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Comparison of digital behavioral interventions to prevent alcohol misuse among adolescents ages 12 to 19: A randomized clinical trial protocol 数字行为干预预防12至19岁青少年酒精滥用的比较:一项随机临床试验方案。
IF 1.9 3区 医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2026-01-01 Epub Date: 2025-11-26 DOI: 10.1016/j.cct.2025.108172
Erin E. Bonar , Jason E. Goldstick , Meredith L. Philyaw-Kotov , Carrie A. Bourque , Susan J. Woolford , Ken Resnicow , Joanna Quigley , Golfo Tzilos Wernette , Sana Ahmed , Debra M. Langlois , Maureen A. Walton
Prevention of alcohol use and misuse among adolescents is a public health priority. A health care visit provides an opportunity for screening for alcohol use and delivery of early interventions. Digital intervention delivery may reduce barriers to implementation in these settings. Herein, we describe the protocol from an ongoing comparative effectiveness study testing digital interventions to prevent escalation of alcohol use among adolescents (ages 12–19) connected to pediatric healthcare. Adolescents screening positive for past-year alcohol use are eligible to participate. Enrolled participants complete a baseline survey and are randomly assigned [stratified by sex and age group (12–14; 15–17; 18–19)] to an interactive, ∼45-min computerized brief intervention (CBI) alone or combined with 8 weeks of text messages. Outcomes are assessed at 3-, 6-, 9-, and 12-months post-baseline. Primary outcomes include past 3-month alcohol consumption. Secondary outcomes include alcohol and drug consequences, illicit and prescription drug misuse, and depression symptoms. In parallel, caregivers are also invited to participate, which involves referral to download the app “Talk. They Hear You.” and completing surveys at baseline, 3-, 6-, 9- and 12- months to report their use of the app. A novel aspect of this study is that we partnered with adolescents, caregivers, and health care staff and clinicians throughout the study to enhance relevance, effectiveness, and potential for future dissemination. This study will provide critical data to inform implementation of digital interventions for pediatric patients with the potential to prevent negative health outcomes and promote adolescent well-being.
预防青少年使用和滥用酒精是一项公共卫生优先事项。卫生保健访问提供了筛查酒精使用和提供早期干预措施的机会。在这些环境中,提供数字化干预可能会减少实施的障碍。在此,我们描述了一项正在进行的比较有效性研究的方案,该研究测试了数字干预措施,以防止与儿科保健相关的青少年(12-19岁)酒精使用的升级。过去一年酒精使用筛查呈阳性的青少年有资格参加。入组的参与者完成基线调查,并被随机分配[按性别和年龄组(12-14岁;15-17岁;18-19岁)分层],单独进行约45分钟的交互式计算机简短干预(CBI),或结合8 周的短信。在基线后3、6、9和12个月评估结果。主要结局包括过去3个月的饮酒量。次要后果包括酒精和药物后果、非法药物和处方药滥用以及抑郁症状。与此同时,护理人员也被邀请参加,其中包括推荐下载应用程序“Talk”。并在基线、3、6、9和12 个月完成调查,报告他们对该应用程序的使用情况。这项研究的一个新颖之处在于,我们在整个研究过程中与青少年、护理人员、卫生保健人员和临床医生合作,以提高相关性、有效性和未来传播的潜力。这项研究将提供关键数据,为儿科患者实施数字干预措施提供信息,这些干预措施有可能预防负面健康结果并促进青少年福祉。
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引用次数: 0
The Investigation of Vitamin D and Menstrual Cycles Trial (the inVitD Trial): A clinical trial of vitamin D supplementation on the hypothalamic-pituitary-ovarian axis 维生素D与月经周期的研究试验(inVitD试验):一项补充维生素D对下丘脑-垂体-卵巢轴的临床试验
IF 1.9 3区 医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2026-01-01 Epub Date: 2025-12-04 DOI: 10.1016/j.cct.2025.108176
Michelle R. Klawans , Olivia Kohrman , W. Braxton Jackson II , Chandra L. Jackson , Christine N. Metz , Ganesa Wegienka , Alison Motsinger-Reif , Anne Z. Steiner , Donna D. Baird , Dale P. Sandler , Anne Marie Z. Jukic

Background

While there is evidence that vitamin D deficiency is associated with long menstrual cycles, delayed ovulation, and reduced fertility, it is yet unknown if increasing vitamin D levels can regulate menstrual cycles, and thus possibly improve fertility. The primary objective of this randomized clinical trial (RCT) is to test the hypothesis that vitamin D supplementation influences the hypothalamic-pituitary-ovarian axis.

