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Background: According to the World Health Organization, mental health is a state of well-being and not merely the absence of disease. However, studies exploring subjective well-being in patients with skin diseases are very rare., Objectives: To assess subjective well-being, i.e. 'happiness', in patients with different skin diseases and to compare them to other patient groups and healthy controls., Methods: A cross-sectional study was conducted from 12/2017 to 04/2019. Patients receiving in- or outpatient care for psoriasis, atopic eczema, nummular eczema, mastocytosis, skin cancer (malignant melanoma and keratinocyte carcinoma), human immunodeficiency virus (HIV) or chronic inflammatory bowel diseases (Crohn's disease and ulcerative colitis) were recruited at two hospitals in Bavaria, Germany. Healthy individuals living in or near Munich served as a control group. All participants filled in a questionnaire assessing happiness, measured as positive affect (PA), negative affect and satisfaction with life (SWL; together representing subjective well-being) and a heuristic evaluation of one's own happiness., Results: Data from 229 dermatologic patients (53.3 ± 18.5 years, 48% women), 49 patients with inflammatory bowel diseases (48.9 ± 18.7 years, 43% women), 49 patients with HIV (46 ± 10.1 years, 10% women) and 106 healthy controls (38.4 ± 13.4 years, 49% women) were analysed. Compared to the controls, dermatologic patients reported lower heuristic happiness (P = 0.023) and PA (P = 0.001) but higher SWL (P = 0.043). Patients with psoriasis and atopic eczema reported the lowest happiness, as they reported significantly lower PA (P = 0.032 and P < 0.001) and heuristic happiness (P = 0.002 and P = 0.015) than the control group. Patients with skin cancer reported higher SWL than the control group (P = 0.003). Dermatologic patients reported lower happiness than patients with HIV but reported greater happiness than patients with IBD., Conclusions: Dermatologic patients experience lower levels of happiness, especially PA, compared to healthy controls. As PA is linked to desirable health outcomes, targeting PA could be a promising holistic approach for the treatment of skin diseases., (© 2019 The Authors. Journal of the European Academy of Dermatology and Venereology published by John Wiley & Sons Ltd on behalf of European Academy of Dermatology and Venereology.)

Negative affective biases are thought to be a key symptom driving and upholding many psychiatric disorders. When presented with ambiguous information, anxious individuals, for example, tend to anticipate lower rewards than asymptomatic individuals (Aylward et al., 2019. Translating a rodent measure of negative bias into humans: the impact of induced anxiety and unmedicated mood and anxiety disorders. Psychological Medicine ). The assumption is that this is because anxious individuals assume "worse" outcomes. However, predictions are often made about high and low rewards, so it is not clear whether the bias is due to the valence (the "worse" option) or just magnitude (the lower number). We therefore explored the roles of valence and magnitude in a translational measure of negative affective bias. We adapted a two-alternative forced choice (2AFC) "reward-reward" task into a "punishment-punishment" paradigm, and followed up with "high reward-high punishment" and "low reward-high punishment" variants. The results from the "punishment-punishment" paradigm - a bias towards higher punishments in healthy controls - suggest that it is outcome magnitude that is important. However, this is qualified by the other variants which indicate that both valence and magnitude are important. Overall, our results temper the assumption that negative affective biases observed in tasks using numeric outcomes are solely as a result of subjective outcome valence.

The aim of the study was to investigate the characteristics of the oscillatory dynamics of brain activity during the perception of negative, positive, and neutral sentences in healthy individuals with differing severity of depressive symptoms at the preclinical stage. The study involved 34 healthy people (22 women). The severity of the symptoms of depression was assessed using Beck's Depression Inventory (BDI II). Using independent component analysis and the function of dipfit in the EEGlab software, the EEG was divided into components and their localizations were calculated. To assess the induced responses, event-related spectral perturbations were calculated. The perception of emotional sentences was accompanied by a more pronounced increase in theta rhythm in the group with lower severity of depressive symptoms. The perception of all types of sentences was accompanied by a decrease in beta rhythm in the group with lower severity of depressive symptoms. The effects were localized to the precuneus. The decrease of oscillatory responses in the theta and beta ranges in individuals with a high severity of depressive symptoms suggests a reduction of attention to the emotional content and meaning of the sentences., Competing Interests: Declaration of Competing Interest The authors report no conflict of interest., (Copyright © 2020. Published by Elsevier B.V.)

Purpose/background: Alzheimer disease (AD) is a public health issue because of the low number of symptomatic drugs and the difficulty to diagnose it at the prodromal stage. The need to develop new treatments and to validate sensitive tests for early diagnosis could be met by developing a challenge model reproducing cognitive impairments of AD. Therefore, we implemented a 24-hour sleep deprivation (SD) design on healthy volunteers in a randomized, double-blind, placebo-controlled, crossover study on 36 healthy volunteers., Methods/procedure: To validate the SD model, cognitive tests were chosen to assess a transient worsening of cognitive functions after SD and a restoration under modafinil as positive control (one dose of 200 mg). Then, the same evaluations were replicated after 15 days of donepezil (5 mg/d) or memantine (10 mg/d). The working memory (WM) function was assessed by the N-back task and the rapid visual processing (RVP) task., Findings/results: The accuracy of the N-back task and the reaction time of the RVP revealed the alteration of the WM with SD and its restoration with modafinil (changes in score after SD compared with baseline before SD), respectively, in the placebo group and in the modafinil group (-0.2% and +1.0% of satisfactory answers, P = 0.022; +21.3 and +1.9 milliseconds of reaction time, P = 0.025). Alzheimer disease drugs also tended to reverse this deterioration: the accuracy of the N-back task was more stable through SD (compared with -3.0% in the placebo group, respectively, in the memantine group and in the donepezil group: -1.4% and -1.6%, P = 0.027 and P = 0.092) and RVP reaction time was less impacted (compared with +41.3 milliseconds in the placebo group, respectively, in the memantine group and in the donepezil group: +16.1 and +29.3 milliseconds, P = 0.034 and P = 0.459)., Implications/conclusions: Our SD challenge model actually led to a worsening of WM that was moderated by both modafinil and AD drugs. To use this approach, the cognitive battery, the vulnerability of the subjects to SD, and the expected drug effect should be carefully considered.

Background and aim: Nutritional deficiencies are frequent in coeliac disease (CeD), mostly because of the nutritional deficits in gluten-free foods and because of wrong behaviors. We aimed to investigate the level of nutritional knowledge in a cohort of CeD patients in comparison with patients with inflammatory bowel disease (IBD) and healthy subjects. Materials and methods: We consecutively recruited CeD patients and matched-sex and -age IBD patients between April and December 2019 at the University Hospital of Padua outpatient clinic. Healthy subjects were also recruited from family and friends of the hospital staff. The CeD patients were asymptomatic on a gluten-free diet, whereas the IBD patients were in remission. All of the subjects completed the Moynihan validated questionnaire to measure their nutritional knowledge. Results : We included 96 CeD patients, 96 IBD patients, and 65 healthy controls. We found that CeD patients were less aware of nutritional recommendations compared with healthy subjects (HS), and were less able to identify nutrient sources compared with IBD patients and to choose healthy food compared with both groups. The Moynihan questionnaire mean total score was not significantly different between CeD and IBD groups (mean 22.5 ± 2.3 for CeD, 22.0 ± 2.2 for IBD), while it was statistically significantly worse in CeD compared with healthy subjects (mean 21.2 ± 2.3 for HS, p = 0.001). Conclusions : CeD patients tend to focus their diet on gluten avoidance, while IBD patients tend to follow a healthier diet, probably because they believe that diet plays a major role in regulating inflammation and, therefore, their symptoms. A dietitian consultation at CeD diagnosis is recommended., Competing Interests: None.

