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IntroductionMajor depressive disorder (MDD) is a leading cause of global disability. Current treatments are limited by poor efficacy in approximately one-third of patients. Neuroinflammation may be an underlying mechanism of MDD and represents a novel target for pharmacological therapy. This study aimed to investigate the effects of a putative centrally acting anti-inflammatory agent, low-dose naltrexone (LDN), in MDD.MethodsPatients with MDD experiencing moderate depressive symptoms and receiving antidepressant treatment were randomized to receive 12 weeks of LDN (up to 4.5 mg per day) or 12 weeks of inactive placebo. The primary outcome measure was the Montgomery-Asberg Depression Rating Scale (MADRS) at 12 weeks, analyzed using a linear mixed-effects model adjusted for baseline.ResultsThirty-seven patients were randomized. At 12 weeks, MADRS scores (M ± SD) were reduced by 10.5 ± 5.6 in the LDN group and 9.8 ± 5.9 placebo group; with no difference between groups (p = 0.97). LDN did not affect high-sensitivity C-reactive protein (hsCRP) levels or exploratory measures of depression, behavioral activation, quality of life, sickness symptoms and mood. There was no evidence that baseline hsCRP modified the effect of LDN on MADRS score.DiscussionAdjunctive LDN does not appear to alter depressive symptoms in moderate MDD. Larger studies are warranted to evaluate LDN in a population with a higher likelihood of neuroinflammatory pathology, such as those with severe, treatment-resistant MDD or comorbid inflammatory conditions. Future studies should utilize stratification tools that are more sensitive and specific to neuroinflammation than hsCRP.Clinical Trial Registrationhttps://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=383741&isReview=true, identifier [ACTRN12622000881730].

To examine whether four pre-selected front-of-pack nutrition labels improve food purchases in real-life grocery shopping settings, we put 1.9 million labels on 1266 food products in four categories in 60 supermarkets and analyzed the nutritional quality of 1,668,301 purchases using the FSA nutrient profiling score. Effect sizes were 17 times smaller on average than those found in comparable laboratory studies. The most effective nutrition label, Nutri-Score, increased the purchases of foods in the top third of their category nutrition-wise by 14%, but had no impact on the purchases of foods with medium, low, or unlabeled nutrition quality. Therefore, Nutri-Score only improved the nutritional quality of the basket of labeled foods purchased by 2.5% (−0.142 FSA points). Nutri-Score’s performance improved with the variance (but not the mean) of the nutritional quality of the category. In-store surveys suggest that Nutri-Score’s ability to attract attention and help shoppers rank products by nutritional quality may explain its performance.

Recent open-label trials show that psychedelics, such as ayahuasca, hold promise as fast-onset antidepressants in treatment-resistant depression. To test the antidepressant effects of ayahuasca, we conducted a parallel-arm, double-blind randomized placebo-controlled trial in 29 patients with treatment-resistant depression. Patients received a single dose of either ayahuasca or placebo. We assessed changes in depression severity with the Montgomery-Åsberg Depression Rating Scale (MADRS) and the Hamilton Depression Rating scale at baseline, and at 1 (D1), 2 (D2), and 7 (D7) days after dosing. We observed significant antidepressant effects of ayahuasca when compared with placebo at all-time points. MADRS scores were significantly lower in the ayahuasca group compared with placebo at D1 and D2 (p = 0.04), and at D7 (p < 0.0001). Between-group effect sizes increased from D1 to D7 (D1: Cohen's d = 0.84; D2: Cohen's d = 0.84; D7: Cohen's d = 1.49). Response rates were high for both groups at D1 and D2, and significantly higher in the ayahuasca group at D7 (64% v. 27%; p = 0.04). Remission rate showed a trend toward significance at D7 (36% v. 7%, p = 0.054). To our knowledge, this is the first controlled trial to test a psychedelic substance in treatment-resistant depression. Overall, this study brings new evidence supporting the safety and therapeutic value of ayahuasca, dosed within an appropriate setting, to help treat depression. This study is registered at http://clinicaltrials.gov (NCT02914769).

