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Patient participation in clinical trials conducted by principal investigators who speak one or more language(s) beyond english: Exploring ethnicity as proxy for language 患者参与由讲一种或多种英语以外语言的主要研究者进行的临床试验:探索作为语言替代物的种族
IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-08-17 DOI: 10.1016/j.conctc.2024.101353

Background

To explore the association between ethnicity, as a proxy for language, and participation in clinical trials (CT) conducted by Principal Investigators (PI) who speak one or more language in addition to English.

Methods

This retrospective, descriptive study utilized CT participant demographic data extracted from the largest Midwestern non-profit healthcare system between January 1, 2019 and 12/31/2021. The CT participant sample (N = 4308) was divided for comparison: CT Participants of Hispanic or Latino Origin (N = 254; 5.90 %) and CT Participants of Non-Hispanic or Latino Origin (N = 4054; 94.10 %). Logistic regressions were performed to generate the crude and adjusted odds of patients of Hispanic or Latino origin participating in CTs conducted by PIs who speak another language in addition to English.

Results

Crude analysis revealed that patients of Hispanic or Latino ethnicity had 2.04 (1.58, 2.64) times greater odds of participating in CTs conducted by PIs who speak another language than English (<0.0001), which increased to 2.67 (1.97, 3.62) times greater odds after adjusting for sex, race, age and insurance (p < 0.0001).

Conclusions

Overall findings indicate that patients of Hispanic or Latino ethnicity, who are more likely to speak Spanish, have greater odds of participating in CTs conducted by PIs who speak another language beyond English. This may imply that cultural sensitivity at the top of a CT study team, as likely to be demonstrated by PIs who speak another language beyond English, may be an important contributor to reducing ethnicity- and language-based barriers to diversity in CTs and a relationship worth exploring further.

背景探讨作为语言替代物的种族与除英语外还会讲一种或多种语言的主要研究者(PI)参与临床试验(CT)之间的关联。方法这项回顾性、描述性研究利用了 2019 年 1 月 1 日至 2021 年 12 月 31 日期间从中西部最大的非营利性医疗保健系统中提取的 CT 参与者人口统计数据。为便于比较,对 CT 参与者样本(N = 4308)进行了划分:西班牙裔或拉丁裔 CT 参与者(N = 254;5.90%)和非西班牙裔或拉丁裔 CT 参与者(N = 4054;94.10%)。结果粗略分析显示,西班牙裔或拉丁裔患者参加由除英语外还会讲其他语言的主治医师主持的 CT 的几率是参加由除英语外还会讲其他语言的主治医师主持的 CT 的几率的 2.04 (1.58, 2.64) 倍(<0.结论总体研究结果表明,西班牙裔或拉丁裔患者更有可能讲西班牙语,他们参与由讲英语以外另一种语言的主治医师进行的 CT 的几率更大。这可能意味着,CT 研究团队高层的文化敏感性(除英语外还会讲另一种语言的 PI 可能会表现出这种敏感性)可能是减少基于种族和语言的 CT 多样性障碍的重要因素,这种关系值得进一步探讨。
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引用次数: 0
Assessing core outcome set uptake in randomized controlled trials for chronic kidney disease: Cross-sectional analysis 评估慢性肾脏病随机对照试验中核心结果集的采用情况:横断面分析
IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-08-15 DOI: 10.1016/j.conctc.2024.101347

Main problem

Chronic kidney disease (CKD) is a progressive condition that affects millions of people worldwide. A standardized core outcome set (COS) was developed for CKD by the International Consortium for Health Outcomes and Measurements in 2019. This study aims to evaluate the frequency of measurement for these outcomes before and after the publication of the COS.

Methods

A literature search was done to gather the phase III/IV clinical trials evaluating chronic kidney disease through ClinicalTrials.gov. Data extraction of included studies was completed in a masked, duplicate fashion. The included studies were evaluated for characteristics such as survival, burden of disease, patient-reported health-related quality of life, and treatment modality-specific outcomes.

Results

Our results showed that the majority of all COS domains were inadequately measured in CKD clinical trials before and after publication of the COS. Despite the increase in COS measurements following publication, the average percent of COS outcomes measured was less than 40 % per year even after four years.

