Contemporary Clinical Trials Communications最新文献_第7页

Corrigendum to “Design and methods of an adaptive trial to test comparative effectiveness of readmission reduction approaches following infection and sepsis hospitalizations (ACCOMPLISH)” [Contemp. Clinic. Trials Commun. 46 (2025) 101504] “用于测试感染和败血症住院后减少再入院方法比较有效性的适应性试验的设计和方法（ACCOMPLISH）”的勘误表[当代医学杂志]。诊所。判例。46 (2025)101504]

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications

Pub Date : 2025-07-03 DOI: 10.1016/j.conctc.2025.101520

Kristin Mayes , Victor B. Talisa , Adelina Malito , Florian B. Mayr , Kelly Williams , Kalpana Char , Richard Wadas , Elizabeth Lorenzi , Kert Viele , Rana Awdish , Derek C. Angus , Chung-Chou Ho Chang , Sachin Yende

引用次数: 0

Statistical analysis plan for the 24-week randomised trial of hypoglycaemia prevention, awareness of symptoms, and treatment: HypoPAST 低血糖预防、症状意识和治疗的24周随机试验的统计分析计划：HypoPAST

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications

Pub Date : 2025-07-02 DOI: 10.1016/j.conctc.2025.101513

Sharmala Thuraisingam , Jennifer A. Halliday , Uffe Søholm , Elizabeth Holmes-Truscott , Christel Hendrieckx , Timothy C. Skinner , Vincent L. Versace , Jane Speight , HypoPAST study group

Background

The HypoPAST (Hypoglycaemia Prevention, Awareness of Symptoms, and Treatment) randomised controlled trial aims to examine the effectiveness of an online psycho-educational intervention for reducing fear of hypoglycaemia among adults with type 1 diabetes. This statistical analysis plan provides the framework to assess the primary, secondary, and safety outcomes of the trial. The plan was written prior to database lock and in accordance with the SPIRIT guidelines.

Methods

HypoPAST is a 24-week, two-arm, parallel-group, hybrid type 1 randomised controlled trial. The primary outcome is the difference in mean Hypoglycaemia Fear Survey II Worry subscale scores at 24 weeks between intervention and control arms. Secondary outcomes include between-arm differences in psychological, clinical and behavioural measures at mid- and end-trial. Primary and secondary outcomes will be analysed using mixed-effects models under the intention-to-treat principle. A sensitivity analysis will examine assumptions regarding missing data, and a per-protocol analysis will estimate the intervention effect among participants who engage with HypoPAST. Table shells for all prespecified analyses are provided to support transparent reporting.

Conclusion

Consistent with best practice, all analyses described were prespecified prior to completion of trial data collection. The analysis methods were developed by statisticians, with input from trial investigators. This analysis plan provides a rigorous framework for the analysis of the HypoPAST trial data, ensuring the results will be robust and reproducible.

Trial registration

The trial is registered on the Australian and New Zealand Clinical Trials Registry: ACTRN12623000894695 (August 21, 2023).

背景：HypoPAST（低血糖预防、症状意识和治疗）随机对照试验旨在研究在线心理教育干预在减少成人1型糖尿病患者对低血糖的恐惧方面的有效性。该统计分析计划提供了评估试验主要、次要和安全性结果的框架。该计划是在数据库锁定之前根据SPIRIT指南编写的。方法：shypopast是一项为期24周、双臂、平行组、混合型1型随机对照试验。主要结局是干预组和对照组在24周时低血糖恐惧调查II焦虑分量表平均得分的差异。次要结局包括试验中期和末期心理、临床和行为测量的组间差异。主要和次要结果将在意向治疗原则下使用混合效应模型进行分析。敏感性分析将检查关于缺失数据的假设，每个协议分析将估计参与HypoPAST的参与者的干预效果。为所有预先指定的分析提供了表壳，以支持透明的报告。结论与最佳实践一致，所描述的所有分析都是在完成试验数据收集之前预先指定的。分析方法是由统计学家根据试验调查人员的意见制定的。该分析计划为HypoPAST试验数据的分析提供了严格的框架，确保结果稳健且可重复。试验注册该试验在澳大利亚和新西兰临床试验注册中心注册：ACTRN12623000894695（2023年8月21日）。

