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

Browse trials for

• Psychological Well-Being 2,193
• Motor Activity 9,798

Keywords

• Digital meditation
• App-based guided meditation
• Miracle of Mind meditation
• Young adults mental health
• Stress and anxiety reduction
• Emotional well-being
• Mindfulness
• Randomized controlled trial
• Active and passive control groups
• Well-being questionnaires
• Physiological stress indicator

Psychological Well-Being

2,193 studies on the registry are indexed under Psychological Well-Being; 728 are open to participants now.

This study's planned enrollment of 354 is above the median of 110 across 1,796 interventional studies indexed under Psychological Well-Being.

Lead sponsor

Beth Israel Deaconess Medical Center is the lead sponsor of 568 studies on the registry; 80 are open to participants now.

Of its 76 completed or terminated interventional studies of FDA-regulated products, 62 (82%) have results posted.

Study arms

• 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.

  Behavioral: Miracle of Mind meditation

• 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.

  Behavioral: Neutral audio learning task

• 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.

Interventions

• BehavioralMiracle of Mind meditation

  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.

• BehavioralNeutral audio learning task

  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.

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"

5. Positive and Negative Affect

   To assess whether the 7-minute digital meditation practiced daily for 4 weeks improves emotional well-being, as measured by the Scale of Positive and Negative Experience (SPANE). The SPANE is a 12-item self-reported measure consisting of two 6-item subscales: Positive Experience (SPANE-P) and Negative Experience (SPANE-N). The SPANE-P score ranges from 6 to 30, with higher scores indicating more frequent positive emotions. The SPANE-N score ranges from 6 to 30, with higher scores indicating more frequent negative emotions and a worse outcome. The SPANE Balance score (SPANE-B) is calculated as SPANE-P minus SPANE-N and ranges from -24 to 24. Higher scores indicate a more favorable balance of positive relative to negative emotional experiences and a better 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

5. Sleep

   To assess differences between study groups in sleep time, efficiency and average deep sleep duration during the 4-week study period, using sleep data collected from participants' compatible wearable devices.

   Time frame: From enrollment to Week 4

Individual participant data

Plan to share: No