Methods

This two-site RCT (NCT05050916) required participants to be aged 19–40 years old, having spontaneous menstrual cycles, and without certain chronic diseases or contraindications for vitamin D supplementation. At baseline participants provided information on their demographics and health history. Blood was drawn at the first clinic visit after which participants collected daily urine samples for one menstrual cycle (phase 1). Those with a 25-hydroxyvitamin D level less than 20 ng/ml (“low”) received cholecalciferol supplementation (randomized to either 4200 IU/week or 50,000 IU/week). A random sample of those without low vitamin D received placebo. Supplement (or placebo) was taken for three menstrual cycles which included collection of daily urine samples and home ovulation testing (phase 2). Participants collected self-administered vaginal and oral swabs and a subset collected menstrual effluent samples. Finally, participants kept a daily menstrual diary and weekly behavior diaries. The primary endpoints were mid-luteal progesterone, rate of estrogen rise, and pre-ovulatory luteinizing hormone.

Discussion

Findings from this RCT will provide insight into the relationship between vitamin D supplementation and menstrual cycle hormones. Vitamin D shows promise as a low-cost, non-hormonal intervention to regulate menstrual cycles.
虽然有证据表明维生素D缺乏与月经周期长、排卵延迟和生育能力下降有关,但目前尚不清楚增加维生素D水平是否能调节月经周期,从而可能提高生育能力。本随机临床试验(RCT)的主要目的是验证维生素D补充剂影响下丘脑-垂体-卵巢轴的假设。该双中心随机对照试验(NCT05050916)要求参与者年龄在19-40岁之间,月经周期自然,无某些慢性疾病或补充维生素D的禁忌症。在基线时,参与者提供了有关其人口统计和健康史的信息。在第一次就诊时抽血,之后参与者收集了一个月经周期(第一阶段)的每日尿样。25-羟基维生素D水平低于20 ng/ml(“低”)的患者接受胆钙化醇补充(随机分为4200 IU/周或50,000 IU/周)。一组维生素D水平不高的人随机接受安慰剂治疗。服用补充剂(或安慰剂)三个月经周期,包括收集每日尿液样本和家庭排卵测试(第二阶段)。参与者收集自行使用的阴道和口腔拭子,一部分人收集月经流出物样本。最后,参与者每天记录月经日记和每周行为日记。主要终点是黄体中期黄体酮、雌激素升高率和排卵前黄体生成素。讨论:这项随机对照试验的发现将为维生素D补充和月经周期激素之间的关系提供见解。维生素D有望作为一种低成本、非激素干预来调节月经周期。
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引用次数: 0
The telehealth vs. web-based delivered home-based walking for veterans with peripheral artery disease (TREK-PAD) trial 远程医疗与基于网络的外周动脉疾病退伍军人家庭步行(TREK-PAD)试验
IF 1.9 3区 医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2026-01-01 Epub Date: 2025-11-07 DOI: 10.1016/j.cct.2025.108139
Elizabeth A. Jackson , Gustavo Aldama , Emily Spangler , Joshua Richman , Kamal Henderson , Gareth Dutton , Donald Dempsey , Alfredo Guzman , Jonathan Myers

Background

Facility-based exercise such as walking is recommended for adults with peripheral artery disease (PAD). PAD is prevalent among US Veterans; thus, understanding effective methods for delivering home-based PAD exercise programs to Veterans is clinically important.

Methods

Veterans with documented PAD will be recruited from three sites (Birmingham, AL, Aurora, CO, and Palo Alto, CA) for a sequential multiple assignment randomized trial (SMART) comparing a web-based delivered walking program to a telehealth delivered walking program or usual care. After 12-weeks of the walking program, participants assigned to one of the walking program intervention arms who do not increase their maximal walking distance will be re-randomized to either receive both web-based and telehealth programs or continue their original assignment till week 24. Follow-up will continue for a third 12-weeks for a total duration of 36-weeks. A total of 225 Veterans will be recruited. The primary outcome of maximal walking distance will be assessed at baseline, 12, 24, and 36-weeks with a standardized treadmill protocol. Additional outcomes include pain-free walking distance and changes in health-related quality of life, measured at the same time points.