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引用次数: 0

Trialing addiction neurocircuitry targets and directionality of brain stimulation effects: A deep TMS/fMRI trial in people with alcohol use disorder 试验成瘾神经回路靶点和脑刺激效应的方向性：酒精使用障碍患者的深度TMS/fMRI试验

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications

Pub Date : 2025-06-30 DOI: 10.1016/j.conctc.2025.101515

Daniel J. Fehring , Jordan Morrison-Ham , Annalee L. Cobden , Justin Mahlberg , Mengxia Gao , Claire E. Kelly , Arshiya Sangchooli , Devon Stoliker , Emily Giddens , Brody Quinn , Antonia Cholewick , Luiza Bonfim Pacheco , Adeel Razi , Natalia Albein-Urios , Antonio Verdejo-Garcia

Background

Excessive alcohol consumption is a global health concern, with an estimated 400 million people living with alcohol use disorder (AUD). Current treatments for AUD have limited efficacy and fail to address its diverse neurobiological underpinnings. There are at least two cortico-striatal circuits relevant to AUD neurobiology: a weakened dorsolateral prefrontal cortex (dlPFC) pathway, and a heightened ventromedial prefrontal cortex (vmPFC) pathway.

Purpose

This trial aims to examine whether deep transcranial magnetic stimulation (dTMS) can recalibrate the neurocircuitry disrupted in AUD as a proof-of-concept for its therapeutic potential. We will assess the capacity of two theta-burst stimulation protocols to modify neuroimaging and behavioral indices of AUD-related neurocircuitry alterations.

Methods

We will conduct a randomized, single-blind, sham-controlled crossover trial with 30 adults with moderate to severe AUD (aged 18–49). Participants will receive two doses of active or sham dTMS (for 2 sessions; 7 days apart; order counterbalanced) targeting the dlPFC or vmPFC with intermittent or continuous theta-burst stimulation, respectively.

Results

Primary, secondary, and exploratory outcomes (i.e., stimulation-induced changes in neural circuit connectivity, executive control/decision-making, and craving-related emotions, respectively) will be collected before and after each dTMS dose. Additional exploratory outcomes (daily craving experiences and weekly alcohol consumption) will be collected across a 90-day period from the first session.

Discussion

This trial innovates by utilizing distinct dTMS approaches to specifically target two functionally segregated neurocircuitries disrupted in AUD. Results will inform the development of a larger-scale trial by establishing optimal therapeutic approaches for AUD.

过量饮酒是一个全球性的健康问题，估计有4亿人患有酒精使用障碍（AUD）。目前对AUD的治疗效果有限，未能解决其多样的神经生物学基础。至少有两个与AUD神经生物学相关的皮质纹状体回路：一个减弱的背外侧前额叶皮层（dlPFC）通路和一个增强的腹内侧前额叶皮层（vmPFC）通路。目的：本试验旨在研究深度经颅磁刺激（dTMS）是否可以重新校准AUD中被破坏的神经回路，作为其治疗潜力的概念验证。我们将评估两种脉冲刺激方案的能力，以改变aud相关神经回路改变的神经影像学和行为指标。方法我们将进行一项随机、单盲、假对照交叉试验，纳入30名患有中重度AUD的成年人（18-49岁）。参与者将接受两剂活性或假dTMS(2个疗程；间隔7天；顺序平衡)分别用间歇或连续的脉冲刺激来靶向dlPFC或vmPFC。结果收集每次dTMS剂量前后的主要、次要和探索性结果（即刺激诱导的神经回路连通性、执行控制/决策和渴望相关情绪的变化）。额外的探索性结果（每天的渴望经历和每周的酒精消费）将在第一次会议后的90天内收集。该试验的创新之处在于利用不同的dTMS方法专门针对AUD中两个功能分离的神经回路。通过建立AUD的最佳治疗方法，研究结果将为开展更大规模的试验提供信息。

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引用次数: 0

Tackling burnout in Australian doctors by blending a web-based cognitive-behavioural therapy program with telehealth psychological support – protocol for a three-arm randomised-controlled trial 通过将基于网络的认知行为治疗项目与远程医疗心理支持相结合，解决澳大利亚医生的职业倦怠问题——一项三组随机对照试验的协议

