Digital Training Program for Line Managers (Managing Minds at Work): Protocol for a Feasibility Pilot Cluster Randomized Controlled Trial.

BACKGROUND: Mental health problems affect 1 in 6 workers annually and are one of the leading causes of sickness absence, with stress, anxiety, and depression being responsible for half of all working days lost in the United Kingdom. Primary interventions with a preventative focus are widely acknowledged as the priority for workplace mental health interventions. Line managers hold a primary role in preventing poor mental health within the workplace and, therefore, need to be equipped with the skills and knowledge to effectively carry out this role. However, most previous intervention studies have directly focused on increasing line managers' understanding and awareness of mental health rather than giving them the skills and competencies to take a proactive preventative approach in how they manage and design work. The Managing Minds at Work (MMW) digital training intervention was collaboratively designed to address this gap. The intervention aims to increase line managers' knowledge and confidence in preventing work-related stress and promoting mental health at work. It consists of 5 modules providing evidence-based interactive content on looking after your mental health, designing and managing work to promote mental well-being, management competencies that prevent work-related stress, developing a psychologically safe workplace, and having conversations about mental health at work. OBJECTIVE: The primary aim of this study is to pilot and feasibility test MMW, a digital training intervention for line managers. METHODS: We use a cluster randomized controlled trial design consisting of 2 arms, the intervention arm and a 3-month waitlist control, in this multicenter feasibility pilot study. Line managers in the intervention arm will complete a baseline questionnaire at screening, immediately post intervention (approximately 6 weeks after baseline), and at 3- and 6-month follow-ups. Line managers in the control arm will complete an initial baseline questionnaire, repeated after 3 months on the waitlist. They will then be granted access to the MMW intervention, following which they will complete the questionnaire post intervention. The direct reports of the line managers in both arms of the trial will also be invited to take part by completing questionnaires at baseline and follow-up. As a feasibility pilot study, a formal sample size is not required. A minimum of 8 clusters (randomized into 2 groups of 4) will be sought to inform a future trial from work organizations of different types and sectors. RESULTS: Recruitment for the study closed in January 2022. Overall, 24 organizations and 224 line managers have been recruited. Data analysis was finished in August 2023. CONCLUSIONS: The results from this feasibility study will provide insight into the usability and acceptability of the MMW intervention and its potential for improving line manager outcomes and those of their direct reports. These results will inform the development of subsequent trials. TRIAL REGISTRATION: ClinicalTrials.gov NCT05154019; https://clinicaltrials.gov/study/NCT05154019. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/48758.

Using intervention mapping to develop evidence-based toolkits that support workers on long-term sick leave and their managers.

BACKGROUND: Managing long-term sickness absence is challenging in countries where employers and managers have the main responsibility to provide return to work support, particularly for workers with poor mental health. Whilst long-term sick leave and return to work frameworks and guidance exist for employers, there are currently no structured return to work protocols for employers or for their workers encompassing best practice strategies to support a positive and timely return to work outcome. PURPOSE: To utilise the intervention mapping (IM) protocol as a framework to develop return to work toolkits that are underpinned by relevant behaviour change theory targeting mental health to promote a positive return to work experiensce for workers on long-term sick leave. METHODS: This paper provides a worked example of intervention mapping (IM) to develop an intervention through a six-step process to combine theory and evidence in the development of two toolkits - one designed for managers and one to be used by workers on long-term sick leave. As part of this process, collaborative planning techniques were used to develop the intervention. A planning group was set up, through which researchers would work alongside employer, worker, and mental health professional representatives to develop the toolkits. Additionally, feedback on the toolkits were sought from the target populations of workers and managers and from wider employer stakeholders (e.g., human resource specialists). The implementation and evaluation of the toolkits as a workplace intervention were also planned. RESULTS: Two toolkits were designed following the six steps of intervention mapping. Feedback from the planning group (n = 5; psychologist, psychiatrist, person with previous experience of poor mental health, employer and charity worker) and participants (n = 14; employers = 3, wellbeing director = 1; human resources = 2, managers = 2, employees with previous experience of poor mental health = 5) target populations indicated that the toolkits were acceptable and much needed. CONCLUSIONS: Using IM allowed the development of an evidence-based practical intervention, whilst incorporating the views of all the impacted stakeholder groups. The feasibility and acceptability of the toolkits and their supporting intervention components, implementation process and methods of assessment will be evaluated in a feasibility pilot randomised controlled trial.

Protocol for a feasibility randomised controlled study of a multicomponent intervention to promote a sustainable return to work of workers on long-term sick leave - PROWORK: PROmoting a Sustainable and Healthy Return to WORK.

