Contemporary Clinical Trials Communications最新文献_第2页

Frontier sites in clinical trials: Opportunities, challenges, and models 临床试验的前沿地点：机遇、挑战和模式

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications

Pub Date : 2025-12-01 DOI: 10.1016/j.conctc.2025.101581

Andrea Bastek , Amanda Zenere , Heather Manley , Camille Finkle , Chad Jaeger , Janet Matthews , Kristie Moffett , Megan Solomon , Paula Underhill

Background

The clinical trials industry faces a growing capacity gap driven by an increasing number of studies combined with site and staff shortages. The Site Enablement League (SEL) Task Force on Frontier Sites was established to explore the potential of non-traditional research sites—termed "frontier sites"—to address these issues by expanding access to underserved populations and embedding clinical research in community settings.

Methods

The task force defined frontier sites and conducted a survey to gather perspectives on their benefits, challenges, and support needs. Twenty-nine valid survey responses were collected. Respondents self-identified as having direct experience with frontier sites (“experienced respondents”) or answered based on their perception of working with frontier sites (“perception respondents”). Free-text responses were coded into categories and analyzed qualitatively and quantitatively.

Results

Access to new participant populations was the most cited benefit, and experienced respondents noted additional gains in site engagement and education. Operational infrastructure deficiencies were the primary challenge identified by both experienced and perception respondents. Experienced respondents highlighted greater concerns about compliance and community resistance. The primary support need identified was enhanced operational support and quality oversight. Differences between experienced and perception respondent groups suggested the need for broader industry education.

Conclusion

Frontier sites offer significant promise for increasing research capacity and diversity, but require substantial operational, educational, and community engagement support. These survey findings provide a foundation for shared understanding across the industry. From that foundation the industry can work to develop a playbook to guide the successful integration of frontier sites into clinical trial operations.

临床试验行业面临着越来越大的能力缺口，原因是研究数量不断增加，加上场地和人员短缺。前沿站点启用联盟（SEL）工作组的成立是为了探索非传统研究站点（称为“前沿站点”）的潜力，通过扩大对服务不足人群的访问和在社区环境中嵌入临床研究来解决这些问题。方法工作组确定了前沿站点，并进行了一项调查，以收集对其利益、挑战和支持需求的看法。收集了29份有效的调查回复。受访者自我认定有直接的边境工作经验（“有经验的受访者”），或根据他们对边境工作的感知来回答（“感知受访者”）。对自由文本回复进行分类，并进行定性和定量分析。结果获得新的参与者群体是被引用最多的好处，有经验的受访者注意到在现场参与和教育方面的额外收益。运营基础设施不足是经验丰富的受访者和有经验的受访者都认为的主要挑战。经验丰富的受访者强调了对合规性和社区阻力的更大担忧。确定的主要支助需要是加强业务支助和质量监督。有经验的受访者和有经验的受访者之间的差异表明，需要进行更广泛的行业教育。前沿站点为提高研究能力和多样性提供了巨大的希望，但需要大量的运营、教育和社区参与支持。这些调查结果为整个行业的共识提供了基础。在此基础上，该行业可以制定一份指南，指导将前沿站点成功整合到临床试验操作中。

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引用次数: 0

A protocol for a randomized controlled trial of photobiomodulation for management of temporomandibular disorder pain in Adults 光生物调节治疗成人颞下颌紊乱性疼痛的随机对照试验方案

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications

Pub Date : 2025-12-01 DOI: 10.1016/j.conctc.2025.101571

Selenia Rubio , Patricia Cabrera , Rory Reever , Cesar Migliorati , Richard Ohrbach , Frank C. Gibson III , Zhigang Li , Angela Mickle , Rosalynn R.Z. Conic , Roger B. Fillingim , Margarete Ribeiro Dasilva

