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Real-world waitlist randomised controlled trial of gameChange VR to treat severe agoraphobic avoidance in patients with psychosis: a study protocol.
INTRODUCTION: Many people with psychosis find the world very frightening. It can be difficult for them to do everyday things-for example, walking down a busy street, travelling on a bus or going to the shops. Sometimes, the fears are so great that individuals rarely leave their homes. gameChange virtual reality therapy is designed to reduce this agoraphobic avoidance. In gameChange, users practise going into computerised immersive versions of ordinary situations. A virtual therapist guides users through the programme. A mental health worker also supports people. People normally do six sessions of gameChange, but now they can do more as headsets can be left with many people. We originally tested gameChange with 346 patients with psychosis. People saw a significant reduction in their fears. People with the most severe problems made the biggest improvements. This led to gameChange receiving National Institute for Health and Care Excellence (NICE) Early Value Assessment (EVA) approval for its use with patients with psychosis who have severe agoraphobic avoidance. NICE EVA approval is conditional on further evidence generation. We aim to carry out a real-world trial of gameChange used in the NHS. The overall aim is to gather evidence on the four essential areas (clinical benefits on agoraphobia, level of engagement and adherence, healthcare resource use, adverse effects) and the two further supporting areas (health-related quality of life, generalisability) identified in the NICE evidence generation plan for gameChange. METHODS AND ANALYSIS: 200 patients with psychosis and severe agoraphobic avoidance will be randomised (1:1) to receive gameChange in addition to treatment as usual (TAU) or to a waitlist control group receiving TAU. Assessments will be conducted blind to group allocation at baseline, 8 weeks (end of treatment) and 26 weeks (follow-up). The trial will be embedded in services in at least seven National Health Service (NHS) trusts across England. The primary outcome is agoraphobic avoidance at 26 weeks assessed with the Oxford Agoraphobic Avoidance Scale. The secondary clinical outcomes are agoraphobic distress, paranoia and social contacts. There will be tests of moderation of the main clinical outcome. Treatment acceptability, adverse effects and cost-effectiveness will also be assessed. The target estimand is the treatment policy estimand and all primary and secondary analyses will be carried out incorporating data from all participants including those who do not complete treatment. ETHICS AND DISSEMINATION: The trial has received ethical approval from the NHS Health Research Authority and Health and Care Research Wales (25/WA/0081). A key output will be the evidence needed for a NICE guidance update on gameChange and a clear recommendation concerning future routine use in the NHS. TRIAL REGISTRATION NUMBER: ISRCTN79060696.
Apathy and impulsivity in neurological and psychiatric disorders
Apathy and impulsivity are debilitating syndromes of motivation that are common across neurological and psychiatric disorders. Both are associated with pathology within well described fronto-striatal networks where dopaminergic neurons play an important role in regulating motivated behavior. In this chapter, we investigate whether dopaminergic dysfunction within this network is associated with either apathetic or impulsive behavior. We focus on patients with Parkinson's disease and schizophrenia, investigating a wide range of behavioral and neuroimaging studies. Current findings suggest that both apathy and impulsivity are associated with altered responsiveness to rewards during decision-making and altered function within fronto-striatal networks. While dopaminergic therapy also alters reward sensitivity, there are instances where the effects of apathy and/or impulsivity on this metric are independent of—and extend beyond—dopaminergic tone. This suggests a more nuanced relationship between fronto-striatal dopamine and human motivation syndromes that warrants further investigation.
Cognitive Therapy for PTSD: Updating Memories and Meanings of Trauma
In the initial days and weeks after a traumatic event, most people will experience at least some symptoms of posttraumatic stress disorder (PTSD) such as intrusive memories, sleep disturbance, feeling emotionally numb, or being easily startled (Rothbaum et al. 1992). Most people will recover in the ensuing months, but for some the symptoms persist, often for years. What prevents these people from recovering? A lesson that we learned in treating and interviewing many trauma survivors is that what people find most distressing about a traumatic event varies greatly from person to person. Understanding the personal meanings of trauma and their relationship with features of trauma memories appears key to helping people with PTSD.
