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CoDesign of a digital intervention for parents with bipolar disorder informed by integrated knowledge translation principles.
OBJECTIVES: To provide detailed information on the codesign of a digital intervention to support parents with bipolar disorder (BD) who have young children. Each step of this process is reported, as well as a detailed description of the final version of the intervention in line with the TIDieR framework. METHODS: Clinical experience and lived experience experts participated in online workshops, meetings, and remote feedback requests, informed by Integrated Knowledge Translation (IKT) principles. The IKT research group responded to each phase of recommendations from the knowledge users. RESULTS: Five clinical experience experts and six lived experience experts engaged with the codesign process. Their recommendations for principles, content, look, and feel, and functionality of the digital intervention were structured over five iterative phases. This led to a final implemented design that was identified by the clinical and lived experience experts (referred to together as the knowledge users group) as genuinely reflecting their input. CONCLUSIONS: The IKT principles offer an accessible structure for engaging with clinical and lived experience experts throughout a codesign process, in this case for a digital intervention for parents with BD. The resulting intervention is described in detail for transparency to aid further evaluation and development and to help other teams planning codesign approaches to intervention development.
Understanding how traumatic brain injury-related changes in fluid biomarkers affect quality of life outcomes in veterans: a prospective observational trial protocol (UNTANGLE)
INTRODUCTION: Traumatic brain injury (TBI) is a major cause of disability, with annual global incidence estimated as 69 million people. Survivors can experience long-term visual changes, altered mental state, neurological deficits and long-term effects that may be associated with mental illness. TBI is prevalent in military personnel due to gunshot wounds, and blast injury. This study aims to evaluate the relationship between evolving visual, biochemical and mental health changes in both military veterans and civilians, suffering from TBI, and detect preliminary indicators of prognosis for TBI recovery, and quality-of-life outcomes. METHODS AND ANALYSIS: UNTANGLE is a 24-month prospective observational pilot study recruiting three patient groups: civilians with acute moderate-severe TBI, military veterans with diagnosis of a previous TBI and a control group of civilians or veterans with no history of a previous TBI. Patients will undergo visual, biochemical and mental health assessments, as well as patient-reported quality of life outcome measures over the course of a 1-year follow-up period. ETHICS AND DISSEMINATION: Ethical approval has been obtained from the Health Research Authority and Health and Care Research Wales with a REC reference number of 23/NW/0203. The results of the study will be presented at scientific meetings and published in peer-reviewed journals, including both civilian and military-related publications. We will also present our findings at national and international meetings of learnt neuroscience and neuropsychiatry and military societies. We anticipate that our pilot study will inform a larger study on the long-term outcomes of TBI and quality of life, specific to military veterans, such that potential interventions may be accessed as quickly as possible. TRIAL REGISTRATION NUMBER: ISRCTN13276511.
Anhedonia as a Potential Transdiagnostic Phenotype With Immune-Related Changes in Recent-Onset Mental Health Disorders
Background: Chronic low-grade inflammation is observed across mental disorders and is associated with difficult-to-treat-symptoms of anhedonia and functional brain changes, reflecting a potential transdiagnostic dimension. Previous investigations have focused on distinct illness categories in people with enduring illness, but few have explored inflammatory changes. We sought to identify an inflammatory signal and the associated brain function underlying anhedonia among young people with recent-onset psychosis and recent-onset depression. Methods: Resting-state functional magnetic resonance imaging, inflammatory markers, and anhedonia symptoms were collected from 108 (mean [SD] age = 26.2 [6.2] years; female = 50) participants with recent-onset psychosis (n = 53) and recent-onset depression (n = 55) from the European Union/Seventh Framework Programme–funded PRONIA (Personalised Prognostic Tools for Early Psychosis Management) study. Time series were extracted using the Schaefer atlas, defining 100 cortical regions of interest. Using advanced multimodal machine learning, an inflammatory marker model and a functional connectivity model were developed to classify participants into an anhedonic group or a normal hedonic group. Results: A repeated nested cross-validation model using inflammatory markers classified normal hedonic and anhedonic recent-onset psychosis/recent-onset depression groups with a balanced accuracy of 63.9% and an area under the curve of 0.61. The functional connectivity model produced a balanced accuracy of 55.2% and an area under the curve of 0.57. Anhedonic group assignment was driven by higher levels of interleukin 6, S100B, and interleukin 1 receptor antagonist and lower levels of interferon gamma, in addition to connectivity within the precuneus and posterior cingulate. Conclusions: We identified a potential transdiagnostic anhedonic subtype that was accounted for by an inflammatory profile and functional connectivity. Results have implications for anhedonia as an emerging transdiagnostic target across emerging mental disorders.
Metabolic syndrome risk prediction in an Australian sample with first-episode psychosis using the psychosis metabolic risk calculator: A validation study
Objective: To examine the accuracy and likely clinical usefulness of the Psychosis Metabolic Risk Calculator (PsyMetRiC) in predicting up-to six-year risk of incident metabolic syndrome in an Australian sample of young people with first-episode psychosis. Method: We conducted a retrospective study at a secondary care early psychosis treatment service among people aged 16-35 years, extracting relevant data at the time of antipsychotic commencement and between one-to-six-years later. We assessed algorithm accuracy primarily via discrimination (C-statistic), calibration (calibration plots) and clinical usefulness (decision curve analysis). Model updating and recalibration generated a site-specific (Australian) PsyMetRiC version. Results: We included 116 people with baseline and follow-up data: 73% male, mean age 20.1 years, mean follow-up 2.6 years, metabolic syndrome prevalence 13%. C-statistics for both partial- (C = 0.71, 95% CI 0.64–0.75) and full-models (C = 0.72, 95% CI 0.65–0.77) were acceptable; however, calibration plots demonstrated consistent under-prediction of risk. Recalibration and updating led to slightly improved C-statistics, greatly improved agreement between observed and predicted risk, and a narrow window of likely clinical usefulness improved significantly. Conclusion: An updated and recalibrated PsyMetRiC model, PsyMetRiC-Australia, shows promise. Validation in a large sample is required to confirm its accuracy and clinical usefulness for the Australian population.
Collaboration across the primary/specialist interface in early intervention in psychosis services: a qualitative study.
Background People with new psychotic symptoms may be managed within an Early Intervention in Psychosis service (EIP). They may be discharged back to primary care at the end of their time in an EIP service. Aim To explore the role of primary care in supporting people with psychosis in an EIP service. Design and Setting Qualitative study, within a programme of work to explore the optimum duration of management within an EIP service. Methods Semi-structured interviews with people in EIP services, carers, general practitioners (GPs) and EIP practitioners. Findings GPs report difficulties in referring people into EIP services, have little contact with people who are supported by EIP services and are not included in planning discharge from EIP service to primary care. Conclusions This study suggests that GPs should have a role in the support of people within EIP services (in particular monitoring and managing physical health) and their carers. Inclusion of GPs in managing discharge from EIP services is vital. We suggest that a joint consultation with the service user, their carer (if they wish) along with EIP care co-ordinator and GP would make this transition smoother.
Nurse-delivered sleep restriction therapy to improve insomnia disorder in primary care: the HABIT RCT
Background Insomnia is a prevalent and distressing sleep disorder. Multicomponent cognitive–behavioural therapy is the recommended first-line treatment, but access remains extremely limited, particularly in primary care where insomnia is managed. One principal component of cognitive–behavioural therapy is a behavioural treatment called sleep restriction therapy, which could potentially be delivered as a brief single-component intervention by generalists in primary care. Objectives The primary objective of the Health-professional Administered Brief Insomnia Therapy trial was to establish whether nurse-delivered sleep restriction therapy in primary care improves insomnia relative to sleep hygiene. Secondary objectives were to establish whether nurse-delivered sleep restriction therapy was cost-effective, and to undertake a process evaluation to understand intervention delivery, fidelity and acceptability. Design Pragmatic, multicentre, individually randomised, parallel-group, superiority trial with embedded process evaluation. Setting National Health Service general practice in three regions of England. Participants Adults aged ≥ 18 years with insomnia disorder were randomised using a validated web-based randomisation programme. Interventions Participants in the intervention group were offered a brief four-session nurse-delivered behavioural treatment involving two in-person sessions and two by phone. Participants were supported to follow a prescribed sleep schedule with the aim of restricting and standardising time in bed. Participants were also provided with a sleep hygiene leaflet. The control group received the same sleep hygiene leaflet by e-mail or post. There was no restriction on usual care. Main outcome measures Outcomes were assessed at 3, 6 and 12 months. Participants were included in the primary analysis if they contributed at least one post-randomisation outcome. The primary end point was self-reported