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1.
BMC Health Serv Res ; 22(1): 1333, 2022 Nov 10.
Article in English | MEDLINE | ID: covidwho-2139275

ABSTRACT

BACKGROUND: Doctors, including junior doctors, are vulnerable to greater levels of distress and mental health difficulties than the public. This is exacerbated by their working conditions and cultures. While this vulnerability has been known for many years, little action has been taken to protect and support junior doctors working in the NHS. As such, we present a series of recommendations from the perspective of junior doctors and other relevant stakeholders, designed to improve junior doctors' working conditions and, thus, their mental health. METHODS: We interviewed 36 junior doctors, asking them for recommendations for improving their working conditions and culture. Additionally, we held an online stakeholder meeting with a variety of healthcare professionals (including junior doctors), undergraduate medical school leads, postgraduate speciality school leads and NHS policymakers where we asked what could be done to improve junior doctors' working conditions. We combined interview data with notes from the stakeholder discussions to produce this set of recommendations. RESULTS: Junior doctor participants and stakeholders made organisational and interpersonal recommendations. Organisational recommendations include the need for more environmental, staff and educational resources as well as changes to rotas. Interpersonal recommendations include changes to communication and recommendations for better support and teamwork. CONCLUSION: We suggest that NHS policymakers, employers and managers consider and hopefully implement the recommendations set out by the study participants and stakeholders as reported in this paper and that the gold standards of practice which are reported here (such as examples of positive learning environments and supportive supervision) are showcased so that others can learn from them.


Subject(s)
Medical Staff, Hospital , Physicians , Humans , Medical Staff, Hospital/psychology , Qualitative Research , Physicians/psychology
2.
Br J Gen Pract ; 72(721): 384-385, 2022 08.
Article in English | MEDLINE | ID: covidwho-2066640
3.
Evid Based Ment Health ; 2022 Oct 12.
Article in English | MEDLINE | ID: covidwho-2064187

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.

4.
PLoS One ; 17(10): e0275166, 2022.
Article in English | MEDLINE | ID: covidwho-2054360

ABSTRACT

Some people experience prolonged symptoms following an acute COVID-19 infection including fatigue, chest pain and breathlessness, headache and cognitive impairment. When symptoms persist for over 12 weeks following the initial infection, and are not explained by an alternative diagnosis, the term post-COVID-19 syndrome is used, or the patient-defined term of Long Covid. Understanding the lived experiences of Long Covid is crucial to supporting its management. However, research on patient experiences of Long Covid is currently not ethnically diverse enough. The study aim is to explore the lived experience of Long Covid, using qualitative interviews and art-based methods, among people from ethnically diverse backgrounds (in the UK), to better understand wider systems of support and healthcare support needs. Co-created artwork will be used to build on the interview findings. A purposive sampling strategy will be used to gain diverse experiences of Long Covid, sampling by demographics, geographic locations and experiences of Long Covid. Individuals (aged >18 years) from Black and ethnic minority backgrounds, who self-report Long Covid symptoms, will be invited to take part in a semi-structured interview. Interviews will be analysed thematically. A sub-sample of participants will be invited to co-create visual artwork to further explore shared narratives of Long Covid, enhance storytelling and increase understanding about the condition. A patient advisory group, representing diversity in ethnicity and experiences of Long Covid, will inform all research stages. Stakeholder workshops with healthcare professionals and persons, systems or networks important to people's management of Long Covid, will advise on the integration of findings to inform management of Long Covid. The study will use patient narratives from people from diverse ethnic backgrounds, to raise awareness of Long Covid and help inform management of Long Covid and how wider social systems and networks may inform better healthcare service access and experiences.


