-Management Behaviours in Adults With Serious Mental Illness: A Systematic Review.

Behavioural interventions can support the adoption of healthier lifestyles and improve physical health outcomes, but it is unclear what factors might drive success of such interventions in people with serious mental illness (SMI). We systematically identified and reviewed evidence of the association between determinants of physical health self-management behaviours in adults with SMI. Data about American Association of Diabetes Educator's Self-Care Behaviours (AADE-7) were mapped against the novel Mechanisms of Action (MoA) framework. Twenty-eight studies were included in the review, reporting evidence on 104 determinant-behaviour links. Beliefs about capabilities and beliefs about consequences were the most important determinants of behaviour, especially for being physically active and healthy eating. There was some evidence that emotion and environmental context and resources played a role in determining reducing risks, being active, and taking medications. We found very limited evidence associated with problem solving, and no study assessed links between MoAs and healthy coping. Although the review predominantly identified evidence about associations from cross-sectional studies that lacked validated and objective measures of self-management behaviours, these findings can facilitate the identification of behaviour change techniques with hypothesised links to determinants to support self-management in people with SMI. Systematic Review Registration: PROSPERO, registration CRD42018099553.

Relationship between Green and Blue Spaces with Mental and Physical Health: A Systematic Review of Longitudinal Observational Studies.

There is growing interest in the ways natural environments influence the development and progression of long-term health conditions. Vegetation and water bodies, also known as green and blue spaces, have the potential to affect health and behaviour through the provision of aesthetic spaces for relaxation, socialisation and physical activity. While research has previously assessed how green and blue spaces affect mental and physical wellbeing, little is known about the relationship between these exposures and health outcomes over time. This systematic review summarised the published evidence from longitudinal observational studies on the relationship between exposure to green and blue space with mental and physical health in adults. Included health outcomes were common mental health conditions, severe mental health conditions and noncommunicable diseases (NCDs). An online bibliographic search of six databases was completed in July 2020. After title, abstract and full-text screening, 44 eligible studies were included in the analysis. Depression, diabetes and obesity were the health conditions most frequently studied in longitudinal relationships. The majority of exposures included indicators of green space availability and urban green space accessibility. Few studies addressed the relationship between blue space and health. The narrative synthesis pointed towards mixed evidence of a protective relationship between exposure to green space and health. There was high heterogeneity in exposure measures and adjustment for confounding between studies. Future policy and research should seek a standardised approach towards measuring green and blue space exposures and employ theoretical grounds for confounder adjustment.

The development and validation of a prognostic model to PREDICT Relapse of depression in adult patients in primary care: protocol for the PREDICTR study.

BACKGROUND: Most patients who present with depression are treated in primary care by general practitioners (GPs). Relapse of depression is common (at least 50% of patients treated for depression will relapse after a single episode) and leads to considerable morbidity and decreased quality of life for patients. The majority of patients will relapse within 6 months, and those with a history of relapse are more likely to relapse in the future than those with no such history. GPs see a largely undifferentiated case-mix of patients, and once patients with depression reach remission, there is limited guidance to help GPs stratify patients according to risk of relapse. We aim to develop a prognostic model to predict an individual's risk of relapse within 6-8 months of entering remission. The long-term objective is to inform the clinical management of depression after the acute phase. METHODS: We will develop a prognostic model using secondary analysis of individual participant data drawn from seven RCTs and one longitudinal cohort study in primary or community care settings. We will use logistic regression to predict the outcome of relapse of depression within 6-8 months. We plan to include the following established relapse predictors in the model: residual depressive symptoms, number of previous depressive episodes, co-morbid anxiety and severity of index episode. We will use a "full model" development approach, including all available predictors. Performance statistics (optimism-adjusted C-statistic, calibration-in-the-large, calibration slope) and calibration plots (with smoothed calibration curves) will be calculated. Generalisability of predictive performance will be assessed through internal-external cross-validation. Clinical utility will be explored through net benefit analysis. DISCUSSION: We will derive a statistical model to predict relapse of depression in remitted depressed patients in primary care. Assuming the model has sufficient predictive performance, we outline the next steps including independent external validation and further assessment of clinical utility and impact. STUDY REGISTRATION: ClinicalTrials.gov ID: NCT04666662.

Effectiveness of collaborative care in reducing suicidal ideation: An individual participant data meta-analysis.

