- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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.
연구 개요
상태
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Myeongjie Im, MA
- 전화번호: +82-10-2588-0859
- 이메일: imj@swu.ac.kr
연구 장소
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Seoul
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Seoul, Seoul, 대한민국, 01797
- Seoul Women's University
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연락하다:
- Myeongjie Im, MA
- 전화번호: +82-10-2588-0859
- 이메일: imj@swu.ac.kr
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수석 연구원:
- Hyunjoo Song, PhD
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in depressive symptoms
기간: 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)
기간: 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
기간: 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)
기간: 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)
기간: 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)
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in subjective stress
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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)
기간: 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)
기간: 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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공동 작업자 및 조사자
수사관
- 수석 연구원: Hyunjoo Song, PhD, Seoul Women's University
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- SWU-2605-004
- RS-2022-KH126068 (기타 보조금/기금 번호: Korea Health Industry Development Institute (KHIDI), Ministry of Health & Welfare, Republic of Korea)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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