BACKGROUND: The cost of sickness absence has major social, psychological and financial implications for individuals and organisations. Return-to-work (RTW) interventions that support good quality communication and contact with the workplace can reduce the length of sickness absence by between 15 and 30 days. However, initiatives promoting a sustainable return to work for workers with poor mental health on long-term sickness absence across small, medium and large enterprises (SMEs and LEs) are limited. This paper describes the protocol of a pilot randomised controlled trial (RCT) to test the feasibility of implementing a RTW intervention across SMEs and LEs across all sectors. METHODS AND DESIGN: A two-arm feasibility RCT with a 4-month intervention will be conducted in SMEs and LE enterprises from the Midlands region, UK. At least 8 organisations (4 controls and interventions), and at least 60 workers and/or managers, will be recruited and randomised into the intervention and control group (30 interventions, 30 controls). Workers on long-term sickness absence (LTSA) (between 8 and 50 days) and managers with a worker on LTSA will be eligible to participate. The intervention is a behavioural change programme, including a managers and workers RTW toolkit, focused on supporting sickness absence and RTW through the provision of knowledge, problem-solving, action planning, goal setting and positive communication that leads to a sustainable RTW. Organisations assigned to the control group will continue with their usual practice. Measurements of mental health, RTW, work outcomes, quality-of-life, workplace support and communication and other demographic data will be taken at baseline, 2 months and 4 months. Feasibility will be assessed based on recruitment, retention, attrition, completion of measures and intervention compliance for which specific process and research outcomes have been established. A process evaluation will explore the experiences and acceptability of the intervention components and evaluation measures. Exploratory economic evaluation will be conducted to further inform a definitive trial. DISCUSSION: This is a novel intervention using a worker-manager approach to promote a sustainable return to work of workers on long-term sick leave due to poor mental wellbeing. If this intervention is shown to be feasible, the outcomes will inform a larger scale randomised control trial. TRIAL REGISTRATION: ISRCTN90032009 (retrospectively registered, date registered 15th December 2020).

STAndardised DIagnostic Assessment for children and young people with emotional difficulties (STADIA): protocol for a multicentre randomised controlled trial.

INTRODUCTION: Emotional disorders (such as anxiety and depression) are associated with considerable distress and impairment in day-to-day function for affected children and young people and for their families. Effective evidence-based interventions are available but require appropriate identification of difficulties to enable timely access to services. Standardised diagnostic assessment (SDA) tools may aid in the detection of emotional disorders, but there is limited evidence on the utility of SDA tools in routine care and equipoise among professionals about their clinical value. METHODS AND ANALYSIS: A multicentre, two-arm, parallel group randomised controlled trial, with embedded qualitative and health economic components. Participants will be randomised in a 1:1 ratio to either the Development and Well-Being Assessment SDA tool as an adjunct to usual clinical care, or usual care only. A total of 1210 participants (children and young people referred to outpatient, specialist Child and Adolescent Mental Health Services with emotional difficulties and their parent/carers) will be recruited from at least 6 sites in England. The primary outcome is a clinician-made diagnosis about the presence of an emotional disorder within 12 months of randomisation. Secondary outcomes include referral acceptance, diagnosis and treatment of emotional disorders, symptoms of emotional difficulties and comorbid disorders and associated functional impairment. ETHICS AND DISSEMINATION: The study received favourable opinion from the South Birmingham Research Ethics Committee (Ref. 19/WM/0133). Results of this trial will be reported to the funder and published in full in the Health Technology Assessment (HTA) Journal series and also submitted for publication in a peer reviewed journal. TRIAL REGISTRATION NUMBER: ISRCTN15748675; Pre-results.

Beliefs about food allergies in adolescents aged 11-19 years: A systematic review.

Aims: Research suggests of people with food allergy (FA), adolescents have the highest risk of fatal allergic reactions to food, yet understanding of this population and how they manage their condition is limited. Understanding beliefs and how they affect behaviour could inform ways to reduce risk taking behaviour and fatal reactions in adolescents. This systematic review aimed to explore beliefs adolescents hold about their FA, and how these may be associated with FA management. Demographics: Adolescents aged 11-19 years with FA. Methodology: A systematic search of seven databases was conducted. Papers of any design were included that reported on the beliefs about FA in adolescents aged 11-19 years. Data was systemised by narrative thematic analysis. Findings: 20 studies were included. Themes included navigating FA in different environments, carriage and use of adrenaline auto-injectors, management of the risk of anaphylaxis, behaviour and understanding of others, and food-allergic identity. Implications: Adolescents with FA hold a variety of condition beliefs; some beliefs were related to behaviour that could lead to an allergic reaction, while other beliefs were related to protective behaviours. Further research into understanding adolescent beliefs in order to inform clinical management and reduce the risk of potential fatal reactions is essential.

Development and Validation of the Anaphylaxis Quality of Life Scale for Adults.

