• Grieving a disrupted biography: an interpretative phenomenological analysis exploring barriers to the use of mindfulness after neurological injury or impairment

      Finlay, K. A.; Hearn, J.H.; Chater, Angel M.; University of Reading; Manchester Metropolitan University; University of Bedfordshire (Biomed Central, 2021-08-24)
      Mindfulness has demonstrated strong utility for enhancing self-management and health outcomes in chronic illness. However, sensation-focused mindfulness techniques may not be appropriate for clinical populations with neurological injury. This study aimed to identify how expert mindfulness teachers with sensory loss/impairment naturalistically adapt and experience mindfulness. We aimed to highlight the rationale for and barriers to mindfulness practice when living with sensory loss. A qualitative, semi-structured interview design was used, analysed via Interpretative Phenomenological Analysis (IPA). Eight (5 females, 3 males) mindfulness teachers with neurological injury were recruited via a national registry of Mindfulness for Health teachers. Interviews (range: 50-93 min) were completed, transcribed verbatim and analysed idiographically for descriptive, linguistic and conceptual themes, before a cross-case analysis was completed. Two superordinate themes were identified: (1) Overcoming a disrupted biography; and (2) Proactive self-management. These themes considered the challenge of reconciling, through grief, a past health status with the present reality of living with sensory loss due to Spinal Cord Injury, Multiple Sclerosis or Functional Neurological Disorder. Mindfulness was experienced as a method by which proactive choices could be made to maintain control and autonomy in health, reducing perceptions of suffering, psychological distress, cognitive reactivity and rumination. Mindfulness was found to support the self-management of health after neurological injury/impairment. Mindfulness meditation presented an initial challenge as trauma and grief processes were (re-)activated during mindfulness sessions. However, mindfulness was found to support the resolution of these grief processes and encourage adaptive approach-based coping and acceptance of health and neurological impairment/injury.
    • Factors that facilitate or hinder whole system integrated care for obesity and mental health: a scoping review protocol

      Liapi, Fani; Chater, Angel M.; Randhawa, Gurch; Pappas, Yannis; University of Bedfordshire (BMJ, 2021-08-10)
      Integrated care aims to improve population health. Obesity and mental health are major health issues worldwide. The complexity of the multifactorial drivers of these public health problems has led to the adoption of a whole system approach. This review aims to highlight factors that influence the planning, implementation and evaluation of whole system integrated care for these conditions. Using the framework of Arksey and O' Malley, we will perform a comprehensive search in the following databases: MEDLINE, CINAHL, PsychINFO, PubMed, British Nursing Database, Web of Science, Health Systems Evidence, Cochrane Library and University of York Centre for Reviews and Dissemination. Further hand-search of reference lists and the grey literature will be conducted. The search will be restricted to articles published from 2000 to 2020. The review is expected to be completed by August 2021. Full texts of the potential studies will be screened for the inclusion criteria. Quality of studies will be appraised. Narrative synthesis will be completed using data extracted from the included studies. A favourable ethics opinion for this study was obtained from the Institute for Health Research Ethics Committee of the University of Bedfordshire (IHREC937). This review expects to identify information relating to factors that facilitate or hinder whole system integrated care for obesity and mental health. The finding from this review will be widely disseminated to stakeholders to inform implementation of whole system integrated care initiatives.
    • Understanding the disproportionate effects of COVID-19 on nurses from ethnic minority backgrounds

      Qureshi, Irtiza; Garcia, Rebecca; Ali, Nasreen; Randhawa, Gurch; University of Bedfordshire; Open University (RCN Publishing, 2021-07-12)
      People from ethnic minority backgrounds in the UK have been disproportionately affected by coronavirus disease 2019 (COVID-19), with higher death rates and suboptimal health outcomes compared with those from white ethnic backgrounds. This trend is reflected in healthcare staff from ethnic minority backgrounds, including nurses, who are disproportionately affected by COVID-19 and have higher death rates from the disease. The theory of intersectionality contends that social categorisations such as gender, race and class can contribute to discrimination and result in disadvantages. In this article, the authors outline several intersecting factors that could be contributing to the disproportionate effects of COVID-19 among nurses from ethnic minority backgrounds, as well as making recommendations for further research in this area.
    • Gestational diabetes mellitus (GDM) and adverse pregnancy outcome in South Asia: a systematic review