insomnia severity with the Insomnia Severity Index at 6 months. Secondary outcomes were health-related and sleep-related quality of life, depressive symptoms, work productivity and activity impairment, self-reported and actigraphy-defined sleep, and hypnotic medication use. Cost-effectiveness was evaluated using the incremental cost per quality-adjusted life-year. For the process evaluation, semistructured interviews were carried out with participants, nurses and practice managers or general practitioners. Due to the nature of the intervention, both participants and nurses were aware of group allocation. Results We recruited 642 participants (n = 321 for sleep restriction therapy; n = 321 for sleep hygiene) between 29 August 2018 and 23 March 2020. Five hundred and eighty participants (90.3%) provided data at a minimum of one follow-up time point; 257 (80.1%) participants in the sleep restriction therapy arm and 291 (90.7%) participants in the sleep hygiene arm provided primary outcome data at 6 months. The estimated adjusted mean difference on the Insomnia Severity Index was −3.05 (95% confidence interval −3.83 to −2.28; p < 0.001, Cohen’s d = −0.74), indicating that participants in the sleep restriction therapy arm [mean (standard deviation) Insomnia Severity Index = 10.9 (5.5)] reported lower insomnia severity compared to sleep hygiene [mean (standard deviation) Insomnia Severity Index = 13.9 (5.2)]. Large treatment effects were also found at 3 (d = –0.95) and 12 months (d = −0.72). Superiority of sleep restriction therapy over sleep hygiene was evident at 3, 6 and 12 months for self-reported sleep, mental health-related quality of life, depressive symptoms, work productivity impairment and sleep-related quality of life. Eight participants in each group experienced serious adverse events but none were judged to be related to the intervention. The incremental cost per quality-adjusted life-year gained was £2075.71, giving a 95.3% probability that the intervention is cost-effective at a cost-effectiveness threshold of £20,000. The process evaluation found that sleep restriction therapy was acceptable to both nurses and patients, and delivered with high fidelity. Limitations While we recruited a clinical sample, 97% were of white ethnic background and 50% had a university degree, which may limit generalisability to the insomnia population in England. Conclusions Brief nurse-delivered sleep restriction therapy in primary care is clinically effective for insomnia disorder, safe, and likely to be cost-effective. Future work Future work should examine the place of sleep restriction therapy in the insomnia treatment pathway, assess generalisability across diverse primary care patients with insomnia, and consider additional methods to enhance patient engagement with treatment. Trial registration This trial is registered as ISRCTN42499563. Funding The award was funded by the National Institute of Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 16/84/01) and is published in full in Health Technology Assessment; Vol. 28, No. 36. See the NIHR Funding and Awards website for further award information.
Association between hospital-diagnosed tinnitus and suicide: A Nationwide Danish longitudinal study.
OBJECTIVES: Tinnitus is a source of significant distress among some people. Associations have been suggested between tinnitus and mental disorders, and with suicidal thoughts and attempts. However, whether this extends to suicide in the general population remains uncertain. METHODS: This is a retrospective cohort study including all individuals aged 15 years or older, using Danish nationwide, longitudinal, population-based register data from 1 January 1990 through 31 December 2021. The main outcome was death by suicide. Poisson regression models were used to estimate adjusted incidence rate ratios (IRR) with the 95% confidence intervals (CI). RESULTS: Among 7,438,007 individuals (49.8% males) observed over 144,050,344 person-years, 85,677 (57.7% males) were diagnosed with tinnitus. In all, 23,824 suicide deaths were identified, of which 225 had tinnitus. Suicide rates were 24.2 and 16.5 per 100,000 person-years for those with and without tinnitus, respectively, giving an adjusted IRR of 1.4 (95% CI 1.2-1.6). Suicide rates were adjusted for demographic characteristics, concomitant hearing loss, and co-existing mental disorders before tinnitus. Increased suicide rates were linked to a higher number of hospital contacts and to recent hospital contacts, suggesting dose-response and temporal associations. CONCLUSIONS: The findings reveal an association between tinnitus and suicide, particularly among individuals with co-existing mental disorders. Dose-response and temporal associations were found between tinnitus and suicide. Concurrent hearing loss had no influence on the tinnitus-suicide association. Attention towards patients experiencing tinnitus related distress is warranted, especially those with pre-existing mental disorders.
