Contemporary clinical trials最新文献

{"title":"Software for complex group sequential designs","authors":"Yujie Zhao,&nbsp;Keaven Anderson","doi":"10.1016/j.cct.2025.107994","DOIUrl":"10.1016/j.cct.2025.107994","url":null,"abstract":"<div><div>Group sequential design (GSD) is a statistical methodology employed in clinical trials to enable interim analyses (IA) and potential early termination based on accumulating data. It has gained significant popularity in the field of clinical trials due to its ability to enhance decision-making and expedite the development of effective treatments. The implementation of GSD has grown progressively intricate in recent times. For instance, in several recent trials, the treatment effect may vary over both time and strata. Given the complexity of GSD, it is crucial to have appropriate software that facilitates the necessary calculations. This article will introduce R packages for GSD using both examples and simulations, notably gsDesign2 and simtrial.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"155 ","pages":"Article 107994"},"PeriodicalIF":2.0,"publicationDate":"2025-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144549700","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The effectiveness and implementation of a STEpwise program to promote INGeniouS ONline supportive solutions for self-management of cancer-related fatigue: The STEPPING-STONe digitally enabled randomized trial","authors":"Maria Alice Franzoi ,&nbsp;Arnaud Pages ,&nbsp;Cecile Charles ,&nbsp;Marcio Debiasi ,&nbsp;Emma Gillanders ,&nbsp;Arlindo Ferreira ,&nbsp;Fanny Jacques ,&nbsp;Sibille Everhard ,&nbsp;Guillaume GaryBobo ,&nbsp;Cesarine Sambou ,&nbsp;François Alla ,&nbsp;Amandine Quivy ,&nbsp;Sophie Morin ,&nbsp;Ines Vaz-Luis","doi":"10.1016/j.cct.2025.107993","DOIUrl":"10.1016/j.cct.2025.107993","url":null,"abstract":"<div><h3>Background</h3><div>Fatigue is one of the most common and disturbing symptoms patients face throughout the cancer care continuum, and it is sub optimally addressed in routine care. Developing effective and scalable tools for symptom management is a central unmet need for achieving comprehensive and patient-centric cancer care delivery. This study aims to evaluate the effectiveness of three digital aid modalities for cancer related fatigue (CRF) focusing on patient empowerment and self-management.</div></div><div><h3>Methods</h3><div>Hybrid type 2 effectiveness-implementation randomized clinical trial. A total of 372 patients diagnosed with cancer and moderate to severe self-reported CRF will be randomized 1:1:1 into one of three intervention arms: educational mobile app, educational mobile app powered with a self-guided fatigue self-management program, or educational mobile app powered with the fatigue self-management program and interactive coaching. Clinical trial procedures will benefit from a pragmatic online platform for digitally enabled research allowing eligibility screening, electronic consent, randomization and collection of patient-reported outcomes and clinical data. The primary endpoint is the difference in fatigue scores measured by the EORTC QLQ-C30 questionnaire between baseline and three months after the end of the program. Secondary endpoints include short and long-term impact on fatigue scores including fatigue subdomains, self-efficacy, overall quality of life, use of health resources, as well a detailed implementation evaluation of both the study intervention and the digitally enabled trial procedures.</div></div><div><h3>Discussion</h3><div>This study will provide high-level evidence on the effectiveness and implementation of digital interventions for CRF. It will also demonstrate the feasibility of using technology to streamline clinical trial procedures.