Pub Date : 2025-12-01Epub Date: 2025-11-04DOI: 10.1016/j.conctc.2025.101568
Eric C. Meyer , Todd Farchione , Nathan A. Kimbrel , Oi-Man Kwok , Michelle L. Pennington , Jessica Rostockyj , Suzy B. Gulliver
{"title":"Corrigendum to “Peer delivered, emotion regulation-focused mental health prevention training for fire fighter trainees: Design and methodology of a randomized controlled trial” [Contempor. Clinic. Trial. Commun. 47 (2025) 101537]","authors":"Eric C. Meyer , Todd Farchione , Nathan A. Kimbrel , Oi-Man Kwok , Michelle L. Pennington , Jessica Rostockyj , Suzy B. Gulliver","doi":"10.1016/j.conctc.2025.101568","DOIUrl":"10.1016/j.conctc.2025.101568","url":null,"abstract":"","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"48 ","pages":"Article 101568"},"PeriodicalIF":1.4,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145747160","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-01Epub Date: 2025-11-15DOI: 10.1016/j.conctc.2025.101570
Katya Garza , Hisham Ahmad , Bhabna Pati , Corrine I. Voils
Background
Men are underrepresented in behavioral weight-loss trials, limiting the generalizability of findings. While gender-tailored programs have shown success, most research and community-based weight management programs remain mixed-gender. Little is known about men's experiences in these settings or how to best adapt mixed-gender programs to improve their relevance to men.
Purpose
To explore men's experiences regarding weight management and to qualitatively evaluate their experiences in the Log2Lose trial.
Methods
Semi-structured interviews were conducted with men who participated in the Log2Lose trial, a randomized study evaluating the effects of financial incentives on weight loss. Interviews explored motivations for enrolling, satisfaction with program components, and suggestions for improvement. Data were analyzed using conventional content analysis.
Results
Nineteen men completed interviews. Most self-identified as White, were middle-aged, married, and college educated. Six themes emerged: 1) Prior weight loss efforts were self-directed and hard to sustain; 2) Rising health concerns prompted men to seek support; 3) Higher-engagers framed weight loss as a personal responsibility, whereas lower-engagers preferred more external accountability; 4) Traditional social roles influenced dietary changes; 5) Peer relatability defined group experiences more than gender composition; 6) Men valued practical content but wanted more tailored support.
Conclusions
Men valued their participation in the Log2Lose trial and identified ways to improve relevance and engagement. This study provides participant-informed guidance to support the development of mixed-gender behavioral interventions that appeal to men and promote more equitable representation in weight loss research.
{"title":"What works for men? Participant perspectives from a mixed-gender weight-management trial with incentives","authors":"Katya Garza , Hisham Ahmad , Bhabna Pati , Corrine I. Voils","doi":"10.1016/j.conctc.2025.101570","DOIUrl":"10.1016/j.conctc.2025.101570","url":null,"abstract":"<div><h3>Background</h3><div>Men are underrepresented in behavioral weight-loss trials, limiting the generalizability of findings. While gender-tailored programs have shown success, most research and community-based weight management programs remain mixed-gender. Little is known about men's experiences in these settings or how to best adapt mixed-gender programs to improve their relevance to men.</div></div><div><h3>Purpose</h3><div>To explore men's experiences regarding weight management and to qualitatively evaluate their experiences in the Log2Lose trial.</div></div><div><h3>Methods</h3><div>Semi-structured interviews were conducted with men who participated in the Log2Lose trial, a randomized study evaluating the effects of financial incentives on weight loss. Interviews explored motivations for enrolling, satisfaction with program components, and suggestions for improvement. Data were analyzed using conventional content analysis.</div></div><div><h3>Results</h3><div>Nineteen men completed interviews. Most self-identified as White, were middle-aged, married, and college educated. Six themes emerged: 1) Prior weight loss efforts were self-directed and hard to sustain; 2) Rising health concerns prompted men to seek support; 3) Higher-engagers framed weight loss as a personal responsibility, whereas lower-engagers preferred more external accountability; 4) Traditional social roles influenced dietary changes; 5) Peer relatability defined group experiences more than gender composition; 6) Men valued practical content but wanted more tailored support.</div></div><div><h3>Conclusions</h3><div>Men valued their participation in the Log2Lose trial and identified ways to improve relevance and engagement. This study provides participant-informed guidance to support the development of mixed-gender behavioral interventions that appeal to men and promote more equitable representation in weight loss research.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"48 ","pages":"Article 101570"},"PeriodicalIF":1.4,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145578716","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-01Epub Date: 2025-12-05DOI: 10.1016/j.conctc.2025.101586
Mohammod Mahmudur Rahman , Md Saiful Islam Saif , Jonathan Beall , Renee’ L. Martin , Gaylan L. Rockswold , William G. Barsan , Frederick K. Korley , Robert Silbergleit , Valerie Stevenson , Byron Gajewski
Background
Accurate accrual prediction is essential for initial planning and ongoing monitoring of clinical trials. Slow accrual can compromise statistical power, increase costs, or lead to premature trial termination. Traditional Bayesian approaches typically assume constant accrual rates and often fail to capture real-world seasonal fluctuations, which can reduce predictive accuracy.
