- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
Accetta volontari sani
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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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Comparatore attivo: 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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Nessun intervento: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Well-being
Lasso di tempo: "Baseline, Week 2 and Week 4"
|
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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Mindfulness
Lasso di tempo: "Baseline and 4 weeks"
|
Quantitatively assess whether the meditation practice enhances Mindfulness
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"Baseline and 4 weeks"
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Overall health
Lasso di tempo: "Baseline, Week 2 and Week 4"
|
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
Lasso di tempo: "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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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Physiological Indicators
Lasso di tempo: 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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Collaboratori e investigatori
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 2026P000078
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .