Abstract Generic descriptions (e.g., ‘girls are emotional’) are argued to play a major role in the development of essentialist reasoning about social categories. Although generics are prevalent across languages, studies exploring if and how generic language leads to essentialism have almost exclusively been conducted in English‐speaking communities and among Western samples. This is a significant limitation as scholars posit that generic language is a universal cue that signals which categories are culturally relevant. However, without research asking whether generics have similar consequences across diverse cultural and linguistic contexts, it is impossible to make a claim of universality. Here, we will fill this gap, by replicating and extending a previous U.S.‐based study assessing the effects of generic language in a sample of Persian‐speaking 6 to 9‐year‐old children ( N = 160) and adults ( N = 160) in Iran. Participants will hear generic (‘Foolies’) or specific (‘This Foolie’) statements (between subjects) that ascribe biological or cultural features to the novel social category of Foolies. We will measure the degree to which exposure to these statements leads to kindhood reasoning (i.e., offering formal explanations for category features) and essentialist reasoning in terms of inheritability. Identifying similar patterns in the Iranian sample as in prior US‐based work will support the hypothesis that generic language signals category importance and licences kindhood but does not contribute directly to reasoning about social categories as biologically inheritable. This work contributes to diversifying the field and critically informs theories of social essentialism.

Abstract: Background: The Psychological Science Accelerator (PSA) recently completed a large-scale moral psychology study using translated versions of the Oxford Utilitarianism Scale (OUS). However, the translated versions have no validity evidence. Objective: The study investigated the structural validity evidence of the OUS across 15 translated versions and produced version-specific validity reports. Methods: We analyzed OUS data from the PSA, which was collected internationally on a centralized online questionnaire . We also collected qualitative feedback from experts for each translated version. Results: For each version, we produced version-specific psychometric reports which include the following: (1) descriptive item and demographics analyses, (2) factor structure evidence using confirmatory factor analyses, (3) measurement invariance testing across languages using multiple-group confirmatory factor analyses and alignment optimization, and (4) reliability analyses using coefficients α and ω.

In this registered report ( N = 423), we investigated in a competitive intergroup context to what extent the perception of targets scoring high in grandiose narcissism varies depending on whether they belong to one’s own group or to an opposing outgroup. In a laboratory study, members of newly formed groups had direct contact with another group and competed for scarce resources. Contrary to our hypothesis, perceivers did not ascribe targets scoring high in narcissistic admiration higher status when they belonged to their ingroup versus the outgroup. Also unexpectedly, they did not like targets scoring high in narcissistic rivalry better when they belonged to their ingroup. Instead, our findings indicate that narcissistic admiration was generally linked to more dominant-expressive behavior and that participants had a stronger inclination to interpret a specific behavior as aggressive when it was shown by a member of the outgroup, rather than a member of the ingroup.

Abstract Objectives We aimed to investigate the effects of directly manipulating response style to simulated voice hearing on emotional and cognitive outcomes in a non‐clinical population. Design A between‐subjects design with one independent variable, response style (with two levels: mindful acceptance vs attentional avoidance). The dependent variables were subjective distress and anxiety (primary outcomes) and performance on a sustained attention task (secondary outcomes). Methods Participants were randomly assigned to one of two response styles (mindful acceptance vs. attentional avoidance). They completed a computerised attention task (continuous performance task) whilst listening to a simulation of voice hearing. Participants rated their experience of anxiety and distress before and after completing the sustained attention task which was used to measure their accuracy and response times. Results One hundred and one participants took part (mindful acceptance ( n  = 54); attentional avoidance ( n  = 47)). There were no statistically significant group differences on post‐test distress and anxiety scores, correct response rate or response times on the computerised attention task. Participants reported a range of different response styles along the spectrum of avoidance to acceptance, but this had no association with their assigned experimental condition. Adherence to task instructions was therefore low. Conclusions We are unable to conclude from this study whether experimentally inducing people to respond to voices under cognitively demanding conditions in an avoidant or accepting way has an impact on their emotional or cognitive outcomes. Further research should focus on the development of more robust and reliable procedures for inducing differences in response style under experimental conditions.

This manuscript is a programmatic Registered Report that is expected to be the basis of two final manuscripts, one of which explores the feedback mechanisms applied researchers adopt in their work and the role of open scholarship in applied research, and the second that focuses upon climate change.

Working together (vs. individually) improves the performance of people from working-class contexts. Consequently, teams with a higher (vs. lower) percentage of individuals from working-class contexts perform better. However, previous research offers two competing mechanisms for this effect. On the one hand, research has provided evidence for a pathway through skills: people from working-class contexts more frequently engage in effective group processes when working together. On the other hand, there is evidence for a pathway through sense of fit: individuals from working-class contexts feel a greater sense of belonging in interdependent settings. In this registered report, we will provide the first simultaneous test of these two proposed mechanisms as the route to successful performance for working-class individuals in teams. Moreover, we will examine if meeting mode—i.e., the extent to which teams work together synchronously (vs. asynchronously)—serves as an important boundary condition for the performance of people from working-class contexts in teams. We hypothesize that the beneficial effects of working together for students from working-class contexts will be diminished when teams work together primarily asynchronously. Lastly, we will provide the first confirmatory test and extension in a real-world collegiate setting where students from working-class contexts are in the majority (in contrast to prior work where they were in the numerical minority). Taken together, this registered report will replicate and extend past research on contextual routes to reduce social class inequalities, and shed light on the mechanisms through which these routes operate.

Objectives: Racial discrimination experiences contribute to health disparities and can influence individuals’ health. Yet, pathways by which discrimination-related experiences affect alcohol craving remain understudied using experimental designs. Additionally, limited research has examined possible differential effects of “major” discrimination and microaggression experiences in everyday life on alcohol craving. This between-groups experiment examined causal effects of everyday racial discrimination on stress, negative emotions, and alcohol craving. We also tested indirect pathways by which discrimination-related experiences were linked to alcohol craving via stress and negative emotions. Method: People of color and Indigenous peoples participated in the study (N=184; Mage=23.90; 47.8% women; 48.9% community adults). Participants were randomized to one of four experimental conditions, in which they experienced in virtual environments either “major” discrimination, microinsult, microinvalidation, or daily hassles unrelated to race/racism. Participants’ levels of stress, negative emotions, and alcohol craving were assessed immediately before and after experimental simulations. Results: Compared to daily hassles unrelated to race/racism, simulated racial discrimination elicited greater stress and negative emotions. Daily hassles caused greater alcohol craving among those who endorsed higher levels of coping motives for drinking. We observed minimal differences in stress and negative emotions across the three racial discrimination conditions, and found no evidence supporting indirect links between racial discrimination and alcohol craving via stress and negative emotions. Conclusion: Everyday racial discrimination—regardless of intensity level—is more stressful than daily hassles unrelated to race/racism. Future research should examine cumulative effects of racial discrimination, and understanding individual difference factors that moderate its immediate and delayed effects.

