Psilocybin-assisted therapy for severe alcohol use disorder: protocol for a double-blind, randomized, placebo-controlled, 7-month parallel-group phase II superiority trial.

BACKGROUND: A significant number of individuals with alcohol use disorder remain unresponsive to currently available treatments, which calls for the development of new alternatives. In parallel, psilocybin-assisted therapy for alcohol use disorder has recently yielded promising preliminary results. Building on extant findings, the proposed study is set to evaluate the feasibility and preliminary clinical efficacy of psilocybin-assisted therapy when incorporated as an auxiliary intervention during inpatient rehabilitation for severe alcohol use disorder. Moreover, it intends to pinpoint the modifications in the two core neurocognitive systems underscored by dual-process models of addiction. METHODS: In this double-blind, randomized, placebo-controlled, 7-month parallel-group phase II superiority trial, 62 participants aged 21-64 years will be enrolled to undergo psilocybin-assisted therapy as part of a 4-week inpatient rehabilitation for severe alcohol use disorder. The experimental group will receive a high dose of psilocybin (30 mg), whereas the control group will receive an active placebo dose of psilocybin (5 mg), both within the context of a brief standardized psychotherapeutic intervention drawing from key elements of acceptance and commitment therapy. The primary clinical outcome is the between-group difference regarding the change in percentage of heavy drinking days from baseline to four weeks posthospital discharge, while safety and feasibility metrics will also be reported as primary outcomes. Key secondary assessments include between-group differences in terms of changes in (1) drinking behavior parameters up to six months posthospital discharge, (2) symptoms of depression, anxiety, trauma, and global functioning, (3) neuroplasticity and key neurocognitive mechanisms associated with addiction, and (4) psychological processes and alcohol-related parameters. DISCUSSION: The discussion outlines issues that might arise from our design. TRIAL REGISTRATION: EudraCT 2022-002369-14 and NCT06160232.

Cross-sectional and longitudinal associations between self-esteem and BMI depends on baseline BMI category in a population-based study.

BACKGROUND: Some studies have reported associations between self-esteem and weight status, but longitudinal data on adults remain scarce. The aim of this population-based study was to analyze the cross-sectional and longitudinal association between self-esteem and body mass index (BMI) and to investigate whether baseline BMI has an impact on this association. METHODS: In 2016, 29,735 participants aged ≥ 18 years in the NutriNet-Santé cohort completed the Rosenberg Self-Esteem Scale. BMI was self-reported yearly over a 4-year period. Association between self-esteem and BMI was assessed using mixed models and logistic regressions. Analyses were stratified by BMI (categorical) at baseline and adjusted on sociodemographic and lifestyle characteristics. RESULTS: At baseline, higher self-esteem was associated with higher BMI in normal weight individuals(p = 0.32), and with lower BMI in obese class II and III individuals (p = 0.13). In addition, higher baseline self-esteem was associated with BMI increase over time in normal weight individuals (p = 0.15). Among normal weight individuals, those with higher self-esteem were less likely to show a decrease in their BMI (p = 0.005), while no association was observed with BMI increase (p = 0.81). DISCUSSION: Our findings suggest that the association between self-esteem and BMI depends on the initial category of BMI, with a negligible effect of self-esteem.

Development and validation of the mindful eating scale (mind-eat scale) in a general population.

BACKGROUND: Mindful eating is a concept that is increasingly being used to promote healthy eating. Observational studies have suggested associations with healthier eating behaviors, lower weight status, and favorable cardiovascular biomarkers. However, existing scales assessing mindful eating have some limitations. Our study aimed to develop and validate a scale assessing the level of mindful eating in a general population. METHODS: The Mind-Eat Scale was developed in four main steps: 1. Generating an initial item pool covering all aspects of mindful eating; 2. Reviewing items with experts and naive individuals; 3. Administering the scale to a large and representative sample from the NutriNet-Santé cohort (N = 3102); 4. Conducting psychometric analyses. Construct validity was assessed using exploratory (EFA) (N1 = 1302) and confirmatory (CFA) (N2 = 1302, N3 = 498) factor analyses. Content, discriminant, convergent, and divergent validity, internal consistency, and test-retest reliability were examined. RESULTS: The initial pool of 95 items was refined to 24 items using EFA. The EFA highlighted six dimensions: Awareness, Non-reactivity, Openness, Gratitude, Non-judgement, and Hunger/Satiety, consisting of four items per dimension. CFAs showed a good fit for first and second-order models. Adequate content validity was confirmed. Discriminant, convergent, and divergent validity were supported by significant differences between subgroups of individuals, and correlations with eating behaviors and psychological well-being scales. The Mind-Eat Scale showed good reliability for all six dimensions, with high McDonald's ω and adequate intraclass correlation coefficients (ICC). CONCLUSIONS: This study validated the first tool assessing a total mindful eating score and its sub-dimensions in a general population. This scale can be an asset for clinical and epidemiological research on dietary behavior and related chronic diseases.

