Tag: Clinical trial

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Examining Social Media User Types and the Impact on a Reproductive Health Web-Based Intervention for Young People in Francophone West Africa: Randomized Factorial Design Using Latent Class Analysis

Background: Web-based interventions present an opportunity for addressing reproductive health outcomes among young Francophone West Africans, but little is known about how social media use impacts such interventions. Objective: This study aimed to identify social media use patterns among young French-speaking West Africans and assess the impact on a reproductive health intervention delivered on Facebook. Methods: French-speaking social media users (aged 15‐24 years) were recruited from Senegal, Côte d’Ivoire, and Burkina Faso via social media advertisements. Using a factorial design for a multiarm parallel study, participants were randomly assigned via block randomization to 4 conditions: comparison (standard content), peer role models (personal narratives from similarly aged peers), online influencers (popular online figures), and a mixed peer role model and online influencer strategy. Participant blinding was implemented. Respondents completed pre- and post- self-administered online surveys between December 2023 and February 2024. Latent class analysis using maximum likelihood estimation was used to examine social media use patterns and related outcomes: contraceptive knowledge, provider awareness, and online service use. Results: In total, 353 participants were randomized to each group, with a final analytic sample of 262 participants. Two social media user types were identified from the completed study: selective users (daily use of WhatsApp and Facebook) and multiplatform users (daily use of WhatsApp, Facebook, Instagram, YouTube, and TikTok). Being 20-24 years old, compared with 15‐19 years, was associated with increased odds of multiplatform use (odds ratio [OR] 3.61, 95% CI 1.46‐9.36; =.008). Furthermore, residing in Senegal was associated with a greater likelihood of multiplatform use, compared with Côte d’Ivoire (OR 0.27, 95% CI 0.08‐0.88; =.03) and Burkina Faso (OR 0.23, 95% CI 0.07‐0.76; =.02). Among selective users (daily users of WhatsApp and Facebook), the peer role model approach demonstrated a 1.84-unit increase in contraceptive knowledge (OR 1.84, 95% CI 0.27‐3.41; =.02), a 1.81-unit increase in provider awareness (OR 1.81, 95% CI 1.15‐2.47; <.001), and a 1.49-unit increase in service use (OR 1.49, 95% CI 0.06‐2.93; =.04), compared with the comparison group. For multiplatform users, the peer role model approachwas associated with a decrease in provider awareness (OR 0.33, 95% CI −0.64 to −0.01; =.04). Unlike the peer role model approach (n=70), generally, online influencer (n=63) and mixed approaches (n=57) did not yield significant outcomes, relative to the comparison group (n= 72). There were no adverse events reported. Conclusions: This study applies latent class analysis in a novel way for this population: examining how a comprehensive measure of social media use moderates digital interventions. This approach is underused in other social media studies in sub-Saharan Africa. Findings suggest that a one-size-fits-all approach in web-based interventions is not ideal, and online peer-to-peer communication is still an important strategy for certain social media users. Trial Registration: ClinicalTrials.gov NCT07636629; https://clinicaltrials.gov/study/NCT07636629
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STAT+: European regulators take steps to bolster clinical trial transparency

In a boost for greater clinical trial transparency, the European Medicines Agency (EMA) is taking what consumer advocacy groups are calling unexpectedly “rapid action” to ensure that study results are made public as required by law.

The move comes after a recent analysis found results for less than half of the studies registered in a key European database were reported within the required time frame and complete results were fully reported for only 42%. The researchers contended that overall compliance with legal reporting requirements was weak and regulatory oversight is lacking.

This was the first analysis to examine the Clinical Trial Information System (CTIS) that was created in 2022 as part of an effort to enhance transparency across the European Union and the European Economic Area. The registry contains more than 8,400 mid- and late-stage trials and, in the coming months and years, sponsors will be legally required to make results public.

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Art therapy for depression: a systematic review and meta-analysis