</div><div>Trial Registration: <span><span>ClinTrials.gov</span><svg><path></path></svg></span> <span><span>NCT06505590</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"155 ","pages":"Article 107993"},"PeriodicalIF":2.0,"publicationDate":"2025-06-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144518009","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The management of pain and anxiety using virtual reality during the care of elderly hospitalized patients: Study protocol for a randomized controlled trial","authors":"Camille Corbel ,&nbsp;Flora Le Cerf ,&nbsp;Françoise Capriz ,&nbsp;Anne Julie Vaillant-Ciszewicz ,&nbsp;Jean Breaud ,&nbsp;Olivier Guérin ,&nbsp;Xavier Corveleyn","doi":"10.1016/j.cct.2025.107990","DOIUrl":"10.1016/j.cct.2025.107990","url":null,"abstract":"<div><h3>Background</h3><div>The medical environment, particularly in geriatric care settings, can be a source of stress and anxiety for patients. This is especially true during recurrent and painful care procedures—such as wound dressing (for pressure ulcers, surgical wounds, or chronic sores) and physiotherapy sessions—which are common in hospitals. In this context, the combination of physical pain, emotional vulnerability, and institutional routines contributes to a globally stressful environment, potentially impairing care quality and increasing the risk of care failure. Virtual reality (VR) offers promising complementary strategies to reduce anxiety and pain during such procedures.</div></div><div><h3>Objective</h3><div>This study aims to assess and compare the effectiveness of personalized and non-personalized virtual reality interventions on pain and anxiety levels in elderly hospitalized patients, relative to standard care.</div></div><div><h3>Method</h3><div>This single-center, randomized controlled trial will involve 120 participants recruited from the geriatric services of Cimiez Hospital in Nice, France, including rehabilitation and follow-up care units, long-term care units, and nursing homes. Participants will be randomly assigned to one of three groups: control group (standard care), personalized VR group, or non-personalized VR group. Each participant will be observed during a painful care session, and pain and anxiety will be assessed before, during, and immediately after the procedure.</div></div><div><h3>Discussion</h3><div>This research aims to evaluate the effectiveness of a personalized and non-personalized virtual reality intervention in relieving pain and anxiety among older hospitalized individuals and compare it with standard care. Finally, the experiences of healthcare professionals involved will also be considered to assess the impact of these interventions on working conditions and patient support.</div><div><strong>Trial registration</strong></div><div><span><span>ClinicalTrials.gov</span><svg><path></path></svg></span>, <span><span>NCT05759026</span><svg><path></path></svg></span>. Registered on March 8, 2023.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"155 ","pages":"Article 107990"},"PeriodicalIF":2.0,"publicationDate":"2025-06-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144490984","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Peer-supported mindfulness-based intervention for managing depressive symptoms in community-dwelling older adults: Protocol for a randomized controlled trial","authors":"Yun-Lin Wang ,&nbsp;Yun-Han Wang ,&nbsp;Dara Kiu Yi Leung ,&nbsp;Stephanie Ming Yin Wong ,&nbsp;Zuna Loong Yee Ng ,&nbsp;Raymond Chi Leung Chan ,&nbsp;Oscar Long Hung Chan ,&nbsp;Wai Chi Chan ,&nbsp;Gloria Hoi Yan Wong ,&nbsp;Terry Yat Sang Lum","doi":"10.1016/j.cct.2025.107991","DOIUrl":"10.1016/j.cct.2025.107991","url":null,"abstract":"<div><h3>Background</h3><div>Depression in old age is a public health concern contributing to individual and societal burdens. Mindfulness-based stress reduction (MBSR) and mindfulness-based cognitive therapy (MBCT) have shown promise in reducing depressive symptoms. However, time commitments associated with these interventions could pose challenges to older adults. To address this, we propose a briefer mindfulness-based intervention (MBI) with peer supporters to engage and support participants experiencing time constraints and distress. This protocol describes a study examining the efficacy of a peer-supported MBI in reducing depressive symptoms among older adults.</div></div><div><h3>Methods</h3><div>The study involves a two-arm randomized controlled trial and a propensity score-matched comparison group. Participants will receive either (1) a social worker-led MBI consisting of six weekly 2-h sessions or (2) the same MBI supplemented with peer supporters. A total of 138 community-dwelling older adults above 60 years old, with mild to moderately severe depressive symptoms, will be recruited through local non-governmental organizations. Study metrics will be assessed at baseline, completion of the intervention, and 3 months following the intervention, through self-assessed questionnaires. The primary outcome is depressive symptoms measured by PHQ-9. Data (<em>n</em> = 69) from a prior study involving mindfulness teacher-led MBCT with the same participant criteria and data collection procedures will be matched to the other two groups using propensity scores.