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.

Supporting physical activity through co-production in people with severe mental ill health (SPACES): protocol for a randomised controlled feasibility trial.

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

Health-risk behaviours among people with severe mental ill health: understanding modifiable risk in the Closing the Gap Health Study.

BACKGROUND: People with severe mental ill health (SMI) experience some of the largest health inequalities of any sector within society. For these inequalities to be reduced, an understanding of the behavioural determinants of health in this population is needed. AIMS: Utilising data from the Closing the Gap Health Study, we aimed to assess the extent to which people with SMI report health-risk factors and behaviours, their interest in modifying them, and the factors associated with being motivated to modify these behaviours. METHOD: Adult (≥18 years old) participants were recruited via primary and secondary care in the English National Health Service. To be eligible, participants needed to have a documented diagnosis of schizophrenia, psychotic disorders or bipolar disorder. Data were collected by survey on demographics, general physical health, diet, physical activity, alcohol, smoking and body mass index. RESULTS: Between April 2016 and March 2020, n = 9914 participants were recruited. Among people with SMI, high rates of obesity (37.5%), infrequent physical activity (62.0%), not meeting current guidelines (≥5) for the consumption of fruit and vegetables (85.0%) and smoking (42.2%) were observed. However, most participants were motivated to reduce health-risk behaviours. Perceiving the importance of health-promoting behaviours, being of poorer general health and being female were significantly associated with being motivated to modify health-risk behaviours. CONCLUSIONS: Despite experiencing poor physical and mental health outcomes compared with the general population, and contrary to popular misconceptions, people with SMI perceive health as important and are motivated to make behavioural changes to improve health.

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.

Sleep health among people with severe mental ill health during the COVID-19 pandemic: Results from a linked UK population cohort study.

Objectives: Sleep problems are a transdiagnostic feature of nearly all psychiatric conditions, and a strong risk factor for initial and recurrent episodes. However, people with severe mental ill health (SMI) are often excluded from general population surveys, and as such the extent and associates of poor sleep in this population are less well understood. This study explores sleep health in an SMI sample during the COVID-19 pandemic, using multiple regression to identify risk factors, including daily routine, wellbeing and demographics. Methods: An existing cohort of people with an SMI diagnosis were sampled. Participants were invited to complete a self-report survey about their health and the impacts of COVID-19 and associated public health measures. Sleep duration, efficiency, and quality were measured using items from the Pittsburgh Sleep Quality Index (PSQI). Results: Two hundred forty-nine adults (aged 21-84 years) completed the survey. Mean sleep duration and efficiency were similar to general population estimates, at 7 h 19 min and 78%, respectively. However, 43% reported "bad" sleep quality that was associated with being younger in age as well as disturbed routine and declined wellbeing. Indeed, 37% reported a disturbed routine during the pandemic. Conclusions: High estimates of perceived poor sleep quality in the SMI population align with previous findings. Supporting people with SMI to maintain routine regularity may work to protect sleep quality and wellbeing. Future research should more closely examine sleep health in people with SMI, using accessible and scalable measures of objective and subjective sleep, examining longitudinal trends.

Influences on the physical and mental health of people with serious mental ill-health during the COVID-19 pandemic: a qualitative interview study.

PURPOSE: People with severe mental ill-health (SMI) experience profound health inequalities. The Optimizing Wellbeing in Self-isolation study (OWLS) explored the effects of the COVID-19 pandemic restrictions on people with SMI, including how and why their physical and mental health may have changed during the pandemic. METHODS: The OLWS study comprised two surveys and two nested qualitative studies. Of 367 people recruited to the study, 235 expressed interest in taking part in a qualitative interview. In the first qualitative study eighteen interviews were conducted with a purposive sample of participants. RESULTS: We identified six factors which influenced peoples' health, positively and negatively: Staying Physically Active; Maintaining a Balanced and Healthy Diet; Work or Not Working; Daily Routine and Good Sleep; Staying Connected to Family, Friends and the Local Community; and Habits, Addictions and Coping with Anxiety Created by the Pandemic. CONCLUSIONS: Different aspects of lifestyle are highly interconnected. For people with SMI, loss of routine and good sleep, poor diet and lack of exercise can compound each other, leading to a decline in physical and mental health. If people are supported to understand what helps them stay well, they can establish their own frameworks to draw on during difficult times.

Transformation Beyond COVID-19: Accessibility in Lived Experience Involvement in Research Post Pandemic. Experience, Reflections and Future Direction From the Closing the Gap Network and OWLS Study.