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications

Pub Date : 2025-06-30 DOI: 10.1016/j.conctc.2025.101514

M.J. Coleshill , M.J. Black , K. Luck , K. Willis , N. Smallwood , H. Stephens , T. Gillings , L. Fraser , M. Putland , L. Kampel , A.M. Martin , N.F. Praharso , A.D. Joffe , S. Harvey , P.A. Baldwin

Background

Burnout has received limited attention in treatment programs, despite high prevalence among health professionals and the threat burnout places upon the mental health and the long-term sustainability of the Australian healthcare system. As part of The Essential Network (TEN), a blended care mental health support service for Australian health professionals, we developed Navigating Burnout – a digital cognitive-behavioural therapy program for health professional burnout. This three-arm randomised-controlled trial (RCT) will examine the effectiveness, acceptability, and cost-effectiveness of Navigating Burnout in both blended care and digital formats in reducing burnout among doctors.

Methods

Doctors (n = 207) with burnout will be randomised to (1) a blended version of Navigating Burnout combining digital resources with five fortnightly telehealth sessions with a clinical psychologist, (2) a digital-only version of Navigating Burnout, or (3) self-care psychoeducation as an active attention control. Burnout, psychosocial wellbeing, workforce engagement and attrition, and service acceptability will be measured at baseline, post-treatment, and 3 months post-treatment.

Results

At 3 months post-treatment, we hypothesise reductions in burnout across both treatment arms, with the strongest effect in the blended care arm. Similar trends are expected for psychosocial and occupational outcomes. High service acceptability across both blended care and digital-only versions of Navigating Burnout is also anticipated.

Conclusions

With this evidence, Navigating Burnout may be incorporated into TEN's person-to-person components. Further, by demonstrating the effectiveness of blended care for burnout, Navigating Burnout may provide a crucially needed service for Australian doctors and replicable model of care for other organisations and support services.

尽管职业倦怠在卫生专业人员中非常普遍，并且职业倦怠对心理健康和澳大利亚卫生保健系统的长期可持续性构成威胁，但在治疗方案中，职业倦怠受到的关注有限。作为基本网络（TEN）的一部分，我们为澳大利亚卫生专业人员提供混合护理心理健康支持服务，我们开发了导航倦怠-一个针对卫生专业人员倦怠的数字认知行为治疗计划。这项三组随机对照试验（RCT）将检验在混合护理和数字格式中导航倦怠在减少医生倦怠方面的有效性、可接受性和成本效益。方法207名出现过劳的医生将被随机分配到(1)使用混合版本的《过劳指南》，该版本结合了数字资源和与临床心理学家进行的五次两周一次的远程医疗会议，(2)使用纯数字版本的《过劳指南》，或(3)使用自我保健心理教育作为主动注意控制。将在基线、治疗后和治疗后3个月测量倦怠、心理健康、劳动力参与和流失以及服务可接受性。结果治疗后3个月，我们假设两个治疗组的倦怠都有所减少，其中混合护理组的效果最强。预计社会心理和职业结果也会出现类似趋势。预计混合护理和数字版本的导航倦怠的高服务可接受性。有了这一证据，导航倦怠可以被纳入TEN的个人对个人组件。此外，通过展示倦怠混合护理的有效性，导航倦怠可能为澳大利亚医生提供至关重要的服务，并为其他组织和支持服务提供可复制的护理模式。

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引用次数: 0

Improving youth access to behavioral health services through integrated care and task shifting: protocol for a cluster-randomized stepped wedge clinical trial 通过综合护理和任务转移改善青少年获得行为健康服务的机会：一项集群随机阶梯楔形临床试验方案

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications

Pub Date : 2025-06-30 DOI: 10.1016/j.conctc.2025.101518

Brigid R. Marriott , Leslie Hulvershorn , Johnathan Oliver , Cara Jones , Lauren M. O'Reilly , Sarah E. Wiehe , Patrick O. Monahan , Sarah Kate Bearman , Lisa Saldana , Matthew C. Aalsma

Background

One promising solution for improving access to mental health services is integrated behavioral health models, in which behavioral health providers address mental health problems within the primary care infrastructure. Additionally, task-shifting, where non-specialists deliver certain services in the place of specialists, may be well-suited to address mental health provider shortages. The current study outlines the protocol for a hybrid type III implementation-effectiveness, cluster-randomized stepped wedge trial to evaluate the implementation of an adapted pediatric integrated behavioral health model (Peds IBH) that includes task-shifting services, explore the facilitators and barriers to the implementation of Peds IBH, and examine connection to behavioral health care pre- and post-implementation.