Evidence about the relationship between lighting and crime is mixed. Although a review of evidence found that improved road/ street lighting was associated with reductions in crime, these reductions occurred in daylight as well as after dark, suggesting any effect was not due only to changes in visual conditions. One limitation of previous studies is that crime data are reported in aggregate and thus previous analyses were required to make simplifications concerning types of crimes or locations. We addressed this issue by working with a UK police force to access records of individual crimes. We used these data to determine whether the risk of crime at a specific time of day is greater after dark than during daylight, using a case and control approach to analyse ten years of crime data. We compared counts of crimes in ‘case’ hours, that are in daylight and darkness at different times of the year, and ‘control’ hours, that are in daylight throughout the year. From these counts we calculated odds ratios as a measure of the effect of darkness on risk of crime. The results supported our three hypotheses: 1) The risk of overall crime occurring after dark was greater than during daylight (OR: 1.28, 95%CI: 1.23–1.34); 2) The risk of crime occurring after dark varied depending on crime category, with five out of fourteen crime categories having odds ratios greater than 1.0; and 3) The risk of crime occurring after dark varied depending on geographical area, with 25 out of 172 Middle Super Output Areas in South Yorkshire having odds ratios greater than 1.0. Our results suggest darkness increases the risk of Bicycle Theft, Burglary, Criminal damage, Robbery – personal, and Vehicle offences, and that some areas may be at more risk of crime occurring after dark than others. These findings suggest the crime types where outdoor lighting may help reduce the risk of crime after dark.

Deciding whether two face photographs depict the same person or not can be a challenging task, and there are substantial individual differences in face matching ability. Far less is known about differences in metacognitive ability; that is, how well people can estimate the quality of their own face matching judgements. The purpose of this Registered Report was to determine the relationship between first-order performance in a face matching task, and three metacognitive measures: metacognitive sensitivity (the information exploited by metacognition), metacognitive efficiency (the quality of metacognitive processing itself), and metacognitive bias (the overall tendency towards high or low confidence). Participants completed a 200-trial unfamiliar face matching task, providing a second-order (metacognitive) confidence rating after each first-order (cognitive) response. Cognitive performance and metacognitive sensitivity showed a substantial positive association (rs = .60), suggesting that they were based on overlapping information, with poorer performers having lower quality information available. Once these differences in the information available to metacognition were accounted for, the quality of metacognitive processing itself (metacognitive efficiency) did not vary systematically with cognitive performance (rs = .00). Moreover, poor performers were not less or more confident overall than good performers, as cognitive performance and metacognitive bias did not correlate significantly (rs = .11). These findings allow us to move beyond consideration of group-level insight and inform regarding individual differences in cognitive and metacognitive abilities.

Construal level theory (CLT) proposes that psychological distance influences the level of abstraction at which something is mentally construed: things perceived as less probable (likelihood distance) or further away from the here (spatial distance), now (temporal distance), or self (social distance) are thought about in more abstract terms. The current study provides replications (two direct and two paradigmatic) that test the core assumptions of CLT, and it explores potential moderators and boundary conditions of the effects. Please read the wiki for information about the project compendium.

Intact cognitive control is critical for goal-directed behavior and is widely studied in healthy and clinical populations using the error-related negativity (ERN). A common assumption in such studies is that ERNs recorded during different experimental paradigms reflect the same construct or functionally equivalent processes and that ERN is functionally distinct from other error-monitoring event-related potentials (ERPs; error positivity [Pe]), other neurophysiological indices of cognitive control (N2), and even other indices unrelated to cognitive control (visual N1). The present registered report represents a replication-plus-extension study of the psychometric validity of cognitive control ERPs (Riesel et al., 2013, Biological Psychology) and evaluated the convergent and divergent validity of ERN, Pe, N2, and visual N1 recorded during three paradigms (flanker, Stroop, Go/no-go). Data from 182 participants were collected from two study sites, and ERP psychometric reliability and validity were evaluated in comparison to ERPs and internalizing and externalizing symptoms. Findings supported replication of convergent and divergent validity of ERN, Pe, and Pe (error minus correct)—these ERPs correlated more with themselves across tasks than with other ERPs measured during the same task. Convergent validity of ERN across tasks was not replicated, despite high internal consistency. ERN was strongly correlated with N2 at levels similar or higher than those in support of convergent validity for other ERPs, although the present study failed to provide evidence of divergent validity for ERN and Pe from N2 or the theoretically-unrelated N1. ERN and ERN were unrelated to internalizing or externalizing symptoms. Present findings underscore the importance of considering the psychometric validity of ERPs as it provides a foundation for interpreting and comparing ERPs across different tasks and studies.

Registered Reports were introduced a decade ago to reduce data dredging and the selective reporting of “statistically significant” results in journal articles. Previous studies have examined the extent to which journals have adopted the procedure and the number of such articles published in these journals. This bibliometric study focuses on the subdiscipline that has most thoroughly adopted the procedure, experimental psychology, and compiles a more complete list of published Registered Reports than used in previous studies and estimates their prevalence in the experimental psychology literature using Web of Science for total article counts. Thirty-six experimental psychology journals were found to have adopted the procedure, but 11 had not published any Registered Reports by the end of 2023. One journal accounted for almost 30% of the 227 Registered Reports, and eight others for a further 50%. Registered Reports represented a small percentage of the total experimental psychology articles published over the period 2013–2023 at 1.2%. Lack of diffusion of Registered Reports through the subdiscipline that has most fully embraced it is likely due to it having little value within the academic incentive system. Future studies would benefit from journals more accurately identifying Registered Reports and the creation of a central registry.