Conclusion

There is a notable deficiency in the complete measurement of COS among all domains both before and after COS publication. We suggest efforts be made to improve the adoption of consistent outcome measures that would benefit the growing population of patients affected by CKD.

主要问题慢性肾脏病(CKD)是一种渐进性疾病,影响着全球数百万人。国际健康结果和测量联合会于 2019 年为 CKD 制定了一套标准化核心结果(COS)。本研究旨在评估 COS 发布前后这些结果的测量频率。方法通过 ClinicalTrials.gov 进行文献检索,收集评估慢性肾病的 III/IV 期临床试验。对纳入研究的数据提取是以蒙面、重复的方式完成的。结果我们的研究结果表明,在 COS 发布前后的 CKD 临床试验中,大多数 COS 领域的测量都不充分。结论在 COS 发布前后,对 COS 所有领域的全面测量都存在明显不足。我们建议努力改进采用一致的结果测量方法,使越来越多的慢性肾脏病患者受益。
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引用次数: 0
Recruitment and retention of pediatric participants for pandemic preparedness research: Experience from the PREMISE EV-D68 Pilot Study 招募和保留儿科参与者参与大流行病防备研究:PREMISE EV-D68 试点研究的经验
IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-08-14 DOI: 10.1016/j.conctc.2024.101351

Recruitment and retention are challenges for prospective pediatric cohort studies, particularly those involving serial venipunctures. We investigated factors underlying enrollment and retention in the Pandemic Response Repository through Microbial and Immune Surveillance and Epidemiology (PREMISE) Enterovirus D68 (EV-D68) Pilot Study, a multicenter prospective longitudinal cohort study assessing the utility of immunologic surveillance for pandemic preparedness. This study enrolls children ≤10 years for two blood draws, pre- and post-EV-D68 season, separated by 6–18 months. Overall, 174 children were enrolled in Cohort 1 of the study and 120 (69 %) of children completed the study, with follow-up blood samples obtained from 101 (58 %) of participants. Families were primarily motivated to participate by a desire to help other children, advance science, and better prepare for the next pandemic. Adding research blood draws to clinically indicated blood draws improved enrollment, and multiple study touch points facilitated retention. These findings can be applied to improve recruitment and retention in future pandemic preparedness efforts and longitudinal pediatric cohort studies.

对于前瞻性儿科队列研究,尤其是涉及连续静脉穿刺的研究来说,招募和保留是一项挑战。我们调查了 "通过微生物和免疫监测及流行病学(PREMISE)建立大流行响应库肠病毒 D68(EV-D68)试点研究 "的入组和保留因素,该研究是一项多中心前瞻性纵向队列研究,旨在评估免疫监测在大流行准备中的效用。这项研究对年龄小于 10 岁的儿童进行了两次抽血,分别在 EV-D68 流行季节之前和之后,间隔时间为 6-18 个月。共有 174 名儿童参加了第一组研究,其中 120 名(69%)儿童完成了研究,101 名(58%)参与者获得了后续血样。这些家庭参与研究的主要动机是希望帮助其他儿童,推动科学发展,并为下一次大流行做好更好的准备。在临床指征抽血的基础上增加研究性抽血可提高招募率,多个研究接触点也有助于留住参与者。这些发现可用于改善未来大流行准备工作和纵向儿科队列研究中的招募和保留情况。
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引用次数: 0
The neurobehavioural effects of cannabidiol in alcohol use disorder: Study protocol for a double-blind, randomised, cross over, placebo-controlled trial 大麻二酚对酒精使用障碍的神经行为影响:双盲、随机、交叉、安慰剂对照试验的研究方案
IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-08-13 DOI: 10.1016/j.conctc.2024.101341