      Mistry, Sabuj Kanti; Das Gupta, Rajat; Alam, Sabiha; Kaur, Kuljeet; Shamim, Abu Ahmed; Puthussery, Shuby; BRAC University, Dhaka; University of New South Wales; University of Dhaka; University of Bedfordshire (Wiley, 2021-07-03)
      Introduction The prevalence of gestational diabetes mellitus (GDM) is increasing in developing countries including the South Asian Nations. The current study aimed to examine the association of GDM with adverse pregnancy outcomes from foetal and maternal perspectives in South Asia. Methods A systematic review was conducted including primary studies published since January 2020 from South Asian countries. Following electronic databases were searched to locate the articles: MEDLINE, EMBASE and EMCARE. Data were extracted using a customized extraction tool and methodological quality of the included studies was assessed using modified Effective Public Health Practice Project (EPHPP) quality assessment tool. Narrative synthesis was performed as statistical pooling was not possible due to the heterogeneous nature of the studies. Results Eight studies were included in the review. Overall, the review found a positive correlation between GDM and adverse foetal outcomes such as macrosomia, neonatal hyperglycaemia, intrauterine growth retardation (IUGR), stillbirths and low birthweight (LBW), but the findings were not conclusive. GDM was also positively associated with preeclampsia but the association between GDM and C-section delivery was not conclusive. Conclusion Policymakers, public health practitioners and researchers in South Asia should take in to account the link between GDM and adverse pregnancy outcomes while designing interventions to promote maternal health in South Asia. Researchers should focus on conducting longitudinal studies in future to clearly understand the epidemiology and pathobiology of this issue.
    • Refugee and immigrant community health champions: a qualitative study of perceived barriers to service access and utilisation of the National Health Service (NHS) in the West Midlands, UK

      Mudyarabikwa, Oliver; Regmi, Krishna; Ouillon, Sinead; Simmonds, Raymond; Coventry University; University of Bedfordshire; MiFriendly Cities Refugee and Migrant Centre, Coventry (Springer, 2021-06-18)
      There has been much discussion recently that better healthcare systems lead to increased service access and utilisation. However, there are still concerns raised among the refugee and immigrant communities about barriers to access and utilisation of primary healthcare services in the UK. This study aimed to explore with refugee and immigrant community health champions (CHCs) their perceptions about such barriers based on feedback in their own discussions with fellow refugees, asylum-seekers and immigrants in the West Midlands, UK. A total of 42 refugees and immigrants were recruited. Qualitative design-focused group discussions were conducted among purposively selected participants. These discussions were conducted between May and September 2019, and data were analysed using thematic analysis. The barriers to service access and utilisation are categorised into four themes: (i) knowledge about health issues that most affected refugees and immigrants; (ii) community indications of factors that obstructed service access; (iii) challenges in identifying local teams involved in service provision; and (iv) accurate knowledge about the different teams and their roles in facilitating access. This study highlighted that the levels of service access and utilisation would depend on the competence and effectiveness of the health system. Urgency and seriousness of individuals’ healthcare needs were the factors that were perceived to strongly influence refugees and immigrants to seek and utilise local services. We identified a number of potential barriers and challenges to service access and utilisation that should be overcome if primary healthcare service is to be planned and delivered effectively, efficiently and equitably in the West Midlands.
    • Understanding failings in patient safety: lessons from the case of surgeon Ian Paterson

      Milligan, Frank; University of Bedfordshire (RCN Publishing, 2021-06-01)
      While rare, incidents of inappropriate and/or unnecessary surgery do occur, so effective surveillance of surgical practice is required to ensure patient safety. This article explores the case of Ian Paterson, a consultant surgeon who was sentenced to 20 years in prison in 2017 for wounding with intent and unlawful wounding, primarily by undertaking inappropriate or unnecessary mastectomies. The article details the main points of the Paterson case, with reference to the subsequent government-commissioned inquiry and its recommendations. It also outlines various strategies for enhancing patient safety, including applying human factors theory, improving auditing, and rationalising NHS and private healthcare. The author concludes that nurses have a crucial role in the surveillance of surgical practice and that combined reporting of surgeons' practice across NHS and private healthcare organisations is required.
    • Cognitive impairment and treatment outcomes among people attending an alcohol intervention service for those aged 50+

      Seddon, Jennifer L.; Wadd, Sarah; Madoc-Jones, Iolo; Elliott, Lawrie; University of Bedfordshire; Glasgow Caledonian University; Wrexham Glyndwr University (Emerald, 2021-05-28)
      Purpose: No studies have evaluated the relationship between cognitive impairment and alcohol treatment outcomes among older drinkers. This study sought to explore the extent of cognitive impairment among older adults seeking alcohol treatment, and examine the relationship between cognitive impairment, treatment retention and alcohol use following treatment. Design/ methodology/ approach: The study used data from the Drink Wise Age Well programme; an alcohol intervention service for older adults (aged 50+). The Montreal Cognitive Assessment (MoCA) was used to screen for cognitive impairment; alcohol use was assessed using the Alcohol Use Disorders Identification Test (AUDIT). Findings: 531 participants completed assessment at treatment entry. Over half the sample were male (57%), with a mean age of 60 years (SD: 7.09). Almost half (48.4%) had cognitive impairment at entry to treatment: 51.6% had normal cognitive function, 41.4% had mild cognitive impairment, 5.8% had moderate cognitive impairment and 1.1% had severe cognitive impairment. Cognitive impairment was not associated with increased treatment drop-out and was not predictive of alcohol use following treatment. Alcohol treatment was associated with a significant improvement in cognitive functioning. Originality/ value: This study suggests there may be a significant amount of unidentified cognitive impairment among older adults attending alcohol treatment. Assessment and routine screening for cognitive impairment in drug and alcohol services may help in care planning and setting treatment goals; in the absence of routine screening opportunities for treatment planning and intervention may be missed.
    • The CARESSES randomised controlled trial: exploring the health-related impact of culturally competent artificial intelligence embedded into socially assistive robots and tested in oder adult care homes

      Papadopoulos, Chris; Castro, Nina; Nigath, Abiha; Davidson, Rosemary; Faulkes, Nicholas; Menicatti, Roberto; Khaliq, Ali Abdul; Recchiuto, Carmine Tommaso; Battistuzzi, Linda; Randhawa, Gurch; et al. (Springer, 2021-04-23)
      This trial represents the final stage of the CARESSES project which aimed to develop and evaluate a culturally competent artificial intelligent system embedded into social robots to support older adult wellbeing. A parallel group, single-blind randomised controlled trial was conducted across older adult care homes in England and Japan. Participants randomly allocated to the Experimental Group or Control Group 1 received a Pepper robot for up 18 h across 2 weeks. Two versions of the CARESSES artificial intelligence were tested: a fully culturally competent system (Experimental Group) and a more limited version (Control Group 1). Control Group 2 (Care As Usual) participants did not receive a robot. Quantitative outcomes of interest reported in the current paper were health-related quality of life (SF-36), loneliness (ULS-8), and perceptions of robotic cultural competence (CCATool-Robotics). Thirty-three residents completed all procedures. The difference in SF-36 Emotional Wellbeing scores between Experimental Group and Care As Usual participants over time was significant (F[1] = 6.614, sig = .019, ηp2 = .258), as was the comparison between Any Robot used and Care As Usual (F[1] = 5.128, sig = .031, ηp2 = .146). There were no significant changes in SF-36 physical health subscales. ULS-8 loneliness scores slightly improved among Experimental and Control Group 1 participants compared to Care As Usual participants, but this was not significant. This study brings new evidence which cautiously supports the value of culturally competent socially assistive robots in improving the psychological wellbeing of older adults residing in care settings.
    • Factors associated with the implementation of non-pharmaceutical interventions for reducing coronavirus disease 2019 (COVID-19): a systematic review