Fear is a universal experience and fuels our response to cope with threat. Persistent fear, after the threat is no longer present, is a central symptom seen in a number of clinical conditions. Exposure therapy, the most common treatment to target fear, aims to reduce fear responses through repeated, controlled exposures to feared situations in the absence of the negative consequence, thus promoting extinction. However, this treatment is by no means effective for all people. This may be due to impaired extinction and the underlying mechanism of inhibitory retrieval. Intentional memory suppression has been shown to be a promising strategy to enhance this underlying inhibitory mechanism. We employed a newly developed paradigm combining aspects of the Think/No-Think procedure with fear extinction. Sixty-eight healthy participants learned 36 strong naturalistic reminder objects for aversive scenes. After learning, half of the objects were paired with an aversive scream (unconditioned stimulus/US). During the extinction phase, while viewing the objects, participants were instructed to repeatedly retrieve (Think instruction) or suppress (No-Think instruction) the corresponding scenes, or passively view the objects (View instruction). We hypothesised that intentional suppression would boost fear extinction, as shown by a reduced US expectancy to threat-conditioned objects that had been subject to memory suppression during extinction training compared to threat-conditioned objects that were passively viewed. Both intentional memory suppression and passive viewing reduced negative valence for upsetting scenes over time. Contrary to our hypothesis, the results indicated that intentional suppression (No-Think instruction) was not more effective in reducing US expectancy and fear than standard extinction (View instruction). Future research should address the limitation of self-reports by using physiological measures and examine whether intentional suppression may impact fear recovery and generalization following a longer extinction delay. The current findings show that, although intentional suppression can support inhibition of memories and reduce their valence, it may not be as effective as standard extinction methods in diminishing fear responses.

Abstract While statistical word learning has been the focus of many studies on monolinguals, it has received little attention in bilinguals. The results of existing studies on statistical word learning in bilinguals are inconsistent, with some research reporting a bilingual advantage over monolinguals but others finding no difference between groups. Thus, our study investigated statistical learning using the cross-situational word learning (CSWL) paradigm between two groups: English–German bilinguals and English monolinguals. Participants (N = 201) learned 1 : 1 mappings (one word maps onto one object) and 1 : 2 mappings (one word maps onto two objects). In contrast to previous studies, we measured learning continuously and analysed trial-by-trial behaviour closely to understand fine-grained learning differences across language groups. Against our predictions, monolinguals generally outperformed bilinguals in word learning regardless of mapping type, and trial-by-trial analyses did not reveal differences in learning as expected. Moreover, language balancedness of bilinguals (operationalized via language entropy) did not account for differences in CSWL performance. These results suggest that any existing word learning advantages may be highly paradigm- and population-specific.

BACKGROUND: Swallowing difficulties (ie, dysphagia) are common among older adults, with a 13% to 54% prevalence. Adequate interventions to improve the swallowing function of older adults would reduce morbidity and enhance health-related quality of life outcomes. Mobile health (mHealth) apps may help alleviate dysphagia symptoms by providing programs that maximize the intensity and frequency of training without requiring high costs or regular clinic visits. OBJECTIVE: The aim of this pilot study was to assess the usability of swallowing training apps by quantitatively and qualitatively evaluating older adults' self-reported data, taking into consideration their educational levels and exposure to mobile technology. We conducted surveys and brief interviews while the participants used a swallowing intervention app we developed. We subsequently identified and resolved individual-specific usability issues to improve future implementation of the app protocol for older persons with swallowing difficulties. METHODS: A total of 11 participants (10 women, 91%; mean age 75.7 years, SD 3.93) from two district-run senior welfare centers took part in this study. The participants were divided into a high-potential group and a low-potential group based on their total number of years of education and smart device usage. To investigate the usability of the app twice (ie, in the second week of the intervention and the postintervention stage), we used mixed methods consisting of both quantitative approaches, namely the System Usability Scale (SUS) and modified Computer Self-Efficacy Scale (mCSES) surveys, and qualitative approaches (ie, interviews). RESULTS: The quantitative results of the SUS and mCSES surveys revealed that the high-potential group was more inclined to adopt and learn new technology than the low-potential group. Specifically, within the high-potential group, a Wilcoxon signed-rank test indicated that the postintervention mCSES scores (median 65.50) were significantly higher than those in the second week of intervention (median 54.00; z=-2.023, P=.04). Additionally, the usability scores in the low-potential group were within the "marginal acceptability" range even after completion of an 8-week intervention program. Qualitative analyses via semi-structured interviews yielded promising outcomes regarding app acceptability, training program utilization, emotional responses, and learning experience. CONCLUSIONS: To the best of the authors' knowledge, this usability and feasibility study is the first report of a swallowing training app designed to improve the swallowing function of older adults. Future research should consider several issues, such as user characteristics, pretraining education, and the intensity and innate characteristics of the intervention program.

BACKGROUND: Specific learning disorder (SLD) of reading skills impacts approximately 7% of children. Speech and reading therapy is currently the gold-standard intervention for improving children's reading abilities. However, intensive interventions are difficult to implement. Recently, numerous studies have investigated the interest of game- and home-based training approaches to enhance children's motivation and facilitate intensive learning activities in home settings. The serious game Poppins Clinical integrates rhythm and specific written language exercises to improve reading skills in children with SLD. OBJECTIVE: This study aimed to assess the noninferiority of Poppins Clinical combined with a reading specialist session once every 2 weeks versus a reading specialist session every week, on the reading skills of children with SLD. METHODS: A total of 306 children with dyslexia will be recruited for this study and randomly assigned to either the experimental or control group. Children in the experimental group will use the serious game Poppins Clinical at home for 20 minutes, 5 days a week, and attend 1 reading therapy session every 2 weeks. The control group will participate in one reading therapy session per week. Poppins Clinical combines rhythm and language exercises integrated into an engaging game designed to maintain user motivation. We will use a noninferiority paradigm to assess the clinical impact of both interventions in terms of reading accuracy, reading speed, and reading comprehension. We will also investigate the evolution of phonological and visual-attentional skills. However, we will explore the impact of the protocol on parental stress and children's perception of their difficulties. Finally, we will also assess the cost of medical care and the impact of introducing the serious game Poppins Clinical on reading therapy. To facilitate recruitment and ensure the representativeness of our sample, the evaluation of the children will be conducted via videoconference using standardized tests that have been adapted for videoconference administration. RESULTS: Patient recruitment is expected to start in December 2024, with study completion by the end of August 2025. CONCLUSIONS: This study should allow us to assess the interest in using the serious game Poppins Clinical in addition to reading therapy to improve reading abilities in children with SLD. TRIAL REGISTRATION: ClinicalTrials.gov NCT06592911; https://clinicaltrials.gov/study/NCT06592911. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/71326.