Research literature published during the COVID-19 pandemic highlights the loss of involvement opportunities for people with lived experience during the pandemic as well as the vital role lived experience advisors play at all times, including highlighting unseen aspects of the impacts of crises such as the COVID-19 pandemic. During the pandemic, researchers from the Closing the Gap Network (CtG) at the University of York worked to expand and diversify patient and public involvement (PPI) whist working on a study exploring the impact of the pandemic and associated restrictions on those with the most severe forms of mental ill health. CtG had a strong record of patient and public involvement pre-pandemic and researchers wanted to ensure that this continued during the pandemic. This paper describes the experience of lived experience involvement during the pandemic from multiple perspectives and makes recommendations for future involvement models, accessibility and recommendations for future research.

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 feasibility and acceptability of a brief psychological intervention for adults with long-term health conditions and subthreshold depression delivered via community pharmacies: a mixed methods evaluation-the Community Pharmacies Mood Intervention Study (CHEMIST).

BACKGROUND: Adults with long-term health conditions (LTCs) are more likely to experience depressive symptoms which can worsen health outcomes and quality of life, and increase healthcare costs. Subthreshold depression may go undetected and/or untreated. The Community Pharmacies Mood Intervention Study (CHEMIST) explored whether community pharmacies represent a suitable setting to offer brief psychological support to people with LTCs and comorbid subthreshold depression. METHODS: A feasibility intervention study with a nested mixed methods evaluation was employed. Adults with subthreshold depression and a minimum of one LTC were recruited from community pharmacies/local general practices and offered a brief psychological support intervention ('Enhanced Support Intervention' (ESI)), based on behavioural activation within a Collaborative Care framework. The intervention included up to six sessions supported by pharmacy staff ('ESI facilitators') trained to deliver the ESI within the community pharmacy setting. Recruitment, retention rates and engagement with the ESI were assessed. Semi-structured, one-to-one interviews with pharmacy staff and study participants, and a focus group with pharmacy staff, explored experiences and acceptability of the study and the ESI. Themes were mapped onto constructs of the Theoretical Framework of Acceptability. RESULTS: Recruitment of ESI participants was challenging and slower than anticipated despite the varied methods of recruitment employed; although, this was useful in identifying barriers and enabling factors for participation. Engagament with the ESI was good with n=17 (71%) recruited participants commencing the ESI. The ESI was found to be acceptable to participants and ESI facilitators. Retention rate at 4 months was good n=20 (87.0%). The main barriers to identifying potential participants for pharmacy staff were lack of time, resources and limited experience in research. The ESI training and support manual were acceptable to ESI facilitators. The ESI and supporting patient workbook were acceptable to people with LTCs and subthreshold depression. CONCLUSIONS: Community pharmacies were viewed as an acceptable setting in which to deliver preventative brief psychological support to people with LTCs at risk of depression. This feasibility study provided important data to inform the design of a pilot randomised controlled trial in this setting and highlighted important considerations for future pharmacy-based research. TRIAL REGISTRATION: ISRCTN11290592.

Loneliness among people with severe mental illness during the COVID-19 pandemic: Results from a linked UK population cohort study.

AIM/GOAL/PURPOSE: Population surveys underrepresent people with severe mental ill health. This paper aims to use multiple regression analyses to explore perceived social support, loneliness and factor associations from self-report survey data collected during the Covid-19 pandemic in a sample of individuals with severe mental ill health. DESIGN/METHODOLOGY/APPROACH: We sampled an already existing cohort of people with severe mental ill health. Researchers contacted participants by phone or by post to invite them to take part in a survey about how the pandemic restrictions had impacted health, Covid-19 experiences, perceived social support, employment and loneliness. Loneliness was measured by the three item UCLA loneliness scale. FINDINGS: In the pandemic sub-cohort, 367 adults with a severe mental ill health diagnosis completed a remote survey. 29-34% of participants reported being lonely. Loneliness was associated with being younger in age (adjusted OR = -.98, p = .02), living alone (adjusted OR = 2.04, p = .01), high levels of social and economic deprivation (adjusted OR = 2.49, p = .04), and lower perceived social support (B = -5.86, p < .001). Living alone was associated with lower perceived social support. Being lonely was associated with a self-reported deterioration in mental health during the pandemic (adjusted OR = 3.46, 95%CI 2.03-5.91). PRACTICAL IMPLICATIONS: Intervention strategies to tackle loneliness in the severe mental ill health population are needed. Further research is needed to follow-up the severe mental ill health population after pandemic restrictions are lifted to understand perceived social support and loneliness trends. ORIGINALITY: Loneliness was a substantial problem for the severe mental ill health population before the Covid-19 pandemic but there is limited evidence to understand perceived social support and loneliness trends during the pandemic.

