Introduction Colorectal cancer (CRC) screening rates are lower among immigrant populations in the United States (US) than the general population. Immigrant communities face structural barriers that disincentivize their engagement from CRC screening. A growing body of literature has evaluated the effects of interventions aimed at increasing CRC screening engagement among various immigrant groups, but there has not yet been a systematic synthesis of this literature. Objective This review will systematically evaluate quantitative studies assessing the effects of interventions designed to increase CRC screening rates among immigrant populations residing in the US. Methods We will conduct a comprehensive search of English language peer-reviewed and grey literature using specific keywords and database-specific structured vocabulary on interventions to improve CRC screening rates among immigrants published in 7 databases (PubMed, Cochrane Library (Wiley), CINAHL (EBSCO), ClinicalTrials.gov, Embase (Ovid), Scopus (Elsevier), and Web of Science) from January 1, 2000 to December 31, 2024. All studies will be imported into Covidence. Two reviewers will independently screen titles, abstracts, and full-texts for inclusion and exclusion criteria. Pilot screenings and consensus discussions will ensure accuracy and agreement in study selection and data extraction. Iterative data extraction of eligible studies will include critical appraisal using the Risk of Bias 2 (ROB2) for randomized controlled trials, while other study designs will be appraised with the risk of bias in nonrandomized studies of interventions (ROBINS-I) tool. Data synthesis will disaggregate pooled effect estimates by ethnicity, to the extent possible. The study protocol was pre-registered in International Prospective Register of Systematic reviews (PROSPERO): CRD42023488183. Expected outputs This systematic review aims to generate an exhaustive summary of the evidence base, including a description of the intervention methods and settings, target populations, recruitment and retention strategies, partnerships and collaborations, and reported outcomes. The results will provide actionable recommendations for public health practitioners, healthcare providers, and policymakers developing tailored interventions and policies aimed at improving CRC screening uptake among diverse immigrant populations in the US.

BACKGROUND: The development of colorectal neoplasia (precancerous lesions and colorectal cancer [CRC]) is linked to both non-modifiable and modifiable risk factors among average CRC risk populations. However, no longitudinal studies have assessed non-modifiable and modifiable risk factors and colorectal neoplasia risk among above-average risk CRC populations that require regular surveillance colonoscopy. Therefore, this research project will establish a large-scale colonoscopy surveillance dataset that collects lifestyle and clinical data at multiple time points to assess the effect of lifestyle changes over time on colorectal neoplasia risk. METHODS: A prospective follow-up study will be conducted among patients who are enrolled in a South Australian colonoscopy surveillance programme. About 21,000 patients will be invited to take self-reported surveys. Existing programme clinical data will be combined with annual prospectively collected survey data for three consecutive years. Surveys will capture changes in lifestyle patterns over time, including diet, physical activity, sleep quality, smoking habits, and alcohol consumption data at several time points using validated tools. Linear and generalised linear mixed effects models and joint modelling will be used to model continuous, categorical, and a combination of longitudinal and survival data on lifestyle scores and colorectal neoplasia risk, respectively. CONCLUSIONS: This study will be the first to investigate how changes in lifestyle patterns over time influence the development of early precancerous lesions and invasive cancer. Inclusion of high-risk lifestyle factors when recommending colonoscopy surveillance intervals could provide an improved, personalised CRC prevention strategy to reduce colorectal neoplasia incidence and colonoscopy workload in those at above-average risk of developing CRC.

Abstract Background Knee osteoarthritis (OA) is a highly prevalent condition. People with knee OA often have other co-morbidities such as obesity. Exercise is advocated in all clinical guidelines for the management of knee OA. It is often undertaken as a home-based program, initially prescribed by a physiotherapist or other qualified health care provider. However, adherence to home-based exercise is often poor, limiting its ability to meaningfully change clinical symptoms of pain and/or physical function. While the efficacy of short message services (SMS) to promote adherence to a range of health behaviours has been demonstrated, its ability to promote home exercise adherence in people with knee OA has not been specifically evaluated. Hence, this trial is investigating whether the addition of an SMS intervention to support adherence to prescribed home-based exercise is more effective than no SMS on self-reported measures of exercise adherence. Methods We are conducting a two-arm parallel-design, assessor-and participant-blinded randomised controlled trial (ADHERE) in people with knee OA and obesity. The trial is enrolling participants exiting from another randomised controlled trial, the TARGET trial, where participants are prescribed a 12-week home-based exercise program (either weight bearing functional exercise or non-weight bearing quadriceps strengthening exercise) for their knee by a physiotherapist and seen five times over the 12 weeks for monitoring and supervision. Following completion of outcome measures for the TARGET trial, participants are immediately enrolled into the ADHERE trial. Participants are asked to continue their prescribed home exercise program unsupervised three times a week for 24-weeks and are randomly allocated to receive a behaviour change theory-informed SMS intervention to support home exercise adherence or to have no SMS intervention. Outcomes are measured at baseline and 24-weeks. Primary outcomes are self-reported adherence measures. Secondary outcomes include self-reported measures of knee pain, physical function, quality-of-life, physical activity, self-efficacy, kinesiophobia, pain catastrophising, participant-perceived global change and an additional adherence measure. Discussion Findings will provide new information into the potential of SMS to improve longer-term exercise adherence and ultimately enhance exercise outcomes in knee OA. Trial registration Prospectively registered with the Australian New Zealand Clinical Trials Registry. Reference: ACTR N12617001243303 Date/version: August 2019/two

Interpersonal violence is a leading cause of death and disability globally, has immediate and long-term impacts on individuals’ health and wellbeing, and impacts global health care expenditures and national economies. A public health approach to violence prevention is crucial, and addressing risk factors is a key priority. Global research has demonstrated that childhood adversity increases risk of a range of poor outcomes across the lifecourse. This study examined the association between being a victim of child abuse and the risk of physical assault (PA), intimate partner violence (IPV), and sexual violence (SV) victimisation in adulthood.

This pre-registered report explores the safe-haven properties of sovereign currencies under the threat of rare disaster risk. Specifically, it address…

Women are widely assumed to be more talkative than men. Disconfirming this assumption, Mehl et al. (2007) provided the first empirical evidence that men and women do not differ significantly in daily word use, speaking about 16,000 words per day each. However, concerns were raised that their sample was too small to yield precise and generalizable estimates, and too age- and context-homogeneous to permit inferences beyond college students. This project replicates and extends the previous study of binary gender differences in daily word use to address these concerns. Pooling data for 2,197 participants (>5-fold the original sample size) from 22 samples (631,030 ambient audio recordings), it updates the estimates of women and men’s daily word use and evaluates the magnitude of their difference. It further explores the extent to which age (as a marker of developmental processes) and experienced stress (as a marker of biobehavioral coping processes) moderate this difference. Finally, it compares the general, age-, and stress-related gender-difference estimates for objectively-observed talkativeness (i.e., EAR-sampled daily word use) to the gender-difference estimates that emerge when looking at subjectively-rated talkativeness (i.e., self-reports of the respective Big Five Inventory item).