Self-compassion and emotion regulation: testing a mediation model.

Self-compassion (SC) seems to play an important role in improving Emotion Regulation (ER). Nevertheless, the results of previous studies regarding the links between SC and ER are not consistent, especially facing diverse models of ER (strategy-based vs skill-based). The goal of this prospective study was to evaluate the links between these three concepts, by testing the predictive roles of SC and ER skills on both ER adaptive and maladaptive strategies, using standardised questionnaires and visual analogue scales. Results of regression analysis showed that self-compassion positively predicts cognitive reappraisal, acceptance, problem-solving, relaxation, self-support, tolerance and ER skills and negatively predicts behavioural avoidance, expressive suppression and ruminations. Results also showed that ER skills positively predict cognitive reappraisal, expression, acceptance, relaxation, self-support and tolerance and negatively predicts behavioural avoidance, expressive suppression and ruminations. Results from a mediation model are also promising regarding both the role of ER skills on the effect of SC on adaptive ER strategy use. Even if this study can be associated with common limits of self-report measures, it highlights the role of SC in a model of ER.

Associations between Resilience and Food Intake Are Mediated by Emotional Eating in the NutriNet-Santé Study.

BACKGROUND: Resilience, the ability to bounce back or recover from stress, has been associated with several health-related behaviors. However, data on food intake and emotional eating are lacking. OBJECTIVES: The objective of this cross-sectional study was to analyze the associations between resilience and diet quality and ultraprocessed food (UPF) and food group consumption, and to assess whether emotional eating was a mediator of these associations. METHODS: In 2017, 17,840 participants (73.5% female, mean age = 55.4 ± 14.0 y) of the NutriNet-Santé study completed the Brief Resilience Scale, the revised 21-item Three-Factor Eating Questionnaire, and ≥3 self-administered 24-h dietary records. Diet quality was assessed with the modified French National Nutrition and Health Program Guideline Score. Foods and beverages consumed were categorized according to their degree of processing by the NOVA classification. We assessed the association between resilience and emotional eating using linear regression models. We also assessed the mediating role of emotional eating in the associations between resilience and diet quality, energy intake, and UPF and food group consumption, controlling for sociodemographic characteristics. RESULTS: In our study, resilience was negatively associated with emotional eating (P < 0.0001). More resilient participants had greater overall diet quality, greater intakes of seafood, whole-grain foods, fats, unsalted oleaginous fruits, and alcoholic beverages, and lower intakes of UPFs, starchy foods, dairy desserts, sugary fatty products, and sugar and confectionery (all P < 0.05). Emotional eating was a mediator of the inverse associations between resilience and intake of energy, UPFs, dairy desserts, sugary fatty products, and of the positive associations between resilience and alcoholic beverages (all P < 0.05), with a 20-70% mediation. CONCLUSIONS: Our findings showed that resilience was associated with an overall better diet quality in the NutriNet-Santé population-based study. These associations were partially explained by emotional eating. These findings suggest that resilience should be considered in the promotion of healthy dietary habits.The study is registered at clinicaltrials.gov as #NCT03335644.

Interoceptive Awareness and Anorexia Nervosa: When Emotions Influence the Perception of Physiological Sensations.

