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Objective: Fraudulent participation is an escalating concern for online clinical trials and research studies and can have a significant negative impact on findings. We aim to shed light on the risk and to provide practical recommendations for detecting and managing such instances. Methods: The FREED‐Mobile (FREED‐M) study is an online, randomized controlled feasibility trial to assess a digital early intervention for young people (aged 16–25) in England or Wales with eating problems. The trial involved baseline (week 0), post‐intervention (week 4), and follow‐up (week 12) surveys, alongside weekly modules provided over 4 weeks on the study website. Study completers were compensated with £20 shopping vouchers. Despite the complexity of the trial design, two instances of fraudulent sign‐ups occurred in January and March 2023. To counter this, we developed a "fraudulent participants protocol" following internal investigations and discussions with collaborators. Results: The implementation of prevention measures such as reCAPTCHA updates, IP address review, and changes in reimbursement effectively halted further fraudulent sign‐ups. Our protocol facilitated the systematic identification and withdrawal of suspected or clear fraudsters and was demonstrably robust at distinguishing between fraudsters and genuine responders. Discussion: All remote, online trials or studies are at risk of fraudulent participation. Drawing from our experience and existing literature, we offer practical recommendations for researchers considering online recruitment and data collection. Vigilance and the integration of deterrents, and data quality checks into the study design from the outset are advised to safeguard research integrity. Public Significance: Fraudulent participation in digital research can have asignificant impact on research findings, potentially leading to biased resultsand misinformed decisions. We developed an effective protocol for theprevention, identification, and management of fraudulent participants. Bysharing our insights and recommendations, we hope to raise awareness of thisissue and provide other researchers with the knowledge and strategies necessaryto safeguard research integrity moving forward. [ABSTRACT FROM AUTHOR]

Objective: The United Kingdom Eating Disorders Genetics Initiative (EDGI UK), part of the National Institute for Health and Care Research (NIHR) Mental Health BioResource, aims to deepen our understanding of the environmental and genetic etiology of eating disorders. EDGI UK launched in February 2020 and is partnered with the UK eating disorders charity, Beat. Multiple EDGI branches exist worldwide. This article serves the dual function of providing an in‐depth description of our study protocol and of describing our initial sample including demographics, diagnoses, and physical and psychiatric comorbidities. Method: EDGI UK recruits via media and clinical services. Anyone living in England, at least 16 years old, with a lifetime probable or clinical eating disorder is eligible to sign up online: edgiuk.org. Participants complete online questionnaires, donate a saliva sample for genetic analysis, and consent to medical record linkage and recontact for future studies. Results: As of September 2022, EDGI UK recruited 7435 survey participants: 98% female, 93.1% white, 97.8% cisgender, 65.9% heterosexual, and 52.1% have a university degree. Over half (57.8%) of these participants have returned their saliva DNA kit. The most common diagnoses are anorexia nervosa (48.3%), purging disorder (37.8%), bulimia nervosa (37.5%), binge‐eating disorder (15.8%), and atypical anorexia nervosa (7.8%). Conclusion: EDGI UK is the largest UK eating disorders study and efforts to increase its diversity are underway. It offers a unique opportunity to accelerate eating disorder research. Researchers and participants with lived experience can collaborate on projects with unparalleled sample size. Public Significance Statement: Eating disorders are debilitating and costly for society but are under‐researched due to underfunding. EDGI UK is one of the largest eating disorder studies worldwide with ongoing recruitment. The collected data constitute a resource for secondary analysis. We will combine data from all international EDGI branches and the NIHR BioResource to facilitate research that improves our understanding of eating disorders and their comorbidities. [ABSTRACT FROM AUTHOR]

Background: While studies from the start of the COVID-19 pandemic have described initial negative effects on mental health and exacerbating mental health inequalities, longer-term studies are only now emerging. Method: In total, 34 465 individuals in the UK completed online questionnaires and were re-contacted over the first 12 months of the pandemic. We used growth mixture modelling to identify trajectories of depression, anxiety and anhedonia symptoms using the 12-month data. We identified sociodemographic predictors of trajectory class membership using multinomial regression models. Results: Most participants had consistently low symptoms of depression or anxiety over the year of assessments (60%, 69% respectively), and a minority had consistently high symptoms (10%, 15%). We also identified participants who appeared to show improvements in symptoms as the pandemic progressed, and others who showed the opposite pattern, marked symptom worsening, until the second national lockdown. Unexpectedly, most participants showed stable low positive affect, indicating anhedonia, throughout the 12-month period. From regression analyses, younger age, reporting a previous mental health diagnosis, non-binary, or self-defined gender, and an unemployed or a student status were significantly associated with membership of the stable high symptom groups for depression and anxiety. Conclusions: While most participants showed little change in their depression and anxiety symptoms across the first year of the pandemic, we highlight the divergent responses of subgroups of participants, who fared both better and worse around national lockdowns. We confirm that previously identified predictors of negative outcomes in the first months of the pandemic also predict negative outcomes over a 12-month period. [ABSTRACT FROM AUTHOR]