</div></div><div><h3>Discussion</h3><div>The study results will suggest the efficacy and scalability of a peer-supported MBI in community mental health services, improving intervention accessibility and the mental health of older adults.</div><div><strong>Trial registration:</strong> <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> <span><span>NCT06528132</span><svg><path></path></svg></span> on 30 July 2024.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"155 ","pages":"Article 107991"},"PeriodicalIF":2.0,"publicationDate":"2025-06-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144368639","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Conducting an implementation intervention study with American Indian and Alaska Native communities: Methodological considerations","authors":"Margaret M. Paschen-Wolff ,&nbsp;Aimee N.C. Campbell ,&nbsp;Ángel Vásquez ,&nbsp;Jill Kessler ,&nbsp;Kelley Jansen ,&nbsp;Catherine P. Arnatt ,&nbsp;Carmen Rosa ,&nbsp;Hanna M. Hebden ,&nbsp;Sandra Radin ,&nbsp;Antony Stately ,&nbsp;Jennifer Shaw ,&nbsp;Favian Kennedy ,&nbsp;Abigail G. Matthews ,&nbsp;Kamilla L. Venner","doi":"10.1016/j.cct.2025.107992","DOIUrl":"10.1016/j.cct.2025.107992","url":null,"abstract":"<div><h3>Background</h3><div>Incorporating American Indian and Alaska Native (AI/AN) traditional practices and knowledge into healthcare can support AI/AN health. Drug overdose deaths disproportionately impact AI/AN communities due to colonization, genocide, historical trauma, discriminatory policies, and under-resourced healthcare. Medications for opioid use disorder (MOUD; e.g., buprenorphine, methadone, naltrexone) are considered the most effective treatment for reducing mortality. Integrating AI/AN cultural practices with MOUD may increase acceptability and uptake of MOUD within AI/AN communities.</div></div><div><h3>Methods</h3><div>National Institute on Drug Abuse (NIDA) Clinical Trials Network (CTN) Protocol #0096 (Tribal MOUD) is a two-phase community-based participatory research (CBPR) trial to develop and evaluate an implementation intervention to culturally center MOUD delivery in AI/AN communities (<em>N</em> = 4 sites). A Collaborative Board (CB) guided intervention development (Phase I completed). A stepped wedge design (two sites/step) allows intervention implementation at all sites and improvements across sites (Phase II ongoing). The primary implementation outcome is the number of consumers with OUD who initiate MOUD in the six months pre-intervention vs. implementation periods; secondary outcomes are MOUD screening and retention (de-identified electronic medical record data). Additional data include organizational predictors (staff surveys) and moderators (consumer assessments) of implementation outcomes; and MOUD intervention acceptability (staff/consumer qualitative interviews).</div></div><div><h3>Conclusions</h3><div>This is the first study to develop and evaluate an implementation intervention to culturally center MOUD delivery in AI/AN communities. Implementation science and CBPR are complimentary for co-developing strategies with AI/AN communities to integrate Indigenous and Western best practices, which may ultimately reduce opioid-related mortality among AI/AN peoples and enhance Indigenous community wellness.</div><div><strong>Clinical Trials NCT Registration Number:</strong> <span><span>NCT04958798</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"155 ","pages":"Article 107992"},"PeriodicalIF":2.0,"publicationDate":"2025-06-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144368708","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluating smoking cessation interventions for people living with HIV in a factorial randomised clinical trial in South Africa using the Multiphase Optimization Strategy (MOST) framework: The Tlogela Trial protocol","authors":"Leisha P. Genade ,&nbsp;Laura Steiner ,&nbsp;Firdaus Nabeemeeah ,&nbsp;Raymond S. Niaura ,&nbsp;Bareng A.S. Nonyane ,&nbsp;Christopher J. Hoffmann ,&nbsp;Hojoon Sohn ,&nbsp;Christopher G. Kemp ,&nbsp;Kate Guastaferro ,&nbsp;Lebohang Mlambo ,&nbsp;Deshan Chetty ,&nbsp;Ziyaad Waja ,&nbsp;Neil Martinson ,&nbsp;Jonathan E. Golub ,&nbsp;Jessica L. Elf","doi":"10.1016/j.cct.2025.107985","DOIUrl":"10.1016/j.cct.2025.107985","url":null,"abstract":"<div><h3>Background</h3><div>Human immunodeficiency virus (HIV) remains an important cause of morbidity and mortality in South Africa (SA) with a gradual shift from opportunistic illness to pulmonary and cardiovascular disease among people living with HIV (PLWH). This shift is exacerbated by increases in prevalence of tobacco smoking and also few resources to support smoking cessation. Evidence-based smoking cessation strategies are yet to be fully evaluated among PLWH in this setting.</div></div><div><h3>Objective</h3><div>This project will optimize a smoking cessation treatment package for PLWH that can be integrated into existing HIV care in SA. We will identify the most effective and/or combination of the interventions and evaluate their potential for implementation and cost-effectiveness.</div></div><div><h3>Methods</h3><div>A balanced 2⁴ full factorial clinical trial will randomise 660 PLWH who smoke tobacco into one of 16 combinations of four intervention components (behavioural counselling, peer counselling, varenicline, and combination nicotine replacement therapy). Participants will be recruited from four healthcare facilities in SA, receive 12 weeks of intervention and the primary outcome will be 7-day point prevalence tobacco abstinence from smoking at one year, measuring both exhaled breath carbon monoxide (CO) and urinary cotinine. A mixed methods approach will be used to evaluate implementation using the Reach, Effectiveness, Adoptions, Implementation, Maintenance framework. Cost, cost-effectiveness, and budget impact of each intervention combination will be evaluated.</div></div><div><h3>Conclusion</h3><div>Results will inform which intervention components, and in what combination, are most efficacious in supporting smoking abstinence among PLWH in SA and those that have the greatest potential for effectiveness when brought to scale.</div></div><div><h3>Clinical Trial Registration Number</h3><div>South African National Clinical Trials Registry.</div><div>Trial No: DOH-27-062023-9076.</div><div><span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> ID: <span><span>NCT05413122</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"155 ","pages":"Article 107985"},"PeriodicalIF":2.0,"publicationDate":"2025-06-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144339893","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A randomized controlled trial of once-weekly semaglutide for limiting post-smoking cessation weight gain in smokers with overweight/obesity: Study protocol","authors":"Luba Yammine ,&nbsp;Heather Leidy ,&nbsp;Kevin C. Maki ,&nbsp;Michael F. Weaver ,&nbsp;Elizabeth A. Bodalski ,&nbsp;Joy M. Schmitz","doi":"10.1016/j.cct.2025.107989","DOIUrl":"10.1016/j.cct.2025.107989","url":null,"abstract":"<div><h3>Background</h3><div>Smoking and obesity are the two leading causes of preventable morbidity and mortality in the U.S. While smoking cessation has tremendous health benefits, most smokers gain weight post-cessation, which may partially attenuate these benefits. Semaglutide 2.4 mg once-weekly, a glucagon-like peptide-1 receptor agonist (GLP-1RA) approved for weight management in adults with overweight/obesity, leads to clinically meaningful reductions in body weight and may thus have utility for preventing weight gain in the context of smoking cessation.</div></div><div><h3>Methods</h3><div>This parallel group, two-arm, double-blind clinical trial will randomize 177 treatment-seeking smokers with a body mass index of ≥30 kg/m² or ≥ 27 kg/m² with at least one weight-related comorbidity to semaglutide 2.4 mg once-weekly or placebo (2:1) for 28 weeks, including 16 weeks of semaglutide dose escalation, followed by 12 weeks at target, 2.4 mg, dose. Both groups will receive 10 weeks of nicotine patches (dose based on baseline number of cigarettes smoked daily) and brief individual smoking cessation counseling. The primary outcome is percent body weight change at the end of treatment. Secondary outcomes are changes in total body weight and fat mass (kg) and waist circumference. Exploratory outcomes are changes in daily energy intake and food choices, food cravings and appetite/satiety, and smoking abstinence rates.