Background: Repetitive transcranial magnetic stimulation (rTMS) and cervical vagus nerve stimulation (VNS) are both FDA approved for the treatment of major depression, while transauricular VNS (taVNS) remains an experimental treatment for depression. VNS stimulates the temporary release of neurotransmitters that promote plasticity, such as acetylcholine and norepinephrine, across the cortex. Theoretically, synchronizing rTMS with VNS could enhance neuroplasticity, potentially providing an additive effect in the treatment of depression. Methods: Our goal is to determine the safety and efficacy of simultaneous VNS and rTMS treatment in patients with treatment-resistant depression. 24 participants with treatment-resistant depression will receive 12 sessions of VNS and sham theta burst rTMS, 12 sessions of unsynchronized VNS and theta burst rTMS (600 pulses per session at 90% resting motor threshold), and 12 sessions of synchronized VNS and rTMS (600 pulses per session at 90% resting motor threshold) in a randomized order. Subjects receive VNS cutaneously through transauricular stimulation if they are new to VNS, or through cervically implanted VNS devices in those who already have a device. Patient Health Questionnaire-9 (PHQ-9 and Hamilton Depression Rating Scale (HDRS) scores are gathered before, during, and up to one month after the trial. Conclusion: To date 4 participants with moderate to severe treatment resistant depression have completed the study. Preliminary findings suggest that combining the two methods is safe and feasible, and 12 sessions of synchronized VNS and rTMS are more effective at acutely reducing depressive symptoms.

Creative thinking is the ability to produce responses that are both original and useful. Like other complex thinking processes, creative thinking draws on higher-order cognitive resources. The impacts of feedback, cognitive load, and self-efficacy on traditional complex thinking activities are well documented; however, little is known about how these factors influence creative thinking, which is unique in its requirement of originality. We investigated the impacts of social comparison performance feedback and creative self-efficacy on cognitive load during two creative thinking (divergent thinking) tasks. Higher creative self-efficacy was associated with lower cognitive load during creative thinking. Positive feedback was associated with lower cognitive load compared to negative feedback. Higher cognitive load negatively impacted creative thinking performance, and the impacts of creative self-efficacy and performance feedback on creative thinking were partially mediated by cognitive load. Implications for providing feedback to students during creative thinking tasks are discussed.

Female role models in video games are rare, and if they are present, they are often heavily sexualized. Objectification theory suggests that exposure to sexualized media characters increases self-objectification and decreases body satisfaction in female users. This study investigated the effect of playing a video game with a sexualized versus a nonsexualized character on women's experiences of self-objectification and body satisfaction. We further studied the effect of character personalization as a core feature of video games on the relation between sexualized avatars, self-objectification and body satisfaction. N = 262 female participants reported state self-objectification and body satisfaction after 30 min of playing the video game The Sims 4 with a sexualized or nonsexualized avatar that was either generic or personalized to look like the participant. We predicted that controlling for trait self-objectification, playing the game with a sexualized character would increase state self-objectification, especially in the personalized condition. Regarding the effect of character sexualization on body satisfaction, competing hypotheses based on priming vs. the Proteus effect were tested, considering character personalization and enjoyment of sexualization as moderators and controlling for trait body satisfaction. The current study did not find evidence for the proposed hypotheses. The findings are discussed in terms of the relevance of objectification theory in explaining effects of sexualized models in interactive media.

Recent findings demonstrated readers' sensitivity to the distinction between consonant and vowel letters. Especially, the way consonants and vowels are organised within written words determines their perceptual structure. The present work attempted to overcome two limitations of previous studies by examining the neurophysiological correlates of this perceptual structure through magnetoencephalography (MEG). One aim was to establish that the extraction of vowel-centred units takes place during early stages of processing. The second objective was to confirm that the vowel-centred structure pertains to the word recognition system and may constitute one level in a hierarchy of neural detectors coding orthographic strings. Participants performed a cross-case matching task in which they had to judge pairs of stimuli as identical or different. The critical manipulation concerned pairs obtained by transposing two letters, so that the vowel-centred structure was either preserved (FOUVERT-fovuert, two vowel letter clusters) or modified (BOUVRET-bovuret). Mismatches were detected faster when the structure was modified. This effect was associated with a significant difference in evoked neuromagnetic fields extending from 129 to 239 msec after the stimulation. Source localization indicated a significant effect in the visual word form area around 200 msec. The results confirm the hypothesis that the vowel-centred structure is extracted during the early phases of letter string processing and that it is encoded in left fusiform regions devoted to visual word recognition.

It has often been suggested that visual illusions affect perception but not actions such as grasping, as predicted by the “two-visual-systems” hypothesis of Milner and Goodale (1995, The Visual Brain in Action, Oxford University press). However, at least for the Ebbinghaus illusion, relevant studies seem to reveal a consistent illusion effect on grasping (Franz & Gegenfurtner, 2008. Grasping visual illusions: consistent data and no dissociation. Cognitive Neuropsychology). Two interpretations are possible: either grasping is not immune to illusions (arguing against dissociable processing mechanisms for vision-for-perception and vision-for-action), or some other factors modulate grasping in ways that mimic a vision-for perception effect in actions. It has been suggested that one such factor may be obstacle avoidance (Haffenden Schiff & Goodale, 2001. The dissociation between perception and action in the Ebbinghaus illusion: nonillusory effects of pictorial cues on grasp. Current Biology, 11, 177–181). In four different labs (total N = 144), we conducted an exact replication of previous studies suggesting obstacle avoidance mechanisms, implementing conditions that tested grasping as well as multiple perceptual tasks. This replication was supplemented by additional conditions to obtain more conclusive results. Our results confirm that grasping is affected by the Ebbinghaus illusion and demonstrate that this effect cannot be explained by obstacle avoidance.

In this study, we propose a pre-registered replication of the research conducted by ten Brinke & Porter (2012). Their study identified four behavioural cues to deception that could distinguish deceptive murderers from genuinely distressed relatives, pleading for the safe return of a missing person, with a high degree of accuracy. By replicating this research using a new sample, we aim to assess the generalizability of these findings and provide further insights into the reliability of behavioral cues in distinguishing between deceptive and genuine pleaders.

According to the Two-Factor theory of delusional belief (see e.g. Coltheart at al., 2011), there exists a cognitive system dedicated to the generation, evaluation, and acceptance or rejection of beliefs. Studies of the neuropsychology of delusion provide evidence that this system is neurally realized in right dorsolateral prefrontal cortex (rDLPFC). Furthermore, we have shown that convincing analogues of many specific delusional beliefs can be created in nonclinical subjects by hypnotic suggestion and we think of hypnosis as having the effect of temporarily interfering with the operation of the belief system, which allows acceptance of the delusional suggestions. If the belief system does depend on rDLPFC, then disrupting the activity of that region of the brain by the application of repetitive transcranial magnetic stimulation (rTMS) will increase hypnotizability. Dienes and Hutton (2013) have reported such an experiment except that it was left DLPFC to which rTMS was applied. An effect on a subjective measure of hypnotizability was observed, but whether there was an effect on an objective measure could not be determined. We report two experiments. The first was an exact replication of the Dienes and Hutton experiment; here we found no effect of rTMS to lDLPFC on any hypnotic measure. Our second experiment used rTMS applied to right rather then left DLPFC. This right-sided stimulation enhanced hypnotizability (when hypnotic response was measured objectively), as predicted by our hypothesis. These results imply a role for rDLPFC in the cognitive process of belief evaluation, as is proposed in our two-factor theory of delusion. They are also consistent with a conception of the acceptance of a hypnotic suggestion as involving suspension of disbelief.

