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Deep transcranial magnetic stimulation (dTMS), an advancement of transcranial magnetic stimulation, was created to reach wider and possibly more profound regions of the brain. At present, there is insufficient high-quality evidence to support the effectiveness and safety of dTMS in treating obsessive-compulsive disorder (OCD). This study used a meta-analysis to evaluate the effectiveness and safety of dTMS for treating OCD. Four randomized controlled trials were found by searching PubMed, Embase, Web of Science, and Cochrane Library up to February 2024. The fixed effects meta-analysis model was used for the purpose of data merging in Stata17. The risk ratio (RR) value was used as the measure of effect size to compare response rates and dropout rates between active and sham dTMS. The meta-analysis included four randomized-controlled trials involving 252 patients with treatment-resistant OCD. Active dTMS showed a notably greater rate of response on the Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) in comparison to sham dTMS after treatment (Y-BOCS: RR = 3.71, 95% confidence interval [ CI ] 2.06 to 6.69) and at the one-month follow-up (Y-BOCS: RR = 2.60, 95% CI 1.59 to 4.26). Subgroup analysis revealed that active dTMS with H-coils was more effective than sham dTMS (RR = 3.57, 95%CI 1.93 to 6.60). No serious adverse events were documented in the studies that were included. The findings suggest that dTMS demonstrates notable efficacy and safety in treating patients with treatment-resistant OCD compared to sham dTMS, with sustained effectiveness noted throughout the one-month post-treatment period. • Active dTMS showed notable efficacy in resistant OCD than sham dTMS. • The effect is still significant one-month after active dTMS treatment. • No severe adverse events were reported in the treatment of OCD with dTMS. [ABSTRACT FROM AUTHOR]

Objective: This study aimed to investigate the efficacy of two internet-delivered psychological treatments for hypoactive sexual desire dysfunction (HSDD) in women: internet-based cognitive behavioral sex therapy (iCBST) and internet-based mindfulness-based sex therapy (iMBST). Method: Women with HSDD were randomly assigned to one of three groups: iCBST, iMBST, or a waitlist control group. The interventions consisted of eight modules delivered via an e-health platform with e-coach support to enhance adherence. Sexual desire and sexual distress were assessed at baseline and at 3-, 6-, and 12-month follow-ups (active conditions only). Per protocol, of the 266 consenting women, 106 were randomized to iCBST (Mage = 36.1, SD = 10.3), 106 to iMBST (Mage = 36.4, SD = 0.2), and 54 to the control condition (Mage = 36.7, SD = 11.0). Primary analyses utilized an intention-to-treat approach with linear mixed models. Clinical significance, assessed with clinical cutoffs and the reliable change index, was examined for active conditions. Results: Compared to the control condition, both iCBST and iMBST demonstrated significant improvements in sexual desire and sexual distress at 3-month (d = 0.89–1.14) and 6-month follow-up (d = 0.74–1.18). Results were sustained at 12-month follow-up, with 35 and 41% demonstrating reliable improvements and additional 20 and 24% achieving clinically significant improvements in sexual desire after iCBST and iMBST. Regarding sexual distress, 49 and 42% exhibited reliable change, with an additional 37%–42% achieving clinically significant improvements. Conclusions: Results provide support for the overall long-term efficacy of psychological therapies in treating HSDD in women. However, fewer than one in four women showed improvements in sexual desire that met the threshold for clinically significant change. What is the public health significance of this article?: This research highlights the potential of internet-delivered cognitive behavioral sex therapy and mindfulness-based sex therapy as valuable and accessible treatments for women experiencing distressing low sexual desire. With their sustained efficacy observed over a 12-month period, these treatments provide effective options for women seeking support for low sexual desire. [ABSTRACT FROM AUTHOR]

Background Published analyses of prostate cancer nested case–control and survival data in the Alpha-Tocopherol, Beta-Carotene Cancer Prevention (ATBC) Study cohort suggested that men with higher baseline vitamin D [25(OH)D] concentrations have both (i) increased prostate cancer risk and (ii) decreased prostate cancer-specific fatality. Methods To investigate possible factors responsible for a spurious association with prostate cancer fatality, we reanalysed baseline serum vitamin D associations with prostate cancer risk and prostate cancer-specific fatality in case–control data nested within the ATBC Study (1000 controls and 1000 incident prostate cancer cases). Conditional logistic regression and Cox proportion hazard models were used, respectively, to estimate odds ratios for risk and hazard ratios for prostate cancer-specific fatality, overall and by disease aggressiveness. We replicated these case–control analyses using baseline serum measurements of alpha-tocopherol (vitamin E), beta-carotene and retinol (vitamin A), and used the entire ATBC Study cohort (⁠ n  = 29 085) to estimate marginal associations between these baseline vitamins and prostate cancer incidence and fatality following blood collection. Results Vitamin D analyses agreed closely with those originally published, with opposite risk and fatality associations. By contrast, the analyses of alpha-tocopherol, beta-carotene and retinol yielded concordant associations for prostate cancer incidence and prostate cancer-specific fatality. Conclusions We found evidence of neither artefacts in the nested prostate cancer case–control data set nor detection or collider biases in the fatality analyses. The present findings therefore support a valid inverse (i.e. beneficial) association between vitamin D and prostate cancer-specific survival that warrants further evaluation, including possibly in controlled trials. [ABSTRACT FROM AUTHOR]

Abstract Background The effects of post‐coronavirus disease 2019 (COVID‐19) syndrome on the cardiorespiratory and muscular fitness in older people are of utmost relevance. This study aimed to evaluate the effects of a 12‐week telerehabilitation programme on cardiorespiratory and muscular fitness and body composition in older patients with post‐COVID‐19 syndrome. Methods One hundred twenty older patients with post‐COVID‐19 syndrome were randomly assigned to one of two groups: patients who carried out the telerehabilitation programme (n = 60; age: 65.0 ± 5.2; female: 14.2%) and a control group (n = 60; age: 64.3 ± 5.0; female: 24.5%). An incremental cardiopulmonary exercise testing, isokinetic strength test, and bioelectrical impedance analysis were performed to compare cardiorespiratory and muscle strength responses and body composition between telerehabilitation and control groups. Results A significant increase in the cardiopulmonary exercise testing duration was found in the telerehabilitation group compared to the control group (mean difference = 88.9 s, P = 0.001). Peak oxygen uptake increased in the telerehabilitation group (mean difference = 3.0 mL·kg−1·min−1, P

Abstract Background Associations of dietary sodium and potassium intake with fracture risk are inconsistent and the effects of salt substitute on fracture incidence are unknown. We assessed the effect of salt substitute compared to regular salt intake on fracture incidence using data from the Salt Substitute and Stroke Study (SSaSS). Methods SSaSS was a cluster-randomized controlled trial conducted in 600 villages in northern China. Villages were randomly allocated into intervention and control groups in a 1:1 ratio. Salt substitute was provided to intervention villages and control villages continued regular salt use for 5 years. The primary outcome for this secondary analysis was the incidence of all fractures. Secondary outcomes included incidence of vertebral fracture, non-vertebral fracture, and fracture of unknown or non-specific location. Results 20,995 participants were included in this study, and 821 fractures occurred during follow-up. Intention-to-treat analyses showed no differences between the salt substitute and regular salt groups in the incidence of all fractures (rate ratio (RR) 0.96; 95% CI 0.81 to 1.14), vertebral fracture (RR 0.82; 95% CI 0.53 to 1.26), non-vertebral fracture (RR 1.05; 95% CI 0.86 to 1.29), or fracture of unknown or non-specific location (RR 0.80; 95% CI 0.54 to 1.18). Conclusions Use of salt substitute compared to regular salt had no detectable effect on the incidence of fracture in a population at high risk of cardiovascular disease and fracture. Trial registration ClinicalTrials.gov, NCT02092090. Registered on March 12, 2014.

