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  • 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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Psychosocial interventions
Original research
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
  1. Elizabeth Littlewood1,
  2. Dean McMillan1,2,
  3. Carolyn Chew Graham3,
  4. Della Bailey1,
  5. Samantha Gascoyne1,
  6. Claire Sloane1,
  7. Lauren Burke1,
  8. Peter Coventry1,4,
  9. Suzanne Crosland1,
  10. Caroline Fairhurst1,
  11. Andrew Henry1,
  12. Catherine Hewitt1,
  13. Kalpita Baird1,
  14. Eloise Ryde1,5,
  15. Leanne Shearsmith6,
  16. Gemma Traviss-Turner6,
  17. Rebecca Woodhouse1,
  18. Judith Webster5,
  19. Nick Meader7,
  20. Rachel Churchill8,
  21. Elizabeth Eddy9,
  22. Paul Heron1,
  23. Nisha Hicklin10,
  24. Roz Shafran11,12,
  25. Osvaldo Almeida13,
  26. Andrew Clegg6,14,
  27. Tom Gentry15,
  28. Andrew Hill6,
  29. Karina Lovell16,
  30. Sarah Dexter-Smith5,
  31. David Ekers1,5,
  32. Simon Gilbody1,17
  1. 1 Health Sciences, University of York, York, UK
  2. 2 Centre for Health and Population Science, Hull York Medical School, Hull, UK
  3. 3 School of Medicine, Keele University, Keele, UK
  4. 4 York Environmental Sustainability Institute, University of York, York, UK
  5. 5 Research and Development Unit, Tees Esk and Wear Valleys NHS Foundation Trust, Darlington, UK
  6. 6 Faculty of Medicine and Health, University of Leeds, Leeds, UK
  7. 7 Faculty of Medical Sciences, University of Newcastle, Newcastle upon Tyne, UK
  8. 8 Cochrane Common Mental Disorders Group, University of York, York, UK
  9. 9 Faculty of Health and Life Sciences, University of Liverpool, Liverpool, UK
  10. 10 Department of Psychology, Royal Holloway University of London, Egham, UK
  11. 11 PPP, University College London Institute of Child Health, London, UK
  12. 12 Paediatric Psychology Services, Great Ormond Street Hospital for Children NHS Foundation Trust, London, UK
  13. 13 UWA Medical School, The University of Western Australia, Perth, Western Australia, Australia
  14. 14 Bradford Institute for Health Research, Bradford Royal Infirmary, Bradford, UK
  15. 15 Health and Care Policy, Age UK, London, UK
  16. 16 Division of Nursing, Midwifery and Social Work, The University of Manchester, Manchester, UK
  17. 17 Centre for Health and Population Sciences, Hull York Medical School, York, UK
  1. Correspondence to Professor Simon Gilbody, Health Sciences, University of York, York YO10 5DD, UK; simon.gilbody{at}york.ac.uk

Abstract

Background Behavioural and cognitive interventions remain credible approaches in addressing loneliness and depression. There was a need to rapidly generate and assimilate trial-based data during COVID-19.

Objectives We undertook a parallel pilot RCT of behavioural activation (a brief behavioural intervention) for depression and loneliness (Behavioural Activation in Social Isolation, the BASIL-C19 trial ISRCTN94091479). We also assimilate these data in a living systematic review (PROSPERO CRD42021298788) of cognitive and/or behavioural interventions.

Methods Participants (≥65 years) with long-term conditions were computer randomised to behavioural activation (n=47) versus care as usual (n=49). Primary outcome was PHQ-9. Secondary outcomes included loneliness (De Jong Scale). Data from the BASIL-C19 trial were included in a metanalysis of depression and loneliness.

Findings The 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).

The BASIL-C19 living systematic review (12 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).

Discussion We delivered a pilot trial of a behavioural intervention targeting loneliness and depression; achieving long-term follow-up. Living meta-analysis provides strong evidence of short-term benefit for loneliness and depression for cognitive and/or behavioural approaches. A fully powered BASIL trial is underway.

Clinical implications Scalable behavioural and cognitive approaches should be considered as population-level strategies for depression and loneliness on the basis of a living systematic review.

  • Adult psychiatry
  • Depression & mood disorders

Data availability statement

Data are available on reasonable request. 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 the independent trial steering and data monitoring committee. Full underlying (non-aggregated) data cannot be made publicly available since the ethics approval of this study does not cover openly publishing non-aggregated data.

https://creativecommons.org/licenses/by/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

https://doi.org/10.1136/ebmental-2022-300530

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    Data availability statement

    Data are available on reasonable request. 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 the independent trial steering and data monitoring committee. Full underlying (non-aggregated) data cannot be made publicly available since the ethics approval of this study does not cover openly publishing non-aggregated data.

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    Footnotes

    • Twitter @Eloise_Ryde, @_GemmaTT, @SimonGilbody

    • Contributors SiG, DE, CCG, LL, DM, CH, DB and SaG planned the trial, contributed to the trial design and drafted the trial protocol. LL, SiG, DM, PC and DE led manuscript writing. LL, SiG and DE oversaw the trial as chief investigators (SiG, DE) and trial manager (LL), and critically revised the manuscript. SiG, LL, DM, CCG, CH, PC, GT-T, AC, TG, AHi, KL contributed to to trial design and trial management meetings. SiG, CCG, DE, DM and DB designed the intervention and BSW training materials, and DB, DM, CCG and DE delivered the BSW training. LL led the day-to-day management of the trial, and SaG and RW were the trial coordinators. DB, SC and DM provided BSW clinical supervision. SaG, LB, AHe, ER, LS and RW facilitated participant recruitment and follow-up data collection, and participated in trial management meetings. ER and LS delivered the BA intervention. CF, KB and CH developed the statistical analysis plan and analysed the quantitative data. SiG, DM, EE, PH, RS designed the living meta-analysis and are guarantors for the PROSPERO-registered review. OA provided unpublished data for the meta-analysis and is an international collaborator to the BASIL programme and the evaluation of behavioural interventions for older people. All authors contributed to the drafts of manuscripts and read the final manuscript. The York Trials Unit act as data custodians for the BASIL-C19 trial and SiG and DM act as data custodians for the living meta-analysis.

    • Funding BASIL C-19 was funded by the NIHR Programme Grants for Applied Research (PGfAR) programme (RP-PG-0217-20006). The scope of our pre-existing research into multimorbidity 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.

    • Disclaimer The NIHR PGfAR programme had no role in the writing of this manuscript or the decision to submit it for publication.

    • Competing interests We have read the journal’s policy and the authors of this manuscript have the following competing interests. DE and CCG were committee members for the NICE Depression Guideline (update) Development Group between 2015 and 2022, and SiG was a member between 2015 and 2018. SiG, PC and DM are supported by the NIHR Yorkshire and Humberside Applied Research Collaboration (ARC) and DE is supported by the North East and North Cumbria ARCs. CCG is part funded by West Midland ARC.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.