IntroductionDepression is among the leading causes of disability globally. Therefore, exploring the various non-medical treatment options for this condition is particularly important. The aim of the review was to assess the effect of art therapy on depressive symptoms.MethodsThe foundation of this review is a pre-planned, explorative, secondary analysis of a previously published umbrella review, encompassing the databases Cochrane Library, Embase, MEDLINE, CINAHL, ERIC, American Psychological Association PsycArticles, American Psychological Association PsycInfo, PSYNDEX, the German Clinical Trials Register, and ClinicalTrials.gov. Included were all randomized trials with any patient population receiving active visual art therapy. The outcome was depressive symptoms measured by depression assessment instruments. We followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines and conducted a bias assessment using a modified Cochrane risk of bias tool. Data was pooled using a random-effects model and visualized in forest plots. A pooled standardized mean difference (SMD) with hedges g was calculated to measure the reduction of depressive symptoms.ResultsOf 3,100 identified reports we included 26 studies. Of these, 19 studies with 997 patients were eligible for inclusion in the meta-analysis. Overall, we found a standardized mean difference of 0.53 (95% CI: 0.30 to 0.76) for depressive symptoms, favoring the intervention group. Main sources of variation were different types of control groups, methodological quality, and patient populations.ConclusionOur results suggest that art therapy is associated with improved depressive symptoms. Therefore, art therapy should be accessible as complementary treatment for patients suffering from depressive symptoms.
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STAT+: New data on Eli Lilly’s ‘triple-G’ drug leave open questions on heart benefit

Eli Lilly reported more results Thursday showing that its next-generation obesity drug is highly efficacious at weight loss, but the data from the study, focused on people with heart disease, aren’t enough to answer a critical question about the therapy — whether it reduces cardiovascular risk.

The Phase 3 study enrolled nearly 2,000 people with severe obesity and heart disease, with or without diabetes. Those on the highest dose of the drug, called retatrutide, lost 22.6% of their weight after 80 weeks, while those on placebo lost 3.2%, when analyzing only the participants who stayed on treatment.

However, on additional analyses that looked at the occurrence of major cardiovascular events such as death, heart attack, or stroke, those taking retatrutide did not have a statistically significant lower risk of major events than those on placebo. Lilly said the trial was not powered to study cardiovascular outcomes and there were fewer heart events than anticipated.

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Safety of transcutaneous electrical stimulation potentiating recovery in acute spinal cord injury syndromes: a trial protocol

Background and objectivesSpinal cord injury (SCI) often results in permanent paralysis, leading to substantial long-term disability and loss of quality-adjusted life years. Strategies to preserve neural function in the hyperacute phase are needed. Transcutaneous spinal cord stimulation (tSCS) improves neurological function in chronic SCI. Earlier implementation in acute SCI may preserve or restore function and improve recovery.MethodsSTEP-RAISE is a Phase 1/2 prospective clinical trial evaluating the safety and preliminary efficacy of tSCS in acute moderate-to-severe traumatic SCI. Electrical current will be delivered to the lumbosacral spinal cord using the investigational ARC-Ex device (ONWARD Medical) via surface electrodes over the thoracolumbar region. Phase 2 is a randomized, triple-blinded, placebo-controlled trial designed to assess treatment effects. Safety outcomes include hemodynamics, spinal cord perfusion pressure, and skin reactions. Efficacy will be assessed using the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) examination with electromyography at baseline, during stimulation, and at 6-month follow-up. Biomarkers include neuronal (UCH-L1) and glial (GFAP) markers and exploratory proteomics in blood and cerebrospinal fluid collected prior to stimulation and at discharge.DiscussionThe STEP-RAISE trial evaluates safety and preliminary efficacy of non-invasive tSCS initiated within 72 h of SCI to improve sensorimotor recovery. Neurophysiological and patient-reported outcomes will characterize recovery and assess whether early tSCS augments functional recovery. This study is designed to estimate treatment effects and inform subsequent trials in acute SCI. Planned enrollment includes 5 participants in Phase 1 and 10 in Phase 2.Clinical trial registrationClinicalTrial.gov: NCT07090473; first posted on 07/29/2025, first open to enrollment 04/2026. https://clinicaltrials.gov/study/NCT07090473
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A Network Visualization Query System for Multidrug Compatibility Based on a WeChat Mini Program: Preliminary Usability and Efficiency Evaluation