Summary The efficacy of digital brief behavioural treatment for insomnia using a smartphone application in conjunction with light therapy was investigated in university students who had insomnia symptoms with late chronotypes. In this two‐arm parallel randomized–controlled trial, participants with insomnia symptoms and late chronotypes were recruited between October and November 2023. The duration of the intervention program was 4 weeks. The smartphone application provides digital brief behavioural treatment for insomnia, including programs for advanced phases. The intervention group used blue‐light‐emitting diode glasses in the morning after waking up for 2–4 weeks. The primary outcome was a change in the Insomnia Severity Index during the study period. The Insomnia Severity Index was obtained weekly using a web questionnaire. Of the 28 students, 14 each were assigned to the intervention and control groups. The mean Insomnia Severity Index scores at baseline were 12.2 and 12.5; after 4 weeks, they declined to 7.2 and 10.6 in the intervention and control groups, respectively. Primary analysis using a linear mixed model showed a significant improvement in the temporal trends of the Insomnia Severity Index in the intervention group (p < 0.001). The scores on the Morningness–Eveningness Questionnaire (p = 0.008) and RU‐SATED (p = 0.005) significantly improved in the intervention group relative to the control group following the intervention. This study demonstrated the effectiveness of the digital brief behavioural treatment for insomnia with light therapy in participants with both insomnia symptoms and late chronotypes. [ABSTRACT FROM AUTHOR]

Introduction: There is a significant demand for interventions that reduce distress related to auditory verbal hallucinations (AVHs). AVH distress is associated with the way voice hearers relate with AVHs. We aimed to establish the feasibility of a randomized controlled trial to demonstrate that adding "Relating Therapy" (RT) to treatment as usual (TAU) is superior to TAU in reducing AVH distress. Methods: We conducted a multicenter, parallel, single-blind, randomized controlled feasibility trial in five mental health centers in Germany. Participants were ≥19 years of age, had persistent and distressing AVHs, and had a diagnosis of a schizophrenia-spectrum disorder. RT was delivered over a maximum of 16 sessions within 5 months. Blind assessments were conducted at baseline and at 5 and 9 months. Feasibility outcomes were the number of patients recruited and retained, and safety and therapist adherence. The primary endpoint was the distress factor score of the AVH subscale of the Psychotic Symptoms Rating Scales at 9 months. Results: Eighty-five of 177 enrolled participants were randomized into RT + TAU (n = 43) or TAU (n = 42). Feasibility was excellent with 87% retention at 9 months, 86% reaching treatment uptake criteria, 98% therapist adherence, and no unexpected serious adverse reactions. Compared to TAU, RT + TAU showed nonsignificant trends toward less AVH distress (b = −2.40, SE = 1.52, p = 0.121, 90% CI (−4.94 to 0.15) and stronger improvement on all but one of the secondary outcomes. Conclusion: A randomized controlled trial of RT is feasible, safe, and well accepted. Our results provide an encouraging basis to further test the efficacy of RT in a definitive multicenter trial. [ABSTRACT FROM AUTHOR]

Exercise interventions are nowadays considered as effective add-on treatments in people with schizophrenia but are usually associated with high dropout rates. Therefore, the present study investigated potential predictors of adherence from a large multicenter study, encompassing two types of exercise training, conducted over a 6-month period with individuals with schizophrenia. First, we examined the role of multiple participants' characteristics, including levels of functioning, symptom severity, cognitive performance, quality of life, and physical fitness. Second, we used K-means clustering to identify clinical subgroups of participants that potentially exhibited superior adherence. Last, we explored if adherence could be predicted on the individual level using Random Forest, Logistic Regression, and Ridge Regression. We found that individuals with higher levels of functioning at baseline were more likely to adhere to the exercise interventions, while other factors such as symptom severity, cognitive performance, quality of life or physical fitness seemed to be less influential. Accordingly, the high-functioning group with low symptoms exhibited a greater likelihood of adhering to the interventions compared to the severely ill group. Despite incorporating various algorithms, it was not possible to predict adherence at the individual level. These findings add to the understanding of the factors that influence adherence to exercise interventions. They underscore the predictive importance of daily life functioning while indicating a lack of association between symptom severity and adherence. Future research should focus on developing targeted strategies to improve adherence, particularly for people with schizophrenia who suffer from impairments in daily functioning. Clinical trials registration The study of this manuscript which the manuscript is based was registered in the International Clinical Trials Database, ClinicalTrials.gov (NCT number: NCT03466112, https://clinicaltrials.gov/ct2/show/NCT03466112?term=NCT03466112&draw=2&rank=1) and in the German Clinical Trials Register (DRKS-ID: DRKS00009804. [ABSTRACT FROM AUTHOR]

Research suggests that providing children with activities that involve using their bodies to form the shapes of letters can help them acquire pre-reading skills. Little is known, however, as to the extent to which such embodied learning interventions are superior to more traditional pencil-and-paper activities, which of specific arm or body movements are most effective, and whether this approach compensates or exacerbates the learning gap between high- and low-skilled pre-readers. Using a preregistered randomized-controlled experiment (N = 160 kindergarten students, M = 5.18 years, 54% girls), the present study assessed the educational effects of 6-week-long training sessions with increasing degrees of bodily movement integration (pencil-and-paper training vs. arm training vs. arm-body training) on five measures of letter knowledge and script. Aligning with theories of embodied cognition and cognitive load in instructional designs, results showed that integrating arm movement exercises into handwriting training bore the greatest acquisitions in pre-reading skills overall and were most beneficial to students with initially low pre-reading skills (compensatory effect against learning inequalities). Implications are drawn on the need to consolidate and replicate present findings, while highlighting their potential for supporting educational effectiveness and equity in kindergarten. [ABSTRACT FROM AUTHOR]

Dementia negatively affects the wellbeing of both caregivers and care recipients. Community-based therapeutic choir singing offers opportunities for music participation and social engagement that are accessible and mutually enjoyable for people with dementia and their family caregivers and promotes shared and meaningful musical interactions, which may support relationship quality. This study aimed to investigate the impact of the Remini-Sing therapeutic choir intervention on relationship quality, quality of life, depression, and social connectedness for dyads, as well as caregiver burden and care recipient anxiety. A randomized-controlled trial design was used with a target sample of 180 dyads. Due to recruitment difficulties, 34 participant dyads were recruited and randomly assigned to a 20-week group singing condition (n  = 16) or a waitlisted control group (n  = 18). Participant dyads consisted of people with dementia and their family caregivers who resided at home in the community. The Remini-Sing therapeutic choirs were held in community settings. Assessments were conducted by masked assessors at baseline, 11 weeks, and 21 weeks. Twenty-one dyads completed assessments at the primary timepoint (Week 11). Issues with recruitment and retention resulted in an unpowered study with no statistically significant findings. Mean decreases in anxiety and depression for choir participants with dementia were supported by medium to large effect sizes, indicating a potential intervention effect to be explored in future powered studies. Key learnings related to study design are discussed regarding recruitment, retention, participant burden, and sustainability, with recommendations made for future dementia research. [ABSTRACT FROM AUTHOR]

Schools provide an ideal setting for delivery of disease prevention programs due to the ability to deliver health education and counseling, including health behavior interventions, to large numbers of students. However, the remote and hybrid learning models that arose during the coronavirus (COVID-19) pandemic created obstacles to these efforts. In this article, we provide insights on collaborating with schools to deliver disease prevention programming during the height of the COVID-19 pandemic, and in subsequent years. We illustrate these strategies by drawing upon our firsthand research experiences engaging high schools in a school-based cancer prevention trial focused on sun safety. Delivery of a cluster-randomized trial of a school-based skin cancer prevention program was initiated in the spring of 2020 at the onset of the COVID-19 pandemic in the U.S. We present multilevel evaluation data on strategies used to reach schools remotely and share lessons learned that may inform similar approaches moving forward during times of crises. Although the COVID-19 pandemic interrupted school-based recruitment for this trial, enrollment improved one year later and did not appear to differ between rural and urban schools. Recruitment strategies and trial-related procedures were modified to address new challenges brought about by the pandemic. Despite the COVID-19 crisis altering US classrooms, disease prevention programming can continue to be offered within schools, given close community partnerships and new adaptations to the ways in which such programming and research are conducted.