</div></div><div><h3>Conclusion</h3><div>We anticipate that semaglutide 2.4 mg once-weekly will provide a clinically meaningful effect on weight management in the context of smoking cessation. If our hypotheses are confirmed, this GLP-1RA could move forward as a pharmacotherapeutic for helping smokers achieve abstinence without weight gain.</div><div>Universal trial number (UTN): U1111–1270-1737.</div><div>Clinical Trial Registration: <span><span>NCT06173778</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"155 ","pages":"Article 107989"},"PeriodicalIF":2.0,"publicationDate":"2025-06-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144483432","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Prehabilitation and rehabilitation in peripheral arterial disease: Protocol and study design of the PREPARE-IT trial","authors":"Jonathan Myers ,&nbsp;Khin Chan ,&nbsp;Patricia Nguyen ,&nbsp;Charles Gronau ,&nbsp;Pallavi Gautam ,&nbsp;Shipra Arya ,&nbsp;Oliver Aalami","doi":"10.1016/j.cct.2025.107984","DOIUrl":"10.1016/j.cct.2025.107984","url":null,"abstract":"<div><h3>Background</h3><div>Both prehabilitation and rehabilitation programs have been shown to improve functional capabilities, surgical outcomes, and quality of life in patients with peripheral arterial disease (PAD). However, referral rates remain low, and the benefits of combined prehabilitation and rehabilitation for PAD have not been explored.</div></div><div><h3>Methods</h3><div>Three hundred patients with symptomatic claudication referred for femoral-popliteal endovascular stenting will be studied. In this randomized trial, the effectiveness of a 6-week pre-operative program of exercise therapy and risk management (prehabilitation) will be compared to: 1) a 6-week program of rehabilitation (post-operative); and 2) both prehabilitation and rehabilitation. Comparisons will be made of time to claudication symptoms, 6-min walk performance, peak VO₂, strength, endothelial function, biomarkers, and quality of life at baseline, 6-weeks (1 week prior to intervention), 14 weeks, and 22 weeks.</div></div><div><h3>Discussion</h3><div>The concept of prehabilitation is based on the principle that patients with higher functional capabilities will better tolerate a surgical intervention and therefore exhibit better outcomes following the intervention. Recent studies have consistently demonstrated better functional, psychosocial, and surgery-related morbidity outcomes among subjects participating in pre-surgical prehabilitation programs, but few such data are available in patients with PAD. The prehabilitation period also provides an ideal opportunity for cardiometabolic risk intervention. The primary aim of this trial is to explore the functional and psychosocial impact of prehabilitation, rehabilitation, and their combination in patients with PAD scheduled for a non-emergent endovascular intervention. We anticipate that the combination of prehabilitation and rehabilitation will result in better outcomes than either intervention alone.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"155 ","pages":"Article 107984"},"PeriodicalIF":2.0,"publicationDate":"2025-06-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144306297","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effects of one month of intermittent fasting on the blood microbiome in healthy volunteers (OMIF): A randomized controlled crossover study protocol","authors":"Junhong Su ,&nbsp;Bettina E. Hansen ,&nbsp;Zhongren Ma ,&nbsp;Maikel P. Peppelenbosch","doi":"10.1016/j.cct.2025.107986","DOIUrl":"10.1016/j.cct.2025.107986","url":null,"abstract":"<div><h3>Background</h3><div>It is hypothesized that the presence of microorganisms in the gut is reflected in circulating blood through small DNA fragments resulting from the degradation of these organisms. Cross-sectional studies have not yet provided a definitive answer regarding the validity of this hypothesis, and the potential presence of a so-called common blood-microbiome remains highly controversial. Both bioinformatical pipelines (which may produce false-positive results) and environmental contamination may obscure the less than 5 % microbial DNA that is postulated to be present within the total blood DNA.