Mesostriatal Dopaminergic Circuit Dysfunction in Schizophrenia: A Multimodal Neuromelanin-sensitive MRI and [18F]-DOPA PET Study.
BACKGROUND: Striatal hyperdopaminergia is implicated in the pathoetiology of schizophrenia, but how this relates to dopaminergic midbrain activity is unclear. Neuromelanin-sensitive MRI (NM-MRI) provides a marker of long-term dopamine function. We examined if midbrain NM-MRI contrast-to-noise ratio (NM-CNR) was higher in people with schizophrenia relative to controls and if this correlated with dopamine synthesis capacity. METHODS: N=154 participants (n=74 individuals with schizophrenia and n=80 healthy controls) underwent NM-MRI of the substantia nigra and ventral tegmental area (SN-VTA). A subset of the schizophrenia group (n=38) also received [18F]-DOPA PET to measure dopamine synthesis capacity (Kicer) in the SN-VTA and striatum. RESULTS: SN-VTA NM-CNR was significantly higher in patients with schizophrenia relative to controls (effect size=0.38, p=0.019). This effect was greatest for voxels in the medial and ventral SN-VTA. In patients, SN-VTA Kicer positively correlated with SN-VTA NM-CNR (r=0.44, p=0.005) and striatal Kicer (r=0.71, p<0.001). Voxelwise analysis demonstrated that SN-VTA NM-CNR was positively associated with striatal Kicer (r=0.53, p=0.005) and that this relationship appeared strongest between the ventral SN-VTA and associative striatum in schizophrenia. CONCLUSIONS: Our results suggest that neuromelanin levels are higher in patients with schizophrenia relative to controls, particularly in midbrain regions that project to parts of the striatum which receive innervation from the limbic and association cortices. The direct relationship between measures of neuromelanin and dopamine synthesis suggests that these aspects of schizophrenia pathophysiology are linked. Our findings highlight specific mesostriatal circuits as the loci of dopamine dysfunction in schizophrenia and, thus, potential therapeutic targets.
Neuroimaging and Clinical Findings in Healthy Middle-Aged Adults With Mild Traumatic Brain Injury in the PREVENT Dementia Study.
IMPORTANCE: Traumatic brain injuries (TBI) represent an important, potentially modifiable risk factor for dementia. Despite frequently observed vascular imaging changes in individuals with TBI, the relationships between TBI-associated changes in brain imaging and clinical outcomes have largely been overlooked in community cases of TBI. OBJECTIVE: To assess whether TBI are associated with and interact with midlife changes in neuroimaging and clinical features in otherwise healthy individuals. DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional analysis used baseline data from the PREVENT Dementia program collected across 5 sites in the UK and Ireland between 2014 and 2020. Eligible participants were cognitively healthy midlife adults aged between 40 and 59 years. Data were analyzed between January 2023 and April 2024. EXPOSURE: Lifetime TBI history was assessed using the Brain Injury Screening Questionnaire. MAIN OUTCOMES AND MEASURES: Cerebral microbleeds and other markers of cerebral small vessel disease (white matter hyperintensities [WMH], lacunes, perivascular spaces) were assessed on 3T magnetic resonance imaging. Clinical measures were cognition, sleep, depression, gait, and cardiovascular disease (CVD) risk, assessed using Computerized Assessment of Information Processing (COGNITO), Pittsburgh Sleep Quality Index, Center for Epidemiologic Studies Depression Scale, clinical interviews, and the Framingham Risk Score, respectively. RESULTS: Of 617 participants (median [IQR] age, 52 [47-56] years; 380 female [61.6%]), 223 (36.1%) had a history of TBI. TBI was associated with higher microbleed count (β = 0.10; 95% CI, 0.01-0.18; P = .03), with a dose-response association observed with increasing number of TBI events (β = 0.05; 95% CI, 0.01-0.09; P = .03). Conversely, TBI was not associated with other measures of small vessel disease, including WMH. Furthermore, TBI moderated microbleed associations with vascular risk factors and clinical outcomes, such that associations were present only in the absence of TBI. Importantly, observations held when analyses were restricted to individuals reporting only mild TBI. CONCLUSIONS AND RELEVANCE: In this cross-sectional study of healthy middle-aged adults, detectable changes in brain imaging and clinical features were associated with remote, even mild, TBI in the general population. The potential contribution of vascular injury to TBI-related neurodegeneration presents promising avenues to identify potential targets, with findings highlighting the need to reduce TBI through early intervention and prevention in both clinical care and policymaking.
