Contemporary clinical trials最新文献_第5页

The Sit Less, Interact and Move More (SLIMM-2) Trial: Protocol for a randomized control trial of a sedentary behavior intervention, resistance training and semaglutide on sedentary behavior in persons with chronic kidney disease 少坐、多互动、多运动（slim -2）试验：慢性肾病患者久坐行为干预、阻力训练和西马鲁肽的随机对照试验方案。

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials

Pub Date : 2025-02-01 DOI: 10.1016/j.cct.2024.107766

Jesse C. Christensen , Shuchi Anand , Glenn M. Chertow , Kate Lyden , Amara Sarwal , Terrence Bjordahl , Robert Boucher , Azeem Mohammed , Evan G. Oro , Farahnaz Akramimoghaddam , Niharika Katkam , Augustine Takyi , George Bissada , Akhil Ramanujam Chakravartula , Edison Lee , Ann Zheng , Guo Wei , Tom Greene , Srinivasan Beddhu

Background

Sedentary behavior is highly prevalent and associated with morbidity and mortality in chronic kidney disease (CKD). A Sit Less, Interact and Move More (SLIMM) sedentary activity coaching intervention can reduce sedentary duration among persons with CKD, but preliminary data suggest that effects may not persist. Prior studies have suggested that moderate/vigorous intensity physical activities are not sustainable in persons with CKD. Therefore, we aimed to determine whether guided resistance training ± oral semaglutide co-intervention improves adherence and/or persistence of the SLIMM intervention.

Method/design

The SLIMM-2 is a two-center study designed with a 3-month sedentary activity coaching (SLIMM) followed by a 9-month randomized controlled trial with three arms: SLIMM + standard of care resistance training + oral placebo, SLIMM + guided resistance training + oral placebo, or SLIMM + guided resistance training + oral semaglutide. The study is recruiting persons with CKD (eGFR 20 to ≤60 ml/min/1.73 m²). ActivPAL, a wearable tri-axial accelerometer, is used to assess outcomes including sedentary duration (primary outcome), stepping duration and the average number of steps per day. Additional outcomes include 6-min walk distance and body fat percentage. Persons randomized to standard of care resistance training will be encouraged to maintain individualized physical activity goals; those randomized to guided resistance training will attend guided sessions per month and be prescribed daily independent exercises.

Results

Enrollment, interventions, and follow-up are ongoing.

Conclusions

Results from the SLIMM-2 study are expected to inform clinical practice, with the potential to enhance physical health and functioning among persons with CKD.

背景：久坐行为在慢性肾脏疾病（CKD）中非常普遍，并与发病率和死亡率相关。少坐，多互动，多动（SLIMM）久坐活动指导干预可以减少CKD患者久坐时间，但初步数据表明效果可能不会持续。先前的研究表明，中度/剧烈强度的体育活动在慢性肾病患者中是不可持续的。因此，我们的目的是确定指导性抗阻训练±口服西马鲁肽联合干预是否能改善SLIMM干预的依从性和/或持久性。方法/设计：SLIMM-2是一项双中心研究，设计为3个月的久坐活动指导（SLIMM），随后是9个月的三组随机对照试验：SLIMM +标准护理抗阻训练+口服安慰剂，SLIMM +引导抗阻训练+口服安慰剂，或SLIMM +引导抗阻训练+口服西马鲁肽。该研究招募CKD患者（eGFR 20至≤60 ml/min/1.73 m2）。ActivPAL是一种可穿戴的三轴加速度计，用于评估结果，包括久坐时间（主要结果）、步行时间和每天的平均步数。其他结果包括6分钟步行距离和体脂率。随机分配到标准护理抗阻训练的人将被鼓励保持个性化的身体活动目标；那些随机分配到指导阻力训练组的人将每月参加指导课程，并规定每天进行独立练习。结果：入组、干预和随访正在进行中。结论：slim -2研究的结果有望为临床实践提供信息，具有增强CKD患者身体健康和功能的潜力。

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引用次数: 0

Improving colonoscopy quality in the national VA healthcare system 提高国家退伍军人医疗系统的结肠镜检查质量。

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials

Pub Date : 2025-02-01 DOI: 10.1016/j.cct.2024.107784

Andrew J. Gawron , Travis Bailey , Rachel Codden , Jason Dominitz , Samir Gupta , Christian Helfrich , Charles Kahi , Lila Krop , Carmel Malvar , Grace McKee , Morgan Millar , Ashley Mog , Tiffany Nguyen-Vu , Olga Patterson , Angela P. Presson , Sameer Saini , Mary Whooley , Yiwen Yao , Susan Zickmund , Tonya Kaltenbach

Background

Colorectal cancer (CRC) prevention is a Veterans Affairs (VA) priority. Colonoscopy quality, especially adenoma detection rate (ADR), is critical for effective screening. Our research indicates considerable variation in ADR among VA providers. Even a slight increase in ADR can reduce fatal CRC rates, and audit and feedback strategies have improved ADR in other settings. A recent report identified deficiencies in VA colonoscopy quality, highlighting the need for standardized documentation and reporting. To address this, we developed the VA Endoscopy Quality Improvement Program (VA-EQuIP), which aims to improve colonoscopy quality through benchmarking and collaborative learning, aligning with VA's modernization priorities and HSR&D and QUERI goals of accelerating evidence-based implementation.

Methods

We will conduct a stepped wedge cluster randomized trial to evaluate whether VA-EQuIP improves provider ADR compared to usual care, the implementation of VA-EQuIP, site-level factors associated with colonoscopy quality improvement, and components of provider behavior change. Using mixed methods our study will measure outcomes like reach, implementation, adoption, maintenance of VA-EQuIP, and provider behavior change. The analysis will include primary and secondary outcomes, such as overall and screening ADR, cecal intubation rate, and bowel preparation quality, using mixed effects generalized linear models and interrupted time-series analyses. Adoption and implementation will be evaluated through usage statistics, surveys, and qualitative interviews to identify factors influencing success.

Discussion

This study will assess the impact of VA-EQuIP on colonoscopy quality metrics and factors associated with effective implementation. VA-EQuIP infrastructure allows for national-scale implementation and evaluation of quality reporting with minimal manual labor, guiding future quality improvement efforts to ensure optimal patient care.

背景：结直肠癌（CRC）预防是退伍军人事务（VA）的优先事项。结肠镜检查质量，特别是腺瘤检出率（ADR）是有效筛查的关键。我们的研究表明，VA供应商之间的ADR存在相当大的差异。即使ADR的轻微增加也能降低CRC的致命性，审计和反馈策略也改善了其他环境下的ADR。最近的一份报告指出了VA结肠镜检查质量的不足，强调了标准化文件和报告的必要性。为了解决这个问题，我们制定了VA内窥镜质量改进计划（VA- equip），旨在通过基准和协作学习来提高结肠镜检查质量，与VA现代化优先事项和HSR&D和QUERI加速循证实施的目标保持一致。方法：我们将进行一项楔形分段随机试验，以评估VA-EQuIP与常规护理相比是否改善了提供者不良反应，VA-EQuIP的实施，与结肠镜检查质量改善相关的现场水平因素，以及提供者行为改变的组成部分。使用混合方法，我们的研究将衡量VA-EQuIP的覆盖范围、实施、采用、维护和提供者行为改变等结果。分析将包括主要和次要结果，如总体和筛选不良反应、盲肠插管率和肠准备质量，使用混合效应广义线性模型和中断时间序列分析。采用和实施将通过使用统计、调查和定性访谈来评估，以确定影响成功的因素。讨论：本研究将评估VA-EQuIP对结肠镜检查质量指标的影响以及与有效实施相关的因素。VA-EQuIP基础设施允许以最少的体力劳动在全国范围内实施和评估质量报告，指导未来的质量改进工作，以确保最佳的患者护理。

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引用次数: 0

Development of the Positive Outcomes through Supported Transition (POST) opioid preventive intervention for youth in the legal system: Study protocol for a sequential multiple assignment randomized trial 通过支持过渡（POST）阿片类药物预防干预对法律系统中青少年的积极结果的发展：一项顺序多任务随机试验的研究方案。

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials

Pub Date : 2025-02-01 DOI: 10.1016/j.cct.2024.107782

Ahnalee M. Brincks , Kevin P. Haggerty , Alexandria Kolberg , Katie M. Albertson , Carolyn A. McCarty , Margaret R. Kuklinski , Ted Ryle , Kym R. Ahrens

Adolescents and young adults in the legal system (AYALS) are at high risk for opioid use disorder (OUD). Effective, efficient interventions to prevent OUD that support youth as they transition to the community are needed. The Positive Outcomes through Supported Transition intervention trial is designed to identify the optimal intensity and sequence of behavioral skills and case management components for OUD prevention.

This sequential, multiple assignment randomized trial addresses three research questions: 1.whether to begin with a high-intensity, broad-scope intervention (Enhanced Adolescent Community Reinforcement Approach; E-ACRA) or a lower intensity intervention (Assertive Community Support; ACS), 2. whether to continue with E-ACRA or step-down to ACS after release, and 3. whether to step-up to E-ACRA or continue ACS for youth reporting problematic substance use after release.

Youth committed to state custody will be recruited prior to their release and randomized to E-ACRA or ACS. At five weeks post-release, E-ACRA participants will be re-randomized to E-ACRA or ACS. ACS participants reporting problematic substance use at five weeks will be re-randomized to E-ACRA or ACS. Primary analyses will test the effects of initial intervention (E-ACRA vs. ACS); secondary analyses will test the effects of second-stage interventions. Cost-effectiveness analysis will determine whether the additional resources deployed to E-ACRA are justified economically by the outcomes achieved.

Prevention is critical for this population. High-intensity interventions can be burdensome for participants (and agencies) and costly to deliver. This study examines how best to sequence high and low intensity interventions to maximize beneficial outcomes for the most youth.

This study's design was pre-registered with clinicaltrials.gov (NCT04901312).

法律系统中的青少年和青壮年（AYALS）是阿片类药物使用障碍（OUD）的高危人群。我们需要采取有效、高效的干预措施，防止青少年染上毒瘾，支持他们向社区过渡。通过支持过渡干预的积极结果试验旨在确定行为技能和病例管理组成部分预防OUD的最佳强度和顺序。这个连续的、多任务随机试验解决了三个研究问题：1。是否从高强度、大范围的干预开始(强化青少年社区强化方法；E-ACRA)或低强度干预(自信社区支持；ACS), 2。2 .放行后是否继续使用E-ACRA或降压至ACS；是升级到E-ACRA还是继续对释放后报告有问题物质使用的青少年进行ACS。被国家拘留的青少年将在释放前被招募并随机分配到E-ACRA或ACS。在释放后5周，E-ACRA参与者将被重新随机分配到E-ACRA或ACS组。在5周后报告有问题物质使用的ACS参与者将被重新随机分配到E-ACRA或ACS组。初步分析将测试初始干预的效果（E-ACRA vs. ACS）；二级分析将检验第二阶段干预措施的效果。成本效益分析将决定为E-ACRA部署的额外资源是否因取得的成果而在经济上是合理的。预防对这一人群至关重要。高强度干预措施对参与者（和机构）来说可能是负担，而且实施起来成本高昂。本研究探讨了如何最好地对高强度和低强度干预进行排序，以最大限度地为大多数年轻人带来有益的结果。本研究的设计已在clinicaltrials.gov （NCT04901312）预注册。

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引用次数: 0

Protocol of an adaptive mobile health intervention for the management of gestational weight gain: The LEAP cluster randomized controlled trial 妊娠期体重增加管理的适应性移动健康干预方案：LEAP集群随机对照试验

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials

Pub Date : 2025-02-01 DOI: 10.1016/j.cct.2024.107781

Sneha B. Sridhar , Assiamira Ferrara , Susan D. Brown , Charles P. Quesenberry , Fei Xu , Emily Liu , Tali Sedgwick , Page Kissel , Hillary D. Serrato Bandera , Cheryl Albright , Monique M. Hedderson

Background

More than half of pregnant patients with overweight or obesity exceed national gestational weight gain (GWG) guidelines, increasing their risk of adverse outcomes. There is an urgent need to develop effective and scalable interventions to improve GWG.

Objective

To describe the protocol of Lifestyle, Eating, and Activity in Pregnancy (LEAP), a cluster randomized controlled trial evaluating a mobile health (mHealth) intervention promoting appropriate GWG in an integrated healthcare system.

Methods

LEAP is a cluster randomized trial with randomization at the clinician level. Patient eligibility includes a pre-pregnancy BMI of 25.0–40.0 kg/m² and singleton pregnancy. Consented patients receive standard care or standard care plus mHealth intervention per their clinician's randomization. The patient adaptive intervention provides personalized, automated feedback on GWG and physical activity using 1) a smartphone application, 2) a Wi-Fi scale and activity tracker; 3) weekly educational topics; and 4) step-wise support (added when GWG is >75th percentile of the GWG guidelines). Intervention clinicians receive newsletters with motivational interviewing tips to facilitate discussing GWG. Primary outcomes are total GWG (last measured weight – pre-pregnancy weight) and weekly rate of GWG (total GWG/gestational weeks at delivery) as continuous variables and categorized per the IOM GWG guidelines. Secondary outcomes include trimester-specific rate of GWG, GWG trajectory, diet and physical activity, postpartum weight retention, birthweight, infant size for gestational age, and infant growth to 12 months.

