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Evaluating the relaxation effects of Shikuwasa (Citrus depressa Hayata) essential oil inhalation in young female adults: Study protocol for a randomised controlled trial 评估吸入 Shikuwasa(早田郁金香)精油对年轻女性成年人的放松效果:随机对照试验的研究方案
IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-07-26 DOI: 10.1016/j.conctc.2024.101342
Fumitake Yamaguchi , Naoki Yoshinaga , Miho Kuroki , Rie Nakasone , Hisanori Kenmotsu , Toshio Ueno , Yukihiro Yada , Michikazu Nakai , Yasuji Arimura

Introduction

The essential oil of Shikuwasa (Citrus depressa Hayata) primarily contains limonene and γ-terpinene, which have potential applications in stress management and relaxation. However, the psychological or physiological relaxation effects of Shikuwasa essential oil on humans are still unknown. This study aims to investigate the short-term relaxation effects of Shikuwasa essential oil, one of the less-studied varieties, compared to inhaling odour-free air in young female adults.

Methods

and analysis: This study is a two-arm, parallel-group, open-label, randomised controlled superiority trial. Forty young female adults will be assigned with a 1:1 allocation ratio to either the Shikuwasa essential oil inhalation group or the odour-free air inhalation group. The primary outcome measure will be subjective tense arousal (subscale of the Japanese version of the University of Wales Institute of Science and Technology Mood Adjective Checklist). Secondary outcomes include objective measures: miosis rate and peripheral skin temperature for evaluating autonomic nervous activity, and cerebral blood flow (assessed using near-infrared spectroscopy) for evaluating central nervous activity. Since these objective outcome measures cannot be performed at the same time, we divide our experiment into three phases and participants will inhale sample vials for 2 min in each experiment. We will also evaluate individual preferences/impressions regarding inhaled samples and any adverse events.

Ethics and dissemination

The study protocol has been reviewed and approved by the Research Ethics Committee of the Faculty of Medicine, University of Miyazaki (reference no: I-0074). The findings of this study will be disseminated to academic and professional audiences via publications in peer-reviewed journals and presentations at academic conferences, and to the broader public via public talks and media/press releases. All study findings, whether negative or positive, will be reported.

Trial registration

UMIN Clinical Trials Registry (UMIN-CTR), UMIN000053914. Prospectively registered on March 20, 2024.

引言 四葛(Citrus depressa Hayata)精油主要含有柠檬烯和γ-萜品烯,可用于压力管理和放松。然而,Shikuwasa 精油对人类的心理或生理放松效果仍然未知。本研究旨在调查 Shikuwasa 精油(研究较少的品种之一)与吸入无味空气相比对年轻女性成年人的短期放松效果:本研究是一项双臂、平行组、开放标签、随机对照的优效试验。40 名年轻女性成人将按 1:1 的分配比例被分配到吸入 Shikuwasa 精油组或吸入无味空气组。主要结果是主观紧张唤醒(威尔士科技大学情绪形容词检查表日语版的分量表)。次要结果包括客观测量:用于评估自律神经活动的瞳孔缩小率和外周皮肤温度,以及用于评估中枢神经活动的脑血流量(使用近红外光谱评估)。由于这些客观结果测量无法同时进行,我们将实验分为三个阶段,参与者将在每个实验中吸入样品瓶 2 分钟。我们还将评估个人对吸入样本的偏好/印象以及任何不良事件。伦理和传播本研究方案已通过宫崎大学医学系研究伦理委员会的审查和批准(参考编号:I-0074)。本研究的结果将通过在同行评审期刊上发表文章和在学术会议上发表演讲的方式向学术和专业受众传播,并通过公开讲座和媒体/新闻稿向更广泛的公众传播。所有研究结果,无论是负面的还是正面的,都将被报道。试验注册UMIN临床试验注册中心(UMIN-CTR),UMIN000053914。前瞻性注册日期为 2024 年 3 月 20 日。
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引用次数: 0
A smartphone app-based mindfulness intervention to enhance recovery from substance use disorders: Protocol for a pilot feasibility randomized controlled trial 基于智能手机应用程序的正念干预,促进药物使用障碍的康复:试点可行性随机对照试验方案
IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-07-26 DOI: 10.1016/j.conctc.2024.101338
Corey R. Roos , Jonathan Bricker , Brian Kiluk , Timothy J. Trull , Sarah Bowen , Katie Witkiewitz , Hedy Kober

Background

Poor long-term recovery outcomes after treatment (e.g., readmission to inpatient treatment) are common among individuals with substance use disorders (SUDs). In-person mindfulness-based treatments (MBTs) are efficacious for SUDs and may improve recovery outcomes. However, existing MBTs for SUD have limited public health reach, and thus scalable delivery methods are needed. A digitally-delivered MBT for SUDs may hold promise.

Methods

We recently developed Mindful Journey, a smartphone app-based adjunctive MBT for improving long-term recovery outcomes. In this paper, we present details on the app and describe the protocol for a single-site pilot feasibility randomized controlled trial of Mindful Journey. In this trial, individuals (n = 34) in an early phase of outpatient treatment for SUDs will be randomized to either treatment-as-usual (TAU) plus Mindful Journey, or TAU only. The trial will focus on testing the feasibility (e.g., engagement) and acceptability of the app (e.g., perceived usability and helpfulness for recovery), as well as feasibility of study procedures (e.g., assessment completion). The trial will incorporate ecological momentary assessment before and after treatment to assess mechanisms in real-time, including mindfulness, craving, difficulties with negative emotion regulation, and savoring. To examine the sensitivity to change of outcomes (substance use, substance-related problems, and psychological distress) and mechanism variables (noted above), we will test within-treatment-condition changes over time.

Discussion

The proposed pilot trial will provide important preliminary data on whether Mindful Journey is feasible and acceptable among individuals with SUDs.

Trial registration

ClinicalTrials.gov NCT05109507.

背景在药物使用障碍(SUD)患者中,治疗后长期康复效果不佳(如再次入院治疗)的情况很常见。面对面的正念治疗(MBTs)对药物滥用性精神障碍(SUDs)具有疗效,并可改善康复结果。然而,现有的基于正念的治疗方法对公众健康的影响有限,因此需要可扩展的治疗方法。我们最近开发了 "心灵之旅"(Mindful Journey),这是一种基于智能手机应用程序的辅助性戒毒治疗方法,可改善长期康复效果。在本文中,我们将详细介绍该应用程序,并描述 "心灵之旅 "单点试点可行性随机对照试验的方案。在这项试验中,处于门诊治疗早期阶段的 SUD 患者(n = 34)将被随机分配到 "常规治疗"(TAU)加 "心灵之旅"(Mindful Journey)或 "常规治疗"(TAU)中。试验将重点测试应用程序的可行性(如参与度)和可接受性(如感知可用性和对康复的帮助),以及研究程序的可行性(如评估完成度)。试验将结合治疗前后的生态瞬间评估,以实时评估各种机制,包括正念、渴求、负面情绪调节困难和品味。为了检查结果(药物使用、药物相关问题和心理困扰)和机制变量(如上所述)变化的敏感性,我们将测试治疗条件内随着时间的推移而发生的变化。讨论拟议的试点试验将提供重要的初步数据,说明 "正念之旅 "在患有药物依赖性疾病的个体中是否可行和可接受。
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引用次数: 0
Music therapy with adults in the subacute phase after stroke: A study protocol 对中风后处于亚急性阶段的成人进行音乐治疗:研究方案
IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-07-25 DOI: 10.1016/j.conctc.2024.101340
Theo Dimitriadis , Mohammed A. Mudarris , Dieuwke S. Veldhuijzen , Andrea W.M. Evers , Wendy L. Magee , Rebecca S. Schaefer