Teachers in the induction phase (i.e., the first 3 years of teaching) can be underprepared to support students who engage in challenging behavior. This can be due to limited preservice education and ongoing professional development in behavior management. Yet, students who engage in challenging behavior are at an increased risk of being referred to intervention services and/or special education, especially at the elementary level. The purposes of this randomized‐controlled trial were to identify the effects of an online behavior management training on teachers in the induction phase, as well as their perceptions of the training. Findings revealed teachers in the intervention group showed significant increases in knowledge, application, and self‐efficacy in applying behavior management strategies. Social‐validity data indicated participants felt the training was highly acceptable, feasible, and effective. Practitioner points: After completing a behavior management training, induction phase teachers (i.e., teachers in their first 3 years of teaching) showed significant increases in knowledge, application, and self‐efficacy in applying behavior management strategies compared to teachers in a waitlist‐control group.Teachers chose a target student in their class to practice implementing strategies with, and target students showed significant decreases in challenging behavior following the behavior management training.Participants reported the behavior management training to be highly acceptable, feasible, and effective. [ABSTRACT FROM AUTHOR]

There is no established treatment for patients with clozapine-resistant schizophrenia (CRS). Clozapine augmentation strategies with antipsychotics or others substances are effective in comparison with placebo while and Electroconvulsive therapy (ECT) showed to be effective in comparison with treatment as usual (TAU) but not with placebo (sham-ECT). In the present double- blind randomized controlled trial, we compared 40 outpatients who received 20 sessions of ECT (n = 21) or sham-ECT (n = 19) (age = 37.40 ± 9.62, males = 77.5 %, illness duration = 14.95 ± 8.32 years, mean total Positive and Negative Syndrome Scale (PANSS) = 101.10 ± 24.91) who fulfilled well-defined CRS criteria including baseline clozapine plasma levels ≥350 ng/mL. The primary outcome was the ≥50 % PANSS Total Score reduction; secondary outcomes were the scores of the PANSS subscales, PANSS five-factor dimensions, PANSS-6 and the Calgary Depression Rating Scale (CDRS). Treatment response was analyzed by percentage reduction, Linear Mixed Models and effect sizes. At baseline both groups showed no differences except for years of school education (included as a covariate). At endpoint, only 1/19 of the completers (5.26 %) in the ECT group and 0/17 in the sham-ECT group showed a ≥50 % total PANSS score reduction. Both groups showed no significant differences of the total PANSS score (F = 0.12; p = 0.73), Positive (F = 0.27, p = 0.61), Negative (F = 0.25, p = 0.62), and General Psychopathology scores (F = 0.01, p = 0.94) as well for all PANSS five factors, the PANSS-6 and CDRS. Thus, the present study found no evidence that ECT is better than Sham-ECT in patients with CRS. Future sham-ECT controlled studies with larger sample sizes are warranted to test the efficacy of ECT for patients with CRS. [ABSTRACT FROM AUTHOR]

Positive Family Connections is a coproduced, positively oriented, family-systems program for families of children with a developmental disability aged 8–13 years. The study was a feasibility cluster randomized-controlled trial which was registered prospectively (International Standard Randomised Controlled Trial Number 14809884). Families (clusters) were randomized 1:1 to take part in Positive Family Connections immediately or to a waitlist condition and were followed up 4 months and 9 months after randomization. Feasibility outcomes included participant and facilitator recruitment rates, retention, intervention adherence, and fidelity. The proposed primary outcome measure was the family APGAR, a measure of family functioning. Quantitative data were analyzed using multilevel modeling. Sixty families (60 primary parental carers and 13 second carers) were randomized. 73.33% of primary parental carers and 71.43% of second carers in the intervention group attended ≥4 intervention sessions, and fidelity of delivery was high (M = 94.02% intervention components delivered). Retention for the proposed primary outcome was 97.26% at 4-month follow-up and 98.63% at 9-month follow-up. Intervention condition was not associated with family APGAR scores at 9-month follow-up (estimate = 0.06, 95% CI [−0.49, 0.61], p =.86, Hedges' g = 0.03, 95% CI [−0.43, 0.49]). However, meaningful improvements were observed for other secondary outcomes related to parental well-being and family relationships. A definitive randomized-controlled trial of Positive Family Connections is feasible. Preliminary evaluation of outcomes shows that Positive Family Connections may be beneficial for parental psychological well-being and family relationships. [ABSTRACT FROM AUTHOR]

Using data from 1721 participants in a community-based randomized control trial of digital cognitive behavioural therapy for insomnia compared with patient education, we employed linear mixed modelling analyses to examine whether chronotype moderated the benefits of digital cognitive behavioural therapy for insomnia on self-reported levels of insomnia severity, fatigue and psychological distress. Baseline self-ratings on the reduced version of the Horne-Östberg Morningness-Eveningness Questionnaire were used to categorize the sample into three chronotypes: morning type (n = 345; 20%); intermediate type (n = 843; 49%); and evening type (n = 524; 30%). Insomnia Severity Index, Chalder Fatigue Questionnaire, and Hospital Anxiety and Depression Scale were assessed pre- and post-intervention (9 weeks). For individuals with self-reported morning or intermediate chronotypes, digital cognitive behavioural therapy for insomnia was superior to patient education on all ratings (Insomnia Severity Index, Chalder Fatigue Questionnaire, and Hospital Anxiety and Depression Scale) at follow-up (p-values ≤ 0.05). For individuals with self-reported evening chronotype, digital cognitive behavioural therapy for insomnia was superior to patient education for Insomnia Severity Index and Chalder Fatigue Questionnaire, but not on the Hospital Anxiety and Depression Scale (p = 0.139). There were significant differences in the treatment effects between the three chronotypes on the Insomnia Severity Index (p = 0.023) estimated difference between evening and morning type of -1.70, 95% confidence interval: -2.96 to -0.45, p = 0.008, and estimated difference between evening and intermediate type -1.53, 95% confidence interval: -3.04 to -0.03, p = 0.046. There were no significant differences in the treatment effects between the three chronotypes on the Chalder Fatigue Questionnaire (p = 0.488) or the Hospital Anxiety and Depression Scale (p = 0.536). We conclude that self-reported chronotype moderates the effects of digital cognitive behavioural therapy for insomnia on insomnia severity, but not on psychological distress or fatigue.

Abstract Background The perioperative antibiotic prophylaxis with 1st or 2nd generation cephalosporins is evidence-based in orthopedic surgery. There are, however, situations with a high risk of prophylaxis-resistant surgical site infections (SSI). Methods We perform a superiority randomized controlled trial with a 10% margin and a power of 90% in favor of the broad-spectrum prophylaxis. We will randomize orthopedic interventions with a high risk for SSI due to selection of resistant pathogens (open fractures, surgery under therapeutic antibiotics, orthopedic tumor surgery, spine surgery with American Society of Anesthesiologists (ASA) score ≥ 3 points) in a prospective-alternating scheme (1:1, standard prophylaxis with cefuroxime versus a broad-spectrum prophylaxis of a combined single-shot of vancomycin 1 g and gentamicin 5 mg/kg parenterally). The primary outcome is “remission” at 6 weeks for most orthopedic surgeries or at 1 year for surgeries with implant. Secondary outcomes are the risk for prophylaxis-resistant SSI pathogens, revision surgery for any reason, change of antibiotic therapy during the treatment of infection, adverse events, and the postoperative healthcare-associated infections other than SSI within 6 weeks (e.g., urine infections or pneumonia). With event-free surgeries to 95% in the broad-spectrum versus 85% in the standard prophylaxis arm, we need 2 × 207 orthopedic surgeries. Discussion In selected patients with a high risk for infections due to selection of prophylaxis-resistant SSI, a broad-spectrum combination with vancomycin and gentamycin might prevent SSIs (and other postoperative infections) better than the prophylaxis with cefuroxime. Trial registration ClinicalTrial.gov NCT05502380. Registered on 12 August 2022. Protocol version: 2 (3 June 2022)

Background and Hypothesis Aerobic exercise interventions in people with schizophrenia have been demonstrated to improve clinical outcomes, but findings regarding the underlying neural mechanisms are limited and mainly focus on the hippocampal formation. Therefore, we conducted a global exploratory analysis of structural and functional neural adaptations after exercise and explored their clinical implications. Study Design In this randomized controlled trial, structural and functional MRI data were available for 91 patients with schizophrenia who performed either aerobic exercise on a bicycle ergometer or underwent a flexibility, strengthening, and balance training as control group. We analyzed clinical and neuroimaging data before and after 6 months of regular exercise. Bayesian linear mixed models and Bayesian logistic regressions were calculated to evaluate effects of exercise on multiple neural outcomes and their potential clinical relevance. Study Results Our results indicated that aerobic exercise in people with schizophrenia led to structural and functional adaptations mainly within the default-mode network, the cortico-striato-pallido-thalamo-cortical loop, and the cerebello-thalamo-cortical pathway. We further observed that volume increases in the right posterior cingulate gyrus as a central node of the default-mode network were linked to improvements in disorder severity. Conclusions These exploratory findings suggest a positive impact of aerobic exercise on 3 cerebral networks that are involved in the pathophysiology of schizophrenia. Clinical Trials Registration The underlying study of this manuscript was registered in the International Clinical Trials Database, ClinicalTrials.gov (NCT number: NCT03466112, https://clinicaltrials.gov/ct2/show/NCT03466112?term=NCT03466112&draw=2&rank=1) and in the German Clinical Trials Register (DRKS-ID: DRKS00009804). [ABSTRACT FROM AUTHOR]

