儿科功能性腹痛障碍（FAPD）患者接受心理治疗后疼痛和焦虑缓解的神经机制的初步临床试验研究方案。
Study protocol for a pilot clinical trial to understand neural mechanisms of response to a psychological treatment for pain and anxiety in pediatric functional abdominal pain disorders (FAPD).
机构信息
Department of Family Medicine, Michigan State University, Grand Rapids, Michigan, United States of America.
College of Human Medicine, Michigan State University, Grand Rapids, Michigan State University, Grand Rapids, Michigan, United States of America.
出版信息
PLoS One. 2024 Mar 18;19(3):e0299170. doi: 10.1371/journal.pone.0299170. eCollection 2024.
BACKGROUND
Functional abdominal pain disorders (FAPD) are the most common chronic pain conditions of childhood and are made worse by co-occurring anxiety. Our research team found that the Aim to Decrease Pain and Anxiety Treatment (ADAPT), a six-session coping skills program using cognitive behavioral therapy strategies, was effective in improving pain-related symptoms and anxiety symptoms compared to standard care. In follow-up, this current randomized clinical trial (RCT) aims to test potential neural mechanisms underlying the effect of ADAPT. Specifically, this two-arm RCT will explore changes in amygdalar functional connectivity (primary outcome) following the ADAPT protocol during the water loading symptom provocation task (WL-SPT). Secondary (e.g., changes in regional cerebral blood flow via pulsed arterial spin labeling MRI) and exploratory (e.g., the association between the changes in functional connectivity and clinical symptoms) outcomes will also be investigated.
METHODS
We will include patients ages 11 to 16 years presenting to outpatient pediatric gastroenterology care at a midwestern children's hospital with a diagnosis of FAPD plus evidence of clinical anxiety based on a validated screening tool (the Generalized Anxiety Disorder-7 [GAD-7] measure). Eligible participants will undergo baseline neuroimaging involving the WL-SPT, and assessment of self-reported pain, anxiety, and additional symptoms, prior to being randomized to a six-week remotely delivered ADAPT program plus standard medical care or standard medical care alone (waitlist). Thereafter, subjects will complete a post assessment neuroimaging visit similar in nature to their first visit.
CONCLUSIONS
This small scale RCT aims to increase understanding of potential neural mechanisms of response to ADAPT.
TRIAL REGISTRATION
ClinicalTrials.gov registration: NCT03518216.
背景
功能性腹痛障碍（FAPD）是儿童最常见的慢性疼痛疾病，同时伴有焦虑会使其加重。我们的研究团队发现，旨在减轻疼痛和焦虑的治疗方法（ADAPT），即一种使用认知行为治疗策略的六节应对技能课程，与标准护理相比，在改善与疼痛相关的症状和焦虑症状方面更有效。在后续研究中，这项目前的随机临床试验（RCT）旨在测试 ADAPT 效果的潜在神经机制。具体来说，这项双臂 RCT 将在水负荷症状激发任务（WL-SPT）期间探索 ADAPT 方案后杏仁核功能连接的变化（主要结果）。次要（例如，通过脉冲动脉自旋标记 MRI 测量的区域脑血流变化）和探索性（例如，功能连接变化与临床症状之间的关联）结果也将进行研究。
方法
我们将纳入在中西部儿童医院接受门诊儿科胃肠病学治疗的 11 至 16 岁的 FAPD 患者，这些患者基于经过验证的筛查工具（广泛性焦虑障碍-7[GAD-7]量表）有 FAPD 诊断且有临床焦虑的证据。符合条件的参与者将进行基线神经影像学检查，包括 WL-SPT，并评估自我报告的疼痛、焦虑和其他症状，然后随机分配到为期六周的远程提供的 ADAPT 计划加标准医疗护理或仅标准医疗护理（候补名单）。此后，受试者将完成一次类似于第一次就诊的后期评估神经影像学访问。
结论
这项小规模 RCT 旨在提高对 ADAPT 反应的潜在神经机制的理解。
试验注册
ClinicalTrials.gov 注册：NCT03518216。
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