Symptom patterns and life with post-acute COVID-19 in children aged 8-17 years: a mixed-methods study protocol.

BACKGROUND: While there is a substantial body of knowledge about acute COVID-19, less is known about long-COVID, where symptoms continue beyond 4 weeks. AIM: To describe longer-term effects of COVID-19 infection in children and young people (CYP) and identify their needs in relation to long-COVID. DESIGN & SETTING: This study comprises an observational prospective cohort study and a linked qualitative study, identifying participants aged 8-17 years in the West Midlands of England. METHOD: CYP will be invited to complete online questionnaires to monitor incidences and symptoms of COVID-19 over a 12-month period. CYP who have experienced long-term effects of COVID will be invited to interview, and those currently experiencing symptoms will be asked to document their experiences in a diary. Professionals who work with CYP will be invited to explore the impact of long-COVID on the wider experiences of CYP, in a focus group. Descriptive statistics will be used to describe the incidence and rates of resolution of symptoms, and comparisons will be made between exposed and non-exposed groups. Logistic regression models will be used to estimate associations between candidate predictors and the development of long-COVID, and linear regression will be used to estimate associations between candidate predictors. Qualitative data will be analysed thematically using the constant comparison method. CONCLUSION: This study will describe features and symptoms of long-COVID and explore the impact of long-COVID within the lives of CYP and their families, to provide better understanding of long-COVID and inform clinical practice.

Recommendations for improving the working conditions and cultures of distressed junior doctors, based on a qualitative study and stakeholder perspectives.

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.

Exploring the lived experience of Long Covid in black and minority ethnic groups in the UK: Protocol for qualitative interviews and art-based methods.

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.

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.

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.

Association of SARS-CoV-2 Infection With Psychological Distress, Psychotropic Prescribing, Fatigue, and Sleep Problems Among UK Primary Care Patients.

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.

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

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.

'Reluctant pioneer': A qualitative study of doctors' experiences as patients with long COVID.

BACKGROUND: The coronavirus disease (COVID-19) pandemic has had far-reaching effects upon lives, healthcare systems and society. Some who had an apparently 'mild' COVID-19 infection continue to suffer from persistent symptoms, including chest pain, breathlessness, fatigue, cognitive impairment, paraesthesia, muscle and joint pains. This has been labelled 'long COVID'. This paper reports the experiences of doctors with long COVID. METHODS: A qualitative study; interviews with doctors experiencing persistent symptoms were conducted by telephone or video call. Interviews were transcribed and analysis conducted using an inductive and thematic approach. RESULTS: Thirteen doctors participated. The following themes are reported: making sense of symptoms, feeling let down, using medical knowledge and connections, wanting to help and be helped, combining patient and professional identity. Experiencing long COVID can be transformative: many expressed hope that good would come of their experiences. Distress related to feelings of being 'let down' and the hard work of trying to access care. Participants highlighted that they felt better able to care for, and empathize with, patients with chronic conditions, particularly where symptoms are unexplained. CONCLUSIONS: The study adds to the literature on the experiences of doctors as patients, in particular where evidence is emerging and the patient has to take the lead in finding solutions to their problems and accessing their own care. PATIENT AND PUBLIC CONTRIBUTION: The study was developed with experts by experience (including co-authors HA and TAB) who contributed to the protocol and ethics application, and commented on analysis and implications. All participants were given the opportunity to comment on findings.

Effects of the COVID-19 pandemic on primary care-recorded mental illness and self-harm episodes in the UK: a population-based cohort study.

BACKGROUND: The COVID-19 pandemic has adversely affected population mental health. We aimed to assess temporal trends in primary care-recorded common mental illness, episodes of self-harm, psychotropic medication prescribing, and general practitioner (GP) referrals to mental health services during the COVID-19 emergency in the UK. METHODS: We did a population-based cohort study using primary care electronic health records from general practices registered on the UK Clinical Practice Research Datalink (CPRD). We included patient records from Jan 1, 2010, to Sept 10, 2020, to establish long-term trends and patterns of seasonality, but focused primarily on the period January, 2019-September, 2020. We extracted data on clinical codes entered into patient records to estimate the incidence of depression and anxiety disorders, self-harm, prescriptions for antidepressants and benzodiazepines, and GP referrals to mental health services, and assessed event rates of all psychotropic prescriptions and self-harm. We used mean-dispersion negative binomial regression models to predict expected monthly incidence and overall event rates, which were then compared with observed rates to assess the percentage reduction in incidence and event rates after March, 2020. We also stratified analyses by sex, age group, and practice-level Index of Multiple Deprivation quintiles. FINDINGS: We identified 14 210 507 patients from 1697 UK general practices registered in the CPRD databases. In April, 2020, compared with expected rates, the incidence of primary care-recorded depression had reduced by 43·0% (95% CI 38·3-47·4), anxiety disorders by 47·8% (44·3-51·2), and first antidepressant prescribing by 36·4% (33·9-38·8) in English general practices. Reductions in first diagnoses of depression and anxiety disorders were largest for adults of working age (18-44 and 45-64 years) and for patients registered at practices in more deprived areas. The incidence of self-harm was 37·6% (34·8-40·3%) lower than expected in April, 2020, and the reduction was greatest for women and individuals aged younger than 45 years. By September, 2020, rates of incident depression, anxiety disorder, and self-harm were similar to expected levels. In Northern Ireland, Scotland, and Wales, rates of incident depression and anxiety disorder remained around a third lower than expected to September, 2020. In April, 2020, the rate of referral to mental health services was less than a quarter of the expected rate for the time of year (75·3% reduction [74·0-76·4]). INTERPRETATION: Consequences of the considerable reductions in primary care-recorded mental illness and self-harm could include more patients subsequently presenting with greater severity of mental illness and increasing incidence of non-fatal self-harm and suicide. Addressing the effects of future lockdowns and longer-term impacts of economic instability on mental health should be prioritised. FUNDING: National Institute for Health Research and Medical Research Council.

Finding the 'right' GP: a qualitative study of the experiences of people with long-COVID.

BACKGROUND: An unknown proportion of people who had an apparently mild COVID-19 infection continue to suffer with persistent symptoms, including chest pain, shortness of breath, muscle and joint pains, headaches, cognitive impairment ('brain fog'), and fatigue. Post-acute COVID-19 ('long-COVID') seems to be a multisystem disease, sometimes occurring after a mild acute illness; people struggling with these persistent symptoms refer to themselves as 'long haulers'. AIM: To explore experiences of people with persisting symptoms following COVID-19 infection, and their views on primary care support received. DESIGN & SETTING: Qualitative methodology, with semi-structured interviews to explore perspectives of people with persisting symptoms following suspected or confirmed COVID-19 infection. Participants were recruited via social media between July-August 2020. METHOD: Interviews were conducted by telephone or video call, digitally recorded, and transcribed with consent. Thematic analysis was conducted applying constant comparison techniques. People with experience of persisting symptoms contributed to study design and data analysis. RESULTS: This article reports analysis of 24 interviews. The main themes include: the ' hard and heavy work ' of enduring and managing symptoms and accessing care; living with uncertainty, helplessness and fear, particularly over whether recovery is possible; the importance of finding the 'right' GP (understanding, empathy, and support needed); and recovery and rehabilitation: what would help? CONCLUSION: This study will raise awareness among primary care professionals, and commissioners, of long-COVID and the range of symptoms people are experiencing. Patients require their GP to believe their symptoms and to demonstrate empathy and understanding. Ongoing support by primary care professionals during recovery and rehabilitation is crucial.