Background: Integrating music into pain treatment demonstrates significant benefits, effectively reducing subjective pain levels and perioperative opioid requirements. Currently, the relationship between the impact of specific types of music and listeners’ socio-cultural background is still unclear. This is especially relevant given that sociological research indicates that these factors can have a notable influence on music preference and perception. Current evidence suggests that individuals who choose their own music may experience greater benefits. However, additional research is needed to comprehensively grasp whether the effect of (preferred) music on pain endurance remains consistent across different socio-cultural backgrounds. Methods: In this study, a collaborative effort between medical and sociological researchers aims to investigate music-induced analgesia differentiated by socio-cultural background in healthy volunteers. Participants (n = 84) will listen to self-, and researcher-chosen music and a podcast as a control condition in a cross-over study design. The primary outcome of this study is pain endurance measured by electric stimuli of increasing intensity. Detailed sociological validated questionnaires will be utilized. Considering the notable influence of educational level on music taste formation found in previous research and its crucial role as a source of socio-cultural differentiation, participants will be stratified based on their level of education. Discussion: This experimental study represents one of the first efforts to gain a socio-culturally differentiated understanding of the therapeutic potential of music. Consequently, this could pave the way to purposefully and inclusively implement personalized music in healthcare settings.

Establishing healthy eating habits during childhood is critical to prevent chronic diseases that develop in adulthood. Tribally owned Early Childhood and Education (ECE) programs signify fundamental influence in childhood obesity disparities. A strategy to improve diet is the use of school gardens; however, few studies have used rigorous methods to assess diet and health outcomes. The purpose of this manuscript is to describe results from the six-month Food Resource Equity for Sustainable Health (FRESH) study among Native American families. We aimed to recruit 176 families of children attending Osage Nation ECE programs in four communities. Two communities received the intervention and two served as wait-list controls. Outcomes included change in dietary intake, body mass index, health status, systolic blood pressure (adults only), and food insecurity in children and parents. There were 193 children (n = 106 intervention; n = 87 control) and 170 adults (n = 93 intervention; n = 77 control) enrolled. Vegetable intake significantly increased in intervention children compared to controls for squash (p = 0.0007) and beans (p = 0.0002). Willingness to try scores increased for beans in intervention children (p = 0.049) and tomatoes in both groups (p = 0.01). FRESH is the first study to implement a farm-to-school intervention in rural, tribally owned ECEs. Future interventions that target healthy dietary intake among children should incorporate a comprehensive parent component in order to support healthy eating for all household members.

Background: Asthma is a chronic respiratory disease with symptoms of attacks of wheezing, shortness of breath, & tightness in the chest. Even with pre-existing treatment exacerbations go uncontrolled. Objective: This study compared asthma control in yoga intervention versus non-yoga intervention group using Asthma Control Test. Methods: In this randomized controlled trial, participants were allocated into two groups in 1:1 ratio - yoga intervention versus non-yoga intervention. Only outcome assessor was blinded. Sample size of 200 was calculated. Individuals between 18 and 60 years of age, diagnosed with mild to moderate asthma with no exacerbation in past one month were screened and enrolled. Per-protocol analysis was done to assess the outcomes of Asthma Control Test and expenditure.(CTRI/2020/02/023534) Results: A total of 192 participants enrolled, 165 completed this study who were considered for final analysis. A significant difference (p

Previous randomized-controlled trials have shown that a peer learning group intervention for career preparation can have positive effects on adolescent career management and the transition to post-comprehensive education in secondary schools. However, this earlier evidence of efficacy has been found by intervention studies that have implemented the method intensively. Earlier studies suggest that tailoring implementation strategies to fit organizational processes may offer opportunities to improve the sustainability and scalability of evidence-based practices. In this study, the implementation of the career preparation intervention was integrated into the school curriculum as a part of regular career counselling, lengthening the delivery timeframe of the intervention programme and using the schools' own guidance counsellors as intervention providers. We conducted a conceptual replication study to investigate how effectively the adapted intervention programme enhanced perceived career preparation skills by carrying out a new cluster randomized-controlled trial among 1068 pupils. Linear mixed models showed that the effect of peer learning sessions on career choice preparedness was positive in comparison to that in the control group. The result suggests that the adapted intervention programme preserved its identifiable positive effects, although dismissing intensive delivery features somewhat reduced the effect size. These study results have implications for school-based career counselling interventions as schools seek to identify evidence-based methods that are cost-efficient and may be integrated into regular school routines. [ABSTRACT FROM AUTHOR]

Machine perfusion is increasingly being tested in clinical transplantation. Despite this, the number of large prospective clinical trials remains limited. The aim of this study was to compare the impact of machine perfusion vs. static cold storage (SCS) on outcomes after liver transplantation. A systematic search of MEDLINE, EMBASE, CINAHL and the Cochrane Central Register of Controlled Trials (CENTRAL) was conducted to identify randomized-controlled trials (RCTs) comparing "post-transplant" outcomes following machine perfusion vs. SCS. Data were pooled using random effect models. Risk ratios (RRs) were calculated for relevant outcomes. The quality of evidence was rated using the GRADE-framework. Seven RCTs were identified (four on hypothermic oxygenated [HOPE] and three on normothermic machine perfusion [NMP]), including a total number of 1,017 patients. Both techniques were associated with significantly lower rates of early allograft dysfunction (NMP: n = 41/282, SCS: n = 74/253, RR 0.50, 95% CI 0.30-0.86, p = 0.01, I2 = 39%; HOPE: n = 45/241, SCS: n = 97/241, RR 0.48, 95% CI 0.35-0.65, p < 0.00001, I2 = 5%). The HOPE approach led to a significant reduction in major complications (Clavien Grade ≥IIIb; HOPE: n = 90/241; SCS: n = 117/241, RR 0.76, 95% CI 0.63-0.93, p = 0.006, I2 = 0%), "re-transplantation" (HOPE: n = 1/163; SCS: n = 11/163; RR 0.21, 95% CI 0.04-0.96, p = 0.04; I2 = 0%) and graft loss (HOPE: n = 7/163; SCS: n = 19/163; RR 0.40, 95% CI 0.17-0.95, p = 0.04; I2 = 0%). Both perfusion techniques were found to 'likely' reduce overall biliary complications and non-anastomotic strictures. Although this study provides the highest current evidence on the role of machine perfusion, outcomes remain limited to a 1-year follow-up after liver transplantation. Comparative RCTs and large real-world cohort studies with longer follow-up are required to enhance the robustness of the data further, thereby supporting the introduction of perfusion technologies into routine clinical practice. CRD42022355252. For a decade, two dynamic perfusion concepts have increasingly been tested in several transplant centres worldwide. We undertook the first systematic review and meta-analysis and identified seven published RCTs, including 1,017 patients, evaluating the effect of machine perfusion (hypothermic and normothermic perfusion techniques) compared to static cold storage in liver transplantation. Both perfusion techniques were associated with lower rates of early allograft dysfunction in the first week after liver transplantation. Hypothermic oxygenated perfusion led to a reduction in major complications, lower "re-transplantation" rates and better graft survival. Both perfusion strategies were found to 'likely' reduce overall biliary complications and non-anastomotic biliary strictures. This study provides the highest current evidence on the role of machine perfusion. Outcomes remain limited to a 1-year post-transplant follow-up. Larger cohort studies with longer follow-up and clinical trials comparing the perfusion techniques are required. This is especially relevant to provide clarity and optimise implementation processes further to support the commissioning of this technology worldwide. [Display omitted] • First systematic review and meta-analysis evaluating the effect of HOPE and NMP compared to SCS in liver transplantation. • HOPE and NMP were associated with lower rates of early allograft dysfunction in the first week after liver transplantation. • HOPE led to a significant reduction in major complications, lower "re-transplantation" rates and better graft survival. • Despite being the highest level of evidence, outcome data on machine perfusion remain limited to 1-year post-transplant follow-up. [ABSTRACT FROM AUTHOR]

