Mitigating the Psychological Impacts of COVID-19 Restrictions on Older People: The UK Behavioural Activation in Social Isolation (BASIL ) COVID-19 Urgent Public Health (UPH) Trial and Living Systematic Review

Background: Older adults were more likely to be socially isolated during the COVID-19 pandemic, with risk of depression and loneliness. Behavioural Activation (BA) could feasibly maintain mental health in the face of COVID isolation.Methods: We undertook a multicentre randomised controlled trial [BASIL+ ISRCTN63034289] of BA to mitigate depression and loneliness among older people. BA was offered by telephone to intervention participants (n=218). Control participants received usual care, with existing COVID wellbeing resources (n=217).Findings: Participants engaged with 5.2 (SD 2.9) of 8 remote BA sessions. Adjusted mean difference (AMD) for depression (PHQ-9) at 3 months [primary outcome] was -1.65 (95% CI -2.54 to -0.75, p<0.001). There was an effect for BA on emotional loneliness at 3 months (AMD -0.37, 95% CI -0.68 to -0.06, p=0.02), but not social loneliness (AMD -0.05, 95% CI -0.33 to 0.23, p=0.72). Other secondary outcomes at 3 months were anxiety (GAD-7: AMD -0.67, 95% CI -1.43 to 0.09, p=0.08) and quality of life (SF12 mental component: AMD 1.99, 95% CI 0.22 to 3.76, p=0.03; physical component: AMD -0.50, 95% CI -2.14 to 1.10, p=0.53).BASIL+ trial results were incorporated into a living systematic review [PROSPERO CRD42021298788], and we found strong evidence of an impact of behavioural and/or cognitive strategies on depression [random effects pooled standardised mean difference -0.32, 95% CI -0.48 to -0.16, 10 studies, n=1,210 participants] and loneliness [random effects pooled standardised mean difference -0.44, 95%CI -0.64 to -0.24, 13 studies, n=1,421 participants] in the short-term (<6 months).Interpretation: BA is an effective intervention that reduces depression and some aspects of loneliness in the short term. This adds to the range of strategies to improve population mental health, particularly among older adults with multiple long-term conditions. These results will be helpful to policy makers in preventing depression and loneliness beyond the pandemic.Trial Registration: The protocol and design for the BASIL+ study was registered (ISRCTN63034289) on 08/02/2021 and is available in the public domainFunding: This project was funded by the NIHR Programme Grants for Applied Research (PGfAR) programme (RP-PG-0217-20006)Declaration of Interest: DE and CCG were current committee members for the NICE Depression Guideline (update) Development Group, and SG was a member between 2015-18. SG, PC , DMcM and EN are supported by the NIHR Yorkshire and Humberside Applied Research Collaboration (ARC) and DE is supported by the North East and North Cumbria ARCsEthical Approval: The BASIL+ trial received ethical approval from a Research Ethics Committee (The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS, UK; +44 (0)207 104 8018; [email protected]) on 11/12/2021 (REC Ref: 20/YH/0347). The sponsor for BASIL+ was Tees, Esk and Wear Valleys NHS Foundation Trust.