Methods

The trial will include 25 pediatric primary care clinics across 13 counties in a large healthcare system. Clinics will be randomized to one of three cohorts, stepped in at 6-month intervals, with a 12-month implementation period. The Peds IBH program will: 1) incorporate task-shifting to treat mild to moderate anxiety, depression, and conduct problems with flexible, transdiagnostic cognitive-behavior therapy to be delivered by bachelor's level interventionists, 2) leverage existing child psychiatry provider consultation programs, and 3) increase sustainability through a different billing model. Quantitative data collection will include surveys (primary care team members, behavioral health providers, and youth and caregivers) and tracking of implementation strategies. Qualitative interviews will be conducted with primary care providers and staff.

Discussion

This trial will evaluate the implementation of the Peds IBH program. While the focus is implementation outcomes, we will assess effectiveness to inform future dissemination efforts.

Trial registration

N/A.

背景改善获得精神卫生服务的一个有希望的解决办法是综合行为卫生模式，其中行为卫生提供者在初级保健基础设施内处理精神卫生问题。此外，任务转移，非专业人员代替专业人员提供某些服务，可能非常适合解决精神卫生提供者短缺的问题。目前的研究概述了一项混合III型实施有效性、集群随机阶梯形试验的方案，以评估包括任务转移服务在内的适应性儿科综合行为健康模型（Peds IBH）的实施情况，探索实施Peds IBH的促进因素和障碍，并检查实施前后与行为健康保健的联系。该试验将包括一个大型医疗保健系统中13个县的25个儿科初级保健诊所。诊所将被随机分配到三个队列中的一个，每隔6个月介入一次，实施期为12个月。儿科IBH项目将：1)结合任务转移，以治疗轻度至中度焦虑、抑郁和行为问题，由本科水平的干预医生提供灵活的、跨诊断的认知行为疗法；2)利用现有的儿童精神病学提供者咨询项目；3)通过不同的计费模式增加可持续性。定量数据收集将包括调查（初级保健小组成员、行为保健提供者、青年和照顾者）和跟踪实施战略。将对初级保健提供者和工作人员进行定性访谈。本试验将评估儿科IBH项目的实施情况。虽然重点是执行结果，但我们将评估有效性，为今后的传播工作提供信息。审判registrationN /。

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引用次数: 0

The use of consumer-grade physical activity monitors: Insight into psychosocial determinants and technology acceptance 使用消费级体育活动监测器：洞察心理社会决定因素和技术接受

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications

Pub Date : 2025-06-30 DOI: 10.1016/j.conctc.2025.101516

Brenda A.J. Berendsen , Rianne H.J. Golsteijn , Lilian Lechner , Catherine Bolman , Denise A. Peels

Background

Consumer-grade physical activity (PA) monitors are used to optimize enrollment in clinical trials, to evaluate PA behavior, or to promote PA. Insight is needed into characteristics of people who use PA monitors and who do not, to enhance recruitment and generalizability of trials. We assessed demographics, psychosocial determinants and technology acceptance of (non-)users of PA monitors.

Methods

Dutch speaking adults were recruited via social media, email and personal contact. In an online questionnaire 533 participants (70 % women, age 43 ± 14 years) reported PA monitor use, PA and psychosocial determinants, and technology acceptance of PA monitors. Concepts were derived from the theory of planned behavior and the technology acceptance model. Primary outcome of the study was use of a consumer-grade PA monitor in the past month, analyzed with a stepwise logistic regression model, including psychosocial determinants, technology acceptance and PA and past tracking behavior.

Results

Of the participants, 40 % reported using a PA monitor in the past month. Demographics and psychosocial determinants of PA explained 12 % of PA monitor use. The odds for using a PA monitor was higher with higher feelings of autonomy (1.772; CI:1.128–2.783). Adding technology acceptance to the regression model increased the explained variance to 66 %, with significant ORs of perceived ease of use (2.403; CI:1.479–3.904), perceived usefulness (0.405; CI:0.224–0.731), attitude towards PA monitors (2.235; CI:1.222–4.087), affective quality (2.293 CI:1.252–4.201), intention to use PA monitors in the near future (4.174; CI:2.320–7.512), and subcultural appeal (0.660; CI:0.455–0.958).