Objectives: Recent studies have established the usage of virtual reality (VR) to help alleviate acute and chronic pain. VR technology can be cost prohibitive and cheaper alternatives are desired. In this study, a Google Cardboard headset ($15) combined with a smartphone was used as a low-cost VR device to assess efficacy in altering the perception of pain. Materials and Methods: The cold pressor test, a minimal-risk method, was used to simulate pain. Participants immersed their hands into ice water, with and without VR, in a crossover manner, and their pain perception data were recorded. Results: Forty-eight healthy volunteer participants completed the study between 2017 and 2018. Participants were randomized to right hand control, left control, right experimental, and left experimental groups, respectively, before the crossover. Data collected included pain threshold (time at which participants first reported pain), pain tolerance (time at which participants removed their hand), and pain intensity (highest reported pain level on a [1-10] scale). Approximately two-thirds of participants had improvements in pain threshold and pain tolerance with a mean improvement of +13.0 seconds ( P  = 0.0045) for pain threshold and +29.8 seconds ( P  = 0.0003) for pain tolerance. Pain intensity had a reduction of 0.43 points ( P  = 0.0371). Conclusion: Our results demonstrate that inexpensive VR devices, such as the Google Cardboard headset used in this study, may be a safe, portable, and cost-effective way to alter the perception and improve tolerance of pain.

Background and objectives: Aquatic exercises have demonstrated several advantages over land-based exercise, but only a few studies have compared the workout intensities and efficiencies in a stage-specific manner. This study aimed to investigate workout intensity during aquatic and land-based running, based on the rating of perceived exertion (RPE). Materials and Methods: Twenty healthy young male subjects underwent a land-based running test (LRT) and an aquatic running test (ART), in the form of a cardiopulmonary exercise treadmill test and a shallow-water running test. The seven stages of the ART were composed of 3 minutes each of the Bruce protocol performed during the LRT. In the ART, the participants were instructed to run in a swimming pool with matching RPE to that obtained at each stage of the LRT. Results: Heart rate (HR) during both LRT and ART exhibited a linear relationship ( r = 0.997 and 0.996, respectively; p < 0.001). During the initial and middle period, HR was higher in the ART than in the LRT. However, in the final period, HR was higher in the LRT than in the ART. Conclusions: In aquatic exercises based on the RPE obtained from the LRT, HR exhibited a linear relationship in both the ART and the LRT. The ART appears to increase cardiac loading more efficiently in the initial period and does not increase cardiac loading abruptly at a later period. Although there is no precise, objective, controlled parameter to compare the ART and the LRT, the RPE may be used as a convenient measurement for workout intensity in aquatic running.

Background and Aims: For a healthy food to be introduced to the consumer's diet, it has to be attractive, yet testing for food acceptance and the sensory postprandial responses is still not standardized. The main objective of this study was to demonstrate that healthier foods can be obtained without impact on the responses to ingestion., Methods: A randomized, cross-over, double-blind, pilot study in non-obese, healthy men (n=8) comparing the responses to a standard sausage rich in animal fat (mortadella) versus a modified product based on a plant-derived fat analogue and an aroma. Palatability and postprandial sensations were measured on 10 cm scales and brain activity was evaluated by functional magnetic resonance imaging before and after each meal on separate days., Results: Both meals were rated equally palatable and induced the same degree of homeostatic sensations (satiety, fullness) with a similar hedonic dimension (improved mood and digestive well-being). Both meals induced similar changes in brain connectivity: decreased activity in the frontal-parietal, basal ganglia and thalamus, visual occipital, sensory-motor, temporal superior and in the "default-mode" networks, while increased activity was detected in the network associated with white matter., Conclusion: A substantial improvement in the nutritional profile of food can be achieved without affecting the responses to ingestion.

Objectives: The current study compared resource realization and psychological distress in patients with different psychiatric diagnoses and healthy individuals and examined the moderating effect of intrapersonal resources (personal strengths) and interpersonal resources (relationships) on the association between incongruence (unsatisfactory realization of personal goals) and psychological distress., Method: In total, 218 participants (45.87% female, mean age = 39.83 years) completed standardized questionnaires at one measurement point., Results: Healthy individuals (n = 56) reported the most resources, followed by patients with psychotic (n = 53), substance use (n = 53), and depressive disorders (n = 56). While patients with psychotic disorders benefited from intra- and interpersonal resources, patients with depression only benefitted from intrapersonal resources. Patients with substance use disorders did not benefit from resources at all., Conclusions: Depending on the diagnosis, patients evaluated their level of resources differently and benefitted in different ways. The results suggest that within psychotherapy, it might be useful to strengthen resources, especially for patients with depressive and substance use disorders., (© 2019 The Authors. Journal of Clinical Psychology Published by Wiley Periodicals, Inc.)

Introduction: Health researchers often face difficulties related to participants' recruitment for their research. However, a new strategy emerges: offering patients-but also citizens who are not ill-the possibility to volunteer as participants to hasten research processes. The French platform "Seintinelles" aims to fulfill this goal and bring together citizens who volunteered to participate to cancer related research. The "Seintinelles Barometer" aims to describe these volunteers' profile., Methods: The Seintinelles Barometer data were collected through a web-based auto-questionnaire proposed to the "Seintinelles" members from June 2017 to November 2018., Results: The sample presents a high level of overrepresentation of women. Participants are characterized by a high level of education. About a third of the participants had suffered from cancer. Two profile of volunteers emerged: the « patients » and the « supportive citizens »., Discussion: The Seintinelles Barometer participants manifest a strong wish to be involved in cancer related research. Therefore, this platform seems to be a promising tool for the development of community-based research in the field of cancer., (Copyright © 2020 Société Française du Cancer. Published by Elsevier Masson SAS. All rights reserved.)

Intake of dietary supplements has increased, despite evidence that some of these have adverse side effects and uncertainty about their effectiveness. This systematic review examined the evidence for the cognitive benefits of a wide range of dietary supplements in healthy young adult samples; the aim was to identify if any might be useful for optimising cognitive performance during deployment in military personnel. Searches were conducted in 9 databases and 13 grey literature repositories for relevant studies published between January 2000 and June 2017. Eligible studies recruited healthy young adults (18-35 years), administered a legal dietary supplement, included a comparison control group, and assessed cognitive outcome(s). Thirty-seven of 394 identified studies met inclusion criteria and were included for synthesis. Most research was deemed of low quality (72.97%; SIGN50 guidelines), highlighting the need for sound empirical research in this area. Nonetheless, we suggest that tyrosine or caffeine could be used in healthy young adults in a military context to enhance cognitive performance when personnel are sleep-deprived. Caffeine also has the potential benefit of improving vigilance and attention during sustained operations offering little opportunity for sleep. Inconsistent findings and methodological limitations preclude firm recommendations about the use of other specific dietary supplements.

Background: Chronic back pain is one of the most common work-related diseases and most important of musculoskeletal disorders in nursing professionals and because of the physical and psychological effects, has a significant impact on quality of life (QOL). Acupressure is a holistic form of complementary medicine. This study aimed to investigate the effect of acupressure on QOL among female nurses with chronic back pain., Materials and Methods: This randomized single-blind clinical trial was conducted on 50 nurses with chronic back pain working at the selected hospitals in Isfahan, Iran. After convenient sampling, the subjects were randomly allocated, through lottery, to the two groups of experimental (n = 25) and sham (n = 25). In the experimental group, acupressure techniques were performed during 9 sessions, 3 times a week for 14 min for each patient. In the sham group, points within 1 cm of the main points were only touched. Data were collected using the SF36 questioner, before, and immediately, 2 weeks, and 4 weeks after the intervention. Data analysis was performed using SPSS software., Results: Independent t-test showed that the mean total score of QOL before the intervention was not significantly different between the two groups before the intervention (P = .68). However, it was significantly higher in the experimental group compared to the Sham group, immediately, 2 weeks, and 1 month after the intervention (P < .001)., Conclusions: Acupressure on specific points of the foot and back improves back pain and as a result, increases QOL. Therefore, acupressure can be used as a drug-free and low-cost approach without side effects to improve QOL in nurses with chronic back pain., Competing Interests: Declaration of competing interest The authors declare that they have no conflict of interest., (Copyright © 2019. Published by Elsevier Inc.)

