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Minimising Young Children's Anxiety through Schools (MY-CATS): statistical analysis plan 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.
BACKGROUND: The Minimising Young Children's Anxiety through Schools (MY-CATS) trial is being conducted to determine whether an online evidence-based parent-guided cognitive behavioural therapy intervention in addition to usual school practice is effective and cost-effective compared with usual school practice in reducing anxiety disorders in children aged 4-7 deemed 'at risk' of anxiety disorders. This update article describes the detailed statistical analysis plan for the MY-CATS trial and reports a review of the underpinning sample size assumptions. METHODS AND DESIGN: The MY-CATS study is a two-arm, definitive superiority pragmatic parallel group cluster randomised controlled trial in which schools will be randomised 1:1 to receive either the intervention (in addition to usual school practice) or the usual school practice only. This update to the (published) protocol provides a detailed description of the study methods, the statistical principles, the trial population and the planned statistical analyses, including additional analyses comprising instrumental variable regression and mediation analysis. TRIAL REGISTRATION: ISRCTN82398107 . Prospectively registered on 14 January 2021.
E-Clinical High Risk for Psychosis: Viewpoint on Potential of Digital Innovations for Preventive Psychiatry.
E-mental health is an emerging area of research that has the potential to overcome some of the current barriers to progress in working with people at clinical high risk for psychosis (CHR-P). This article provides an overview of how e-mental health could be used in the detection, prediction, and treatment in the CHR-P population. Specifically, we evaluate e-detection, e-prediction, and e-therapeutics for this clinical population. E-mental health holds great promise to improve current management of CHR-P individuals.
Integrating neuroscience in psychiatry: a cultural-ecosocial systemic approach.
Psychiatry has increasingly adopted explanations for psychopathology that are based on neurobiological reductionism. With the recognition of health disparities and the realisation that someone's postcode can be a better predictor of health outcomes than their genetic code, there are increasing efforts to ensure cultural and social-structural competence in psychiatric practice. Although neuroscientific and social-cultural approaches in psychiatry remain largely separate, they can be brought together in a multilevel explanatory framework to advance psychiatric theory, research, and practice. In this Personal View, we outline how a cultural-ecosocial systems approach to integrating neuroscience in psychiatry can promote social-contextual and systemic thinking for more clinically useful formulations and person-centred care.
Prebiotic and Probiotic Modulation of the Microbiota–Gut–Brain Axis in Depression
Emerging evidence demonstrates that alterations to the gut microbiota can affect mood, suggesting that the microbiota–gut–brain (MGB) axis contributes to the pathogenesis of depression. Many of these pathways overlap with the way in which the gut microbiota are thought to contribute to metabolic disease progression and obesity. In rodents, prebiotics and probiotics have been shown to modulate the composition and function of the gut microbiota. Together with germ-free rodent models, probiotics have provided compelling evidence for a causal relationship between microbes, microbial metabolites, and altered neurochemical signalling and inflammatory pathways in the brain. In humans, probiotic supplementation has demonstrated modest antidepressant effects in individuals with depressive symptoms, though more studies in clinically relevant populations are needed. This review critically discusses the role of the MGB axis in depression pathophysiology, integrating preclinical and clinical evidence, as well as the putative routes of communication between the microbiota–gut interface and the brain. A critical overview of the current approaches to investigating microbiome changes in depression is provided. To effectively translate preclinical breakthroughs in MGB axis research into novel therapies, rigorous placebo-controlled trials alongside a mechanistic and biochemical understanding of prebiotic and probiotic action are required from future research.
Improving sleep and learning in rehabilitation after stroke, part 2 (INSPIRES2): study protocol for a home-based randomised control trial of digital cognitive behavioural therapy (dCBT) for insomnia.
INTRODUCTION: Consolidation of motor skill learning, a key component of rehabilitation post-stroke, is known to be sleep dependent. However, disrupted sleep is highly prevalent after stroke and is often associated with poor motor recovery and quality of life. Previous research has shown that digital cognitive behavioural therapy (dCBT) for insomnia can be effective at improving sleep quality after stroke. Therefore, the aim of this trial is to evaluate the potential for sleep improvement using a dCBT programme, to improve rehabilitation outcomes after stroke. METHODS AND ANALYSIS: We will conduct a parallel-arm randomised controlled trial of dCBT (Sleepio) versus treatment as usual among individuals following stroke affecting the upper limb. Up to 100 participants will be randomly allocated (2:1) into either the intervention (6-8 week dCBT) or control (continued treatment as usual) group. The primary outcome of the study will be change in insomnia symptoms pre to post intervention compared with treatment as usual. Secondary outcomes include improvement in overnight motor memory consolidation and sleep measures between intervention groups, correlations between changes in sleep behaviour and overnight motor memory consolidation in the dCBT group and changes in symptoms of depression and fatigue between the dCBT and control groups. Analysis of covariance models and correlations will be used to analyse data from the primary and secondary outcomes. ETHICS AND DISSEMINATION: The study has received approval from the National Research Ethics Service (22/EM/0080), Health Research Authority (HRA) and Health and Care Research Wales (HCRW), IRAS ID: 306 291. The results of this trial will be disseminated via presentations at scientific conferences, peer-reviewed publication, public engagement events, stakeholder organisations and other forms of media where appropriate. TRIAL REGISTRATION NUMBER: NCT05511285.
Partnerships at the Interface of Education and Mental Health Services: The Utilisation and Acceptability of the Provision of Specialist Liaison and Teacher Skills Training.
Partnerships between school staff and mental health professionals have the potential to improve access to mental health support for students, but uncertainty remains regarding whether and how they work in practice. We report on two pilot projects aimed at understanding the implementation drivers of tailored strategies for supporting and engaging front-line school staff in student mental health. The first project provided regular, accessible mental health professionals with whom school staff could meet and discuss individual or systemic mental health concerns (a school 'InReach' service), and the other offered a short skills training programme on commonly used psychotherapeutic techniques (the School Mental Health Toolbox; SMHT). The findings from the activity of 15 InReach workers over 3 years and 105 individuals who attended the SMHT training demonstrate that school staff made good use of these services. The InReach workers reported more than 1200 activities in schools (notably in providing specialist advice and support, especially for anxiety and emotional difficulties), whilst most SMHT training attendees reported the utilisation of the tools (in particular, supporting better sleep and relaxation techniques). The measures of acceptability and the possible impacts of the two services were also positive. These pilot studies suggest that investment into partnerships at the interface of education and mental health services can improve the availability of mental health support to students.