Stroke is a highly disabling condition, for which music therapy is regularly used in rehabilitation. One possible mechanism for the effects of music therapy is the motivational aspect of music, for example regarding treatment adherence based on improved mood. In this study, changes in motivation related to Neurologic Music Therapy (NMT) techniques during rehabilitation in the subacute phase after stroke will be investigated. Using a randomised within-subjects cross-over design, the effects of two NMT techniques and related motivational indices will be investigated. Data will be collected at three timepoints: baseline (TP1), after being randomised into groups and receiving NMT or standard care (TP2), and then at a third time point after the cross-over and having received both conditions (TP3). This design allows to counteract order effects, time effects due to spontaneous and/or nonlinear recovery, as well as single-subject comparisons in a relatively heterogeneous sample. Twenty adult participants who have experienced a supratentorial ischaemic or haemorrhagic stroke and are experiencing upper-limb impairments and/or cognitive deficits will be included. Behavioural measures of motor function, cognition, and quality of life will be collected, along with self-reported indices of overall motivation. The study outcomes will have implications for the understanding of the underlying mechanisms of music therapy in stroke recovery, more specifically regarding the relevance of motivational states in neurorehabilitation.

中风是一种高度致残的疾病,音乐疗法经常被用于康复治疗。音乐疗法产生效果的一个可能机制是音乐的激励作用,例如在改善情绪的基础上坚持治疗。本研究将调查中风后亚急性阶段康复过程中与神经音乐治疗(NMT)技术相关的动机变化。研究将采用随机受试者内交叉设计,调查两种 NMT 技术和相关动机指数的效果。数据将在三个时间点收集:基线(TP1)、随机分组并接受 NMT 或标准护理后(TP2),以及交叉后的第三个时间点(TP3)。这种设计可以抵消顺序效应、自发和/或非线性恢复导致的时间效应,以及在相对异质的样本中进行的单个受试者比较。研究将包括 20 名经历过脑室上缺血性或出血性中风、上肢功能障碍和/或认知障碍的成年参与者。将收集有关运动功能、认知和生活质量的行为测量指标,以及总体动机的自我报告指标。研究结果将有助于了解音乐疗法在中风康复中的潜在机制,特别是动机状态在神经康复中的相关性。
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引用次数: 0
Adjunctive methylphenidate extended release in patients with schizophrenia: Protocol of a single-centre fixed dose cross-over open-label trial to improve functional and cognitive outcomes 精神分裂症患者辅助使用哌醋甲酯缓释剂:旨在改善功能和认知结果的单中心固定剂量交叉开放标签试验方案
IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-07-25 DOI: 10.1016/j.conctc.2024.101337
Naista Zhand , David Attwood , Alain Labelle , Ridha Joober , Carrie Robertson , Philip D. Harvey

Background

Cognitive symptoms, among the core symptoms of schizophrenia, are associated with poor functional outcome and burden of illness. To date, there is no effective pharmacological treatment for these symptom clusters. Augmentation with psychostimulants has been proposed as a potential treatment option.

Objectives

The present study aims to assess off-label use of adjunctive methylphenidate extended release (ER) in patients with schizophrenia who are stable on antipsychotic medications, and to assess its efficacy on functioning and cognitive outcome.

Methods

This is a single centre study at the Royal Ottawa Mental Health Centre. An open-label fixed dose controlled cross-over trial is planned. Eligible participants will be randomized into one of two arms of the study: 1) four weeks of add-on methylphenidate ER 36 mg, or 2) four weeks of treatment as usual. At 4 weeks, participants will switch arms. The duration of the study includes 8 weeks of treatment and a follow-up visit at 12 weeks. Primary outcome measures include tablet-based tests of functioning and cognition (VRFCAT and BAC) and will be administered at baseline and every 4 weeks. We are aiming to recruit a total of 24 participants.

Expected outcomes

The proposed project intends to assess a potential treatment option for cognitive deficits of schizophrenia, for which there are no recommendations by current treatment guidelines. The novelty and significance of the current study is that it investigates this intervention and assess applicability of it in a “real world setting” in a tertiary care hospital.

