Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II) (BEGIN II)
2 września 2026 zaktualizowane przez: 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.
Przegląd badań
Status
Jeszcze nie rekrutacja
Interwencja / Leczenie
Typ studiów
Interwencyjne
Zapisy (Szacowany)
354
Faza
- Nie dotyczy
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
Akceptuje zdrowych ochotników
Tak
Opis
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 studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Zapobieganie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: 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.
|
|
Aktywny komparator: 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.
|
|
Brak interwencji: 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.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Well-being
Ramy czasowe: "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"
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Mindfulness
Ramy czasowe: "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"
|
|
Overall health
Ramy czasowe: "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"
|
|
Stress
Ramy czasowe: "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"
|
|
Anxiety
Ramy czasowe: "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"
|
|
Positive and Negative Affect
Ramy czasowe: "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"
|
Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Heart Rate
Ramy czasowe: 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
|
|
Heart Rate Variability
Ramy czasowe: 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.
|
From enrollment to Week 4
|
|
Breathing Rate
Ramy czasowe: 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
|
From enrollment to Week 4
|
|
Step Counts
Ramy czasowe: 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.
|
From enrollment to Week 4
|
|
Sleep
Ramy czasowe: From enrollment to Week 4
|
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
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
15 września 2026
Zakończenie podstawowe (Szacowany)
31 grudnia 2028
Ukończenie studiów (Szacowany)
31 grudnia 2028
Daty rejestracji na studia
Pierwszy przesłany
10 kwietnia 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
21 maja 2026
Pierwszy wysłany (Rzeczywisty)
26 maja 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
4 września 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
2 września 2026
Ostatnia weryfikacja
1 sierpnia 2026
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 2026P000078
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
NIE
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .