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      Behavioural activation to mitigate the psychological impacts of COVID-19 restrictions on older people in England and Wales (BASIL+): a pragmatic randomised controlled trial

      research-article
      , Prof, FMedSci DSc a , b , * , * , , PhD a , c , * , , PhD a , b , c , * , , MSc a , , MSc a , , MSc a , , PhD a , , MSc a , , MD d , , PhD a , e , , BA a , , MSc a , , MSc a , c , , MSc a , c , , PhD a , , MSc a , c , , MSc f , , PhD a , g , , MSc a , , MD f , , DClinPsy c , h , , PhD a , , PhD f , , PhD i , , PhD a , , PhD f , , PhD j , , Prof, PhD a , c , , BASIL trials collective
      The Lancet. Healthy Longevity
      Elsevier Ltd

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          Summary

          Background

          Older adults were more likely to be socially isolated during the COVID-19 pandemic, with increased risk of depression and loneliness. We aimed to investigate whether a behavioural activation intervention delivered via telephone could mitigate depression and loneliness in at-risk older people during the COVID-19 pandemic.

          Methods

          BASIL+ (Behavioural Activation in Social Isolation) was a pragmatic randomised controlled trial conducted among patients recruited from general practices in England and Wales, and was designed to assess the effectiveness of behavioural activation in mitigating depression and loneliness among older people during the COVID-19 pandemic. Eligible participants were aged 65 years and older, socially isolated, with a score of 5 or higher on the Patient Health Questionnaire-9 (PHQ-9), and had multiple long-term conditions. Participants were allocated in a 1:1 ratio to the intervention (behavioural activation) or control groups by use of simple randomisation without stratification. Behavioural activation was delivered by telephone; participants were offered up to eight weekly sessions with trained BASIL+ Support Workers. Behavioural activation was adapted to maintain social connections and encourage socially reinforcing activities. Participants in the control group received usual care with existing COVID-19 wellbeing resources. The primary clinical outcome was self-reported depression severity, assessed by the PHQ-9, at 3 months. Outcomes were assessed masked to allocation and analysis was by treatment allocation. This trial is registered with the ISRCTN registry (ISRCTN63034289).

          Findings

          Between Feb 8, 2021, and Feb 28, 2022, 449 eligible participants were identified and 435 from 26 general practices were recruited and randomly assigned (1:1) to the behavioural activation intervention (n=218) or to the control group (usual care with signposting; n=217). The mean age of participants was 75·7 years (SD 6·7); 270 (62·1%) of 435 participants were female, and 418 (96·1%) were White. Participants in the intervention group attended an average of 5·2 (SD 2·9) of eight remote behavioural activation sessions. The adjusted mean difference in PHQ-9 scores between the control and intervention groups at 3 months was –1·65 (95% CI –2·54 to –0·75, p=0·0003). No adverse events were reported that were attributable to the behavioural activation intervention.

          Interpretation

          Behavioural activation is an effective and potentially scalable intervention that can reduce symptoms of depression and emotional loneliness in at-risk groups in the short term. The findings of this trial add to the range of strategies to improve the mental health of older adults with multiple long-term conditions. These results can be helpful to policy makers beyond the pandemic in reducing the global burden of depression and addressing the health impacts of loneliness, particularly in at-risk groups.

          Funding

          UK National Institute for Health and Care Research.

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          Most cited references35

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          A brief measure for assessing generalized anxiety disorder: the GAD-7.