Methods
We developed a Bayesian seasonal accrual model that extends the traditional homogeneous model by incorporating quarter-specific priors to account for seasonal variation. The model combines prior knowledge with observed data up to the monitoring point to obtain accrual predictions using the Bayesian posterior predictive distribution. We applied this approach to quarterly accrual data from two ongoing trials: the Hyperbaric Oxygen Brain Injury Treatment (HOBIT) trial and the Brain Oxygen Optimization in Severe TBI Phase-3 (BOOST-3) trial. Along with the Deviance Information Criterion, model performance was evaluated using RMSE, bias, and standard deviation, calculated from internal predictions of total accruals within observed seasonal quarters. Posterior predictive distributions of accrual after 36 and 30 quarters were also generated.
Results
Both trials exhibited seasonal trends, with the highest accrual rates in summer. The seasonal model yielded lower DIC in both trials. In HOBIT, internal prediction accuracy did not improve, likely due to uniformly low accrual rates. In contrast, the seasonal model outperformed the homogeneous model in BOOST-3 trial, yielding substantially lower RMSE, bias, and SD.
Conclusion
Incorporating seasonal effects into accrual modeling can enhance prediction accuracy, particularly in larger trials with high enrollment, and supports more accurate trial forecasting and resource allocation.
{"title":"A Bayesian model with seasonal effects for predicting accrual in clinical trials: Application to HOBIT and BOOST-3 trials for severe traumatic brain injury","authors":"Mohammod Mahmudur Rahman , Md Saiful Islam Saif , Jonathan Beall , Renee’ L. Martin , Gaylan L. Rockswold , William G. Barsan , Frederick K. Korley , Robert Silbergleit , Valerie Stevenson , Byron Gajewski","doi":"10.1016/j.conctc.2025.101586","DOIUrl":"10.1016/j.conctc.2025.101586","url":null,"abstract":"<div><h3>Background</h3><div>Accurate accrual prediction is essential for initial planning and ongoing monitoring of clinical trials. Slow accrual can compromise statistical power, increase costs, or lead to premature trial termination. Traditional Bayesian approaches typically assume constant accrual rates and often fail to capture real-world seasonal fluctuations, which can reduce predictive accuracy.</div></div><div><h3>Methods</h3><div>We developed a Bayesian seasonal accrual model that extends the traditional homogeneous model by incorporating quarter-specific priors to account for seasonal variation. The model combines prior knowledge with observed data up to the monitoring point to obtain accrual predictions using the Bayesian posterior predictive distribution. We applied this approach to quarterly accrual data from two ongoing trials: the Hyperbaric Oxygen Brain Injury Treatment (HOBIT) trial and the Brain Oxygen Optimization in Severe TBI Phase-3 (BOOST-3) trial. Along with the Deviance Information Criterion, model performance was evaluated using RMSE, bias, and standard deviation, calculated from internal predictions of total accruals within observed seasonal quarters. Posterior predictive distributions of accrual after 36 and 30 quarters were also generated.</div></div><div><h3>Results</h3><div>Both trials exhibited seasonal trends, with the highest accrual rates in summer. The seasonal model yielded lower DIC in both trials. In HOBIT, internal prediction accuracy did not improve, likely due to uniformly low accrual rates. In contrast, the seasonal model outperformed the homogeneous model in BOOST-3 trial, yielding substantially lower RMSE, bias, and SD.</div></div><div><h3>Conclusion</h3><div>Incorporating seasonal effects into accrual modeling can enhance prediction accuracy, particularly in larger trials with high enrollment, and supports more accurate trial forecasting and resource allocation.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"48 ","pages":"Article 101586"},"PeriodicalIF":1.4,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145690253","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-01Epub Date: 2025-10-08DOI: 10.1016/j.conctc.2025.101558
Samantha A. Lee , Diego Trujillo , Garth D. Meckler , Carl Eriksson , Trang Huynh , Nathan Bahr , Jyotsna Sanjeevi , Matt Hansen , Jeanne-Marie Guise
Background
Pediatric out-of-hospital cardiac arrest is a leading cause of death in children. This paper describes the study protocol for the randomized control trial to test a linear cognitive aid app (RESCUER) designed to support Emergency Medical Services (EMS) clinicians in responding to neonatal and pediatric out-of-hospital cardiac arrest (POHCA).