</div></div><div><h3>Method/design</h3><div>This study aims to validate the existence of the blood microbiome using one month of intermittent fasting (OMIF). Through a prospective, randomized, controlled cross-over trial, we will evaluate the effect of OMIF on the composition and function of the blood microbiome in healthy volunteers, with secondary outcomes on clarifying the relationship between the gut and blood microbiome. Healthy volunteers aged 18–65 will be enrolled. All volunteers will undergo OMIF, a washout period and an ad libitum diet for another month, with the order of the interventions assigned randomly. We will assess the dynamics in blood microbiome in response to OMIF versus those seen during an ad libitum diet, using shotgun sequencing. Physiological changes will be monitored A dietary recall interview will be conducted during the trial to evaluate energy intake, and movement data collected from Health App will be used to assess changes in physical activity.</div></div><div><h3>Conclusion</h3><div>If successful, this trial provides a proof-of-concept study documenting the existence of a bona fide blood microbiome.</div><div>Clinical Trial Registration: <span><span>NCT06678516</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"155 ","pages":"Article 107986"},"PeriodicalIF":2.0,"publicationDate":"2025-06-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144316053","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Virtual versus in-person ROSE program (La Luz) as universal prevention for perinatal depression: Protocol for a randomized controlled trial in a safety net hospital","authors":"Daphne Y. Liu ,&nbsp;Nicholas S. Perry ,&nbsp;Catherine H. Demers ,&nbsp;Jennifer S. Hyer ,&nbsp;Anely Alamo ,&nbsp;Paige Vuksanovich ,&nbsp;Nandi Dube ,&nbsp;Erin R. Flanagan ,&nbsp;Robert J. Gallop ,&nbsp;Galena K. Rhoades ,&nbsp;Elysia Poggi Davis","doi":"10.1016/j.cct.2025.107988","DOIUrl":"10.1016/j.cct.2025.107988","url":null,"abstract":"<div><div>Perinatal depression disproportionally affects underserved communities, who need effective and accessible prevention programs. Reach Out, Stay strong, Essentials for new mothers (ROSE) has demonstrated effectiveness in preventing postpartum depression in underserved populations when delivered in person. This ongoing randomized controlled trial (RCT) tests the novel virtual implementation of ROSE as universal prevention in a Federally Qualified Health Center setting. We adopted the name, La Luz, for ROSE to be culturally relevant to our population. Pregnant individuals &lt;30 gestational weeks (target <em>N</em> = 900) are randomized to either the virtual or in-person La Luz program, which consists of four 90-min group sessions. Groups are offered in English and Spanish, based on participants' preference. Participants complete surveys at seven timepoints: before program, 28 gestational weeks, 35 gestational weeks, and 6-weeks, 3-months, 6-months, and 12-months postpartum. Primary outcomes are postpartum depression severity measured by the 20-item Symptom Checklist (SCL-20) and 10-item Center of Epidemiologic Studies Depression Scale (CESD-10). We will perform intent-to-treat analysis to test whether virtual La Luz is non-inferior to in-person La Luz. This study also evaluates implementation process and outcomes of both modalities of La Luz to inform the development of an implementation toolkit. This RCT contributes to our knowledge of perinatal depression prevention and addresses access barriers for underserved populations. If effectiveness of virtual La Luz is demonstrated, the new evidence for a scalable low-cost prevention can be used to reduce perinatal depression and offer accessible treatment options for people who face significant barriers to care. <span><span>Clinicaltrials.gov</span><svg><path></path></svg></span> registration identifier: <span><span>NCT05766475</span><svg><path></path></svg></span>.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"155 ","pages":"Article 107988"},"PeriodicalIF":2.0,"publicationDate":"2025-06-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144316054","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}