Background: Parkinson disease (PD) has been described and studied extensively in White populations, with little known about how the disease manifests and progresses in patients from the Black community. Studies investigating disease features in Black populations are uncommon, with some suggesting that the Black population with PD is more disabled and has greater disease severity and different clinical features compared with the White population with PD. These health disparities are likely to influence the quality of care for Black patients with PD. Objective: This study aimed to investigate the motor and nonmotor symptoms and quality of life in Black and White participants with PD in a case-case design. Methods: This is an observational, prospective, multicenter, case-case design study. Other aims will investigate the management of PD in Black individuals and the presence of shared or unique genetic risk factors among the Black PD population. A total of 400 Black and 200 White participants with PD will be recruited. Data will be collected at 7 US sites and entered into a Research Electronic Data Capture database. Linear multivariate regression analysis will be used, except for comparing PD management, which will be analyzed using the chi-square test or Fisher exact test. Bonferroni correction will be applied. This protocol also describes plans for educational programming for clinicians and patients at the end of the study in partnership with national PD organizations. Results: The Rush Institutional Review Board approved the project as the single-site institutional review board in February 2022, and it was funded by the National Institute of Neurological Disorders and Stroke in April 2022. Recruitment began in July 2022. At the time of submission of this manuscript, 131 participants had been recruited. Conclusions: To our knowledge, this is the largest study of PD phenotype and management in Black patients in the United States. The planned collaboration with the Global Parkinson’s Genetics Program and PD GENEration will enhance our understanding of genetic risk factors for PD in this understudied population.

Many pregnant women do not meet guidelines for physical activity, and women with twin pregnancies are less likely to be physically active compared with singleton pregnancies. During and following pregnancy, physical activity patterns and their related predictors have not been previously explored in women pregnant with twins. Therefore, we aimed to examine stability and change in leisure-time physical activity (LTPA) from pre-pregnancy, during pregnancy, and up to 18 months after childbirth in women pregnant with twins and identify predictors of their LTPA patterns. This study was based on data from a nationwide, prospective cohort study, the Norwegian Mother, Father and Child Cohort Study (1999-2008), and the Medical Birth Registry of Norway. We used latent class growth analysis and logistic regression to identify patterns of LTPA and associated predictors among women pregnant with twins (n = 1,796). Two patterns were identified: low/moderate (53.3%) and high (46.7%). Parity, pre-pregnancy overweight and obesity, and primary education were associated with 36-60% lower odds of belonging to the high LTPA class compared to the low-to-moderate LTPA class. There is an urgent need to study the potential consequences of physical activity in twin pregnancies on maternal and fetal health.

Background: In long-term residential care (LTRC), caregivers’ attempts to provide person-centered care can be challenging when assisting residents living with a communication disorder (eg, aphasia) and/or a language-cultural barrier. Mobile communication technology, which includes smartphones and tablets and their software apps, offers an innovative solution for preventing and overcoming communication breakdowns during activities of daily living. There is a need to better understand the availability, relevance, and stability of commercially available communication apps (cApps) that could support person-centered care in the LTRC setting. Objective: This study aimed to (1) systematically identify and evaluate commercially available cApps that could support person-centered communication (PCC) in LTRC and (2) examine the stability of cApps over 2 years. Methods: We conducted systematic searches of the Canadian App Store (iPhone Operating System platform) in 2015 and 2017 using predefined search terms. cApps that met the study’s inclusion criteria underwent content review and quality assessment. Results: Although the 2015 searches identified 519 unique apps, only 27 cApps were eligible for evaluation. The 2015 review identified 2 augmentative and alternative cApps and 2 translation apps as most appropriate for LTRC. Despite a 205% increase (from 199 to 607) in the number of augmentative and alternative communication and translation apps assessed for eligibility in the 2017 review, the top recommended cApps showed suitability for LTRC and marketplace stability. Conclusions: The recommended existing cApps included some PCC features and demonstrated marketplace longevity. However, cApps that focus on the inclusion of more PCC features may be better suited for use in LTRC, which warrants future development. Furthermore, cApp content and quality would improve by including research evidence and experiential knowledge (eg, nurses and health care aides) to inform app development. cApps offer care staff a tool that could promote social participation and person-centered care.

Background: Adults with autism have a strong desire and need for employment that matches their strengths, skills, and interests. Yet, they are more likely to be un- or underemployed than their neurotypical peers. Facilitators to successful employment include positive attitudes toward and awareness of autism in the workplace, and provision of adequate support and accommodations, including mental health support. Despite previous workplace programs identifying the need for adapted recruitment and interviewing processes, awareness training, and ongoing employee support, there are no programs that specifically provide these supports and adaptations for employees with autism. Objective: In this study protocol, we describe a framework for a new end-to-end supported workplace program for adults with autism that encompasses 8 key areas to promote inclusive workplaces and improve recruitment and retention of employees with autism. Methods: Candidates with autism (n=15) will complete 2 workplace skills training sessions at the University of Sydney’s Brain and Mind Centre, before attending a tailored interview, onboarding session, and paid 12-week placement at consulting firm Ernst and Young (EY). EY managers and colleagues (n=30) will complete a half-day awareness and inclusion training program before supporting the adults with autism through their 12-week placements. Tailored mental health support will also be provided. This mixed methods cohort study will assess the change in the daily functioning and well-being of employees with autism, as well as the change in the managers’ and colleagues’ knowledge, attitude, and confidence in working with adults with autism following the training programs. These changes will be analyzed using repeated measures of ANOVAs. Results: Data collection for this study was completed in February 2022. As of November 2024, data analysis was in progress. This study is expected to be submitted for publication in June 2025. Conclusions: This study holds the potential to enhance the recruitment and retention of adults with autism, as well as their overall experience in the workplace.

Background: There is an ongoing syndemic of HIV and sexually transmitted infections (STIs) in the United States, particularly among men who have sex with men (MSM). We have increasingly effective and diverse measures of prevention, including various types of pre-exposure prophylaxis (PrEP) for HIV prevention and doxycycline postexposure prophylaxis (doxyPEP) for STI prevention. As options expand, we need to understand how to use a combination of these strategies and other supports for MSM to best curb the syndemic. Objective: We designed a patient-preference trial to understand patient preferences for PrEP and doxyPEP, how preferences may change over time, and methods for preventing premature discontinuation of PrEP. Methods: We enrolled HIV-negative MSM in metropolitan Atlanta, Georgia. Participants could elect to take PrEP (daily or on-demand), doxyPEP, both, or neither, along with app-based support to evaluate for risk factors of discontinuation or behavioral changes that might affect their choice of prevention methods. Participants were able to switch prevention methods at any time. Oral PrEP and doxyPEP users are currently being offered quarterly in-person or at-home HIV, syphilis, gonorrhea, and chlamydia testing along with opportunities for motivational interviewing. Results: We enrolled individuals from November 2021 to September 2023. Among 240 participants, the median age was 30 (IQR 25-35), 63% (n=150) self-identified as non-Hispanic Black, and 69% (n=166) were insured. Most participants (n=144, 60%) elected to take daily PrEP plus doxyPEP, with a smaller proportion taking on-demand PrEP plus doxyPEP (n=34, 14%) or daily PrEP without doxyPEP (n=33, 14%). Conclusions: We designed an ongoing study to evaluate the preferences for PrEP and doxyPEP among MSM in metropolitan Atlanta. Enrollment was completed in 22 months and included a diverse cohort of MSM that will be followed longitudinally to evaluate prevention preferences over time. At baseline, most participants preferred to take a combination of daily PrEP and doxyPEP for HIV and STI prevention. Trial Registration: Clinicaltrials.gov NCT05072093; https://clinicaltrials.gov/study/NCT05072093

Background: Wearable activity monitors are increasingly used to characterize physical behavior. The development and validation of these characterization methods require criterion-labeled data typically collected in a laboratory or simulated free-living environment, which does not generally translate well to free-living due to limited behavior engagement in development that is not representative of free living. Objective: The Free-Living Physical Activity in Youth (FLPAY) study was designed in 2 parts to establish a criterion dataset for novel method development for identifying periods of transition between activities in youth. Methods: The FLPAY study used criterion measures of behavior (direct observation) and energy expenditure (indirect calorimetry) to label data from research-grade accelerometer-based devices for the purpose of developing and cross-validating models to identify transitions, classify activity type, and estimate energy expenditure in youth aged 6-18 years. The first part of this study was a simulated free-living protocol in the laboratory, comprising short (roughly 60-90 s) and long (roughly 4-5 min) bouts of 16 activities that were completed in various orders over the span of 2 visits. The second part of this study involved an independent sample of participants who agreed to be measured twice (2 hours each time) in free-living environments such as the home and community. Results: The FLPAY study was funded from 2016 to 2020. A no-cost extension was granted for 2021. A few secondary outcomes have been published, but extensive analysis of primary data is ongoing. Conclusions: The 2-part design of the FLPAY study emphasized the collection of naturalistic behaviors and periods of transition between activities in both structured and unstructured environments. This filled an important gap, considering the traditional focus on scripted activity routines in structured laboratory environments. This protocol paper details the FLPAY procedures and participants, along with details about criterion datasets, which will be useful in future studies analyzing the wealth of device-based data in diverse ways.

The development of the minimal self - distinguished in the facets sense of agency, body ownership, and interoception – has recently gained attention in developmental science. While research proposes the presence of minimal self facets in young children, interrelations among the three facets and cognitive mechanisms driving their development remain debated. Current theories suggest that minimal self facets are dynamic and plastic, affected by top-down processes and cognitive representations. To advance developmental theorizing, the present registered report had four aims. It a) examined how strongly the three minimal self facets are related, and b) investigated the impact of one central cognitive process – the internal working model (IWM) of attachment – on young children’s explicit self, and c), their minimal self. Furthermore, it d) explored whether the impact of the IWM is particularly strong in emotional contexts. A total of 120 fiveyear-old children from an urban German area participated. Established measures were used to assess all three minimal self facets, explicit selfconcept, and dimensional security of attachment IWM. We found no significant relations between the three minimal self facets and no prediction of minimal self facets by attachment security. Thus, the study provides no evidence for an influence of attachment IWM on minimal self facets in childhood. Exploratory analyses showed a relation between attachment categories and the malleability of sense of body ownership suggesting that a categorical approach to attachment is relevant for considerations of minimal self facets. We suggest that future research should integrate the sensorimotor grounding of attachment.

Background: Dental students’ competencies are shaped by their training, yet traditional methods with mannequins often lack the depth necessary for comprehensive understanding, potentially impacting clinical proficiency. Immersive reality (IR) innovatively offers interactive and scenario-based environments that may enhance skill acquisition. Objective: This study evaluates the effectiveness of IR-based training implementation in comparison with conventional training methods for dental extractions. Methods: A prospective multicenter randomized clinical trial was conducted. Students were randomized to either IR-based training on open and closed extractions or conventional hands-on tutorials by oral surgeons. Post training, participants’ satisfaction and understanding were assessed and analyzed. Results: As of September 2025, 60 students from Hasanuddin University, Makassar, and Padjajaran University, Bandung, have been enrolled, and study enrollment will be expanded to Universitas Sumatera Utara, Medan. Data collection is ongoing and will conclude in November 2025, with expected dissemination in early 2026. Conclusions: IR-based training offers a novel approach that may boost motivation, knowledge retention, and skill transfer in dental education. This pilot protocol explores IR’s feasibility and potential to advance dental students’ competencies. Trial Registration: Indonesian Clinical Research Registry INA-QES4CC5; https://ina-crr.kemkes.go.id/en/studi/207 International Registered Report Identifier (IRRID): DERR1-10.2196/74978

Background: Electronic gambling machines and online gambling are the reputedly most damaging gambling type from a public health perspective. Pop-up messages are often used as a responsible gambling (RG) measure to prevent harm for these screen-based types of gambling. Despite some evidence of effectiveness in the literature for these messages, limitations persist, among which low ecological validity is of particular concern. Objective: This study aims to test (1) the potential of pop-up messages as a prevention measure in a gambling setting and (2) whether this potential is moderated by characteristics of people exposed to the messages. Secondary objectives also tackle some fundamental assumptions of gambling studies conducted in a laboratory setting. Methods: This is a 2-arm stratified block randomized controlled study. In total, 80 participants are recruited under the false pretense of evaluating the realism of a gambling session in a laboratory replicating a bar. Duplicity is also used to make participants believe that they are risking their own money during the experimentation (ie, winnings and losses are real). Participants are randomized to one of the two arms in a 1:1 ratio: (1) experimental group (regular gambling session with prevention pop-up messages presented on a fixed schedule) and (2) active control group (regular gambling session). Outcomes measures include behaviors and cognitive and emotional responses to the pop-up messages. The believability of the gambling session’s realism is also evaluated. Results: Recruitment began in February 2024 and concluded in December 2024. Results are expected to be published in 2026. No results are currently available. Conclusions: This study will provide new insights on the efficacy of pop-up messages as a prevention measure for gambling as well as the appropriateness of laboratory studies as a substitute to a real-life setting.

Abstract Single-cell multimodal omics technologies have empowered the profiling of complex biological systems at a resolution and scale that were previously unattainable. These biotechnologies have propelled the fast-paced innovation and development of data integration methods, leading to a critical need for their systematic categorisation, evaluation, and benchmark. Navigating and selecting the most pertinent integration approach poses a significant challenge, contingent upon the tasks relevant to the study goals and the combination of modalities and batches present in the data at hand. Understanding how well each method performs multiple tasks, including dimension reduction, batch correction, cell type classification and clustering, imputation, feature selection, and spatial registration, and at which combinations will help guide this decision. This study develops a much-needed guideline on choosing the most appropriate method for single-cell multimodal omics data analysis through a systematic categorisation and comprehensive benchmarking of current methods. The Stage 1 protocol for this Registered Report was accepted in principle on 30th July 2024. The protocol, as accepted by the journal, can be found at https://springernature.figshare.com/articles/journal_contribution/Multi-task_benchmarking_of_single-cell_multimodal_omics_integration_methods/26789902 .