Background: There is substantial variation in patient symptoms following psychological therapy for depression and anxiety. However, reliance on endpoint outcomes ignores additional interindividual variation during therapy. Knowing a patient's likely symptom trajectories could guide clinical decisions. We aimed to identify latent classes of patients with similar symptom trajectories over the course of psychological therapy and explore associations between baseline variables and trajectory class. Methods: Patients received high-intensity psychological treatment for common mental health problems at National Health Service Improving Access to Psychological Therapies services in South London (N = 16 258). To identify trajectories, we performed growth mixture modelling of depression and anxiety symptoms over 11 sessions. We then ran multinomial regressions to identify baseline variables associated with trajectory class membership. Results: Trajectories of depression and anxiety symptoms were highly similar and best modelled by four classes. Three classes started with moderate-severe symptoms and showed (1) no change, (2) gradual improvement, and (3) fast improvement. A final class (4) showed initially mild symptoms and minimal improvement. Within the moderate-severe baseline symptom classes, patients in the two showing improvement as opposed to no change tended not to be prescribed psychotropic medication or report a disability and were in employment. Patients showing fast improvement additionally reported lower baseline functional impairment on average. Conclusions: Multiple trajectory classes of depression and anxiety symptoms were associated with baseline characteristics. Identifying the most likely trajectory for a patient at the start of treatment could inform decisions about the suitability and continuation of therapy, ultimately improving patient outcomes. [ABSTRACT FROM AUTHOR]

Similarly, higher body mass index was found to associate independently with increased susceptibility to SARS-CoV-2 infection and COVID-19, and higher titres of anti-S antibodies following COVID-19 and vaccination against SARS-CoV-2.[7],[9],[10] The mechanisms underlying these associations are also worthy of investigation. Follow-up online questionnaires capturing incident symptoms of COVID-19 and other acute respiratory infections, incident swab test-confirmed COVID-19, doses of SARS-CoV-2 vaccine received and quality of life are completed at monthly intervals. A major strength is that COVIDENCE UK was established specifically in response to the SARS-CoV-2 outbreak; thus, in contrast to previously established cohort studies, our questionnaires were tailored to capture potential risk factors and incident symptoms of COVID-19. Key Features The COVIDENCE UK cohort was established to investigate risk factors for, and impacts of, COVID-19 in UK residents aged >=16 years. [Extracted from the article]

Objective: The disruption caused by the COVID‐19 pandemic has been associated with poor mental health, including increases in eating disorders and self‐harm symptoms. We investigated risk and protective factors for the new onset of these symptoms during the pandemic. Method: Data were from the COVID‐19 Psychiatry and Neurological Genetics study and the Repeated Assessment of Mental health in Pandemics Study (n = 36,715). Exposures were socio‐demographic characteristics, lifetime psychiatric disorder, and COVID‐related variables, including SARS‐CoV‐2 infection/illness with COVID‐19. We identified four subsamples of participants without pre‐pandemic experience of our outcomes: binge eating (n = 24,211), low weight (n = 24,364), suicidal and/or self‐harm ideation (n = 18,040), and self‐harm (n = 29,948). Participants reported on our outcomes at frequent intervals (fortnightly to monthly). We fitted multiple logistic regression models to identify factors associated with the new onset of our outcomes. Results: Within each subsample, new onset was reported by: 21% for binge eating, 10.8% for low weight, 23.5% for suicidal and/or self‐harm ideation, and 3.5% for self‐harm. Shared risk factors included having a lifetime psychiatric disorder, not being in paid employment, higher pandemic worry scores, and being racially minoritized. Conversely, infection with SARS‐CoV‐2/illness with COVID‐19 was linked to lower odds of binge eating, low weight, and suicidal and/or self‐harm ideation. Discussion: Overall, we detected shared risk factors that may drive the comorbidity between eating disorders and self‐harm. Subgroups of individuals with these risk factors may require more frequent monitoring during future pandemics. Public Significance: In a sample of 35,000 UK residents, people who had a psychiatric disorder, identified as being part of a racially minoritized group, were not in paid employment, or were more worried about the pandemic were more likely to experience binge eating, low weight, suicidal and/or self‐harm ideation, and self‐harm for the first time during the pandemic. People with these risk factors may need particular attention during future pandemics to enable early identification of new psychiatric symptoms. [ABSTRACT FROM AUTHOR]