Conclusions

This study confirmed the value of integrating consumer-grade PA in clinical trials, since they were used regardless of the amount of leisure time PA, motivation, age, and educational level. This indicates that trials that use people's own PA trackers to recruit and screen participants or in interventions likely includes a generalizable sample. Furthermore, the results provide concrete pointers within technology acceptance that could contribute to recruitment in trials relying on participants' own PA monitors.

消费级身体活动（PA）监测仪用于优化临床试验的入组，评估PA行为，或促进PA。需要深入了解使用PA监测器和不使用PA监测器的人的特征，以加强试验的招募和推广。我们评估了（非）PA监测器用户的人口统计学、社会心理决定因素和技术接受程度。方法通过社交媒体、电子邮件和个人联系招募说荷兰语的成年人。在一份在线问卷调查中，533名参与者（70%为女性，年龄43±14岁）报告了心电监护仪的使用情况、心电监护仪和心理社会决定因素以及对心电监护仪的技术接受程度。概念来源于计划行为理论和技术接受模型。该研究的主要结果是在过去一个月使用消费级PA监测仪，用逐步逻辑回归模型进行分析，包括心理社会决定因素、技术接受程度、PA和过去跟踪行为。结果：在参与者中，40%的人报告在过去的一个月里使用过PA监测器。人口统计学和心理社会因素解释了12%的PA监测仪的使用。自主性越强，使用PA监护仪的几率越高(1.772；置信区间:1.128—-2.783)。在回归模型中加入技术接受度将解释方差增加到66%，感知易用性的or显著(2.403；CI: 1.479-3.904)，感知有用性(0.405；CI: 0.224-0.731)，对PA监测器的态度(2.235；CI: 1.222-4.087)，情感品质（2.293 CI: 1.252-4.201），近期使用PA监视器的意向(4.174；CI: 2.320-7.512)，亚文化吸引力(0.660；置信区间:0.455—-0.958)。本研究证实了在临床试验中整合消费级PA的价值，因为它们与休闲时间PA的数量、动机、年龄和教育水平无关。这表明，使用人们自己的PA追踪器来招募和筛选参与者或干预措施的试验可能包括一个可推广的样本。此外，结果在技术接受方面提供了具体的指针，这可能有助于在依靠参与者自己的PA监视器的试验中招募人员。

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引用次数: 0

Experience and lessons learned relating to investigational product supply in the design and delivery of a paediatric investigator-initiated clinical trial 在设计和交付儿科研究者发起的临床试验中与研究产品供应有关的经验和教训

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications

Pub Date : 2025-06-30 DOI: 10.1016/j.conctc.2025.101517

Mandy Wan , Mark A. Turner , Gilles Cambonie , Ruth Kemper , Naouel Bouafia , Lea Levoyer , Alpha Diallo , Mikko Hallman , Jean-Christophe Rozé

The management of investigational product (IP) supply is a complex endeavour when designing and delivering clinical trials. In contrast to industry-sponsored trials where IP supplies are coordinated by teams of specialists working together throughout the entire supply chain, investigator initiated clinical trials often face IP-related challenges that can result in substantial trial delays, higher costs, and even early termination of the trial. Despite the challenges faced by investigators, there has been relatively few discussions on this topic in the literature. In this short communication, we describe our experiences and the lessons learned in managing IP supply during the design and execution of a multinational paediatric investigator initiated clinical trial. These experiences are shared to provide researchers with tools and strategies to improve the future implementation of investigator-initiated clinical trials.

在设计和提供临床试验时，研究产品（IP）供应的管理是一项复杂的工作。与由行业赞助的试验相比，知识产权供应由整个供应链中的专家团队共同协调，研究者发起的临床试验经常面临与知识产权相关的挑战，这些挑战可能导致大量的试验延迟，更高的成本，甚至提前终止试验。尽管研究人员面临着挑战，但文献中关于这一主题的讨论相对较少。在这篇简短的交流中，我们描述了我们在设计和执行一项多国儿科研究者发起的临床试验期间管理知识产权供应的经验和教训。分享这些经验，为研究人员提供工具和策略，以改进未来研究者发起的临床试验的实施。