BACKGROUND: Anaphylaxis is a severe and potentially life-threatening allergic reaction that can have a detrimental impact on quality of life (QoL). There are no validated scales to measure the impact of anaphylaxis on QoL of adults. OBJECTIVE: The aim of this study was to develop and assess the reliability and validity of a QoL scale for adults with anaphylaxis (Anaphylaxis Quality of Life Scale for Adults [A-QoL-Adults]). METHODS: All participants were recruited from a specialist allergy clinic and had a confirmed diagnosis of anaphylaxis (as per the World Allergy Organization diagnostic criteria) to food, drugs, venom, or latex or had spontaneous anaphylaxis. Interviews were conducted with 13 adults; data were analyzed using thematic analysis to extract items for a QoL scale. A prototype QoL scale was then completed by 115 participants alongside validated scales to measure generic QoL (World Health Organization Quality of Life Scale [Brief Version] [WHOQoL BREF]), anxiety and depression (Hospital Anxiety and Depression Scale [HADS]), and stress (Perceived Stress Scale [PSS]). RESULTS: The A-QoL-Adults scale has 21 items demonstrating excellent internal reliability (Cronbach α = 0.96). Factor analysis produced 3 subscales: Emotional Impact; Social Impact; and Limitations on Life. Each has excellent internal reliability (0.92, 0.92, and 0.91, respectively). Poorer anaphylaxis-related QoL (total A-QoL-Adults score and subscale scores) correlated significantly with poorer general QoL and greater anxiety, depression, and stress (all P < .01 with medium-to-large effect sizes). CONCLUSIONS: The A-QoL-Adults scale is a reliable measure of QoL in adults with anaphylaxis and shows good construct validity. It will offer health care professionals a means to further understand the impact of anaphylaxis on adult patients and could help direct and monitor allergy management and the need for further psychological intervention.

Experiences and emotional strain of NHS frontline workers during the peak of the COVID-19 pandemic.

BACKGROUND: The mental health of the population has been negatively affected due to the pandemic. Frontline healthcare workers with increased exposure to COVID diagnosis, treatment and care were especially likely to report psychological burden, fear, anxiety and depression. AIM: To elicit how working as a health professional during the pandemic is impacting on the psychological wellbeing of frontline staff. METHOD: United Kingdom population of healthcare workers were approached by advertising the survey via social media, NHS trusts and other organisations. Open-ended survey answers were qualitatively explored using content analysis. RESULTS: Survey collected data from 395 NHS staff was developed into three themes; (1) Despair and uncertainty: feeling overwhelmed trying to protect everyone, (2) Behavioural and psychological impact: affecting wellbeing and functioning and (3) Coping and employer support: getting the right help. CONCLUSION: NHS staff felt enormous burden to adequately complete their professional, personal and civil responsibility to keep everyone safe leading to negative psychological and behavioural consequences and desire for NHS employers to offer better support. As the pandemic progresses, the results of this study may inform NHS employers on how optimum support can be offered to help them cope with negative psychological consequences of the pandemic.

"It's not an illness, it's just bad luck": The impact of anaphylaxis on quality of life in adults.

BACKGROUND: An increasing number of adults are being diagnosed with anaphylaxis, but its impact on health-related quality of life (HRQol) is not known. OBJECTIVE: The aim of this study was to explore the impact of anaphylaxis on HRQoL of newly diagnosed adults. METHODS: Interviews were conducted with 13 adults (aged 40-71; five males) with anaphylaxis (meeting WAO diagnostic criteria) to drugs, food, venom or spontaneous anaphylaxis, recruited using purposive sampling from allergy clinics in Birmingham, UK. Data were transcribed verbatim and analysed using thematic analysis. RESULTS: Four themes were generated from the analysis: the journey from fear to frustration; the need to maintain a healthy identity; control over uncertainty; and the supportive role of others. Participants described their first experiences of anaphylaxis as frightening. Managing the condition was associated with frustration and anxiety, in part due to uncertainty regarding when anaphylaxis might occur. Participants did not consider their allergy as an illness and wanted to retain an identity as a healthy person. They felt a strong need to have control over their anaphylaxis so that it did not take over their lives. The support from others was extremely important, but a lack of understanding of anaphylaxis sometimes hindered that support. CONCLUSIONS AND CLINICAL RELEVANCE: Anaphylaxis has an adverse impact on the HRQoL of adults irrespective of the cause. More information about anaphylaxis and its management from healthcare professionals may help patients gain a sense of control over their condition and reduce the worry and anxiety associated with it.

Why aren't you stopping now?!' Exploring accounts of white women breastfeeding beyond six months in the East of England.

Breastfeeding infants for a period of two years is endorsed by international health agencies such as the World Health Organisation. However, discourses of breastfeeding in a British context are complex and contradictory, juxtaposing representations of breastfeeding as healthy and a moral obligation for mothers with views of the act as unseemly and an expectation that nursing women practice 'socially sensitive lactation' especially in public spaces. Sustained breastfeeding rates in the UK are poor and most British women discontinue breastfeeding well before six months. Mothers who elect to feed their infants at the breast for longer than these normative periods appear to experience suspicion and disapproval, especially in a public context and breastfeeding women are only legally protected in feeding their infants in public for up to six months. Although breastfeeding research is flourishing, research on this particular population of mothers remains relatively limited. Therefore, in this study, we explore in-depth experiential accounts of eight women, resident in a town in the East of England, who breastfed their infants beyond six months. Using interpretative phenomenological analysis four themes are presented. Really horrible looks': stigma from families and the community', 'Feeling quite exposed': managing extended breastfeeding etiquette', 'Weird freaky paedophiles': representations of extended breastfeeding women in the media' and 'You really need that': the importance of support for longer-term breastfeeding women'. Applications to extended breastfeeding promotion and advocacy are discussed.