背景认知症状是精神分裂症的核心症状之一,与不良的功能预后和疾病负担有关。迄今为止,还没有针对这些症状群的有效药物治疗方法。本研究旨在对稳定服用抗精神病药物的精神分裂症患者在标签外使用哌醋甲酯缓释剂(ER)进行评估,并评估其对患者功能和认知结果的疗效。计划进行一项开放标签固定剂量对照交叉试验。符合条件的参与者将被随机分配到两组研究中的一组:1)接受为期四周的哌醋甲酯 ER 36 毫克附加治疗,或 2)接受为期四周的常规治疗。4周后,参与者将互换治疗组。研究持续时间包括 8 周的治疗和 12 周的随访。主要结果测量包括基于片剂的功能和认知测试(VRFCAT 和 BAC),将在基线和每 4 周进行一次。我们的目标是共招募 24 名参与者。预期成果拟议项目旨在评估精神分裂症认知缺陷的潜在治疗方案,目前的治疗指南尚未对此提出建议。本研究的新颖性和重要意义在于,它调查了这种干预方法,并评估了它在一家三甲医院的 "真实环境 "中的适用性。
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引用次数: 0
A clinical randomized trial: Effects of early application of sacubitril/valsartan on ventricular remodeling and prognosis in acute myocardial infarction patients 临床随机试验:早期应用沙库比妥/缬沙坦对急性心肌梗死患者心室重塑和预后的影响
IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-07-25 DOI: 10.1016/j.conctc.2024.101303
Zhengfeng Liu , Kun Cui , Guangdong Wang , Wenqing Jin , Qiong Yao , Yuanzheng Zhang

Objectives

To explore the effects of early application of sacubitril/valsartan on ventricular remodeling and prognosis in patients with acute myocardial infarction (AMI).

Methods

Total of 295 patients with AMI admitted to the hospital were enrolled between August 2019 and August 2021. According to different treatment methods, they were divided into observation group (sacubitril/valsartan sodium tables combined with standard treatment, 132 patients) and control group (benazepril hydrochloride tablets combined with standard treatment, 163 patients). The levels of plasma N-terminal pro-brain natriuretic peptide (NT-proBNP), creatinine (Cr) and serum K+ before and at 6 months after treatment, standard deviation of all normal-to-normal intervals (SDNN), standard deviation of the average all normal-to-normal intervals (SDANN), root mean square of differences between adjacent normal-to-normal intervals/root mean square differences of successive R-R (RMSSD), left ventricular end-diastolic volume (LVEDV), left ventricular ejection fraction (LVEF) and left ventricular end-systolic volume (LVESV) in the two groups were compared. The adverse reactions during treatment and major adverse cardiac events (MACE) during 6 months of follow-up in both groups were statistically analyzed.

Results

The levels of NT-proBNP, Cr and K+, LVEDV and LVESV in observation group were significantly lower than those in control group (P < 0.05), while LVEF, SDNN, SDANN and RMSSD were significantly higher than those in control group (P < 0.05). The incidence of MACE in observation group was lower than that in control group during 6 months of follow-up (7.58 % vs 27.61 %, P < 0.05), but there was no significant difference in the incidence of adverse reactions (9.85 % vs 12.88 %, P > 0.05).

