- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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.
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:
- Intervention group: Participants will complete a 7-minute Miracle of Mind meditation each day using a mobile app.
- Active comparator group: Participants will listen to a neutral 7-minute audio lesson each day.
- 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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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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.
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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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Comparador activo: 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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Sin intervención: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Well-being
Periodo de tiempo: "Baseline, Week 2 and Week 4"
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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.
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"Baseline, Week 2 and Week 4"
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Mindfulness
Periodo de tiempo: "Baseline and 4 weeks"
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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.
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"Baseline and 4 weeks"
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Overall health
Periodo de tiempo: "Baseline, Week 2 and Week 4"
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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.
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"Baseline, Week 2 and Week 4"
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Stress
Periodo de tiempo: "Baseline, Week 1, Week 2, Week 3 and Week 4"
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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.
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"Baseline, Week 1, Week 2, Week 3 and Week 4"
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Anxiety
Periodo de tiempo: "Baseline, Week 1, Week 2, Week 3 and Week 4"
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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.
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"Baseline, Week 1, Week 2, Week 3 and Week 4"
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Positive and Negative Affect
Periodo de tiempo: "Baseline, Week 1, Week 2, Week 3 and Week 4"
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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. |
"Baseline, Week 1, Week 2, Week 3 and Week 4"
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Heart Rate
Periodo de tiempo: From enrollment to Week 4
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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).
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From enrollment to Week 4
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Heart Rate Variability
Periodo de tiempo: From enrollment to Week 4
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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.
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From enrollment to Week 4
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Breathing Rate
Periodo de tiempo: From enrollment to Week 4
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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
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From enrollment to Week 4
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Step Counts
Periodo de tiempo: From enrollment to Week 4
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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.
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From enrollment to Week 4
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Sleep
Periodo de tiempo: From enrollment to Week 4
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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.
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From enrollment to Week 4
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
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Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2026P000078
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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