Evidence-based treatments for painful temporomandibular disorders (TMD) are lacking. The most common treatments for painful TMDs, intraoral appliances and pain medication, provide suboptimal pain control, often leading to treatment-limiting adverse effects. Photobiomodulation therapy (PBM) shows substantial potential for the management of pain in people with a TMD; however, its efficacy for TMD pain reduction has not been rigorously tested. We will conduct a double-blind, randomized, placebo-controlled clinical trial of multimodal PBM for TMD pain. This single-site trial will randomize 130 participants, aged 18 years and older, with chronic painful TMD. Individuals will complete a detailed medical history to confirm eligibility criteria, followed by a clinical exam to confirm TMD case status according to the Diagnostic Criteria for TMD (DC/TMD). Eligible participants will be randomized to either active or sham PBM treatment. Participants will complete eight treatment visits scheduled 2–5 days apart. This will be followed by a post-intervention visit that will include symptom questionnaires, TMD exam, pressure pain threshold (PPT) measures, and blood draw. A 6-month follow-up visit will include a TMD exam, questionnaires, and pressure pain threshold measures. Analyses will determine intervention effects on the primary outcome (pain intensity) and multiple secondary outcomes and will examine whether changes in inflammation and pain sensitivity are associated with the intervention response.

Clinicaltrials.gov identifier

NCT05916235

目前缺乏针对疼痛性颞下颌疾病（TMD）的循证治疗方法。对于疼痛的颞下颌关节痛，最常见的治疗方法，口腔内矫治器和止痛药，提供了次优的疼痛控制，往往导致治疗限制的不良反应。光生物调节疗法（PBM）显示出治疗TMD患者疼痛的巨大潜力；然而，其减轻TMD疼痛的功效尚未经过严格的测试。我们将进行一项双盲、随机、安慰剂对照的多模式PBM治疗TMD疼痛的临床试验。这项单点试验将随机抽取130名18岁及以上的慢性疼痛性TMD患者。个人将完成详细的病史以确认资格标准，然后根据TMD诊断标准（DC/TMD）进行临床检查以确认TMD病例状态。符合条件的参与者将随机接受积极或假PBM治疗。参与者将完成8次治疗访问，间隔2-5天。随后将进行干预后随访，包括症状问卷调查、TMD检查、压痛阈值（PPT）测量和抽血。6个月的随访将包括TMD检查、问卷调查和压力痛阈测量。分析将确定干预对主要结局（疼痛强度）和多个次要结局的影响，并将检查炎症和疼痛敏感性的变化是否与干预反应相关

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引用次数: 0

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 更新的监管指南对当代无并发症尿路感染临床试验研究结果的影响以及对试验进行和药物开发的影响：EAGLE-2和EAGLE-3的比较分析

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications

Pub Date : 2025-12-01 DOI: 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).

目的了解现行非劣效性随机对照试验（RCTs）对非复杂性尿路感染（uUTI）疗效结局的影响。方法seagle -2和EAGLE-3为临床3期非劣效性随机对照试验，对uUTI女性患者口服吉波替达素（1500mg，每日2次，连用5天）与呋喃妥因（100mg BID，连用5天）进行对照。复合（临床和微生物学）主要终点，治疗反应（成功或失败），在治愈试验（10-13天）对呋喃妥英敏感尿路病原体（≥105菌落形成单位/mL）的参与者进行评估。成功需要症状的解决和微生物的根除；缺少数据或额外使用抗菌药物被认为是失败的。EAGLE-2/ 3结果与历史呋喃妥因随机对照试验进行比较，探索性终点-症状“缓解或接近缓解”（仅剩下一种轻微症状）和研究者评估的临床反应(IACR) -被用作临床成功的替代指标。结果在不同终点的EAGLE-2/ 3组中，硝基呋喃妥英治疗成功率（47% / 44%）明显低于历史研究（61% - 94%）。基于症状“缓解或接近缓解”的临床成功率，吉波替达星/呋喃妥英分别为78.3% / 77.2% （EAGLE-2）和75.7% / 75.3% （EAGLE-3）。IACR率分别为84.5% / 82.6% （EAGLE-2）和75.5% / 76.4% (EAGLE-3)（事后分析）。结论：在比较当代和历史uUTI随机对照试验时，需要考虑主要终点成功标准的差异。这些试验已在Clinicaltrials.gov上注册（EAGLE-2, NCT04020341; EAGLE-3, NCT04187144）。

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引用次数: 0

Design and rationale for the VICTRIVA study: A randomized, double-blind, phase 3b study of vedolizumab in combination with upadacitinib in Crohn's disease VICTRIVA研究的设计和基本原理：vedolizumab联合upadacitinib治疗克罗恩病的随机、双盲、3b期研究

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications

Pub Date : 2025-12-01 DOI: 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.

Clinical trials registration

ClinicalTrials.gov, NCT06227910.

克罗恩病（CD）患者的缓解率表明一种高级靶向治疗的治疗上限，这代表了一种未满足的需求。双重靶向治疗可能提供更有效的治疗方法。VICTRIVA （NCT06227910）是一项随机、双盲、3b期临床试验，在有生物学经验的biologic-naïve成年CD患者中进行，主要目的是评估vedolizumab联合upadacitinib诱导是否在第12周(W)时比单独使用vedolizumab提高临床缓解率和内镜下反应率。患者将以1:1的比例随机分配至维多单抗（300 mg, W0, W2， W6和W10）和更新他替尼45 mg或安慰剂每日。W12应答者将进入维持组直至W52 （vedolizumab单药治疗每8周[Q8W]从W14至W52；如果需要Q4W升级）。尽管剂量增加，但在维持治疗期间失去反应的患者将进入拯救亚研究（vedolizumab Q4W + upadacitinib 45mg，持续12周，然后对恢复反应的患者进行vedolizumab单药治疗）。评估包括患者报告的结果（PROs）、CD活动指数（CDAI）和简单内镜下CD评分（SES-CD）。在全球范围内，将招募396名患者（每组198名）。其中，最少50%和最多50%将是biologic-naïve。共同主要终点是W12时CDAI临床缓解和SES-CD内镜下反应。关键次要终点包括W12时PRO2临床缓解、CDAI临床缓解、SES-CD内窥镜反应和W52时PRO2临床缓解。安全性终点包括治疗中出现的不良事件的发生率。结论victriva将评估vedolizumab联合upadacitinib诱导治疗相对于vedolizumab单药治疗的有效性和安全性，旨在打破目前的治疗天花板。临床试验注册：clinicaltrials .gov, NCT06227910。

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引用次数: 0

Evaluating continuous identity cognitive therapy for veterans with a recent suicidal episode: An open-label group pilot study 评估最近有自杀倾向的退伍军人的持续身份认知疗法：一项开放标签小组试点研究

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications

Pub Date : 2025-12-01 DOI: 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.

Clinical trial registration

NCT04731519.

对于经历过自杀想法和/或行为的退伍军人，特别是那些从自杀事件中恢复过来的退伍军人，有效的康复导向治疗存在差距。本研究旨在评估持续身份认知疗法（CI-CT）的可行性和可接受性，并通过迭代开发过程来完善其干预措施。CI-CT是一种面向近期有自杀倾向的退伍军人的新型康复导向心理治疗方法。CI-CT在认知治疗框架内整合了个人同一性和自我的理论。它旨在通过构建一个连贯的、有意义的自我叙述来修复个人身份，将现在与一个清晰、详细、现实和期望的未来自我联系起来。方法采用CI-CT单臂试验，评价其治疗的可行性和可接受性。试验是迭代进行的，每次试验都结合了前一次试验的经验教训和修改。参与者（N = 15名同意，N = 12名开始治疗，11名完成完整干预）是在过去两年内有自杀企图或自杀计划的美国退伍军人。结果从招募率、出勤率、低辍学率、高随访评估完成率和参与者反馈来看，sci - ct具有较高的可行性和可接受性。此外，有高水平的测量客户满意度和积极的定性反馈。高出勤率和保留率以及积极的退伍军人反馈支持在随机临床试验中进一步探索和测试CI-CT。临床试验注册号nct04731519。

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引用次数: 0

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] 对“同伴提供的，以情绪调节为重点的消防员培训生心理健康预防培训：随机对照试验的设计和方法”的更正[当代]。诊所。审判。common . 47 (2025) 101537]

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications

Pub Date : 2025-12-01 DOI: 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

引用次数: 0

A Bayesian model with seasonal effects for predicting accrual in clinical trials: Application to HOBIT and BOOST-3 trials for severe traumatic brain injury 具有季节效应的贝叶斯模型预测临床试验中应计收益：应用于严重创伤性脑损伤的HOBIT和BOOST-3试验

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications

Pub Date : 2025-12-01 DOI: 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.