Background: Pediatric asthma is the most common chronic illness among children in the Netherlands. Scheduled hospital visits provide limited insight into therapy adherence and inhalation technique, which are critical for disease control. Smart inhalers that provide immediate feedback may offer a solution for monitoring and improving these parameters at home, leading to better asthma control. Objective: This study aimed to improve asthma control through immediate feedback on therapy adherence and inhalation technique, with the use of a smart inhaler. Methods: The IMAGINE (Improving Adherence by Guiding Inhalation via Electronic Monitoring) study was a randomized controlled trial consisting of 3 phases: an observational run-in phase in which adherence and technique were recorded, a randomized phase with feedback for the intervention group and recording for the control group, followed by an observational phase with only recording for both groups. Asthma control was measured with clinical outcomes including predicted forced expiratory volume in 1 second, lung function reversibility, lung function variability, the Asthma Control Test, and the Childhood Asthma Control Test. Results: Between October 2019 and October 2023, a total of 34 children were enrolled and randomized. Overall, improvements were observed at the end of phase 2 in clinical parameters (reversibility, lung function variability, Asthma Control Test, and Childhood Asthma Control Test), except for predicted forced expiratory volume in 1 second. However, no significant differences between the intervention and control groups over time were observed. At the end of phase 2, 87% (13/15) of control participants and 78% (10/13) of intervention participants met one or more predefined clinical criteria. Inhalation technique and therapy adherence did not differ over time between the groups (P=.70 and P=.14, respectively). Conclusions: While smart inhaler feedback did not lead to better outcomes compared with no feedback, clinical improvements were observed in both groups. Future studies should explore how adaptive smart inhaler interventions can be optimized to support personalized care and enhance patient ownership in asthma management.

Background: Breast cancer is the most frequently diagnosed cancer among women worldwide and a leading cause of cancer-related mortality. Mammographic screening significantly improves early detection and survival rates. However, the pain and discomfort experienced during mammography, primarily due to breast compression, can serve as major deterrents to participation in routine screening programs. Psychological factors such as anxiety, fear, and pain catastrophizing have been shown to influence pain perception and the experience during mammography. These factors may affect women's decisions to participate in or avoid screening, undermining public health efforts for early detection. Objective: This study aims to synthesize the scientific literature on the psychological factors influencing pain perception and experience in women undergoing mammography. Methods: The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) will be followed in this review. This review will include all the studies that provided psychological factors. Full-text articles will be sourced from the following databases: Scopus and PubMed, published in peer-reviewed and indexed journals. There will be no restrictions on publication dates. Grey literature will be excluded. The search strategy will be developed using keywords and Boolean operators tailored for each database. The JBI Critical Appraisal Checklist will be used to assess the quality of individual studies. Data analysis will be conducted using narrative synthesis. Any disagreements during the selection of studies will be discussed and resolved by the entire team. Results: We will summarize the selection of the eligible studies using a flowchart. The results will be presented in a table of evidence, and the findings will be submitted for publication in a journal. Conclusions: This is the first systematic review protocol to assess the psychological factors influencing pain perception and experience during mammography. The findings are expected to inform strategies for improving patient compliance. Therefore, the authors plan to publish the review outcome in a peer-reviewed journal.

Background: Research examining the design and impact of health literacy (HL) programs and interventions on preservice teachers’ HL and health and physical education (HPE) teaching practices to enhance students’ HL is nonexistent. However, research indicates that many teachers and preservice teachers report low levels of HL, and recent research has highlighted preservice teachers’ challenges in teaching HPE to enhance their students’ HL capabilities. This is concerning, as HL is a focus in curricula and schooling both in Australia and internationally. Therefore, teachers are engaging in professional development aimed at enhancing their HL teaching practices, which raises questions about how further development of initial teacher education can enhance preservice teachers’ HL capabilities and teaching practices in schools. Objective: This protocol aims to provide details of a study to be conducted in the University of Sydney, involving final-year HPE preservice teachers, aimed at developing their HL capabilities and teaching practices. Methods: The proposed methodology underpinning the research program follows a 7-stage design-based research approach, with the 7 stages outlined in 4 sequential studies. These 4 studies include a systematic review, a qualitative focus group study, a pilot study, and a controlled trial study. This paper details the plan for conducting the 4 studies in a comprehensive and transparent manner, thus contributing to the methodological evidence base in this field. Results: The pilot study was conducted between July 2024 and December 2024, and data analysis was conducted between January 2025 and June 2025. The controlled trial will be conducted between July 2025 and December 2025. Final data analysis will occur between January 2026 and June 2026. Conclusions: This project will assist in determining what key stakeholders see as important to include in an initial teacher education program designed to enhance HPE preservice teachers’ HL capabilities and teaching practices. The design principles generated from this project will contribute to the inclusion and development of initial teacher education programs and practices and strengthen preservice teachers’ HL and their teaching of HPE, thereby enhancing HL teaching practices. This is significant considering that HL is included in the curriculum internationally, and the development of HL for school-age students has been identified as a World Health Organization goal.

Background: Globally, approximately 55 million people are living with dementia. Osteoarthritis occurs in half of all older adults and is associated with pain, depression, and increased dementia risk. Currently, no program exists for people with osteoarthritis and cognitive decline that addresses modifiable risk factors, such as physical inactivity and lifestyle behaviors. Objective: This study aims to examine the feasibility, acceptability, and health outcomes following the 12-week Healthy Body and Mind Program, designed for people with osteoarthritis who are experiencing cognitive decline. The findings will inform the designs of larger trials. Methods: In total, 20 consenting participants aged 45 years or older with osteoarthritis and cognitive decline will be randomly allocated to the 12-week program or a waitlist control group. Feasibility and acceptability will be assessed based on retention and adherence rates to the program, the number of people who provide consent to take part in the study, and evaluation questions following completion of the program. Health outcomes will include quality of life, cognition (global, attention, learning, and memory), pain, psychological health (stress, anxiety, and depression), and physical health. Results: This study has been reviewed and approved by the University of New South Wales Human Research Ethics Committee (HC230506). This project will be carried out according to the National Statement on Ethical Conduct in Human Research (2007). As of October 2025, we have enrolled 18 participants and completed their data collection. Results are expected to be published in peer-reviewed journals during the first quarter of 2026. Participant confidentiality will be maintained in line with ethical considerations. Conclusions: This protocol reports methods to determine feasibility, acceptability, and preliminary health outcome data of the Healthy Body and Mind Program informed by individuals with lived experience of dementia and osteoarthritis. Trial Registration: ClinicalTrials.gov NCT06070818; clinicaltrials.gov/study/NCT06070818 International Registered Report Identifier (IRRID): DERR1-10.2196/75816