Subject(s)
COVID-19 , Ethnicity , COVID-19/complications , COVID-19/epidemiology , Humans , Minority Groups , Qualitative Research , United Kingdom/epidemiology
6.
BMJ Open ; 12(8): e061331, 2022 08 23.
Article in English | MEDLINE | ID: covidwho-2001846

ABSTRACT

OBJECTIVES: This paper explored the self-reported prevalence of depression, anxiety and stress among junior doctors during the COVID-19 pandemic. It also reports the association between working conditions and psychological distress experienced by junior doctors. DESIGN: A cross-sectional online survey study was conducted, using the 21-item Depression, Anxiety and Stress Scale and Health and Safety Executive scale to measure psychological well-being and working cultures of junior doctors. SETTING: The National Health Service in the UK. PARTICIPANTS: A sample of 456 UK junior doctors was recruited online during the COVID-19 pandemic from March 2020 to January 2021. RESULTS: Junior doctors reported poor mental health, with over 40% scoring extremely severely depressed (45.2%), anxious (63.2%) and stressed (40.2%). Both gender and ethnicity were found to have a significant influence on levels of anxiety. Hierarchical multiple linear regression analysis outlined the specific working conditions which significantly predicted depression (increased demands (ß=0.101), relationships (ß=0.27), unsupportive manager (ß=-0.111)), anxiety (relationships (ß=0.31), change (ß=0.18), demands (ß=0.179)) and stress (relationships (ß=0.18), demands (ß=0.28), role (ß=0.11)). CONCLUSIONS: The findings illustrate the importance of working conditions for junior doctors' mental health, as they were significant predictors for depression, anxiety and stress. Therefore, if the mental health of junior doctors is to be improved, it is important that changes or interventions specifically target the working environment rather than factors within the individual clinician.


Subject(s)
COVID-19 , Psychological Distress , COVID-19/epidemiology , Cross-Sectional Studies , Depression/epidemiology , Depression/psychology , Humans , Pandemics , State Medicine , United Kingdom/epidemiology
8.
Br J Gen Pract ; 72(717): 174, 2022 04.
Article in English | MEDLINE | ID: covidwho-1887255
9.
Br J Gen Pract ; 72(719): 253-254, 2022 06.
Article in English | MEDLINE | ID: covidwho-1865580
10.
BMJ Qual Saf ; 31(5): 337-339, 2022 05.
Article in English | MEDLINE | ID: covidwho-1807442
11.
PLoS One ; 17(3): e0263856, 2022.
Article in English | MEDLINE | ID: covidwho-1759945

ABSTRACT

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.


Subject(s)
COVID-19 , Ocimum basilicum , Aged , Cost-Benefit Analysis , Depression/prevention & control , Humans , Loneliness , Pandemics , Quality of Life , Randomized Controlled Trials as Topic , Social Isolation
12.
Health Expect ; 25(5): 2107-2123, 2022 10.
Article in English | MEDLINE | ID: covidwho-1636591

ABSTRACT

BACKGROUND: Around 2 million people have migrated from Central and Eastern Europe to the UK since 2004. The UK Central and Eastern European Community (UK-CEE) are disproportionately exposed to the social determinants of poor physical and mental health. Their health and healthcare beliefs remain under-researched, particularly regarding primary care. OBJECTIVE: This review explores UK-CEE community members' use and perceptions of UK general practice. METHODS: A systematic search of nine bibliographic databases identified 2094 publications that fulfilled the search criteria. Grey literature searches identified 16 additional relevant publications. Screening by title and abstract identified 201 publications of relevance, decreasing to 65 after full-text screening. Publications were critically appraised, with data extracted and coded. Thematic analysis using constant comparison allowed generation of higher-order thematic constructs. RESULTS: Full UK-CEE national representation was achieved. Comparatively low levels of GP registration were described, with ability, desire and need to engage with GP services shaped by the interconnected nature of individual community members' cultural and sociodemographic factors. Difficulties overcoming access and in-consultation barriers are common, with health expectations frequently unmet. Distrust and dissatisfaction with general practice often persist, promoting alternative health-seeking approaches including transnational healthcare. Marginalized UK-CEE community subgroups including Roma, trafficked and homeless individuals have particularly poor GP engagement and outcomes. Limited data on the impact of Brexit and COVID-19 could be identified. CONCLUSIONS: Review findings demonstrate the need for codesigned approaches to remove barriers to engagement, culturally adapt and develop trust in GP care for UK-CEE individuals. COMMUNITY INVOLVEMENT: Community members and stakeholders shaped the conceptualisation of the review question and validation of emergent themes.