Current treatments for alcohol use disorders (AUD) have limited efficacy. Recently, Cannabidiol (CBD) has been examined in a multitude of clinical settings. Preclinical and clinical results suggest that CBD might be particularly well suited for the treatment of AUD and may reduce alcohol cue and stress-induced craving and alcohol seeking. This study aims to investigate this new pharmacotherapy with a particular focus on neurobiological and physiological indicators of craving. Methods: In this double-blind, within-subject, randomised, placebo-controlled, cross-over study, non-treatment seekers will be randomly allocated to three days of four 200 mg CBD gel capsules (800 mg/day) or placebo, with an 18-day washout period. Cognitive, clinical, and neuroimaging assessments will be completed during these three days. The CBD and placebo assessments will be compared. The primary outcomes are i) BOLD signal as a proxy for regional activity during a cue reactivity and a fear response task measured with functional magnetic resonance imaging (fMRI), ii) heart rate variability and skin conductance levels as a proxy for psychophysiological responses to alcohol stimuli. The secondary outcomes are: i) neurometabolite levels (γ-Aminobutyric acid, ethanol, glutathione, and glutamate + glutamine (combined signal)) using magnetic resonance spectroscopy (MRS); ii) functional connectivity using resting state fMRI (rsfMRI); iii) executive functioning task results; iv) clinical outcomes such as craving, anxiety, and sleep. Discussion: This study will improve the understanding of the mechanisms of action of CBD and provide early signals of efficacy regarding the therapeutic potential of CBD in the treatment of alcohol use disorder.

ClinicalTrials.gov Identifier: NCT05387148.

目前治疗酒精使用障碍(AUD)的方法疗效有限。最近,大麻二酚(CBD)已在多种临床环境中得到研究。临床前和临床结果表明,大麻二酚可能特别适用于治疗 AUD,并可减少酒精线索和压力引起的渴求和酒精寻求。本研究旨在研究这种新的药物疗法,尤其关注渴求的神经生物学和生理学指标。研究方法在这项双盲、受试者内、随机、安慰剂对照、交叉研究中,未寻求治疗者将被随机分配到为期三天的四粒 200 毫克 CBD 凝胶胶囊(800 毫克/天)或安慰剂中,并有 18 天的冲洗期。认知、临床和神经影像学评估将在这三天内完成。将对 CBD 和安慰剂的评估结果进行比较。主要结果是:i)用功能磁共振成像(fMRI)测量 BOLD 信号,作为线索反应性和恐惧反应任务期间区域活动的代表;ii)心率变异性和皮肤电导水平,作为酒精刺激下心理生理反应的代表。次要结果包括:i) 利用磁共振波谱(MRS)测量神经代谢物水平(γ-氨基丁酸、乙醇、谷胱甘肽和谷氨酸+谷氨酰胺(组合信号));ii) 利用静息状态磁共振成像(rsfMRI)测量功能连接;iii) 执行功能任务结果;iv) 临床结果,如渴望、焦虑和睡眠。讨论:这项研究将增进人们对 CBD 作用机制的了解,并为 CBD 治疗酒精使用障碍的潜在疗效提供早期信号:NCT05387148。
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引用次数: 0
Continued confusion in mild traumatic brain injury hyperbaric oxygen studies 轻度脑外伤高压氧研究中的持续困惑
IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-08-12 DOI: 10.1016/j.conctc.2024.101348
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引用次数: 0
A prospective randomized controlled study of multi-intravenous infusion of umbilical cord mesenchymal stem cells in patients with heart failure and reduced ejection fraction (PRIME-HFrEF) trial: Rationale and design 心力衰竭和射血分数降低患者多静脉输注脐带间充质干细胞的前瞻性随机对照研究(PRIME-HFrEF)试验:原理与设计
IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-08-12 DOI: 10.1016/j.conctc.2024.101350

Background and objective

The use of mesenchymal stem cells for heart failure treatment has gained increasing interest. However, most studies have relied on a single injection approach, with no research yet confirming the effects of multiple administrations. The present trial aims to investigate the safety and efficacy of multi-intravenous infusion of umbilical cord-mesenchymal stem cells (UC-MSCs) in patients with heart failure and reduced ejection fraction (HFrEF).

Methods

The PRIME-HFrEF trial is a single-center, prospective, randomized, triple-blinded, placebo-controlled trial of multi-intravenous infusion of UC-MSCs in HFrEF patients. A total of 40 patients meeting the inclusion criteria for HFrEF were enrolled and randomized 1:1 to the MSC group or the placebo group. Patients enrolled will receive intravenous injections of either UC-MSCs or placebo every 6 weeks for three times. Both groups will be followed up for 12 months. The primary safety endpoint is the incidence of serious adverse events. The primary efficacy endpoint is a change in left ventricular ejection fraction (LVEF) measured by left ventricular opacification (LVO) with contrast echocardiography and magnetic resonance imaging (MRI) at 12 months. The secondary endpoints include a composite of the incidence of death and re-hospitalization caused by heart failure at the 12th month, serum NT-proBNP, growth stimulation expressed gene 2 (ST2), and a change of right ventricular structure and function.

