Mental Health Promotion and Intervention in Occupational Settings: Protocol for a Pilot Study of the MENTUPP Intervention

Depression and anxiety are the most prevalent mental health difficulties in the EU, causing immense suffering and costing the global economy EUR 1 trillion each year in lost productivity. Employees in construction, health and information and communications technology have an elevated risk of mental health difficulties. Most mental health interventions for the workplace have been targeted at larger companies and small and medium-sized enterprises (SMEs) are often overlooked despite most people being employed in SMEs. The MENTUPP intervention aims to improve mental health and wellbeing and reduce depression, anxiety, and suicidal behaviour. The MENTUPP project involves the development, implementation, and evaluation of a multilevel intervention targeting both clinical and non-clinical mental health issues and combating the stigma of mental (ill-)health, with a specific focus on SMEs. The intervention is underpinned by a framework of how to create a mentally healthy workplace by employing an integrated approach and has been informed by several systematic reviews designed to understand organisational mental health interventions and a consultation survey with key experts in the area. The intervention is facilitated through the MENTUPP Hub, an online platform that presents interactive psychoeducational materials, toolkits, and links to additional resources in an accessible and user-friendly manner. This paper presents the pilot study protocol for delivering the MENTUPP intervention in eight European countries and Australia. Each intervention country will aim to recruit at least 23 participants in 1–3 SMEs in one of the three high-risk sectors. The central aim of the pilot study will be to examine the feasibility, acceptability, and uptake of the MENTUPP intervention across the target SMEs. The findings will contribute to devising the protocol for a cluster randomised controlled trial (cRCT) of the MENTUPP intervention. Findings from this study will also be used to inform the optimisation phase of the MENTUPP intervention which will aim to improve the materials and the implementation of the intervention as well as enhancing the evaluation strategy which will be employed for the cRCT.

Minimising Young Children’s Anxiety through Schools (MY-CATS): Protocol for a Cluster Randomised Controlled Trial to Evaluate the Effectiveness and Cost-effectiveness of an Online Parent-led Intervention Compared With Usual School Practice for Young Children Identified as at-risk for Anxiety Disorders

BackgroundIdentifying and supporting young children who are at-risk of developing anxiety disorders would benefit children, families, and wider society. Elevated anxiety symptoms, inhibited temperament, and high parental anxiety are established risk factors for later anxiety disorders, but it remains unclear who is most likely to benefit from prevention and early intervention programmes. Delivering an online intervention through schools to parents of young children who have one or more of these risks could maximise reach.The primary aim of this trial is to evaluate the effectiveness and cost-effectiveness of delivering an online parent-led intervention, compared with usual school provision only, for children (aged 4-7) identified as at-risk for anxiety disorders on the basis of at least one risk factor. We also aim to identify the characteristics of children who do and do not benefit from intervention and mechanisms of change from the intervention.MethodsThe design will be a parallel group, superiority cluster randomised controlled trial, with schools (clusters) randomised to intervention or usual school practice arms in a 1:1 ratio stratified according to level of deprivation within the school. The study will recruit and randomise at least 60 primary/infant schools in England, and on the basis of recruiting 60 schools, we will recruit 1080 trial participants (540 per arm). Parents of all children (aged 4-7) in sampled Reception, Year 1, and Year 2 classes will be invited to complete screening questionnaires. Children who screen positive on the basis of anxiety symptoms, and/or behavioural inhibition, and/or parent anxiety symptoms will be eligible for the trial. Parents/carers of children in schools allocated to the intervention arm will be offered a brief online intervention; schools in both arms will continue to provide any usual support for children and parents throughout the trial. Assessments will be completed at: screening, baseline (before randomisation), 6-weeks, 12-weeks, and 12-months post randomisation. The primary outcome will be the absence/presence of an anxiety disorder diagnosis at 12-months. DiscussionThe trial will determine if delivering an online intervention for parents of young children at-risk of anxiety disorders identified through screening in schools is effective and cost-effective. Trial registration: ISRCTN 82398107. Prospectively registered on 14.1.2021. https://www.isrctn.com/ISRCTN82398107

The feasibility and acceptability of a classroom-based physical activity program for children attending specialist schools: a mixed-methods pilot study

Background Children with disabilities often engage in less than the recommended amount of daily physical activity (PA). Classroom-based PA breaks are a favourable method of promoting PA for children. However, evaluations of these programs in specialist schools are scarce, with even less research into their feasibility and acceptability. This may hinder effective implementation and program scalability. This pilot study investigated the feasibility and acceptability of implementing a classroom-based PA break program in Australian specialist school classrooms, using the Australian Joy of Moving (AJoM) program. Methods Forty primary/junior classes and their teachers across five specialist schools implemented the AJoM program for eight weeks as the intervention group within a pilot cluster randomised controlled trial. A mixed-methods design investigated classroom teachers’ (N = 22; 6 males, 16 females) perspectives of the feasibility and acceptability of the program after implementation through semi-structured telephone interviews (n = 7 teachers), qualitative survey responses (n = 18 teachers) and quantitative survey items (n = 19 teachers). Qualitative data were analysed using predominantly deductive thematic analysis. Quantitative data were analysed using descriptive statistics. Results Classroom-based PA breaks may be feasible for getting children with disabilities more active at school. However, considerable variation exists in teachers’ perception of the AJoM experience. While several teachers indicate that the program content could be pertinent for their class, common divergences in perceptions of feasibility and acceptability appear to relate to the age and developmental level or needs of the students in the class. Conclusions This study provides preliminary evidence for the feasibility and acceptability of implementing classroom-based PA breaks in specialist schools. However, results demonstrate the importance of (1) allowing a high level of flexibility in the design and implementation of programs to meet the varying needs of class groups and (2) providing a large variety of resources to cater to the heterogeneity of the children. Trial registration This trial was prospectively registered with the Australian New Zealand Clinical Trials Registry (ACTRN12619000193178) on 11 February 2019.