Subject(s)
COVID-19 , General Practice , Humans , United Kingdom , European Union , Community Participation
13.
BMJ Open ; 11(12): e050016, 2021 12 16.
Article in English | MEDLINE | ID: covidwho-1598606

ABSTRACT

OBJECTIVES: Ten per cent of patients diagnosed with pancreatic cancer undergo pancreaticoduodenectomy. There is limited previous research focusing on psychological well-being; unmet support needs impact negatively on quality of life. This paper reports the psychological impact of a pancreatic cancer diagnosis and subsequent pancreaticoduodenectomy, exploring how patients' lives alter following surgery and how they seek support. DESIGN: Inductive qualitative study involving in-depth semistructured interviews with 20 participants who had undergone pancreaticoduodenectomy for pancreatic or distal biliary duct cancer. Interviews were audiorecorded, transcribed and anonymised, and thematic analysis used principles of constant comparison. SETTING: Single National Health Service Trust in Northwest England. PARTICIPANTS: Patients were eligible for inclusion if they had had pancreaticoduodenectomy for head of pancreas cancer, periampullary cancer or distal cholangiocarcinoma between 6 months and 6 years previously, and had completed adjuvant chemotherapy. RESULTS: Analysis identified the following main themes: diagnosis and decision making around surgery; recovery from surgery and chemotherapy; burden of monitoring and ongoing symptoms; adjusting to 'a new normal'; understanding around prognosis; support-seeking. Participants seized the chance to have surgery, often without seeming to absorb the risks or their prognosis. They perceived that they were unable to control their life trajectory and, although they valued close monitoring, experienced anxiety around their appointments. Participants expressed uncertainty about whether they would be able to return to their former activities. There were tensions in their comments about support-seeking, but most felt that emotional support should be offered proactively. CONCLUSIONS: Patients should be made aware of potential psychological sequelae, and that treatment completion may trigger the need for more support. Clinical nurse specialists (CNSs) were identified as key members of the team in proactively offering support; further training for CNSs should be encouraged. Understanding patients' experience of living with cancer and the impact of treatment is crucial in enabling the development of improved support interventions.


Subject(s)
Pancreatic Neoplasms , Pancreaticoduodenectomy , Adaptation, Psychological , Humans , Nurse Clinicians , Pancreatic Neoplasms/psychology , Pancreatic Neoplasms/surgery , Pancreaticoduodenectomy/adverse effects , Pancreaticoduodenectomy/psychology , Patient Care Team , Prognosis , Qualitative Research , Quality of Life/psychology , State Medicine
14.
BJGP Open ; 5(6)2021.
Article in English | MEDLINE | ID: covidwho-1574322

ABSTRACT

BACKGROUND: Severe acute respiratory coronavirus 2 (SARS-CoV-2), also known as coronavirus disease 2019 (COVID-19), resulted in unprecedented societal and healthcare provision change, which has been implemented at pace. Little is known about the indirect impacts of these changes and what the future effects may be. AIM: To explore patients' and clinicians' experiences of managing heart failure (HF) during the COVID-19 pandemic. DESIGN & SETTING: Qualitative study in three regions of the UK: Cambridgeshire, Greater Manchester, and the West Midlands. METHOD: Semi-structured interviews (n = 30) were conducted with older adults with established HF and healthcare providers from primary and secondary health services involved in their care. Interviews were analysed thematically. RESULTS: Compliance with the government guidance 'Stay at home, protect the NHS, and save lives' during the COVID-19 pandemic, and perceptions relating to risk from COVID-19 and underlying morbidity, drove 'being careful' behaviours and organisational changes. Enacting behavioural change and implementing organisational change resulted in opportunities and challenges for health and healthcare practice. CONCLUSION: Perception of risk led to significant behavioural and organisational change during the pandemic. Some changes described by both patients and clinicians, such as enhanced relationships and self-monitoring, present as opportunities, and consideration should be given as to how to maintain or develop these. Equally, indirect impacts of COVID-19 and the associated lockdown, such as disengagement and withdrawal, and the fallout from reluctance to access health services, should be acknowledged and interventions to address these challenges are needed.