ABSTRACT: Anorexia nervosa (AN) is related to difficulties in emotion regulation, including a deficit in interoceptive awareness. The lack of interoceptive awareness is considered a vulnerability involved in the development and maintenance of anorexic symptoms. Surprisingly, no study has been conducted that focuses on these associations in an emotional context. This study measures the interoceptive awareness-using heartbeat self-counting and a sphygmomanometer-of 25 subjects suffering from AN and 25 control subjects, first at rest and then in an emotional situation. The results show that a deficit in interoceptive awareness was observed for the subjects suffering from AN at rest as well as when an emotional context was induced. This study encourages future investigations to focus on the impact of interoceptive deficit in AN to develop as efficient a care regimen as possible for these subjects.

External validity of social psychological experiments is a concern, but these models are useful.

We agree that external validity of social psychological experiments is a concern, we disagree these models are useless. Experiments, reconsidered from a situated cognition perspective and non-linearly combined with other methods (qualitative and simulations) allow grasping decision dynamics beyond bias outcomes. Dynamic (vs. discrete) insights regarding these processes are key to understand missing forces and bias in real-world social groups.

Improvement of Radial Cheek Lines With Hyaluronic Acid-Based Dermal Filler VYC-17.5L: Results of the BEAM Study.

BACKGROUND: Radial cheek lines (RCL) may convey an older, potentially less attractive appearance. OBJECTIVE: To evaluate the effectiveness of hyaluronic acid-based dermal filler VYC-17.5L for correcting RCL. MATERIALS AND METHODS: Fifty-three women (40-65 years) received injections of VYC-17.5L in both cheeks on Day 1 (optional Day 14 touch-up). Effectiveness was evaluated on Day 45 by subject-rated dynamic RCL improvement (Global Aesthetic Improvement Scale [GAIS]; primary end point) and independent, noninjecting investigator-rated GAIS; subject Self-Perception of Age (SPA); subject-assessed satisfaction with and natural look of treatment; and instrument-assessed changes in static and dynamic RCL roughness, amplitude, and texture (secondary end points). Safety assessments included injection site responses (ISRs). RESULTS: On Day 45, 98% of subjects rated RCL as improved or much improved (investigator rated: 95%). Subjects with same or older SPA before treatment (n = 38) perceived themselves as 2.0 and 5.5 average years younger after treatment, respectively. Day 45 mean satisfaction with and natural look of treated areas was 7.9/10 and 7.2/10, respectively. Treatment significantly improved RCL roughness, amplitude, and texture (all p < .001). Most common ISRs were hematoma (35.9%), bruising (30.2%), and irregularities/bumps (22.6%); most ISRs were mild. CONCLUSION: VYC-17.5L effectively corrected dynamic RCL, improved instrument-assessed indicators of skin quality, and resulted in younger age perception.

Efficacy, Patient-Reported Outcomes, and Safety in Male Subjects Treated With OnabotulinumtoxinA for Improvement of Moderate to Severe Horizontal Forehead Lines.

BACKGROUND: Men represent a growing segment of the facial aesthetic market. OBJECTIVE: To evaluate investigator-assessed efficacy, patient-reported outcomes, and safety after onabotulinumtoxinA treatment of forehead lines (FHL) in men. METHODS: Subjects with moderate to severe FHL received onabotulinumtoxinA (frontalis: 20 U; glabellar complex: 20 U, with/without 24 U in crow's feet regions) or placebo in 6-month, double-blind periods of 2 pivotal trials. Results for men were pooled. RESULTS: Men comprised 12% (140/1,178) of subjects. Day 30 male responder rates for achieving at least 1-grade Facial Wrinkle Scale (FWS) improvement at maximum eyebrow elevation and at rest were 98.2% and 93.3%, respectively; a significant difference in responder rates was maintained versus placebo (p < .05) through Day 150. Despite men having proportionately more severe FHL at baseline, 81.8% and 79.8% achieved Day 30 FWS ratings of none or mild at maximum eyebrow elevation and at rest, respectively (p < .05); significance versus placebo was maintained through Day 120. Men reported high satisfaction rates and improved psychological impacts. No new safety signals were detected. CONCLUSION: Standard dosing and administration of onabotulinumtoxinA significantly improved static and dynamic FHL appearance, despite men having proportionately more severe FHL at baseline. Men reported high satisfaction and appearance-related psychological impact improvements.