Conclusions

LEAP addresses gaps in the implementation of GWG interventions in healthcare settings. The adaptive and mHealth nature of the intervention may enhance scalability.

Trial Registration: ClinicalTrials.gov NCT03880461.

背景：超过一半的超重或肥胖孕妇超过了国家妊娠期体重增加（GWG）指南，增加了不良结局的风险。迫切需要制定有效和可扩展的干预措施来改善全球变暖效应。目的：描述孕期生活方式、饮食和活动（LEAP）方案，这是一项评估移动健康（mHealth）干预措施在综合医疗保健系统中促进适当GWG的整群随机对照试验。方法：LEAP是一项临床水平随机化的聚类随机试验。患者资格包括孕前BMI 25.0-40.0 kg/m2和单胎妊娠。同意的患者接受标准治疗或标准治疗加移动健康干预根据他们的临床医生的随机分组。患者自适应干预提供个性化、自动化的GWG和身体活动反馈，使用1)智能手机应用程序，2)Wi-Fi秤和活动跟踪器；3)每周教育专题；4)逐步支持（当GWG达到GWG指南的第75个百分位数时添加）。干预临床医生收到带有动机访谈技巧的通讯，以促进对GWG的讨论。主要结果是总GWG（最后测量体重-孕前体重）和每周GWG率（总GWG/分娩时妊娠周数）作为连续变量，并根据IOM GWG指南进行分类。次要结局包括妊娠期GWG特异性发生率、GWG轨迹、饮食和身体活动、产后体重保持、出生体重、胎龄婴儿尺寸和婴儿生长至12 个月。结论：LEAP解决了卫生保健机构实施GWG干预措施方面的差距。干预措施的适应性和移动健康特性可以增强可伸缩性。试验注册：ClinicalTrials.govNCT03880461。

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引用次数: 0

Optimizing diabetes management interventions for Black and Hispanic adults using the multiphase optimization strategy: Protocol for a randomized mixed methods factorial trial 使用多阶段优化策略优化黑人和西班牙裔成年人的糖尿病管理干预措施：随机混合方法析因试验方案

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials

Pub Date : 2025-02-01 DOI: 10.1016/j.cct.2024.107804

Olayinka O. Shiyanbola , Martha A. Maurer , Megan E. Piper , Daniel Bolt , Lisa K. Sharp , Mariétou H. Ouayogodé , Edwin Fisher

Background

Black and Hispanic adults with diabetes are more likely to experience diabetes complications and die from diabetes compared to non-Hispanic whites. This disparity may be due to medication adherence being negatively affected by social determinants of health (SDOH) and negative beliefs about diabetes and diabetes medicines. Pharmacist delivered medication therapy management (MTM) improves clinical outcomes. However, pharmacists have limited capacity and expertise to address SDOH barriers and health misperceptions. Supplementing MTM with Community Health Workers (CHWs) to address these factors may be more effective with potential for implementation.

Aim

To investigate what combination of two possible components, pharmacist delivered MTM and CHWs addressing SDOH barriers and health misperceptions, represents the optimized intervention for Black and Hispanic adults with uncontrolled diabetes.

Methods/design

We will use a 2 × 2 factorial design (MTM, CHW: ON vs. OFF) where participants will be randomized to one of four treatment conditions in a 6-month intervention delivered mostly by phone. We will recruit 376 Black or Hispanic adults with type 2 diabetes and hemoglobin A1C of ≥8 %, a clinical indicator of uncontrolled type 2 diabetes. The primary outcome is A1C measured at 6 months, and at 12 months for sustained change. The secondary outcome is medication adherence. Several psychosocial factors will be examined as potential mediators. An embedded experimental mixed methods approach will be used to obtain participant perspectives through qualitative interviews and integrated to assess intervention acceptability.

Discussion

Our findings will identify the optimized intervention, e.g., comprising MTM or CHW or both intervention components, that effectively and efficiently improves diabetes outcomes among Black and Hispanic adults with uncontrolled diabetes, informing dissemination.