15.
BMJ Open ; 11(12): e056122, 2021 12 13.
Article in English | MEDLINE | ID: covidwho-1571205

ABSTRACT

OBJECTIVES: This paper reports findings exploring junior doctors' experiences of working during the COVID-19 pandemic in the UK. DESIGN: Qualitative study using in-depth interviews with 15 junior doctors. Interviews were audio-recorded, transcribed, anonymised and imported into NVivo V.12 to facilitate data management. Data were analysed using reflexive thematic analysis. SETTING: National Health Service (NHS) England. PARTICIPANTS: A purposive sample of 12 female and 3 male junior doctors who indicated severe depression and/or anxiety on the DASS-21 questionnaire or high suicidality on Paykel's measure were recruited. These doctors self-identified as having lived experience of distress due to their working conditions. RESULTS: We report three major themes. First, the challenges of working during the COVID-19 pandemic, which were both personal and organisational. Personal challenges were characterised by helplessness and included the trauma of seeing many patients dying, fears about safety and being powerless to switch off. Work-related challenges revolved around change and uncertainty and included increasing workloads, decreasing staff numbers and negative impacts on relationships with colleagues and patients. The second theme was strategies for coping with the impact of COVID-19 on work, which were also both personal and organisational. Personal coping strategies, which appeared limited in their usefulness, were problem and emotion focused. Several participants appeared to have moved from coping towards learnt helplessness. Some organisations reacted to COVID-19 collaboratively and flexibly. Third, participants reported a positive impact of the COVID-19 pandemic on working practices, which included simplified new ways of working-such as consistent teams and longer rotations-as well as increased camaraderie and support. CONCLUSIONS: The trauma that junior doctors experienced while working during COVID-19 led to powerlessness and a reduction in the benefit of individual coping strategies. This may have resulted in feelings of resignation. We recommend that, postpandemic, junior doctors are assigned to consistent teams and offered ongoing support.


Subject(s)
COVID-19 , Female , Humans , Male , Medical Staff, Hospital , Pandemics , SARS-CoV-2 , State Medicine
16.
Br J Gen Pract ; 71(713): 556-557, 2021 12.
Article in English | MEDLINE | ID: covidwho-1561388
17.
BMJ Open ; 11(11): e048524, 2021 11 22.
Article in English | MEDLINE | ID: covidwho-1528552

ABSTRACT

INTRODUCTION: The Community Ageing Research 75+ (CARE75+) study is a longitudinal cohort study collecting extensive health and social data, with a focus on frailty, independence and quality of life in older age. CARE75+ was the first international experimental frailty research cohort designed using trial within cohorts (TwiCs) methodology, aligning epidemiological research with clinical trial evaluation of interventions to improve the health and well-being of older people. CARE75+ REMOTE is an extension of CARE75+ using a remote model that does not require face-to-face interactions for data collection in the current circumstances of a global pandemic and will provide an efficient, sustainable data collection model. METHODS AND ANALYSIS: Prospective cohort study using TwiCs. One thousand community-dwelling older people (≥75 years) will be recruited from UK general practices by telephone. Exclusions include: nursing home/care home residents; those with an estimated life expectancy of 3 months or less; and people receiving palliative care. DATA COLLECTION: Assessments will be conducted by telephone, web-submission or postal questionnaire: baseline, 6 months, 12 months, 18 months, 24 months, 30 months and 36 months. Measures include activities of daily living, mood, health-related quality of life, comorbidities, medications, frailty, informal care, healthcare and social care service use. Consent will be sought for data linkage and invitations to additional studies (sub-studies). ETHICS AND DISSEMINATION: CARE75+ was approved by the National Research Ethics Service (NRES) Committee Yorkshire and the Humber-Bradford Leeds 10 October 2014 (14/YH/1120). CARE75+ REMOTE (amendment 13) was approved on the 18th November 2020. Consent is sought if an individual is willing to participate and has capacity to provide informed consent. Consultee assent is sought if an individual lacks capacity. Results will be disseminated in peer-reviewed scientific journals and conferences. Results will be summarised and disseminated to study participants via newsletters, local engagement events and on a bespoke website. TRIAL REGISTRATION NUMBER: ISRCTN16588124.