Objective
This randomized controlled trial (RCT) will investigate the effects of the RESCUER app compared with existing EMS practices and tools during simulated POHCAs.
Study design
This RCT will be conducted with EMS first responders from rural and urban EMS agencies in the United States (US). EMS teams will be randomized to respond to simulated neonatal and POHCAs using either (1) the RESCUER app or (2) their current standard of care and tools. In addition to randomized assignment to intervention and control, we also will randomize the order of simulation scenarios.
Main outcome measures
Primary outcomes include time to complete American Heart Association (AHA) recommended steps for NRP and PALS. Secondary outcomes include participants’ self-rated cognitive load, measured teamwork, and user-focused assessments of feasibility, usability and usefulness of tools.1,2
Conclusion
We hypothesize that the app will decrease time to complete AHA recommended steps for NRP and PALS, compared to EMS teams’ current standard of care and tools. This study will examine whether an app used by EMS teams in responding to simulated neonatal and pediatric OHCAs will improve resuscitation performance and decrease cognitive load.
{"title":"RESCUER mobile app to support pediatric resuscitation: Study protocol for a randomized controlled trial","authors":"Samantha A. Lee , Diego Trujillo , Garth D. Meckler , Carl Eriksson , Trang Huynh , Nathan Bahr , Jyotsna Sanjeevi , Matt Hansen , Jeanne-Marie Guise","doi":"10.1016/j.conctc.2025.101558","DOIUrl":"10.1016/j.conctc.2025.101558","url":null,"abstract":"<div><h3>Background</h3><div>Pediatric out-of-hospital cardiac arrest is a leading cause of death in children. This paper describes the study protocol for the randomized control trial to test a linear cognitive aid app (RESCUER) designed to support Emergency Medical Services (EMS) clinicians in responding to neonatal and pediatric out-of-hospital cardiac arrest (POHCA).</div></div><div><h3>Objective</h3><div>This randomized controlled trial (RCT) will investigate the effects of the RESCUER app compared with existing EMS practices and tools during simulated POHCAs.</div></div><div><h3>Study design</h3><div>This RCT will be conducted with EMS first responders from rural and urban EMS agencies in the United States (US). EMS teams will be randomized to respond to simulated neonatal and POHCAs using either (1) the RESCUER app or (2) their current standard of care and tools. In addition to randomized assignment to intervention and control, we also will randomize the order of simulation scenarios.</div></div><div><h3>Main outcome measures</h3><div>Primary outcomes include time to complete American Heart Association (AHA) recommended steps for NRP and PALS. Secondary outcomes include participants’ self-rated cognitive load, measured teamwork, and user-focused assessments of feasibility, usability and usefulness of tools.<sup>1,2</sup></div></div><div><h3>Conclusion</h3><div>We hypothesize that the app will decrease time to complete AHA recommended steps for NRP and PALS, compared to EMS teams’ current standard of care and tools. This study will examine whether an app used by EMS teams in responding to simulated neonatal and pediatric OHCAs will improve resuscitation performance and decrease cognitive load.</div></div><div><h3>Trial Registration Number</h3><div>NCT06768099 (<span><span>ClinicalTrials.gov</span><svg><path></path></svg></span>).</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"48 ","pages":"Article 101558"},"PeriodicalIF":1.4,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145333354","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-01Epub Date: 2025-10-09DOI: 10.1016/j.conctc.2025.101557
Rui Fang , Wanyao Yang , Yue Zhou , Lei Zhao , Le Xie , Jiaxuan Tian , Danhong Liu , Shasha Zhou , Qing Chen , Yanmei Peng , Yunhua Luo , Dahua Wu , Jinwen Ge