Conclusion

Early application of sacubitril/valsartan sodium can effectively delay ventricular remodeling, improve cardiac function and heart rate variability indexes, reduce NT-proBNP level and improve prognosis in AMI patients.
摘要] 目的 探讨早期应用沙库比特利/缬沙坦对急性心肌梗死(AMI)患者心室重构及预后的影响。 方法 选取2019年8月-2021年8月期间该院收治的AMI患者共295例。根据治疗方法的不同,分为观察组(沙库比特利/缬沙坦钠片联合标准治疗,132例)和对照组(盐酸贝那普利片联合标准治疗,163例)。治疗前和治疗后 6 个月的血浆 N 端前脑钠肽 (NT-proBNP)、肌酐 (Cr) 和血清 K+ 水平、所有正常至正常区间的标准偏差 (SDNN)、所有正常至正常区间平均值的标准偏差 (SDANN)、比较两组相邻正常间期差的均方根/连续 R-R 差的均方根(RMSSD)、左室舒张末期容积(LVEDV)、左室射血分数(LVEF)和左室收缩末期容积(LVESV)。结果 观察组NT-proBNP、Cr、K+、LVEDV、LVESV水平显著低于对照组(P< 0.05),而LVEF、SDNN、SDANN、RMSSD显著高于对照组(P< 0.05)。结论早期应用沙库比特利/缬沙坦钠可有效延缓AMI患者心室重构,改善心功能和心率变异性指标,降低NT-proBNP水平,改善预后。
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引用次数: 0
Design and methodology of the first open-label trial of MDMA-assisted therapy for veterans with post-traumatic stress disorder and alcohol use disorder: Considerations for a randomized controlled trial 针对患有创伤后应激障碍和酒精使用障碍的退伍军人的首个开放标签试验--MDMA 辅助疗法的设计与方法:随机对照试验的注意事项
IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-07-20 DOI: 10.1016/j.conctc.2024.101333
Erica Eaton , Christy Capone , Brian J. Gully , Zoe E. Brown , Mollie Monnig , Michael S. Worden , Robert M. Swift , Carolina L. Haass-Koffler

Background

Posttraumatic stress disorder (PTSD) and alcohol use disorder (AUD) commonly co-occur and are associated with more severe symptomatology than either disorder alone, increased risk of suicide, and poorer response to existing treatments. A promising therapeutic intervention is the integration of 3,4-methylenedioxymethamphetamine (MDMA) and psychotherapy. The Food and Drug Administration (FDA) designated MDMA- assisted therapy (MDMA-AT) as a Breakthrough Therapy for PTSD based on results from six Phase 2 clinical trials. Case data from the first study evaluating MDMA-AT study for AUD found the treatment was well tolerated and alcohol use was significantly reduced post treatment.

Methods

This manuscript reports the premise, design, and methodology of the first open-label trial of MDMA-AT for military veterans (N = 12) with PTSD and AUD. Neuroimaging and biomarker data are included to evaluate brain changes, and neuroinflammation, pre-post treatment.

Conclusions

The clinical component (comorbidity) and the regulatory processes (Schedule I drug) for setting up this clinical trial are long and complex. The research community will benefit from this work to establish common clinical trial outcomes, standardized protocols, and risk assessments for FDA approval.

Clinicaltrials.gov

NCT05943665.

背景创伤后应激障碍(PTSD)和酒精使用障碍(AUD)通常同时存在,而且症状比单独存在的任何一种障碍都严重,自杀风险增加,对现有治疗方法的反应较差。3,4-亚甲二氧基甲基苯丙胺(MDMA)与心理治疗相结合是一种很有前景的治疗干预方法。美国食品和药物管理局(FDA)根据六项二期临床试验的结果,将亚甲二氧基甲基苯丙胺辅助疗法(MDMA-AT)指定为治疗创伤后应激障碍的突破性疗法。本手稿报告了针对患有创伤后应激障碍和 AUD 的退伍军人(N = 12)进行的首次 MDMA-AT 开放标签试验的前提、设计和方法。其中包括神经影像学和生物标志物数据,以评估治疗前和治疗后的大脑变化和神经炎症。结论:建立这项临床试验的临床部分(合并症)和监管过程(一级药物)漫长而复杂。研究界将从这项工作中获益,以建立通用的临床试验结果、标准化方案和风险评估,从而获得 FDA 批准。
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引用次数: 0
Balance chiropractic therapy for cervical spondylotic radiculopathy: A randomized controlled trial 治疗颈椎根性病变的平衡整脊疗法:随机对照试验
IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-07-14 DOI: 10.1016/j.conctc.2024.101323
Wenxiong Li , Yaxin Chang , Qi Feng , Yan Cheng , Jichao Yin , Yindi Sun , Feng Yang

Objective

To assess the clinical effectiveness of the balance chiropractic therapy (BCT) compared with traction therapy (TT) for patients with cervical spondylotic radiculopathy.

