Pub Date : 2025-12-01DOI: 10.1016/j.conctc.2025.101572
Florian Wagenlehner , Keith S. Kaye , David A. Talan , Amanda J. Sheets , Nicole E. Scangarella-Oman , Emily Jarvis , Jeremy Dennison , Salim Janmohamed , Matthew Helgeson , Caroline Perry
Aim
To understand the impact of current regulatory guidance for non-inferiority, randomized controlled trials (RCTs) in uncomplicated urinary tract infection (uUTI) on efficacy outcomes.
Methods
EAGLE-2 and EAGLE-3 were phase 3, non-inferiority RCTs of oral gepotidacin (1500 mg twice daily for 5 days) vs nitrofurantoin (100 mg BID for 5 days) in females with uUTI. The composite (clinical and microbiological) primary endpoint, therapeutic response (success or failure), was assessed at test-of-cure (day 10–13) in participants with nitrofurantoin-susceptible uropathogens (≥105 colony forming units/mL). Success required symptom resolution plus microbiological eradication; missing data or additional antibacterial use were considered failure. EAGLE-2/-3 results were compared with historic nitrofurantoin RCTs and exploratory endpoints – symptom “resolution or near resolution” (one mild symptom remaining) and investigator-assessed clinical response (IACR) – were used as alternative measures of clinical success.
Results
Nitrofurantoin therapeutic success was substantially lower in EAGLE-2/-3 (47 %/44 %) than historic studies (61–94 %) using different endpoints. Clinical success rates based on “resolution or near resolution” of symptoms were: 78.3 %/77.2 % (EAGLE-2) and 75.7 %/75.3 % (EAGLE-3) for gepotidacin/nitrofurantoin, respectively. IACR rates were: 84.5 %/82.6 % (EAGLE-2) and 75.5 %/76.4 % (EAGLE-3) (post hoc analysis).
Conclusion
Differences in primary endpoint success criteria need to be considered when comparing contemporary and historic uUTI RCTs.
The trials are registered at Clinicaltrials.gov (EAGLE-2, NCT04020341; EAGLE-3, NCT04187144).
{"title":"Impact of updated regulatory guidelines on study results in contemporary uncomplicated urinary tract infection clinical trials and implications for trial conduct and drug development: a comparative analysis with EAGLE-2 and EAGLE-3","authors":"Florian Wagenlehner , Keith S. Kaye , David A. Talan , Amanda J. Sheets , Nicole E. Scangarella-Oman , Emily Jarvis , Jeremy Dennison , Salim Janmohamed , Matthew Helgeson , Caroline Perry","doi":"10.1016/j.conctc.2025.101572","DOIUrl":"10.1016/j.conctc.2025.101572","url":null,"abstract":"<div><h3>Aim</h3><div>To understand the impact of current regulatory guidance for non-inferiority, randomized controlled trials (RCTs) in uncomplicated urinary tract infection (uUTI) on efficacy outcomes.</div></div><div><h3>Methods</h3><div>EAGLE-2 and EAGLE-3 were phase 3, non-inferiority RCTs of oral gepotidacin (1500 mg twice daily for 5 days) vs nitrofurantoin (100 mg BID for 5 days) in females with uUTI. The composite (clinical and microbiological) primary endpoint, therapeutic response (success or failure), was assessed at test-of-cure (day 10–13) in participants with nitrofurantoin-susceptible uropathogens (≥10<sup>5</sup> colony forming units/mL). Success required symptom resolution plus microbiological eradication; missing data or additional antibacterial use were considered failure. EAGLE-2/-3 results were compared with historic nitrofurantoin RCTs and exploratory endpoints – symptom “resolution or near resolution” (one mild symptom remaining) and investigator-assessed clinical response (IACR) – were used as alternative measures of clinical success.