Behavioural activation to prevent depression and loneliness among socially isolated older people with long-term conditions: The BASIL COVID-19 pilot randomised controlled trial.
Hot off the press!
The first set of findings from the BASIL pilot study published in @PLOSMedicine
We're the first study to report trial-based evidence for an intervention to address the psychological impact of #COVID19 in older adults.
The Good Practice is a research site for the Basil Study and recruited patients from Brompton Health PCN to take part in the exciting clinical research project.
By collaborating with The Redclife Surgery and NIHR (National Institute of Health Research) they were the first site to reach their recruitment target.
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.
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).
Why was this study done?
- Older people with long-term conditions (LTCs) have been impacted by the Coronavirus Disease 2019 (COVID-19) pandemic and its restrictions. They are at risk of social isolation and, in turn, this could cause depression and loneliness, which are bad for health. Psychological approaches, such as behavioural activation (BA), could be helpful.
- A fair test is needed to demonstrate if BA can prevent the onset of depression and loneliness, but before we can do this, it is important to test this out in a smaller scale study.
What did the researchers do and find?
- We designed a brief telephone-delivered intervention based on sound psychological principles known as BA. Here, we present the result of a pilot trial.
- We demonstrate that the intervention is acceptable to older people who are socially isolated as a consequence of the pandemic. We tested whether it is possible to collect important outcomes in the short term.
- There was some preliminary evidence that levels of loneliness were reduced at 3 months when BA is offered.
What do these findings mean?
- This was a smaller scale pilot study, and our procedures worked well.
- If BA is shown to work, then this will be useful for policymakers in offering support to people who are socially isolated.
- This will also be useful once the COVID-19 pandemic has passed, since loneliness is common in older populations, and effective scalable solutions will be needed even after COVID-19.
- The Behavioural Activation in Social Isolation (BASIL) pilot trial was not designed to test differences in outcomes between the 2 groups. We will now test this in a much larger study.
Behavioural activation to prevent depression and loneliness among socially isolated older people with long-term conditions: The BASIL COVID-19 pilot randomised controlled trial
Simon Gilbody, Elizabeth Littlewood, Dean McMillan, Carolyn A. Chew-Graham, Della Bailey, Samantha Gascoyne, Claire Sloan, Lauren Burke, Peter Coventry, Suzanne Crosland Subject Areas For more information about PLOS Subject Areas, click here. We want your feedback. Do these Subject Areas make sense for this article?