Background: Cognitive screening measures are widely administered in everyday clinical practice in different geriatric settings. Despite the presence of several extended-like screening tests, Mini-Mental State Examination (MMSE) continues to be largely used not only by neuropsychologists, neurologists, and psychiatrists but also by general practitioners and other health-related specialties., Aim: We herein provide normative data for the MMSE in a large sample of community-dwelling healthy participants aged over 50 years old stratified by age and education., Material and Methods: The sample included 925 community-dwelling healthy participants (age range: 50-91 years) of both genders (231 males/694 females) with different educational level (range: 1-16 years). Demographic-related effects were examined for the total MMSE score using hierarchical regression analysis; normative data are presented in mean ± standard deviation and percentile ranks and divided into seven overlapping age tables with different midpoints at 55, 60, 65, 70, 75, 80, and 85 years using the overlapping cell procedure., Results: Initial analysis did not show any effect of gender but revealed significant correlation between age, education, and total MMSE. Hierarchical regression analysis revealed that education significantly accounted for 17.3% of the total variance in the MMSE with age adding a significant 7.4% to the final model (adjusted R 2  = 0.246, F = 151.872, p < 0.001; age: β = -0.286, p < 0.001; education: β = 0.332, p < 0.001). The sample was stratified according to the overlapping cell procedure with regard to age (age groups: 50-60, 55-65, 60-70, 65-75, 70-80, 75-85, 80-91); four educational levels were considered: 1-5, 6-9, 10-12, and 13-16 years., Conclusions: Current normative data for the Greek version of the MMSE are provided as a useful set of norms for clinical and research practice.

Background: The role of the trigeminal autonomic reflex in headache syndromes, such as cluster headache, is undisputed but sparsely investigated. The aim of the present study was therefore, to identify neural correlates that play a role in the initiation of the trigeminal autonomic reflex. We further aimed to discriminate between components of the reflex that are involved in nociceptive compared to non-nociceptive processing., Methods: Kinetic Oscillation Stimulation (KOS) in the left nostril was applied in order to provoke autonomic symptoms (e.g. lacrimation) via the trigeminal autonomic reflex in 26 healthy participants using functional magnetic resonance imaging. Unpleasantness and painfulness were assessed on a visual analog scale (VAS), in order to assess the quality of the stimulus (e.g. pain or no pain)., Results: During non-painful activation, specific regions involved in the trigeminal autonomic reflex became activated, including several brainstem nuclei but also cerebellar and bilateral insular regions. However, when the input leading to activation of the trigeminal autonomic reflex was perceived as painful, activation of the anterior hypothalamus, the locus coeruleus (LC), the ventral posteriomedial nucleus of the thalamus (VPM), as well as an activation of ipsilateral insular regions, was observed., Conclusion: Our results suggest the anterior hypothalamus, besides the thalamus and specific brain stem regions, play a significant role in networks that mediate autonomic output (e.g. lacrimation) following trigeminal input, but only if the trigeminal system is activated by a stimulus comprising a painful component.

Recent sociological research has raised important sociological and ethical questions about the role of financial rewards in terms of healthy volunteer involvement in clinical trials. Research suggests that it would be parochial to assume financial rewards alone are sufficient to explain repeat healthy volunteering. This paper explores other factors that might explain repeat healthy volunteering behaviours in phase I clinical drug trials. Drawing on qualitative research with healthy volunteers, the paper argues that while healthy volunteers make rational decisions to take part in drug trials, understanding how they become repeat volunteers requires considering varied relationships and networks involved. Drawing on Deleuze's concept of 'event' and 'becoming-with', the paper illustrates the relational, processual and embodied nature of trust in repeat healthy volunteer involvement in clinical drug trials. The paper concludes that repeat healthy volunteering is a constant flux of negotiating trust and mistrust. The paper contributes to sociological debates about trust and public engagement with technological innovations to illustrate trust among healthy volunteers as processual and changeable., (Copyright © 2019 Elsevier Ltd. All rights reserved.)

Background : Test and Treat has been widely adopted throughout sub-Saharan Africa, whereby all HIV-positive individuals initiate antiretroviral therapy (ART) immediately upon diagnosis and continue for life. However, clients who feel healthy may delay ART initiation, despite being eligible under new treatment guidelines. Objective : We examined health care worker (HCW) perceptions and experiences on how feeling healthy positively or negatively influences treatment initiation among HIV-positive clients in Malawi. Methods : We conducted 12 focus group discussions with 101 HCWs across six health facilities in Central Malawi. Data were analyzed through constant comparison methods using Atlas.ti7.5. Results : Feeling healthy influences perceptions of ART initiation among HIV-positive clients. HCWs described that healthy clients feel that there are few tangible benefits to immediate ART initiation, but numerous risks. Fear of stigma and unwanted disclosure, disruption of daily activities, fear of side effects, and limited knowledge about the benefits of early initiation were perceived by HCWs to deter healthy clients from initiating ART. Conclusion : Feeling healthy may exacerbate barriers to ART initiation. Strategies to reach healthy clients are needed, such as chronic care models, differentiated models of care that minimize disruptions to daily activities, and community sensitization on the benefits of early initiation.

The human capability to learn new motor skills depends on the efficient engagement of cognitive-motor resources, as reflected by mental workload, and psychological mechanisms (e.g., self-efficacy). While numerous investigations have examined the relationship between motor behavior and mental workload or self-efficacy in a performance context, a fairly limited effort focused on the combined examination of these notions during learning. Thus, this study aimed to examine their concomitant dynamics during the learning of a novel reaching skill practiced throughout multiple sessions. Individuals had to learn to control a virtual robotic arm via a human-machine interface by using limited head motion throughout eight practice sessions while motor performance, mental workload, and self-efficacy were assessed. The results revealed that as individuals learned to control the robotic arm, performance improved at the fastest rate, followed by a more gradual reduction of mental workload and finally an increase in self-efficacy. These results suggest that once the performance improved, less cognitive-motor resources were recruited, leading to an attenuated mental workload. Considering that attention is a primary cognitive resource driving mental workload, it is suggested that during early learning, attentional resources are primarily allocated to address task demands and not enough are available to assess self-efficacy. However, as the performance becomes more automatic, a lower level of mental workload is attained driven by decreased recruitment of attentional resources. These available resources allow for a reliable assessment of self-efficacy resulting in a subsequent observable change. These results are also discussed in terms of the application to the training and design of assistive technologies., (Copyright © 2019 IBRO. Published by Elsevier Ltd. All rights reserved.)

High rates of variability in the amplitude of transcranial magnetic stimulation (TMS)-induced motor evoked potentials (MEPs), a popular method for assessing corticospinal excitability (CSE), make it essential to examine inherent reliability of the MEP amplitude. We aimed to investigate the effects of different intertrial intervals (ITIs) of single-pulse TMS on the amplitude, variability, and test-retest reliability of MEPs. Twenty-five TMS single pulses were recorded at four different ITIs of 5, 10, 15, and 20 sec from 15 healthy participants who attended two experimental sessions. Repeated measures analysis of variance (rmANOVA) and standardized z -value standard deviations (SDs) were used to investigate the effects of ITIs on MEP amplitudes and variability. Test-retest reliability of MEP amplitudes was also assessed using rmANOVA and intraclass correlation (ICC). rmANOVA revealed significantly larger MEP amplitudes following ITIs of 10, 15, and 20 sec compared with ITI 5, with no significant increases between ITIs of 15 and 20 sec. Standardized z -value SDs revealed variability rate reduction following longer ITIs with significant reductions occurring following ITIs of 10, 15, and 20 sec compared with ITI 5 with no significant difference between ITIs of 15 and 20 sec. rmANOVA showed no significant Time main effect on the MEP changes confirming within- and between-session agreement. ICCs reported significant within- and between-session reliability in all selected ITIs. The findings of the current study indicate that longer ITIs up to 15 sec can significantly induce larger MEPs with lower variability and higher reliability. The increase in ITIs not only reduces the chance of TMS-induced changes in CSE but also helps us to use this assessment tool in studies with smaller sample sizes.