Conclusion

Determining the efficacy of delivering a home-based walking program can address barriers to facility-based programs which are often not available and create participant burden, particularly to those residing in rural areas distant from healthcare facilities. Veterans are both vulnerable to such barriers and overburdened by PAD. This study will contribute to current evidence related to home-based exercise interventions for Veterans with PAD.
背景:对于患有外周动脉疾病(PAD)的成年人,推荐以步行等设施为基础的运动。PAD在美国退伍军人中很普遍;因此,了解为退伍军人提供家庭PAD运动项目的有效方法在临床上具有重要意义。方法:将从三个地点(Birmingham, AL, Aurora, CO和Palo Alto, CA)招募患有PAD的退伍军人,进行顺序多任务随机试验(SMART),比较基于网络的步行计划与远程医疗提供的步行计划或常规护理。经过12周的步行计划,被分配到不增加最大步行距离的步行计划干预组的参与者将被重新随机分配,要么接受网络和远程医疗计划,要么继续他们原来的任务,直到第24周。第三次随访将持续12周,总持续时间为36周。将招募225名退伍军人。最大步行距离的主要结果将在基线、12周、24周和36周采用标准化的跑步机方案进行评估。其他结果包括在同一时间点测量的无痛步行距离和健康相关生活质量的变化。结论:确定以家庭为基础的步行计划的有效性可以解决以设施为基础的计划的障碍,这些障碍通常不可用,并造成参与者负担,特别是那些居住在远离医疗机构的农村地区的参与者。退伍军人既容易受到这些障碍的影响,又因PAD而负担过重。这项研究将为当前与PAD退伍军人家庭运动干预相关的证据做出贡献。
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引用次数: 0
A comparison of institutional review board models and study efficiency in the Environmental influences on Child Health Outcomes Cohort Consortium 环境对儿童健康结局的影响:机构审查委员会模型与研究效率的比较。
IF 1.9 3区 医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2026-01-01 Epub Date: 2025-11-11 DOI: 10.1016/j.cct.2025.108140
Taylor Kohlmann , Angel Chen , Polly Armsby , C. Ashley Finlen Copeland , Tracy Gentry , Marla Jordan , Maurine Morris , Ana Trampe , Jyoti Angal , Lauren Sims Taylor , Annemarie Stroustrup , Carlos A. Camargo Jr. , N. David Yanez , P. Brian Smith , for the ECHO Cohort Consortium

Background

Institutional review board (IRB) approval is a key step in site activation and study initiation. Single IRBs aim to improve the timeliness of IRB review through centralization and standardization, whereas local IRBs conduct reviews only for specific sites. In Cycle 1 of the Environmental influences on Child Health Outcomes (ECHO) Cohort Consortium, 110 sites chose either single or local IRB review, providing the opportunity to compare the efficiency of single versus local IRBs within one multicenter observational study.

Objectives

Data were collected from the ECHO Coordinating Center at the Duke Clinical Research Institute. Primary outcomes included: 1) time from IRB submission to approval and 2) time from regulatory pack receipt to first participant enrollment. Secondary outcomes included: 1) time from regulatory pack receipt to IRB submission, 2) time from IRB approval to site activation, and 3) time from site activation to first participant enrollment. We compared these outcomes between sites using local versus single IRBs.

Results

No significant differences were identified between the local and single IRB groups for the primary and secondary outcomes. The time from IRB submission to approval was similar for local and single IRBs (median [IQR]: 20 days [10−33]; 19 days [11–27]; p = 0.71, respectively). The time from regulatory pack receipt to first participant enrollment was similar for local and single IRBs (median [IQR]: 243 days [16–309]; 191 days [137–233]; p = 0.50, respectively).