背景：与非西班牙裔白人相比，黑人和西班牙裔成人糖尿病患者更容易出现糖尿病并发症并死于糖尿病。这种差异可能是由于药物依从性受到健康社会决定因素（SDOH）和对糖尿病和糖尿病药物的负面信念的负面影响。药师提供的药物治疗管理（MTM）改善了临床结果。然而，药剂师在解决SDOH障碍和健康误解方面的能力和专业知识有限。以社区卫生工作者（chw）补充MTM来解决这些因素可能更有效，具有实施潜力。目的：探讨药师提供MTM和CHWs解决SDOH障碍和健康误解的两种可能成分的组合，代表了黑人和西班牙裔成人未控制糖尿病的最佳干预措施。方法/设计：我们将采用2 × 2因子设计（MTM, CHW: ON vs. OFF），在为期6个月的主要通过电话提供的干预中，参与者将被随机分为四种治疗条件之一。我们将招募376名患有2型糖尿病且糖化血红蛋白≥8%（2型糖尿病未控制的临床指标）的黑人或西班牙裔成年人。主要结果是6个月时测量A1C， 12个月时测量持续变化。第二个结果是药物依从性。几个社会心理因素将作为潜在的中介进行检查。将采用嵌入式实验混合方法，通过定性访谈获得参与者的观点，并综合评估干预的可接受性。讨论：我们的研究结果将确定优化的干预措施，例如，包括MTM或CHW或两种干预成分，有效地改善黑人和西班牙裔成人未控制糖尿病的糖尿病结局，并为推广提供信息。

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引用次数: 0

The LvL UP trial: Protocol for a sequential, multiple assignment, randomised controlled trial to assess the effectiveness of a blended mobile lifestyle intervention

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials

Pub Date : 2025-02-01 DOI: 10.1016/j.cct.2025.107833

Oscar Castro , Jacqueline Louise Mair , Shenglin Zheng , Sarah Yi Xuan Tan , Ahmad Ishqi Jabir , Xiaoxi Yan , Bibhas Chakraborty , E Shyong Tai , Rob M. van Dam , Florian von Wangenheim , Elgar Fleisch , Konstadina Griva , Tobias Kowatsch , Falk Müller-Riemenschneider

Background

Blended mobile health (mHealth) interventions – combining self-guided and human support components – could play a major role in preventing non-communicable diseases (NCDs) and common mental disorders (CMDs). This protocol describes a sequential, multiple assignment, randomised trial aimed at (i) evaluating the effectiveness and cost-effectiveness of LvL UP, an mHealth lifestyle intervention for the prevention of NCDs and CMDs, and (ii) establishing the optimal blended approach in LvL UP that balances effective personalised lifestyle support with scalability.

Methods

LvL UP is a 6-month mHealth holistic intervention targeting physical activity, diet, and emotional regulation. In this trial, young and middle-aged Singaporean adults at risk of developing NCDs or CMDs will be randomly allocated to one of two initial conditions (‘LvL UP’ or ‘comparison’). After 4 weeks, participants categorised as non-responders from the LvL UP group will be re-randomised into second-stage conditions: (i) continuing with the initial intervention (LvL UP) or (ii) additional motivational interviewing (MI) support sessions by trained health coaches (LvL UP + adaptive MI). The primary outcome is mental well-being. Secondary outcomes include anthropometric measurements, resting blood pressure, blood metabolic profile, health status, and health behaviours (physical activity, diet). Outcomes will be measured at baseline, 6 months (post-intervention), and 12 months (follow-up).

Discussion

In addition to evaluating the effectiveness of LvL UP, the proposed study design will contribute to increasing evidence on how to introduce human support in mHealth interventions to maximise their effectiveness while remaining scalable.

Trial registration

The LvL UP Pilot trial was prospectively registered with ClinicalTrials.gov (NCT06360029).

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引用次数: 0

Web-Based Pain Coping Skills Training (PCST) for Managing Aromatase Inhibitor-Associated Arthralgia in Breast Cancer Survivors: Randomized Controlled Trial Protocol 基于网络的疼痛应对技能培训（PCST）用于管理乳腺癌幸存者芳香酶抑制剂相关关节痛：随机对照试验方案。

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials

Pub Date : 2025-02-01 DOI: 10.1016/j.cct.2024.107780

Zahra Hosseinian , Ashley Lehan , Jessica M. Powers , Adrian Melendez , Hannah M. Fisher , Rebecca Shelby , Tamara Somers , Francis Keefe , Judith Paice , Gretchen Kimmick , James Burns , Ann Marie Flores , Rina S. Fox , Karen Kaiser , David Farrell , Kelly Westbrook , Christine Rini

Background

Aromatase inhibitors (AIs) are a cornerstone of adjuvant systemic therapy for postmenopausal patients with hormone-receptor positive (HR+) breast cancer. Although AIs decrease cancer recurrence rates and improve survival rates, approximately 50 % of patients experience arthralgia—persistent pain related to worse patient outcomes and poor AI adherence. Current medical interventions for AI-associated arthralgia have limited efficacy and side effects that restrict their use among older patients.