Randomized controlled trials (RCTs), as the highest level of evidence and the gold standard in clinical research, occupy a central position in modern medical research due to their stringent variable control and high internal validity. However, their vacuum-like research environment and standardized treatment approaches face significant challenges in traditional Chinese medicine (TCM), which emphasizes Treatment Tailored to Individual and Treatment Based on Syndrome Differentiation, focusing on personalized treatment according to a patient's constitution, age, gender, and lifestyle, and diagnosis based on specific syndromes. This approach lacks systematic modern clinical research and unified standards, conflicting with RCTs' standardized design, thus limiting TCM trials and posing serious challenges to its modernization and internationalization. This study systematically collected and categorized data on the registration status, study type, design, interventions and control measures, research objectives, primary outcome measures of registered trials by searching the ClinicalTrials.gov using TCM-related keywords. It reveals the current status and distribution patterns of TCM clinical registration trials. Evidence suggests that TCM clinical trials urgently need to seek a balance between standardized research and individualized treatment to address the limitations of RCTs in the TCM field, like implementation difficulties and the neglect of individual differences. To address this, the paper proposes an innovative research framework centered on pragmatic RCTs, highlighting randomization based on patient preferences to gather real-world evidence. Additionally, it suggests constructing a multidimensional core information set for standardized diagnosis of TCM syndromes by integrating disease and syndrome data to enhance diagnostic scientificity and increase the credibility and international acceptance of TCM clinical trials. The introduction of this framework effectively integrates the traditional characteristics of TCM with modern scientific methods, providing essential theoretical support and innovative solutions for the design and implementation of TCM clinical research, thereby enhancing TCM's role in global health.

Abstract Randomized controlled trials (RCTs) continue to be the basis for essential evidence regarding the efficacy of interventions such as cancer therapies. Limitations associated with RCT designs, including selective study populations, strict treatment regimens, and being time-limited, mean they do not provide complete information about an intervention’s safety or the applicability of the trial’s results to a wider range of patients seen in real-world clinical practice. For example, recent data from Alberta showed that almost 40% of patients in the province’s cancer registry would be trial-ineligible per common exclusion criteria. Real-world evidence (RWE) offers an opportunity to complement the RCT evidence base with this kind of information about safety and about use in wider patient populations. It is also increasingly recognized for being able to provide information about an intervention’s effectiveness and is considered by regulators as an important component of the evidence base in drug approvals. Here, we examine the limitations of RCTs in oncology research, review the different types of RWE available in this area, and discuss the strengths and limitations of RWE for complementing RCT oncology data. There is a growing awareness of the importance of real-world evidence (RWE) in understanding its application to management and informing treatment choices in oncology. This article provides an overview of the strengths and limitations of randomized controlled trial and how it complements RCT oncology data, providing oncologists with additional information to make optimal clinical decisions for their patients.

IntroductionSocial contact-based video interventions effectively reduce stigma toward individuals with psychosis.ObjectivesWe recently demonstrated the efficacy of a 90-second social contact–based video intervention in reducing stigma. The current randomized controlled study presents four briefer videos differing in presenter’s gender and race, with baseline, postintervention, and 30-day follow-up assessments. The study aimed to examine whether people changing their attitudes following the intervention.MethodsUsing a crowdsourcing platform (CloudResearch), we recruited and assigned 1,993 race and gender-balanced participants ages 18–35 years to one of four brief video-based interventions (Black female, White female, Black male, and White male presenters) or a nonintervention control condition. In the videos, a young presenter with psychosis humanized their illness through an evocative description of living a meaningful and productive life.ResultsFive-by-three ANOVA showed a significant group-by-time interaction for the total score of all five stigma domains: social distance, stereotyping, separateness, social restriction, and perceived recovery. A one-way ANOVA showed greater reductions in video intervention groups than control at post-intervention and 30-day follow-up, but no differences between video groups.ConclusionsThis randomized controlled study replicated and extended previous research findings by showing stigma reduction across videos that differ in the presenter’s gender and race, thus enhancing generalizability. The videos described the experience of psychosis and reduced stigma, suggesting their potential utility on social media platforms to increase the likelihood of seeking services and ultimately may improve access to care among young individuals with psychosis. Future research should address intersectional stigma experienced by culturally tailoring the narrative.DisclosureNo significant relationships.

