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

Background Older 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. Methods We undertook an external randomised pilot trial ([ISRCTN94091479][1]) 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). Findings Remote 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. Interpretation Behavioural 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. Funding This study was funded by National Institute for Health Research (NIHR) Programme Grants for Applied Research (PGfAR) RP-PG-0217-20006 ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Trial ISRCTN94091479 ### Clinical Protocols ### Funding Statement This project was funded by the NIHR Programme Grants for Applied Research (PGfAR) programme (RP-PG-0217-20006). The scope of our pre-existing research into multi-morbidity in older people was extended at the outset of the COVID-19 pandemic with the agreement of the funder to consider loneliness and depression in this vulnerable group. The NIHR PGfAR programme had no role in the writing of this manuscript or the decision to submit it for publication. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: Yorkshire & The Humber - Leeds West Research Ethics Committee Approval Reference 18/YH/0380 All necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable. Yes Anonymised data will be made available upon reasonable request, which must include a protocol and statistical analysis plan and not be in conflict with our prespecified publication plan, consistent with our data sharing policy (available on request from SG). The BASIL research collective is especially keen that the BASIL data contributes to prospective meta-analyses and individual patient data meta-analyses. Requests for data sharing will be considered by SG and the independent trial steering and data monitoring committee. [1]: /external-ref?link_type=ISRCTN&access_num=ISRCTN94091479