Methods

Subjects were enrolled from four hospitals. Eligible patients will be randomized to one of the two arms: the treatment group and the control group. In the treatment group, patients received the BCT for 20 days, while patients in the control group received TT. Patients visited the physician at 1- and 3-month follow-up. The primary outcome was pain severity measured with a Visual Analog Scale (VAS). Secondary outcomes included cervical curvature measured using the Borden method, a composite of functional status measured by the Neck Disability Index (NDI), patient health status (evaluated by the SF-36 health survey) and adverse events (AEs) as reported in the trial.

Results

Of the 240 randomly assigned patients, 120 participants were assigned to the BCT and 120 to the TT. 231 (96.3 %) provided follow-up data at 1 and 3 months. There were no significant differences in baseline data between the two groups (P > 0.05), indicating good comparability. According to the results, after BCT and TT treatment, the pain VAS score, cervical curvature, NDI scores and SF-36 scores of two groups was significantly improved (P < 0.05). Furthermore, at 20 days of treatment and 1 and 3 months of follow-up, the participants in the BCT group showed superior treatment outcomes on both primary and secondary measures.

Conclusion

The BCT may be a novel strategy for the treatment of the cervical spondylotic radiculopathy.

Trial registration

Clinical Trials.gov Identifier: NCT02705131. Registered on March 10, 2016, https://clinicaltrials.gov/study/NCT02705131?cond=NCT02705131&rank=1&tab=table.

目的 评估平衡整脊疗法(BCT)与牵引疗法(TT)对颈椎根性病变患者的临床疗效。符合条件的患者将被随机分为两组:治疗组和对照组。治疗组患者接受为期 20 天的 BCT 治疗,而对照组患者则接受 TT 治疗。患者在 1 个月和 3 个月的随访中接受医生的检查。主要结果是用视觉模拟量表(VAS)测量疼痛的严重程度。次要结果包括使用 Borden 方法测量的颈椎曲度、使用颈部残疾指数(NDI)测量的功能状态综合指数、患者健康状况(通过 SF-36 健康调查进行评估)以及试验报告的不良事件(AEs)。231人(96.3%)提供了1个月和3个月的随访数据。两组患者的基线数据无明显差异(P> 0.05),具有良好的可比性。结果显示,经过 BCT 和 TT 治疗后,两组患者的疼痛 VAS 评分、颈椎曲度、NDI 评分和 SF-36 评分均有明显改善(P < 0.05)。此外,在治疗20天、随访1个月和3个月时,BCT组的参与者在主要和次要指标上都显示出了更优越的治疗效果。试验注册Clinical Trials.gov Identifier:NCT02705131。注册时间:2016年3月10日,https://clinicaltrials.gov/study/NCT02705131?cond=NCT02705131&rank=1&tab=table。
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引用次数: 0
The role of intermediaries in connecting individuals to local physical activity – protocol for a pilot feasibility trial 中介机构在将个人与当地体育活动联系起来方面的作用--试点可行性试验方案
IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-07-09 DOI: 10.1016/j.conctc.2024.101332
Megan O'Grady , Deirdre Connolly , Emer Barrett

Background

Intermediaries are health-related workers who facilitate connections to local physical activities. Intermediaries deliver interventions by receiving referrals, conducting assessments, connecting referred individuals to activities and/or services in the community, and following up with them over time. However, it is unclear whether individuals who are referred to physical activities by an intermediary improve their physical activity levels, and what their perspectives and experiences are of participating in this intervention. To date there has been a lack of studies investigating the effect of this intervention on physical activity using appropriate outcome measures.

