A Validation Study of the Neuro-cognitive Emotion Monitoring-Intervention (NEMO-I) Application in Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Change in depressive symptoms
研究概览
简要总结
This study aims to evaluate the validity and effectiveness of NEMO-I (Neuro-cognitive Emotion Monitoring-Intervention), a mobile application designed to help adolescents monitor and manage their cognitive and emotional functioning in everyday settings. NEMO-I delivers evidence-based psychological techniques-such as mindfulness, self-regulation training, and emotion monitoring-in a gamified format consisting of seven brief activities that users can complete at home in about 10 minutes each.
A total of 140 middle and high school students will participate. Participants will complete standardized neuropsychological and psychological assessments before and after the intervention period. During the 21-day intervention period, participants will use the NEMO-I application at home each day at their convenience (a minimum of 10 minutes per day is recommended). By comparing pre- and post-intervention assessment results, this study seeks to determine whether the application produces meaningful benefits for adolescent mental health and to establish its suitability as a digital mental health tool.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Middle or high school students currently enrolled in school
- •Using an Android-based smartphone
- •Voluntary agreement to participate, with consent from a legal guardian
排除标准
- •Borderline intellectual functioning or intellectual disability (IQ below 80)
- •Visual or hearing impairment
- •Prior diagnosis of intellectual, visual, or hearing impairment
研究组 & 干预措施
NEMO-I Intervention Group
Participants in this single-arm study use the NEMO-I mobile application at home for 21 days, at their convenience each day (a minimum of 10 minutes per day is recommended). Cognitive and emotional outcomes are assessed before and after the intervention period.
干预措施: NEMO-I (Neuro-cognitive Emotion Monitoring-Intervention) (Behavioral)
结局指标
主要结局
Change in depressive symptoms
时间窗: Baseline (pre-intervention) and after the 21-day intervention period
Depressive symptoms are measured using the Beck Depression Inventory-II (BDI-II), a 21-item self-report questionnaire. Total scores range from 0 to 63, with higher scores indicating more severe depressive symptoms. Change is assessed by comparing pre- and post-intervention scores.
Change in inhibitory control (Color-Word Stroop Test, CWST)
时间窗: Baseline(pre-intervention) and after the 21-day intervention period
Inhibitory control is assessed using the Color-Word Stroop Test (CWST), which measures the efficiency of the frontal-lobe inhibition process. Performance is indexed by response time and error rate under the color-word interference condition. Change is assessed by comparing pre- and post-intervention performance.
Change in anxiety symptoms
时间窗: Baseline(pre-intervention) and after the 21-day intervention period
Anxiety symptoms are measured using the Beck Anxiety Inventory (BAI), a 21-item self-report questionnaire assessing the severity of anxiety-related symptoms. Higher scores indicate greater anxiety. Change is assessed by comparing pre- and post-intervention scores.
Change in neuro-cognitive and emotional function (NEMO-A)
时间窗: Baseline (pre-intervention) and after the 21-day intervention period
Neuro-cognitive and emotional function is assessed using the NEMO-A (Neuro-cognitive Emotion Monitoring-Assessment) application, a tablet-based, game-format assessment consisting of five subtasks. It measures domains including sustained attention, working memory, emotional sensitivity, emotion processing and recognition, audiovisual emotional integration, cognitive control, and executive function. Performance is indexed by accuracy and response time, and change is assessed by comparing pre- and post-intervention performance.
Change in visual attention and processing speed (Children's Color Trails Test, CCTT)
时间窗: Baseline (pre-intervention) and after the 21-day intervention period
Visual attention, psychomotor speed, sequential processing, and divided/sustained visual attention are assessed using the Children's Color Trails Test (CCTT). Performance is indexed by completion time (seconds). Change is assessed by comparing pre- and post-intervention performance.
Change in set-shifting ability (Trail Making Test-B, TMT-B)
时间窗: Baseline (pre-intervention) and after the 21-day intervention period
Set-shifting ability and cognitive flexibility are assessed using the Trail Making Test-B (TMT-B), which requires alternating between numbers and letters in sequence. Performance is indexed by completion time (seconds). Change is assessed by comparing pre- and post-intervention performance.
次要结局
- Change in subjective stress(Baseline (pre-intervention) and after the 21-day intervention period)
- Change in daily stress(Baseline(pre-intervention) and after the 21-day intervention period)
- Change in alexithymia(Baseline (pre-intervention) and after the 21-day intervention period)
- Change in executive function difficulties (self-report)(Baseline (pre-intervention) and after the 21-day intervention period)
- Change in peer relationship quality(Baseline (pre-intervention) and after the 21-day intervention period)
- Change in problem behaviors (CBCL 6-18, parent report)(Baseline (pre-intervention) and after the 21-day intervention period)
- Change in ADHD symptoms (ARS, parent report)(Baseline (pre-intervention) and after the 21-day intervention period)