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OBJECTIVE: CBT-T is a brief (10-week) cognitive-behavioral therapy for non-underweight eating disorders. This report describes the findings from a single center, single group, feasibility trial of online CBT-T in the workplace as an alternative to health service settings. METHOD: This trial was approved by the Biomedical and Scientific Research Ethics committee, University of Warwick, UK (reference 125/20-21) and was registered with ISRCTN (reference number: ISRCTN45943700). Recruitment was based on self-reported eating and weight concerns rather than diagnosis, potentially enabling access to treatment for employees who have not previously sought help and for those with sub-threshold eating disorder symptoms. Assessments took place at baseline, mid-treatment (week 4), post-treatment (week 10), and follow-up (1 and 3 months post-treatment). Participant experiences following treatment were assessed using quantitative and qualitative approaches. RESULTS: For the primary outcomes, pre-determined benchmarks of high feasibility and acceptability were met, based on recruiting >40 participants (N = 47), low attrition (38%), and a high attendance rate (98%) over the course of the therapy. Participant experiences revealed low previous help-seeking for eating disorder concerns (21%). Qualitative findings indicated a wide range of positive impacts of the therapy and the workplace as the therapeutic setting. Analysis of secondary outcomes for participants with clinical and sub-threshold eating disorder symptoms showed strong effect sizes for eating pathology, anxiety and depression, and moderate effect sizes for work outcomes. DISCUSSION: These pilot findings provide a strong rationale for a fully powered randomized controlled trial to determine the effectiveness of CBT-T in the workplace. PUBLIC SIGNIFICANCE: This study demonstrates the feasibility of implementing an eating disorders intervention (online CBT-T) in the workplace as an alternative to traditional healthcare settings. Recruitment was based on self-reported eating and weight concerns rather than diagnosis, potentially enabling access to treatment for employees who had not previously sought help. The data also provide insights into recruitment, acceptability, effectiveness, and future viability of CBT-T in the workplace.
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Terapia Cognitivo-Comportamental , Transtornos da Alimentação e da Ingestão de Alimentos , Humanos , Estudos de Viabilidade , Transtornos da Alimentação e da Ingestão de Alimentos/terapia , Local de Trabalho , Autorrelato , Resultado do TratamentoRESUMO
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.
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Licença Médica , Local de Trabalho , Humanos , Instituições de Caridade , Pessoal de Saúde , Saúde MentalRESUMO
OBJECTIVE: CBT-T is a brief (10 sessions) version of cognitive behavioral therapy for non-underweight eating disorders. This report describes the protocol for a single center, single group, feasibility trial of online CBT-T in the workplace as an alternative to the health-service setting. By offering mental health services for eating disorders in the workplace, greater accessibility and increased help-seeking behaviors could be achieved. METHOD: Treatment will be delivered online over 10 weeks and offered to employees based on self-referral rather than meeting diagnostic criteria, making treatment available to employees with sub-threshold eating disorder symptoms. RESULTS: Assessments will be conducted at baseline, mid-treatment (week 4), posttreatment (week 10) and at follow-up (1 month and 3 months posttreatment). For the primary outcome, measures will include recruitment, attrition and attendance data using pre-set benchmarks to determine high, medium or low feasibility and acceptability. Qualitative participant experiences data will be analyzed using thematic analysis. Impact on work engagement and effect sizes will be determined from secondary outcome measures; the latter enabling sample size calculations for future study. DISCUSSION: These pilot data will provide insights to recruitment, acceptability, effectiveness and viability of a future fully powered clinical trial of online CBT-T in the workplace. PUBLIC SIGNIFICANCE STATEMENT: This study will present feasibility data from an eating disorders intervention (online CBT-T) using the workplace as an alternative to the healthcare setting to recruit and treat workers. Recruitment will be based on self-reported eating and weight concerns rather than diagnosis potentially enabling treatment to employees who have not previously sought help. The data will also provide insights to recruitment, acceptability, effectiveness, and future viability of CBT-T in the workplace.
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Terapia Cognitivo-Comportamental , Transtornos da Alimentação e da Ingestão de Alimentos , Terapia Cognitivo-Comportamental/métodos , Estudos de Viabilidade , Transtornos da Alimentação e da Ingestão de Alimentos/terapia , Humanos , Resultado do Tratamento , Local de TrabalhoRESUMO
Employees with mental health problems often struggle to remain in employment. During the COVID-19 pandemic, these employees face multiple additional stressors, which are likely to worsen their mental health and work productivity. Currently, it is unclear how to best support employees with mental health problems (and their managers) to improve wellbeing and productivity. We aim to develop a new intervention (MENTOR) that will jointly involve employees, managers, and a new professional (mental health employment liaison worker, MHELW), to help employees who are still at work with a mental health condition and currently receiving professional support for their mental health. A feasibility pilot study will then be undertaken to examine the feasibility and acceptability of the intervention from the perspective of employees and line managers. The study involves a feasibility randomised controlled study comparing outcomes of participants randomised to receive the intervention (MENTOR) with wait-list controls. Participants allocated to the waitlist control group will receive the intervention after three months. We aim to randomise 56 employee-manager pairs recruited from multiple organisations in the Midlands region of England. An intervention including 10 sessions for employees and managers (3 individual sessions and 4 joint sessions) will be delivered over 12 weeks by trained MHELWs. Primary outcomes include measures of feasibility and acceptability of the intervention and work productivity. Secondary outcomes include mental health outcomes. Qualitative interviews will be undertaken with a purposively selected sub-sample of employees and line managers at three-month post-intervention assessment. To our knowledge, this will be the first trial with a joint employee-manager intervention delivered by MHELWs. Anticipated challenges are dual-level consent (employees and managers), participants' attrition, and recruitment strategies. If the intervention and trial processes are shown to be feasible and acceptable, the outcomes from this study will inform future randomised controlled trials. Trial registration: This trial is pre-registered with the ISRCTN registry, registration number: ISRCTN79256498. Protocol version: 3.0_March_2023. https://www.isrctn.com/ISRCTN79256498.