          Generalized anxiety disorder (GAD) is one of the most common mental disorders; however, there is no brief clinical measure for assessing GAD. The objective of this study was to develop a brief self-report scale to identify probable cases of GAD and evaluate its reliability and validity. A criterion-standard study was performed in 15 primary care clinics in the United States from November 2004 through June 2005. Of a total of 2740 adult patients completing a study questionnaire, 965 patients had a telephone interview with a mental health professional within 1 week. For criterion and construct validity, GAD self-report scale diagnoses were compared with independent diagnoses made by mental health professionals; functional status measures; disability days; and health care use. A 7-item anxiety scale (GAD-7) had good reliability, as well as criterion, construct, factorial, and procedural validity. A cut point was identified that optimized sensitivity (89%) and specificity (82%). Increasing scores on the scale were strongly associated with multiple domains of functional impairment (all 6 Medical Outcomes Study Short-Form General Health Survey scales and disability days). Although GAD and depression symptoms frequently co-occurred, factor analysis confirmed them as distinct dimensions. Moreover, GAD and depression symptoms had differing but independent effects on functional impairment and disability. There was good agreement between self-report and interviewer-administered versions of the scale. The GAD-7 is a valid and efficient tool for screening for GAD and assessing its severity in clinical practice and research.
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            A new look at the statistical model identification

            IEEE Transactions on Automatic Control, 19(6), 716-723
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              Multidisciplinary research priorities for the COVID-19 pandemic: a call for action for mental health science

              Summary The coronavirus disease 2019 (COVID-19) pandemic is having a profound effect on all aspects of society, including mental health and physical health. We explore the psychological, social, and neuroscientific effects of COVID-19 and set out the immediate priorities and longer-term strategies for mental health science research. These priorities were informed by surveys of the public and an expert panel convened by the UK Academy of Medical Sciences and the mental health research charity, MQ: Transforming Mental Health, in the first weeks of the pandemic in the UK in March, 2020. We urge UK research funding agencies to work with researchers, people with lived experience, and others to establish a high level coordination group to ensure that these research priorities are addressed, and to allow new ones to be identified over time. The need to maintain high-quality research standards is imperative. International collaboration and a global perspective will be beneficial. An immediate priority is collecting high-quality data on the mental health effects of the COVID-19 pandemic across the whole population and vulnerable groups, and on brain function, cognition, and mental health of patients with COVID-19. There is an urgent need for research to address how mental health consequences for vulnerable groups can be mitigated under pandemic conditions, and on the impact of repeated media consumption and health messaging around COVID-19. Discovery, evaluation, and refinement of mechanistically driven interventions to address the psychological, social, and neuroscientific aspects of the pandemic are required. Rising to this challenge will require integration across disciplines and sectors, and should be done together with people with lived experience. New funding will be required to meet these priorities, and it can be efficiently leveraged by the UK's world-leading infrastructure. This Position Paper provides a strategy that may be both adapted for, and integrated with, research efforts in other countries.
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                Author and article information

                Contributors
                Journal
                Lancet Healthy Longev
                Lancet Healthy Longev
                The Lancet. Healthy Longevity
                Elsevier Ltd
                2666-7568
                1 February 2024
                February 2024
                : 5
                : 2
                : e97-e107
                Affiliations
                [a ]Department of Health Sciences, University of York, York, UK
                [b ]Hull York Medical School, University of York, York, UK
                [c ]Tees, Esk and Wear Valleys NHS Foundation Trust, Research & Development, Flatts Lane Centre, Middlesbrough, UK
                [d ]School of Medicine, Keele University, Staffordshire, UK
                [e ]York Environmental Sustainability Institute, University of York, York, UK
                [f ]School of Medicine, University of Leeds, Leeds, UK
                [g ]Patient and Public Representative, Thornton-le-Dale, UK
                [h ]Age UK, London, UK
                [i ]Division of Nursing, Midwifery & Social Work, University of Manchester, Manchester, UK
                [j ]NIHR Clinical Research Network, Newcastle, UK
                Author notes
                [* ]Correspondence to: Prof Simon Gilbody, Department of Health Sciences, University of York, York YO10 5DD, UK simon.gilbody@ 123456york.ac.uk
                [*]

                Joint first authors

                [†]

                Senior author

                Article
                S2666-7568(23)00238-6
                10.1016/S2666-7568(23)00238-6
                10834375
                6ead16a1-17ac-4f89-88d5-261a4dd65701
                © 2024 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY-NC-ND 4.0 license

                This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).

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