How self-compassion moderates the effect of body surveillance on subjective happiness and depression among women.

According to objectification theory (Fredrickson & Roberts, 1997), being treated as an object leads women to engage in self-objectification, which in turn increases body surveillance and body shame as well as impairs mental health. However, very little is known about what factors could act as buffers against the detrimental consequences of self-objectification. This paper seeks to understand the role of self-compassion (the ability to kindly accept oneself or show self-directed kindness while suffering) in the perception that women have of their own bodies. Results indicate that self-compassion moderated the effect of body surveillance on depression and happiness separately among women. More specifically, for women low in self-compassion, body surveillance was negatively associated with happiness, which was explained by increased depression. In sum, our results indicate that self-compassion protects against the detrimental consequences of body surveillance.

Peritraumatic dissociation and post-traumatic stress disorder in individuals exposed to armed conflict in the Democratic Republic of Congo.

The purpose of this study was to verify the hypothesis that there is an association between peritraumatic dissociation (PD) and post-traumatic stress disorder (PTSD) in individuals exposed to recurrent armed conflict. More specifically, we sought to evaluate whether PD differentially predicts PTSD according to the degree of exposure to the potentially traumatic event (PTE), the level of education, and gender. A total of 120 individuals between 17 and 75 years of age, including 51 women, completed the Traumatic Events List, the Peritraumatic Dissociative Experiences Questionnaire, and the French version of the Posttraumatic Stress Disorder Checklist Scale, as well as a questionnaire providing information regarding sociodemographic details. The group of participants with high scores for PD had significantly more PTSD. PD differentially predicts PTSD depending on the level of education and gender of the individual. Those who had been physically assaulted and raped, as well as the less educated, were more likely to be dissociated during PTE· exposure compared to witnesses and those with a higher level of education. The primary target population for prevention and early management should comprise individuals with high levels of PD, low levels of education, and women.

The generation and transport of reactive nitrogen species from a low temperature atmospheric pressure air plasma source.

The reactive chemical species generated by non-equilibrium plasma under atmospheric pressure conditions are key enablers for many emerging applications spanning the fields of biomedicine, manufacturing and agriculture. Despite showing great application potential, insight in to the underpinning reactive species generation and transport mechanisms remains scarce. This contribution focuses on the spatiotemporal behaviour of reactive nitrogen species (RNS) created and transported by an atmospheric pressure air surface barrier discharge (SBD) using both laser induced fluorescence and particle imaging velocimetry measurements combined with experimentally validated numerical modelling. It was observed that highly reactive species such as N are confined to the discharge region while less reactive species such as NO, NO2 and N2O closely followed the induced flow. The concentration of key RNS was found to be in the 10-100 ppm range at a position of 25 mm downstream of the discharge region. A close agreement between the experimental and computational results was achieved and the findings provide a valuable insight in to the role of electrohydrodynamic forces in dictating the spatiotemporal distribution of reactive chemical species beyond the plasma generation region, which is ultimately a key contributor towards downstream treatment uniformity and application efficacy.

Differential profiles of four groups of children referred to an autism diagnostic service in Belgium: Autism-specific hallmarks.

OBJECTIVE:: This article aims at exploring distinctive hallmarks of autistic disorders compared to other groups presenting mimicking and/or overlapping conditions. METHOD:: The exploratory study involved 196 children with autism, intellectual disability, language impairment and psycho-affective disorders previously referred to an autism diagnostic service. The autism discriminative tool (ADT), a behavioural checklist, was used to compile and analyse the children's profiles based on the clinical information gathered during diagnostic assessments. All samples were compared and analysed separately according to the checklist's four domains. RESULTS:: Children with autism showed greater frequency and severity of impairments on the ADT's social and communication categories. These children also differed from other groups in terms of specific rigid behaviours and high frequency of atypical sensory responses. CONCLUSIONS:: Results illustrate the psychopathology of autism spectrum disorder suspected children referred to a specialized autism diagnostic service, doing so by providing us with specific clinical profiles.