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COVID-19 , Saúde Mental , Humanos , Estudos de Viabilidade , Mentores , Pandemias , Projetos Piloto , COVID-19/epidemiologia , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
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.
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INTRODUCTION: One in six workers experience some form of mental health problems at work costing the UK economy an estimated £70 billion/year. Digital interventions provide low cost and easily scalable delivery methods to implement psychological interventions in the workplace. This trial tests the feasibility of implementing a self-guided 8-week digital cognitive behavioural therapy intervention for subthreshold to clinical depression and/or anxiety versus waitlist control (ie, life as usual) in the workplace. METHODS AND ANALYSIS: Feasibility of implementation will be tested using a mixed-methods evaluation of the two-arm randomised waitlist-control trial. Evaluation will include examination of organisational buy-in, and the engagement of employees through the trial indicated by the completion of outcome measures. In addition, we also explore how participants use the platform, the appropriateness of the analysis both with reference to the outcome measures and linear modelling. Finally, we examine the acceptability of the intervention based on participants experiences using qualitative interviews. Assessments take place at baseline (T0), at 8 weeks post-treatment (T1), at short-term follow-up 4 weeks post-treatment (T2) and long-term follow-ups (6 and 12 months after-end of treatment). We will recruit from 1 July 2021 to 31 December 2021 for employees and self-employed workers with depression and anxiety symptoms (subclinical and clinical levels) who are not seeking or engaged in treatment at the time of the trial. ETHICS AND DISSEMINATION: Full approval was given by the University of Warwick Biomedical and Research Ethics Committee (BSREC 45/20-21). The current protocol version is 2.8 (August 2021). Publication of results in peer-reviewed journals will inform the scientific, clinical and business communities. We will disseminate results through webinars, conferences, newsletter as well as a lay summary of results on the study website (mhpp.me). TRIAL REGISTRATION NUMBER: ISRCTN31161020.
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Terapia Cognitivo-Comportamental , Saúde Mental , Humanos , Estudos de Viabilidade , Terapia Cognitivo-Comportamental/métodos , Bem-Estar Psicológico , Ansiedade/terapia , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
INTRODUCTION: This trial tests the efficacy of implementing a hybrid digital cognitive-behavioural therapy for insomnia (dCBT-I) and emotion regulation (ER) in the workplace. The study protocol follows the SPIRIT (Standard Protocol Items: Recommendations for Intervention Trials) 2013 recommendations. METHODS AND ANALYSIS: This is a mixed methods evaluation with a two-arm randomised waitlist control design of a 6-week dCBT-I+ER intervention through self-guided online platform and four videoconferencing therapy sessions. A process evaluation will examine the fidelity of delivery and experiences of the intervention. The primary outcomes are the Insomnia Severity Index, the Patient Health Questionnaire-9 and the Generalised Anxiety Disorder-7. The secondary outcomes are job productivity, job satisfaction, well-being, quality of life, self-reported (sleep diary data) and objective (actigraphy) sleep parameters, and usage of online intervention platform. Assessments take place at baseline (T0), week 8 post-treatment (T1) and week 12 postrandomisation (T2). We will recruit 156 workers with sleep and ER problems ranging from subclinical to clinical levels not engaged in treatment at the time of the trial. ETHICS AND DISSEMINATION: Full approval was given by the University of Warwick Biomedical and Research Ethics Committee (BSREC 45/20-21). The current protocol version is 2.9_Dec21. Publication of results will inform the scientific, clinical and business communities through peer-reviewed articles, webinars, conferences and newsletters. TRIAL REGISTRATION NUMBER: ISRCTN13596153.
