Badia-Aguarón Tania, Royuela-Colomer Estíbaliz, Pera-Guardiola Vanessa, Vergés-Balasch Pere, Cebolla Ausiàs, Luciano Juan V, Soler Joaquim, Feliu-Soler Albert, Huguet Miguel Anna
Department of Basic, Developmental and Educational Psychology, Faculty of Psychology, Autonomous University of Barcelona, Barcelona, Spain.
Psychological Research in Fibromyalgia and Chronic Pain (AGORA Research Group), Parc Sanitari Sant Joan de Déu, Barcelona, Spain.
Front Psychol. 2024 Feb 7;15:1291198. doi: 10.3389/fpsyg.2024.1291198. eCollection 2024.
Attention Deficit Hyperactivity Disorder (ADHD) has a global mean prevalence of 5%. Cognitive Training (CT) and Mindfulness-Based Interventions (MBIs) have shown promising results in managing ADHD symptoms, but they are not its Treatment-As-Usual (TAU). The NeuroMind Study aims to evaluate the preliminary effectiveness and feasibility of three interventions: Mindfulness for Health (M4H), CT using the NeuronUP® platform (CT), and a combination of both, Mindfulness Cognitive Training (MCT). There is empirical evidence supporting the effectiveness of the M4H and NeuronUP® platform; however, this study explores for the first time the effectiveness of MCT and CT, as well as the integration of M4H into TAU. The objectives of this 5-month Randomized Controlled Trial (RCT) are: (1) To analyze the preliminary effectiveness and feasibility of M4H, CT or a combination of both (MCT) added to TAU for children with ADHD; (2) To evaluate the role of psychological process variables (mindfulness and emotional regulation) as mediators of 5-month follow-up clinical outcomes; (3) To preliminarily explore whether specific sociodemographic and clinical characteristics can predict the short-and medium-term clinical response to the specific treatments.
Participants will be 120 children (7 to 12 years) with ADHD recruited at Child and Adolescent Mental Health Service (CAMHS) Sant Joan de Déu Terres de Lleida (Spain) randomly allocated to one of the four study arms: TAU vs. TAU + CT vs. TAU + M4H vs. TAU + MCT. An assessment to collect ADHD symptoms, Executive Functions (EF), comorbid symptoms and global functioning will be conducted pre-intervention, post-intervention (2 months after baseline) and at the 5-month follow-up. Linear mixed models and mediational models will be computed.
If the preliminary effectiveness and feasibility of the MCT are demonstrated, this study could be a preliminary basis to do a full RCT with a larger sample to definitively validate the intervention. The MCT could be applied in clinical practice if it is definitively validated.ClinicalTrials.gov, identifier, NCT05937347. https://clinicaltrials.gov/study/NCT05937347?locStr=Spain&country=Spain&cond=ADHD&intr=Mindfulness&rank=1.
注意缺陷多动障碍（ADHD）的全球平均患病率为5%。认知训练（CT）和基于正念的干预措施（MBIs）在管理ADHD症状方面已显示出有前景的结果，但它们并非常规治疗（TAU）。NeuroMind研究旨在评估三种干预措施的初步有效性和可行性：健康正念（M4H）、使用NeuronUP®平台的认知训练（CT）以及两者的结合，即正念认知训练（MCT）。有实证证据支持M4H和NeuronUP®平台的有效性；然而，本研究首次探索MCT和CT的有效性，以及将M4H纳入常规治疗的情况。这项为期5个月的随机对照试验（RCT）的目标是：（1）分析将M4H、CT或两者结合（MCT）添加到常规治疗中对ADHD儿童的初步有效性和可行性；（2）评估心理过程变量（正念和情绪调节）作为5个月随访临床结果中介的作用；（3）初步探索特定的社会人口学和临床特征是否可以预测对特定治疗的短期和中期临床反应。
参与者将是120名年龄在7至12岁的ADHD儿童，他们在西班牙莱里达省圣琼·德·迪乌·特雷斯儿童和青少年心理健康服务中心（CAMHS）招募，并随机分配到四个研究组之一：常规治疗组与常规治疗+CT组与常规治疗+M4H组与常规治疗+MCT组。在干预前、干预后（基线后2个月）和5个月随访时进行评估，以收集ADHD症状、执行功能（EF）、共病症状和整体功能。将计算线性混合模型和中介模型。
如果证明了MCT的初步有效性和可行性，本研究可以作为进行更大样本的完整RCT以最终验证该干预措施的初步基础。如果MCT得到最终验证，它可以应用于临床实践。ClinicalTrials.gov标识符：NCT05937347。https://clinicaltrials.gov/study/NCT05937347?locStr=Spain&country=Spain&cond=ADHD&intr=Mindfulness&rank=1。