There are two general views regarding the organization of object knowledge. The feature-based view assumes that object knowledge is grounded in a widely distributed neural network in terms of sensory/function features (e.g., Warrington & Shallice, 1984), while the category-based view assumes in addition that object knowledge is organized by taxonomic and thematic categories (e.g., Schwartz et al., 2011). Using a functional magnetic resonance imaging (fMRI) adaptation paradigm, we compared predictions from the feature- and category-based views by examining the neural substrates recruited as subjects read word pairs that were identical, taxonomically related, thematically related or unrelated while controlling for the function features involved across the two categories. We improved upon previous study designs and employed an fMRI adaptation task, obtaining results overall consistent with both the category-based and feature-based views. Consistent with the category-based view, we observed for both hypothesized regions of interest (ROI) and exploratory (whole-brain analyses) reduced activity in the left anterior temporal lobe (ATL) for taxonomically related versus unrelated word pairs, and for the exploratory analysis only, reduced activity in the right ATL. In addition, the exploratory analyses revealed reduced activity in the left temporo-parietal junction (TPJ) for thematically related versus unrelated word pairs. Consistent with the feature-based view, we found in the exploratory analyses that activity reduced in the bilateral precentral gyri (i.e., function regions) including part of premotor cortex as the function relatedness ratings increased. However, we did not find a relationship between adaptation effects in the bilateral ATLs and left TPJ and corresponding ratings of taxonomic/thematic relationships suggesting that the adaptation effects may potentially not reflect aspects of taxonomy that have been traditionally assumed. Together, our findings indicate that both feature and category information are important for the organization of object knowledge although the exact nature of those organization principles is an important question for future research.

The generation of gamma-band (>30 Hz) cortical activity is thought to depend on the reciprocal connections of excitatory glutamatergic principal cells with inhibitory GABAergic interneurons. Both in vitro and in vivo animal studies have shown that blockade of glutamatergic α-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid (AMPA) receptors reduces the amplitude of gamma-band activity. In this registered report, we hypothesised that similar effects would be observed in humans following administration of perampanel, a first in class AMPA antagonist, used in the treatment of epilepsy. In a single-blind placebo-controlled crossover study, 20 healthy male participants completed two study days. On one day participants were given a 6 mg dose of perampanel and on the other an inactive placebo. magnetoencephalography (MEG) recordings of brain activity were taken before and two hours after drug administration, with activity in the visual cortex probed using a stimulation protocol known to induce gamma-band activity in the primary visual cortex. As hypothesised, our results indicated a decrease in gamma-band amplitudes following perampanel administration. The decreases in gamma-band amplitudes observed were temporally restricted to the early time-period of stimulus presentation (up to 400 msec) with no significant effects observed on early evoked responses or alpha rhythms. This suggests that the early time-window of induced visual gamma-band activity, thought to reflect input to the visual cortex from the lateral geniculate nucleus, is most sensitive to AMPA blocking drugs.

We investigated whether internal models of the relationship between lip movements and corresponding speech sounds [Auditory-Visual (AV) speech] could be updated via experience. AV associations were indexed by early and late event related potentials (ERPs) and by oscillatory power and phase locking. Different AV experience was produced via a context manipulation. Participants were presented with valid (the conventional pairing) and invalid AV speech items in either a ‘reliable’ context (80% AVvalid items) or an ‘unreliable’ context (80% AVinvalid items). The results showed that for the reliable context, there was N1 facilitation for AV compared to auditory only speech. This N1 facilitation was not affected by AV validity. Later ERPs showed a difference in amplitude between valid and invalid AV speech and there was significant enhancement of power for valid versus invalid AV speech. These response patterns did not change over the context manipulation, suggesting that the internal models of AV speech were not updated by experience. The results also showed that the facilitation of N1 responses did not vary as a function of the salience of visual speech (as previously reported); in post-hoc analyses, it appeared instead that N1 facilitation varied according to the relative time of the acoustic onset, suggesting for AV events N1 may be more sensitive to the relationship of AV timing than form.

The prominent sensory recruitment model argues that visual working memory (WM) is maintained via representations in the same early visual cortex brain regions that initially encode sensory stimuli, either in the identical neural populations as perceptual representations or in distinct neural populations. While recent research seems to reject the former (strong) sensory recruitment model, the latter (flexible) account remains plausible. Moreover, this flexibility could explain a recent result of high theoretical impact (Harrison & Bays, The Journal of Neuroscience, 38 (12), 3116-3123, 2018) – a failure to observe interactions between items held in visual WM – that has been taken to reject the sensory recruitment model. Harrison and Bays (The Journal of Neuroscience, 38 (12), 3116-3123, 2018) tested the sensory recruitment model by comparing the precision of memoranda in radially and tangentially oriented memory arrays. Because perceptual visual crowding effects are greater in radial than tangential arrays, they reasoned that a failure to observe such anisotropy in WM would reject the sensory recruitment model. In the present Registered Report or Replication, we replicated their study with greater sensitivity and extended their task by controlling a potential strategic confound. Specifically, participants might remap memory items to new locations, reducing interactions between proximal memoranda. To combat remapping, we cued participants to report either a memory item or its precise location – with this report cue presented only after a memory maintenance period. Our results suggest that, similar to visual perceptual crowding, location-bound visual memoranda interact with one another when remapping is prevented. Thus, our results support at least a flexible form of the sensory recruitment model.

There is considerable variability in the degree to which individuals rely on their peers to make decisions. Although theoretical models predict that environmental risks shift the cost–benefit trade-off associated with social information use, this idea has received little empirical support. Here we aim to test the effect of childhood environmental adversity on humans' susceptibility to follow others’ opinion in the context of a standard face evaluation task. Results collected in a pilot study involving 121 adult participants tested online showed that susceptibility to social influence and childhood environmental adversity are positively associated. Computational analyses further confirmed that this effect is not explained by the fact that participants exposed to early adversity produce noisier decisions overall but that they are indeed more likely to follow the group's opinion. To test the robustness of these findings, a pre-registered direct replication using an optimal sample size was run. The results obtained from 262 participants in the pre-registered study did not reveal a significant association between childhood adversity and task performance but the meta-analysis ran on both the pilot and the pre-registered study replicated the initial finding. This work provides experimental evidence for an association between individuals' past ecology and their susceptibility to social influence.

Many studies have documented framing effects in economic games. These studies, however, have tended to use minimal framing cues (e.g. a single sentence labelling the frame), and the frames did not involve unambiguous offer expectations. Results often did not differ substantially from those in the unframed games. Here we test the hypothesis that, in contrast to the modal offer in the unframed ultimatum game (UG) (e.g. 60% to the proposer and 40% to the responder), offers in a UG explicitly framed either as a currency exchange or a windfall will closely conform to expectations for the frame and diverge substantially from the modal offer. Participants recruited from MTurk were randomized into one of two conditions. In the control condition, participants played a standard UG. In the treatment conditions, players were provided a vignette explicitly describing the frame with their roles: some were customers and bankers in a currency exchange, and others were in a windfall scenario. We predicted (i) that modal offers in the currency exchange would involve an asymmetric split where greater than 80% went to customers and less than 20% went to bankers, and (ii) that variation in windfall offers would converge onto a 50–50 split with significantly less variation than the control condition. Our first prediction was confirmed with substantial effect sizes (d = 1.09 and d = −2.04), whereas we found no evidence for our second prediction. The first result provides further evidence that it is difficult to draw firm conclusions about economic decision-making from decontextualized games.

