Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorBeth Israel Deaconess Medical Center

About this trial

This study is testing whether a short, daily, app-based meditation can help young adults feel better in their everyday lives.

Adults aged 18-40 years who live in the United States and have not meditated regularly (defined as more than four times per week at any point in their lives) are invited to participate.

Participants will be randomly assigned to one of three groups for 4 weeks:

1. Intervention group: Participants will complete a 7-minute Miracle of Mind meditation each day using a mobile app. 2. Active comparator group: Participants will listen to a neutral 7-minute audio lesson each day. 3. Control group: Participants will continue their usual daily routine without adding anything new.

All participants will complete brief online surveys at the start of the study and several times during the 4-week study period. Surveys will ask about mood, stress, anxiety, overall well-being, and mindfulness.

Participants who already wear a smartwatch, such as a Fitbit or Apple Watch, may choose to share heart rate and related data so that researchers can examine whether meditation may also affect physical signs of stress.

Investigators will compare changes over time among the three groups to determine whether the daily 7-minute meditation helps young adults feel better, experience less stress, and become more emotionally resilient.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Miracle of Mind meditation

    Behavioral

    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.

  • Neutral audio learning task

    Behavioral

    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.

Treatment groups

354 Participants
are divided into 3 treatment groups
Group A: Intervention arm: Daily Miracle of Mind meditationExperimental treatment 1 intervention
Group B: Active control arm: Daily neutral audio learningActive comparator 1 intervention
Group C: Passive control arm: Usual routineNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Well-being

To assess whether a 7-minute digital meditation practiced daily for 4 weeks improves mental well-being, as measured by the World Health Organization-Five Well-Being Index (WHO-5). The WHO-5 total raw score ranges from 0 to 25 where higher scores indicate better mental well-being.

Time frame
"Baseline, Week 2 and Week 4"

Secondary outcomes

1

Mindfulness

To assess whether the 7-minute digital meditation practiced daily for 4 weeks improves mindfulness, as measured by the Mindful Attention Awareness Scale (MAAS). The MAAS mean score ranges from 1 to 6; higher scores indicate greater dispositional mindfulness and attention to present-moment experiences.

Time frame
"Baseline and 4 weeks"
2

Overall health

To assess whether the 7-minute digital meditation practiced daily for 4 weeks improves overall health, as measured by the Whole Person Health Index (WPHI). The WPHI is a 9-item self-reported measure where total scores range from 9 to 45. Higher scores indicate better overall self-reported whole-person health.

Time frame
"Baseline, Week 2 and Week 4"
3

Stress

To assess whether the 7-minute digital meditation practiced daily for 4 weeks reduces psychological distress, as measured by the Schwartz Outcome Scale-10 (SOS-10). The SOS-10 total score ranges from 0 to 60. Higher scores indicate better psychological well-being and functioning, and lower levels of psychological distress.

Time frame
"Baseline, Week 1, Week 2, Week 3 and Week 4"
4

Anxiety

To assess whether the 7-minute digital meditation practiced daily for 4 weeks reduces anxiety, as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Short Form 8a. The PROMIS Anxiety Short Form 8a includes 8 items, each scored from 1 to 5. The summed raw score ranges from 8 to 40, with higher scores indicating greater anxiety symptoms and a worse outcome.

Time frame
"Baseline, Week 1, Week 2, Week 3 and Week 4"

Other outcomes

1

Heart Rate

To assess differences between study groups in trajectories of heart rate during the 4-week study period, using heart rate data collected from participants' compatible wearable devices. Heart rate will be expressed in beats per minute (bpm).

Time frame
From enrollment to Week 4
2

Heart Rate Variability

To assess differences between study groups in trajectories of heart rate variability during the 4-week study period, using heart rate variability data collected from participants' compatible wearable devices. Heart rate variability will be reported using the pre-specified device-derived metric and units, such as milliseconds (ms). Higher values generally indicate greater beat-to-beat variability.

Time frame
From enrollment to Week 4
3

Breathing Rate

To assess differences between study groups in trajectories of breathing rate during the 4-week study period, using respiratory-rate data collected from participants' compatible wearable devices. Breathing rate will be expressed in breaths per minute. Higher values indicate a higher breathing rate

Time frame
From enrollment to Week 4
4

Step Counts

To assess differences between study groups in daily physical activity during the 4-week study period, using daily step-count data collected from participants' compatible wearable devices. Step count will be reported as the total number of steps per day. Values range from 0 upward, with higher values indicating more ambulatory physical activity.

Time frame
From enrollment to Week 4

Locations

This trial has no locations.

Sponsors and contacts

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