GP-delivered medication review of polypharmacy, deprescribing, and patient priorities in older people with multimorbidity in Irish primary care (SPPiRE Study): A cluster randomised controlled trial

Background There is a rising prevalence of multimorbidity, particularly in older patients, and a need for evidence-based medicines management interventions for this population. The Supporting Prescribing in Older Adults with Multimorbidity in Irish Primary Care (SPPiRE) trial aimed to investigate the effect of a general practitioner (GP)-delivered, individualised medication review in reducing polypharmacy and potentially inappropriate prescriptions (PIPs) in community-dwelling older patients with multimorbidity in primary care. Methods and findings We conducted a cluster randomised controlled trial (RCT) set in 51 GP practices throughout the Republic of Ireland. A total of 404 patients, aged ≥65 years with complex multimorbidity, defined as being prescribed ≥15 regular medicines, were recruited from April 2017 and followed up until October 2020. Furthermore, 26 intervention GP practices received access to the SPPiRE website where they completed an educational module and used a template for an individualised patient medication review that identified PIP, opportunities for deprescribing, and patient priorities for care. A total of 25 control GP practices delivered usual care. An independent blinded pharmacist assessed primary outcome measures that were the number of medicines and the proportion of patients with any PIP (from a predefined list of 34 indicators based predominantly on the STOPP/START version 2 criteria). We performed an intention-to-treat analysis using multilevel modelling. Recruited participants had substantial disease and treatment burden at baseline with a mean of 17.37 (standard deviation [SD] 3.50) medicines. At 6-month follow-up, both intervention and control groups had reductions in the numbers of medicines with a small but significantly greater reduction in the intervention group (incidence rate ratio [IRR] 0.95, 95% confidence interval [CI]: 0.899 to 0.999, p = 0.045). There was no significant effect on the odds of having at least 1 PIP in the intervention versus control group (odds ratio [OR] 0.39, 95% CI: 0.140 to 1.064, p = 0.066). Adverse events recorded included mortality, emergency department (ED) presentations, and adverse drug withdrawal events (ADWEs), and there was no evidence of harm. Less than 2% of drug withdrawals in the intervention group led to a reported ADWE. Due to the inability to electronically extract data, primary outcomes were measured at just 2 time points, and this is the main limitation of this work. Conclusions The SPPiRE intervention resulted in a small but significant reduction in the number of medicines but no evidence of a clear effect on PIP. This reduction in significant polypharmacy may have more of an impact at a population rather than individual patient level. Trial registration ISRCTN Registry ISRCTN12752680.

Effectiveness of two tobacco cessation methods among TB patients

BACKGROUND: Tobacco and TB are the world´s two greatest public health problems. Exposure to tobacco has been shown to be associated with higher risk of acquiring TB and adverse outcomes such as relapse and TB mortality.OBJECTIVE: To assess and compare self-reported tobacco quit status and biochemically verified cotinine levels among TB patients at different time intervals among two study groups.METHODS: A cluster, randomised controlled trial was conducted on TB patients attending DOTS centres in Delhi, India, who reported using tobacco in any form. Participants were assigned into one of two treatment groups. Centres were randomly assigned to two intervention groups: 1) integrated intervention using behavioural counselling with nicotine replacement therapy (NRT) gum, and 2) intervention using behavioural counselling alone (50 each in intervention and control group). The subjects were followed at Week 1, Month 1, Month 3 and Month 6 for tobacco cessation.RESULTS: At the end of 6 months, patients who received the integrated intervention had significantly higher rate of success in quitting tobacco than those who received the conventional TB treatment alone (78.7% vs. 57.8%; P < 0.03).CONCLUSION: DOTS with tobacco use dependence treatment was successful in our study in helping TB patients to quit tobacco dependence and should therefore be offered to every tobacco user.

Cluster randomised controlled trial to assess a tailored intervention to reduce antibiotic prescribing in rural China: study protocol

IntroductionUp to 80% of patients with respiratory tract infections (RTI) attending healthcare facilities in rural areas of China are prescribed antibiotics, many of which are unnecessary. Since 2009, China has implemented several policies to try to reduce inappropriate antibiotic use; however, antibiotic prescribing remains high in rural health facilities.Methods and analysisA cluster randomised controlled trial will be carried out to estimate the effectiveness and cost effectiveness of a complex intervention in reducing antibiotic prescribing at township health centres in Anhui Province, China. 40 Township health centres will be randomised at a 1:1 ratio to the intervention or usual care arms. In the intervention group, practitioners will receive an intervention comprising: (1) training to support appropriate antibiotic prescribing for RTI, (2) a computer-based treatment decision support system, (3) virtual peer support, (4) a leaflet for patients and (5) a letter of commitment to optimise antibiotic use to display in their clinic. The primary outcome is the percentage of antibiotics (intravenous and oral) prescribed for RTI patients. Secondary outcomes include patient symptom severity and duration, recovery status, satisfaction, antibiotic consumption. A full economic evaluation will be conducted within the trial period. Costs and savings for both clinics and patients will be considered and quality of life will be measured by EuroQoL (EQ-5D-5L). A qualitative process evaluation will explore practitioner and patient views and experiences of trial processes, intervention fidelity and acceptability, and barriers and facilitators to implementation.Ethics and disseminationEthical approval was obtained from the Biomedical Research Ethics Committee of Anhui Medical University (Ref: 20180259); the study has undergone due diligence checks and is registered at the University of Bristol (Ref: 2020-3137). Research findings will be disseminated to stakeholders through conferences and peer-reviewed journals in China, the UK and internationally.Trial registration numberISRCTN30652037.