Recent theories suggest that familiar faces have a robust representation in memory because they have been encountered over a wide variety of contexts and image changes (e.g. lighting, viewpoint and expression). By contrast, unfamiliar faces are encountered only once, and so they do not benefit from such richness of experience and are represented based on image-specific details. In this registered report, we used a repeat detection task to test whether familiar faces are recognized better than unfamiliar faces across image changes. Participants viewed a stream of more than 1000 celebrity face images for 0.5 s each, any of which might be repeated at a later point and has to be detected. Some participants saw the same image at repeats, while others saw a different image of the same face. A post-experimental familiarity check allowed us to determine which celebrities were and were not familiar to each participant. We had three predictions: (i) detection would be better for familiar than unfamiliar faces, (ii) detection would be better across same rather than different images, and (iii) detection of familiar faces would be comparable across same and different images, but detection of unfamiliar faces would be poorer across different images. We obtained support for the first two predictions but not the last. Instead, we found that repeat detection of faces, regardless of familiarity, was poorer across different images. Our study suggests that the robustness of familiar face recognition may have limits, and that under some conditions, familiar face recognition can be just as influenced by image changes as unfamiliar face recognition.

Having a sense of meaning in life (MIL) has been acknowledged as a catalyst to psychological flourishing. As such, understanding ways to promote MIL represents a worthy goal for those interested in bolstering positive outcomes. This study sought to replicate the findings of Heintzelman, Trent & King (2013 Psychol. Sci. 24, 991–998 (doi:10.1177/0956797612465878)), who found that MIL could be influenced by external stimulation. Their findings suggest that exposure to coherent stimuli produces significantly higher MIL scores than exposure to incoherent stimuli. Using materials and methodology provided by the corresponding author of the original paper, this study attempted to directly test this manipulation under conditions with increased statistical power. All tests, however, failed to replicate. Possible explanations for these discrepant findings are discussed, and potential future directions for this area of the literature are proposed.

The neurophysiological and behavioral correlates of action-related language processing have been debated for long time. A precursor in this field was the study by Buccino et al. (2005) combining transcranial magnetic stimulation (TMS) and behavioral measures (reaction times, RTs) to study the effect of listening to hand- and foot-related sentences. In the TMS experiment, the authors showed a decrease of motor evoked potentials (MEPs) recorded from hand muscles when processing hand-related verbs as compared to foot-related verbs. Similarly, MEPs recorded from leg muscles decreased when participants processed foot-related as compared to hand-related verbs. In the behavioral experiment, using the same stimuli and a semantic decision task the authors found slower RTs when the participants used the body effector (hand or foot) involved in the actual execution of the action expressed by the presented verb to give their motor responses. These findings were interpreted as an interference effect due to a simultaneous involvement of the motor system in both a language and a motor task. Our replication aimed to enlarge the sample size and replicate the findings with higher statistical power. The TMS experiment showed a significant modulation of hand MEPs, but in the sense of a motor facilitation when processing hand-related verbs. On the contrary, the behavioral experiment did not show significant results. The results are discussed within the general debate on the time-course of the modulation of motor cortex during implicit and explicit language processing and in relation to the studies on action observation/understanding.

Presented by OSF

Partition dependence is the phenomenon in which individuals’ evaluations of probabilities are influenced by the partitioning of the information in the way the information is presented or framed. In a Registered Report experiment with an American online Prolific sample (N = 603), we conducted a replication and extension of Studies 1a, 1b, 3 and 4 from a classic article by Fox and Rottenstreich (Fox & Rottenstreich 2003 Psychol. Sci. 14, 195–200 (doi:10.1111/1467-9280.02431)) demonstrating the phenomenon. They showed that participants’ estimations of an event’s likelihood shifted based on minor adjustments of the framing that suggested a change in partitioning perspective (‘ignorance prior’ priming). Based on a pre-registered replication evaluation criterion, we concluded a mostly successful replication of the findings of Fox and Rottenstreich (2003). Specifically, we found support for partition dependence in scenarios from Study 1a Items 1 and 2, Study 1b and Study 3, with weaker effects, yet with no consistent support for Study 1a Item 3 and Study 4. Our extensions further explored the robustness of partition dependence by examining participants’ probability evaluations of complementary events (happen versus not happen) and the impact of task order on judgement and decision making. Overall, the findings suggest support for partition dependence, yet as more nuanced and context-dependent than expected, and the need for further research to understand its mechanisms, robustness and implications across different contexts. Materials, data and code are available on at https://osf.io/g9czs/. This Registered Report has been officially endorsed by Peer Community in Registered Reports: https://doi.org/10.24072/pci.rr.100877.

Men are hypothesized to show stronger preferences for physical attractiveness in potential mates than women are, particularly when assessing the attractiveness of potential mates for short-term relationships. By contrast, women are thought to show stronger preferences for social status in potential mates than men are, particularly when assessing the attractiveness of potential mates for long-term relationships. These mate-preference sex differences are often claimed to be ‘universal' (i.e. stable across cultures). Consequently, we used an established ‘budget-allocation' task to investigate Chinese and UK participants' preferences for physical attractiveness and social status in potential mates. Confirmatory analyses replicated these sex differences in both samples, consistent with the suggestion that they occur in diverse cultures. However, confirmatory analyses also showed that Chinese women had stronger preferences for social status than UK women did, suggesting cultural differences in the magnitude of mate-preference sex differences can also occur.

Abstract The present study explores the effect of exposure to news in a social media environment on people’s perceived knowledge and on the “Illusion of knowledge” —that is, the overestimation of perceived knowledge relative to actual knowledge. Using a mixed, within-subjects design, participants ( N = 828) engaged in a two-session study featuring pre- and post-exposure assessments. Participants scrolled through a social media newsfeed and completed assessments of perceived and actual knowledge. We hypothesized that (1) social media exposure would increase perceived knowledge, (2) this increase would not align with actual knowledge, and (3) higher topic involvement would exacerbate these effects. While most of the preregistered hypotheses did not receive clear statistical support, some effects were consistent with our predictions. Perceived knowledge increased over time, suggesting a general exposure effect; however, differences between exposed and non-exposed topics were not statistically significant, possibly due to test effects or limited engagement with the platform. A strong illusion of knowledge was observed across topics, suggesting robust overestimation. This high baseline may have created a ceiling that constrained the detection of exposure effects. This study was conducted as a Registered Report ( https://doi.org/10.24072/pci.rr.100986 ), accepted in principle prior to data collection. To our knowledge, it represents one of the most ecologically valid attempts in the literature to simulate social media exposure in an experimental setting.

Background: eHealth interventions have the potential to address challenges related to access, service engagement, and continuity of care in the delivery of mental health services. However, the initial development and evaluation of such interventions can require substantive amounts of financial and human resource investments to bring them to scale. Therefore, it may be warranted to pay greater attention to policy, services, and research with respect to eHealth platforms that have the potential to be adapted for use across settings. Yet, limited attention has been placed on the methods and processes for adapting eHealth interventions to improve their applicability across cultural, geographical, and contextual boundaries. Objective: In this paper, we describe an adaptation framework and protocol to adapt an eHealth intervention designed to promote recovery and prevent relapses in youth receiving specialized services for first-episode psychosis. The Web-based platform, called Horyzons, was initially developed and tested in Australia and is now being prepared for evaluation in Canada. Methods: Service users and service providers from 2 specialized early intervention programs for first-episode psychosis located in different provinces will explore a beta-version of the eHealth intervention through focus group discussions and extended personal explorations to identify the need for, and content of contextual and cultural adaptations. An iterative consultation process will then take place with service providers and users to develop and assess platform adaptations in preparation for a pilot study with a live version of the platform. Results: Data collection was completed in August 2017, and analysis and adaptation are in process. The first results of the study will be submitted for publication in 2018 and will provide preliminary insights into the acceptability of the Web-based platform (eg, perceived use and perceived usefulness) from service provider and service user perspectives. The project will also provide knowledge about the adaptations and process needed to prepare the platform for evaluation in Canada. Conclusions: This study contributes to an important gap in the literature pertaining to the specific principles, methods, and steps involved in adapting eHealth interventions for implementation and evaluation across a diverse range of cultural, geographical, and health care settings.