Target mechanisms of mindfulness-based programmes and practices: a scoping review
QuestionMindfulness-based programmes (MBPs) and practices have demonstrated effects in mental health and well-being, yet questions regarding the target mechanisms that drive change across the population remain unresolved.Study selection and analysisFive databases were searched for randomised controlled trials that evaluate the indirect effects (IEs) of an MBP or mindfulness practice in relation to mental health and well-being outcomes through psychological mechanisms.Findings27 eligible studies were identified, with only four exploring mechanisms in the context of specific mindfulness practices. Significant IEs were reported for mindfulness skills, decentering and attitudes of mindfulness (eg, self-compassion) across different outcomes, population samples, mental health strategies and active comparators. Evidence gap maps and requirements for testing and reporting IEs are provided to help guide future work.ConclusionsMindfulness skills, decentering and attitudes of mindfulness may be key intervention targets for addressing the mental health of whole populations. However, future work needs to address significant knowledge gaps regarding the evidence for alternative mechanisms (eg, attention and awareness) in relation to unique outcomes (eg, well-being), mental health strategies (ie, promotion) and active comparators. High-quality trials, with powered multivariate mediation analyses that meet key requirements, will be needed to advance this area of work.Trial registration number10.17605/OSF.IO/NY2AH.
S13. DO PATIENTS WITH RECENT-ONSET DEPRESSION DIFFER CLINICALLY AND NEUROBIOLOGICALLY FROM DEPRESSED PATIENTS WITH A CLINICAL HIGH-RISK STATE FOR PSYCHOSIS?
Abstract Background Major depressive disorder (MDD) is one of the most common mental disorders, with a lifetime prevalence of 14.6%. The impact of depression is considerable; poor social and economic functioning and significant life limitations [1]. Depression is also the most common co-morbidity seen with other mental disorders. The prevalence of depressive disorder in schizophrenia has been reported to be around 40% [2]. When examining very early phases of illness, in groups identified as at clinical high risk (CHR) for psychosis, high rates of ‘co-morbid’ axis one diagnoses are reported, with over 50% reaching criteria for a depressive disorder. Those people with schizophrenia send depression are significantly more likely to relapse, to be a safety concern (be arrested, victimized or suicidal), have greater substance-related problems and poorer recovery [2]. In addition, depression has been linked to increased risk of transition from CHR to FEP, suggesting that in this group depression also indicates a poorer outcome [3]. Currently, the diagnosis of depression is based on the phenomenological evaluation of symptoms and behavior. However, there remains significant debate around the heterogeneity of depressive symptoms and their function as prognostic indicators [4]. Neuroimaging holds “diagnostic potential” for depression [5]. However, studies show that brain alterations are often small and reliability is difficult, and there has been no neuroimaging investigation of depression as a co-morbid diagnosis. We aim to further understand the symptom profile of depression in emerging mental disorders, including in the clinical high risk group (CHR) and recent onset psychosis (ROP) as compared to those with recent onset depression (ROD). This has important implications for the accurate identification of a potentially malleable target for treatment, and indeed development of novel therapeutic options. We also aim to explore the ability of brain imagining (structural MRI) to add accuracy to the classification prediction models Methods Data from the PRONIA study, an EUFP7 funded 8 center study recruiting ROD, CHR and ROP participants will be presented. Analysis will include demographic information and BDI-II (Beck Depression Inventory), CAARMS (Comprehensive Assessment of the At Risk Mental State), SANS (Scale for the assessment of negative symptoms) total score PANSS (Positive and negative Symptom Score) and SPI-A together with structural MRI imaging. We will report descriptive detail from the PRONIA discovery sample (n716), machine learning classification with Neurominer® and VBM analysis of sMRI scans across groups. Results Data from BDI-II symptom endorsement suggests a ‘classical depression phenotype’ corresponding to Becks ‘cognitive triad’; “life is pointless, future hopeless, self as worthless” may separate depression in ROD from ROP, with other symptoms potentially able to separate ROP from ROD. In classification, a 65% sensitivity and specificity are found. Data will also be presented on the CHR group and their alignment, together with VBM analysis for structural MRI examining correlates with highly weighted classifying symptoms in and across all three groups. Discussion When given early in the course of illness, interventions have the greatest potential impact, and characterization and accurate diagnosis of depression in emerging mental disorders is an important goal. This study suggests it may be possible to accurately identify depression in different diagnostic categories, including major depressive disorder, psychosis and clinical high risk, and that neuroimaging holds potential to add to diagnostic accuracy in complex co-morbid disorders.