      Regmi, Krishna; Lwin, Cho Mar; University of Bedfordshire; University of Dundee; University of Medicine Mandalay (MDPI, 2021-04-17)
      There has been much discussion recently about the importance of implementing nonpharmaceutical interventions (NPIs) to protect the public from coronavirus disease 2019 (COVID19) infection. Different governments across the world have adopted NPIs (e.g., social distancing, quarantine, isolation, lockdowns, curfews, travel restrictions, closures of schools and colleges). Two fundamental strategies, namely a strict containment strategy—also called suppression strategy— and a mitigation strategy have been adopted in different countries, mainly to reduce the reproduction number (R) to below one and hence to reduce case numbers to low levels or eliminate humanto-human transmission, as well as to use NPIs to interrupt transmission completely and to reduce the health impact of epidemics, respectively. However, the adoption of these NPI strategies is varied and the factors impacting NPI are inconsistent and unclear. This study, therefore, aimed to review the factors associated with the implementation of NPIs (social distancing, social isolation and quarantine) for reducing COVID-19. Following PRISMA guidelines, we searched for published and unpublished studies, undertaking a systematic search of: MEDLINE, EMBASE, Allied and Complementary Medicine, COVID-19 Research, WHO database on COVID-19, and Google Scholar. Thirtythree studies were included in the study. Seven descriptive themes emerged on enablers and barriers to NPIs: the positive impact of NPIs, effective public health interventions, positive change in people’s behaviour and concerns about COVID-19, the role of mass media, physical and psychological impacts, and ethnicity/age associated with COVID-19. This study has highlighted that the effectiveness of NPIs in isolation is likely to be limited, therefore, a combination of multiple measures e.g., SD, isolation and quarantine, and workplace distancing appeared more effective in reducing COVID-19. Studies suggest that targeted approaches alongside social distancing might be the way forward, and more acceptable. Further research to promote country- and context-specific adoption of NPIs to deliver public health measures is needed. Studies comparing the effectiveness of interventions and strategies will help provide more evidence for future pandemics.
    • Overcoming hurdles to intervention studies with autistic children with profound communication difficulties and their families

      McKinney, Ailbhe; Weisblatt, Emma J.L.; Hotson, Kathryn L.; Ahmed, Zahra Bilal; Dias, Claudia; BenShalom, Dorit; Foster, Juliet; Murphy, Suzanne; Villar, Sofia S.; Belmonte, Matthew K.; et al. (Sage, 2021-04-07)
      Autistic children and adults who are non-verbal/minimally verbal or have an intellectual disability have often been excluded from Autism Spectrum Disorder research. Historical, practical and theoretical reasons for this exclusion continue to deter some researchers from work with this underserved population. We discuss why these reasons are neither convincing nor ethical, and provide strategies for dealing with practical issues. As part of a randomised controlled trial of an intervention for children with profound autism, we reflected as a multi-disciplinary team on what we had learnt from these children, their families and each other. We provide 10 strategies to overcome what appeared initially to be barriers to collecting data with this population. These hurdles and our solutions are organised by theme: interacting physically with children, how to play and test, navigating difficult behaviours, selecting suitable outcome measures, relating with parents, managing siblings, involving stakeholders, timing interactions, the clinician’s role in managing expectations, and recruitment. The aim of this article is to provide researchers with the tools to feel motivated to conduct research with children with profound autism and their families, a difficult but worthwhile endeavour. Many of these lessons also apply to conducting research with non-autistic children with intellectual disabilities.
    • Improving support for breastfeeding mothers: a qualitative study on the experiences of breastfeeding among mothers who reside in a deprived and culturally diverse community