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引用次数: 0

Study protocol for a randomized controlled effectiveness trial of THRIVE group and peer coaching to promote suicide recovery in crisis stabilization centers THRIVE小组和同伴辅导促进危机稳定中心自杀康复的随机对照有效性试验研究方案

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications

Pub Date : 2025-06-23 DOI: 10.1016/j.conctc.2025.101511

Jennifer D. Lockman , Anthony R. Pisani , M. Alexis Kirk , Kimberly A. Van Orden , Ian J. Cero , Margaret E. Balfour , Kristina Mossgraber , David Jacobowitz , Kenneth R. Conner

Crisis Stabilization Centers (CSCs) offer a person-centered, community-based alternative to Emergency Departments for suicide prevention. CSCs may facilitate the expansion of the 988 Suicide Prevention Lifeline by providing callers with places to go in communities to receive treatment. However, new, recovery-focused psychological interventions for suicide prevention that can be rapidly implemented in CSCs are needed to be effective. This pilot study examines the feasibility, acceptability, and target engagement of the Toward Recovery, Hope, Interpersonal Connection, Values, and Engagement (i.e., THRIVE) for CSCs. THRIVE includes a psychotherapy group and peer-led recovery coaching calls after discharge. This project consists of three phases to adapt, pilot, and test THRIVE in CSCs in preparation for a full-scale effectiveness trial. In phase I, we will use the Model for Implementation Design and Impact (i.e., MADI) to adapt THRIVE to CSCs’ implementation needs (n = 25). In phase II, we will assess the feasibility and acceptability of THRIVE through CSC Stakeholder feedback and completing a pilot trial of THRIVE with CSC guests (n = 20). In phase III, we will complete a pilot randomized effectiveness trial of THRIVE (n = 162) to test the effectiveness of THRIVE on treatment initiation. We will also examine target engagement (i.e., as thwarted belongingness, and perceived burdensomeness) of the THRIVE intervention. Participants will be randomized to (a) Thrive + Discharge & Safety Planning as Usual (i.e., Intervention Arm): or (b) Discharge & Safety Planning as Usual (i.e., Control Arm). Participants complete assessments at baseline, discharge, 1 month, and 3 months. This protocol demonstrates strategies for involving community-based practice partners in research and is the first randomized controlled trial in a CSC sponsored by the National Institute of Mental Health (NIMH).

危机稳定中心（CSCs）提供了一个以人为本，以社区为基础的替代自杀预防急诊科。社区服务中心可为988预防自杀热线的人士提供社区内接受治疗的地方，以促进该热线的扩展。然而，新的、以康复为重点的自杀预防心理干预措施需要在csc中迅速实施才能有效。本初步研究考察了面向社会服务提供者的康复、希望、人际关系、价值观和参与（即茁壮成长）的可行性、可接受性和目标参与。THRIVE包括一个心理治疗小组和出院后的同伴康复辅导电话。该项目分为三个阶段，分别在csc中适应、试点和测试THRIVE，为全面的有效性试验做准备。在第一阶段，我们将使用实施设计和影响模型（即MADI）使THRIVE适应CSCs的实施需求（n = 25）。在第二阶段，我们将通过CSC利益相关者的反馈来评估THRIVE的可行性和可接受性，并在CSC客户（n = 20）中完成THRIVE的试点试验。在III期，我们将完成一项THRIVE的随机有效性试验（n = 162），以测试THRIVE在治疗开始时的有效性。我们还将研究THRIVE干预的目标参与（即受挫的归属感和感知负担）。参与者将被随机分配到(a)茁壮成长+放电；一如既往的安全计划（即干预臂）；或(b)放电&安培；一如既往的安全规划（即控制臂）。参与者在基线、出院、1个月和3个月完成评估。该方案展示了将社区实践伙伴纳入研究的策略，并且是由国家精神卫生研究所（NIMH）赞助的CSC中的第一个随机对照试验。

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引用次数: 0

Pilot optimization trial of a sexual and reproductive health program for Latina teens and their female caregivers: A study protocol 拉丁裔青少年及其女性照顾者性健康和生殖健康项目的试点优化试验：一项研究方案

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications

Pub Date : 2025-06-23 DOI: 10.1016/j.conctc.2025.101512

Katherine G. Merrill , Jacqueline Silva , Wendy Chu , Gisel Romero , Vanessa Melgoza , Blanca Gabino , Corin Mora , Sara Vargas , Jacqueline Fuentes , Caitlin Kelleher-Montero , Nicholle Courrejolles , Kate Guastaferro , Felicia Scott-Wellington , Susana Salgado , Angela Sedeño

Background

Latina teens experience sexual and reproductive health disparities; however, few effective interventions designed for Latina teens and their families exist. Floreciendo is a sexual and reproductive health intervention for Latina teens (14–18 years) and their female caregivers (e.g., mothers, sisters), delivered by trained staff at community partner organizations (CPOs).

