Effectiveness of a Neurofeedback Intervention on Symptoms of Anxiety and Psychological Distress Associated With Smartphone Use in Young Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Anxiety
研究概览
简要总结
Introduction: Given the growing increase in addiction to social networks and smartphone use in young people and its implications for health, it is necessary to investigate effective interventions for the appropriate use of these technologies and coping with possible signs of addiction.
Objective: To evaluate the effect of an intervention based on neurofeedback techniques on anxiety and other disorders associated with problematic use of mobile phones and the internet in young adults.
Methodology: Randomised controlled clinical trial with two parallel groups: an intervention group (IG) and a control group (CG). The study population will be young adults aged 18-30 years. A sample size of 40 participants has been estimated, 20 in each group to detect a difference of 3.9 points or more on the DASS-21 anxiety questionnaire.
All participants will receive an educational workshop on the responsible use of new technologies and the promotion of healthy lifestyles. The IG, in addition to this educational workshop, will receive 25 neurofeedback sessions during 12 weeks, 2-3 sessions/week with the MUSE neurofeedback device.
A baseline and 3-month post-intervention assessment will be conducted for both groups to study change variables related to smartphone addiction (Smartphone Addiction Scale-Short Version (SAS-SV)), nomophobia (Nomophobia Questionnaire (NMP-Q)), depression, anxiety and stress (Depression, Anxiety and Stress Scale 21-item (DASS-21)) and sleep quality.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Have one or more mobile devices such as smartphones.
- •Have a compatible mobile device to install and use the Muse: EEG Meditation & Sleep application.
- •Be fully functional.
- •Willingness to voluntarily participate in the study and sign the informed consent form.
排除标准
- •History of severe psychiatric disorders (such as schizoaffective disorders, bipolar disorder, major depressive episode with symptoms or other non-organic psychotic disorders) requiring psychiatric treatment in the 6 months prior to study entry.
- •History of brain injury or other problems contraindicating the use of neurofeedback.
研究组 & 干预措施
Control
Health education, a 25-minute session, on mobile phone addiction and promotion of healthy lifestyles
干预措施: Health education (Other)
Neurofeedback
3 weekly 30-minute neurofeedback sessions per week for 12 weeks
干预措施: Neurofeedback (Other)
结局指标
主要结局
Anxiety
时间窗: Baseline, 3-months
Anxiety evaluated through Depression, Anxiety and Stress Scale 21-item (DASS-21). Minimum 0 - maximum 63
次要结局
- Nomophobia(Baseline, 3-months)
- Sleep Quality(Baseline, 3-months)
研究者
José Ignacio Recio Rodriguez
Principal investigator
University of Salamanca