Background: Older adults with advanced dementia require significant care, leading to high stress levels in caregivers. Objectives: The current study aimed to evaluate the effects of an Integrative Stress Reduction Program on Thai caregiver's outcomes of stress, sleep quality, and caregiver-assessed neuropsychiatric symptoms of persons with dementia. Methods: A single-blind randomized-controlled trial was conducted. A sample of family caregivers of people with dementia was recruited from memory clinics at outpatient community health centers in Thailand and randomly assigned to the experimental and control groups. Participants in the experimental group were enrolled in 5 intervention sessions over 4 weeks, while the control group received usual care. Outcome variables were collected at baseline, 4 weeks postintervention, and 8 weeks of follow-up. Results: Compared with the control group, caregivers in the experimental group (n = 27) had significantly decreased stress (p <.01) and better sleep quality (p <.01), and caregivers reported that their family members with dementia (n = 27) had decreased neuropsychiatric symptoms (p <.01) after the intervention (week 4) and at the 8-week follow-up. Conclusions: The Integrative Stress Reduction Program improved outcomes for caregivers and decreased neuropsychiatric symptoms in people with dementia. [ABSTRACT FROM AUTHOR]

Emotional disorders are the most prevalent mental health conditions affecting children and adolescents. Thus, it becomes essential to develop and test early intervention strategies that are accessible, attractive, and can effectively improve their emotional functioning. A randomized control trial compared the prevention effects of the REThink therapeutic game to those of a standard face-to-face prevention program, and a waitlist which was transformed at follow-up into care as usual. Out of 142 healthy children and adolescents who completed the intervention stage, 137 (mean age: 12.84, SD: 1.97) completed a follow-up assessment measuring emotional symptoms, depressive mood and emotion regulation. We also tested potential moderators of its long-term effects, such as parental psychological control, parent attachment and childhood trauma. Our results highlighted the fact that the REThink intervention had a durable impact on the children's mental health and their ability to regulate their emotions. Moreover, we found that trauma, parent psychological control and parent attachment moderated the maintenance of the improvements. Future research needs to further document how to personalize the game and prevention program components to better address the characteristics of the youths at risk for mental health problems. ClinicalTrials.gov NCT03308981, from 13.10.2017. [ABSTRACT FROM AUTHOR]

Purpose: The aim of this study was to assess the effect of systematic lateral retinacular release (LRR) on anterior knee pain (AKP), as well as its impact on the functional and radiological outcomes after total knee arthroplasty (TKA) with patellar resurfacing. Methods: A prospective randomized study was designed. It included patients scheduled for a TKA procedure with patellar resurfacing, who were recruited and randomized into either the LRR group or the non-release group. 198 patients were included in the final analysis. The pressure pain threshold (PPT) assessed by pressure algometry (PA), the visual analogue scale (VAS), Feller's patellar score, the Knee Society Score (KSS), patellar height, and patellar tilt were recorded both preoperatively and at the 1-year follow-up. The Mann–Whitney U test was performed to determine comparisons between both groups as well as to determine differences' intragroup. Results: Relative to the clinical variables and scores, no difference was detected between the two groups at the 1-year follow-up (p = n.s.). However, there was a slight difference in patellar tilt (0.1º vs. 1.4º, p = 0.044), with higher tilt values in the non-release group. There was no difference in terms of improvement in the clinical and radiological scores and variables recorded between the two groups (p = n.s.). Conclusion: LRR in primary TKA with patellar resurfacing does not show an improvement in AKP and functional outcomes over patellar resurfacing without release. Level of evidence: I. [ABSTRACT FROM AUTHOR]

Disturbed interoception (i.e., the sensing, awareness, and regulation of internal body signals) has been found across several mental disorders, leading to the development of interoception‐based interventions (IBIs). Searching PubMed and PsycINFO, we conducted the first systematic review of randomized‐controlled trials (RCTs) investigating the efficacy of behavioral IBIs at improving interoception and target symptoms of mental disorders in comparison to a non‐interoception‐based control condition [CRD42021297993]. Thirty‐one RCTs fulfilled inclusion criteria. Across all studies, a pattern emerged with 20 (64.5%) RCTs demonstrating IBIs to be more efficacious at improving interoception compared to control conditions. The most promising results were found for post‐traumatic stress disorder, irritable bowel syndrome, fibromyalgia and substance use disorders. Regarding symptom improvement, the evidence was inconclusive. The IBIs were heterogenous in their approach to improving interoception. The quality of RCTs was moderate to good. In conclusion, IBIs are potentially efficacious at improving interoception for some mental disorders. In terms of symptom reduction, the evidence is less promising. Future research on the efficacy of IBIs is needed. [ABSTRACT FROM AUTHOR]

Background Quick symptomatic remission after the onset of psychotic symptoms is critical in schizophrenia treatment, determining the subsequent disease course and recovery. In this context, only every second patient with acute schizophrenia achieves symptomatic remission within three months of initiating antipsychotic treatment. The potential indication extension of clozapine—the most effective antipsychotic—to be introduced at an earlier stage (before treatment-resistance) is supported by several lines of evidence, but respective clinical trials are lacking. Methods Two hundred-twenty patients with acute non-treatment-resistant schizophrenia will be randomized in this double-blind, 8-week parallel-group multicentric trial to either clozapine or olanzapine. The primary endpoint is the number of patients in symptomatic remission at the end of week 8 according to international consensus criteria ('Andreasen criteria'). Secondary endpoints and other assessments comprise a comprehensive safety assessment (i. e., myocarditis screening), changes in psychopathology, global functioning, cognition, affective symptoms and quality of life, and patients' and relatives' views on treatment. Discussion This multicentre trial aims to examine whether clozapine is more effective than a highly effective second-generation antipsychotics (SGAs), olanzapine, in acute schizophrenia patients who do not meet the criteria for treatment-naïve or treatment-resistant schizophrenia. Increasing the likelihood to achieve symptomatic remission in acute schizophrenia can improve the overall outcome, reduce disease-associated burden and potentially prevent mid- and long-term disease chronicity. [ABSTRACT FROM AUTHOR]

N-acetyl cysteine (NAC) is a potent antioxidant that modulates glutamatergic signalling which is thought to play a role in alcohol use disorder (AUD). There have been no clinical trials investigating NAC for AUD. We aimed to conduct a 28 day double-blind, placebo-controlled (PL) randomized trial of NAC in the treatment of AUD (NCT03879759). A total of 42 participants with AUD (56% alcohol-related liver disease) were randomized to receive placebo or NAC 2400 mg/day. Feasibility outcomes included treatment retention and adverse events. Primary clinical outcomes included alcohol consumption (heavy drinking days, standard drinks per drinking day). Secondary clinical outcome measures included craving, liver tests, and psychological outcomes. There were no significant differences in overall retention between treatment groups (χ2(1) = 0.14, P  = 0.71: 86% vs 76% for placebo and NAC, respectively). The most commonly reported adverse event in NAC-treated individuals included headache (14%). For standard drinks per drinking day, there was a significant overall effect of time (F  = 9.18, P  < 0.001), no significant effect of treatment (F  = 0.75, P  = 0.79), and a significant time x treatment (NAC vs PL) effect (F  = 2.73, P  < 0.05). For number of heavy drinks per day, there was a significant overall effect of time (F  = 3.16, P  < 0.05) but no significant effect of treatment or time x treatment (P  = 0.17). There were no significant NAC vs PL effects on secondary clinical outcome measures. In the first trial of NAC for the management of AUD, NAC appears to be feasible and safe. Although there was a significant effect of NAC vs placebo on some alcohol measures such as drinks per drinking day, there does appear to be a variable pattern of effect across time suggesting that a larger trial incorporating a longer treatment duration is now required to determine efficacy. [ABSTRACT FROM AUTHOR]