Multisensory Floral Clock: Enhanced Multisensory Timekeeping with Technological Design
In recent years, there has been a growing interest in biophilic design and its beneficial effects on human well-being. This article explores the concept of biophilic multisensory timekeeping design through the creation of a Multisensory Floral Clock. Inspired by Carl Linnaeus’s 18th-century floral clock, this innovative project integrates visual and olfactory elements to provide a calming and immersive timekeeping experience. Each hour is represented by a mechanical flower that opens and releases a corresponding scents, aligned with natural patterns of blooming. The design leverages biophilic principles and historical and contemporary multisensory timekeeping practices, such as Chinese and Japanese incense clocks, to enhance the experience of everyday life. This article focuses on presenting the design and conceptual framework, discussing the benefits of biophilic design/art, the challenges of floral scents integration, and the potential impact on emotional, cognitive, and physiological well-being. This article primarily explores whether the Multisensory Floral Clock can reduce the stress associated with conventional timekeeping by offering a more engaging and nature-connected experience, with pilot testing and audience feedback to be conducted in future studies.
Detection of cognitive deficits years prior to clinical diagnosis across neurological conditions
Abstract Understanding the cognitive trajectory of a neurological disease can provide important insight on underlying mechanisms and disease progression. Cognitive impairment is now well established as beginning many years before the diagnosis of Alzheimer’s disease, but pre-diagnostic profiles are unclear for other neurological conditions that may be associated with cognitive impairment. We analysed data from the prospective UK Biobank cohort with study baseline assessment performed between 2006-2010 and participants followed until 2021. We examined data from 497,252 participants, aged between 38 and 72 years at baseline, with an imaging sub-sample of 42,468 participants. Using time-to-diagnosis and time-from-diagnosis data in relation to time of assessment, we compared a continuous measure of executive function and magnetic resonance imaging brain measures of total grey matter and hippocampal volume in individuals with ischaemic stroke, focal epilepsy, Parkinson’s disease, multiple sclerosis, motor neurone disease (amyotrophic lateral sclerosis) and migraine. Of the 497,252 participants (226,206 [45.5%] men, mean [SD] age, 57.5[8.1] years), 12,755 had ischaemic stroke, 6,758 had a diagnosis of focal epilepsy, 3,315 had Parkinson’s disease, 2,315 had multiple sclerosis, 559 had motor neurone disease and 18,254 had migraine either at study baseline or diagnosed during the follow-up period. Apart from motor neurone disease, all conditions had lower pre-diagnosis executive function compared to controls (assessment performed median 7.4 years before diagnosis). At a group level, focal epilepsy and multiple sclerosis showed a gradual worsening in executive function up to 15 years prior to diagnosis, while ischaemic stroke was characterised by a modest decline for a few years followed by a substantial reduction at the time of diagnosis. By contrast, participants with migraine showed a mild reduction in pre-diagnosis cognition compared to controls which improved following clinical diagnosis. Pre-diagnosis MRI grey matter volume was lower than controls for stroke, Parkinson’s disease and multiple sclerosis (scans performed median 1.7 years before diagnosis), while other conditions had lower volumes post-diagnosis. These cognitive trajectory models reveal disease-specific temporal patterns at a group level, including a long cognitive prodrome associated with focal epilepsy and multiple sclerosis. The findings may help to prioritise risk management of individual diseases and inform clinical decision-making.
The Oxford Cognitive Screen in culturally diverse populations: A comparative study of Suriname and Belgium
Abstract Objective: Post-stroke neurocognitive disorders are highly prevalent, yet screening tools that are fit for culturally diverse populations are scarce. This study evaluates the impact of cultural differences on the Oxford Cognitive Screen (OCS), a stroke-specific screening tool. Methods: To evaluate cultural differences, we compared two populations with varying degrees of cultural diversity and Western, Educated, Industrialized, Rich and Democratic (WEIRD) characteristics. We adapted the Dutch OCS for Suriname through a multi-stage process. Using Bayesian hierarchical regression analysis, we compared 264 Surinamese participants, assessed with the adapted Dutch OCS, with 247 Belgian participants, assessed with the Dutch OCS, while controlling for age and education. We further investigated whether the associations of age and education with performance were comparable between the two populations. Results: Our findings revealed minimal differences in OCS performance between the Belgian and Surinamese populations. Both populations showed similar age-related decline and education-related improvement across all subtests, except for Picture naming, where the age-related decline was more pronounced in the Belgian population. Conclusion: These findings suggest that with minimal adaptation, the OCS is a viable tool for screening post-stroke neurocognitive disorders in culturally diverse populations.
Estimating the Reproducibility of Experimental Philosophy
Responding to recent concerns about the reliability of the published literature in psychology and other disciplines, we formed the X-Phi Replicability Project (XRP) to estimate the reproducibility of experimental philosophy (osf.io/dvkpr). Drawing on a representative sample of 40 x-phi studies published between 2003 and 2015, we enlisted 20 research teams across 8 countries to conduct a high-quality replication of each study in order to compare the results to the original published findings. We found that x-phi studies – as represented in our sample – successfully replicated about 70% of the time. We discuss possible reasons for this relatively high replication rate in the field of experimental philosophy and offer suggestions for best research practices going forward.