准确的权责发生制预测对于临床试验的初始计划和持续监测至关重要。缓慢的累积可能损害统计能力，增加成本，或导致试验过早终止。传统的贝叶斯方法通常假设恒定的应计利率，往往无法捕捉到现实世界的季节性波动，这可能会降低预测的准确性。方法我们开发了一个贝叶斯季节权责发生制模型，该模型扩展了传统的同质模型，通过纳入季度特定先验来考虑季节变化。该模型将先验知识与监测数据结合起来，利用贝叶斯后验预测分布获得应计收益预测。我们将这种方法应用于两项正在进行的试验的季度应计数据：高压氧脑损伤治疗（HOBIT）试验和重度TBI脑氧优化3期（BOOST-3）试验。与偏差信息标准一起，使用RMSE、偏倚和标准偏差来评估模型的性能，标准偏差是根据观察到的季节性季度内总应计收益的内部预测计算出来的。36个季度和30个季度后应计收益的后验预测分布也被生成。结果两项试验均表现出季节性趋势，夏季累计发病率最高。季节性模型在两项试验中均产生较低的DIC。在HOBIT，内部预测的准确性没有提高，可能是由于统一的低应计率。相比之下，在BOOST-3试验中，季节性模型优于均匀模型，产生更低的RMSE、偏倚和SD。结论在权责发生制模型中加入季节效应可以提高预测精度，特别是在大型、高入组的试验中，并支持更准确的试验预测和资源分配。

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引用次数: 0

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 Bud应用程序：一项针对国际学生自杀的可修改风险和保护因素的内部试点阶段随机对照试验协议

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications

Pub Date : 2025-12-01 DOI: 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.

Trial registration

ACTRN12625000584437.

国际学生面临较高的心理健康问题和自杀风险，但在获得及时和符合文化要求的治疗方面遇到多重障碍。主要的挑战包括心理困扰率高、心理健康素养低、寻求帮助的人数减少，往往还伴随着感到负担、缺乏归属感和情绪调节方面的困难。Bud是一款自我引导、共同设计的移动应用程序，旨在通过可访问的数字干预来解决这些挑战。本文概述了一项随机对照试验的方案，该试验评估了在澳大利亚高等院校就读的国际学生中使用Bud的有效性、可接受性、参与度和安全性。该试验还包括一个内部试点阶段，以确保试验程序的可行性，并制定招聘、留任和聘用的基准。302名参与者的社区样本将被随机分配到干预组（Bud应用程序）或积极对照组（在线心理健康情况说明书），为期四周。评估将在基线、基线后两周和基线后四周在线完成。主要结局是心理困扰，次要结局包括求助意向、感知负担和归属感、情绪调节、心理健康素养和自杀意念。可接受性和参与度将使用自我报告和客观措施进行评估。我们将与20位参与者进行访谈，进一步探讨他们对Bud的看法。这项试验将首次对专门针对国际学生的自杀预防工具进行评估。如果有效，Bud可以提供一个可扩展的、与文化相关的解决方案，以改善学生的心理健康，减少获得服务的障碍。registrationACTRN12625000584437审判。

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引用次数: 0

Retraction notice to “Filipinos Fit and trim - A feasible and efficacious DPP-based intervention trial” [Contemporary Clinical trials Communications 12 (2018) 76–84] 撤回“菲律宾人健康和修剪——可行有效的dpp干预试验”的通知[当代临床试验通讯12 (2018)76-84]

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications

Pub Date : 2025-12-01 DOI: 10.1016/j.conctc.2025.101573

Melinda S. Bender , Bruce A. Cooper , Elena Flowers , Raymond Ma , Shoshana Arai

引用次数: 0

The effect of combined rhythmic breathing and aromatherapy on pain intensity and anxiety in patients with unstable angina 节奏呼吸联合芳香疗法对不稳定型心绞痛患者疼痛强度和焦虑的影响

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications

Pub Date : 2025-12-01 DOI: 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.

不稳定型心绞痛是一种严重的心脏疾病，其特征是剧烈的胸痛和焦虑，这大大降低了患者的幸福感。目的探讨节奏呼吸联合芳香疗法对不稳定型心绞痛患者疼痛和焦虑的影响。方法56例受试者被随机分为干预组（n = 28）和对照组（n = 28）。干预组接受有节奏的呼吸练习，同时使用40%稀释的大马士革玫瑰精油进行芳香疗法，每小时进行三次，持续3小时。疼痛和焦虑在基线和干预后1、2和3小时使用视觉模拟量表进行测量。结果重复测量方差分析显示，干预组与对照组相比，疼痛和焦虑在时间上有显著的减少（P < .001）。结论节奏呼吸与芳香疗法联合干预可有效减轻不稳定型心绞痛患者的疼痛和焦虑。这些结果强调了非药物方法治疗心脏病的精神和身体影响的前景。

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