Background: Cardiovascular disease is the leading cause of mortality worldwide, accounting for 13%-15% of all deaths. Cardiac rehabilitation has poor compliance and adherence. Telerehabilitation has been introduced to increase patients’ participation, access, and adherence with the help of digital technologies. The target group is patients with heart failure. A telerehabilitation program called “Future Patient” has been developed and consists of three phases: (1) titration of medicine (0-3 months), (2) implementation of the telerehabilitation protocols (3 months), and (3) follow-up with rehabilitation in everyday life (6 months). Patients in the Future Patient program measure their blood pressure, pulse, weight, number of steps taken, sleep, and respiration and answer questions online regarding their well-being. All data are transmitted and accessed in the HeartPortal by patients and health care professionals. Methods: A randomized controlled study will be performed. The intervention group will follow the Future Patient Telerehabilitation program, and the control group will follow the traditional cardiac rehabilitation program. The primary outcome is quality of life measured by the Kansas City Cardiomyopathy Questionnaire. Secondary outcomes are development of clinical data; illness perception; motivation; anxiety and depression; health and electronic health literacy; qualitative exploration of patients’, spouses’, and health care professionals’ experiences of participating in the telerehabilitation program; and a health economy evaluation of the program. Outcomes were assessed using questionnaires and through the data generated by digital technologies. Results: Data collection began in December 2016 and will be completed in October 2019. The study results will be published in peer-reviewed journals and presented at international conferences. Results from the Future Patient Telerehabilitation program are expected to be published by the spring of 2020. Conclusions: The expected outcomes are increased quality of life, increased motivation and illness perception, reduced anxiety and depressions, improved electronic health literacy, and health economics benefits. We expect the study to have a clinical impact for future telerehabilitation of patients with heart failure.

Introduction Exercise-based cardiac rehabilitation (CR) independently alters the clinical course of cardiovascular diseases resulting in a significant reduction in all-cause and cardiac mortality. However, only 15%–30% of all eligible patients participate in a phase 2 ambulatory programme. The uptake rate of community-based programmes following phase 2 CR and adherence to long-term exercise is extremely poor. Newer care models, involving telerehabilitation programmes that are delivered remotely, show considerable promise for increasing adherence. In this view, the PATHway (Physical Activity Towards Health) platform was developed and now needs to be evaluated in terms of its feasibility and clinical efficacy. Methods and analysis In a multicentre randomised controlled pilot trial, 120 participants (m/f, age 40–80 years) completing a phase 2 ambulatory CR programme will be randomised on a 1:1 basis to PATHway or usual care. PATHway involves a comprehensive, internetenabled, sensor-based home CR platform and provides individualised heart rate monitored exercise programmes (exerclasses and exergames) as the basis on which to provide a personalised lifestyle intervention programme. The control group will receive usual care. Study outcomes will be assessed at baseline, 3 months and 6 months after completion of phase 2 of the CR programme. The primary outcome is the change in active energy expenditure.

Stress is one of, if not the, most ubiquitously studied risk factor across the health sciences. This unlikely to change given that the primary drivers of mortality and disability are chronic, stress-mediated illnesses (often highly comorbid with psychopathology). We argue that an important limitation of stress research is the consistency with which the Trier Social Stress Test is used when the research questions are not specific to social stress. We advocate for precision stress research using qualitatively different stressors to facilitate exploration of how different types of stressors might differentially impact health outcomes, including psychopathology. This registered report validates a reward-salient stress task (a modified Anger Incentive Delay Task; AIDT) in a sample of 101 emerging adults, over half of whom reported clinically relevant anxiety, hypo/mania, depression, and/or suicidal ideation, who participated in a study between 2020 and 2022. This task involves teaching participants a game where they can win money. Part way through, the “goal frustration” condition changes the rules such that correct responses to trials with anticipatory stimuli indicating the possibility to win money actually lose money on 56% of trials despite visual feedback indicating that responses were successful. Results consistently indicated that the AIDT successfully reduced positive emotions and motivation and increased negative emotions. The magnitude of these responses were predicted by individual differences in reward and punishment sensitivity. Given the breadth of psychopathologies that share both stress and reward and punishment sensitivity as risk factors, a reward-salient acute stress task is an important tool for precision psychopathology research.

Background: In addition to medical intervention and counseling, patients with cardiovascular disease (CVD) need to manage their disease and its consequences by themselves in daily life. Objective: The aim of this paper is to describe the development of “Vascular View,” a comprehensive, multi-component, tailored, Web-based, self-management support program for patients with CVD, and how this program will be tested in an early randomized controlled trial (RCT).

Background: Multiple international agencies, including the World Health Organization and the International Monetary Fund, have emphasized the importance of maternal mental health for optimal child health and development. Adequate social support is vital for the most vulnerable to postpartum mood disorders. Hence, an urgent need for sustainable social support programs to aid mothers ease into their new parenting role exists. Objective: This study protocol aims to examine the effectiveness of a technology-based peer support intervention program among mothers at risk for postnatal depression in the early postpartum period. Methods: A randomized controlled 2-group pretest and repeated posttest experimental design will be used. The study will recruit 118 mothers from the postnatal wards of a tertiary public hospital in Singapore. Eligible mothers will be randomly allocated to receive either the peer support intervention program or routine perinatal care from the hospital. Peer volunteers will be mothers who have experienced self-reported depression and will be receiving face-to-face training to support new mothers at risk of depression. Outcome measures include postnatal depression, anxiety, loneliness, and social support. Data will be collected at immediate postnatal period (day of discharge from the hospital), at fourth week and twelfth week post childbirth. Results: The recruitment and training of peer support volunteers (N=20) ended in June 2017, whereas recruitment of study participants commenced in July 2017 and is still ongoing. The current recruitment for new mothers stands at 73, with 36 in the control group and 37 in the intervention group. Data collection is projected to be completed by May 2018. Conclusions: This study will identify a potentially effective and clinically useful method to prevent postnatal depression in new mothers, which is the top cause of maternal morbidity. Receiving social support from others who share similar experiences may enhance the positive parenting experiences of mothers, which in turn can improve the psychosocial well-being of the mothers, tighten mother-child bond, and enhance overall family dynamics for mothers and infants. Trial Registration: International Standard Randomized Controlled Trial Number ISRCTN14864807; http://www.isrctn.com/ISRCTN14864807 (Archived by WebCite at http://www.webcitation.org/6xtBNvBTX)

Background: Recently, internet-based interventions have been proposed as effective treatments for people with panic disorder (PD). However, little is known about the clinical effects of integrating mobile technology into these interventions. Because users carry their smartphones with them throughout the day, we hypothesize that this technology can be used to significantly support individuals with monitoring and overcoming their PD symptoms. The aim of the present study is to evaluate the efficacy and cost-effectiveness of a newly developed hybrid intervention that combines internet/PC with smartphone delivery to treat the symptoms of PD. The intervention is based on cognitive behavioral therapy and consists of six modules over a total of six weeks. Methods/Design: A two-arm randomized controlled trial (RCT) will be conducted to evaluate the effects of a hybrid online training module for PD. Based on a power calculation (d =0.60; 1-β of 80%; α =0.05), 90 participants with mild to moderate panic symptoms with or without agoraphobia (as assessed by the Panic and Agoraphobia Scale) will be recruited from the general population and randomly assigned to either the intervention group or a six-month waitlist control group. The primary outcome measure will be the severity of panic symptoms. Secondary outcomes will include depression, quality of life, and an observer-based rating of panic severity. Furthermore, data regarding acceptance and the usability of the smartphone app will be assessed. Assessments will take place at baseline as well as eight weeks, three months, and six months after randomization. Moreover, a cost-effectiveness analysis will be performed from a societal perspective. Data will be analyzed on an intention-to-treat basis and per protocol. Discussion: To our knowledge, this RCT is one of the first to examine the efficacy of a hybrid online training for adult PD. This study seeks to contribute to the emerging field of hybrid online training. If the intervention is efficacious, then research on this hybrid online training should be extended. The cost-effectiveness analysis will also indicate whether online training is an economical tool for treating PD among adults. Trial registration: German Clinical Trial Register: DRKS00005223 (registered on 15 August 2013).