</div></div><div><h3>Results</h3><div>Nitrofurantoin therapeutic success was substantially lower in EAGLE-2/-3 (47 %/44 %) than historic studies (61–94 %) using different endpoints. Clinical success rates based on “resolution or near resolution” of symptoms were: 78.3 %/77.2 % (EAGLE-2) and 75.7 %/75.3 % (EAGLE-3) for gepotidacin/nitrofurantoin, respectively. IACR rates were: 84.5 %/82.6 % (EAGLE-2) and 75.5 %/76.4 % (EAGLE-3) (post hoc analysis).</div></div><div><h3>Conclusion</h3><div>Differences in primary endpoint success criteria need to be considered when comparing contemporary and historic uUTI RCTs.</div><div>The trials are registered at <span><span>Clinicaltrials.gov</span><svg><path></path></svg></span> (EAGLE-2, NCT04020341; EAGLE-3, NCT04187144).</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"48 ","pages":"Article 101572"},"PeriodicalIF":1.4,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145623720","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 : 2025-12-01DOI: 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 : 2025-12-01DOI: 10.1016/j.conctc.2025.101574
Silvio Danese , Bruce E. Sands , Brian G. Feagan , Vipul Jairath , Remo Panaccione , Laurent Peyrin-Biroulet , Peter M. Irving , Stefan Schreiber , Iris Dotan , Marc Ferrante , Geert R. D'Haens , Stephen Jones , Marcelo Freire , Dirk Lindner , Shashi Adsul , Pooja Oberai , Jean-Frédéric Colombel
Introduction
Remission rates in patients with Crohn's disease (CD) suggest a therapeutic ceiling with one advanced targeted treatment, representing an unmet need. Dual targeted therapy may provide a more effective treatment approach.
Methods
The primary objective of VICTRIVA (NCT06227910), a randomized, double-blind, phase 3b trial in biologic-experienced and biologic-naïve adults with CD, is to assess whether vedolizumab combined with upadacitinib induction improves rates of clinical remission and endoscopic response at week (W)12 vs. vedolizumab alone. Patients will be randomized 1:1 to vedolizumab (300 mg at W0, W2, W6, and W10) and either upadacitinib 45 mg or placebo daily. W12 responders will enter the maintenance arm up to W52 (vedolizumab monotherapy every 8 weeks [Q8W] from W14 to W52; Q4W escalation if needed). Patients who lose response during maintenance treatment despite dose escalation will enter the rescue substudy (vedolizumab Q4W plus upadacitinib 45 mg for 12 weeks, then vedolizumab monotherapy in patients who regain response). Assessments include patient-reported outcomes (PROs), CD activity index (CDAI), and Simple Endoscopic Score for CD (SES-CD). Globally, 396 patients (198 in each group) will be enrolled. Of these, a minimum of 50 and maximum of 50 % will be biologic-naïve. Co-primary endpoints are CDAI clinical remission and SES-CD endoscopic response at W12. Key secondary endpoints include PRO2 clinical remission at W12, and CDAI clinical remission, SES-CD endoscopic response, and PRO2 clinical remission at W52. Safety endpoints include the incidence of treatment-emergent adverse events.
Conclusion
VICTRIVA will evaluate the efficacy and safety of combined vedolizumab and upadacitinib induction therapy relative to vedolizumab monotherapy, aiming to break the current therapeutic ceiling.