To assess whether CC is more effective at reducing suicidal ideation in people with depression compared with usual care, and whether study and patient factors moderate treatment effects. METHOD: We searched Medline, Embase, PubMed, PsycINFO, CINAHL, CENTRAL from inception to March 2020 for Randomised Controlled Trials (RCTs) that compared the effectiveness of CC with usual care in depressed adults, and reported changes in suicidal ideation at 4 to 6 months post-randomisation. Mixed-effects models accounted for clustering of participants within trials and heterogeneity across trials. This study is registered with PROSPERO, CRD42020201747. RESULTS: We extracted data from 28 RCTs (11,165 patients) of 83 eligible studies. We observed a small significant clinical improvement of CC on suicidal ideation, compared with usual care (SMD, -0.11 [95%CI, -0.15 to -0.08]; I2, 0·47% [95%CI 0.04% to 4.90%]). CC interventions with a recognised psychological treatment were associated with small reductions in suicidal ideation (SMD, -0.15 [95%CI -0.19 to -0.11]). CC was more effective for reducing suicidal ideation among patients aged over 65 years (SMD, - 0.18 [95%CI -0.25 to -0.11]). CONCLUSION: Primary care based CC with an embedded psychological intervention is the most effective CC framework for reducing suicidal ideation and older patients may benefit the most.

Barriers to attending initial psychological therapy service appointments for common mental health problems: A mixed-methods systematic review.

BACKGROUND: Non-attendance at initial appointments is a widespread problem which affects mental health services and patients. METHODS: This mixed methods systematic review identified and synthesised the available literature on factors, which could be modified either by patients or by services, that can influence early attrition to services offering psychological support for common mental health problems. Searches were conducted January 2017, updated Oct 2019, in MEDLINE, CINAHL Plus, EMBASE, Cochrane Library and PsycINFO. Screening, data extraction and quality appraisal were completed independently by two reviewers. Quality appraisals used Joanna Briggs Institute tools. RESULTS: Of the 31,758 references identified (21,123 unique), 34 studies were selected for inclusion. Studies used cohort (14), cross-sectional (10) and qualitative (9) designs. An additional study reported both quantitative and qualitative components. Findings from observational studies related to the presenting problem, beliefs about symptoms and treatment, contact with services, practical challenges and social support. Themes from qualitative studies centred around individual perceptions of symptoms and support, social and cultural influences, experiences with services and practical issues. Similarities and differences between quantitative and qualitative syntheses are discussed in a combined synthesis. LIMITATIONS: This review did not attempt to measure the effect of factors affecting attendance, or the effectiveness of interventions to reduce non-attendance to initial treatment appointments. CONCLUSIONS: Ensuring treatments offered matched patient perceptions of problems, reducing patient concerns around engagement, and offering prompt responses with flexibility to accommodate patient circumstances consistently influenced initial attendance. More work is needed to improve perceptions of mental health services in the community.

Frailty and depression predict instrumental activities of daily living in older adults: A population-based longitudinal study using the CARE75+ cohort.

OBJECTIVES: To evaluate if depression contributes, independently and/or in interaction with frailty, to loss of independence in instrumental activities of daily living (ADL) in older adults with frailty. METHODS: Longitudinal cohort study of people aged ≥75 years living in the community. We used multi-level linear regression model to quantify the relationship between depression (≥5 Geriatric Depression Scale) and frailty (electronic frailty index), and instrumental activities of daily living (Nottingham Extended Activities of Daily Living scale; range: 0-66; higher score implies greater independence). The model was adjusted for known confounders (age; gender; ethnicity; education; living situation; medical comorbidity). RESULTS: 553 participants were included at baseline; 53% were female with a mean age of 81 (5.0 SD) years. Depression and frailty (moderate and severe levels) were independently associated with reduced instrumental activities of daily living scores. In the adjusted analysis, the regression coefficient was -6.4 (95% CI: -8.3 to -4.5, p<0.05) for depression, -1.5 (95% CI: -3.8 to 0.9, p = 0.22) for mild frailty, -6.1 (95% CI: -8.6 to -3.6, p<0.05) for moderate frailty, and -10.1 (95% CI: -13.5 to -6.8, p<0.05) for severe frailty. Moreover, depression interacted with frailty to further reduce instrumental activities of daily living score in individuals with mild or moderate frailty. These relationships remained significant after adjusting for confounders. CONCLUSION: Frailty and depression are independently associated with reduced independence in instrumental activities of daily living. Also, depression interacts with frailty to further reduce independence for mild to moderately frail individuals, suggesting that clinical management of frailty should integrate physical and mental health care.