      Cook, Erica Jane; Powell, Faye; Ali, Nasreen; Penn-Jones, Catrin Pedder; Ochieng, Bertha; Randhawa, Gurch; ; University of Bedfordshire; De Montfort University (BMC, 2021-04-06)
      The United Kingdom has one of the lowest breastfeeding rates in Europe, with the initiation and continuation of breastfeeding shown to be closely related to the mothers' age, ethnicity and social class. Whilst the barriers that influence a woman's decision to breastfeed are well documented, less is known how these barriers vary by the UK's diverse population. As such, this study aimed to explore mothers' experiences of breastfeeding and accessing breastfeeding services offered locally amongst a deprived and culturally diverse community. A qualitative interpretive study comprising of 63 mothers (white British n = 8, Pakistani n = 13, Bangladeshi n = 10, black African n = 15 and Polish n = 17) who took part in single-sex focus groups, conducted in local community centres across the most deprived and ethnically diverse wards in Luton, UK. The focus groups were audio-recorded, transcribed and analysed thematically using Framework Analysis. The most common barriers to breastfeeding irrespective of ethnicity were perceptions surrounding pain and lack of milk. Confidence and motivation were found to be crucial facilitators of breastfeeding; whereby mothers felt that interventions should seek to reassure and support mothers not only during the early stages but throughout the breastfeeding journey. Mothers particularly valued the practical support provided by health care professions particularly surrounding positioning and attachment techniques. However, many mothers felt that the support from health care professionals was not always followed through. The findings presented inform important recommendations for the design and implementation of future programs and interventions targeted at reducing breastfeeding inequalities. Interventions should focus on providing mothers practical support and reassurance not only during the early stages but throughout their breastfeeding journey. The findings also highlight the need for tailoring services to support diverse communities which acknowledge different traditional and familial practices.
    • The impact of COVID-19 on health behaviour, well-being, and long-term physical health.

      McBride, Emily; Arden, Madelynne A.; Chater, Angel M.; Chilcot, Joseph; ; University College London; Sheffield Hallam University; University of Bedfordshire; King's College London (Wiley, 2021-03-31)
      Editorial
    • Addressing the needs of older adults receiving alcohol treatment during the Covid-19 pandemic: a qualitative study

      Seddon, Jennifer L.; Trevena, Paulina; Wadd, Sarah; Elliott, Lawrie; Dutton, Maureen; McCann, Michelle; Willmott, Sarah; University of Bedfordshire; Glasgow Caledonian University (Taylor and Francis, 2021-03-22)
      Background: The Covid-19 global pandemic resulted in major changes to the provision of alcohol treatment in the UK, these changes coincided with increases in the use of alcohol. This study sought to understand the impact of the pandemic on older adults in alcohol treatment, and to explore how changes in the provision of alcohol treatment were experienced. Method: Semi-structured interviews were completed with older adults (aged 55+) in alcohol treatment, as well as alcohol practitioners providing support to older adults. Data were analysed using thematic analysis. Alcohol use was assessed using the Alcohol Use Disorders Identification Test – Consumption (AUDIT-C). Results: Thirty older adults in alcohol treatment and fifteen alcohol practitioners were recruited. The Covid-19 pandemic was found to result in both increases and decreases in alcohol use; changes in alcohol use depended on a number of factors, such as living arrangements, family support, physical and mental health. Many alcohol treatment services moved to a model of remote support during the pandemic. However, face-to-face service provision was considered to be essential by both older adults in alcohol treatment and alcohol practitioners. Engagement with online support was low, with older adults facing barriers in using online technology. Conclusion: The study highlights the importance of face-to-face treatment and intervention for older adults in alcohol treatment. Addiction services may see increased demand for treatment as a result of the pandemic; it is important that services consider the needs of older adults, many of whom may be marginalised by a remote model of service provision.
    • Understanding physician behaviour in the 6-8 weeks hip check in primary care: a qualitative study using the COM-B

      Chater, Angel M.; Milton, Sarah; Green, Judith; Gilworth, Gill; Roposch, Andreas; ; University of Bedfordshire; King's College London; University College London; Great Ormond Street Hospital for Children (BMJ Publishing Group, 2021-03-19)
      A compulsory hip check is performed on an infant at 6-8 weeks in primary care for the detection of developmental dysplasia of the hip (DDH). Missed diagnoses and infants incorrectly labelled with DDH remain an important problem. The nature of physician behaviour as a likely source of this problem has not been explored. The aims of this study were to make a behavioural diagnosis of general practitioners (GPs) who perform these hip checks, and identify potential behavioural change techniques that could make the hip checks more effective. Qualitative study with in-depth semistructured interviews of 6-8 weeks checks. We used the Capability, Opportunity, Motivation and Behaviour model in making a behavioural diagnosis and elicited factors that can be linked to improving the assessment. Primary care. 17 GPs (15 female) who had between 5 and 34 years of work experience were interviewed. Capability related to knowledge of evidence-based criteria and skill to identify DDH were important behavioural factors. Both physical (clinic time and space) and social (practice norms), opportunity were essential for optimal behaviour. Furthermore, motivation related to the importance of the 6-8 weeks check and confidence to perform the check and refer appropriately were identified in the behavioural diagnosis. Aspects of capability, opportunity and motivation affect GPs' diagnosis and referral behaviours in relation to DDH. The findings from this work extend current knowledge and will inform the development of an intervention aimed at improving the diagnosis of DDH.
    • A randomised-controlled feasibility study of the REgulate your SItting Time (RESIT) intervention for reducing sitting time in individuals with type 2 diabetes: study protocol

