- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07700264
A Validation Study of the Neuro-cognitive Emotion Monitoring-Intervention (NEMO-I) Application in Adolescents
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Myeongjie Im, MA
- Numéro de téléphone: +82-10-2588-0859
- E-mail: imj@swu.ac.kr
Lieux d'étude
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Seoul
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Seoul, Seoul, Corée du Sud, 01797
- Seoul Women's University
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Contact:
- Myeongjie Im, MA
- Numéro de téléphone: +82-10-2588-0859
- E-mail: imj@swu.ac.kr
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Chercheur principal:
- Hyunjoo Song, PhD
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
Accepte les volontaires sains
La description
Inclusion Criteria:
- Middle or high school students currently enrolled in school
- Using an Android-based smartphone
- Voluntary agreement to participate, with consent from a legal guardian
Exclusion Criteria:
- Borderline intellectual functioning or intellectual disability (IQ below 80)
- Visual or hearing impairment
- Prior diagnosis of intellectual, visual, or hearing impairment
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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.
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NEMO-I is a mobile application that delivers evidence-based psychological techniques in a gamified format.
It consists of seven brief activities-including facial expression imitation, singing, breathing and stretching with nature sounds, reading tips for everyday concerns, rhythm-based instrument play, room decoration, and mindfulness-each designed to be completed at home in about 10 minutes.
Participants use the application daily during the 21-day intervention period, at their convenience, with a recommended minimum of 10 minutes per day.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in depressive symptoms
Délai: Baseline (pre-intervention) and after the 21-day intervention period
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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.
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Baseline (pre-intervention) and after the 21-day intervention period
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Change in inhibitory control (Color-Word Stroop Test, CWST)
Délai: Baseline(pre-intervention) and after the 21-day intervention period
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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.
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Baseline(pre-intervention) and after the 21-day intervention period
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Change in anxiety symptoms
Délai: Baseline(pre-intervention) and after the 21-day intervention period
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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.
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Baseline(pre-intervention) and after the 21-day intervention period
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Change in neuro-cognitive and emotional function (NEMO-A)
Délai: Baseline (pre-intervention) and after the 21-day intervention period
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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.
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Baseline (pre-intervention) and after the 21-day intervention period
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Change in visual attention and processing speed (Children's Color Trails Test, CCTT)
Délai: Baseline (pre-intervention) and after the 21-day intervention period
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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.
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Baseline (pre-intervention) and after the 21-day intervention period
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Change in set-shifting ability (Trail Making Test-B, TMT-B)
Délai: Baseline (pre-intervention) and after the 21-day intervention period
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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.
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Baseline (pre-intervention) and after the 21-day intervention period
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in subjective stress
Délai: Baseline (pre-intervention) and after the 21-day intervention period
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Subjective stress is measured using a Visual Analog Scale (VAS), on which participants rate their current perceived stress level from 1 (no stress) to 10 (extreme stress).
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Baseline (pre-intervention) and after the 21-day intervention period
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Change in daily stress
Délai: Baseline(pre-intervention) and after the 21-day intervention period
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Daily stress is measured using a 26-item self-report scale assessing stress experienced in everyday domains such as parents, school, academics, peer relationships, appearance, and finances, rated on a 5-point Likert scale.
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Baseline(pre-intervention) and after the 21-day intervention period
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Change in alexithymia
Délai: Baseline (pre-intervention) and after the 21-day intervention period
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Difficulty identifying and describing one's own emotions is measured using the Korean version of the 20-item Toronto Alexithymia Scale (TAS-20K), rated on a 5-point Likert scale.
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Baseline (pre-intervention) and after the 21-day intervention period
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Change in executive function difficulties (self-report)
Délai: Baseline (pre-intervention) and after the 21-day intervention period
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Self-reported executive function difficulties are measured using the Brief Self-Report Questionnaire of Executive Function Difficulty for children and adolescents (40 items), rated on a 3-point Likert scale.
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Baseline (pre-intervention) and after the 21-day intervention period
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Change in peer relationship quality
Délai: Baseline (pre-intervention) and after the 21-day intervention period
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The quality of peer relationships is measured using a 13-item self-report scale rated on a 4-point Likert scale, including items reflecting conflict and negative peer interactions.
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Baseline (pre-intervention) and after the 21-day intervention period
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Change in problem behaviors (CBCL 6-18, parent report)
Délai: Baseline (pre-intervention) and after the 21-day intervention period
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Problem behaviors are assessed using the Child Behavior Checklist for Ages 6-18 (CBCL 6-18), completed by a parent or primary caregiver.
It includes internalizing problems (e.g., anxiety, depression, somatic complaints) and externalizing problems (e.g., rule-breaking, aggressive behavior).
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Baseline (pre-intervention) and after the 21-day intervention period
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Change in ADHD symptoms (ARS, parent report)
Délai: Baseline (pre-intervention) and after the 21-day intervention period
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Attention-deficit/hyperactivity symptoms are assessed using the ADHD Rating Scale (ARS), an 18-item parent-report questionnaire comprising inattention and hyperactivity/impulsivity subscales.
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Baseline (pre-intervention) and after the 21-day intervention period
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Hyunjoo Song, PhD, Seoul Women's University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- SWU-2605-004
- RS-2022-KH126068 (Autre subvention/numéro de financement: Korea Health Industry Development Institute (KHIDI), Ministry of Health & Welfare, Republic of Korea)
Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
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