Methods

This will be a mixed methods pilot feasibility study. Participants will be individuals referred or self-referred to an intermediary and connected to local physical activities. Participants will be recruited through two types of intermediary services in Ireland; social prescribing and local sports partnerships. A total of 30 participants will be recruited (15 per service). Baseline demographic information will be taken upon enrolment to the study and three questionnaires will be completed: the International Physical Activity Questionnaire - Short Form, Self-Efficacy for Exercise Scale and Short Warwick Edinburgh Mental Well-being Scale. The questionnaires will be repeated after 12 weeks and in addition semi-structured interviews will be carried out to explore intervention content and delivery, as well as acceptability of the intervention and evaluation design.

Discussion

This overall aim of this proposed study is to investigate the feasibility of an intervention delivered by an intermediary to improve physical activity and health-related outcomes of community-dwelling individuals.

Registration

ClinicalTrials.gov (NCT06260995).

背景中间人是与健康相关的工作人员,他们负责促进与当地体育活动的联系。中间人通过接受转介、进行评估、将被转介者与社区活动和/或服务联系起来,并对他们进行长期跟踪,从而提供干预措施。然而,目前还不清楚被中介机构转介参加体育活动的人是否提高了体育活动水平,也不清楚他们对参与这种干预措施的看法和体验。迄今为止,还没有研究使用适当的结果测量方法来调查这种干预对体育锻炼的影响。参与者将是转介或自我转介到中介机构并与当地体育活动建立联系的个人。参与者将通过爱尔兰的两种中介服务招募:社会处方和地方体育合作。总共将招募 30 名参与者(每个服务机构 15 名)。研究人员将在报名时收集基线人口信息,并填写三份问卷:国际体育活动问卷--简表、运动自我效能量表和沃里克-爱丁堡心理健康简表。12 周后将重复这些问卷,此外还将进行半结构化访谈,以探讨干预内容和实施方式,以及干预和评估设计的可接受性。讨论本研究的总体目标是调查由中介机构实施干预的可行性,以改善社区居民的体育锻炼和健康相关结果。
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引用次数: 0
Regulatory landscape with U.S. patient requirements and Clinical Trial Diversity expectations 美国患者要求和临床试验多样性期望的监管环境
IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-07-06 DOI: 10.1016/j.conctc.2024.101331
Elizabeth George , Alicia Baker McDowell , Melissa Vozza , Talley Mitchell , Ben Quartley , Cassandra S. Kennedy , Bill Hanlon

The Food and Drug Administration (FDA) has an expectation that products filed for marketing authorization have to include data that are representative of the US patient population. Any foreign clinical data that is submitted has to represent an ethnically diverse population that is generated utilizing qualified Principal Investigators (PIs) and conducted according to Good Clinical Practices (GCP) requirements outlined in 21 CFR 312.120, Foreign clinical studies not conducted under an IND. With the recent passing of the Omnibus Legislation, FDA now also has the authority to require Diversity Plans for all Phase 3 clinical trials of new drugs or “as appropriate, another pivotal study of a new drug.” The FDA has released a guidance document, “Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials” (April 2022), for the industry with expectations to update the document in 2023 now that legislation is passed. This whitepaper discusses the FDA guidance and expectations of sponsors with regards to foreign clinical data and the intersection with enrolling ethnically diverse populations in clinical studies.

