- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Myeongjie Im, MA
- Phone Number: +82-10-2588-0859
- Email: imj@swu.ac.kr
Study Locations
-
-
Seoul
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Seoul, Seoul, South Korea, 01797
- Seoul Women's University
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Contact:
- Myeongjie Im, MA
- Phone Number: +82-10-2588-0859
- Email: imj@swu.ac.kr
-
Principal Investigator:
- Hyunjoo Song, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in depressive symptoms
Time Frame: 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)
Time Frame: 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
Time Frame: 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)
Time Frame: 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
|
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Change in visual attention and processing speed (Children's Color Trails Test, CCTT)
Time Frame: 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)
Time Frame: 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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in subjective stress
Time Frame: 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).
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Baseline (pre-intervention) and after the 21-day intervention period
|
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Change in daily stress
Time Frame: 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
Time Frame: 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)
Time Frame: 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
Time Frame: 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.
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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)
Time Frame: 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)
Time Frame: 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
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hyunjoo Song, PhD, Seoul Women's University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- SWU-2605-004
- RS-2022-KH126068 (Other Grant/Funding Number: Korea Health Industry Development Institute (KHIDI), Ministry of Health & Welfare, Republic of Korea)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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