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

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.

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

ObjectivesThe COVID-19 pandemic has heightened the need to address loneliness and social isolation (and associated incidence of depression) amongst 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 Activation, BA) to prevent and reduce loneliness and depression in older people with long term conditions (LTCs) during the COVID-19 pandemic. DesignAn embedded qualitative study was conducted with semi-structured interviews to generate data that was first analysed inductively using thematic analysis and then deductively using the Theoretical Framework of Acceptability (TFA). SettingNational Health Service and third sector organisations in England. ParticipantsSixteen older adults and 9 Support Workers (BSWs) participating in the BASIL pilot trial. ResultsOlder adults and BSWs 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. The intervention was understood by older adults & BSWs, although less understanding in older adults without low mood. A manageable burden was involved with delivering and participating in the intervention. For ethicality, older adults valued social contact and making changes, BSWs valued being able to observe those changes. Opportunity cost was low for BSWs & older adults. BA 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 LTCs. Self-efficacy developed over time and with experience for both BSWs and older adults. ConclusionsOverall, the BASIL pilot study processes and BA intervention were found to be acceptable. Use of the TFA provided valuable insights into how the intervention was experienced and how the acceptability of study processes and the BA intervention could be enhanced ahead of the larger definitive trial (BASIL+). Strengths & LimitationsO_LIThe use of TFA in both informing the topic guide and conducting the analysis, demonstrating a systematic enquiry into acceptability, and contributing to the wider field as well as the topic area. C_LIO_LIThe length of the interviews facilitated an in-depth exploration of older adults and BASIL Support Workers experiences. C_LIO_LIConducting the interviews by telephone whilst discussing feasibility of telephone delivery may have enabled contextual cues to be discussed that may have been missed in a face-to-face interview set up, however may have led to a self-selecting sample of people who were comfortable with the telephone. C_LIO_LIA limitation is that the short timescale for the study meant that participants had to be interviewed as they completed 3m outcome measures, rather than using strategic sampling. C_LI

Mitigating the psychological impacts of COVID-19 restrictions: The Behavioural Activation in Social Isolation (BASIL) pilot randomised controlled trial to prevent depression and loneliness among older people with long term conditions

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