Conclusions

The PRIME-HFrEF study is designed to shed new light on multiple UC-MSC administration regimens for heart failure treatment.

背景和目的间充质干细胞用于治疗心力衰竭的兴趣日益浓厚。然而,大多数研究都依赖于单次注射方法,尚未有研究证实多次给药的效果。方法PRIME-HFrEF试验是一项单中心、前瞻性、随机、三重盲、安慰剂对照试验,在HFrEF患者中多次静脉注射脐带间充质干细胞(UC-MSCs)。共有 40 名符合 HFrEF 纳入标准的患者入选,并按 1:1 随机分配到间充质干细胞组或安慰剂组。入组患者将接受静脉注射 UC 间充质干细胞或安慰剂,每 6 周一次,共注射 3 次。两组患者都将接受 12 个月的随访。主要安全性终点是严重不良事件的发生率。主要疗效终点是12个月时通过对比超声心动图和磁共振成像(MRI)测量的左心室射血分数(LVEF)的变化。次要终点包括第 12 个月时因心衰死亡和再次住院的发生率、血清 NT-proBNP、生长刺激表达基因 2 (ST2) 以及右心室结构和功能的变化。
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引用次数: 0
A randomized controlled trial protocol for the introduction of a multidisciplinary individualized nutritional intervention in children with cerebral palsy 为脑瘫儿童引入多学科个性化营养干预的随机对照试验方案
IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-08-07 DOI: 10.1016/j.conctc.2024.101343

Introduction

Children with Cerebral Palsy (CP) encounter substantial nutritional challenges that impair their health and quality of life. Despite the importance of nutrition in managing CP and the recognition of physiological, behavioral, and social causes of malnutrition, research on the effectiveness of individualized nutritional interventions developed and supported by multidisciplinary teams is scarce.

Aim

The study will evaluate the impact of an individualized nutritional intervention developed and supported by a multidisciplinary team on the anthropometric outcomes and overall health of children with CP.

Methods

A single-center, randomized controlled trial, conducted at the Medical University of Varna, Bulgaria, will enroll 100 children aged 2–12 years and diagnosed with CP. Participants will be randomly assigned to either an intervention group, receiving comprehensive structured dietary assessment and individualized nutrition plan developed by a multidisciplinary team of experts, or to a standard care group. Outcomes assessed will focus on anthropometric measures of nutritional status, but also include health outcomes, child development and clinical assessments, and quality of life indicators.

Ethics

Ethical approval for this study has been obtained from the Medical Ethics Committee at the Medical University of Varna (Protocol No. 134 dated 20.07.2023).

Conclusion

This study will assess the benefits of a multidisciplinary, individualized nutritional intervention for children with CP. The findings will have implications for clinical guidelines and interventions aiming to improve their care and quality of life.

导言脑瘫(CP)儿童面临着巨大的营养挑战,这损害了他们的健康和生活质量。该研究将评估由多学科团队开发和支持的个性化营养干预对 CP 儿童人体测量结果和整体健康的影响。方法在保加利亚瓦尔纳医科大学进行的单中心随机对照试验将招募 100 名年龄在 2-12 岁、被诊断为 CP 的儿童。参与者将被随机分配到干预组(接受由多学科专家团队制定的全面结构化饮食评估和个性化营养计划)或标准护理组。评估结果将侧重于营养状况的人体测量指标,但也包括健康结果、儿童发育和临床评估以及生活质量指标。伦理本研究已获得瓦尔纳医科大学医学伦理委员会的伦理批准(2023 年 7 月 20 日第 134 号协议)。研究结果将对旨在改善其护理和生活质量的临床指南和干预措施产生影响。
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引用次数: 0
Sample size considerations for single-arm clinical trials with time-to-event endpoint using the gamma distribution 使用伽马分布的单臂临床试验中时间到事件终点的样本量考虑因素
IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-08-02 DOI: 10.1016/j.conctc.2024.101344

Background

Time-to-event (TTE) endpoints are evaluated as the primary endpoint in single-arm clinical trials; however, limited options are available in statistical software for sample size calculation. In single-arm trials with TTE endpoints, the non-parametric log-rank test is commonly used. Parametric options for single-arm design assume survival times follow exponential distribution or Weibull distribution.