Changes in sensorimotor network dynamics in resting-state recordings in Parkinson's disease.
Non-invasive recordings of magnetoencephalography have been used for developing biomarkers for neural changes associated with Parkinson's disease that can be measured across the entire course of the disease. These studies, however, have yielded inconsistent findings. Here, we investigated whether analysing motor cortical activity within the context of large-scale brain network activity provides a more sensitive marker of changes in Parkinson's disease using magnetoencephalography. We extracted motor cortical beta power and beta bursts from resting-state magnetoencephalography scans of patients with Parkinson's disease (N = 28) and well-matched healthy controls (N = 36). To situate beta bursts in their brain network contexts, we used a time-delay-embedded hidden Markov model to extract brain network activity and investigated co-occurrence patterns between brain networks and beta bursts. Parkinson's disease was associated with decreased beta power in motor cortical power spectra, but no significant differences in motor cortical beta-burst dynamics occurred when using a conventional beta-burst analysis. Dynamics of a large-scale sensorimotor network extracted with the time-delay-embedded hidden Markov model approach revealed significant decreases in the occurrence of this network with Parkinson's disease. By comparing conventional burst and time-delay-embedded hidden Markov model state occurrences, we observed that motor beta bursts occurred during both sensorimotor and non-sensorimotor network activations. When using the large-scale network information provided by the time-delay-embedded hidden Markov model to focus on bursts that were active during sensorimotor network activations, significant decreases in burst dynamics could be observed in patients with Parkinson's disease. In conclusion, our findings suggest that decreased motor cortical beta power in Parkinson's disease is prominently associated with changes in sensorimotor network dynamics using magnetoencephalography. Thus, investigating large-scale networks or considering the large-scale network context of motor cortical activations may be crucial for identifying alterations in the sensorimotor network that are prevalent in Parkinson's disease and might help resolve contradicting findings in the literature.
Precision computerised cognitive behavioural therapy (cCBT) intervention for adolescents with depression (SPARX-UK): protocol for the process evaluation of a pilot randomised controlled feasibility trial.
INTRODUCTION: While digital technologies can increase the availability and access to evidence-based interventions, little is known about how users engage with them and the mechanisms associated with effective outcomes. Process evaluations are an important component in understanding the aforementioned factors. The 'SPARX-UK' study is a randomised controlled pilot and feasibility trial evaluating personalised human-supported (from an 'eCoach') vs a self-directed computerised cognitive behavioural therapy intervention (cCBT), called SPARX (Smart, Positive, Active, Realistic, X-factor thoughts), aimed at adolescents with mild to moderate depression. We are comparing supported vs self-directed delivery of SPARX to establish which format should be used in a proposed definitive trial of SPARX. The control is a waitlist group. We will conduct a process evaluation alongside the trial to determine how the intervention is implemented and provide context for interpreting the feasibility trial outcomes. We will also look at the acceptability of SPARX and how users engage with the intervention. This protocol paper describes the rationale, aims and methodology of the SPARX-UK trial process evaluation. METHODS AND ANALYSIS: The process evaluation will use a mixed-methods design following the UK Medical Research Council's 2015 guidelines, comprising quantitative and qualitative data collection. This will include analysing data usage of participants in the intervention arms; purposively sampled, semi-structured interviews of adolescents, parents/guardians, eCoaches and clinicians/practitioners from the SPARX-UK trial; and analysis of qualitative comments from a survey from those who dropped out early from the trial. Quantitative data will be analysed descriptively. We will use thematic analysis in a framework approach to analyse qualitative data. Quantitative and qualitative data will be mixed and integrated to provide an understanding of how the intervention was implemented and how adolescents interacted with the intervention. This process evaluation will explore the experiences of adolescent participants, parents/guardians, eCoaches and clinicians/practitioners in relation to a complex digital intervention. ETHICS: Ethical approval was granted by the National Health Service (NHS) Health Research Authority South West - Cornwall & Plymouth Research Ethics Committee (Ethics Ref: 22/SW/0149). DISSEMINATION: Contextualising how the intervention was implemented, and the variations in uptake and engagement, will help us to understand the trial findings in greater depth. The findings from this process evaluation will also inform the decision about whether and how to proceed with a full randomised controlled trial, as well as the development of more effective interventions which can be personalised more precisely via varying levels of human support. We plan to publish the findings of the process evaluation and the wider project in peer-reviewed journals, as well as disseminate via academic conferences. TRIAL REGISTRATION NUMBER: ISRCTN: ISRCTN15124804. Registered on 16 January 2023, https://www.isrctn.com/ISRCTN15124804.