Methods

This protocol describes a hybrid type 2 mixed-methods study with a pilot 2³ factorial experimental design which draws on the multiphase optimization strategy (MOST) framework. Small groups of teen-caregiver dyads (target n = 92 dyads/184 participants) will be randomized to 1 of 8 conditions across four CPOs. All will receive the Foundations in Sexual Risk Prevention (i.e., constant) component. Groups of dyads will be randomized to different combinations of three intervention components of Floreciendo, which are either “on” or “off”: 1) Condoms and Contraception, 2) Family Strengthening, and 3) Gender and Relationships. Our aim is to examine the feasibility of using a factorial design and the acceptability of the intervention components. We will also explore effectiveness outcomes—including risky sexual behavior (primary) and incidence of sexually transmitted infections and unplanned pregnancy (secondary)—and implementation outcomes, including appropriateness, feasibility, adoption, sustainability, cost, and fidelity. Qualitative data will build on quantitative data. We will conduct focus group discussions and key informant interviews with Latina teens, female caregivers, facilitators, CPO leadership, and collaborators.

Discussion

Results will be used to guide intervention component and implementation refinement and will inform plans to conduct a fully powered optimization trial of Floreciendo.

拉丁裔青少年在性健康和生殖健康方面存在差距；然而，为拉丁裔青少年及其家庭设计的有效干预措施很少。Floreciendo是一项针对拉丁裔青少年（14-18岁）及其女性照顾者（如母亲、姐妹）的性健康和生殖健康干预措施，由社区伙伴组织训练有素的工作人员提供。方法采用多阶段优化策略（MOST）框架，采用2型混合方法进行23因子试验设计。小组青少年监护人（目标n = 92对/184名参与者）将被随机分配到四个cpo的8个条件中的1个。所有人都将获得预防性风险基础（即恒定）部分。二人组将被随机分配到Floreciendo的三种干预成分的不同组合中，这三种干预成分要么是“开”的，要么是“关”的：1)避孕套和避孕，2)加强家庭，3)性别和关系。我们的目的是检验使用因子设计的可行性和干预成分的可接受性。我们还将探讨有效性结果——包括危险的性行为（主要）、性传播感染和意外怀孕的发生率（次要）——以及实施结果，包括适当性、可行性、采用、可持续性、成本和保真度。定性数据将以定量数据为基础。我们将与拉丁裔青少年、女性看护人、辅导员、CPO领导和合作者进行焦点小组讨论和关键线人访谈。讨论结果将用于指导干预组件和实施改进，并将告知进行Floreciendo全动力优化试验的计划。

{"title":"Pilot optimization trial of a sexual and reproductive health program for Latina teens and their female caregivers: A study protocol","authors":"Katherine G. Merrill , Jacqueline Silva , Wendy Chu , Gisel Romero , Vanessa Melgoza , Blanca Gabino , Corin Mora , Sara Vargas , Jacqueline Fuentes , Caitlin Kelleher-Montero , Nicholle Courrejolles , Kate Guastaferro , Felicia Scott-Wellington , Susana Salgado , Angela Sedeño","doi":"10.1016/j.conctc.2025.101512","DOIUrl":"10.1016/j.conctc.2025.101512","url":null,"abstract":"<div><h3>Background</h3><div>Latina teens experience sexual and reproductive health disparities; however, few effective interventions designed for Latina teens and their families exist. Floreciendo is a sexual and reproductive health intervention for Latina teens (14–18 years) and their female caregivers (e.g., mothers, sisters), delivered by trained staff at community partner organizations (CPOs).</div></div><div><h3>Methods</h3><div>This protocol describes a hybrid type 2 mixed-methods study with a pilot 2<sup>3</sup> factorial experimental design which draws on the multiphase optimization strategy (MOST) framework. Small groups of teen-caregiver dyads (target n = 92 dyads/184 participants) will be randomized to 1 of 8 conditions across four CPOs. All will receive the Foundations in Sexual Risk Prevention (i.e., constant) component. Groups of dyads will be randomized to different combinations of three intervention components of Floreciendo, which are either “on” or “off”: 1) Condoms and Contraception, 2) Family Strengthening, and 3) Gender and Relationships. Our aim is to examine the feasibility of using a factorial design and the acceptability of the intervention components. We will also explore effectiveness outcomes—including risky sexual behavior (primary) and incidence of sexually transmitted infections and unplanned pregnancy (secondary)—and implementation outcomes, including appropriateness, feasibility, adoption, sustainability, cost, and fidelity. Qualitative data will build on quantitative data. We will conduct focus group discussions and key informant interviews with Latina teens, female caregivers, facilitators, CPO leadership, and collaborators.</div></div><div><h3>Discussion</h3><div>Results will be used to guide intervention component and implementation refinement and will inform plans to conduct a fully powered optimization trial of Floreciendo.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"46 ","pages":"Article 101512"},"PeriodicalIF":1.4,"publicationDate":"2025-06-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144517575","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}