Conclusion

Multiple factors influence review timelines. Single IRBs do not guarantee faster review; additional work is needed to evaluate their impact on study timelines.
背景:机构审查委员会(IRB)的批准是激活和研究启动的关键步骤。单一审核委员会的目的是通过集中和标准化来提高审核的及时性,而本地审核委员会只对特定的站点进行审核。在环境对儿童健康结果的影响(ECHO)队列联盟的第1周期中,110个站点选择了单一或当地IRB审查,提供了在一项多中心观察性研究中比较单一和当地IRB效率的机会。目的:数据收集自杜克临床研究所ECHO协调中心。主要结果包括:1)从IRB提交到批准的时间和2)从监管包收到到首次参与者登记的时间。次要结果包括:1)从监管包收到到IRB提交的时间,2)从IRB批准到站点激活的时间,以及3)从站点激活到首次参与者注册的时间。我们比较了使用本地irb和单一irb的站点之间的这些结果。结果:局部和单一IRB组在主要和次要结局方面没有显著差异。本地IRB和单一IRB从提交到批准的时间相似(中位数[IQR]: 20 天[10-33];19 天[11-27];p = 0.71)。本地和单一irb从收到监管包到首次受试者入组的时间相似(中位数[IQR]: 243 天[16-309];191 天[137-233];p = 0.50)。结论:多种因素影响评审时间。单一irb不能保证更快的审查;需要进一步的工作来评估它们对学习时间的影响。
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引用次数: 0
Rationale for the Feasibility and Acceptability of Smartwatch Technology in an Exercise Regimen (FASTER) study in older individuals 智能手表技术在老年人运动方案(FASTER)研究中的可行性和可接受性的基本原理。
IF 1.9 3区 医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2026-01-01 Epub Date: 2025-11-18 DOI: 10.1016/j.cct.2025.108152
Jenna Hauben , Jacsen Luthy , Toluwaniose Nafiu , Alexis Brengartner , Mohamed Omar , Donya Nemati , Songzhu Zhao , Guy Brock , Kelly Urse , John Paro , Joshua J. Joseph

Background

Less than 15 % of individuals 65+ meet physical activity guidelines for aerobic and muscle-strengthening activities. Thus, in this study we will examine the feasibility and acceptability of utilizing smartwatches among Exercise is Medicine (EIM), a physician referral exercise program, for participants aged 65+ to improve physical activity.

Methods

We will conduct a single-arm trial. Participants will complete an 11-week exercise program combined with a smartwatch, monthly webinars, and two follow-up sessions at 6 and 12 months. Surveys will measure acceptability of the exercise program and the wearable smartwatch. The number of active participants, participant attendance and program completion rates will assess feasibility of the program.

Setting

Ambulatory care clinics affiliated with a medical center and community centers in Central Ohio.

Design

Single-arm pilot study.

Interventions

FASTER will consist of 3 one-on-one and 16 group sessions over 11 weeks in addition to wellness webinars and two follow-up one-on-one sessions 6 and 12 months after program completion. The one-on-one and group sessions will be led by an American College of Sports Medicine (ACSM) certified exercise physiologist with EIM credentials. All participants will receive a Fitbit smartwatch to use throughout the program.

Outcomes

The primary outcome is the feasibility and acceptability of FASTER. Secondary outcomes are change in physical activity, biometric measures, mental health, and quality of life.