Protocol of a cost-effectiveness analysis of a combined intervention for depression and parenting compared with enhanced standard of care for perinatally depressed, HIV-positive women and their infants in rural South Africa.
INTRODUCTION: Poverty, HIV and perinatal depression represent a triple threat to public health in sub-Saharan Africa because of their combined negative effects on parenting and child development. In the resource-constrained context of low-income and middle-income countries, a lay-counsellor-delivered intervention that combines a psychological and parenting intervention could offer the potential to mitigate the consequences of perinatal depression while also optimising scarce resources for healthcare.Measuring the cost-effectiveness of such a novel intervention will help decision-makers to better understand the relative costs and effects associated with replicating the intervention, thereby supporting evidence-based decision-making. This protocol sets out the methodological framework for analysing the cost-effectiveness of a cluster randomised controlled trial (RCT) that compares a combined intervention to enhanced standard of care when treating depressed, HIV-positive pregnant women and their infants in rural South Africa. METHODS AND ANALYSIS: This cost-effectiveness analysis (CEA) protocol complies with the Consolidated Health Economic Evaluation Reporting Standards 2022 checklist. A societal perspective will be chosen.The proposed methods will determine the cost and efficiency of implementing the intervention as per the randomised control trial protocol, as well as the cost of replicating the intervention in a non-research setting. The costs will be calculated using an appropriately adjusted version of the Standardised Early Childhood Development Costing Tool.Primary health outcomes will be used in combination with costs to determine the cost per improvement in maternal perinatal depression at 12 months postnatal and the cost per improvement in child cognitive development at 24 months of age. To facilitate priority setting, the incremental cost-effectiveness ratios for improvements in child cognitive development will be ranked against six other child cognitive-development interventions according to Verguet et al's methodology (2022).A combination of activity-based and ingredient-based costing approaches will be used to identify, measure and value activities and inputs for all alternatives. Outcomes data will be sourced from the RCT team. ETHICS AND DISSEMINATION: The University of Oxford is the sponsor of the CEA. Ethics approval has been obtained from the Human Sciences Research Council (HSRC, #REC 5/23/08/17), South Africa and the Oxford Tropical Research Ethics Committee (OxTREC #31-17), UK.Consent for publication is not applicable since no participant data are used in this protocol.We plan to disseminate the CEA results to key policymakers and researchers in the form of a policy brief, meetings and academic papers. TRIAL REGISTRATION DETAILS: ISRCTN registry #11 284 870 (14/11/2017) and SANCTR DOH-27-102020-9097 (17/11/2017).
Study protocol: perinatal mood treatment study
Perinatal depression (PND) affects up to 20% of women and is associated with significant impairment and disability in affected women. In addition, perinatal depression is associated with broader public health and multigenerational consequences. Innovative approaches are needed to reduce the burden of perinatal depression through identification, tracking, and treatment of depressive symptoms during the perinatal period. This study is a randomized clinical trial comparing the relative efficacy of a multi-tiered system of care, Screening and Treatment of Anxiety and Depression (STAND) to perinatal care delivered by a reproductive psychiatrist in reducing symptoms of depression and anxiety. A sample of 167 individuals was randomized between week 28 of pregnancy and 6 months postpartum. A secondary aim compares the original online therapy intervention used in the first half of the study to a newer online therapy program used in the second half of the study for individuals assigned to the STAND treatment. The study measures, intervention groups, and analysis methods are described, as well as expected implications. The findings from this study may improve the methods for tracking symptom changes over time, monitoring treatment response, and providing personalized care for individuals with PND. As such, this study may improve the lives of patients with PND and their families and lower the related health care costs to society. Trial registration NCT: 9/24/2021 NCT direct link: https://www.clinicaltrials.gov/study/NCT05056454?term=NCT05056454&rank=1&a=1.