Behavioral experiments vs. verbal interventions in cognitive therapy for social anxiety disorder: A randomized controlled trial.
OBJECTIVE: The efficacy of cognitive therapy (CT) for social anxiety disorder (SAD) is well documented, although effect sizes (ES) vary significantly across studies. These variations may be attributable to differences in the active components of the treatments. A key component potentially influencing outcomes is the use of behavioral experiments (BEs), as opposed to purely verbal interventions (VIs) for changing social anxiety related negative beliefs. The present trial compared the effectiveness of CT incorporating behavioral experiments (CT-BE) with that of CT focusing more exclusively on verbal interventions (CT-VI). We hypothesized that CT-BE would lead to greater reductions in social anxiety symptoms. METHODS: Sixty patients were randomly assigned to one of two treatment conditions: CT-BE or CT-VI (n = 30 per group). The primary outcome was the severity of social anxiety symptoms, which was assessed via the clinician-administered Liebowitz Social Anxiety Scale (LSAS). This measure was also used to compute response. The secondary outcomes included the self-administered Social Phobia Inventory (SPIN), clinician-rated and self-rated depression, and clinician-rated skills in emotion regulation regarding social anxiety. Assessments were conducted at baseline, posttreatment and (for clinician-administered measures) 6-months follow-up. RESULTS: No significant differences between treatment groups were found for social anxiety outcomes or any other measure at post-treatment, however, a statistical trend in favor of CT-BE was observed for the primary outcome LSAS (p = .072). Between-group ES for anxiety outcomes at post-treatment were sizeable (d = 0.55 for LSAS, d = 0.41 for SPIN), suggesting a potential advantage of CT-BE over CT-VI. Although both treatments showed high overall effectiveness, as reflected in large within-participant ES for anxiety outcomes and high response probabilities (97.7 % for CT-BE, 74.9 % for CT-VI), within-participant ES for anxiety-related outcomes were particularly high in the CT-BE group (up to d = 2.59) and substantially exceeded those in the CT-VI group (up to d = 1.02). At follow-up, significant group differences emerged for emotion regulation, favoring CT-BE (p
From risk to resilience: rethinking anti-bullying interventions to improve mental health outcomes
Being bullied has been described as one of the most tractable risk factors for mental health, and yet the link between bullying and poor mental health is a complex, multifactorial one. Drawing on resilience theory, this paper highlights the importance of protective factors at various levels, including individual, family, school, and community. There is a relative lack of high-quality research investigating protective factors that promote resilience among bullied children. I propose that identifying causal protective factors through rigorous research methods will help build more effective multisystemic interventions. These interventions should target different socioecological risk and protective factors to improve outcomes for bullied children. By integrating knowledge from diverse domains, such as effective parenting programmes and school-based interventions, we may develop more comprehensive approaches to support children’s overall social and emotional functioning.
Learning Variability Network Exchange (LEVANTE): A Global Framework for Measuring Children's Learning Variability Through Collaborative Data Sharing.
Despite the ubiquity of variation in child development within individuals, across groups, and across tasks, timescales, and contexts, dominant methods in developmental science and education research still favor group averages, short snapshots of time, and single environments. The Learning Variability Network Exchange (LEVANTE) is a framework designed to enable coordinated data collection by research teams worldwide, with the goal of measuring variability in children's learning and development. The LEVANTE measure set aims to capture variability in learning outcomes (literacy and numeracy) as well as in core cognitive and social constructs. LEVANTE will yield a large, open access longitudinal dataset for long-term research use, both creating a multidisciplinary research network and facilitating the science of learning variability.
Disorders of Language and Literacy Across Learning Contexts
A child struggling in school causes concern. Difficulties with school tasks can leave children frustrated and parents and teachers wondering why they are not learning. Indeed, school underachievement is one of the most common reasons for referral to a visiting specialist in school or to a child guidance clinic. Underachievement may arise for many different reasons. In this chapter we will focus on difficulties of language and literacy, noting that many children with such difficulties also struggle with maths. The rationale for our focus is that language and literacy are the foundation for learning across school systems — here we present a global perspective on the critical issues of how to identify, assess, prevent, and remediate such difficulties, the symptoms of which may differ according to the language of schooling and the learning context. We will also consider underachievement when it is secondary to another condition focusing on a small selection of co-occurring (comorbid) disorders. Sections on assessment and intervention focus on the current evidence base. We close the chapter with a discussion of priorities that low-income communities can set for the educational management of children with learning difficulties.