Discussion

Incorporating wearable smartwatch technology into a physician referral exercise program may be a novel way to improve physical activity and health in older adults.
Clinical Trial Registration Number: NCT06287255
背景:65岁以上的人群中,只有不到15% 符合有氧运动和肌肉强化运动指南。因此,在本研究中,我们将研究在运动医学(EIM)中使用智能手表的可行性和可接受性,EIM是一项医生推荐的运动计划,针对65岁以上的参与者改善身体活动。方法:我们将进行单臂试验。参与者将完成一项为期11周的锻炼计划,其中包括智能手表、每月的网络研讨会,以及分别在 个月的第6和第12个月的两次后续会议。调查将衡量锻炼计划和可穿戴智能手表的接受程度。积极参与者的数量,参与者出席率和项目完成率将评估项目的可行性。地点:俄亥俄州中部一家医疗中心和社区中心附属的流动护理诊所。设计:单臂先导研究。干预措施:除了健康网络研讨会和项目完成后6个月和12个 月的两次后续一对一会议外,FASTER将在11 周内包括3次一对一和16次小组会议。一对一和小组会议将由美国运动医学学院(ACSM)认证的运动生理学家领导,并拥有EIM证书。所有参与者都将获得Fitbit智能手表,在整个项目中使用。结局:主要结局是FASTER的可行性和可接受性。次要结果是身体活动、生物测量、心理健康和生活质量的变化。讨论:将可穿戴智能手表技术纳入医生推荐的锻炼计划可能是改善老年人身体活动和健康的一种新方法。临床试验注册号:NCT06287255。
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引用次数: 0
SMARTs with treatment preference: Pragmatic SMART design and methods motivated by STAR*D 治疗偏好的SMART:务实的SMART设计和STAR*D驱动的方法
IF 1.9 3区 医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2026-01-01 Epub Date: 2025-11-24 DOI: 10.1016/j.cct.2025.108162
Sarah Medley , Marianthie Wank , Roy N. Tamura , Thomas M. Braun , Kelley M. Kidwell
Effective care for chronic conditions with high rates of non-response or relapse requires personalized and adaptive treatment guidelines known as dynamic treatment regimens (DTRs). Sequential, multiple assignment, randomized trials (SMARTs) are the gold standard for estimating DTRs, but SMARTs, like any trial, may struggle with recruitment and retention due to patient treatment preferences. A partially randomized, patient preference SMART (PRPP-SMART) design overcomes these issues by assigning participants with a preference to their preferred treatment and randomizing indifferent participants at each stage of the SMART. The PRPP-SMART design and methods were motivated in part by STAR*D (NCT00021528), which produced second- and third-line treatment recommendations for patients with major depressive disorder (MDD) who tend to have comorbidities, prior treatment history, and treatment preferences. Traditional, randomized clinical trials typically fail to recruit generalizable study populations, and traditional methods are not appropriate to combine data from randomized and non-randomized participants. We have previously shown that weighted and replicated regression models (WRRMs) combining data from all participants in a PRPP-SMART estimate DTR effects given binary outcomes with minimal bias. Here, we evaluate WRRMs to estimate PRPP-SMART DTRs with continuous outcomes and find that the performance of our method is robust to different preference rates and outcome distributions. We illustrate our method using data adapted from STAR*D which considered preferences in treatment assignment but did not compare DTRs. The PRPP-SMART design and methods presented here would have overcome many shortcomings of STAR*D and establish a framework for meaningful DTR estimates in future pragmatic SMARTs.
对无反应或复发率高的慢性病的有效护理需要个性化和适应性治疗指南,即动态治疗方案(DTRs)。顺序、多任务、随机试验(SMARTs)是估计dtr的黄金标准,但与任何试验一样,SMARTs可能由于患者的治疗偏好而在招募和保留方面存在困难。部分随机化的患者偏好SMART (PRPP-SMART)设计克服了这些问题,为参与者分配了他们偏好的治疗方案,并在SMART的每个阶段随机分配了无关的参与者。PRPP-SMART设计和方法的部分动机是STAR*D (NCT00021528),该研究为倾向于有合并症、既往治疗史和治疗偏好的重度抑郁症(MDD)患者提供二线和三线治疗建议。传统的随机临床试验通常无法招募可推广的研究人群,传统方法也不适合将随机和非随机参与者的数据结合起来。我们之前已经表明,加权和复制回归模型(wrrm)结合了PRPP-SMART中所有参与者的数据,以最小的偏差估计二元结果的DTR效果。在这里,我们评估wrrm来估计具有连续结果的PRPP-SMART dtr,并发现我们的方法对不同的偏好率和结果分布具有鲁棒性。我们使用STAR*D的数据来说明我们的方法,STAR*D考虑了治疗分配的偏好,但没有比较dtr。本文提出的PRPP-SMART设计和方法将克服STAR*D的许多缺点,并在未来的实用smart中建立有意义的DTR估计框架。
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引用次数: 0
Addressing PTSD symptoms in first responders and healthcare workers through trauma-focused treatment in Employee Assistance Programs: Protocol for a randomized controlled trial 通过员工援助项目中的创伤治疗来解决急救人员和医护人员的创伤后应激障碍症状:一项随机对照试验方案。
IF 1.9 3区 医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2026-01-01 Epub Date: 2025-12-04 DOI: 10.1016/j.cct.2025.108174
Rebecca K. Sripada , James Garlick , Naomi Hemphill , Heather M. Walters , Dara Ganoczy , H. Myra Kim , Kara Zivin , Andrea L. Nevedal , Kimberly M. Avallone , Jeffrey A. Cigrang , Sheila A.M. Rauch

Background

Healthcare workers and first responders are frequently exposed to traumatic events and subsequently are more susceptible to posttraumatic stress disorder (PTSD), but few receive treatment. Although Employee Assistance Programs (EAPs) are available at almost all large-sized companies, they lack the capacity to provide time-intensive first-line treatments for PTSD. To address this problem, our study team adapted a standard first-line PTSD treatment into a brief, 4–6 session format (Processing Emotions in Primary Care; PE-PC) and demonstrated its efficacy in military and veteran populations. This paper describes a study protocol to leverage the existing resource of the EAP to test intervention effectiveness among healthcare workers and first responders with treatment need.