Mobile apps for mental health have the potential to overcome access barriers to mental health care, but there is little information on whether patients use the interventions as intended and the impact they have on mental health outcomes. The objective of our study was to document and compare use patterns and clinical outcomes across the United States between 3 different self-guided mobile apps for depression. Participants were recruited through Web-based advertisements and social media and were randomly assigned to 1 of 3 mood apps. Treatment and assessment were conducted remotely on each participant's smartphone or tablet with minimal contact with study staff. We enrolled 626 English-speaking adults (≥18 years old) with mild to moderate depression as determined by a 9-item Patient Health Questionnaire (PHQ-9) score ≥5, or if their score on item 10 was ≥2. The apps were (1) Project: EVO, a cognitive training app theorized to mitigate depressive symptoms by improving cognitive control, (2) iPST, an app based on an evidence-based psychotherapy for depression, and (3) Health Tips, a treatment control. Outcomes were scores on the PHQ-9 and the Sheehan Disability Scale. Adherence to treatment was measured as number of times participants opened and used the apps as instructed. We randomly assigned 211 participants to iPST, 209 to Project: EVO, and 206 to Health Tips. Among the participants, 77.0% (482/626) had a PHQ-9 score >10 (moderately depressed). Among the participants using the 2 active apps, 57.9% (243/420) did not download their assigned intervention app but did not differ demographically from those who did. Differential treatment effects were present in participants with baseline PHQ-9 score >10, with the cognitive training and problem-solving apps resulting in greater effects on mood than the information control app (χ22=6.46, P=.04). Mobile apps for depression appear to have their greatest impact on people with more moderate levels of depression. In particular, an app that is designed to engage cognitive correlates of depression had the strongest effect on depressed mood in this sample. This study suggests that mobile apps reach many people and are useful for more moderate levels of depression. Clinicaltrials.gov NCT00540865; https://www.clinicaltrials.gov/ct2/show/NCT00540865 (Archived by WebCite at http://www.webcitation.org/6mj8IPqQr).

The integration of artificial intelligence (AI) into health sciences students' education holds significant importance. The rapid advancement of AI has opened new horizons in scientific writing and has the potential to reshape human-technology interactions. AI in education may impact critical thinking, leading to unintended consequences that need to be addressed. Understanding the implications of AI adoption in education is essential for ensuring its responsible and effective use, empowering health sciences students to navigate AI-driven technologies' evolving field with essential knowledge and skills. This study aims to provide details on the study protocol and the methods used to investigate the usability and efficacy of ChatGPT, a large language model. The primary focus is on assessing its role as a supplementary learning tool for improving learning processes and outcomes among undergraduate health sciences students, with a specific emphasis on chronic diseases. This single-blinded, crossover, randomized, controlled trial is part of a broader mixed methods study, and the primary emphasis of this paper is on the quantitative component of the overall research. A total of 50 students will be recruited for this study. The alternative hypothesis posits that there will be a significant difference in learning outcomes and technology usability between students using ChatGPT (group A) and those using standard web-based tools (group B) to access resources and complete assignments. Participants will be allocated to sequence AB or BA in a 1:1 ratio using computer-generated randomization. Both arms include students' participation in a writing assignment intervention, with a washout period of 21 days between interventions. The primary outcome is the measure of the technology usability and effectiveness of ChatGPT, whereas the secondary outcome is the measure of students' perceptions and experiences with ChatGPT as a learning tool. Outcome data will be collected up to 24 hours after the interventions. This study aims to understand the potential benefits and challenges of incorporating AI as an educational tool, particularly in the context of student learning. The findings are expected to identify critical areas that need attention and help educators develop a deeper understanding of AI's impact on the educational field. By exploring the differences in the usability and efficacy between ChatGPT and conventional web-based tools, this study seeks to inform educators and students on the responsible integration of AI into academic settings, with a specific focus on health sciences education. By exploring the usability and efficacy of ChatGPT compared with conventional web-based tools, this study seeks to inform educators and students about the responsible integration of AI into academic settings. ClinicalTrails.gov NCT05963802; https://clinicaltrials.gov/study/NCT05963802. PRR1-10.2196/51873.