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Terapia Cognitivo-Comportamental , Regulação Emocional , Distúrbios do Início e da Manutenção do Sono , Terapia Cognitivo-Comportamental/métodos , Humanos , Qualidade de Vida , Ensaios Clínicos Controlados Aleatórios como Assunto , Sono , Distúrbios do Início e da Manutenção do Sono/terapia , Resultado do Tratamento , Local de TrabalhoRESUMO
Mental ill-health is the leading cause of sickness absence, creating a high economic burden. Workplace interventions aimed at supporting employers in the prevention of mental ill-health in the workforce are urgently required. Managing Minds at Work is a digital intervention aimed at supporting line managers in promoting better mental health at work through a preventative approach. This intervention was developed as part of the Mental Health and Productivity Pilot, a wider initiative aimed at supporting employers across the Midlands region of the United Kingdom to improve the future of workplace mental health and wellbeing. The aim of the study is to describe the design and development of the Managing Minds at Work digital training program, prior to feasibility testing. We adopted a collaborative participatory design involving co-design (users as partners) and principles of user-centred design (pilot and usability testing). An agile methodology was used to co-create intervention content with a stakeholder virtual community of practice. Development processes were mapped to core elements of the Medical Research Council (MRC) framework for developing and evaluating complex interventions. The program covers five broad areas: (i) promoting self-care techniques among line managers; (ii) designing work to prevent work-related stress; (iii) management competencies to prevent and reduce stress; (iv) having conversations with employees about mental health; (v) building a psychologically safe work environment. It was considered by stakeholders to be appropriate for any type of organization, irrespective of their size or resources. Pilot and usability testing (n = 37 surveys) aligned with the Technology Acceptance Model (TAM) demonstrated that the program was perceived to be useful, relevant, and easy to use by managers across sectors, organization types, and sizes. We identified positive impacts on manager attitudes and behavioral intentions related to preventing mental ill-health and promoting good mental wellbeing at work. The next step is to explore the feasibility and acceptability of Managing Minds at Work with line managers in diverse employment settings.
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Saúde Mental , Local de Trabalho , Humanos , Organizações , Autocuidado , Inquéritos e Questionários , Local de Trabalho/psicologiaRESUMO
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).
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BACKGROUND AND AIM: Coronavirus disease 2019 (COVID-19) is an acute infectious respiratory disease caused by severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) and has spread rapidly globally, resulting in a pandemic. In humans, the main routes of transmission are respiratory droplets and close contact with infected individuals or through contact with an object infected with the virus, followed by touching mouth, nose, or eyes. It is assumed that SARS-CoV-2 was originated in wild animals and was then transmitted to humans. Although some wildlife and domestic animals can be naturally or experimentally infected with the virus, the intermediate hosts that transmitted it to humans are still unknown. Understanding the dynamics of SARS-CoV-2 associated with possible zoonotic transmission of intermediate hosts is considered critical. Reportedly, cats or dogs living with COVID-19-positive humans tested positive for the disease, suggesting that the virus was transmitted to the animals from humans. Information regarding the epidemiological investigation and comprehensive studies is limited. Therefore, it is still unclear how high is the correlation of infection in humans and pet animals, especially those living together. The aim of this study was to investigate the possibility of SARS-CoV-2 infection in the pets of patients with COVID-19 who were hospitalized at the Wangaya hospital, Denpasar, Bali, Indonesia. MATERIALS AND METHODS: A total of seven clinically asymptomatic pets (six dogs of different races and sexes and a cat [age, 360-2920 days]) were included in this study. These animals belonged to patients with confirmed SARS-CoV-2 infection from August to November 2020. Nasal swab and nasopharyngeal samples were collected from the pets individually under anesthetic condition and were collected 6-12 days after confirmed SARS-CoV-2 infection in owners and hospitalization at the Wangaya Hospital. The swab samples were then processed for RNA isolation and tested using reverse transcription-polymerase chain reaction (RT-PCR) for SARS-CoV-2, in accordance with the World Health Organization manual 2020. RESULTS: RT-PCR results for all seven RNA samples, prepared from the swab samples, were negative. For the samples, all PCR products were below the threshold limit, suggesting no genetic material belonging to the samples tested. CONCLUSION: This was the first preliminary study of COVID-19 on pets in pandemic using RT-PCR. The study tested a very limited quantity of samples, and all of them were negative. However, the way in which the samples were prepared was considered appropriate. Therefore, in further studies, testing of more samples of pets of more individuals with confirmed SARS-CoV-2 infection is required.
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AIM: To consider findings from a study that evaluated case management of individuals with long-term conditions (LTCs) by a community matron (CM) service. The paper highlights issues related to the implementation of a new role and the impact this had on the experience of care across hospital and community settings for patients and their carers. BACKGROUND: The introduction of the role of CM was intended to increase effective management of patients with complex comorbid LTCs through the introduction of case management, thereby reducing unplanned hospital admissions. METHODS: The overall methodological approach was one of mixed methods. This paper reports the qualitative findings from CMs (n = 15); patients (n = 13); family carers (n = 8); and secondary care staff who interface with the CM service (n = 7). Data were collected between October 2009 and May 2010. FINDINGS: A thematic analysis resulted in the identification of four themes: (1) visibility; (2) interpersonal relationships; (3) leadership; and (4) systems/professional boundaries. Patients enjoyed being seen as a whole and family carers appreciated the coordination aspect of the role. Difficulties arose from the limited understanding of the CM role and from a lack of a shared vision across healthcare professionals concerning the role and its goals.