Instituto de Investigación Biomédica de Salamanca (IBSAL), Salamanca, Spain.
Facultad de Enfermería y Fisioterapia, Universidad de Salamanca, Unidad de Investigación de Atención Primaria de Salamanca (APISAL), Instituto de Investigación Biomédica de Salamanca (IBSAL), Red de Investigación en Cronicidad, Atención Primaria y Promoción de la Salud (RICAPPS), Salamanca, Spain.
Front Public Health. 2024 Sep 4;12:1410932. doi: 10.3389/fpubh.2024.1410932. eCollection 2024.
Nomophobia is a specific phobia characterized by the appearance of anxiety, nervousness, discomfort and distress when the mobile phone is not used and is considered an emerging public health problem because of the negative consequences on the physical and mental health of young people and adolescents, especially women. Neurofeedback-Assisted Mindfulness Training Programs may prove beneficials for improving self-control abilities, a key ability in addressing addictive behaviors. The main objective of this study is to evaluate the impact, in a young population aged 18-35 years, of an intervention based on Neurofeedback-Assisted Mindfulness Training Program (NAMTP) on disorders associated with problematic use of mobile phones. The effect of the intervention on the total score in the nomophobia test and habits of internet and social network use, as well as on signs of depression, anxiety and stress will be analyzed. As a secondary objective, the effect of the intervention on signs of insomnia will be analyzed.
Randomized, controlled clinical-trial with two-parallel groups. 40 young adults (18-35 years) will be included and randomly assigned to Intervention Group-NAMTP or Control Group (CG). The NAMTP will include a total of 25 sessions (2-3/week) during 3-months. Each session will have a duration of 10/15 min. The instrument to be used for the neurofeedback sessions is MUSE (InteraXon Inc.). Study variables will be collected at the baseline visit and at the final visit (3-months after randomization). During these visits, questionnaires will be administered to evaluate the main and secondary variables that will include the Smartphone Addiction Scale-Short Version, Nomophobia Questionnaire, Depression, Anxiety and Stress Scale 21-item (DASS-21) and Athens Insomnia Scale.
This trial will make an important contribution to the need for evidence of effective education programs and other primary care interventions through new non-invasive interventions in reducing the risk of developing addictions to new technologies and alleviating the symptoms of discomfort associated with this problem.
The project was approved by the Clinical Research Ethics Committee of the Salamanca Health Area (CEIm Code: PI 2023 071340).
ClinicalTrials.gov, http://www.Clinicaltrials.gov/ct2/show/NCT06188910.
手机恐惧症是一种特定的恐惧症，表现为当手机无法使用时出现焦虑、紧张、不适和痛苦，由于其对年轻人和青少年身心健康的负面影响，被认为是一个新兴的公共卫生问题。神经反馈辅助正念训练计划可能对提高自我控制能力有益，自我控制能力是解决成瘾行为的关键能力。本研究的主要目的是评估基于神经反馈辅助正念训练计划（NAMTP）的干预措施对 18-35 岁年轻人群中与手机使用问题相关的障碍的影响。将分析干预对手机恐惧症测试总评分、互联网和社交网络使用习惯以及抑郁、焦虑和压力的影响。作为次要目标，将分析干预对失眠迹象的影响。
随机、对照的临床试验，采用平行分组。将纳入 40 名 18-35 岁的年轻成年人，并随机分为干预组-NAMTP 或对照组（CG）。NAMTP 将包括总共 25 次课程（每周 2-3 次），持续 3 个月。每次课程持续 10/15 分钟。用于神经反馈课程的仪器是 MUSE（InteraXon Inc.）。将在基线访视和最终访视（随机分组后 3 个月）时收集研究变量。在这些访视期间，将进行问卷调查，以评估主要和次要变量，包括智能手机成瘾量表-简短版、手机恐惧症问卷、抑郁、焦虑和压力量表 21 项（DASS-21）和雅典失眠量表。
本试验将为有效教育计划和其他初级保健干预措施的需求做出重要贡献，通过新的非侵入性干预措施降低对新技术成瘾的风险，并缓解与该问题相关的不适症状。
该项目已获得萨拉曼卡卫生区临床研究伦理委员会的批准（CEIm 代码：PI 2023 071340）。
ClinicalTrials.gov，http://www.Clinicaltrials.gov/ct2/show/NCT06188910。