Objective

The SKIP-Arthralgia trial will test the efficacy of Pain Coping Skills Training (PCST), a cognitive-behavioral therapy (CBT)-informed intervention, delivered via a web-based program called painTRAINER®. PCST and similar CBT-informed pain interventions are efficacious in non-cancer pain and commonly delivered via the Internet, although they have not been tested as a treatment for AI-associated arthralgia.

Methods

452 breast cancer survivors with AI-associated arthralgia will complete a baseline assessment before being randomized to either painTRAINER plus enhanced usual care (EUC; educational materials about AI therapy, arthralgia, and pain), or to EUC alone. Follow-up assessments will occur approximately 2 weeks after the 8- to 10-week intervention period (post-intervention) and at 3- and 6-months post-intervention. Primary outcomes are pain severity and interference at post-intervention. Secondary outcomes include emotional distress, AI adherence, and health-related quality of life.

Discussion

This trial aims to fill a gap in evidence-based behavioral pain interventions for breast cancer survivors with AI-associated arthralgia by providing an effective, accessible intervention that could be implemented quickly, including in areas with limited PCST access. If successful, this study could enhance health outcomes for breast cancer survivors on AI therapy and improve adherence to this life-saving medication.

背景：芳香化酶抑制剂（AIs）是绝经后激素受体阳性（HR+）乳腺癌患者辅助全身治疗的基石。尽管人工智能降低了癌症复发率并提高了生存率，但大约50% %的患者会经历关节痛——与患者预后较差和人工智能依从性差相关的持续性疼痛。目前针对人工智能相关关节痛的医疗干预措施疗效有限，副作用也限制了其在老年患者中的使用。目的：SKIP-Arthralgia试验将测试疼痛应对技能训练（PCST）的疗效，PCST是一种认知行为疗法（CBT）干预，通过一个名为painTRAINER®的网络程序提供。PCST和类似的基于cbt的疼痛干预措施在非癌症疼痛中是有效的，通常通过互联网提供，尽管它们尚未作为人工智能相关关节痛的治疗方法进行测试。方法：452名患有人工智能相关关节痛的乳腺癌幸存者将完成基线评估，然后随机分配到painTRAINER加增强常规护理组(EUC；有关人工智能治疗、关节痛和疼痛的教育材料)，或仅EUC。随访评估将在8至10周干预期（干预后）后约2 周以及干预后3个月和6个月进行。主要结局是疼痛严重程度和干预后的干预。次要结局包括情绪困扰、人工智能依从性和健康相关生活质量。讨论：本试验旨在通过提供一种有效的、可获得的、可快速实施的干预措施，包括在PCST准入有限的地区，填补对患有人工智能相关关节痛的乳腺癌幸存者的循证行为疼痛干预措施的空白。如果成功，这项研究可以提高乳腺癌幸存者接受人工智能治疗的健康结果，并提高对这种救命药物的依从性。

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引用次数: 0

Efficacy of traditional and gamified attention bias modification for depression: Study protocol for a randomized controlled trial 传统和游戏化的注意偏倚修正对抑郁症的疗效：随机对照试验的研究方案。

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials

Pub Date : 2025-02-01 DOI: 10.1016/j.cct.2024.107797

Beatrice Fadrigon , Ariel Tseng , Rachel L. Weisenburger , Andrew Levihn-Coon , Mary E. McNamara , Jason Shumake , Jasper A.J. Smits , Tracy A. Dennis-Tiwary , Christopher G. Beevers

Cognitive models posit that negatively biased attention toward dysphoric information has a causal role in the maintenance of depression-related psychopathology. Attention bias modification (ABM) tests this idea by altering an attentional bias and examining subsequent effects on depression. Prior work finds that ABM alters negatively biased attention for dysphoric information and reduces depression; however, a number of studies have failed to show these effects. Other research suggests that adding game-like elements (i.e.game play, achievements, levels, challenges, and points) to cognitive training can enhance participant engagement. No prior work has examined the efficacy of gamified ABM for depression. The goal of this study is to conduct a large (N = 600) efficacy trial comparing gamified, mobile ABM and traditional, web-based ABM to traditional, web-based sham ABM among adults with elevated symptoms of depression. Participants in all conditions are asked to complete 16 ABM sessions across a four week period (i.e., 4 training sessions per week). We hypothesize that gamified and traditional ABM will lead to significantly greater reductions in self-reported and interviewer-rated depression symptoms than traditional sham ABM. We further hypothesize that gamified ABM will be non-inferior to traditional ABM. Our third hypothesis is that people with a strong attentional bias will experience greater reductions in depression in response to either gamified or traditional ABM compared to sham ABM. Secondary analyses will examine putative mediators of ABM. Finally, we will estimate the durability of ABM by collecting post-treatment symptom data 2-, 3-, and 6-months after the acute ABM period.