A French Translation of the Pleasure Arousal Dominance (PAD) Semantic Differential Scale for the Measure of Affect and Drive.

Multivariate studies have repeatedly confirmed that three basic dimensions of human emotional behavior, called pleasure (P), arousal (A) and dominance (D) are persistent in organizing human judgments for a wide range of perceptual and symbolic stimuli. The Mehrabian and Russell's PAD semantic differential scale is a well-established tool to measure these categories, but no standardized French translation is available for research. The aim of this study was to validate a French version of the PAD. For this purpose, (1) Mehrabian and Russell's PAD was translated through a process of translations and back-translations and (2) this French PAD was tested in a population of 111 French-speaking adults on 21 images of the International Affective Picture System (IAPS). A confirmatory factor analysis revealed the expected three-factor structure; the French PAD also distributed the images in the affective space according to the expected boomerang-shape. The present version of PAD is thus a valid French translation of Mehrabian and Russell's original PAD.

Beware of multiple traumas in PTSD assessment: the role of reactivation mechanism in intrusive and hyper-arousal symptoms.

OBJECTIVES: Post-traumatic stress disorder (PTSD) is a major public health problem defined by three symptom clusters: intrusion thoughts, avoidance mechanisms and hyper-arousal. Several authors have emphasized, that some or all of these symptoms related to a past traumatic experience could be reactivated, even after long asymptomatic periods. This study investigates the role of an additional trauma in the reactivation of a childhood trauma among a group of former hidden children (n = 65), the Jewish youths who spent World War II in various hideaway shelters in Nazi-occupied Europe. They were compared with a control group. METHOD: The presence or absence of an additional trauma in adulthood was assessed and PTSD symptoms were measured by using the Impact of Event Scale-Revised. RESULTS: An additional trauma reactivates PTSD symptoms of intrusion thoughts and, marginally, symptoms of hyper-arousal. At the opposite, symptoms of avoidance were not reactivated. CONCLUSION: Our results confirm the role of an additional trauma in the reactivation of traumatic memories, related to an earlier trauma, in later life. Clinical and theoretical implications are discussed and perspectives are proposed.

Psychological and socio-demographic data contributing to the resilience of holocaust survivors.

The authors provide a within-group study of 65 Former Hidden Children (FHC; i.e., Jewish youths who spent World War II in various hideaway shelters across Nazi-occupied Europe) evaluated by the Hopkins Symptom Check List (HSCL), the Sense of Coherence Scale (SOCS), the Resilience Scale for Adults (RSA), and a socio-demographic questionnaire. The aim of the present article is to address the sensitization model of resilience (consisting in a reduction of resistance to additional stress due to previous exposure to trauma) and to identify the family, psychological, and socio-demographic characteristics that predict resilience among a group of FHC. The RSA score is negatively correlated with the number of post-war traumas and positively correlated with the SOCS score. FHC who have children present a higher RSA score than FHC who have no children. RSA global score negatively and significantly predicts HSCL score. In a global multivariate model, and in accordance with the sensitization model, the number of post-war traumas negatively predicts the RSA score. Moreover, the SOCS score and the number of children positively predict it. Therapeutic implications are discussed, limitations are considered, and further investigations are proposed.

The Reflective Mind of the Anxious in Action: Metacognitive Beliefs and Maladaptive Emotional Regulation Strategies Constrain Working Memory Efficiency.

The Attentional Control Theory (ACT) posits that, while trait anxiety may not directly impact performance, it can influence processing efficiency by prompting the use of compensatory mechanisms. The specific nature of these mechanisms, which might be reflective, is not detailed by the ACT. In a study involving 110 students (M = 20.12; SD = 2.10), surveys were administered to assess the students' metacognitive beliefs, trait anxiety, and emotion regulation strategies (ERSs). The participants engaged in two working memory exercises: the digit span task from the WAIS-IV and an emotional n-back task. The findings indicated that anxiety, metacognitive beliefs, and maladaptive ERSs did not affect task performance but were correlated with increased response times. Several regression analyses demonstrated that a lack of confidence in one's cognitive abilities and maladaptive ERSs predict higher reaction times (RT) in the n-back task. Additionally, maladaptive ERSs also predict an increased use of strategies in the digit span task. Finally, two mediation analyses revealed that anxiety increases processing efficiency, and this relation is mediated by the use of maladaptive ERSs. These results underscore the importance of the reflective level in mediating the effects of trait anxiety on efficiency. They highlight the necessity of incorporating metacognitive beliefs and maladaptive emotion regulation strategies for a thorough comprehension of the Attentional Control Theory. Recognizing these factors offers valuable perspectives for enhancing cognitive capabilities and fostering academic achievement.