Background: Vortioxetine and venlafaxine are antidepressants which have shown established efficacy to treat major depressive disorder (MDD). There are no studies that compared them for their efficacy in cognitive symptoms of depression. The study aimed to compare the effect of vortioxetine and venlafaxine on the change in cognitive scores in adults with MDD. Methods: The present study was an open-label, active-controlled parallel design randomized clinical trial. After randomization, baseline clinical evaluations by Montgomery--Asberg Depression Rating Scale (MADRS) and Social and Occupational Functioning Assessment Scale (SOFAS) were done and coding (subset of WAIS-IV), WCST, TMT, Stroop test, PGI memory were used to assess cognition in 100 unmedicated MDD patients. They were reassessed after eight weeks of monotherapy with vortioxetine or venlafaxine. Results: Primary cognitive measure (coding score) was found to be significantly higher (Mean Difference = 0.680; 95% CI:.202 to 1.158; P = 0.006) in vortioxetine in comparison with venlafaxine. Stroop test scores (word score, color score, color--word score) were also found to be significantly higher with vortioxetine. In other cognitive measures (WCST scores: total trials, total errors score, total perseverative responses score, total perseverative errors scores; TMT-A and B scores), a significant decrease in scores with vortioxetine in comparison with venlafaxine were observed. A significant decrease in MADRS and increase in SOFAS scores were observed with vortioxetine in comparison with venlafaxine. Both the drugs alleviated the symptoms of depression but vortioxetine was better tolerated. Conclusion: Our study findings suggest that improvement in cognitive scores is significantly higher with vortioxetine than venlafaxine over the eight weeks of monotherapy. [ABSTRACT FROM AUTHOR]

Abstract Background Progress of cholangitis to cholangiosepsis is a frequent observation in patients with secondary sclerosing cholangitis in critically ill patients (SSC–CIP). Adequate biliary drainage may reduce episodes of cholangiosepsis and therefore stabilize liver function and improve survival. The primary objective of the BISCIT study is to demonstrate that scheduled biliary interventions will reduce incidence of cholangiosepsis, liver transplantation, or death in patients with SSC–CIP. Methods A total of 104 patients will be randomized at ten study sites. Patients with SSC–CIP, confirmed by endoscopic retrograde cholangiography (ERC), will be randomized 1:1 either in the intervention group which will be treated with scheduled biliary interventions (i.e., therapeutic ERC) every 8 weeks for 6 months or in the control group which will receive standard of care. The randomization will be stratified by center. The composite primary efficacy endpoint is defined as (1) occurrence of death, (2) necessity of liver transplantation, or (3) occurrence of cholangiosepsis within 6 months following randomization. Discussion Prospective evaluation of endoscopic treatment procedures is urgently needed to establish an evidence-based therapeutic treatment algorithm in SSC–CIP. A positive trial result could change the current standard of care for patients with SSC–CIP. The results of this study will be disseminated through presentations at international congresses, workshops, and peer-reviewed publications. Trial registration The trial was registered at ClinicalTrials.gov (NCT05396755, date of registration: May 31, 2022, last update: May 31, 2022).

The Social-Emotional Prevention Program (SEP) encompasses a multifaceted approach (classroom curriculum, with teacher and parent training) intended to increase preschool children's social adjustment, as well as to reduce risk of emotional and behavioral problems. The present study's focus was on implementing the technology-assisted SEP version and was aimed at (a) investigating the program's effectiveness on children's social-emotional competencies and parental practices, as well as (b) testing the program's conceptual framework, with an emphasis on children's emotion regulation (ER) skills and parental emotion socialization practices as explanatory intervention mechanisms. A randomized-controlled trial (RCT) was conducted with five schools assigned to either the intervention or to a comparison condition (wait-list control). Structural equation models (SEM) and complier average causal effects (CACE) were conducted to evaluate SEP effectiveness on teacher- and parent-rated child outcomes (primary outcomes) and parenting behaviors (secondary outcomes). Findings from the present study indicated that (a) SEP fosters increased social-emotional competencies and increased use of adaptive ER strategies, with teacher and parent ratings converging to support these outcomes; (b) parental participation in the program increased the use of reappraisal and emotion coaching strategies; and (c) children's ER mediated the intervention's effect on social competence, whereas parental coaching and parental ER mediated SEP effects on children's ER. This study's findings suggest that the SEP may be an effective universal intervention for promoting preschoolers' social-emotional competence and may provide emerging evidence to support the program's hypothesized mechanisms of change. • A school-based intervention combines face-to-face with technology-assisted delivery • Parent and teacher ratings converge to support the program's effectiveness • Parent participation contributes to the intervention's positive outcomes • Improved emotion regulation represents a mechanism for increased social skills • Emotion related parenting practices contribute to gains in preschoolers' ER [ABSTRACT FROM AUTHOR]

Abstract Background Young mothers are more likely to provide a suboptimal early language environment for their children who in turn show impairments in their language development, yet few studies have used observational methods to assess the effectiveness of home-visiting programmes in improving the language outcomes of young mothers and their children. The Family Nurse Partnership (FNP) is a licensed home-visiting intervention developed in the USA and introduced into practice in England. The intervention involves up to 64 structured home visits from early pregnancy until the child's second birthday by specially recruited and trained Family Nurses. We assessed the effectiveness of FNP in improving the language outcomes of first-time teenage mothers and their infants. Method We conducted a pragmatic, non-blinded, randomised controlled trial to test whether the FNP programme improved mothers’ and children’s language production at 24 months postpartum. Eligible participants were nulliparous, aged 19 years or younger, and were recruited at less than 25 weeks’ gestation from community midwifery settings (Country). Pregnant young mothers were randomly assigned to FNP plus usual care (n = 243) or usual care alone (n = 233). At 24 months postpartum, mother–child dyads were observed during a standardised free-play task with their first-born child and features of their language production was coded. Data was analysed using multi-level modelling; linear or poisson/negative binomial regression models were used as appropriate. Results A small effect of FNP on mothers’ productive language was detected, where mothers in the FNP group demonstrated higher mean length of utterances than mothers who received usual care alone, mean difference (adjusted by minimisation variables and by site, linear regression) = 0.10, p

Abstract Background No results of controlled trials are available for any of the few treatments offered to children with interstitial lung diseases (chILD). We evaluated hydroxychloroquine (HCQ) in a phase 2, prospective, multicentre, 1:1-randomized, double-blind, placebo-controlled, parallel-group/crossover trial. HCQ (START arm) or placebo were given for 4 weeks. Then all subjects received HCQ for another 4 weeks. In the STOP arm subjects already taking HCQ were randomized to 12 weeks of HCQ or placebo (= withdrawal of HCQ). Then all subjects stopped treatment and were observed for another 12 weeks. Results 26 subjects were included in the START arm, 9 in the STOP arm, of these four subjects participated in both arms. The primary endpoint, presence or absence of a response to treatment, assessed as oxygenation (calculated from a change in transcutaneous O2-saturation of ≥ 5%, respiratory rate ≥ 20% or level of respiratory support), did not differ between placebo and HCQ groups. Secondary endpoints including change of O2-saturation ≥ 3%, health related quality of life, pulmonary function and 6-min-walk-test distance, were not different between groups. Finally combining all placebo and all HCQ treatment periods did not identify significant treatment effects. Overall effect sizes were small. HCQ was well tolerated, adverse events were not different between placebo and HCQ. Conclusions Acknowledging important shortcomings of the study, including a small study population, the treatment duration, lack of outcomes like lung function testing below age of 6 years, the small effect size of HCQ treatment observed requires careful reassessments of prescriptions in everyday practice (EudraCT-Nr.: 2013-003714-40, www.clinicaltrialsregister.eu , registered 02.07.2013). Registration The study was registered on 2 July 2013 (Eudra-CT Number: 2013-003714-40), whereas the approval by BfArM was received 24.11.2014, followed by the approval by the lead EC of the University Hospital Munich on 20.01.2015. At clinicaltrials.gov the trial was additionally registered on November 8, 2015 (NCT02615938).

Abstract Background/aims Borderline personality disorder (BPD) is a severe mental disorder characterized by an unstable sense of self, intense and rapidly changing affect, as well as impulsive and self-destructive behaviors. Interpersonal relationships of individuals with BPD are characterized by marked instability, a lack of dependability, and quick changes between love and hate. For children of individuals with BPD, this can lead to permanent stress and attachment insecurity and an increased risk of adverse physical and mental health development. To reduce dysfunctional parenting and improve positive parenting, and in turn, to promote healthy child development, a group intervention for mothers with BPD was developed. This study aims to evaluate this first disorder-specific parenting intervention for BPD in a randomized controlled trial. Method In a parallel-group, two-arm, randomized controlled trial, an initial N = 178 mothers diagnosed with BPD and their children aged 6 months to 6 years are assigned to either the parenting intervention or a waiting control group. If taking place, participants of both groups continue their regular treatment for BPD diagnosis (e.g., individual therapy, medication). The primary outcomes are changes in parenting from baseline (day 0) to post intervention (week 12) and follow-up (6 months after group intervention; month 9). The waiting control group can attend the group intervention at the end of all assessments. Participants allocated to the intervention group are expected to show improvement in their parenting and a reduction in child abuse potential. Maternal emotion regulation and mental distress are analyzed as secondary outcomes. Discussion Mothers with BPD may need tailored help when reporting difficulties raising their children. The first disorder-specific parenting intervention has been developed to close this gap. ProChild is part of a large government-supported consortium, which aims to investigate different aspects of abuse and maltreatment in childhood and adolescence. Trial registration ClinicalTrials.gov NCT04169048 . Registered on Nov 19, 2019.

