- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07607782
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II) (BEGIN II)
This study is testing whether a short, daily, app-based meditation can help young adults feel better in their everyday lives.
We will invite about 354 adults between 18 and 40 years old who live in the United States to join.
Everyone who joins will be randomly placed into one of three groups for 4 weeks: Intervention group will do a 7-minute Miracle of Mind meditation each day using a phone app. Active comparator group will listen to a neutral 7-minute audio lesson each day. Control group will continue their usual daily routine without adding anything new.
All participants will answer short online surveys at the start and several times during the 4 weeks, sharing how they feel about their mood, stress, anxiety, overall well-being, and mindfulness.
Participants who already wear a smartwatch (like a Fitbit or Apple Watch) can choose to share their heart rate-related data so we can see whether the meditation might also affect physical signs of stress.
Investigators will compare how participants in the three groups change over time to see if the daily 7-minute meditation helps young adults feel better, less stressed, and more emotionally resilient.
연구 개요
상태
연구 유형
등록 (추정된)
단계
- 해당 없음
참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Individuals between the ages of 18-40 years
- Currently residing in the USA
- Individuals who are English speaking
- Willing and able to download an application on iOS/Android
Exclusion Criteria:
- Individuals who are non-English speaking
- Unable to access an iOS/Android smartphone
- Individuals who regularly practice any form of meditation >4 times per week
- Individuals scoring 9-12 on the PHQ-4, or ≥3 on either the PHQ-2 or GAD-2 subscale
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Intervention arm: Daily Miracle of Mind meditation
Participants in this group will use a study app to do a 7-minute Miracle of Mind guided meditation once a day for 4 weeks.
The meditation is voice-guided, done while seated, and uses simple breathing techniques.
No prior meditation experience is required.
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Miracle of Mind is a 7-minute meditation that incorporates breath and awareness to enhance mental health and clarity.
The practice involves voice-guided seated meditation with simple breathing techniques.
This is a simple, safe intervention that does not require any previous meditation experience.
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활성 비교기: Active control arm: Daily neutral audio learning
Participants in this group will use the same study app to listen to a neutral 7-minute audio lesson once a day for 4 weeks.
The lessons cover general educational topics and are designed not to be emotional, inspirational, or related to psychology.
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Active control participants are asked to listen to an approximately 7-minute neutral audio learning task daily in the 3Cs app for the duration of the study.
A total of 28 audio learning tasks were sourced from the SDG Academy and Harvard University YouTube and SoundCloud content were screened prior to inclusion.
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간섭 없음: Passive control arm: Usual routine
Participants in this group will not receive any new activity through the app and will continue their usual daily routine for 4 weeks.
They will complete the same study surveys as the other groups but will not be asked to meditate or listen to audio lessons.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Well-being
기간: "Baseline, Week 2 and Week 4"
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Quantitatively assess whether a 7-minute digital meditation practiced daily for 4 weeks improves mental well-being, using validated questionnaires.
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"Baseline, Week 2 and Week 4"
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Mindfulness
기간: "Baseline and 4 weeks"
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Quantitatively assess whether the meditation practice enhances Mindfulness
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"Baseline and 4 weeks"
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Overall health
기간: "Baseline, Week 2 and Week 4"
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Quantitatively assess whether the meditation practice enhances overall health
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"Baseline, Week 2 and Week 4"
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Stress and Anxiety
기간: "Baseline, Week 1, Week 2, Week 3 and Week 4"
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Quantitatively assess whether the meditation practice reduces stress and anxiety.
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"Baseline, Week 1, Week 2, Week 3 and Week 4"
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Physiological Indicators
기간: From enrollment to Week 4
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To assess physiological and emotional dynamics associated with the 7-Minute Miracle of Mind meditation by examining group differences in trajectories of HR, RR, and HRV over 4 weeks and the relationship between meditation practice frequency and within-person mood variability.
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From enrollment to Week 4
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공동 작업자 및 조사자
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
키워드
기타 연구 ID 번호
- 2026P000078
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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