Background: Intravenous drug incompatibility is a significant medication safety hazard, particularly in complex multidrug regimens. Traditional text-based, pairwise query methods are inefficient and impose a substantial cognitive load on clinicians. While network visualization has the potential to address these challenges, its application in drug compatibility queries remains underexplored. Objective: This study aimed to design, develop, and evaluate a novel drug compatibility query system based on a WeChat Mini Program. The system integrates diverse data sources and uses network visualization to present complex compatibility relationships. We sought to empirically assess its impact on efficiency and user experience. Methods: A preliminary crossover usability and efficiency evaluation was conducted. Phase 1 involved the construction of a drug compatibility knowledge base from authoritative handbooks and drug labels, and the development of the query system. Phase 2 comprised a system evaluation with 36 pharmacists, 6 physicians, and 5 nurses. The evaluation included a scenario-based task completion time analysis comparing the system (Mode A) with traditional print-based resources (Mode B), a quality assessment using the Mobile Application Rating Scale (MARS), and structured posttask user feedback to gather insights on user experience. Results: The query system demonstrated a substantial reduction in task completion time, with median time savings of 2.85 (IQR 1.98‐4.15) minutes, 5.45 (IQR 3.95‐7.20) minutes, and 31.2 (IQR 27.5‐35.1) minutes, respectively, in 3 scenarios with different complexity. The system received a high mean overall quality score of 3.88 (SD 0.35) on the MARS. The functionality dimension scored the highest (mean 4.21, SD 0.51), while engagement scored the lowest (mean 3.21, SD 0.62). Posttask structured feedback revealed five major areas of user feedback: (1) baseline experience and first impressions, (2) user experience with network visualization, (3) perceived efficiency and cognitive load, (4) trust and information quality, and (5) future application considerations. Users praised the system’s efficiency and intuitive design but expressed a strong need for transparent data sources and management advice to build trust. Conclusions: A query system based on network visualization demonstrates potential to support the efficiency of multidrug compatibility queries within this preliminary evaluation. It may mitigate cognitive load and offer an at-a-glance understanding of complex drug relationships. However, formal clinical accuracy validation remains a mandatory precondition before bedside clinical deployment is considered.
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Deprexis for Veteran Depression: Open-Label Pilot Trial Examining Feasibility, Acceptability, and Preliminary Efficacy

Background: Depression carries the highest burden of mental health–related disability in the United States. Approximately 13% of military veterans report elevated rates of depression. Despite the availability of evidence-based treatments for depression, nearly 50% of veterans in need of mental health care remain untreated. Internet-based interventions show promise in reducing this gap; however, there are currently no standard self-guided internet-based interventions for depressive symptoms in veterans. Deprexis is one such intervention that leverages cognitive behavioral therapy to target depressive symptoms. Objective: This pilot study evaluated the feasibility, acceptability, and preliminary effectiveness of Deprexis, a fully self-guided internet-based intervention for depression, in US military veterans with mild to severe depressive symptoms. Methods: This open-label pilot trial recruited 19 veterans with mild to severe depression (mean age 55.5, SD 8.2 y; baseline Quick Inventory of Depressive Symptomatology—Self-Report [QIDS-SR]: mean 16.2, SD 4.1) for an 8-week course of Deprexis, with self-report assessments at baseline, posttreatment (8 wk), and follow-up (16 wk). Primary outcomes included depressive symptoms (QIDS-SR), functional disability (World Health Organization Disability Assessment Schedule 2.0), and symptom-related disability (Sheehan Disability Scale). Feasibility was assessed through recruitment and retention rates, and acceptability was measured using validated questionnaires (Credibility and Expectancy Questionnaire and Client Satisfaction Questionnaire). Multilevel models examined change over time, with effect sizes calculated using pooled SDs from unconditional models. Results: Recruitment and retention targets were met, with 15 out of 19 (79%) participants meeting the adherence criteria (ie, ≥60 min of active program use). Of these, 14 participants completed posttreatment questionnaires and were included in the completer analyses. The program received a positive acceptability rating: of the 18 participants who completed follow-up assessments, 78% (n=14) rated services as good or excellent and 72% (n=13) were satisfied with the amount of help received. No safety concerns were reported. Among completers (n=14), QIDS-SR scores decreased from baseline to posttreatment (estimate −2.22, SE 1.44; =.14; =−0.54, 95% CI −1.07 to 0.13) and follow-up (estimate −2.85, SE 1.19; =.02; =−0.70, 95% CI −1.21 to −0.08) with moderate-to-large effect sizes. Effect sizes were similar in the total sample. Functioning (World Health Organization Disability Assessment Schedule 2.0) improved among completers at follow-up (estimate −8.09, SE 3.80; =.045; =−0.41, 95% CI −0.96 to −0.05). Disability (Sheehan Disability Scale) did not significantly improve from baseline to posttreatment or follow-up. Conclusions: This pilot trial demonstrates that Deprexis is feasible and acceptable for veterans with mild to severe depression, with preliminary evidence of effectiveness for depressive symptoms. The delayed emergence of functional improvements and sustained gains at follow-up support the potential of this scalable intervention. The results provide a strong foundation for the ongoing randomized controlled trial. Trial Registration: ClinicalTrials.gov NCT06217198; https://clinicaltrials.gov/study/NCT06217198 International Registered Report Identifier (IRRID): RR2-10.2196/59119
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