<div><h3>Background</h3><div>Convalescent coronavirus disease 2019 (COVID-19) refers to a series of clinical syndromes in patients with COVID-19 infection that follow the relevant discharge indications but do not fulfill the criteria for a clinical cure, and these patients are discharged from the hospital with residual multifunctional deficits, including coughing, fatigue, and insomnia. Due to the prolonged convalescent COVID-19 infection, patients continue to experience symptoms or develop new symptoms after three months of infection, and some symptoms persist for over two months without any apparent triggers, which has a significant impact on the health status and quality of life of the population. Patients with convalescent COVID-19 lack a definitive pharmacological treatment. Traditional Chinese medicine (TCM) exhibits a distinct, synergistic effect on the treatment of convalescent COVID-19. However, there exists a limited number of clinical trials on TCM with lower evidence levels in convalescent COVID-19. Therefore, randomized trials are urgently required.</div></div><div><h3>Methods</h3><div>A multicenter, randomized, double-blind, placebo-controlled, phase II clinical trial was performed to evaluate the efficacy and safety of Shenlingkangfu (SLKF) granules in treating patients with convalescent COVID-19 and lung-spleen qi deficiency syndrome. Eligible participants were aged 18–75 years, had a confirmed severe acute respiratory syndrome coronavirus 2 infection following a positive result for COVID-19 via polymerase chain reaction (PCR) or rapid antigen test at least six months prior, and satisfied clinical criteria. Individuals with a history of severe pulmonary dysfunction or major liver and kidney illness or those on medications were excluded. Multicenter subjects satisfying all criteria were assigned (1:1) randomly into an intervention group and a control group. After a 2-day adjustment period, a total of 154 participants were randomly divided into an intervention group and a control group. The intervention group was given the SLKF granules orally once a bag, 16.9 g, twice daily, whereas the control group received the SLKF granule simulation at the same dosage. The trial was conducted over 1 month, with assessments performed at baseline and 3 months.</div></div><div><h3>Results</h3><div>The primary outcomes were the therapeutic efficacy rate and total clinical symptom score. The secondary outcomes included the fatigue self-assessment scale, pain visual analog scale, Pittsburgh sleep quality index, mini-mental state examination, hospital anxiety and depression scale, TCM syndrome score, C-reactive protein, erythrocyte sedimentation rate, and interleukin-6. Three routine examinations, liver and kidney function tests, and electrocardiography were used as safety indicators.</div></div><div><h3>Conclusions</h3><div>This study aimed to verify whether SLKF granules can significantly improve clinical symptoms, including fatigue, loss of appetit
{"title":"Efficacy and safety of Chinese medicine compound for the convalescent COVID-19 patients: Protocol of a multi-centered, randomized, double-blinded, placebo-controlled clinical trial","authors":"Rui Fang , Wanyao Yang , Yue Zhou , Lei Zhao , Le Xie , Jiaxuan Tian , Danhong Liu , Shasha Zhou , Qing Chen , Yanmei Peng , Yunhua Luo , Dahua Wu , Jinwen Ge","doi":"10.1016/j.conctc.2025.101557","DOIUrl":"10.1016/j.conctc.2025.101557","url":null,"abstract":"<div><h3>Background</h3><div>Convalescent coronavirus disease 2019 (COVID-19) refers to a series of clinical syndromes in patients with COVID-19 infection that follow the relevant discharge indications but do not fulfill the criteria for a clinical cure, and these patients are discharged from the hospital with residual multifunctional deficits, including coughing, fatigue, and insomnia. Due to the prolonged convalescent COVID-19 infection, patients continue to experience symptoms or develop new symptoms after three months of infection, and some symptoms persist for over two months without any apparent triggers, which has a significant impact on the health status and quality of life of the population. Patients with convalescent COVID-19 lack a definitive pharmacological treatment. Traditional Chinese medicine (TCM) exhibits a distinct, synergistic effect on the treatment of convalescent COVID-19. However, there exists a limited number of clinical trials on TCM with lower evidence levels in convalescent COVID-19. Therefore, randomized trials are urgently required.