- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
|
Active Comparator: 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.
|
|
No Intervention: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Well-being
Time Frame: "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"
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mindfulness
Time Frame: "Baseline and 4 weeks"
|
Quantitatively assess whether the meditation practice enhances Mindfulness
|
"Baseline and 4 weeks"
|
|
Overall health
Time Frame: "Baseline, Week 2 and Week 4"
|
Quantitatively assess whether the meditation practice enhances overall health
|
"Baseline, Week 2 and Week 4"
|
|
Stress and Anxiety
Time Frame: "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"
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Physiological Indicators
Time Frame: 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.
|
From enrollment to Week 4
|
Collaborators and Investigators
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2026P000078
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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