Cognitive or behavioural interventions (or both) to prevent or mitigate loneliness in adolescents, adults, and older adults

Eddy, Elizabeth; Heron, Paul; McMillan, Dean; Dawson, Sarah; Ekers, David; Hickin, Nisha; Littlewood, Elizabeth; Shafran, Roz; Meader, Nicholas; Gilbody, Simon

doi:10.1002/14651858.cd013791

Cited by 9 publications

(14 citation statements)

References 56 publications

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“…Loneliness is not an inevitable consequence of social isolation, and strategies to prevent or mitigate loneliness were recognised as a population priority even before COVID-19 [ 10 , 11 ]. There are a number of promising interventions that focus on using social networks [ 12 ] or adapting the strategies central to cognitive behavioural therapy [ 13 ]. It is recognised that strategies that, for instance, maintain social connectedness could be important in ensuring the population mental health of older people [ 14 ], particularly during the pandemic [ 4 ] and in the planning for post-pandemic recovery [ 15 ].…”

Section: Introductionmentioning

confidence: 99%

Behavioural activation to prevent depression and loneliness among socially isolated older people with long-term conditions: The BASIL COVID-19 pilot randomised controlled trial

et al. 2021

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Background 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. Conclusions 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). Trial registration ISRCTN94091479.

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Section: Introductionmentioning

confidence: 99%

Behavioural activation to prevent depression and loneliness among socially isolated older people with long-term conditions: The BASIL COVID-19 pilot randomised controlled trial

et al. 2021

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“…There are few trials of cognitive or behavioural interventions [53], and we anticipate this will be the largest such trial. In time we anticipate that the results of BASIL + will contribute to Cochrane reviews in this topic [54]. BASIL + builds on the work conducted in the BASIL-C19 external pilot RCT [23] and will provide further lessons for the efficient delivery of mental health trials beyond the pandemic.…”

Section: Discussionmentioning

confidence: 99%

Behavioural Activation for Social IsoLation (BASIL⁺) trial (Behavioural activation to mitigate depression and loneliness among older people with long-term conditions): Protocol for a fully-powered pragmatic randomised controlled trial

Burke

Littlewood

Gascoyne

et al. 2022

Preprint

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Introduction Depression is a leading mental health problem worldwide. People with long-term conditions are at increased risk of experiencing depression. The COVID-19 pandemic led to strict social restrictions being imposed across the UK population. Social isolation can have negative consequences on the physical and mental wellbeing of older adults. In the Behavioural Activation in Social IsoLation (BASIL + ) trial we will test whether a brief psychological intervention (based on Behavioural Activation), delivered remotely, can mitigate depression and loneliness in older adults with long-term conditions during isolation. Methods We will conduct a two-arm, parallel-group, randomised controlled trial across several research sites, to evaluate the clinical and cost-effectiveness of the BASIL + intervention. Participants will be recruited via participating general practices across England and Wales. Participants must be aged ≥65 with two or more long-term conditions, or a condition that may indicate they are within a ‘clinically extremely vulnerable’ group in relation to COVID-19, and have scored ≥5 on the Patient Health Questionnaire (PHQ9), to be eligible for inclusion. Randomisation will be 1:1, stratified by research site. Intervention participants will receive up to eight intervention sessions delivered remotely by trained BASIL + Support Workers and supported by a self-help booklet. Control participants will receive usual care, with additional signposting to reputable sources of self-help and information, including advice on keeping mentally and physically well. A qualitative process evaluation will also be undertaken to explore the acceptability of the BASIL + intervention, as well as barriers and enablers to integrating the intervention into participants’ existing health and care support, and the impact of the intervention on participants’ mood and general wellbeing in the context of the COVID-19 restrictions. Semi-structured interviews will be conducted with intervention participants, participant’s caregivers/supportive others and BASIL + Support Workers. Outcome data will be collected at one, three, and 12 months post-randomisation. Clinical and cost-effectiveness will be evaluated. The primary outcome is depressive symptoms at the three-month follow up, measured by the PHQ9. Secondary outcomes include loneliness, social isolation, anxiety, quality of life, and a bespoke health services use questionnaire. Discussion This study is the first large-scale trial evaluating a brief Behavioural Activation intervention in this population, and builds upon the results of a successful external pilot trial. Trial Registration ClinicalTrials.Gov identifier ISRCTN63034289, registered on 5th February 2021.

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“…Using all trial data to February 2022 we then updated an earlier Cochrane 25 and non-Cochrane 26 meta-analysis of cognitive or behavioural interventions to prevent or mitigate loneliness and depression in adult populations in light of the BASIL-C19 results. The planned living systematic review and meta-analysis protocol was registered on the PROSPERO database (review protocol CRD42021298788).…”

Section: Trial Methodsmentioning

confidence: 99%

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

Littlewood

McMillan

Chew-Graham

et al. 2022

Preprint

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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 summaryWhy was this study done?⍰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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Cognitive or behavioural interventions (or both) to prevent or mitigate loneliness in adolescents, adults, and older adults

Cited by 9 publications

References 56 publications

Behavioural activation to prevent depression and loneliness among socially isolated older people with long-term conditions: The BASIL COVID-19 pilot randomised controlled trial

Behavioural activation to prevent depression and loneliness among socially isolated older people with long-term conditions: The BASIL COVID-19 pilot randomised controlled trial

Behavioural Activation for Social IsoLation (BASIL⁺) trial (Behavioural activation to mitigate depression and loneliness among older people with long-term conditions): Protocol for a fully-powered pragmatic randomised controlled trial

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

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Cognitive or behavioural interventions (or both) to prevent or mitigate loneliness in adolescents, adults, and older adults

Cited by 9 publications

References 56 publications

Behavioural activation to prevent depression and loneliness among socially isolated older people with long-term conditions: The BASIL COVID-19 pilot randomised controlled trial

Behavioural activation to prevent depression and loneliness among socially isolated older people with long-term conditions: The BASIL COVID-19 pilot randomised controlled trial

Behavioural Activation for Social IsoLation (BASIL+) trial (Behavioural activation to mitigate depression and loneliness among older people with long-term conditions): Protocol for a fully-powered pragmatic randomised controlled trial

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

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Behavioural Activation for Social IsoLation (BASIL⁺) trial (Behavioural activation to mitigate depression and loneliness among older people with long-term conditions): Protocol for a fully-powered pragmatic randomised controlled trial