The Role of Animal Ownership for People with Severe Mental Illness during the COVID-19 Pandemic: A Mixed-Method Study Investigating Links with Health and Loneliness.

Research has reported the benefits of companion animals for people with severe mental illness (SMI). However, this evidence base is fragmented and unclear. The COVID-19 pandemic presents an opportunity to explore the role of companion animals in the context of social distancing and isolation measures for people with SMI. Therefore, we aimed to investigate the links between mental and physical health and animal ownership in people with SMI and to explore animal owners' perceptions related to human-animal interactions during the pandemic restrictions. A survey was conducted with a previously assembled cohort of individuals with SMI in the UK. The survey included previously validated and new bespoke items measuring demographics, and outcomes related to mental and physical health, and human-animal interactions. The survey also included a question inviting free-text responses, allowing participants to describe any experiences of their human-animal relationships during the pandemic. Of 315 participants who consented to participate, 249 (79%) completed the survey. Of these, 115 (46.2%) had at least one companion animal. Regression analyses indicated that animal ownership was not significantly associated with well-being and loneliness. However, animal ownership was associated with a self-reported decline in mental health (b = 0.640, 95% CI [0.102-1.231], p = 0.025), but no self-reported change in physical health. Thematic analysis identified two main themes relating to the positive and negative impact of animal ownership during pandemic restrictions. Animal ownership appeared to be linked to self-reported mental health decline in people with SMI during the second wave of the pandemic in the UK. However, the thematic analysis also highlighted the perceived benefit of animal ownership during this time. Further targeted investigation of the role of human-animal relationships and the perceived human-animal bond for human health is warranted.

Use of the Internet and Digital Devices Among People With Severe Mental Ill Health During the COVID-19 Pandemic Restrictions.

Background: Restrictions due to the COVID-19 pandemic have led to everyday reliance on digitalisation of life, including access to health care services. People with severe mental ill health (SMI-e.g., bipolar or psychosis spectrum disorders) are at greater risk for digital exclusion and it is unknown to what extent they adapted to online service delivery. This study explored use of the Internet and digital devices during the pandemic restrictions and its association with physical and mental health changes. Methods: Three hundred sixty seven adults with an SMI diagnosis completed a survey (online or offline) and provided information on access to Internet connexion and devices, internet knowledge, online activities, and barriers to using the Internet. They also self-reported changes in mental and physical health since the beginning of the pandemic restrictions. Results: During the pandemic restrictions 61.6% were limited or non-users of the Internet. The majority had access to the Internet and digital devices but around half reported knowledge deficits. Most common activities were accessing information and entertainment (88.9%), staying in touch with friends and families (84.8%), and purchasing goods (other than food) (84.3%). Most common barriers were finding the Internet "not interesting" (28.3%) or "too difficult" (27.9%), as well as "security concerns" (22.1-24.3%). Using the Internet "a lot" (vs. "just a bit or not at all") during the pandemic was associated with younger age (18-30: Adj ORs 4.76; 31-45: 6.39; Ps < 0.001; vs. 66+), having a diagnosis of bipolar disorder (compared to psychosis; Adj OR = 3.88, P < 0.001), or reporting a decline in mental health (compared to no decline; Adj OR = 1.92, P = 0.01). Conclusion: Most people with SMI were limited or non-users of the Internet during the pandemic, which seems to be mainly attributable to lack of interest and skills, rather than lack of devices or connectivity. Older adults with psychosis should be the focus of interventions to support digital engagement in people with SMI.

Health risk behaviours among people with severe mental ill health during the COVID-19 pandemic: Analysis of linked cohort data.

BACKGROUND: People with severe mental ill health (SMI) experience a mortality gap of 15-20 years. COVID-19 has amplified population health inequalities, and there is concern that people with SMI will be disproportionately affected. Understanding how health risk behaviours have changed during the pandemic is important when developing strategies to mitigate future increases in health inequalities. METHODS: We sampled from an existing cohort of people with SMI. Researchers contacted participants by phone or post to invite them to take part in a survey about how the pandemic had affected them. We asked people about their health risk behaviours and how these had changed during the pandemic. We created an index of changed behaviours, comprising dietary factors, smoking, lack of exercise, and drinking patterns. By creating data linkages, we compared their responses during pandemic restrictions to responses they gave prior to the pandemic. OUTCOMES: 367 people provided health risk data. The mean age of the participants was 50.5 (range = 20 to 86, SD ± 15.69) with 51.0% male and 77.4% white British. 47.5% of participants reported taking less physical activity during the pandemic and of those who smoke 54.5% reported smoking more heavily. Self-reported deterioration in physical health was significantly associated with an increase in health risk behaviours (adjusted OR for physical health 1.59, 95%CI 1.22-2.07; adjusted OR for Age 0.99, 95%CI 0.98-1.00). INTERPRETATION: COVID-19 is likely to amplify health inequalities for people with SMI. Health services should target health risk behaviours for people with SMI to mitigate the immediate and long lasting impacts of the COVID-19 pandemic.