Method

We are currently conducting a Hybrid Type 1 Effectiveness-Implementation trial to test the effectiveness of PE-PC, delivered by EAP counselors, versus EAP treatment as usual (TAU) in 360 healthcare workers and first responders with PTSD, and gather data regarding implementation. The specific aims are to compare the effectiveness of PE-PC versus EAP TAU in reducing PTSD symptoms at 6-week (post-treatment), 3-, and 6-month follow-ups, and prepare for future implementation through process evaluation and implementation mapping. We expect the study to yield an implementation strategy that is targeted to address EAP-specific implementation barriers.

Conclusions

This project will contribute a point-of-care intervention for frontline healthcare workers and first responders with PTSD, thus improving clinical practice for populations vulnerable to PTSD and increasing preparedness for public health emergencies.
ClinicalTrials.gov Identifier: NCT05751473
背景:卫生保健工作者和急救人员经常暴露于创伤性事件,随后更容易患创伤后应激障碍(PTSD),但很少接受治疗。尽管几乎所有的大公司都有员工援助计划(eap),但它们缺乏为创伤后应激障碍提供耗时的一线治疗的能力。为了解决这个问题,我们的研究小组将标准的一线创伤后应激障碍治疗改成了简短的4-6次治疗(初级护理中的情绪处理;PE-PC),并在军人和退伍军人群体中证明了其疗效。本文描述了一项研究方案,利用现有的EAP资源来测试医疗工作者和有治疗需求的急救人员的干预效果。方法:我们目前正在进行一项混合类型1有效性-实施试验,以测试由EAP辅导员提供的PE-PC与EAP常规治疗(TAU)在360名医疗工作者和创伤后应激障碍急救人员中的有效性,并收集有关实施的数据。具体目的是比较PE-PC与EAP TAU在6周(治疗后)、3个月和6个月随访时减轻PTSD症状的有效性,并通过过程评估和实施绘图为未来的实施做准备。我们期望这项研究能够产生一种针对解决eap特定实施障碍的实施策略。结论:该项目将为一线医护人员和创伤后应激障碍的第一响应者提供护理点干预,从而改善易患创伤后应激障碍人群的临床实践,提高对突发公共卫生事件的准备。临床试验:gov标识符:NCT05751473。
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引用次数: 0
Protocol for a hybrid type 1 effectiveness-implementation study of mindfulness-based therapy for insomnia in Black women 正念治疗黑人女性失眠的混合1型有效性-实施研究方案
IF 1.9 3区 医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2026-01-01 Epub Date: 2025-11-25 DOI: 10.1016/j.cct.2025.108166
Soohyun Nam , Guangyu Tong , Joanne Iennaco , Debbie Humphries , Monica Ordway , Minjung Lee , Siobhan Thompson , Milagrosa Seguinot , Fernando Morales , Kwasheba Harriot , Nilda Paris , Katurah A. Bryant , Kristine Weidner , Taneha Edwards , Robin Whittemore
Black women in the U.S. disproportionately suffer from insomnia and related cardiometabolic health burdens. However, there is a lack of sleep intervention and implementation research specifically targeting Black women. The aim of this study is to co-design and evaluate equity-focused, community-engaged implementation strategies for an online, group-based mindfulness-based therapy for insomnia (MBTI) tailored for Black women, and to test the effectiveness of MBTI. The study will utilize trained registered nurses to deliver the online MBTI sessions and integrate community health workers (CHWs) to address social determinants of health. This two-phase, study includes: (1) qualitative individual interviews with Black women, CHWs, and clinicians to identify barriers/facilitators to online MBTI (N = 10–40) (2) the development of equity-focused implementation strategies through community engagement process with the Community Advisory Board (clinicians, CHWs, social workers, and community-based organization members), and (3) a Hybrid Type 1 randomized controlled trial comparing online group-based MBTI to a waitlist control (N = 340). Implementation outcomes include acceptability (mean summary score ≥ 3.5 out of 5-point Likert scale), feasibility (≥ 80 %), fidelity (≥ 85 %), cost, and contextual factors; effectiveness outcomes include changes in Insomnia Severity Index scores (≥ 7-point reduction post-intervention) and actigraphy-measured sleep (an increase in total sleep time 20–40 min post-intervention). This study addresses the urgent need for equity-focused intervention and implementation research in sleep health. The study will evaluate how tailoring evidence-based interventions to community needs, leveraging CHWs, and embedding community partnership throughout the process improves access, uptake, and outcomes in Black women with insomnia.