This article empirically examines how healthy volunteers evaluate and make sense of the risks of phase I clinical drug trials. This is an ethically important topic because healthy volunteers are exposed to risk but can gain no medical benefit from their trial participation. Based on in-depth qualitative interviews with 178 healthy volunteers enrolled in various clinical trials, we found that participants focus on myriad characteristics of clinical trials when assessing risk and making enrolment decisions. These factors include the short-term and long-term effects; required medical procedures; the type of trial, including its design, therapeutic area of investigation, and dosage of the drug; the amount of compensation; and trust in the research clinic. In making determinations about the study risks, participants rely on information provided during the consent process, their own and others' experiences in clinical trials, and comparisons among studies. Our findings indicate that the informed consent process succeeds in communicating well about certain types of risk information while simultaneously creating lacunae that are problematically filled by participants through their collective experiences and assumptions about risk. We discuss the ethical implications of these findings and make recommendations for improving the consent process in healthy volunteer trials.

Intranasal oxytocin produces anorectic effects on snack intake in men when tested in the absence of deprivation-induced hunger, but its effects on food intake in women without eating disorders have not been reported. Oxytocin may reduce food intake by reducing stress eating, since it inhibits ACTH release. The present study adopted a double-blind, repeated measures and fully concealed crossover protocol in which 38 women self-administered 24 IU of oxytocin or placebo intranasally, ate lunch, and underwent two consecutive stress tests. Snack intake was assessed 15-20 min after lunch, via a sham taste test. Salivary cortisol was measured throughout the test period every 15 min. Oxytocin significantly reduced sweet fatty snack intake independently of any effect on salivary cortisol, which declined over time at a similar rate after either drug or placebo. Ratings of sweet taste were slightly reduced by oxytocin, but only in self-reported stress eaters. These results differ from previous studies with men that found an effect of oxytocin on postprandial cortisol levels. However, previous research assayed the less active form of plasma cortisol and did not control for protein intake, which can drive elevated cortisol. The finding that oxytocin reduces snack intake in females after acute stress has important implications for appetite regulation and its treatment in obese people and in those with eating disorders., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Trauma survivors with post-traumatic stress disorder (PTSD) frequently experience intrusive trauma memories associated with a feeling of "nowness". Information-processing models of PTSD ascribe these symptoms to an insufficient integration of memories with their spatio-temporal context in the past, turning them into powerful stressors. Here, we tested the idea that automatic associations of trauma reminders with the present or the past predict intrusive memories. We instructed 96 healthy participants to view two different traumatic films. Participants then underwent a computerized training that established implicit contingencies between film reminder pictures with the verbal responses "now" or "past" to increase and reduce intrusions, respectively. The training successfully altered implicit spatio-temporal associations for film reminder stimuli on a subsequent Implicit Association Test (IAT). There were no additional transfer effects for tense usage during a free recall task after one week and for the development of intrusion symptoms (one-week diary, retrospective questionnaire). However, participants who associated one film more strongly with the present and the other with the past consistently reported relatively more intrusive memories related to the former film. Thus, our results lend support to information processing models of PTSD and warrant further investigation of the causal role of implicit associations with spatio-temporal information., (Copyright © 2019 Elsevier Ltd. All rights reserved.)

Involvement of the cerebellum to non-motor related aspects of behavior is becoming increasingly clear. The aim of this study was to investigate the role of the cerebellum in reactive and proactive behavioral control and interference. In a double-blind controlled within-subject design, 26 healthy volunteers underwent real and sham cerebellar transcranial direct current stimulation (tDCS) while performing a go/no-go task and a delay discounting task. Results showed that the number of go/no-go commission errors was significantly lower during real as compared with sham cerebellar tDCS. No effects of tDCS were observed on delay discounting. Our findings provide further behavioral support for the involvement of the cerebellum in fast neural processes associated with response inhibition.

Background: Previous social science research has shown how some healthy phase I trial participants identify themselves as workers and rely on trials as a major source of income. The term "professionalization" has been used to denote this phenomenon., Purpose: We aim to examine a component of healthy trial participants' professionalization that has not yet been systematically studied: how repeat phase I trial participants develop and claim expertise that distinguishes them from others and makes them uniquely positioned to perform high-quality clinical trial labor. We also aim to explain the significance of these research results for protection of healthy participants in phase I trials., Methods: This qualitative exploratory study was conducted in Russia, in two phase I trial units. It involved semi-structured interviews with 28 healthy trial participants with varying lengths of experience in trials, observations of work done in trial units, and interpretive conversations with investigative staff., Results: Interviewed healthy individuals who repeatedly participate in phase I trials describe developing knowledge and skills that involve appreciating the meaning of trial procedures, coming up with techniques to efficiently follow them, organizing themselves and others in the course of a trial, and sharing tacit ways of doing trial work well with other less experienced participants. Our results suggest that a prerequisite for such expertise-centered professionalization is the emergence of a positive identity linked to seeing value in trial participation work. A crucial component of professionalization thus understood is the development of a work ethic that entails caring about results and being reliable partners for investigators., Limitations: The attitudes and behaviors presented in this article are not suggested to be universally shared among healthy trial participants, but rather represent a particular instance of professionalization that coexists with other views and tactics., Conclusions: A way of better protecting healthy trial participants begins with recognizing their skills, knowledge, and the centrality of the contribution they are making to pharmaceutical research. Currently, the expertise of experienced trial participants is recognized on the work floor only; therefore, the professionalization we described is informal. Yet, the informal professionalization process is inherently risky as it does not involve any change in the formal conditions of trial participants' work. Instituting formal measures for protecting healthy trial participants as skilled workers combined with recognition of their expertise is essential.

Strong evidence suggests that sleep plays a role in memory consolidation, which involves both stabilizing memory into long-term storage as well as integrating new information into existing stores. The current study investigated consolidation, across a day of wakefulness or night of sleep, of emotional and neutral directly learned visual paired associates (A-B/B-C pairs) as well as formation of memory for relational pairs formed via overlapping learned components (A-C pairs). Participants learned 40 negative and 40 neutral face-object pairs followed by a baseline test in session 1 either in the morning or evening. They then spent a 12-hour retention period during which participants either went about their normal day or spent the night in the sleep lab. During session 2, participants completed a surprise test to assess their memory for relational pairs (A-C) as well as memory for direct associates (A-B/B-C). As hypothesized, the results demonstrated that a 12-hour retention period predominantly spent asleep, compared to awake, benefited memory for both relational and direct associative memory. However, contrary to the hypothesis that emotional salience would promote preferential consolidation, sleep appeared to benefit both negative and neutral information similarly for direct associative and relational memories, suggesting that sleep may interact with other factors affecting encoding (e.g., depth of encoding) to benefit direct and relational associative memory. As one of the few studies examining the role of nocturnal sleep and emotion on both direct and relational associative memory, our findings suggest key insights into how overnight sleep consolidates these different forms of memory.