</div></div><div><h3>Methods</h3><div>A multicenter, randomized, double-blind, placebo-controlled, phase II clinical trial was performed to evaluate the efficacy and safety of Shenlingkangfu (SLKF) granules in treating patients with convalescent COVID-19 and lung-spleen qi deficiency syndrome. Eligible participants were aged 18–75 years, had a confirmed severe acute respiratory syndrome coronavirus 2 infection following a positive result for COVID-19 via polymerase chain reaction (PCR) or rapid antigen test at least six months prior, and satisfied clinical criteria. Individuals with a history of severe pulmonary dysfunction or major liver and kidney illness or those on medications were excluded. Multicenter subjects satisfying all criteria were assigned (1:1) randomly into an intervention group and a control group. After a 2-day adjustment period, a total of 154 participants were randomly divided into an intervention group and a control group. The intervention group was given the SLKF granules orally once a bag, 16.9 g, twice daily, whereas the control group received the SLKF granule simulation at the same dosage. The trial was conducted over 1 month, with assessments performed at baseline and 3 months.</div></div><div><h3>Results</h3><div>The primary outcomes were the therapeutic efficacy rate and total clinical symptom score. The secondary outcomes included the fatigue self-assessment scale, pain visual analog scale, Pittsburgh sleep quality index, mini-mental state examination, hospital anxiety and depression scale, TCM syndrome score, C-reactive protein, erythrocyte sedimentation rate, and interleukin-6. Three routine examinations, liver and kidney function tests, and electrocardiography were used as safety indicators.</div></div><div><h3>Conclusions</h3><div>This study aimed to verify whether SLKF granules can significantly improve clinical symptoms, including fatigue, loss of appetit","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"48 ","pages":"Article 101557"},"PeriodicalIF":1.4,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145333355","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-01Epub Date: 2025-10-26DOI: 10.1016/j.conctc.2025.101564
Susan B. Racette , Jordan A. Gunning , Danielle E. Eagan , Isabella Zaniletti , Tracy L. Smith , Candice J. DeCuna , Yehansa S. Hettiwatte , Migbare T. Demeke , Nevine A. Khan , Emily L. Aliskevich , Janina Krell-Roesch , Yonas E. Geda
Background and objective
Time-restricted eating (TRE) may slow neurodegeneration and cognitive decline by stimulating metabolic processes that are neuroprotective. The primary aim of the TRE in Alzheimer's Disease (TREAD) pilot trial is to evaluate the feasibility of implementing a TRE intervention among individuals with mild cognitive impairment (MCI) and to obtain preliminary data on cognitive domains and blood biomarkers that are responsive to TRE.
Methods
TREAD is an intervention trial for 30 adults aged 55–89 years with MCI. A pre/post design is used, with neuropsychological assessments, surveys, and blood biomarkers of cardiometabolic health and AD obtained before and after the intervention. The TRE intervention involves 16 h of continuous fasting and an 8 h eating window on 5 or more days per week for 12 weeks. Feasibility measures include participant enrollment, retention, adherence, acceptability of the intervention, and safety. Cognitive measures include executive function, working memory, processing speed, auditory attention, auditory verbal learning, visuospatial memory, category fluency, and phonemic fluency.
Summary
TREAD is exploring an innovative approach to address cognitive decline and will provide critical preliminary data to inform and power a larger, longer-term, randomized controlled trial of TRE on cognitive trajectory among adults with cognitive impairment.