Background: The potential of mHealth technologies in the care of patients with diabetes and other chronic conditions has captured the attention of clinicians and researchers. Efforts to date have incorporated a variety of tools and techniques, including Web-based portals, short message service (SMS) text messaging, remote collection of biometric data, electronic coaching, electronic-based health education, secure email communication between visits, and electronic collection of lifestyle and quality-of-life surveys. Each of these tools, used alone or in combination, have demonstrated varying degrees of effectiveness. Some of the more promising results have been demonstrated using regular collection of biometric devices, SMS text messaging, secure email communication with clinical teams, and regular reporting of quality-of-life variables. In this study, we seek to incorporate several of the most promising mHealth capabilities in a patient-centered medical home (PCMH) workflow.

Background: The European Medicines Agency (EMA) requires vaccine manufacturers to conduct enhanced real-time surveillance of seasonal influenza vaccination. The EMA has specified a list of adverse events of interest to be monitored. The EMA sets out 3 different ways to conduct such surveillance: (1) active surveillance, (2) enhanced passive surveillance, or (3) electronic health record data mining (EHR-DM). English general practice (GP) is a suitable setting to implement enhanced passive surveillance and EHR-DM. Objective: This study aimed to test the feasibility of conducting enhanced passive surveillance in GP using the yellow card scheme (adverse events of interest reporting cards) to determine if it has any advantages over EHR-DM alone. Methods: A total of 9 GPs in England participated, of which 3 tested the feasibility of enhanced passive surveillance and the other 6 EHR-DM alone. The 3 that tested EPS provided patients with yellow (adverse events) cards for patients to report any adverse events. Data were extracted from all 9 GPs’ EHRs between weeks 35 and 49 (08/24/2015 to 12/06/2015), the main period of influenza vaccination. We conducted weekly analysis and end-of-study analyses. Results: Our GPs were largely distributed across England with a registered population of 81,040. In the week 49 report, 15,863/81,040 people (19.57% of the registered practice population) were vaccinated. In the EPS practices, staff managed to hand out the cards to 61.25% (4150/6776) of the vaccinees, and of these cards, 1.98% (82/4150) were returned to the GP offices. Adverse events of interests were reported by 113 /7223 people (1.56%) in the enhanced passive surveillance practices, compared with 322/8640 people (3.73%) in the EHR-DM practices. Conclusions: Overall, we demonstrated that GPs EHR-DM was an appropriate method of enhanced surveillance. However, the use of yellow cards, in enhanced passive surveillance practices, did not enhance the collection of adverse events of interests as demonstrated in this study. Their return rate was poor, data entry from them was not straightforward, and there were issues with data reconciliation. We concluded that customized cards prespecifying the EMA’s adverse events of interests, combined with EHR-DM, were needed to maximize data collection.

Background: Depression during pregnancy and in the postpartum period is associated with a number of poor outcomes for women and their children. Although effective interventions exist for common mental disorders that occur during pregnancy and the postpartum period, most cases in low- and middle-income countries go untreated because of a lack of trained professionals. Task-sharing models such as the Thinking Healthy Program have shown great potential in feasibility and efficacy trials as a strategy for expanding access to treatment in low-resource settings, but there are significant barriers to scale-up. We are addressing this gap by adapting Thinking Healthy for automated delivery via a mobile phone. This new intervention, Healthy Moms, uses an existing artificial intelligence system called Tess (Zuri in Kenya) to drive conversations with users. Objective: The objective of this pilot study is to test the Healthy Moms perinatal depression intervention using a single-case experimental design with pregnant women and new mothers recruited from public hospitals outside of Nairobi, Kenya. Methods: We will invite patients to complete a brief, automated screening delivered via text messages to determine their eligibility. Enrolled participants will be randomized to a 1- or 2-week baseline period and then invited to begin using Zuri. Participants will be prompted to rate their mood via short message service every 3 days during the baseline and intervention periods. We will review system logs and conduct in-depth interviews with participants to study engagement with the intervention, feasibility, and acceptability. We will use visual inspection, in-depth interviews, and Bayesian estimation to generate preliminary data about the potential response to treatment. Results: Our team adapted the intervention content in April and May 2018 and completed an initial prepilot round of formative testing with 10 women from a private maternity hospital in May and June. In preparation for this pilot study, we used feedback from these users to revise the structure and content of the intervention. Recruitment for this protocol began in early 2019. Results are expected toward the end of 2019. Conclusions: The main limitation of this pilot study is that we will recruit women who live in urban and periurban centers in one part of Kenya. The results of this study may not generalize to the broader population of Kenyan women, but that is not an objective of this phase of work. Our primary objective is to gather preliminary data to know how to build and test a more robust service. We are working toward a larger study with a more diverse population. International Registered Report Identifier (IRRID): DERR1-10.2196/11800

Background: Adoption of an active lifestyle plays an important role in the management of type 2 diabetes. Online interventions targeting lifestyle changes in adults with type 2 diabetes have provided mixed results. Previous research highlights the importance of creating theory-based interventions adapted to the population’s specific needs. The online intervention “MyPlan 2.0” targets physical activity and sedentary behavior in adults with type 2 diabetes. This intervention is grounded in the self-regulation framework and, by incorporating the feedback of users with type 2 diabetes, iteratively adapted to its target population. Objective: The aim of this paper is to thoroughly describe “MyPlan 2.0” and the study protocol that will be used to test the effectiveness of this intervention to alter patients’ levels of physical activity and sedentary behavior. Methods: A two-arm superiority randomized controlled trial will be performed. Physical activity and sedentary behavior will be measured using accelerometers and questionnaires. Furthermore, using questionnaires and diaries, patients’ stressors and personal determinants for change will be explored in depth. To evaluate the primary outcomes of the intervention, multilevel analyses will be conducted. Results: The randomized controlled trial started in January 2018. As participants can start at different moments, we aim to finish all testing by July 2019. Conclusions: This study will increase our understanding about whether and how a theory-based online intervention can help adults with type 2 diabetes increase their level of physical activity and decrease their sedentary time. International Registered Report Identifier (IRRID): DERR1-10.2196/12413