{"title":"Design and rationale for the VICTRIVA study: A randomized, double-blind, phase 3b study of vedolizumab in combination with upadacitinib in Crohn's disease","authors":"Silvio Danese , Bruce E. Sands , Brian G. Feagan , Vipul Jairath , Remo Panaccione , Laurent Peyrin-Biroulet , Peter M. Irving , Stefan Schreiber , Iris Dotan , Marc Ferrante , Geert R. D'Haens , Stephen Jones , Marcelo Freire , Dirk Lindner , Shashi Adsul , Pooja Oberai , Jean-Frédéric Colombel","doi":"10.1016/j.conctc.2025.101574","DOIUrl":"10.1016/j.conctc.2025.101574","url":null,"abstract":"<div><h3>Introduction</h3><div>Remission rates in patients with Crohn's disease (CD) suggest a therapeutic ceiling with one advanced targeted treatment, representing an unmet need. Dual targeted therapy may provide a more effective treatment approach.</div></div><div><h3>Methods</h3><div>The primary objective of VICTRIVA (NCT06227910), a randomized, double-blind, phase 3b trial in biologic-experienced and biologic-naïve adults with CD, is to assess whether vedolizumab combined with upadacitinib induction improves rates of clinical remission and endoscopic response at week (W)12 vs. vedolizumab alone. Patients will be randomized 1:1 to vedolizumab (300 mg at W0, W2, W6, and W10) and either upadacitinib 45 mg or placebo daily. W12 responders will enter the maintenance arm up to W52 (vedolizumab monotherapy every 8 weeks [Q8W] from W14 to W52; Q4W escalation if needed). Patients who lose response during maintenance treatment despite dose escalation will enter the rescue substudy (vedolizumab Q4W plus upadacitinib 45 mg for 12 weeks, then vedolizumab monotherapy in patients who regain response). Assessments include patient-reported outcomes (PROs), CD activity index (CDAI), and Simple Endoscopic Score for CD (SES-CD). Globally, 396 patients (198 in each group) will be enrolled. Of these, a minimum of 50 and maximum of 50 % will be biologic-naïve. Co-primary endpoints are CDAI clinical remission and SES-CD endoscopic response at W12. Key secondary endpoints include PRO2 clinical remission at W12, and CDAI clinical remission, SES-CD endoscopic response, and PRO2 clinical remission at W52. Safety endpoints include the incidence of treatment-emergent adverse events.</div></div><div><h3>Conclusion</h3><div>VICTRIVA will evaluate the efficacy and safety of combined vedolizumab and upadacitinib induction therapy relative to vedolizumab monotherapy, aiming to break the current therapeutic ceiling.</div></div><div><h3>Clinical trials registration</h3><div><span><span>ClinicalTrials.gov</span><svg><path></path></svg></span>, NCT06227910.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"48 ","pages":"Article 101574"},"PeriodicalIF":1.4,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145623827","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 : 2025-12-01DOI: 10.1016/j.conctc.2025.101576
Yosef Sokol , Sofie Glatt , Sarah Andrusier , Chynna Levin , Caroline Boucher , Josephine Ridley , Clayton H. Brown , Yulia Landa , Shirley Glynn , Marianne Goodman
Introduction
There is a gap in effective recovery-oriented treatments for Veterans experiencing suicidal thoughts and/or behaviors, particularly those recovering from a suicidal episode. This study aimed to evaluate the feasibility and acceptability of Continuous Identity Cognitive Therapy (CI-CT), a novel recovery-oriented psychotherapy for Veterans with a history of a recent suicidal episode, and to refine the intervention through an iterative development process. CI-CT integrates theories of personal identity and selfhood within a cognitive therapy framework. It aims to repair personal identity through the construction of a coherent, meaningful self-narrative connecting the present to a clear, detailed, realistic, and desired future self.
Method
Three one-arm trials of CI-CT were conducted to evaluate feasibility and acceptability of the therapy. Trials were conducted iteratively, with each trial incorporating lessons and modifications from the previous one. Participants (N = 15 consented, with N = 12 initiating therapy and 11 completing the full intervention) were U.S. Veterans with a history of a suicide attempt or plan with intent within the past two years.
Results
CI-CT had high levels of feasibility and acceptability based on recruitment rates, attendance rates, low dropout rates, high completion rate of follow-up assessments, and participant feedback. In addition, there were high levels of measured client satisfaction and positive qualitative feedback.
Discussion
The high attendance and retention rates and positive Veteran feedback support further exploration and testing of CI-CT in a randomized clinical trial.