美国食品和药物管理局 (FDA) 要求申请上市许可的产品必须包含能代表美国患者群体的数据。提交的任何国外临床数据必须代表不同种族的人群,这些数据必须由合格的主要研究者 (PI) 生成,并按照 21 CFR 312.120(非 IND 下进行的国外临床研究)中概述的良好临床实践 (GCP) 要求进行。随着最近综合立法的通过,FDA 现在还有权要求所有新药 3 期临床试验或 "酌情要求新药的另一项关键研究 "实施多样性计划。FDA 已为业界发布了一份指导文件《改善临床试验中代表性不足的种族和民族参与者的多元化计划》(2022 年 4 月),并预计在立法通过后于 2023 年更新该文件。本白皮书讨论了 FDA 的指导意见和申办者对国外临床数据的期望,以及在临床研究中招募不同种族人群的交叉问题。
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引用次数: 0
Syrian refugee young adults as community mental health workers implementing problem management plus: Protocol for a pilot randomized controlled trial to measure the mechanisms of effect on their own wellbeing, stress and coping 叙利亚青年难民作为社区心理健康工作者实施问题管理加:试点随机对照试验协议,以衡量对其自身福祉、压力和应对的影响机制
IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL Pub Date : 2024-06-28 DOI: 10.1016/j.conctc.2024.101325
Rima Nakkash , Lilian Ghandour , Grant Brown , Catherine Panter-Brick , Hailey Bomar , Malak Tleis , Hanan Al Masri , Marwa Fares , Fadi Al Halabi , Yamen Najjar , Bayan Louis , Maha Hodroj , Yara Chamoun , Myriam Zarzour , Rima A. Afifi

This pilot randomized controlled trial protocol aims to (1) assess the impact on the wellbeing of Syrian refugee young adults (18–24 years) of being a community mental health worker (CMHW) implementing WHO's evidence-based psychosocial intervention - Problem Management Plus (PM+) - with adults in their community, and (2) identify the mechanisms associated with the outcomes of enhanced wellbeing and coping, and reduced stress among these CMHWs. Over 108 million people have been forcibly displaced as of the end of 2022. Mental health consequences of these displacements are significant, yet human resources for health are not sufficient to meet the needs. A large proportion of refugee populations are youth and young adults (YA). Evidence indicates their engagement in supporting their communities leads to their own enhanced wellbeing and that of their community. This trial trains Syrian refugees to serve their communities as CMHW (n=19) or tutors (n=19) and compare wellbeing, stress and coping outcomes between these two groups and a control group (n = 40). We will also assess 7 mechanisms as potential pathways for the interventions to influence outcomes. Surveys will assess outcomes and mechanisms, hair samples will measure stress cortisol. The primary analysis will use a Bayesian Hierarchical Model approach to model the trajectories of the mechanisms and primary study endpoints over time for individuals in each of the arms. Our results will elucidate critical mechanisms in which engagement of young adults to support their community enhances their own wellbeing.

Trial registration

National Institutes of Mental Health, NCT05265611, Registered prospectively in 2021.

Lebanon clinical trials registry #

LBCTR2023015206, Registered in 2023.

这项试点随机对照试验方案旨在:(1)评估作为社区心理健康工作者(CMHW)对叙利亚难民中的年轻成年人(18-24 岁)实施世界卫生组织的循证社会心理干预措施--问题管理+(PM+)--对其社区中成年人的幸福感的影响;(2)确定与这些社区心理健康工作者的幸福感和应对能力增强以及压力减轻的结果相关的机制。截至 2022 年底,已有超过 1.08 亿人被迫流离失所。这些流离失所现象对心理健康造成了严重后果,但卫生方面的人力资源却不足以满足这些需求。难民人口中有很大一部分是青年和年轻成年人(YA)。有证据表明,他们参与支持自己的社区可提高自身和社区的福祉。本试验将培训叙利亚难民作为社区医疗卫生工作者(19 人)或辅导员(19 人)为社区服务,并比较这两组与对照组(40 人)之间的福利、压力和应对结果。我们还将评估 7 种机制,作为干预措施影响结果的潜在途径。调查将评估结果和机制,头发样本将测量压力皮质醇。主要分析将使用贝叶斯层次模型方法来模拟每组个体的机制和主要研究终点随时间变化的轨迹。我们的研究结果将阐明年轻成年人参与支持社区提高自身幸福感的关键机制。试验注册美国国家心理卫生研究所,NCT05265611,2021 年进行前瞻性注册。黎巴嫩临床试验注册 #LBCTR2023015206,2023 年注册。
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引用次数: 0
期刊
Contemporary Clinical Trials Communications
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