Background: Physical exercise can slow down the decline of the cognitive function of the older adults, yet the review evidence is not conclusive. The purpose of this study was to compare the effects of aerobic and resistance training on cognitive ability. Methods: A computerized literature search was carried out using PubMed, Cochrane Library, Embase SCOPUS, Web of Science, CNKI (China National Knowledge Infrastructure), Wanfang, and VIP database to identify relevant articles from inception through to 1 October 2022. Based on a preliminary search of the database and the references cited, 10,338 records were identified. For the measured values of the research results, the standardized mean difference (SMD) and 95% confidence interval (CI) were used to synthesize the effect size. Results: Finally, 10 studies were included in this meta-analysis. Since the outcome indicators of each literature are different in evaluating the old cognitive ability, a subgroup analysis was performed on the included literature. The study of results suggests that aerobic or resistance training interventions significantly improved cognitive ability in older adults compared with control interventions with the Mini-Mental State Examination (MD 2.76; 95% CI 2.52 to 3.00), the Montreal Cognitive Assessment (MD 2.64; 95% CI 2.33 to 2.94), the Wechsler Adult Intelligence Scale (MD 2.86; 95% CI 2.25 to 3.47), the Wechsler Memory Scale (MD 9.33; 95% CI 7.12 to 11.54), the Wisconsin Card Sorting Test (MD 5.31; 95% CI 1.20 to 9.43), the Trail Making Tests (MD −8.94; 95% CI −9.81 to −8.07), and the Stroop Color and Word Test (MD −5.20; 95% CI −7.89 to −2.51). Conclusion: Physical exercise improved the cognitive function of the older adults in all mental states. To improve cognitive ability, this meta-analysis recommended that patients perform at least moderate-intensity aerobic exercise and resistance exercise on as many days as possible in the week to comply with current exercise guidelines while providing evidence for clinicians.

Background Digital technologies such as wearables, websites and mobile applications are increasingly used in interventions targeting physical activity (PA). Increasing access to such technologies makes an attractive prospect for helping individuals of low socioeconomic status (SES) in becoming more active and healthier. However, little is known about their effectiveness in such populations. The aim of this systematic review was to explore whether digital interventions were effective in promoting PA in low SES populations, whether interventions are of equal benefit to higher SES individuals and whether the number or type of behaviour change techniques (BCTs) used in digital PA interventions was associated with intervention effects. Methods A systematic search strategy was used to identify eligible studies from MEDLINE, Embase, PsycINFO, Web of Science, Scopus and The Cochrane Library, published between January 1990 and March 2020. Randomised controlled trials, using digital technology as the primary intervention tool, and a control group that did not receive any digital technology-based intervention were included, provided they had a measure of PA as an outcome. Lastly, studies that did not have any measure of SES were excluded from the review. Risk of Bias was assessed using the Cochrane Risk of Bias tool version 2. Results Of the 14,589 records initially identified, 19 studies were included in the final meta-analysis. Using random-effects models, in low SES there was a standardised mean difference (SMD (95%CI)) in PA between intervention and control groups of 0.06 (− 0.08,0.20). In high SES the SMD was 0.34 (0.22,0.45). Heterogeneity was modest in both low (I 2  = 0.18) and high (I 2  = 0) SES groups. The studies used a range of digital technologies and BCTs in their interventions, but the main findings were consistent across all of the sub-group analyses (digital interventions with a PA only focus, country, chronic disease, and duration of intervention) and there was no association with the number or type of BCTs. Discussion Digital interventions targeting PA do not show equivalent efficacy for people of low and high SES. For people of low SES, there is no evidence that digital PA interventions are effective, irrespective of the behaviour change techniques used. In contrast, the same interventions in high SES participants do indicate effectiveness. To reduce inequalities and improve effectiveness, future development of digital interventions aimed at improving PA must make more effort to meet the needs of low SES people within the target population.