{"title":"Time-restricted eating in Alzheimer's disease: TREAD pilot trial design","authors":"Susan B. Racette , Jordan A. Gunning , Danielle E. Eagan , Isabella Zaniletti , Tracy L. Smith , Candice J. DeCuna , Yehansa S. Hettiwatte , Migbare T. Demeke , Nevine A. Khan , Emily L. Aliskevich , Janina Krell-Roesch , Yonas E. Geda","doi":"10.1016/j.conctc.2025.101564","DOIUrl":"10.1016/j.conctc.2025.101564","url":null,"abstract":"<div><h3>Background and objective</h3><div>Time-restricted eating (TRE) may slow neurodegeneration and cognitive decline by stimulating metabolic processes that are neuroprotective. The primary aim of the TRE in Alzheimer's Disease (TREAD) pilot trial is to evaluate the feasibility of implementing a TRE intervention among individuals with mild cognitive impairment (MCI) and to obtain preliminary data on cognitive domains and blood biomarkers that are responsive to TRE.</div></div><div><h3>Methods</h3><div>TREAD is an intervention trial for 30 adults aged 55–89 years with MCI. A pre/post design is used, with neuropsychological assessments, surveys, and blood biomarkers of cardiometabolic health and AD obtained before and after the intervention. The TRE intervention involves 16 h of continuous fasting and an 8 h eating window on 5 or more days per week for 12 weeks. Feasibility measures include participant enrollment, retention, adherence, acceptability of the intervention, and safety. Cognitive measures include executive function, working memory, processing speed, auditory attention, auditory verbal learning, visuospatial memory, category fluency, and phonemic fluency.</div></div><div><h3>Summary</h3><div>TREAD is exploring an innovative approach to address cognitive decline and will provide critical preliminary data to inform and power a larger, longer-term, randomized controlled trial of TRE on cognitive trajectory among adults with cognitive impairment.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"48 ","pages":"Article 101564"},"PeriodicalIF":1.4,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145417034","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-01Epub Date: 2025-10-11DOI: 10.1016/j.conctc.2025.101559
Alexandra R. Brown , Edward F. Ellerbeck , Debra K. Sullivan , Eve-Lynn Nelson , Jennifer R. Klemp , Byron J. Gajewski , Jarron Michael Saint Onge , Christie A. Befort
Rural communities experience disproportionately high rates of obesity and related chronic diseases. Rural residents report a lack of weight control programs within their communities, leaving primary care physicians (PCPs)at the center of obesity treatment. PCP involvement significantly enhances uptake and maintenance of weight loss behaviors, but PCPs face significant challenges in delivering consistent, high quality obesity treatment. Capitalizing on the rapid expansion of telehealth, this cluster-randomized trial will evaluate the effectiveness of a novel team-based treatment approach in reducing weight compared to standard quarterly PCP visits. Team Care is a telemedicine approach that pairs intensive telemedicine group visits with quarterly individual team-based clinic visits that simultaneously engage the participant, the local PCP, and a lifestyle coach. This combines the benefits of group-based treatment with home-based telemedicine delivery, and critically, integrates team-based care in local rural clinics. We hypothesize that the team-based approach will be more effective in achieving weight loss at 18 months. Sixteen practices from rural Kansas will be randomized to deliver the team-based approach or standard of care to 35 participants per practice (n = 560) age 20 to 75 with a BMI at least 30 kg/m2. Secondary endpoints include clinical cut points for weight loss, quality of life indicators, and implementation process measures. This research will advance knowledge of obesity treatment in rural primary care by directly comparing the effectiveness of an alternative model of care with the current standard of care. The results may warrant a new standard of care for obesity treatment in rural primary care practices.
