Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II) (BEGIN II)
2 de setembro de 2026 atualizado por: Balachundhar Subramaniam, Beth Israel Deaconess Medical Center
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.
Visão geral do estudo
Status
Ainda não está recrutando
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Estimado)
354
Estágio
- Não aplicável
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Sim
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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.
|
|
Comparador Ativo: 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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Sem intervenção: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Well-being
Prazo: "Baseline, Week 2 and Week 4"
|
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.
|
"Baseline, Week 2 and Week 4"
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Mindfulness
Prazo: "Baseline and 4 weeks"
|
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.
|
"Baseline and 4 weeks"
|
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Overall health
Prazo: "Baseline, Week 2 and Week 4"
|
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.
|
"Baseline, Week 2 and Week 4"
|
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Stress
Prazo: "Baseline, Week 1, Week 2, Week 3 and Week 4"
|
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.
|
"Baseline, Week 1, Week 2, Week 3 and Week 4"
|
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Anxiety
Prazo: "Baseline, Week 1, Week 2, Week 3 and Week 4"
|
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.
|
"Baseline, Week 1, Week 2, Week 3 and Week 4"
|
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Positive and Negative Affect
Prazo: "Baseline, Week 1, Week 2, Week 3 and Week 4"
|
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"
|
Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Heart Rate
Prazo: From enrollment to Week 4
|
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).
|
From enrollment to Week 4
|
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Heart Rate Variability
Prazo: From enrollment to Week 4
|
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
Prazo: From enrollment to Week 4
|
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
Prazo: From enrollment to Week 4
|
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
Prazo: 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.
|
From enrollment to Week 4
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
15 de setembro de 2026
Conclusão Primária (Estimado)
31 de dezembro de 2028
Conclusão do estudo (Estimado)
31 de dezembro de 2028
Datas de inscrição no estudo
Enviado pela primeira vez
10 de abril de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
21 de maio de 2026
Primeira postagem (Real)
26 de maio de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
4 de setembro de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
2 de setembro de 2026
Última verificação
1 de agosto de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2026P000078
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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