Designing digital patient experiences: The digital health design framework.
BACKGROUND: Digital health (DH) brings considerable benefits, but it comes with potential risks. Human Factors (HF) play a critical role in providing high-quality and acceptable DH solutions. Consultation with designers is crucial for reflecting on and improving current DH design practices. OBJECTIVES: We investigated the general DH design processes, challenges, and corresponding strategies that can improve the digital patient experience (PEx). METHODS: A semi-structured interview study with 24 design professionals. All audio recordings were transcribed, deidentified, grammatically corrected, and imported into ATLAS.ti for data analysis. Three coders participated in data coding following the thematic analysis approach. RESULTS: We identified eight DH design stages and grouped them into four phases: preparation, problem-thinking, problem-solving, and implementation. The analysis presented twelve design challenges associated with contextual, practical, managerial, and commercial aspects that can hinder the design process. We identified eight common strategies used by respondents to tackle these challenges. CONCLUSIONS: We propose a Digital Health Design (DHD) framework to improve the digital PEx. It provides an overview of design deliverables, activities, stakeholders, challenges, and corresponding strategies for each design stage.
The process of co‐design for a new anxiety intervention for autistic children
AbstractBackgroundMental health difficulties are common for autistic people; however, almost no interventions have been co‐designed with the autistic community. Co‐design has the potential to add important insights from lived experience into intervention design, but there are currently limited examples of how rigorously to undertake this practice. This paper details a worked model of co‐design and its process, focussed on adapting an evidenced parent‐led intervention for non‐autistic child anxiety (HYC), to meet the needs of young autistic children. The aim is to provide an example of co‐design, integrating autistic, parental, academic, clinical, experience and expertise.MethodsUsing prior literature and theory, including Experience‐Based Co‐Design, we developed an iterative and collaborative process between the research team and an expert reference group (ERG). The research team comprised autistic and non‐autistic members. The ERG included parents (autistic and non‐autistic) of autistic children with anxiety problems, autistic adults with experience of anxiety problems, and clinicians with experience supporting autistic children with anxiety problems. The ERG and research team reviewed information from qualitative research interviews with autistic children with anxiety problems and their parents along with information from clinical experience and the academic literature to reach consensus on the adapted intervention design.ResultsThe creation of a truly co‐designed intervention that includes a neurodiversity‐affirmative perspective, alongside CBT techniques. With anxiety problems experienced by autistic children being framed by combining the impacts of being neurodivergent in a neurotypical world, developmental science and well known cognitive behavioural models of child‐anxiety.ConclusionCo‐design can help to integrate multiple perspectives and result in the creation of interventions that are potentially relevant and acceptable to autistic people, their family members, and clinicians.
Direct serotonin release in humans shapes aversive learning and inhibition.
The role of serotonin in human behaviour is informed by approaches which allow in vivo modification of synaptic serotonin. However, characterising the effects of increased serotonin signalling in human models of behaviour is challenging given the limitations of available experimental probes, notably selective serotonin reuptake inhibitors. Here we use a now-accessible approach to directly increase synaptic serotonin in humans (a selective serotonin releasing agent) and examine its influence on domains of behaviour historically considered core functions of serotonin. Computational techniques, including reinforcement learning and drift diffusion modelling, explain participant behaviour at baseline and after week-long intervention. Reinforcement learning models reveal that increasing synaptic serotonin reduces sensitivity for outcomes in aversive contexts. Furthermore, increasing synaptic serotonin enhances behavioural inhibition, and shifts bias towards impulse control during exposure to aversive emotional probes. These effects are seen in the context of overall improvements in memory for neutral verbal information. Our findings highlight the direct effects of increasing synaptic serotonin on human behaviour, underlining its role in guiding decision-making within aversive and more neutral contexts, and offering implications for longstanding theories of central serotonin function.