{"title":"Protocol for the rural engagement in TelemedTeam for options in obesity treatment solutions (RE-TOOL): Cluster randomized trial investigating team-based telemedicine in rural primary care","authors":"Alexandra R. Brown , Edward F. Ellerbeck , Debra K. Sullivan , Eve-Lynn Nelson , Jennifer R. Klemp , Byron J. Gajewski , Jarron Michael Saint Onge , Christie A. Befort","doi":"10.1016/j.conctc.2025.101559","DOIUrl":"10.1016/j.conctc.2025.101559","url":null,"abstract":"<div><div>Rural communities experience disproportionately high rates of obesity and related chronic diseases. Rural residents report a lack of weight control programs within their communities, leaving primary care physicians (PCPs)at the center of obesity treatment. PCP involvement significantly enhances uptake and maintenance of weight loss behaviors, but PCPs face significant challenges in delivering consistent, high quality obesity treatment. Capitalizing on the rapid expansion of telehealth, this cluster-randomized trial will evaluate the effectiveness of a novel team-based treatment approach in reducing weight compared to standard quarterly PCP visits. Team Care is a telemedicine approach that pairs intensive telemedicine group visits with quarterly individual team-based clinic visits that simultaneously engage the participant, the local PCP, and a lifestyle coach. This combines the benefits of group-based treatment with home-based telemedicine delivery, and critically, integrates team-based care in local rural clinics. We hypothesize that the team-based approach will be more effective in achieving weight loss at 18 months. Sixteen practices from rural Kansas will be randomized to deliver the team-based approach or standard of care to 35 participants per practice (n = 560) age 20 to 75 with a BMI at least 30 kg/m2. Secondary endpoints include clinical cut points for weight loss, quality of life indicators, and implementation process measures. This research will advance knowledge of obesity treatment in rural primary care by directly comparing the effectiveness of an alternative model of care with the current standard of care. The results may warrant a new standard of care for obesity treatment in rural primary care practices.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"48 ","pages":"Article 101559"},"PeriodicalIF":1.4,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145333356","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-01Epub Date: 2025-09-16DOI: 10.1016/j.conctc.2025.101555
Carla S. Stover , Sarah Meshberg-Cohen , Galina A. Portnoy , Satvika Char , Carter W. McCaskill , Quyen A. Do , James Dziura , Steve Martino
Substance Use (SU) and Family Violence (FV) are both critical public health concerns and often occur together. However, most existing interventions target only one of these problems, without consideration of the other, and fail to address when individuals with these issues are parents. The current Stage II randomized clinical trial (RCT) aims to compare two individually delivered interventions, Fathers for Change (F4C) and Individual Drug Counseling (IDC) in 280 fathers who have used physical or psychological violence towards a partner, have a substance use disorder, and have a biological child between the ages of 3 months and 12 years. They will be recruited from two locations (Department of Veteran Affairs [VA] and community substance use treatment clinic). This efficacy study aims to demonstrate that F4C can achieve comparable SU reductions to IDC, while also reducing FV, with increases in emotion regulation meditating the relationship between the intervention group and reduced SU and FV. Findings from this study have large scale clinical and public health implications that can help target and address co-occurring SU and FV and mitigate negative outcomes for affected children and families.
{"title":"Efficacy of an integrated treatment for fathers with Co-occurring substance misuse and family violence","authors":"Carla S. Stover , Sarah Meshberg-Cohen , Galina A. Portnoy , Satvika Char , Carter W. McCaskill , Quyen A. Do , James Dziura , Steve Martino","doi":"10.1016/j.conctc.2025.101555","DOIUrl":"10.1016/j.conctc.2025.101555","url":null,"abstract":"<div><div>Substance Use (SU) and Family Violence (FV) are both critical public health concerns and often occur together. However, most existing interventions target only one of these problems, without consideration of the other, and fail to address when individuals with these issues are parents. The current Stage II randomized clinical trial (RCT) aims to compare two individually delivered interventions, Fathers for Change (F4C) and Individual Drug Counseling (IDC) in 280 fathers who have used physical or psychological violence towards a partner, have a substance use disorder, and have a biological child between the ages of 3 months and 12 years. They will be recruited from two locations (Department of Veteran Affairs [VA] and community substance use treatment clinic). This efficacy study aims to demonstrate that F4C can achieve comparable SU reductions to IDC, while also reducing FV, with increases in emotion regulation meditating the relationship between the intervention group and reduced SU and FV. Findings from this study have large scale clinical and public health implications that can help target and address co-occurring SU and FV and mitigate negative outcomes for affected children and families.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"48 ","pages":"Article 101555"},"PeriodicalIF":1.4,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145108168","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-01Epub Date: 2025-11-26DOI: 10.1016/j.conctc.2025.101578
Samuel McKay , Christina Ng , Jennifer Nicholas , Vivienne Browne , Gina Chinnery , Isabella Choi , Bailey Nation-Ingle , Kristal Alison , Ella Perlow , Michelle Lamblin , Elise Carrotte , Ellie Brown , Gregory Armstrong , Jocelyn I. Meza , Madhavan Mani , Jo Robinson
International students face elevated risk for mental health problems and suicide, yet encounter multiple barriers to accessing timely and culturally responsive treatments. Key challenges include high rates of psychological distress, low mental health literacy, and reduced help-seeking, often compounded by perceived burdensomeness, a lack of belonging, and difficulties with emotion regulation. Bud is a self-guided, co-designed mobile app developed to address these challenges through an accessible digital intervention. This paper outlines a protocol for a randomized controlled trial evaluating the effectiveness, acceptability, engagement, and safety of Bud among international students enrolled at Australian tertiary institutions. The trial also includes an internal pilot phase to ensure the feasibility of the trial procedures, with benchmarks for recruitment, retention, and engagement. A community sample of 302 participants will be randomly assigned to either the intervention group (Bud app) or the active control group (online mental health fact sheets) for four weeks. Assessments will be completed online at baseline, two weeks, and four weeks post-baseline. The primary outcome is psychological distress, with secondary outcomes including help-seeking intentions, perceived burdensomeness and belonging, emotion regulation, mental health literacy, and suicidal ideation. Acceptability and engagement will be assessed using self-report and objective measures. Interviews will be conducted with a subset of 20 participants to explore their views on Bud further. This trial will provide the first evaluation of a suicide prevention tool specifically for international students. If effective, Bud could offer a scalable and culturally relevant solution to improve student mental health and reduce service access barriers.