Background: Voluntary shifts of visuospatial attention are associated with a lateralization of parieto-occipital alpha power (7-13Hz), i.e. higher power in the hemisphere ipsilateral and lower power contralateral to the locus of attention. Recent noninvasive neuromodulation studies demonstrated that alpha power can be experimentally increased using transcranial alternating current stimulation (tACS)., Objective/hypothesis: We hypothesized that tACS at alpha frequency over the left parietal cortex induces shifts of attention to the left hemifield. However, spatial attention shifts not only occur voluntarily (endogenous/ top-down), but also stimulus-driven (exogenous/ bottom-up). To study the task-specificity of the potential effects of tACS on attentional processes, we administered three conceptually different spatial attention tasks., Methods: 36 healthy volunteers were recruited from an academic environment. In two separate sessions, we applied either high-density tACS at 10Hz, or sham tACS, for 35-40 minutes to their left parietal cortex. We systematically compared performance on endogenous attention, exogenous attention, and stimulus detection tasks., Results: In the endogenous attention task, a greater leftward bias in reaction times was induced during left parietal 10Hz tACS as compared to sham. There were no stimulation effects in either the exogenous attention or the stimulus detection task., Conclusion: The study demonstrates that high-density tACS at 10Hz can be used to modulate visuospatial attention performance. The tACS effect is task-specific, indicating that not all forms of attention are equally susceptible to the stimulation., Competing Interests: The authors have declared that no competing interests exist.

Background: There is a growing interest in mobile technology for obesity management. Despite the known effectiveness of workplace-based weight loss programs, there are few studies on mobile phone-delivered interventions., Objective: This study aimed to develop and verify an integrated and personalized mobile technology-based weight control program, named Health-On, optimized for workplaces., Methods: A weight reduction algorithm was developed for calorie prescription, continuous monitoring, periodic feedback and reevaluation, goal resetting, and offline intervention with behavior-changing strategies. A total of 30 obese volunteers (body mass index ≥25 kg/m 2 ) participated in the 12-week Health-On pilot program. The primary outcome was weight reduction, and secondary outcomes were improved anthropometric measures, metabolic profiles, and fat computed tomography measures, all assessed pre- and postintervention., Results: Health-On incorporated proprietary algorithms and several strategies intended to maximize adherence, using compatible online and offline interventions. The mean weight of 30 participants decreased by 5.8%, and median weight also decreased from 81.3 kg (interquartile range [IQR] 77.1-87.8) before intervention to 76.6 kg (IQR 70.8-79.5) after the 12-week intervention period (P<.001). The metabolic profiles and fat measures (blood pressure, glycosylated hemoglobin, total cholesterol, triglyceride, high-density lipoprotein, low-density lipoprotein, alanine aminotransferase, and visceral and subcutaneous adipose tissue; P<.05) also improved significantly., Conclusions: In this single-group evaluation of 30 participants before and after the Health-On program, body weight decreased and metabolic profiles and fat measures improved. Follow-up studies are needed to assess effectiveness and long-term adherence., (©Min Kyu Han, Belong Cho, Hyuktae Kwon, Ki Young Son, Hyejin Lee, Joo Kyung Lee, Jinho Park. Originally published in JMIR Mhealth and Uhealth (http://mhealth.jmir.org), 04.11.2019.)

Purpose: The present study aimed to determine the extent of information that healthy volunteers need in an informed consent form (ICF) to support their decision whether to participate in a bioequivalence study, a type of clinical studies involving the testing of pharmacokinetic equivalence of a generic drug with a brand-name drug in volunteer subjects., Methods: This cross-sectional, descriptive study determined the perspectives of individuals who used to participate in bioequivalence studies, using an electronic-based questionnaire. A 5-point modified Likert scale was used to indicate the importance of each element of the ICF content, with an anchored rating scale from 1 (not important) to 5 (very important) for each item., Results: Of 300 questionnaires distributed, all (100%) were returned. The respondents considered most items to be necessary for their decision, with the score ranging from 3.25 to 4.60 (mean overall score = 4.16 ± 0.30). The four top-rated items were the "major foreseeable risk" (4.60 ± 0.72), "participant's responsibility during participation" (4.52 ± 0.72), "confidentiality and the limit of confidentiality" (4.52 ± 0.82), and "all possible adverse effects of the drug" (4.47 ± 0.74), while the relatively less concerned items were related to general information., Conclusions: Most elements of the ICF content required were considered as important by the previously experienced volunteers in bioequivalence studies, notwithstanding that some elements were perceived as more important than others. The data from this study could be used to better tailor relevant information in an ICF to the needs of research participants in bioequivalence studies.

Objective: The aim of this study is to compare actual driving performance and skills related to driving of patients using benzodiazepine anxiolytics or hypnotics for at least 6 months to that of healthy controls., Methods: Participants were 44 long-term users of benzodiazepine and benzodiazepine-related anxiolytics (n = 12) and hypnotics (n = 32) and 65 matched healthy controls. Performance was assessed using an on-the-road driving test measuring standard deviation of lateral position (SDLP, in cm) and a battery of neurocognitive tasks. Performance differences between groups were compared with a blood alcohol concentration of 0.5 mg/ml to determine clinical relevance., Results: Compared with controls, SDLP was significantly increased in hypnotic users (+1.70 cm) but not in anxiolytic users (+1.48 cm). Anxiolytic and hypnotic users showed significant and clinically relevant impairment on neurocognitive task measuring executive functioning, vigilance, and reaction time. For patients using hypnotics for at least 3 years, no significant driving impairment was observed., Conclusion: Impairing effects of benzodiazepine hypnotics on driving performance may mitigate over time following longer term use (i.e. 3 years or more) although neurocognitive impairments may remain., (© 2019 The Authors. Human Psychopharmacology: Clinical and Experimental published by John Wiley & Sons Ltd.)

Background: Nightmares are associated with parental bonding styles and various psychiatric disorders, but the exact connections between different nightmare experience features and family relationships in healthy volunteers and nightmare disorder patients are still unclear., Methods: We therefore invited 62 nightmare disorder patients and 135 healthy volunteers to undergo tests of the Nightmare Experience Questionnaire (NEQ), the Family Relationship Questionnaire (FRQ), and the Plutchik - van Praag Depression Inventory (PVP)., Results: Besides the higher nightmare frequency and the higher PVP and four NEQ scale scores, the nightmare disorder patients had higher scores of FRQ Paternal Abuse, and lower ones of General Attachment, Maternal Encouragement, Maternal Freedom Release, and Paternal Freedom Release. The PVP was correlated with some NEQ and FRQ scales in both healthy volunteers and patients, and it functioned as a mediator between Physical Effect and Maternal Dominance in patients. Regarding predicting NEQ by FRQ, Paternal Abuse predicted Physical Effect, Maternal Dominance predicted Physical Effect and Horrible Stimulation, General Attachment predicted Horrible Stimulation (-) in healthy volunteers; Maternal Dominance predicted Physical Effect, Meaning Interpretation, and Horrible Stimulation, Paternal Freedom Release predicted Physical Effect (-), and Paternal Dominance predicted Meaning Interpretation and nightmare frequency in patients., Conclusions: Our study has demonstrated that the inappropriate family relationships were linked with different aspects of nightmare experience, especially in nightmare disorder patients.

Attention-deficit/hyperactivity disorder (ADHD) is a neurodevelopmental disorder in children and adults. It is characterized by inappropriate levels of inattention (IA) and/or hyperactivity and impulsivity (HI). The ADHD diagnosis is hypothesized to represent the extreme of a continuous distribution of ADHD symptoms in the general population. In this study, we investigated whether factors linked to adult ADHD as a disorder are associated with adult ADHD symptoms in the general population. Our population-based sample included 4987 adults (mean age 56.1 years; 53.8% female) recruited by the Nijmegen Biomedical Study (NBS). Participants completed the Dutch ADHD DSM-IV Rating Scale for current and childhood ADHD symptoms, the Symptom Check List-90-R (SCL-90-R) anxiety subscale, and the Eysenk Personality Questionnaire (EPQR-S). Partial Spearman correlation and Hurdle negative binomial regression analysis were used to assess how age, sex, childhood ADHD symptoms, anxiety symptoms, and personality traits (neuroticism, extraversion, and psychoticism) are associated with current IA and HI symptoms. Increasing age was associated with a lower proportion of participants reporting HI symptoms and with reduced levels of HI; IA levels remained fairly stable over the age-range, but the probability of reporting IA symptoms increased throughout middle/late adulthood. Females were more likely to report IA symptoms than males. Childhood ADHD symptoms, neuroticism, and psychoticism were positively associated with current IA and HI symptoms, while extraversion had an opposite association with these symptom domains. Anxiety symptoms affected HI symptoms in females. Our results indicate that factors associated with categorical ADHD are also correlated with ADHD symptoms in the adult population., (Copyright © 2019 Elsevier B.V. and ECNP. All rights reserved.)