ClinicalTrials.gov ID: NCT06361095

认知模型认为，对令人不安的信息的负性偏见注意在维持抑郁相关的精神病理中起着因果作用。注意偏差修正（Attention bias modification，简称ABM）通过改变注意偏差并检查其对抑郁症的后续影响来验证这一观点。先前的研究发现，ABM改变了对令人不安的信息的负性偏见注意，减少了抑郁；然而，许多研究都未能证明这些影响。其他研究表明，在认知训练中添加类似游戏的元素（如游戏玩法、成就、关卡、挑战和点数）可以提高参与者的参与度。之前还没有研究游戏化ABM对抑郁症的疗效。本研究的目的是进行一项大型（N = 600）疗效试验，比较游戏化、移动ABM、传统的、基于网络的ABM和传统的、基于网络的假ABM在抑郁症症状升高的成年人中的疗效。所有条件下的参与者都被要求在四周的时间内完成16次ABM课程（即每周4次培训课程）。我们假设，与传统的假ABM相比，游戏化和传统的ABM会显著地减少自我报告和访谈者评价的抑郁症状。我们进一步假设，游戏化的ABM将不逊色于传统的ABM。我们的第三个假设是，与假ABM相比，具有强烈注意偏见的人在游戏化或传统ABM的反应中抑郁程度会更低。二级分析将检查假定的ABM介质。最后，我们将通过收集急性ABM期后2、3和6个月的治疗后症状数据来估计ABM的持久性。ClinicalTrials.gov ID: NCT06361095。

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引用次数: 0

Protocol for a randomized controlled trial of strength at home in Israel: A trauma informed intervention for intimate partner violence based on a social-information processing model 以色列 "在家的力量 "随机对照试验方案：基于社会信息处理模型的亲密伴侣暴力创伤知情干预。

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials

Pub Date : 2025-02-01 DOI: 10.1016/j.cct.2024.107775

Ohad Gilbar , Liron Cohen , Madeline Smethurst , Suzannah Creech , Ziv Azaria-Mizrachi , Naomi Ben-Gal , Casey Taft

Background

The social information processing (SIP) model of trauma and intimate partner violence (IPV), which emphasizes the impact of trauma on one's ability to accurately process social information and subsequent failure to generate and enact nonaggressive responses, has gained attention in the United States. Recent clinical trial evidence suggests that the Strength at Home (SAH) intervention, a 12-session program that is based on this model, is efficacious in reducing and ending abusive behavior among U.S. veterans. However, such a clinical trial has yet to be conducted among a civilian population nor in a different cultural context (e.g., Israel). This paper describes the methods of a randomized controlled trial to test the efficacy of SAH compared to a treatment as usual comparison condition in Israel.

Methods

300 men referred (court-, clinically-, and self-referred) to IPV intervention from adult outpatient clinics at Social Affairs and Social Services offices in Israel will be randomly assigned to the SAH intervention or a treatment-as-usual comparison group. Outcomes are measured at six timepoints (baseline, post-treatment, and four 3-month follow-ups). The primary outcome is use of IPV; however, we will also examine reductions in SIP deficits. Secondary outcomes include symptoms of posttraumatic stress disorder (PTSD), depression, and anxiety, and changes in emotion regulation strategies.

Conclusion

Study findings will determine the efficacy of SAH in a civilian population and in a different cultural context. Additionally, findings will determine whether SIP is a mechanism of change for such intervention.