Summary: Background: The impact of environmental hygiene on the occurrence of hospital-acquired infections (HAIs) remains a subject of debate. We determined the effect of three different surface-cleaning strategies on the incidence of HAIs. Methods: Between June 2017 and August 2018 we conducted a pragmatic, cluster-randomized controlled crossover trial at 18 non-ICU wards in the university hospital of Berlin, Germany. Surfaces in patient rooms on the study wards were routinely cleaned using one of three agents: Soap-based (reference), disinfectant and probiotic. Each strategy was used on each ward for four consecutive months (4m-4m-4m). There was a one-month wash-in period at the beginning of the study and after each change in strategy. The order of strategies used was randomized for each ward. Primary outcome was the incidence of HAIs. The trial was registered with the German Clinical Trials Register, DRKS00012675. Findings: 13,896 admitted patients met the inclusion criteria, including 4708 in the soap-based (reference) arm, 4535 in the disinfectant arm and 4653 in the probiotic arm. In the reference group, the incidence density of HAIs was 2.31 per 1000 exposure days. The incidence density was similar in the disinfectant arm 2.21 cases per 1000 exposure days (IRR 0.95; 95% CI 0.69–1.31; p = 0.953) and the probiotic arm 2.21 cases per 1000 exposure days (IRR 0.96; 95% CI 0.69–1.32; p = 0.955). Interpretation: In non-ICU wards, routine surface disinfection proved not superior to soap-based or probiotic cleaning in terms of HAI prevention. Thus, probiotic cleaning could be an interesting alternative, especially in terms of environmental protection. Funding: Federal Ministry of Education and Research of Germany (03Z0818C). Bill and Melinda Gates Foundation (INV-004308).

Chronic ankle instability (CAI) is associated with decreased neural excitability that negatively impacts function. This study assessed a 2-week neuromuscular electrical stimulation (NMES) or transcutaneous electrical nerve stimulation (TENS) intervention over the ankle pronators on neural excitability, performance, and patient-reported function in patients with CAI. Randomized controlled trial. Twenty participants with CAI completed the study. Participants were assessed for reflexive and corticospinal excitability to the ankle muscles, dynamic balance, side-hop test performance and patient-reported outcomes at baseline, post-intervention (2-weeks), and retention (4-weeks). Between baseline and post-intervention, participants reported for 5 sessions where they received either sub-noxious NMES (n = 11) or sensory-level TENS (n = 9) over the ankle pronators. Improved reflexive excitability to the ankle pronators was observed in TENS at post-intervention (p = 0.030) and retention (p = 0.029). Cortical excitability to the dorsiflexors increased in TENS at post-intervention (p = 0.017), but not at retention (p = 0.511). No significant changes were found for other neural measures, balance ability, hopping, or patient-reported function (p > 0.050). Our results suggest TENS modified neural excitability; however, these changes were not enough to impact clinical function. While TENS may be capable of neuromodulation, it may require rehabilitative exercise to generate lasting changes. NCT04322409. Level 2. • TENS over the ankle pronators improves neural excitability in patients with CAI. • Observed changes in excitability did not impact function over the intervention. • Neuromodulatory effects of TENS may be enhanced when paired with exercises. [ABSTRACT FROM AUTHOR]

Background: Adults with intellectual disabilities have a higher prevalence of unhealthy eating habits, stress, low levels of mobility, and comparable drug consumption as the general population. Consequently, they suffer from several chronic diseases earlier and more often, but there are fewer prevention and health promotion services including this population. The goal of this study is to determine if an advanced practice nursing approach in the community with home visits is an effective way to improve the health status of adults with intellectual disabilities. Methods: We will conduct a randomized-controlled trial with waiting list design in Hamburg, Germany. Inclusion criteria are diagnosis ICD F70-F79 and exclusion criteria are care level > 3 according to the German Social Code XI or being at the end-of-life. Participants will be block randomized. The intervention consists of advanced practice nurses performing case management, social space analysis, prevention planning, and counseling through four outreach home visits on nutrition, mobility, addiction, and stress. Comparison is usual care. The primary outcome is health status (WHODAS) after 12 months. Secondary outcomes are health-related quality of life (EQ-5D) and resilience (RS-11) after 6 and 12 months. The calculated sample size is 256 with an estimated dropout of 30%. Raters and analysts will be blinded. Analysis will be performed using ANCOVAs. Discussion: By providing case management and utilizing their nursing expertise, advanced practice nurses will provide valuable input and guidance on prevention and health promotion for people with intellectual disabilities. They will close the gap between health and social care, which is prominent in Germany, through cooperation between the existing care sectors. The findings will be disseminated in peer-reviewed journals and presented at national and international conferences. Trial registration: German Clinical Trials Register, DRKS00028771, registered 4 July 2022, Universal Trial Number: U1111-1277–0595. [ABSTRACT FROM AUTHOR]

Skin aging is one of the most concerning issues that occur after menopause. The Genistein Nutraceutical (GEN) product, containing genistein, vitamin E, vitamin B3, and ceramide, has been formulated as a topical anti-aging product for improving the health of postmenopausal women's facial skin. This study aimed to investigate the efficacy and safety of the GEN product on postmenopausal women's facial skin. This randomized, double-blind, placebo-controlled trial randomly assigned 50 postmenopausal women to receive either the GEN product (n = 25) or the placebo (PLA) product (n = 25), topically applied twice daily for 6 weeks. The outcome assessments included multiple skin parameters related to skin wrinkling, color, hydration, and facial skin quality at baseline and week 6. The percentage mean changes or absolute mean changes, where appropriate, in skin parameters were compared between the two groups. The mean age of the participants was 55.8 ± 3.4 years. For skin wrinkling and skin color parameters, only skin redness was significantly higher in the GEN group when compared to the PLA group. Following the application of the GEN product, skin hydration increased while fine pores and their area decreased. Subgroup analysis of older women (age ≥ 56 years) with adequate compliance found significant differences between the two groups in the percentage mean changes of most skin wrinkle parameters. The GEN product has benefits for the facial skin of postmenopausal women, particularly those who are older. It can moisturize facial skin, lessen wrinkles, and enhance redness. [ABSTRACT FROM AUTHOR]

Background: Suicide is the leading cause of death among Australians. One commonly cited explanation is the impact of social media, in particular, the ways in which young people use social media to communicate about their own experiences and their exposure to suicide-related content posted by others. Guidelines designed to assist mainstream media to safely report about suicide are widespread. Until recently, no guidelines existed that targeted social media or young people. In response, we developed the #chatsafe guidelines and a supporting social media campaign, which together make up the #chatsafe intervention. The intervention was tested in a pilot study with positive results. However, the study was limited by the lack of a control group. Objective: The aim of this study is to assess the impact of the #chatsafe social media intervention on young people's safety and confidence when communicating on the web about suicide. Methods: The study employs a pragmatic, parallel, superiority randomized controlled design. It will be conducted in accordance with the Consolidated Standards of Reporting Trials statement over 18 months. Participants will be 400 young people aged 16-25 years (200 per arm). Participants will be recruited via social media advertising and assessed at 3 time points: time 1-baseline; time 2-8-week postintervention commencement; and time 3-4-week postintervention. They will be asked to complete a weekly survey to monitor safety and evaluate each piece of social media content. The intervention comprises an 8-week social media campaign including social media posts shared on public Instagram profiles. The intervention group will receive the #chatsafe suicide prevention content and the control group will receive sexual health content. Both groups will receive 24 pieces of content delivered to their mobile phones via text message. The primary outcome is safety when communicating on the web about suicide, as measured via the purpose-designed #chatsafe online safety questionnaire. Additional outcomes include willingness to intervene against suicide, internet self-efficacy, safety, and acceptability. Results: The study was funded in November 2020, approved by the University of Melbourne Human Research Ethics Committee on October 7, 2022, and prospectively registered with the Australian New Zealand Clinical Trials registry. Trial recruitment began in November 2022 and study completion is anticipated by June 2024. Conclusions: This will be the first randomized controlled trial internationally to test the impact of a social media intervention designed to equip young people to communicate safely on the web about suicide. Given the rising rates of youth suicide in Australia and the acceptability of social media among young people, incorporating social media-based interventions into the suicide prevention landscape is an obvious next step. This intervention, if effective, could also be extended internationally, thereby improving web-based safety for young people not just in Australia but globally. [ABSTRACT FROM AUTHOR]

