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A Validation Study of the Neuro-cognitive Emotion Monitoring-Intervention (NEMO-I) Application in Adolescents

8. Juli 2026 aktualisiert von: Seoul Women's University

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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

140

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

  • Name: Myeongjie Im, MA
  • Telefonnummer: +82-10-2588-0859
  • E-Mail: imj@swu.ac.kr

Studienorte

  • Südkorea
    • Seoul
      • Seoul, Seoul, Südkorea, 01797
        • Seoul Women's University
        • Kontakt:
          • Myeongjie Im, MA
          • Telefonnummer: +82-10-2588-0859
          • E-Mail: imj@swu.ac.kr
        • Hauptermittler:
          • Hyunjoo Song, PhD

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind
  • Erwachsene

Akzeptiert gesunde Freiwillige

Ja

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Unterstützende Pflege
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Verhalten: NEMO-I (Neuro-cognitive Emotion Monitoring-Intervention)
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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in depressive symptoms
Zeitfenster: 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.
Baseline (pre-intervention) and after the 21-day intervention period
Change in inhibitory control (Color-Word Stroop Test, CWST)
Zeitfenster: 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.
Baseline(pre-intervention) and after the 21-day intervention period
Change in anxiety symptoms
Zeitfenster: 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.
Baseline(pre-intervention) and after the 21-day intervention period
Change in neuro-cognitive and emotional function (NEMO-A)
Zeitfenster: 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.
Baseline (pre-intervention) and after the 21-day intervention period
Change in visual attention and processing speed (Children's Color Trails Test, CCTT)
Zeitfenster: 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.
Baseline (pre-intervention) and after the 21-day intervention period
Change in set-shifting ability (Trail Making Test-B, TMT-B)
Zeitfenster: 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.
Baseline (pre-intervention) and after the 21-day intervention period

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in subjective stress
Zeitfenster: Baseline (pre-intervention) and after the 21-day intervention period
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).
Baseline (pre-intervention) and after the 21-day intervention period
Change in daily stress
Zeitfenster: Baseline(pre-intervention) and after the 21-day intervention period
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.
Baseline(pre-intervention) and after the 21-day intervention period
Change in alexithymia
Zeitfenster: Baseline (pre-intervention) and after the 21-day intervention period
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.
Baseline (pre-intervention) and after the 21-day intervention period
Change in executive function difficulties (self-report)
Zeitfenster: Baseline (pre-intervention) and after the 21-day intervention period
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.
Baseline (pre-intervention) and after the 21-day intervention period
Change in peer relationship quality
Zeitfenster: Baseline (pre-intervention) and after the 21-day intervention period
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.
Baseline (pre-intervention) and after the 21-day intervention period
Change in problem behaviors (CBCL 6-18, parent report)
Zeitfenster: Baseline (pre-intervention) and after the 21-day intervention period
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).
Baseline (pre-intervention) and after the 21-day intervention period
Change in ADHD symptoms (ARS, parent report)
Zeitfenster: Baseline (pre-intervention) and after the 21-day intervention period
Attention-deficit/hyperactivity symptoms are assessed using the ADHD Rating Scale (ARS), an 18-item parent-report questionnaire comprising inattention and hyperactivity/impulsivity subscales.
Baseline (pre-intervention) and after the 21-day intervention period

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Seoul Women's University

Mitarbeiter

Korea Health Industry Development Institute
Ministry of Health & Welfare, Korea

Ermittler

  • Hauptermittler: Hyunjoo Song, PhD, Seoul Women's University

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

10. Juli 2026

Primärer Abschluss (Geschätzt)

28. Februar 2027

Studienabschluss (Geschätzt)

30. April 2027

Studienanmeldedaten

Zuerst eingereicht

2. Juli 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

8. Juli 2026

Zuerst gepostet (Tatsächlich)

14. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

14. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

8. Juli 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Andere Studien-ID-Nummern

  • SWU-2605-004
  • RS-2022-KH126068 (Andere Zuschuss-/Finanzierungsnummer: Korea Health Industry Development Institute (KHIDI), Ministry of Health & Welfare, Republic of Korea)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

Individual participant data will not be shared with other researchers, as participants and their legal guardians were informed during the informed consent process that collected data would not be provided to third parties.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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