Background: The rising burden of chronic diseases among older adults in China underscores the urgent need for an integrated and efficient health care system. Existing services are often fragmented, lacking coordination and accessibility, particularly for urban community-dwelling older adults with multiple comorbidities. There is a critical demand for person-centered integrated care that enables resource sharing, expert guidance, and the safe, continuous management of chronic conditions. Objective: This study aims to extend the theoretical understanding of case-managed integrated care informed by the Program of Research to Integrate the Services for the Maintenance of Autonomy (PRISMA) model within urban Chinese communities. It will examine older adults’ expectations for case-managed integrated care, develop and validate a measurement instrument to quantify these expectations, and build an evidence-based framework to adapt the PRISMA model to the Chinese context. Methods: An exploratory sequential mixed methods design will be used across 3 phases. Phase I involves qualitative interviews with community-dwelling older adults and other stakeholders to explore unmet health care needs and perceptions of case-managed integrated care. Phase II entails the development and psychometric validation of a questionnaire informed by the findings from phase I. Phase III involves a large-scale cross-sectional survey in Wenzhou, Taiyuan, and Hainan to quantify expectations for case-managed integrated care and identify associated sociodemographic factors. A data integration approach will be used to synthesize both qualitative and quantitative findings, providing a comprehensive understanding of expectations regarding the proposed integrated care. Results: Data collection is scheduled to begin in December 2025, with the study expected to last 24 months. Ethics approval has been obtained from the Institutional Ethics Committee. Conclusions: This study seeks to evaluate the feasibility of culturally adapting the PRISMA model for case-managed integrated care to address critical gaps in existing health care service delivery. The findings are expected to inform policy formulation, guide the implementation of integrated community care strategies, and ultimately improve health outcomes and quality of life for older adults in urban China.

Background: In 2022, 54% of people with HIV were aged 50 years and older; however, clinical care for HIV in the United States often falls short of comprehensively integrating care for aging-related conditions. In response, the Health Resources and Services Administration HIV/AIDS Bureau Ryan White HIV/AIDS Program funded a new initiative comprising 10 demonstration sites to test emerging interventions to support people aging with HIV, as well as a capacity-building provider and an evaluation provider. NORC at the University of Chicago received an award for the evaluation provider. Objective: This protocol aimed to describe the application of the Health Resources and Services Administration HIV/AIDS Bureau implementation science (IS) framework to a multisite evaluation, a related evaluation protocol, the technical assistance provided to support the evaluation, and the initiative’s dissemination plan. Methods: Using a theory-based approach, NORC developed a mixed methods evaluation plan using an IS hybrid type 2 study with two main aims: (1) to describe implementation outcomes and (2) to assess client-level outcomes. Implementation outcomes were assessed at the organizational level using tools including a survey of site characteristics, key informant interviews, and documentation of monthly monitoring calls and costs. Client-level outcomes were assessed through a survey and a medical chart abstraction tool. NORC also collected data on the sites’ engagement with the capacity-building provider and their satisfaction with the services provided. Results: The evaluation was funded in August 2022. Organizational-level data collection began upon institutional review board approval in April 2023. All sites were enrolling clients in the intervention and evaluation by September 2023, and 626 clients enrolled by December 2023. Data collection is expected to continue through December 2024. Analysis of the baseline results is currently underway, and comprehensive findings are expected by late 2025. Conclusions: To the best of our knowledge, this is the first national study to evaluate emerging clinical interventions for people aging with HIV using an IS framework. The findings will build an evidence base for advancing HIV clinical care to meet the needs of the aging population.

Background: The impact of air pollution on early childhood development in low-pollution settings is well known. However, comprehensive evidence from high-pollution environments such as the Delhi National Capital Region in India remains limited. Objective: This maternal-child cohort study aims to investigate the impact of air pollution on pregnancy outcomes and early childhood development, providing critical insights to inform targeted interventions and public health policy. Methods: This longitudinal maternal-child cohort study will enroll 2500 pregnant women from rural and urban Delhi National Capital Region and follow their children up to 2 years of age. Maternal data on pregnancy complications, delivery mode, parity, and gestational weight gain will be collected from clinical records and structured questionnaires, while newborn outcomes (gestational age, birth weight, anthropometry, and congenital anomalies) will be assessed from birth records and clinical examination. Early childhood development will be evaluated through standardized anthropometry and the Developmental Assessment Scale for Indian Infants. For a 10% subsample, trimester-specific and postnatal indoor and outdoor air pollution exposure (particulate matter with a diameter of less than 2.5 micrometers and particulate matter with a diameter of less than 10 micrometers) will be monitored using portable air quality monitors, along with household surveys and time-activity diaries. Maternal and infant blood samples will be analyzed for inflammatory, oxidative stress, and cardiovascular biomarkers. Exposure estimates will be integrated into personal exposure models, and associations with health outcomes will be examined using multivariable regression and longitudinal mixed-effects models. Results: As of July 2025, 45% of the planned sample size have been recruited, with baseline data collection completed, and 10% undergoing exposure assessment and sample collection. Conclusions: This study will provide a comprehensive evaluation of the effects of air pollution on maternal health, pregnancy outcomes, and early childhood development in urban and rural settings in India. This will generate context-specific evidence to support maternal and child health policies, air pollution mitigation strategies, and personal protection measures for pregnant women and infants in polluted environments.