背景：创伤和亲密伴侣暴力（IPV）的社会信息处理模型（SIP）强调创伤对一个人准确处理社会信息的能力的影响，以及随之而来的无法产生和实施非攻击性反应的问题。最近的临床试验证据表明，"在家的力量"（SAH）干预--一个基于该模式的 12 节课程--对于减少和终止美国退伍军人的虐待行为是有效的。然而，这样的临床试验尚未在平民群体中或不同的文化背景下（如以色列）进行过。本文介绍了一项随机对照试验的方法，该试验旨在测试 SAH 在以色列与常规治疗对比条件下的疗效。方法：将从以色列社会事务和社会服务办公室的成人门诊诊所转介 300 名男性（法院转介、临床转介和自我转介）到 IPV 干预组，并随机分配到 SAH 干预组或常规治疗对比组。结果将在六个时间点（基线、治疗后和四个为期三个月的随访）进行测量。主要结果是使用 IPV；但是，我们也将检查 SIP 缺陷的减少情况。次要结果包括创伤后应激障碍（PTSD）、抑郁和焦虑症状，以及情绪调节策略的变化：研究结果将确定 SAH 在平民群体和不同文化背景下的疗效。此外，研究结果还将确定 SIP 是否是此类干预的改变机制。

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引用次数: 0

A one-day acceptance and commitment therapy workshop for the prevention of chronic post-surgical pain and long-term opioid use following spine surgery: Protocol for a pilot feasibility randomized controlled trial 为期一天的接受和承诺治疗研讨会，预防脊柱手术后慢性术后疼痛和长期阿片类药物使用：一项试点可行性随机对照试验方案。

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials

Pub Date : 2025-02-01 DOI: 10.1016/j.cct.2024.107785

Jolin B. Yamin , Bethany D. Pester , Ramya Kommu , Caroline Allen , Diya Dharmendran , Kylie Steinhilber , Madelyn Crago , Savannah Kazemipour , Angelina Franqueiro , Delia Fentazi , Kristin L. Schreiber , Robert R. Edwards , Robert N. Jamison , Samantha M. Meints

Background

Back pain is increasingly common, leading to more spine surgeries. While most people experience pain relief and improved function after surgery, many continue to suffer from chronic post-surgical pain (CPSP) with limited functional improvement. CPSP is often treated with opioids, raising concerns about misuse, poor functional outcomes, and broader public health impacts. Therefore, perioperative interventions are needed to enhance outcomes and reduce the risk of opioid misuse after surgery.

Objective

This article outlines a study protocol evaluating the feasibility, acceptability, and preliminary efficacy of a brief, perioperative Acceptance and Commitment Therapy (ACT) intervention aimed at improving pain and reducing opioid use after spine surgery.

Design

In this pilot randomized controlled trial, participants scheduled for spine surgery (anticipated N = 100) are assigned to the ACT intervention or a treatment-as-usual group.

Intervention

The ACT intervention is a 5-h, single-session, virtual workshop with a booster call two weeks post-workshop or post-surgery, whichever is later.

Outcome measures

The primary outcome is patient-reported treatment helpfulness immediately after the intervention. Secondary outcomes include patient-reported treatment credibility and expectancy post-intervention, treatment helpfulness at 1 month post-surgery, and pain interference, pain intensity and opioid use at 1, 3, and 6 months post-surgery.

Conclusion

This pilot trial examines a novel, brief ACT intervention aimed at preventing CPSP and reducing opioid dependence. If successful, feasibility and preliminary efficacy results will be utilized to inform a future, full-scale randomized trial of this intervention.

背景：背部疼痛越来越普遍，导致更多的脊柱手术。虽然大多数人在手术后经历疼痛缓解和功能改善，但许多人继续遭受慢性术后疼痛（CPSP），功能改善有限。CPSP通常用阿片类药物治疗，这引起了人们对滥用、不良功能结局和更广泛的公共卫生影响的担忧。因此，围手术期干预是必要的，以提高预后，降低术后阿片类药物滥用的风险。目的：本文概述了一项研究方案，评估了一种简短的围手术期接受和承诺治疗（ACT）干预的可行性、可接受性和初步疗效，旨在改善脊柱手术后疼痛和减少阿片类药物的使用。设计：在这项试点随机对照试验中，计划进行脊柱手术的参与者（预期N = 100）被分配到ACT干预组或常规治疗组。干预：ACT干预是一个5小时的单次虚拟研讨会，在研讨会后或手术后两周（以较晚者为准）进行一次强化电话会议。结果测量：主要结果是干预后患者报告的治疗效果。次要结局包括干预后患者报告的治疗可信度和期望，手术后1 个月的治疗帮助，以及手术后1、3和6 个月的疼痛干扰、疼痛强度和阿片类药物使用。结论：这项试点试验研究了一种新的、短暂的ACT干预措施，旨在预防CPSP和减少阿片类药物依赖。如果成功，可行性和初步疗效结果将用于该干预措施的未来全面随机试验。

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引用次数: 0