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BackgroundBehavioural and cognitive interventions remain a credible approach in preventing loneliness and depression. There was a need to rapidly generate and assimilate trial-based data during COVID-19. ObjectivesWe undertook a COVID-19 parallel pilot RCT of behavioural activation for depression and loneliness [the BASIL-C19 trial ISRCTN94091479]. We also assimilate these data in a COVID-19 living systematic review [PROSPERO CRD42021298788]. MethodsPrimary care participants (>=65 years) with long-term conditions were computer randomised to Behavioural Activation (n=47) versus care-as-usual (n=49). The single blinded primary outcome was the PHQ-9. Secondary outcomes included loneliness (De Jong Gierveld Scale). Data from the BASIL-C19 trial were included in a random effects meta-analysis of depression and loneliness. FindingsThe 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). Secondary 12-month trial outcomes suggested evidence of benefit for behavioural activation. The BASIL-C19 meta-analysis (13 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). DiscussionWe found a signal of effect in reducing loneliness and depression in the BASIL trial. Living meta-analysis provides strong evidence of short-term benefit for loneliness and depression. Clinical implicationsScalable behavioural and cognitive approaches should be considered as population-level strategies for depression and loneliness on the basis of the living systematic review. FundingThis study was funded by National Institute for Health and Care Research (NIHR) Programme Grants for Applied Research (PGfAR) RP-PG-0217-20006. Author summaryO_ST_ABSWhy was this study done?C_ST_ABS Older people with long-term conditions have been impacted by COVID-19 pandemic restrictions and have experienced social isolation. In turn, this puts them at risk for depression and loneliness, and these are bad for health and wellbeing. Psychosocial approaches, such as behavioural activation, could be helpful. Trial-based evidence is needed to demonstrate if it is possible to prevent the onset, or mitigate the impact, of loneliness and depression. There are few studies of brief psychosocial interventions to mitigate depression and loneliness, and it is important to know how emerging trial-based data adds to existing evidence. What did the researchers do and find? There was preliminary evidence that levels of loneliness were reduced at 3 months when behavioural activation was offered. At longer term (12-month) follow-up there were signals of ongoing positive impact. When BASIL-C19 data were assimilated into a living systematic review there is clear evidence of impact of brief psychological interventions on depression and loneliness in the short-term. More research into the longer-term impact is needed. What does all this mean? Behavioural activation now shows evidence of benefit which will be useful for policy makers in offering support to people who are socially isolated. This research knowledge will be useful once the COVID-19 pandemic has passed, since loneliness is common in older populations and effective scalable solutions will be needed to tackle this problem. As new trial-based data emerges, our living systematic review and meta-analysis will be updated since this is an area of active research.
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BackgroundOlder adults with long-term conditions have become more socially isolated (often due to advice to shield to protect them from COVID-19) and are thus 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 is a plausible intervention, but a trial is needed. MethodsWe undertook an external randomised pilot trial (ISRCTN94091479) designed to test recruitment, retention and engagement with, and the acceptability and preliminary effects of the intervention. Participants aged [≥] 65 years with two or more long-term conditions were recruited between June and October 2020. Behavioural Activation was offered to intervention participants (n=47), and control participants received usual care (n=49). FindingsRemote recruitment was possible and 45/47 (95.7%) randomised to the intervention completed one or more sessions (median 6 sessions). 90 (93.8%) completed the one month follow-up, and 86 (89.6%) completed the three month follow-up. The between-group comparison for the primary clinical outcome at one 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 three months, the PHQ-9 adjusted mean difference was 0.19 (95% CI -1.36 to 1.75). When we examined loneliness, the between-group difference in the De Jong Gierveld Loneliness scale at one month was 0.28 (95% CI -0.51 to 1.06), and there was statistically significant between group difference at three months (-0.87; 95% CI -1.56 to -0.18). Participants who withdrew had minimal depressive symptoms at entry. InterpretationBehavioural Activation is a plausible intervention to mitigate the psychological impacts of COVID-19 isolation for older adults. 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 this will now be confirmed in a fully powered RCT. FundingThis study was funded by National Institute for Health Research (NIHR) Programme Grants for Applied Research (PGfAR) RP-PG-0217-20006
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ObjectiveTo estimate mortality of care home (CH) residents, and matched community-dwelling controls, during the Covid-19 pandemic from primary care electronic health records. DesignMatched cohort study SettingGeneral practices contributing to the Clinical Practice Research Datalink Aurum Database in England. ParticipantsThere were 83,627 CH residents contributing data in 2020, with 26,923 deaths; 80,730 (97%) were matched on age, gender and general practice with 300,445 community-dwelling adults. Main outcome measuresAll-cause mortality. Adjusted rate ratios (RR) by negative binomial regression were adjusted for age, gender, number of long-term conditions (LTCs), frailty category, region, calendar month or week, and clustering by general practice. ResultsDuring April 2020, the mortality rate of CH residents was 27.2 deaths per 1,000 patients per week, compared with 2.31 per 1,000 for controls, RR 11.1 (95% confidence interval 10.1 to 12.2). Compared with CH residents, LTCs and frailty were differentially associated with greater mortality in community-dwelling controls. During April 2020, mortality rates per 1,000 patients per week for persons with 9+ LTCs were: CH, 37.9; controls 17.7; RR 2.14 (1.18 to 3.89). In severe frailty, mortality rates were: CH, 29.6; controls 5.1; RR 6.17 (5.74 to 6.62). ConclusionsIndividual-patient data from primary care electronic health records may be used to estimate mortality in care home residents. Mortality is substantially higher than for community-dwelling comparators and showed a disproportionate increase in the first wave of the Covid-19 pandemic. Multiple morbidity and frailty were associated with greater absolute risks but lower relative risks because community-dwelling frail or multi-morbid patients also experienced high mortality.