{"title":"Evaluating continuous identity cognitive therapy for veterans with a recent suicidal episode: An open-label group pilot study","authors":"Yosef Sokol , Sofie Glatt , Sarah Andrusier , Chynna Levin , Caroline Boucher , Josephine Ridley , Clayton H. Brown , Yulia Landa , Shirley Glynn , Marianne Goodman","doi":"10.1016/j.conctc.2025.101576","DOIUrl":"10.1016/j.conctc.2025.101576","url":null,"abstract":"<div><h3>Introduction</h3><div>There is a gap in effective recovery-oriented treatments for Veterans experiencing suicidal thoughts and/or behaviors, particularly those recovering from a suicidal episode. This study aimed to evaluate the feasibility and acceptability of Continuous Identity Cognitive Therapy (CI-CT), a novel recovery-oriented psychotherapy for Veterans with a history of a recent suicidal episode, and to refine the intervention through an iterative development process. CI-CT integrates theories of personal identity and selfhood within a cognitive therapy framework. It aims to repair personal identity through the construction of a coherent, meaningful self-narrative connecting the present to a clear, detailed, realistic, and desired future self.</div></div><div><h3>Method</h3><div>Three one-arm trials of CI-CT were conducted to evaluate feasibility and acceptability of the therapy. Trials were conducted iteratively, with each trial incorporating lessons and modifications from the previous one. Participants (N = 15 consented, with N = 12 initiating therapy and 11 completing the full intervention) were U.S. Veterans with a history of a suicide attempt or plan with intent within the past two years.</div></div><div><h3>Results</h3><div>CI-CT had high levels of feasibility and acceptability based on recruitment rates, attendance rates, low dropout rates, high completion rate of follow-up assessments, and participant feedback. In addition, there were high levels of measured client satisfaction and positive qualitative feedback.</div></div><div><h3>Discussion</h3><div>The high attendance and retention rates and positive Veteran feedback support further exploration and testing of CI-CT in a randomized clinical trial.</div></div><div><h3>Clinical trial registration</h3><div>NCT04731519.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"48 ","pages":"Article 101576"},"PeriodicalIF":1.4,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145623829","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 : 2025-12-01DOI: 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 : 2025-12-01DOI: 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}
Pub Date : 2025-12-01DOI: 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 : 2025-12-01DOI: 10.1016/j.conctc.2025.101575
Sahar Nouri, Nasrin Hanifi, Farhad Ramezani-Badr
Background
Unstable angina is a serious heart condition characterized by intense chest pain and anxiety, which substantially reduces patients’ well-being.
Objective
This study examined the combined effects of rhythmic breathing and aromatherapy on pain and anxiety in unstable angina.
Methods
This two-arm randomized controlled trial involved 56 participants, who were equally allocated to an intervention group (n = 28) and a control group (n = 28). The intervention group received rhythmic breathing exercises combined with aromatherapy using 40 % diluted damask rose essential oil, administered in three sessions per hour over a 3-h period. Pain and anxiety were measured using Visual Analog Scales at baseline and at 1-, 2-, and 3-h post-intervention.
Results
Repeated measures ANOVA indicated a significant time-based decrease in pain and anxiety within the intervention group, contrasting with the control group (P < .001).
Conclusion
Pain and anxiety were effectively reduced in unstable angina patients through a combined intervention of rhythmic breathing and aromatherapy. These results highlight the promise of non-drug methods for treating the mental and physical effects of heart disease.