Trait Anxiety, Emotion Regulation, and Metacognitive Beliefs: An Observational Study Incorporating Separate Network and Correlation Analyses to Examine Associations with Executive Functions and Academic Achievement.

Trait anxiety, emotion regulation strategies, and metacognitive beliefs influence executive functions (EFs) and academic achievement. This study examines their interplay and impact on academic success. In total, 275 adolescents (10-17 years) and parents completed an online questionnaire assessing trait anxiety, emotion regulation strategies, metacognition, parent-reported behaviors related to executive functioning, and overall school average. Preliminary analyses confirmed consistency with the existing literature for each variable and their interaction. Furthermore, we conducted a network analysis among the main variables. This analysis supports the need to pay more attention to reflective variables-maladaptive emotion regulation strategies and metacognitive beliefs about worry-when studying trait anxiety. These variables were linked to problematic executive functioning in adolescents, and the latter was negatively linked to academic achievement. This study offers innovative insights by investigating relationships less explored in the scientific literature. It reveals high and significant correlations between metacognitive beliefs, maladaptive emotion regulation strategies, and trait anxiety (r > 0.500, p < 0.001) but also between these variables and both executive functioning and academic achievement. These findings offer new perspectives for research and underscore the importance of holistically examining the psychological factors related to academic success.

Plasma surface modification of polylactic acid to promote interaction with fibroblasts.

In this work, medium pressure plasma treatment of polylactic acid (PLA) is investigated. PLA is a biocompatible aliphatic polymer, which can be used for bone fixation devices and tissue engineering scaffolds. Due to inadequate surface properties, cell adhesion and proliferation are far less than optimal and a surface modification is required for most biomedical applications. By using a dielectric barrier discharge (DBD) operating at medium pressure in different atmospheres, the surface properties of a PLA foil are modified. After plasma treatment, water contact angle measurements showed an increased hydrophilic character of the foil surface. X-ray photoelectron spectroscopy (XPS) revealed an increased oxygen content. Cell culture tests showed that plasma modification of PLA films increased the initial cell attachment both quantitatively and qualitatively. After 1 day, cells on plasma-treated PLA showed a superior cell morphology in comparison with unmodified PLA samples. However, after 7 days of culture, no significant differences were observed between untreated and plasma-modified PLA samples. While plasma treatment improves the initial cell attachment, it does not seem to influence cell proliferation. It has also been observed that the difference between the 3 discharge gases is negligible when looking at the improved cell-material interactions. From economical point of view, plasma treatments in air are thus the best choice.

Ethics and Meditation: A New Educational Combination to Boost Verbal Creativity and Sense of Responsibility.

Both creativity and responsibility are important higher-order skills to develop to meet the challenges of the Anthropocene, and both are related to attentional states of consciousness and to ethics. Meditation is a set of practices that trains attentional and emotional regulation. A few studies have shown that different kinds of meditation can foster different kinds of creative thinking, and others have begun to investigate the effect of the combination of meditation and ethics on ethical characteristics (but not yet on creativity or precisely on responsibility, so far). Here, we present a nonrandomized trial with an active control group among second-year science university students (n = 84) to test the effect of the secular Meditation-Based Ethics of Responsibility (MBER) program on creative potential, self-reported awareness, and sense of one's own responsibility. The results show a large effect of the program on sense of one's own responsibility and convergent and divergent creative writing tasks, both in conceptual-semantic and engineering-like verbal ideation. They also suggest that convergent conceptual-semantic thinking might moderate the effect of the MBER program on the awareness and sense of one's own responsibility. This work opens up new research and educational perspectives linked to necessary behavioral changes in the Anthropocene.