Subject(s)
Activities of Daily Living , Quality of Life , Aged , Aging , Humans , Longitudinal Studies , Prospective Studies
18.
JAMA Netw Open ; 4(11): e2134803, 2021 11 01.
Article in English | MEDLINE | ID: covidwho-1516698

ABSTRACT

Importance: Infection with SARS-CoV-2 is associated with fatigue and sleep problems long after the acute phase of COVID-19. In addition, there are concerns of SARS-CoV-2 infection causing psychiatric illness; however, evidence of a direct effect is inconclusive. Objective: To assess risk of risk of incident or repeat psychiatric illness, fatigue, or sleep problems following SARS-CoV-2 infection and to analyze changes according to demographic subgroups. Design, Setting, and Participants: This cohort study assembled matched cohorts using the Clinical Practice Research Datalink Aurum, a UK primary care registry of 11 923 499 individuals aged 16 years or older. Patients were followed-up for up to 10 months, from February 1 to December 9, 2020. Individuals with less than 2 years of historical data or less than 1 week follow-up were excluded. Individuals with positive results on a SARS-CoV-2 test without prior mental illness or with anxiety or depression, psychosis, fatigue, or sleep problems were matched with up to 4 controls based on sex, general practice, and year of birth. Controls were individuals who had negative SARS-CoV-2 test results. Data were analyzed from January to July 2021. Exposure: SARS-CoV-2 infection, determined via polymerase chain reaction testing. Main Outcomes and Measures: Cox proportional hazard models estimated the association between a positive SARS-CoV-2 test result and subsequent psychiatric morbidity (depression, anxiety, psychosis, or self-harm), sleep problems, fatigue, or psychotropic prescribing. Models adjusted for comorbidities, ethnicity, smoking, and body mass index. Results: Of 11 923 105 eligible individuals (6 011 020 [50.4%] women and 5 912 085 [49.6%] men; median [IQR] age, 44 [30-61] years), 232 780 individuals (2.0%) had positive result on a SARS-CoV-2 test. After applying selection criteria, 86 922 individuals were in the matched cohort without prior mental illness, 19 020 individuals had prior anxiety or depression, 1036 individuals had psychosis, 4152 individuals had fatigue, and 4539 individuals had sleep problems. After adjusting for observed confounders, there was an association between positive SARS-CoV-2 test results and psychiatric morbidity (adjusted hazard ratio [aHR], 1.83; 95% CI, 1.66-2.02), fatigue (aHR, 5.98; 95% CI, 5.33-6.71), and sleep problems (aHR, 3.16; 95% CI, 2.64-3.78). However, there was a similar risk of incident psychiatric morbidity for those with a negative SARS-CoV-2 test results (aHR, 1.71; 95% CI, 1.65-1.77) and a larger increase associated with influenza (aHR, 2.98; 95% CI, 1.55-5.75). Conclusions and Relevance: In this cohort study of individuals registered at an English primary care practice during the pandemic, there was consistent evidence that SARS-CoV-2 infection was associated with increased risk of fatigue and sleep problems. However, the results from the negative control analysis suggest that unobserved confounding may be responsible for at least some of the positive association between COVID-19 and psychiatric morbidity.


Subject(s)
COVID-19/complications , Fatigue/etiology , Pandemics , Psychological Distress , Psychotropic Drugs/therapeutic use , Sleep Wake Disorders/etiology , Sleep , Adult , Anxiety/drug therapy , Anxiety/epidemiology , Anxiety/etiology , COVID-19/psychology , COVID-19/virology , Cohort Studies , Depression/drug therapy , Depression/epidemiology , Depression/etiology , England/epidemiology , Fatigue/epidemiology , Female , Humans , Male , Middle Aged , Prevalence , Primary Health Care , Psychotic Disorders/drug therapy , Psychotic Disorders/epidemiology , Psychotic Disorders/etiology , Risk Factors , SARS-CoV-2 , Sleep Wake Disorders/epidemiology , Stress, Psychological/etiology
19.
Br J Gen Pract ; 71(712): 508-509, 2021 11.
Article in English | MEDLINE | ID: covidwho-1497379
20.
PLoS Med ; 18(10): e1003779, 2021 10.
Article in English | MEDLINE | ID: covidwho-1463302

ABSTRACT

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.


Subject(s)
COVID-19/psychology , Depression/prevention & control , Health Promotion/methods , Health Services for the Aged , Loneliness , Pandemics , Social Isolation , Aged , Exercise , Female , Health Behavior , Humans , Internet , Male , Pilot Projects , Program Evaluation , SARS-CoV-2 , Social Participation , State Medicine , United Kingdom
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