Background: High sodium intake is a significant public health problem in the United States. Interventions that lower sodium intake can decrease blood pressure and improve cardiovascular outcomes. Restaurants and grocery stores are prime targets for intervention with about 77% of all sodium intake in the average US diet coming from processed and restaurant foods. Objective: This study proposes that a mobile app intervention that promotes low-sodium alternatives at grocery stores and restaurants will reduce dietary intake of sodium and improve confidence following a low-sodium diet in hypertension. Methods: In this single-center, prospective, open-label study, patients will be randomized to a mobile app or usual care for 8 weeks. We will randomize 50 patients (age>18 years) diagnosed with hypertension and on antihypertensive therapy for at least 3 months in a 1:1 manner stratified by gender. Study subjects will receive the mobile app, LowSalt4Life, or usual dietary advice for 8 weeks. LowSalt4Life provides a multifaceted intervention based on just-in-time contextual tailored messages at grocery stores and restaurants. The primary endpoint is the change in the estimated 24-hour urinary excretion of sodium from spot urine. Secondary outcomes include change in the sodium content of the food frequency questionnaire, confidence in following a low-sodium diet, urine chloride and creatinine dipsticks, and blood pressure. Results: The project was funded in May 2016 until April 2018. This trial is currently enrolling patients. To date, 26 of the 50 patients needed have been enrolled. Results will be available in the Spring of 2019. Conclusions: This randomized controlled trial will test the efficacy of just-in-time contextual tailored messages through a novel mobile app 8-week intervention on urinary sodium excretion in patients with hypertension. We will address a critical evidence gap in the care of patients with hypertension. If effective, this intervention could be scaled to assess effects on blood pressure and cardiovascular events in hypertension. Trial Registration: ClinicalTrials.gov NCT03099343; https://clinicaltrials.gov/ct2/show/NCT03099343 (Archived by WebCite at http://www.webcitation.org/735HNzKlQ) International Registered Report Identifier (IRRID): PRR1-10.2196/11282

Background: Although smartphone-based clinical training to support emergency care training is more affordable than traditional avenues of training, it is still in its infancy and remains poorly implemented. In addition, its current implementations tend to be invariant to the evolving learning needs of the intended users. In resource-limited settings, the use of such platforms coupled with serious-gaming approaches remain largely unexplored and underdeveloped, even though they offer promise in terms of addressing the health workforce skill imbalance and lack of training opportunities associated with the high neonatal mortality rates in these settings. Objective: This randomized controlled study aims to assess the effectiveness of offering adaptive versus standard feedback through a smartphone-based serious game on health care providers’ knowledge gain on the management of a neonatal medical emergency. Methods: The study is aimed at health care workers (physicians, nurses, and clinical officers) who provide bedside neonatal care in low-income settings. We will use data captured through an Android smartphone-based serious-game app that will be downloaded to personal phones belonging to the study participants. The intervention will be adaptive feedback provided within the app. The data captured will include the level of feedback provided to participants as they learn to use the mobile app, and performance data from attempts made during the assessment questions on interactive tasks participants perform as they progress through the app on emergency neonatal care delivery. The primary endpoint will be the first two complete rounds of learning within the app, from which the individuals’ “learning gains” and Morris G intervention effect size will be computed. To minimize bias, participants will be assigned to an experimental or a control group by a within-app random generator, and this process will be concealed to both the study participants and the investigators until the primary endpoint is reached. Results: This project was funded in November 2016. It has been approved by the Central University Research Ethics Committee of the University of Oxford and the Scientific and Ethics Review Unit of the Kenya Medical Research Institute. Recruitment and data collection began from February 2019 and will continue up to July 31, 2019. As of July 18, 2019, we enrolled 541 participants, of whom 238 reached the primary endpoint, with a further 19 qualitative interviews conducted to support evaluation. Full analysis will be conducted once we reach the end of the study recruitment period. Conclusions: This study will be used to explore the effectiveness of adaptive feedback in a smartphone-based serious game on health care providers in a low-income setting. This aspect of medical education is a largely unexplored topic in this context. In this randomized experiment, the risk of performance bias across arms is moderate, given that the active ingredient of the intervention (ie, knowledge) is a latent trait that is difficult to comprehensively control for in a real-world setting. However, the influence of any resulting bias that has the ability to alter the results will be assessed using alternative methods such as qualitative interviews. Trial Registration: Pan African Clinical Trials Registry PACTR201901783811130; https://pactr.samrc.ac.za/TrialDisplay. aspx?TrialID=5836 International Registered Report Identifier (IRRID): PRR1-10.2196/13034

Background: People who inject drugs are at a disproportionate risk for contracting hepatitis C virus (HCV). However, use of HCV prevention and treatment services remains suboptimal among people with substance use disorders due to various health system, societal, and individual barriers. Mobile health applications offer promising strategies to support people in recovery from substance use disorders. We sought to determine whether the Addiction-Comprehensive Health Enhancement Support System (A-CHESS), an existing mobile health application for opioid use disorder, could be adapted to improve HCV screening and treatment. Objective: The goals of this paper are to describe: (1) the components and functionality of an HCV intervention incorporated into the existing A-CHESS system; and (2) how data are collected and will be used to evaluate HCV testing, linkage to care, and treatment. Methods: People with recent opioid use were enrolled in a randomized controlled trial to test whether A-CHESS reduced relapse. We developed and implemented HCV intervention content within the A-CHESS platform to simultaneously evaluate whether A-CHESS improved secondary outcomes related to HCV care. All A-CHESS users received the HCV intervention content, which includes educational information, private messages tailored to an individual’s stage of HCV care, and a public discussion forum. Data on patients’ HCV risk behaviors and stage of care were collected through quarterly telephone interviews and weekly surveys delivered through A-CHESS. The proportion of people with opioid use disorder who are HCV untested, HCV-negative, HCV antibody-positive, or HCV RNA–positive, as well as linked to care, treated and cured at baseline is described here. The 24-month follow-up is ongoing and will be completed in April 2020. Survey data will then be used to assess whether individuals who received the HCV-enhanced A-CHESS intervention were more likely to reduce risky injection behaviors, receive HCV testing, link to medical care, initiate treatment, and be cured of HCV compared to the control group. Results: Between April 2016 and April 2018, 416 individuals were enrolled and completed the baseline interview. Of these individuals, 207 were then randomly assigned to the control arm and 209 were assigned to the intervention arm. At baseline, 202 individuals (49%) self-reported ever testing HCV antibody-positive. Of those, 179 (89%) reported receiving HCV RNA confirmatory testing, 134 (66%) tested HCV RNA–positive, 125 (62%) were linked to medical care and 27 (13%) were treated and cured of HCV. Of the remaining 214 individuals who had never tested HCV antibody–positive, 129 (31%) had tested HCV antibody–negative within the past year and 85 (20%) had not been tested within the past year. Conclusions: The A-CHESS mobile health system allows for the implementation of a bundle of services as well as the collection of longitudinal data related to drug use and HCV care among people with opioid use disorders. This study will provide preliminary evidence to determine whether HCV-specific services embedded into the A-CHESS program can improve HCV outcomes for people engaged in addiction treatment. Trial Registration: ClinicalTrials.gov NCT02712034; https://clinicaltrials.gov/ct2/show/NCT02712034 International Registered Report Identifier (IRRID): DERR1-10.2196/12620

Background: Although maintaining a healthy weight and physical conditioning are requirements of active military duty, many US veterans rapidly gain weight and lose conditioning when they separate from active-duty service. Mobile health (mHealth) interventions that incorporate wearables for activity monitoring have become common, but it is unclear how to optimize engagement over time. Personalized health coaching, either through tailored automated messaging or by individual health coaches, has the potential to increase the efficacy of mHealth programs. In an attempt to preserve conditioning and ward off weight gain, we developed Stay Strong, a mobile app that is tailored to veterans of recent conflicts and tracks physical activity monitored by Fitbit Charge 2 devices and weight measured on a Bluetooth-enabled scale.