引用次数: 0

Virtual sailing exercise to improve major depressive disorder: A pilot clinical trial protocol 虚拟帆船运动改善重度抑郁症：一项试点临床试验方案

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications

Pub Date : 2025-06-20 DOI: 10.1016/j.conctc.2025.101510

Radietya Alvarabie , Yang Yun , Alexandra Gaillard , Oren Tirosh , Gurdeep Sarai , Elissa Burjawi , Denny Meyer , Junhua Xiao

Background

Major Depressive Disorder (MDD) is a prevalent and chronic psychiatric disorder associated with substantially reduced quality of life. However, current mental health management strategies— particularly for non-pharmacological interventions—to reduce this burden are limited in their efficacy. This pilot trial will, for the first time, assess if simulated sailing, combining virtual reality with recreational exercise, is a promising exercise-based therapeutic approach to reducing depression and improving the quality of life for people with MDD.

Methods

To evaluate the effectiveness of virtual sailing on MDD, 58 adults aged between 18 and 64 who have a diagnosis of MDD and can consent and participate in virtual sailing exercises will be recruited for the trial. Exclusion criteria include suicidality, severe mental illness, ongoing psychiatric treatment, and life circumstances that would hinder participation. After the pre-exercise screening, eligible participants will participate in simulated sailing sessions (30 min per session, one session per week) over six weeks. The primary outcome measurements include the evaluation of depression, anxiety, stress, quality of life, clinical improvement, and overall functioning as well as motor coordination. The second aim is to investigate if the virtual sailing program results in neuroplastic changes in the brain that restore altered resting-state functional connectivity and metabolites in MDD using Magnetic Resonance Imaging. Participants will be assessed at baseline and after the last sailing session.

Conclusion

The findings of this pilot study will inform a new therapeutic approach aimed at reducing depression and improving the quality of life for people with MDD.

背景：重度抑郁症（MDD）是一种普遍存在的慢性精神疾病，与生活质量显著下降有关。然而，目前的心理健康管理策略-特别是非药物干预-减轻这种负担的效果有限。这项试点试验将首次评估模拟帆船，将虚拟现实与休闲运动相结合，是否是一种有希望的基于运动的治疗方法，以减少抑郁症和改善重度抑郁症患者的生活质量。方法为了评估虚拟帆船运动对重度抑郁症的治疗效果，研究人员招募了58名年龄在18 - 64岁之间、被诊断为重度抑郁症且同意并参与虚拟帆船运动的成年人进行试验。排除标准包括自杀倾向、严重精神疾病、正在进行的精神治疗以及可能妨碍参与的生活环境。在运动前筛选后，符合条件的参与者将参加模拟帆船课程（每次30分钟，每周一次），为期六周。主要结果测量包括抑郁、焦虑、压力、生活质量、临床改善、整体功能和运动协调的评估。第二个目的是研究虚拟航海程序是否会导致大脑的神经可塑性变化，从而恢复MDD患者静息状态下功能连接和代谢物的改变。参赛者将在基线和最后一节帆船比赛结束后接受评估。结论本初步研究的结果将为减少抑郁症和改善重度抑郁症患者的生活质量提供新的治疗方法。

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引用次数: 0