      Bailey, Daniel Paul; Edwardson, Charlotte L.; Pappas, Yannis; Dong, Feng; Hewson, David; Biddle, Stuart J. H.; Brierley, Marsha L.; Chater, Angel M. (BMC, 2021-03-19)
      People with type 2 diabetes mellitus (T2DM) generally spend a large amount of time sitting. This increases their risk of cardiovascular disease, premature mortality, diabetes-related complications and mental health problems. There is a paucity of research that has evaluated interventions aimed at reducing and breaking up sitting in people with T2DM. The primary aim of this study is to assess the feasibility of delivering and evaluating a tailored intervention to reduce and break up sitting in ambulatory adults with T2DM.
    • Exploring how newly qualified dentists perceive certain legal and ethical issues in view of the GDC standards

      Thakrar, Bindiya; Wassif, Hoda; Denchic Dental Spa; University of Bedfordshire (Springer Nature, 2021-03-11)
      Introduction This study focuses on how the legal and ethical requirements presented by the General Dental Council (GDC) in their Standards for the dental team (2013) document are perceived by newly qualified dentists; that is, those who have been qualified for less than five years.Aim The aim of the study was to investigate how the GDC guidance and the set standards for the dental team are perceived and understood by newly qualified dental practitioners, and how the guidance and the standards influence clinicians' decision-making. The study explored the newly qualified dentists' exposure to law and ethics, the GDC and their regulatory document, together with the clinical and non-clinical influence of this regulation on daily practice.Methods Empirical qualitative data were collected using semi-structured interviews of nine newly qualified dentists, with an average of 80 minutes for each interview. The data were analysed using thematic analysis.Results Three main themes were identified through the newly qualified dentists' perceptions of the GDC selected standards. These included sense of fear, morale and the business of dental practice, with further subthemes identified.Conclusion Results from this study present an opportunity and a challenge, as there is some fear and uncertainty among newly qualified dentists about the application of some of the GDC standards in practice. Further training in law and ethics as well as additional support for newly qualified dental practitioners is needed.
    • Effect of e-learning on health sciences education: a protocol for systematic review and meta-analysis

      Regmi, Krishna; Jones, Linda; University of Bedfordshire; University of Dundee (Routledge, 2021-02-24)
      E-learning has been widely used in higher education as it provides better access to learning resources online, utilising technology to enhance learning. Despite growing evidence claiming that e-learning is as effective as traditional means of learning, the evidence is still very limited. This protocol aims to measure the impact of e-learning as compared to traditional face-to-face learning, both measured and perceived, on health sciences education – in terms of improving students’/health professionals’ satisfaction, knowledge, skills, and behaviours and patient-related outcomes. We will conduct a systematic review and meta-analysis of both randomised controlled trials and non-randomised controlled trials. Major databases will be searched for studies, and will be reported in accordance with PRISMA. A thematic analysis will be conducted for the included studies. If sufficient data are available, the random-effects model for meta-analysis will be performed. The outcome of this study will provide a basis for developing the best methods of e-learning in health sciences education.
    • Evaluating ‘Enhancing Pragmatic Language skills for Young children with Social communication impairments’ (E-PLAYS): a feasibility cluster-randomised controlled trial