Background: Hearing impairment (HI) is a common sensory deficit with considerable impacts on social well-being (SWB) in adults. Evidence on the effectiveness of auditory rehabilitation and hearing health education in the social domain of health for individuals with HI is scarce. Objective: This study aims to test the feasibility and efficacy of providing free hearing aids or a combined offline and online hearing health education intervention on social isolation and functioning among Chinese adults with HI. Methods: This study is a 3-arm, single-blinded, randomized controlled trial (RCT) with a follow-up at 24 months after the baseline study. A total of 435 participants aged 18 years and older with some degree of HI will be recruited and randomly assigned to 2 intervention groups and 1 control group. Free hearing-aid provision, as well as a hearing health education program that is combined with online and offline lessons, will be implemented in 2 intervention groups, respectively. The control group will not receive any intervention. The primary outcomes include social isolation and functioning in society. The secondary outcomes include social engagement, a sense of mastery, self-efficacy, psychological resilience, chronic diseases, life satisfaction, hearing health literacy, and hearing care usage. Results: Participants were recruited for hearing tests in September 2022, during which baseline results were collected through in-person interviews. Follow-up interviews were conducted in September 2024. The primary analysis will use ANOVA, linear mixed-effects modeling, structural equation modeling, and cost-effectiveness analysis. Conclusions: The findings of this study will provide evidence for the impact and cost-effectiveness of a community-based auditory or hearing health education intervention on SWB among Chinese adults with HI, which may contribute to promoting hearing health and reducing adverse health consequences in an aging society. Trial Registration: Chinese Clinical Trial Registry ChiCTR2200062148; https://www.chictr.org.cn/showproj.html?proj=174741

Background: End-stage kidney disease (ESKD) or kidney failure is a condition where the kidneys lose the ability to function. African American individuals are 4 times as likely to develop ESKD compared to White American individuals. In addition, African American patients are less likely to have an optimal dialysis start and to choose renal replacement therapy modalities that align with their goals and values. Our prior work shows that culturally tailored, in-person education improves patient outcomes. This is the foundation for our innovative intervention using an African American virtual patient educator as an option for hospitalized patients with chronic kidney disease (CKD). Objective: The Interactive Computer-Adaptive Chronic Kidney Disease (I-C-CKD) study will determine whether the computerized adaptive education and usual hospital care impact the health literacy of African American patients with kidney disease. It will also assess how patients’ lifestyle and commitment to health goals are impacted by the method of health literacy education. Methods: We will screen, recruit, and enroll hospitalized patients who self-identify as African American and have advanced CKD based on their estimated glomerular filtration rate. Eligible patients who verbally consented will be randomly assigned into either the computerized adaptive education intervention group or the control group (usual hospital care). Patients in the intervention group will receive a culturally tailored, adaptive education module. To analyze pretest, posttest, and follow-up survey results on patient CKD knowledge, ESKD treatment options, and health goals, we will use a paired, 2-tailed t test with a Bonferroni adjustment for multiple comparisons. Results: Recruitment for the I-C-CKD study began on May 2, 2023. We are currently recruiting and have enrolled 96 patients who completed both pretest and posttest surveys as of December 2024. This includes 50 patients in the control group and 46 patients in the intervention group. Data analysis has not occurred. Conclusions: African American individuals often receive less patient education about self-care and treatment options for CKD. We hope this study provides a solution to increase hospitalized African American patients’ knowledge of CKD and motivation for CKD self-care through computerized adaptive education, reduce disparities, and improve patient outcomes. Trial Registration: ClinicalTrials.gov NCT06364358; https://clinicaltrials.gov/study/NCT06364358

Background: HIV preexposure prophylaxis (PrEP) has potential for preventing HIV during the perinatal period, but few strategies promote person-centered shared decision-making (SDM) about PrEP use in these contexts. The MyChoice study aims to evaluate the feasibility, acceptability, and appropriateness of an SDM approach to support pregnant and breastfeeding women in Lilongwe, Malawi, integrating PrEP into antenatal care to encourage consistent use. Objective: Two pilot studies will assess the feasibility, acceptability, and appropriateness of an SDM intervention to support pregnant and breastfeeding women in making informed HIV prevention choices. The intervention will also explore the perspectives of participants, their male partners, and implementers. Each study compares the MyChoice intervention to standard-of-care PrEP counseling, with different HIV prevention method choices available. Methods: We will conduct 2 pilot randomized trials to evaluate the MyChoice intervention, designed to support PrEP decision-making among pregnant women in Lilongwe. Both studies will compare the MyChoice intervention to standard-of-care PrEP counseling. Study 1 will include 100 participants who will be offered oral PrEP and condoms for 3 months. Study 2 will include 50 participants who will be offered oral PrEP or injectable long-acting cabotegravir and condoms for 2 months. The primary end points for MyChoice study 1 are intervention acceptability, intervention appropriateness, and intervention feasibility, whereas for MyChoice study 2 they are intervention acceptability and intervention appropriateness. The secondary end point for MyChoice study 1 is decisional conflict, and for MyChoice study 2, it is the feasibility of study procedures. Exploratory end points include PrEP uptake assessment and dried blood spot measurement of PrEP adherence for MyChoice study 1 and PrEP uptake assessment for MyChoice study 2. Results: Data collection started on July 30, 2024, for study 1 and on February 10, 2025, for study 2. A total of 100 participants were enrolled in MyChoice study 1, and 50 participants were enrolled in MyChoice study 2. Study follow-up has been completed. Data analysis is expected to be completed by November 2025. Conclusions: The MyChoice pilot studies will provide critical evidence on a novel intervention for PrEP decision-making during pregnancy and breastfeeding. If feasible and acceptable, these results will form the basis for larger efficacy trials to promote PrEP uptake during pregnancy.

Background: Obsessive-compulsive disorder (OCD) is a chronic mental health condition, and standard treatment often results in incomplete symptom relief. Growing evidence suggests that nutritional supplements, including vitamins, minerals, and amino acids, may serve as potential adjunctive treatments for OCD by influencing neurotransmitter regulation and inflammation. Objective: Our systematic review aims to assess the comparative efficacy of nutritional supplements on relevant clinical outcomes in individuals with OCD. Methods: A protocol was developed and registered for this systematic review. Randomized controlled trials assessing the efficacy of nutritional supplementation compared with standard treatments (pharmacological and psychological interventions) will be included. Primary outcomes are changes in cognitive performance, quality of life, and psychiatric symptoms. Secondary outcomes include the presence of comorbidities or multimorbidities (eg, metabolic syndrome). Systematic searches will be conducted in MEDLINE, Embase, CENTRAL, and ClinicalTrials.gov from their inception onward. Two independent researchers will screen the citations and full-text studies. The risk of bias and study quality will be evaluated using validated tools, and association measures with 95% CIs will be calculated. Potential sources of heterogeneity will also be analyzed. Results: The search commenced in January 2025. Between June and August 2025, studies were identified and the full texts reviewed. Data extraction is anticipated to be completed in September 2025. The final synthesis is scheduled for December 2025. Conclusions: We aim to address the gaps in the current treatment paradigm for OCD by evaluating the efficacy of nutritional supplementation as an adjunctive therapy. These findings may provide insights into the potential of these supplements to improve cognitive and psychiatric outcomes. This protocol establishes a foundation for the rigorous synthesis of available evidence, which may inform future clinical practices and support the integration of nutritional strategies in OCD management.