Well siblings of chronically ill children experience family disruptions that profoundly affect them. Previous research focusing on well siblings' experiences has often produced inconsistent findings, likely the result of varying study designs and samples. The purposes of this synthesis research study were twofold: (a) to assess the applicability of existing grounded theory of sibling response to a child's cancer to a wider range of childhood conditions; and (b) to refine the existing theory to reflect the experiences of the broader sample. Data for the synthesis came from a National Institute of Nursing Research-funded mixed-methods synthesis examining the intersection of childhood chronic illness and family life. The current analysis was based on well sibling results extracted from 78 research reports published between 2000 and 2014. An existing grounded theory, Creating a Tenuous Balance (CTB), was discovered at the outset of analysis and used as the primary framework for coding and synthesizing results. The focus of most studies was siblings' responses to 14 chronic conditions, with cancer being the most often studied. Results reflected siblings' perspectives of their experiences as well as perspectives of parents and the ill child. The analysis substantiated all four patterns of sibling behavior included in CTB, with the patterns of adapting to changes in personal and family life, and handling strong emotions being especially challenging aspects of the sibling experience. Moreover, the results expanded several aspects of CTB. The analysis provided evidence of the applicability of the theory to a varied group of chronic conditions and enabled us to identify important areas for developing interventions to support siblings., (© 2019 Wiley Periodicals, Inc.)

Over 70% of older adults report chronic or acute pain, and pain threatens affective wellbeing. The strategies older adults use to maintain affective wellbeing following acute pain remain unknown. Specific strategies that can be used to manage pain include recalling, recognizing, and responding to positive stimuli and prioritizing close over knowledgeable social partners. The study tested whether older adults used positivity-enhancing strategies and maintained affective wellbeing following acute pain better than younger adults. Fifty older (ages 65-85) and 50 younger (ages 18-30) pain-free adults experienced a control and a pain condition and were given the chance to employ positivity-enhancing strategies. Older and younger adults similarly used positivity-enhancing strategies following pain. Younger adults demonstrated reduced preference for knowledgeable social partners after experiencing pain. Pain-related affective changes were similar between age groups. Older and younger adults may cope with acute pain similarly, highlighting future directions for exploring age differences in pain coping.

Breast cancer is the most common cancer and the second leading cause of death among women. Regarding the lack of knowledge about the cause of breast cancer and considering the fact that all women are prone to this disease, training on methods of early diagnosis to reduce its complications is of great importance. Thus, this study aimed to determine the effect of education based on the health belief model on breast cancer screening behaviors in health volunteers of health centers in Isfahan. In this experimental study, 480 healthy volunteers were randomly divided into two groups: the case (n = 240) and control (n = 240). The training program was designed according to health belief model structures. Before the training interventional program, the Champion standard questionnaire and functional checklist were completed for both groups. A standard questionnaire was completed during three stages (before, immediately after, and 2 months after the training). The experimental group received the educational intervention during eight sessions, and the collected data was eventually analyzed using the SPSS statistical software version 16 with relevant statistical tests. Participation of all individuals in the present research was voluntary and with informed consent. The results showed that mean scores of knowledge, perceived susceptibility, severity, benefits, barriers, self-efficacy, and behavioral intention related to breast self-examination (BSE) and mammography in the intervention group significantly increased compared with those of the control group immediately after and 2 months after educational intervention. There was a significant difference between groups in BSE skill 2 months after the intervention, but there was no significant difference between the two groups in BSE behavior and mammography 2 months after the intervention. The results confirmed the efficiency and effectiveness of an educational intervention based on the health belief model on improving factors affecting breast cancer screening behaviors.

The aim of the study was to examine the effects of acute dissociation on emotional responsivity in healthy individuals. We used a previously validated technique (mirror-gazing, Caputo, 2010) to experimentally induce acute dissociation in non-clinical participants and assessed post-induction subjective responsivity (ratings of valence and arousal) to standardized emotional images. Fifty non-clinical participants were randomised to either the dissociation induction (n = 25) or control conditions (n = 25). The dissociation manipulation effect was corroborated by a significant post-induction elevation in state dissociation in the dissociation-induction group relative to controls (p = .004). The dissociation-induction group rated negative (p = .028) and neutral (p = .025) stimuli as significantly less unpleasant than controls. There was also a non-significant trend for positive stimuli to be rated as less pleasant by the dissociation-induction group compared to controls (p = .060). These findings provide experimental evidence for the short-term alleviation (i.e., emotional numbing) of negative affect during dissociative states, which may serve as a coping mechanism for some individuals. However, this tendency of emotional numbing also reduced positive affective responses to pleasant stimuli to some extent. Further investigation of dissociative phenomena and their impact on emotional processing appears warranted., (Copyright © 2019 Elsevier Ltd. All rights reserved.)

Background: A reduced willingness to perform effort based on the magnitude and probability of potential rewards has been associated with diminished dopamine function and may be relevant to attention-deficit/hyperactivity disorder (ADHD). Here, we investigated the influence of ADHD status and methylphenidate on effort-based decisions. We hypothesized that ADHD participants would make fewer high-effort selections than non-ADHD subjects, and that methylphenidate would increase the number of high-effort selections. Furthermore, we hypothesized there would be associations among ADHD severity and methylphenidate-related changes in effort-based and attentional performance across all participants., Methods and Participants: ADHD (n = 23) and non-ADHD (n = 23) adults completed the Effort Expenditure for Rewards Task in which participants select between low-effort and high-effort options to receive monetary rewards at varying levels of reward magnitude and probability. A test of attentional performance was also completed., Results: Overall, participants made more high-effort selections as potential reward magnitude and probability increased. ADHD participants did not make fewer high-effort selections than non-ADHD participants, but ADHD participants showed greater methylphenidate-related increases in high-effort selections. ADHD participants had worse attentional performance than non-ADHD participants. ADHD severity was associated with methylphenidate-related changes in high-effort selections, but not changes in attentional performance., Conclusions: These results indicate that methylphenidate increases the willingness to perform effort in individuals with ADHD, possibly due to disorder-related motivational deficits. This provides support for theories of insufficient effort allocation among individuals with ADHD., Trial Registration: Clinicaltrials.gov Identifier, NCT02630017., (Copyright © 2019 Elsevier Inc. All rights reserved.)

The extraversion personality trait has a positive correlation with social interaction. In neuroimaging studies, investigations on extraversion in face-to-face verbal interactions are still scarce. This study presents an electroencephalography (EEG)-based investigation of the extraversion personality trait in relation to eye contact during face-to-face interactions, as this is a vital signal in social interactions. A sample of healthy male participants were selected (consisting of sixteen more extraverted and sixteen less extraverted individuals) and evaluated with the Eysenck's Personality Inventory (EPI) and Big Five Inventory (BFI) tools. EEG alpha oscillations in the occipital region were measured to investigate extraversion personality trait correlates of eye contact during a face-to-face interaction task and an eyes-open condition. The results revealed that the extraversion personality trait has a significant positive correlation with EEG alpha coherence in the occipital region, presumably due to its relationship with eye contact during the interaction task. Furthermore, the decrease in EEG alpha power during the interaction task compared to the eyes-open condition was found to be greater in the less extraverted participants; however, no significant difference was observed between the less and more extraverted participants. Overall, these findings encourage further research towards the understanding of neural mechanism correlates of the extraversion personality trait-particularly in social interaction., Competing Interests: The authors have declared that no competing interests exist.

