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Background: Healthcare workers (HCWs) have faced considerable pressures during the COVID-19 pandemic. For some, this has resulted in mental health distress and disorder. Although interventions have sought to support HCWs, few have been evaluated. Aims: We aimed to determine the effectiveness of the 'Foundations' application (app) on general (non-psychotic) psychiatric morbidity. Method: We conducted a multicentre randomised controlled trial of HCWs at 16 NHS trusts (trial registration number: EudraCT: 2021-001279-18). Participants were randomly assigned to the app or wait-list control group. Measures were assessed at baseline, after 4 and 8 weeks. The primary outcome was general psychiatric morbidity (using the General Health Questionnaire). Secondary outcomes included: well-being; presenteeism; anxiety; depression and insomnia. The primary analysis used mixed-effects multivariable regression, presented as adjusted mean differences (aMD). Results: Between 22 March and 3 June 2021, 1002 participants were randomised (500:502), and 894 (89.2%) followed-up. The sample was predominately women (754/894, 84.3%), with a mean age of 44⋅3 years (interquartile range (IQR) 34–53). Participants randomised to the app had a reduction in psychiatric morbidity symptoms (aMD = −1.39, 95% CI −2.05 to −0.74), improvement in well-being (aMD = 0⋅54, 95% CI 0⋅20 to 0⋅89) and reduction in insomnia (adjusted odds ratio (aOR) = 0⋅36, 95% CI 0⋅21 to 0⋅60). No other significant findings were found, or adverse events reported. Conclusions: The app had an effect in reducing psychiatric morbidity symptoms in a sample of HCWs. Given it is scalable with no adverse effects, the app may be used as part of an organisation's tiered staff support package. Further evidence is needed on long-term effectiveness and cost-effectiveness. [ABSTRACT FROM AUTHOR]

Introduction: The COVID-19 pandemic has had profound effects on the working lives of healthcare workers (HCWs), but the extent to which their well-being and mental health have been affected remains unclear. This longitudinal cohort study aims to recruit a cohort of National Health Service (NHS) HCWs, conducting surveys at regular intervals to provide evidence about the prevalence of symptoms of mental disorders, and investigate associated factors such as occupational contexts and support interventions available., Methods and Analysis: All staff, students and volunteers working in the 18 participating NHS Trusts in England will be sent emails inviting them to complete a survey at baseline, with email invitations for the follow-up surveys sent 6 months and 12 months later. Opening in late April 2020, the baseline survey collects data on demographics, occupational/organisational factors, experiences of COVID-19, validated measures of symptoms of poor mental health (eg, depression, anxiety, post-traumatic stress disorder), and constructs such as resilience and moral injury. These surveys will be complemented by in-depth psychiatric interviews with a sample of HCWs. Qualitative interviews will also be conducted, to gain deeper understanding of the support programmes used or desired by staff, and facilitators and barriers to accessing such programmes., Ethics and Dissemination: Ethical approval for the study was granted by the Health Research Authority (reference: 20/HRA/210, IRAS: 282686) and local Trust Research and Development approval. Cohort data are collected via Qualtrics online survey software, pseudonymised and held on secure university servers. Participants are aware that they can withdraw from the study at any time, and there is signposting to support services if participants feel they need it. Only those consenting to be contacted about further research will be invited to participate in further components. Findings will be rapidly shared with NHS Trusts, and via academic publications in due course., Competing Interests: Competing interests: MH, RoR and SW are senior NIHR Investigators. This paper represents independent research part-funded by the NIHR Maudsley Biomedical Research Centre Trust and King’s College London (MH, SW, SS). The views expressed are those of the authors and not necessarily those of the NHS, the NIHR, or the Department of Health and Social Care. RoR reports grants from DHSC/UKRI/ESRC COVID-19 Rapid Response Call, grants from Rosetrees Trust, grants from King’s Together rapid response call, grants from University College London (UCL) (Wellcome Trust) rapid response call, during the conduct of the study; and grants from NIHR outside the submitted work. MH reports grants from DHSC/UKRI/ESRC COVID-19 Rapid Response Call, grants from Rosetrees Trust, grants from King’s Together rapid response call, grants from UCL Partners rapid response call, during the conduct of the study; grants from Innovative Medicines Initiative and EFPIA, RADAR-CNS consortium, grants from MRC, grants from NIHR, outside the submitted work. SS reports grants from UKRI/ESRC/DHSC, grants from UCL, grants from UKRI/MRC/DHSC, grants from Rosetrees Trust, grants from King’s Together Fund, during the conduct of the study. NG reports a potential COI with NHSEI, during the conduct of the study; and is the managing director of March on Stress Ltd which has provided training for a number of NHS organisations, although it is not clear if the company has delivered training to any of the participating trusts or not as NG is not directly involved in commissioning specific pieces of work., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ.)