Abstract Aim No effective pharmacological interventions have been developed for patients with methamphetamine use disorder. Ifenprodil is a blocker of G protein‐activated inwardly rectifying potassium channels, which play a key role in the mechanism of action of addictive substances. We conducted a randomized, double‑blind, exploratory, dose‐ranging, placebo‐controlled trial to examine the clinical efficacy of ifenprodil for the treatment of methamphetamine use disorder. Methods Participants were assigned to three groups: placebo, 60 mg/d ifenprodil, or 120 mg/d ifenprodil. The drug administration period was 84 days. The primary outcome was the use or nonuse of methamphetamine during the drug administration period in the placebo group vs 120 mg/d ifenprodil group. We also assessed drug use status, relapse risk based on the Stimulant Relapse Risk Scale (SRRS), drug craving, and methamphetamine in urine as secondary outcomes. We further evaluated drug use status and SRRS subscale scores in patients who were not taking addiction medications during the study. Results Ifenprodil did not affect the primary or secondary outcomes. However, the additional analyses showed that the number of days of methamphetamine use during the follow‐up period and scores on the emotionality problems subscale of the SRRS improved in the 120 mg/d ifenprodil group. The safety of ifenprodil was confirmed in patients with methamphetamine use disorder. Conclusion The present findings did not confirm the efficacy of ifenprodil for methamphetamine use disorder treatment based on the primary or secondary outcomes, but we found evidence of its safety and efficacy in reducing emotionality problems. Clinical trial registration The study was registered at the University Hospital Medical Information Network Clinical Trial Registry (no. UMIN000030849) and Japan Registry of Clinical Trials (no. jRCTs031180080). The main registration site is jRCT (https://jrct.niph.go.jp/).

OBJECTIVE:To assess the comparative effectiveness of alternative incentive-based interventions to promote HIV testing among men. DESIGN:Randomized clinical trial. METHODS:We enumerated four Ugandan parishes and enrolled men at least 18 years. Participants were randomized to six groups that received incentives of varying type and amount for HIV testing at a 13-day community health campaign. Incentive types were: gain-framed (control): participants were told they would receive a prize for testing; loss-framed: participants were told they had won a prize, shown several prizes, asked to select one, then told they would lose the prize if they did not test; lotteries: those who tested had a chance to win larger prizes. Each incentive type had a low and high amount (∼US$1 and US$5/participant). The primary outcome was HIV-testing uptake at the community health campaign. RESULTS:Of 2532 participants, 1924 (76%) tested for HIV; 7.6% of those tested were HIV-positive. There was no significant difference in testing uptake in the two lottery groups (78%; P = 0.076) or two loss-framed groups (77%; P = 0.235) vs. two gain-framed groups (74%). Across incentive types, testing did not differ significantly in high-cost (76%) vs. low-cost (75%; P = 0.416) groups. Within low-cost groups, testing uptake was significantly higher in the lottery (80%) vs. gain-framed (72%; P = 0.009) group. CONCLUSION:Overall, neither offering incentives via lotteries nor framing incentives as losses resulted in significant increases in HIV testing compared with standard gain-framed incentives. However, when offering low-cost incentives to promote HIV testing, providing lottery-based rewards may be a better strategy than gain-framed incentives.

Background: Eating in absence of hunger is quite common and often associated with an increased energy intake co-existent with a poorer food choice. Intuitive eating (IE), i.e., eating in accordance with internal hunger and satiety cues, may protect from overeating. IE, however, requires accurate perception and processing of one's own bodily signals, also referred to as interoceptive sensitivity. Training interoceptive sensitivity might therefore be an effective method to promote IE and prevent overeating. As most studies on eating behavior are conducted in younger adults and close social relationships influence health-related behavior, this study focuses on middle-aged and older couples. Methods: The present pilot randomized intervention study aims at investigating the feasibility and effectiveness of a 21-day mindfulness-based training program designed to increase interoceptive sensitivity. A total of N = 60 couples participating in the NutriAct Family Study, aged 50–80 years, will be recruited. This randomized-controlled intervention study comprises three measurement points (pre-intervention, post-intervention, 4-week follow-up) and a 21-day training that consists of daily mindfulness-based guided audio exercises (e.g., body scan). A three-arm intervention study design is applied to compare two intervention groups (training together as a couple vs. training alone) with a control group (no training). Each measurement point includes the assessment of self-reported and objective indicators of interoceptive sensitivity (primary outcome), self-reported indicators of intuitive and maladaptive eating (secondary outcomes), and additional variables. A training evaluation applying focus group discussions will be conducted to assess participants' overall acceptance of the training and its feasibility. Discussion: By investigating the feasibility and effectiveness of a mindfulness-based training program to increase interoceptive sensitivity, the present study will contribute to a deeper understanding of how to promote healthy eating in older age. Trial registration: German Clinical Trials Register (DRKS), no. DRKS00024903. Retrospectively registered on April 21, 2021. [ABSTRACT FROM AUTHOR]

Background: The loss of a sibling can have a long-term impact on the mental and physical health of the surviving sibling throughout adolescence and later adulthood. Even though bereaved siblings can be identified as a high-risk group, evidence-based interventions for this bereavement group are still missing. Aim: To evaluate the treatment effects of an internet-based writing intervention for bereaved siblings aged 16–65 years. Design: A two-armed randomized controlled trial (DRKS00011514) compared the intervention to a waiting list control group. The 6-week intervention consisted of six structured writing assignments that were based on cognitive behavioral therapy, focusing on the specific situation of bereaved siblings. Setting/participants: Eighty-six bereaved siblings (loss >1 month ago, no severe psychiatric symptoms) were randomly allocated to the intervention group (n = 47) or the waiting list control group (n = 39). Primary outcomes were symptoms of prolonged grief disorder and depression; secondary outcomes were posttraumatic stress symptoms and survivor guilt. Results: Symptoms of depression and prolonged grief disorder improved significantly in the intention-to-treat analyses from pre-to post-measurement compared with the control group (g Depression = −0.62, g Grief = 0.33). In the intervention group, all primary and secondary outcomes decreased significantly from baseline to 12-month follow-up (g s = −0.38 to −1.04). A significant clinical change could be found for depression (34%) compared to the waitlist control group (10%). Conclusions: Bereaved siblings profited from this brief internet-based writing intervention in the short- and long-term. However, future research, such as dismantling studies, may help to further optimize the benefits of an intervention aimed at bereaved siblings. [ABSTRACT FROM AUTHOR]

• A shared-reading intervention impacted teachers' use of diverse vocabulary • It impacted teachers' use of word explanations and multi-clause utterances • These changes in teacher talk quality explained variance in children's vocabulary • Teacher talk quality did not explain variance in children's syntactic comprehension This study examined whether a shared reading intervention in preschools serving multilingual populations in Norway had effects on teacher talk quality and whether these effects mediated child second-language outcomes. Four hundred sixty-four children aged 3–5 years participated. They attended 123 classrooms that were randomly assigned to a shared-reading intervention condition or a comparison condition. The children's second-language vocabulary and grammar skills were assessed pre- and post-intervention, with 7.4 months between the 2 assessments. We asked whether the intervention affected qualities of teacher talk hypothesized to impact children's language, and whether identified changes in teacher talk mediated child second-language vocabulary and grammar outcomes. Results revealed that by the end of the school year teachers in the intervention group demonstrated significantly higher quality in their talk during shared reading, assessed as diversity of word types, use of word explanations and ratio of multi-clause utterances. These differences in teacher talk quality explained variance in children's second-language vocabulary outcomes by the end of the intervention year, but not in their second-language syntactic comprehension. [ABSTRACT FROM AUTHOR]