As intelligent machines have become widespread in various applications, it has become increasingly important to operate them efficiently. Monitoring human operators' trust is required for productive interactions between humans and machines. However, neurocognitive understanding of human trust in machines is limited. In this study, we analysed human behaviours and electroencephalograms (EEGs) obtained during non-reciprocal human-machine interactions. Human subjects supervised their partner agents by monitoring and intervening in the agents' actions in this non-reciprocal interaction, which reflected practical uses of autonomous or smart systems. Furthermore, we diversified the agents with external and internal human-like factors to understand the influence of anthropomorphism of machine agents. Agents' internal human-likenesses were manifested in the way they conducted a task and affected subjects' trust levels. From EEG analysis, we could define brain responses correlated with increase and decrease of trust. The effects of trust variations on brain responses were more pronounced with agents who were externally closer to humans and who elicited greater trust from the subjects. This research provides a theoretical basis for modelling human neural activities indicate trust in partner machines and can thereby contribute to the design of machines to promote efficient interactions with humans.

Level of education is known to confound neuropsychological test performance. The INECO Frontal Screening (IFS) is an easy-to-use and brief measure of several domains of executive function, which has previously shown reliably clinical usefulness and superior psychometric performance when compared to other frontal screening instruments. However, previous studies with the IFS have been limited to participants with high levels of education, preventing its generalizability to populations with less than 12 years of formal education. This is crucial, as less than half of the Latin American population and a large percentage of immigrants in developed countries attain high school education. The aim of this study was to generate IFS normative data in a sample stratified by age and education levels. One hundred and sixty one healthy adults were assessed with the IFS as well as measures of global cognitive screening, namely, the Addenbrooke Cognitive Examination Revised and the Mini-Mental State Examination. Multiple lineal regression analysis showed significant effects for education and nonsignificant effects for age. A correction grid for IFS raw scores was developed and cut-off scores were calculated. The correction grid and cut-off scores may be useful in the interpretation of IFS scores in participants with low education.

Introduction: Chronic kidney disease (CKD) negatively affects the physical and biopsychosocial aspects of the lives of individuals with the disease, thereby affecting the quality of life (QOL) of patients and their families., Objectives: This study aimed to measure the QOL of individuals with CKD and compare the QOL scores of patients with CKD to the scores of disease-free individuals to find factors associated with better QOL., Method: The local Ethics Committee approved this cross-sectional study. The study was carried out at a public clinic and a private hemodialysis clinic. Participants were asked to answer the WHOQOL-BREF and a sociodemographic questionnaire. Statistical tests were used according to the variables of interest and significance was attributed to differences with p-values < 0.05., Results: Nearly two thirds (59%) of the case group members were males and 55% did not have a spouse; 53% were seen at a private clinic and 57% had complications. The variables that more significantly affected QOL were smoking (perception of QOL) (Bi = - 0.4061; p = 0.032), undergoing hemodialysis (general health status) (Bi = - 0.3029; p = 0.034), and duration of sessions (Bi = 0.117; p = 0.039) (environmental domain)., Conclusion: The QOL of patients with CKD was significantly lower when compared to controls in the physical and psychological domains. Several variables affected the perception of QOL and should be considered in clinical assessment.

Background and Objectives: Deviations in interoception might contribute to the development and maintenance of mental disorders. The improvement of interoceptive accuracy (IA) is desirable but assessment and training methods remain controversial. For instance, it was assumed that performance increases in heartbeat counting paradigms after cardiac feedback were due to an improvement of knowledge with regard to heart rate rather than due to an actual improvement in IA., Methods: Here, we examined effects of contingent cardiac feedback training, non-contingent cardiac feedback, mindfulness practice, and a waiting period with external attentional focus on IA. 100 healthy participants underwent a mental tracking paradigm before and after 20 min of training or waiting., Results: Results revealed a significant increase of IA in the contingent feedback condition (d = 1.21, p ≤ .001) and no significant changes after non-contingent feedback, mindfulness practice or waiting (d ≤ 0.37; p ≥ .06). Furthermore, IA increase was significantly higher after the contingent feedback training compared to all other conditions, including non-contingent feedback., Limitations: Future studies need to replicate these findings in clinical samples and examine time dependent effects., Conclusions: The results provide evidence for the trainability of heartbeat perception. IA improvements may reduce the symptom burden in people suffering from mental disorders and psychophysiological conditions that have been linked to lower interoceptive accuracy such as depression, somatic symptom disorder, chronic pain, and functional somatic syndromes. Consequently, exploration of biofeedback training procedures shall be continued with the aim of identifying relevant mediators of beneficial effects and future implementation in clinical practice., (Copyright © 2018 Elsevier Ltd. All rights reserved.)

Aims/background: A fundamental part of all clinical trials is informed consent, reflecting the respect for the volunteer's autonomy. Research participation is voluntary; therefore, certain aspects of the proposed study must be disclosed so that volunteers can make an informed decision. In this study, we aimed to examine the level of comprehension and recall of healthy volunteers from the informed consent process., Methods: The study was carried out at a single phase I clinical trials unit. A questionnaire was administered to each volunteer to assess recall of important aspects of the study at the day-1 visit following the informed consent process. The questionnaire contained seven questions regarding study objectives, route, frequency and type of drug administration, adverse effects, number of subjects previously exposed and remuneration. One point was awarded for each correct answer., Results: A total of 266 volunteers were administered the questionnaire. The mean total score (±standard deviation) for all volunteers was 4.5 ± 1.1 points out of 7, with a range of 0.8-6.7. For all 10 studies, 91% of volunteers responded correctly when answering about the route of administration, and 90% were able to accurately state the correct payment amount. Only 7% were able to repeat the aims of the study correctly., Conclusion: The poor performance of our study volunteers raises concerns about recall of information prior to study drug administration. This has implications for the volunteer's safety and ability to provide true informed consent. Interventions to improve recall prior to dosing should be undertaken.

Background and Objectives: In psychoeducation before exposure treatment patients are sometimes provided with information about the (low) probability that the feared outcome would occur. Since it has been proposed in the literature that this might have adverse effects, the current study investigated the effect of providing participants with this type of safety information on return of fear., Method: In an ABA-renewal paradigm, participants in the experimental group were instructed between acquisition and extinction that the probability of US-occurrence would be extremely small in the remainder of the experiment. Participants in the control group did not receive this information., Results: Less return of fear in US-expectancy ratings was observed in participants who received the safety information., Limitations: We failed to find successful acquisition in the skin-conductance data, which prevented us from interpreting the results of this outcome measure., Conclusions: These results suggest that providing safety information is not deleterious for the effects of exposure and can even be beneficial for its effects. However, further clinical research is needed., (Copyright © 2018. Published by Elsevier Ltd.)

Background and Objectives: Evolutionary theories propose that socially anxious individuals are especially sensitive to social-rank signals, presumably at the expense of the attunement to signals of affiliation. Despite this theoretical claim, few empirical attempts examined the association between social anxiety (SA) and sensitivity to specific features of social-rank and affiliation. This study aims to fill this gap., Method: Participants (N = 67) completed two tasks in which two emotionally neutral computer-generated male faces of the same character were presented side-by-side. In the Social-Rank-Sensitivity Task, the faces within each pair differed in their level of dominance and, in the Affiliation-Sensitivity Task, the faces differed in their level of trustworthiness. The participants' task was to decide which of the two faces looked more dominant or friendly., Results: There were no differences in accuracy between high- and low-SA participants in the Affiliation-Sensitivity Task. In contrast, high-SA participants were more accurate than low-SA participants in the Social-Rank-Sensitivity Task. No group differences were found in decision latencies in either task., Limitations: Limitations of the study are that a non-clinical sample was used and that only computer-generated male faces were considered., Conclusions: Our findings suggest that SA is related to an enhanced ability to discriminate faces based on social-rank features. Examining sensitivity to facial cues signaling social-rank and affiliation may help to specify the nature of social threat sensitivity in SA., (Copyright © 2018 Elsevier Ltd. All rights reserved.)

