NCT07700264

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
9mo left

Started Jul 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress8%
Jul 2026Apr 2027

First Submitted

Initial submission to the registry

July 2, 2026

Completed
8 days until next milestone

Study Start

First participant enrolled

July 10, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 14, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2027

Last Updated

July 14, 2026

Status Verified

July 1, 2026

Enrollment Period

8 months

First QC Date

July 2, 2026

Last Update Submit

July 8, 2026

Conditions

Keywords

Digital mental health interventionadolescentsmobile based interventionemotioncognitive functionNEMO-I

Outcome Measures

Primary Outcomes (6)

  • Change in depressive symptoms

    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)

    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

    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)

    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)

    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)

    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

Secondary Outcomes (7)

  • 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

  • +2 more secondary outcomes

Study Arms (1)

NEMO-I Intervention Group

EXPERIMENTAL

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.

Behavioral: NEMO-I (Neuro-cognitive Emotion Monitoring-Intervention)

Interventions

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.

NEMO-I Intervention Group

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Middle or high school students currently enrolled in school
  • Using an Android-based smartphone
  • Voluntary agreement to participate, with consent from a legal guardian

You may not qualify if:

  • Borderline intellectual functioning or intellectual disability (IQ below 80)
  • Visual or hearing impairment
  • Prior diagnosis of intellectual, visual, or hearing impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul Women's University

Seoul, Seoul, 01797, South Korea

Location

Study Officials

  • Hyunjoo Song, PhD

    Seoul Women's University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Myeongjie Im, MA

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2026

First Posted

July 14, 2026

Study Start

July 10, 2026

Primary Completion (Estimated)

February 28, 2027

Study Completion (Estimated)

April 30, 2027

Last Updated

July 14, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

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.

Locations