Trial registration

ClinicalTrials.gov Identifier: NCT06348082
美国黑人女性遭受失眠和相关心脏代谢健康负担的比例过高。然而,目前还缺乏专门针对黑人女性的睡眠干预和实施研究。本研究的目的是共同设计和评估为黑人女性量身定制的基于群体的在线正念失眠治疗(MBTI)的以公平为中心、社区参与的实施策略,并测试MBTI的有效性。该研究将利用训练有素的注册护士提供在线MBTI课程,并整合社区卫生工作者(chw)来解决健康的社会决定因素。本研究分为两个阶段,包括:(1)对黑人妇女、社区卫生工作者和临床医生进行定性个人访谈,以确定在线MBTI的障碍/促进因素(N = 10-40)(2)通过社区咨询委员会(临床医生、社区卫生工作者、社会工作者和社区组织成员)的社区参与过程,制定以公平为重点的实施策略,以及(3)一项混合1型随机对照试验,比较基于在线群体的MBTI和候补名单对照(N = 340)。实施结果包括可接受性(5分李克特量表的平均总得分≥3.5分)、可行性(≥80%)、保真度(≥85%)、成本和背景因素;有效性结果包括失眠严重指数得分的变化(干预后减少≥7分)和活动记录仪测量的睡眠(干预后总睡眠时间增加20-40分钟)。本研究解决了睡眠健康公平干预和实施研究的迫切需求。该研究将评估如何根据社区需求定制循证干预措施,利用社区卫生工作者,并在整个过程中融入社区伙伴关系,以改善黑人失眠妇女的获取、吸收和结果。临床试验注册号:NCT06348082
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引用次数: 0
Increasing timely colonoscopy surveillance for patients with high-risk colorectal polyps: Protocol for a cluster randomized trial 增加对高危结肠息肉患者的及时结肠镜检查:一项聚类随机试验方案。
IF 1.9 3区 医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2026-01-01 Epub Date: 2025-11-17 DOI: 10.1016/j.cct.2025.108147
Folasade P. May , Jenna A. McEwan , Jessica J. Tuan , Catherine M. Crespi , Cleo K. Maehara , Jamie O. Yang , Alexandria Uy , Samir Gupta , Yuna Kang , Anthony Myint , Bita V. Naini , Joann G. Elmore , Srikanth Kadiyala , Michael K. Ong , Alex A.T. Bui , Alison B. Hamilton , L. Cindy Chang , Alex Gelvezon , William Hsu , Roshan Bastani

Introduction

Colorectal cancer (CRC) is largely preventable through the removal of precancerous polyps from the colon and rectum. Polyp surveillance guidelines recommend that individuals with polyps categorized as high-risk neoplasia (HRN) undergo surveillance colonoscopy 3 years after HRN diagnosis. However, over half of patients fail to receive their surveillance colonoscopy within this recommended timeframe, highlighting the need for effective interventions to improve 3-year colonoscopy surveillance rates.

Methods

A hybrid type 1 effectiveness-implementation, 2-group cluster-randomized trial is being conducted at 30 primary health care clinics in a large, urban academic health center in Southern California. The study includes two arms: (1) a multilevel intervention arm in which a natural language processing (NLP) algorithm processes electronic health record (EHR) data to facilitate the identification of patients with HRN and providers and patients receive electronic notification when surveillance colonoscopy is due; and (2) a usual care arm, where no intervention is applied.

Results

The primary outcome will be completion of surveillance colonoscopy within 3.5 years of the HRN diagnosis. The secondary outcome will be time from the HRN diagnosis to completion of surveillance colonoscopy.

