- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Myeongjie Im, MA
- Numero di telefono: +82-10-2588-0859
- Email: imj@swu.ac.kr
Luoghi di studio
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Seoul
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Seoul, Seoul, Corea del Sud, 01797
- Seoul Women's University
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Contatto:
- Myeongjie Im, MA
- Numero di telefono: +82-10-2588-0859
- Email: imj@swu.ac.kr
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Investigatore principale:
- Hyunjoo Song, PhD
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
Accetta volontari sani
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Change in depressive symptoms
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change in subjective stress
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Hyunjoo Song, PhD, Seoul Women's University
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Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- SWU-2605-004
- RS-2022-KH126068 (Altro numero di sovvenzione/finanziamento: Korea Health Industry Development Institute (KHIDI), Ministry of Health & Welfare, Republic of Korea)
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