While risk of harm is an important focus for whether clinical research on humans can and should proceed, there is uncertainty about what constitutes harm to a trial participant. In Phase I trials on healthy volunteers, the purpose of the research is to document and measure safety concerns associated with investigational drugs, and participants are financially compensated for their enrollment in these studies. In this article, we investigate how characterizations of harm are narrated by healthy volunteers in the context of the adverse events (AEs) they experience during clinical trials. Drawing upon qualitative research, we find that participants largely minimize, deny, or re-attribute the cause of these AEs. We illustrate how participants' interpretations of AEs may be shaped both by the clinical trial environment and their economic motivation to participate. While these narratives are emblematic of the larger ambiguity surrounding harm in the context of clinical trial participation, we argue that these interpretations also problematically maintain the narrative of the safety of clinical trials, the ethics of testing investigational drugs on healthy people, and the rigor of data collected in the specter of such ambiguity.

Background: To date there are no validated tests in Italian to assess cognitive functions in Bipolar Disorder. Therefore, this study aimed to provide normative data for the Italian version of the Brief Assessment of Cognition in Affective Disorders (BAC-A), a battery targeting neuro- and affective-cognition in affective disorders., Methods: Data were collected from 228 healthy participants (age range: 18-67; mean age: 34.68 ± 12.15 years) across eight recruiting sites. The influence of age, sex and education was measured and adjusted for using multivariate stepwise regression models. Normative values were established by means of the Equivalent Score approach., Results: Most of the BAC-A subtests showed patterns of association with age (inversely associated with overall cognitive performance), education (positively associated with Verbal Memory and Fluency, Digit Sequencing and Affective Processing subtests) and sex (females performed better than males in the Affective Interference Test but worse in the Emotion Inhibition Task, Digit Sequencing and Tower of London)., Limitations: The sample size was not sufficiently large for developing stratified norms, using 10-years ranges. Moreover, the participants included in the study were, on average, highly educated., Conclusions: The normative data of the BAC-A provided in this study can serve as a cognitive functioning reference for Italian-speaking participants within the age range of the study sample. This can increase the applicability of this test in both clinical and research settings. The reliability and validity of the Italian BAC-A need to be further investigated., (Copyright © 2019. Published by Elsevier B.V.)

Background: Alzheimer's disease (AD) is recognized as one of the greatest global public health challenges. There is increasing consensus that optimal disease modification using pharmaceuticals may best be achieved earlier in the disease continuum before symptoms occur. However, more needs to be understood about what outcomes are meaningful to potential participants in clinical trials within this preventative paradigm and how people make trade-offs between risks and benefits. The Electronic Person-Specific Outcome Measure (ePSOM) programme is developing an app to capture person-specific outcomes and preferences in clinical trials., Objective: As one phase in the ePSOM programme, this study explored what matters when developing new treatments to prevent AD and how trade-offs are made between risks and benefits, from three perspectives., Design: Focus groups were conducted with people living with memory problems (n = 21) and healthy volunteers (n = 10), and telephone interviews with health and social care professionals (n = 10). Differences and overlap between the three groups were explored., Results: Outcomes that matter lie in five key domains in relation to what matters in everyday life: Everyday Functioning; Relationships and Social Connections; Enjoying Life; Sense of Identity; and Alleviating  Symptoms. Insights were gained into the significance of reducing the risk of developing dementia with drugs and the processes of weighing up risks versus benefits., Discussion and Conclusions: The key domains identified are being used to inform the next stage of the ePSOM programme which is to develop a survey to be distributed nationally in the UK to explore these issues further., (© 2019 The Authors Health Expectations published by John Wiley & Sons Ltd.)

Objective: Transcranial direct current stimulation (tDCS) over the primary motor cortex (M1) has shown efficacy in a number of chronic pain conditions. Despite attempts to dissect the analgesic mechanisms, it is unknown whether M1 tDCS modulates the central integration of spinal nociception. To test this, we investigated the top-down modulation of spinal excitability using temporal summation (TS) of the nociceptive withdrawal reflex (NWR)., Methods: In this randomized, blinded, cross-over study, eight healthy subjects received electrically evoked TS of the NWR, which was delivered at 5 Hz at a threshold and a suprathreshold (1.1× threshold) to elicit TS resulting in different levels of pain. Subjects were asked to rate their pain after each stimulation. Changes in the TS of the NWR and pain ratings were investigated following 20 minutes of 2-mA anodal tDCS or sham stimulation applied over M1., Results: Baseline recordings showed that TS of the NWR was induced with both threshold and suprathreshold stimulation. Suprathreshold stimulation was also associated with a higher pain intensity rating. After brain stimulation, there was no effect over the lower-intensity TS of the NWR or pain ratings in both the tDCS and sham conditions. However, tDCS reduced TS of the NWR and associated pain ratings following higher-intensity suprathreshold stimulation., Conclusions: These results indicate that M1 tDCS can indirectly modulate the central integration of suprathreshold nociceptive processing in the spinal cord. It is possible that the analgesic efficacy of tDCS is dependent on plasticity induced within pain pathways following repeated, high-intensity stimulation, which may explain the beneficial effects seen in chronic pain patients., (© 2018 American Academy of Pain Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background and Objectives: Visual Schema Displacement Therapy (VSDT) is a novel therapy which has been described as a treatment for stress and dysfunction caused by a traumatic event. Although its developers claim this therapy is quicker and more beneficial than other forms of trauma therapy, its effectiveness has not been tested., Methods: We compared the efficacy of VSDT to an abbreviated EMDR protocol and a non-active control condition (CC) in two studies. In Study 1 participants (N = 30) were asked to recall three negative emotional memories under three conditions: VSDT, EMDR, and a CC, each lasting 8 min. Emotional disturbance and vividness of the memories were rated before and after the (within group) conditions. The experiment was replicated using a between group study. In Study 2 participants (N = 75) were assigned to one of the three conditions, and a follow-up after 6-8 days was added., Results: In both studies VSDT and EMDR were superior to the CC in reducing emotional disturbance, and VSDT was superior to EMDR. VSDT and EMDR outperformed the CC in terms of reducing vividness., Limitation: Results need to be replicated in clinical samples., Conclusions: It is unclear how VSDT yields positive effects, but irrespective of its causal mechanisms, VSDT warrants clinical exploration., (Copyright © 2018 Elsevier Ltd. All rights reserved.)

Objective: The present study aimed to investigate the factor structure of a set of neurocognitive tests theoretically assessing executive functions (EF), verbal abilities (VA), and processing speed (PS). This study extended previous research by analyzing if each test is better explained by the specific factor to which it theoretically belongs or by a more general neurocognitive factor; and also by analyzing the relations between the neurocognitive factors., Methods: Using confirmatory factor analysis (CFA) we examined the factor structure of nine neurocognitive tests (EF: Working Memory, Tower, Divided Attention, Stroop, and Verbal Fluency tests; VA: Word List and Confrontation Naming tests; PS: Coding and Telephone Search tests) in a nonclinical sample (N = 90; 18-33 years old, 76 women). We tested five factor models of neurocognitive functioning: a one-factor model; two models with two-correlated factors; and two models with three-correlated factors., Results: A three-correlated-factor model, with EF, VA, and PS factors, was the most suitable for our neuropsychological data. The Verbal Fluency test was better explained by the VA factor rather than by the EF factor. The EF factor was correlated with the PS factor, but not with the VA factor., Conclusions: Most of the neurocognitive measures used in the present study loaded in the expected factors (with the exception of the Verbal Fluency that was apparently more related to VA). EF and PS represent related but separable functions. Our results highlight the need for a careful interpretation of test scores since performance on one test usually requires multiple functions., (© The Author(s) 2018. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)