      Murphy, Suzanne; Joffe, Victoria; Donald, Louisa; Radley, Jessica; Sunthararajah, Sailaa; Welch, Charlie; Bell, Kerry; Messer, David J.; Crafter, Sarah; Fairhurst, Caroline; et al. (Springer Nature, 2021-01-04)
      Background This article reports the results from a feasibility study of an intervention (‘E-PLAYS’) aimed at supporting children who experience difficulties with social communication. E-PLAYS is based around a dyadic computer game, which aims to develop collaborative and communication skills. A pilot study found that when E-PLAYS was delivered by researchers, improvements on communication test scores and on collaborative behaviours were observed. The aim of this study was to ascertain the feasibility of running a full-scale trial to test the effectiveness of E-PLAYS in a National Health Service (NHS) setting with delivery by speech and language therapists and teaching assistants. Methods The study was a two-arm feasibility cluster-randomised controlled trial of the E-PLAYS intervention with a treatment as usual control arm. Data relating to recruitment and retention, treatment fidelity, acceptability to participants, suitability of outcomes and feasibility of collecting health economic measures and of determining cost-effectiveness were collected. Speech and language therapists selected suitable children (ages 4–7 years old) from their caseload. E-PLAYS intervention (experimental group) was then delivered by teaching assistants overseen by speech and language therapists. The control group received usual care. Assessments included blinded language measures and observations, non-blinded teacher-reported measures of peer relations and classroom behaviour and non-blinded parent-reported use of health and education resources and quality of life. Results Planned recruitment was for 70 children, in the event, 50 children were recruited which was sufficient for feasibility purposes. E-PLAYS was very highly rated by children, teaching assistants and speech and language therapists and treatment fidelity did not pose any issues. We were able to collect health economic data which suggests that E-PLAYS would be a low-cost intervention. Conclusion Based on recruitment, retention and adherence rates and our outcome measures, a full-scale randomised controlled trial estimated appears feasible and warranted to assess the effectiveness of E-PLAYS for use by the NHS and schools. Trial registration ISRCTN 14818949 (retrospectively registered)
    • A randomised controlled trial of energetic activity for depression in young people (READY): a multi-site feasibility trial protocol

      Howlett, Neil; Bottoms, Lindsay; Chater, Angel M.; Clark, A.B.; Clarke, T.; David, L.; Irvine, K.; Jones, A.; Jones, J.; Mengoni, S.E.; et al. (BioMed Central Ltd, 2021-01-04)
      Background: Prevalence of depression is increasing in young people, and there is a need to develop and evaluate behavioural interventions which may provide benefits equal to or greater than talking therapies or pharmacological alternatives. Exercise could be beneficial for young people living with depression, but robust, large-scale trials of effectiveness and the impact of exercise intensity are lacking. This study aims to test whether a randomised controlled trial (RCT) of an intervention targeting young people living with depression is feasible by determining whether it is possible to recruit and retain young people, develop and deliver the intervention as planned, and evaluate training and delivery. Methods: The design is a three-arm cluster randomised controlled feasibility trial with embedded process evaluation. Participants will be help-seeking young people, aged 13–17 years experiencing mild to moderate low mood or depression, referred from three counties in England. The intervention will be delivered by registered exercise professionals, supported by mental health support workers, twice a week for 12 weeks. The three arms will be high-intensity exercise, low-intensity exercise, and a social activity control. All arms will receive a ‘healthy living’ behaviour change session prior to each exercise session and the two exercise groups are energy matched. The outcomes are referral, recruitment, and retention rates; attendance at exercise sessions; adherence to and ability to reach intensity during exercise sessions; proportions of missing data; adverse events, all measured at baseline, 3, and 6 months; resource use; and reach and representativeness. Discussion: UK National Health Service (NHS) policy is to provide young people with advice about using exercise to help depression but there is no evidence-based exercise intervention to either complement or as an alternative to medication or talking therapies. UK National Institute for Health and Care Excellence (NICE) guidelines suggest that exercise can be an effective treatment, but the evidence base is relatively weak. This feasibility trial will provide evidence about whether it is feasible to recruit and retain young people to a full RCT to assess the effectiveness and cost-effectiveness of an exercise intervention for depression. Trial registration: ISRCTN, ISRCTN66452702. Registered 9 April 2020.