{"title":"The Bud App: A protocol for a randomized controlled trial with an internal pilot phase targeting modifiable risk and protective factors for suicide among international students","authors":"Samuel McKay , Christina Ng , Jennifer Nicholas , Vivienne Browne , Gina Chinnery , Isabella Choi , Bailey Nation-Ingle , Kristal Alison , Ella Perlow , Michelle Lamblin , Elise Carrotte , Ellie Brown , Gregory Armstrong , Jocelyn I. Meza , Madhavan Mani , Jo Robinson","doi":"10.1016/j.conctc.2025.101578","DOIUrl":"10.1016/j.conctc.2025.101578","url":null,"abstract":"<div><div>International students face elevated risk for mental health problems and suicide, yet encounter multiple barriers to accessing timely and culturally responsive treatments. Key challenges include high rates of psychological distress, low mental health literacy, and reduced help-seeking, often compounded by perceived burdensomeness, a lack of belonging, and difficulties with emotion regulation. Bud is a self-guided, co-designed mobile app developed to address these challenges through an accessible digital intervention. This paper outlines a protocol for a randomized controlled trial evaluating the effectiveness, acceptability, engagement, and safety of Bud among international students enrolled at Australian tertiary institutions. The trial also includes an internal pilot phase to ensure the feasibility of the trial procedures, with benchmarks for recruitment, retention, and engagement. A community sample of 302 participants will be randomly assigned to either the intervention group (Bud app) or the active control group (online mental health fact sheets) for four weeks. Assessments will be completed online at baseline, two weeks, and four weeks post-baseline. The primary outcome is psychological distress, with secondary outcomes including help-seeking intentions, perceived burdensomeness and belonging, emotion regulation, mental health literacy, and suicidal ideation. Acceptability and engagement will be assessed using self-report and objective measures. Interviews will be conducted with a subset of 20 participants to explore their views on Bud further. This trial will provide the first evaluation of a suicide prevention tool specifically for international students. If effective, Bud could offer a scalable and culturally relevant solution to improve student mental health and reduce service access barriers.</div></div><div><h3>Trial registration</h3><div>ACTRN12625000584437.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"48 ","pages":"Article 101578"},"PeriodicalIF":1.4,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145623828","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2025-12-01Epub Date: 2025-11-19DOI: 10.1016/j.conctc.2025.101573
Melinda S. Bender , Bruce A. Cooper , Elena Flowers , Raymond Ma , Shoshana Arai
{"title":"Retraction notice to “Filipinos Fit and trim - A feasible and efficacious DPP-based intervention trial” [Contemporary Clinical trials Communications 12 (2018) 76–84]","authors":"Melinda S. Bender , Bruce A. Cooper , Elena Flowers , Raymond Ma , Shoshana Arai","doi":"10.1016/j.conctc.2025.101573","DOIUrl":"10.1016/j.conctc.2025.101573","url":null,"abstract":"","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"48 ","pages":"Article 101573"},"PeriodicalIF":1.4,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145747159","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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