{"title":"The effect of combined rhythmic breathing and aromatherapy on pain intensity and anxiety in patients with unstable angina","authors":"Sahar Nouri, Nasrin Hanifi, Farhad Ramezani-Badr","doi":"10.1016/j.conctc.2025.101575","DOIUrl":"10.1016/j.conctc.2025.101575","url":null,"abstract":"<div><h3>Background</h3><div>Unstable angina is a serious heart condition characterized by intense chest pain and anxiety, which substantially reduces patients’ well-being.</div></div><div><h3>Objective</h3><div>This study examined the combined effects of rhythmic breathing and aromatherapy on pain and anxiety in unstable angina.</div></div><div><h3>Methods</h3><div>This two-arm randomized controlled trial involved 56 participants, who were equally allocated to an intervention group (n = 28) and a control group (n = 28). The intervention group received rhythmic breathing exercises combined with aromatherapy using 40 % diluted damask rose essential oil, administered in three sessions per hour over a 3-h period. <strong>Pain and anxiety were measured using Visual Analog Scales at baseline and at 1-, 2-, and 3-h post-intervention.</strong></div></div><div><h3>Results</h3><div>Repeated measures ANOVA indicated a significant time-based decrease in pain and anxiety within the intervention group, contrasting with the control group (P < .001).</div></div><div><h3>Conclusion</h3><div>Pain and anxiety were effectively reduced in unstable angina patients through a combined intervention of rhythmic breathing and aromatherapy. These results highlight the promise of non-drug methods for treating the mental and physical effects of heart disease.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"48 ","pages":"Article 101575"},"PeriodicalIF":1.4,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145623718","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}
Randomised controlled trials (RCTs) are the gold standard for evaluating healthcare interventions. Participatory research, in which the public is engaged in research activities, enhances their understanding of trials but requires innovative strategies to reach diverse populations, particularly children. This article outlines the design of the REST (Randomised Evaluation of Sleeping with a Toy or comfort item) trial, a child-led study investigating whether sleeping with a comfort item affects sleep quality in children compared to not using one.
The REST trial was created with children aged 7 to 12 through The Kid's Trial, an online initiative where children co-design and co-conduct a randomised trial. The REST trial is a two-arm, pragmatic, superiority RCT. Children worldwide participate from home and are randomly assigned (1:1) to either sleep with or without a comfort item for 7 nights. The primary outcome is sleep-related impairment (SRI), measured using the PROMIS Pediatric Short Form v1.0 Sleep-Related Impairment 4a questionnaire. The secondary outcome is sleep quality, evaluated using a single-item Sleep Quality Scale. Data are collected via online self-reported questionnaires at baseline and eight days post-randomisation. Recruitment is global, targeting caregivers through online media, with study materials available on a dedicated website.
The REST trial aims to enrol 292 participants to achieve 80 % power to detect a 3-point difference in SRI. Findings will explore the impact of comfort items on sleep and demonstrate the feasibility and benefits of child-led participatory research, fostering scientific literacy and critical thinking.
{"title":"The REST (randomised evaluation of sleeping with a toy or comfort item) trial: a protocol for an online, randomised trial of comfort item use on sleep quality in children","authors":"Simone Lepage , Laura Flight , Nikki Totton , Declan Devane","doi":"10.1016/j.conctc.2025.101580","DOIUrl":"10.1016/j.conctc.2025.101580","url":null,"abstract":"<div><div>Randomised controlled trials (RCTs) are the gold standard for evaluating healthcare interventions. Participatory research, in which the public is engaged in research activities, enhances their understanding of trials but requires innovative strategies to reach diverse populations, particularly children. This article outlines the design of the REST (Randomised Evaluation of Sleeping with a Toy or comfort item) trial, a child-led study investigating whether sleeping with a comfort item affects sleep quality in children compared to not using one.</div><div>The REST trial was created with children aged 7 to 12 through The Kid's Trial, an online initiative where children co-design and co-conduct a randomised trial. The REST trial is a two-arm, pragmatic, superiority RCT. Children worldwide participate from home and are randomly assigned (1:1) to either sleep with or without a comfort item for 7 nights. The primary outcome is sleep-related impairment (SRI), measured using the PROMIS Pediatric Short Form v1.0 Sleep-Related Impairment 4a questionnaire. The secondary outcome is sleep quality, evaluated using a single-item Sleep Quality Scale. Data are collected via online self-reported questionnaires at baseline and eight days post-randomisation. Recruitment is global, targeting caregivers through online media, with study materials available on a dedicated website.</div><div>The REST trial aims to enrol 292 participants to achieve 80 % power to detect a 3-point difference in SRI. Findings will explore the impact of comfort items on sleep and demonstrate the feasibility and benefits of child-led participatory research, fostering scientific literacy and critical thinking.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"48 ","pages":"Article 101580"},"PeriodicalIF":1.4,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145623721","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 : 2025-11-15DOI: 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":"2025-11-15","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}
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