- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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.
|
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.
|
|
Aktiv komparator: 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.
|
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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Ingen indgriben: 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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Well-being
Tidsramme: "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.
|
"Baseline, Week 2 and Week 4"
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Mindfulness
Tidsramme: "Baseline and 4 weeks"
|
Quantitatively assess whether the meditation practice enhances Mindfulness
|
"Baseline and 4 weeks"
|
|
Overall health
Tidsramme: "Baseline, Week 2 and Week 4"
|
Quantitatively assess whether the meditation practice enhances overall health
|
"Baseline, Week 2 and Week 4"
|
|
Stress and Anxiety
Tidsramme: "Baseline, Week 1, Week 2, Week 3 and Week 4"
|
Quantitatively assess whether the meditation practice reduces stress and anxiety.
|
"Baseline, Week 1, Week 2, Week 3 and Week 4"
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Physiological Indicators
Tidsramme: From enrollment to Week 4
|
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
|
Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2026P000078
Plan for individuelle deltagerdata (IPD)
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Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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Kliniske forsøg med Miracle of Mind meditation
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Lille Catholic UniversityIkke rekrutterer endnu
-
Institut de Myologie, FranceTilmelding efter invitationMyotonisk dystrofi type 1Frankrig
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Sarasota Memorial Health Care SystemFlorida Atlantic UniversityTilmelding efter invitation
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Seyhan District Health Directorate, AdanaRekrutteringMeditationTyrkiet (Türkiye)
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Poitiers University HospitalIkke rekrutterer endnu
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Children's Hospital of PhiladelphiaUniversity of PennsylvaniaTilmelding efter invitationSmerter, postoperativ | Nyresten | Angst postoperativForenede Stater
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Universidad de AntioquiaIkke rekrutterer endnuDepression | Stress, psykologisk | Angst | Trivsel | Mindfulness
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London Health Sciences Centre Research Institute...Ikke rekrutterer endnuNedsat syn, ét øje, uspecificeret øje | SvagsynsblindhedCanada
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State University of New York at BuffaloIkke rekrutterer endnu