Methods

The exponential- or Weibull-distributed survival time assumption does not always reflect hazard pattern of real-life diseases. We therefore propose gamma distribution as an alternative parametric option for designing single-arm studies with TTE endpoints. We outline a sample size calculation approach using gamma distribution with a known shape parameter and explain how to extract the gamma shape estimate from previously published resources. In addition, we conduct simulations to assess the accuracy of the extracted gamma shape parameter and to explore the impact on sample size calculation when survival time distribution is misspecified.

Results

Our simulations show that if a previously published study (sample sizes 60 and censoring proportions 20 %) reported median and inter-quartile range of survival time, we can obtain a reasonably accurate gamma shape estimate, and use it to design new studies. When true survival time is Weibull-distributed, sample size calculation could be underestimated or overestimated depending on the hazard shape.

Conclusions

We show how to use gamma distribution in designing a single-arm trial, thereby offering more options beyond the exponential and Weibull. We provide a simulation-based assessment to ensure an accurate estimation of the gamma shape and recommend caution to avoid misspecification of the underlying distribution.

背景时间-事件(TTE)终点在单臂临床试验中作为主要终点进行评估;然而,统计软件中用于样本量计算的选项有限。在以 TTE 为终点的单臂试验中,通常使用非参数对数秩检验。方法指数分布或 Weibull 分布的生存时间假设并不总能反映现实生活中疾病的危害模式。因此,我们建议将伽玛分布作为设计 TTE 终点单臂研究的另一种参数选择。我们概述了使用已知形状参数的伽玛分布计算样本量的方法,并解释了如何从以前发表的资料中提取伽玛形状估计值。此外,我们还进行了模拟,以评估提取的伽玛形状参数的准确性,并探讨当生存时间分布被错误指定时对样本量计算的影响。结果我们的模拟显示,如果以前发表的研究(样本量≥60,删减比例≤20%)报告了生存时间的中位数和四分位间范围,我们就能获得相当准确的伽玛形状估计值,并用它来设计新的研究。结论我们展示了如何在设计单臂试验时使用伽马分布,从而在指数分布和威布尔分布之外提供更多选择。我们提供了一种基于模拟的评估方法,以确保准确估计伽马分布的形状,并建议小心谨慎,避免对基础分布进行错误规范。
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引用次数: 0
Maximizing the reach of universal child sexual abuse prevention: Protocol for an equivalence trial 最大限度地普及儿童性虐待预防措施:等效试验方案
IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-07-31 DOI: 10.1016/j.conctc.2024.101345

Background

Child sexual abuse (CSA) affects 1 in 5 girls and 1 in 12 boys before age 18. Universal school-based prevention programs are an effective and cost-efficient method of teaching students an array of personal safety skills. However, the programmatic reach of universal school-based programs is limited by the inherent reliance on the school infrastructure and a dearth of available alternative delivery modalities.

Methods

The design for this study will use a rigorous cluster randomized design (N = 180 classrooms) to determine the equivalence of two delivery modalities of Safe Touches: as usual vs. modified. The as usual workshop will be delivered by two facilitators with live puppet skits (n = 90). Whereas, the modified workshop will be delivered by one facilitator using prerecorded skit videos (n = 90). We will determine the equivalence by measuring concept learning acquisition preworkshop to immediate postworkshop (Aim 1) and retention at 3-months postworkshop (Aim 2) among students in classrooms that receive the as usual or modified workshops. To conclude equivalence, it is imperative to also examine factors that may impact future dissemination and implementation, specifically program adoption among school personnel and implementation fidelity between the two modalities (Aim 3).

Conclusion

Study findings will inform the ongoing development of effective CSA prevention programs and policy decisions regarding the sustainable integration of such programs within schools.

Clinical trial registration

NCT06195852.

背景儿童性虐待(CSA)影响着 18 岁前五分之一的女孩和十二分之一的男孩。普及校本预防计划是教授学生一系列个人安全技能的有效且经济的方法。本研究将采用严格的分组随机设计(N = 180 间教室),以确定 "安全触摸 "的两种授课方式的等效性:照常授课与改良授课。常规工作坊将由两名主持人以木偶剧的形式进行(人数=90)。而修改后的工作坊将由一名主持人使用预先录制的短剧视频进行讲授(人数 = 90)。我们将通过测量工作坊前和工作坊后学生的概念学习掌握情况(目标 1)以及工作坊后 3 个月学生的概念学习保持情况(目标 2)来确定工作坊的等效性。为了得出等效性结论,还必须研究可能影响未来传播和实施的因素,特别是学校工作人员对项目的采纳情况以及两种模式之间的实施保真度(目标 3)。结论研究结果将为有效的 CSA 预防项目的持续发展以及有关在学校内可持续整合此类项目的政策决策提供信息。
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引用次数: 0
Combining one-session treatment with a homework program including app-based technology to enhance the treatment of childhood specific phobias: A study protocol of a multicenter pragmatic randomized controlled trial 将一次疗程治疗与包括应用程序技术在内的家庭作业计划相结合,加强对儿童特定恐惧症的治疗:多中心实用随机对照试验的研究方案
IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-07-30 DOI: 10.1016/j.conctc.2024.101346

Introduction

Childhood specific phobias are among the most common and earliest onset mental disorders with a lifetime prevalence of more than ten percent. Brief intensive cognitive behavioral therapy (CBT) programs such as the One-Session Treatment (OST) are found to be effective in the remission of the specific phobias following treatment, but there is still room for improvement. The goal of the current study is to examine whether the long-term efficacy of OST increases by using a homework program supported by an app specifically designed for children; the Kids Beat Anxiety (KibA) homework program.

Methods

Children aged between 7 and 14 years with a specific phobia receive OST preceded by a three-week baseline phase to control for time-effects. Directly following OST, children are randomized to either a four-week homework period supported by an app (OST + app), or standard One-Session Treatment with a four-week homework period that is only supported by therapist instructions (OST-only). Primary outcome variables are diagnosis and severity of the specific phobia. Secondary outcomes include behavioral avoidance, self-reported fear, and functional impairment. Data will be analyzed based on intention-to-treat and per protocol samples using mixed-effects multilevel linear models.

Ethics and dissemination

The current study was approved by the METC of the Academic Medical Center, Amsterdam, The Netherlands (number: NL72697.018.20) and the Ethical Committee of the Ruhr University, Bochum, Germany (number: 663). Results of this trial will be published in peer-reviewed journals.

Trial registration

The study was pre-registered at the Dutch Trial Register, number: NL 9216.

导言:儿童特异性恐惧症是最常见、发病最早的精神障碍之一,终生患病率超过百分之十。简短强化认知行为疗法(CBT)项目,如 "一疗程疗法"(OST),在治疗后可有效缓解特异性恐惧症,但仍有改进的余地。本研究的目的是通过使用一个由专门为儿童设计的应用程序(儿童战胜焦虑(KibA)家庭作业程序)支持的家庭作业程序,来检验 OST 的长期疗效是否会提高。方法7 至 14 岁患有特定恐惧症的儿童在接受 OST 治疗之前,先接受为期三周的基线阶段治疗,以控制时间效应。OST 结束后,孩子们会被随机分配到一个为期四周、由应用程序支持的家庭作业阶段(OST + 应用程序),或一个为期四周、仅由治疗师指导的家庭作业阶段(仅 OST)。主要结果变量是特定恐惧症的诊断和严重程度。次要结果包括行为回避、自我报告的恐惧和功能障碍。本研究已获得荷兰阿姆斯特丹学术医学中心 METC(编号:NL72697.018.20)和德国波鸿鲁尔大学伦理委员会(编号:663)的批准。该试验的结果将在同行评审期刊上发表。试验登记该研究已在荷兰试验登记处进行了预先登记,登记号为 NL 9216:NL 9216。
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引用次数: 0
期刊
Contemporary Clinical Trials Communications
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