Conclusions

This study evaluates the effectiveness of a multilevel health system intervention designed to improve adherence to surveillance colonoscopy guidelines for patients with a history of high-risk colorectal polyps. The findings are expected to offer valuable insights into strategies for leveraging EHR-informed algorithms to increase surveillance rates and improve CRC outcomes.
Trial Registration: NCT06376565
导读:结肠直肠癌(CRC)在很大程度上是可以通过从结肠和直肠切除癌前息肉来预防的。息肉监测指南建议高风险瘤变(HRN)息肉患者在HRN诊断后3 年进行监测结肠镜检查。然而,超过一半的患者未能在推荐的时间范围内接受监测结肠镜检查,这突出表明需要采取有效的干预措施来提高3年结肠镜检查的监测率。方法:在南加州一个大型城市学术卫生中心的30个初级卫生保健诊所进行了一项混合1型有效性实施、2组集群随机试验。该研究包括两个部分:(1)一个多层次干预部分,其中自然语言处理(NLP)算法处理电子健康记录(EHR)数据,以促进HRN患者的识别,提供者和患者在监测结肠镜检查时接收电子通知;(2)常规护理组,不进行干预。结果:主要结果将是在HRN诊断后3.5 年内完成结肠镜检查。次要结果是HRN诊断到结肠镜检查完成的时间。结论:本研究评估了多层次卫生系统干预的有效性,旨在提高有高危结肠息肉病史患者对结肠镜检查指南的依从性。研究结果有望为利用ehr知情算法提高监测率和改善CRC结果的策略提供有价值的见解。试验注册:NCT06376565。
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引用次数: 0
Combination Therapy of Resilience Intervention with Biologics in Crohn's Disease (CATHARSIS): Study protocol for a randomized controlled trial 弹性干预与生物制剂联合治疗克罗恩病(CATHARSIS):一项随机对照试验的研究方案。
IF 1.9 3区 医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2026-01-01 Epub Date: 2025-11-17 DOI: 10.1016/j.cct.2025.108151
Laurie Keefer , Ryan Ungaro , Ayanna Lewis , Josie Lee , Candela de Amorrortu , Taryn Lores , Tina Siganporia , Saurabh Mehandru , Francesca Petralia , Jean-Frederic Colombel

Background

Remission rates in Crohn's disease (CD) with standard therapies have plateaued in recent decades. There is a need to investigate more innovative strategies to raise the “therapeutic ceiling”. Combining orthogonal treatments that target differing pathways of disease pathogenesis may maximize synergistic therapeutic efficacy. In particular, the addition of interventions that target the gut-brain axis warrant investigation. Our overarching goal is to demonstrate the value of a new “combination therapy” that addresses psychological and physical health simultaneously, targeting the gut-brain axis, to improve CD outcomes. We will test the efficacy of combining brain-gut behavior therapy with biologic treatment in a randomized, controlled clinical trial, following behavioral clinical trial guidelines for gastroenterology.

Methods

We will recruit 170 adults with CD aged between 18 and 80 years starting an anti-tumor necrosis factor or anti-interleukin-23 medication. Participants will be randomized in a 1:1 ratio to receive a program of either brain-gut behavioral therapy (intervention group) or emotional support (time and attention control group). Both programs consist of seven sessions within a 12-week period. Patient-reported outcomes including well-being and disease activity will be measured at weeks 0, 12, 24, 36, and 52, with the primary outcomes reflected at week 24. Outcomes will be evaluated for group X time interactions.

Conclusions

This trial will be the first of its kind to rigorously evaluate the efficacy of a treatment approach that combines brain-gut behavioral therapy and biologics for people with CD.
背景:近几十年来,克罗恩病(CD)的标准治疗缓解率趋于稳定。有必要研究更多的创新策略,以提高“治疗天花板”。结合针对不同疾病发病途径的正交治疗可以最大限度地提高协同治疗效果。特别是,针对肠-脑轴的干预措施值得研究。我们的首要目标是证明一种新的“联合疗法”的价值,这种疗法同时解决心理和身体健康问题,针对肠-脑轴,以改善乳糜泻的预后。我们将遵循胃肠病学行为临床试验指南,在随机对照临床试验中测试脑-肠行为治疗与生物治疗相结合的疗效。方法:我们将招募170名年龄在18至80 岁之间的成年CD患者,开始使用抗肿瘤坏死因子或抗白细胞介素-23药物。参与者将以1:1的比例随机接受脑-肠行为治疗(干预组)或情感支持(时间和注意力对照组)。这两个项目在12周的时间内都包括7节课。将在第0、12、24、36和52周测量患者报告的结果,包括健康状况和疾病活动,主要结果反映在第24周。将评估X组时间相互作用的结果。结论:该试验将是同类试验中首次严格评估脑-肠行为疗法和生物制剂联合治疗乳糜泻患者的疗效。
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引用次数: 0
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Contemporary clinical trials
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