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.

Investigating smoking and nicotine dependence among people with severe mental illness during the COVID-19 pandemic: analysis of linked data from a UK Closing the Gap cohort.

Smoking rates are higher for people who use mental health services, which contributes substantially to health inequalities. Smoking can lead to worse COVID-19 outcomes, yet it remains unclear whether smoking has changed for people who use mental health services. We examined smoking patterns in a large clinical cohort of people with severe mental illness, before and during the pandemic. We found high levels of nicotine dependence and heavier patterns of smoking. Although some people had reported quitting, it is likely that smoking inequalities have become further entrenched. Mental health services should seek to mitigate this modifiable risk and source of poor health.

Smoking cessation in severe mental illness: combined long-term quit rates from the UK SCIMITAR trials programme.

Smoking contributes to health inequalities for people with severe mental illness (SMI). Although smoking cessation interventions are effective in the short term, there are few long-term trial-based estimates of abstinence. The SCIMITAR trials programme includes the largest trial to date of a smoking cessation intervention for people with SMI, but this was underpowered to detect anticipated long-term quit rates. By pooling pilot and full-trial data we found that quit rates were maintained at 12 months (OR = 1.67, 95% CI 1.02-2.73, P = 0.04). Policymakers can now be confident that bespoke smoking cessation interventions produce successful short- and long-term quitting.

Exploring Access to Mental Health and Primary Care Services for People With Severe Mental Illness During the COVID-19 Restrictions.

AIMS: To explore: how satisfied people with severe mental illness (SMI) are with the support received during the pandemic; understand any difficulties encountered when accessing both mental health and primary care services; consider ways to mitigate these difficulties; and assess the perceived need for future support from mental health services. MATERIALS AND METHODS: A representative sample was drawn from a large transdiagnostic clinical cohort of people with SMI, which was recruited between April 2016 and March 2020. The sample was re-surveyed a few months after the beginning of the restrictions. Descriptive frequency statistics were used to analyze the quantitative data. The free text responses were analyzed thematically. RESULTS: 367 participants responded to the survey. Two thirds were receiving support from mental health services with the rest supported in primary care or self-managing. A quarter thought they would need more mental health support in the coming year. Half had needed to used community mental health services during the pandemic and the majority had been able to get support. A minority reported that their mental health had deteriorated but they had either not got the supported they wanted or had not sought help. The biggest service change was the reduction in face-to-face appointments and increasing use of phone and video call support. Nearly half of those using mental health services found this change acceptable or even preferred it. However, acceptability was influenced by several factors, and participants were more likely to report that they had received all the support they needed, when seen in person. DISCUSSION: Although most participants were satisfied with the mental health support they had received, a minority were not. This, couple with findings on future need for mental health support has implications for post pandemic demand on services. Remote care has brought benefits but also risks that it could increase inequalities in access to services.

A Year Into the Pandemic: The Diversity of Experience Amongst People With Severe Mental Ill Health.

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

Challenges and solutions to nicotine replacement therapy access: observations from SCIMITAR.

BACKGROUND: Given that smoking results in poor physical and mental health, reducing tobacco harm is of high importance. Recommendations published by the National Institute for Health and Care Excellence to reduce smoking harms included provision of support, use of nicotine containing products and commissioning of smoking cessation services. AIMS: This report explores the difficulties in obtaining such support, as observed in a recently conducted randomised controlled trial in patients with severe mental ill health, and outlines suggestions to improve facilitation of provision. METHOD: Data collected during the Smoking Cessation Intervention for Severe Mental Ill Health Trial (SCIMITAR+) (trial Registration ISRCTN72955454), was reviewed to identify the difficulties experienced, across the trial, with regards to access and provision of nicotine replacements therapy (NRT). Actions taken to facilitate access and provision of NRT were collated to outline how provision could be better facilitated. RESULTS: Access to NRT varied across study settings and in some instances proved impossible for patients to access. Difficulty in access was irrespective of a diagnosis of severe mental ill health. Where NRT was provided, this was not always provided in accordance with NICE guidelines. CONCLUSIONS: Availability of smoking cessation support, and NRT provision would benefit from being made clearer, simpler and more easily accessible so as to enhance smoking cessation rates.

Cost-effectiveness of a specialist smoking cessation package compared with standard smoking cessation services for people with severe mental illness in England: a trial-based economic evaluation from the SCIMITAR+ study.

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