Background: Self-management is integral for control of type 2 diabetes mellitus (T2DM). Patient self-management is improved when they receive real-time information on their health status and behaviors and ongoing facilitation from health professionals. However, timely information for these behaviors is notably absent in the health care system. Providing real-time data could help improve patient understanding of the dynamics of their illness and assist clinicians in developing targeted approaches to improve health outcomes and in delivering personalized care when and where it is most needed. Mobile technologies (eg, wearables, apps, and connected scales) have the potential to make these patient-provider interactions a reality. What strategies might best help patients overcome self-management challenges using self-generated diabetes-related data? How might clinicians effectively guide patient self-management with the advantage of real-time data? Objective: This study aims to describe the protocol for an ongoing study (June 2016-May 2019) that examines trajectories of symptoms, health behaviors, and associated challenges among individuals with T2DM utilizing multiple mobile technologies, including a wireless body scale, wireless glucometer, and a wrist-worn accelerometer over a 6-month period. Methods: We are conducting an explanatory sequential mixed methods study of 60 patients with T2DM recruited from a primary care clinic. Patients were asked to track relevant clinical data for 6 months using a wireless body scale, wireless glucometer, a wrist-worn accelerometer, and a medication adherence text message (short message service, SMS) survey. Data generated from the devices were then analyzed and visualized. A subset of patients is currently being interviewed to discuss their challenges and successes in diabetes self-management, and they are being shown visualizations of their own data. Following the data collection period, we will conduct interviews with study clinicians to explore ways in which they might collaborate with patients. Results: This study has received regulatory approval. Patient enrollment ongoing with a sample size of 60 patients is complete, and up to 20 clinicians will be enrolled. At the patient level, data collection is complete, but data analysis is pending. At the clinician level, data collection is currently ongoing. Conclusions: This study seeks to expand the use of mobile technologies to generate real-time data to enhance self-management strategies. It also seeks to obtain both patient and provider perspectives on using real-time data to develop algorithms for software that will facilitate real-time self-management strategies. We expect that the findings of this study will offer important insight into how to support patients and providers using real-time data to manage a complex chronic illness. International Registered Report Identifier (IRRID): DERR1-10.2196/13517

Background: Sleep disturbance in adolescents is common, with up to one-third reporting significant symptoms of insomnia. Research with adults has demonstrated that Web-based cognitive behavioral therapy for insomnia (CBTi) can improve both sleep and mental health. However, research with adolescents is lacking, and we know little about whether CBTi would have similar effects on this younger population. Objective: This paper summarizes the protocol of a study to assess the feasibility of adding supported Web-based CBTi to the usual care of young people aged 14-17 years attending specialist Child and Adolescent Mental Health Services (CAMHS). Methods: This is an open trial where we will recruit young people (N=50) aged 14-17 years attending specialist CAMHS with primary or comorbid symptoms of insomnia. In addition to their usual care, young people will be provided with Sleepio, a 6-session, Web-based CBTi self-help program for insomnia. Sleepio teaches a range of techniques including sleep hygiene, relaxation training, stimulus control, sleep restriction, and cognitive techniques that participants will be helped to apply through brief, weekly telephone support calls. Questionnaires and interviews will be completed at baseline and postintervention (8-10 weeks) and will assess sleep, symptoms of depression and anxiety, and acceptability of Sleepio and telephone support. Results: Recruitment started in May 2018 and continued until the end of October 2018. Conclusions: This study will provide preliminary evidence about whether supported Web-based CBTi is acceptable to young people with mental health problems and about the postintervention effects on sleep and symptoms of anxiety and depression. This information will determine whether a randomized trial to determine the effectiveness of Sleepio should be undertaken. International Registered Report Identifier (IRRID): DRR1-10.2196/11324

Background: Pediatric hematopoietic cell transplantation (HCT), commonly referred to as blood and marrow transplantation (BMT), is an intense treatment modality that requires the involvement of engaged caregivers during the patient’s (child’s) prolonged hospitalization. The ubiquity of electronic health records (EHRs) and a trend toward patient-centered care could allow a novel health information technology (IT) system to increase parental engagement. The paucity of research on acute care, hospital-based (inpatient) health IT applications for patients or caregivers provides an opportunity for testing the feasibility of such applications. The pediatric BMT population represents an ideal patient group to conduct an evaluation due to the lengthy inpatient stays and a heightened need for patient activation. Objective: The primary objective of this study is to assess the feasibility of implementing the BMT Roadmap in caregivers as an intervention during their child’s inpatient hospitalization. The BMT Roadmap is an inpatient portal prototype optimized for tablet with a user-centered design. It integrates patient-specific laboratory and medication data from the EHR in real-time and provides support in terms of discharge goals, home care education, and other components. Feasibility will be proven if (1) the BMT Roadmap functions and can be managed by the study team without unexpected effort, (2) the system is accessed by users at a defined minimum threshold, and (3) the qualitative and quantitative research conducted provides quality data that address the perceived usefulness of the BMT Roadmap and could inform a study in a larger sample size. Methods: This will be a single-arm, nonrandomized feasibility study. We aim to enroll 10 adult caregivers (age ≥ 18 years) of pediatric patients (aged 0-25 years) undergoing autologous (self-donor) or allogeneic (alternative donor) BMT. Assenting minors (aged 10-18) will also be invited to participate. Recruitment of study participants will take place in the outpatient pediatric BMT clinic. After signing an informed consent, the research study team will provide participants with the BMT Roadmap, available on an Apple iPad, which will used throughout the inpatient hospitalization. To measure the study outcomes, approximately 6-8 semistructured qualitative interviews will be conducted periodically from pre-BMT to 100 days post-BMT and an additional 15-20 semistructured interviews will be conducted among BMT health care providers to assess perceived usefulness and usability of the system, as well as any associated workflow impacts. Quantitative survey instruments will only be administered to adult participants (age ≥ 18 years). Results: Recruitment will begin in September 2015, and preliminary findings are expected in 2016. Conclusions: This protocol offers a framework for the design and analysis of a personalized health IT system that has the potential to increase patient and caregiver engagement in acute care, hospital-based contexts.

Background: HIV incidence is growing most rapidly in the United States among young men who have sex with men (YMSM). Overwhelming evidence demonstrates that routine testing and expanded use of pre-exposure prophylaxis (PrEP) would dramatically reduce the population burden of HIV; however, uptake of both interventions is suboptimal among young adults. The use of mobile phone apps by YMSM is ubiquitous and may offer unique opportunities for public health interventions. MyChoices is a theory-driven app to increase HIV testing and PrEP uptake. It was developed by an interdisciplinary team based on feedback from a diverse sample of YMSM. Objective: The aim of this paper is to describe the protocol for the refinement, beta testing, and pilot randomized controlled trial (RCT) to examine the acceptability and feasibility of the MyChoices app. Methods: This 3-phase study includes 4 theater testing groups for app refinement with a total of approximately 30 YMSM; for beta testing, including quantitative assessments and exit interviews, with approximately 15 YMSM over a 2-month period; and for a pilot RCT with 60 YMSM. The pilot will assess feasibility, acceptability, and preliminary efficacy of the MyChoices app, compared with referrals only, in increasing HIV testing and PrEP uptake. All participants will be recruited at iTech clinical research sites in Boston, MA, and Bronx, NY. Results: App refinement is underway. Enrollment for the pilot RCT began in October 2018. Conclusions: MyChoices is one of the first comprehensive, theory-driven HIV prevention apps designed specifically for YMSM. If MyChoices demonstrates acceptability and feasibility in this pilot RCT, a multicity, 3-arm randomized controlled efficacy trial of this app and another youth-optimized app (LYNX) versus standard of care is planned within iTech. If shown to be efficacious, the app will be scalable, with the ability to reach YMSM across the United States as well as be geographically individualized, with app content integrated with local prevention and testing activities.