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Meditation Apps for Stress Management in Black Women

16 września 2026 zaktualizowane przez: Sunny Wonsun Kim, Ph.D, Arizona State University

Feasibility, Acceptability, and Preliminary Effects of Culturally-Adapted and Generic Meditation Apps for Stress Reduction in Middle-Aged Black Women

This randomized remote pilot study will evaluate the feasibility, acceptability, and preliminary effects of two meditation and mindfulness applications among approximately 40 Black women ages 35-64 experiencing moderate to high stress.

Participants will be randomly assigned in a 1:1 ratio to Exhale™, a culturally adapted meditation app designed for Black women, or Levelhead, a general mindfulness app. Participants will be asked to complete at least one session using their assigned app per day, lasting approximately 5 minutes or longer, at least 5 days per week for 4 weeks.

Participants will complete online questionnaires at baseline and after the 4-week intervention. Daily Remind messages and weekly study check-ins will support engagement. Outcomes include recruitment, retention, adherence, assessment completion, satisfaction, usability, perceived stress, race-based stress, sleep, depression, anxiety, cultural relevance, and brief participant feedback.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

This study is a two-arm, randomized, fully remote pilot study comparing Exhale™, a culturally adapted meditation application designed for Black women, with Levelhead, a general science-based mindfulness application.

Approximately 40 Black women ages 35-64 who report moderate to high perceived stress will be enrolled. After eligibility screening, informed consent, and completion of baseline questionnaires through REDCap, participants will be randomized in a 1:1 ratio to Exhale™ or Levelhead using the REDCap randomization module.

Participants in both groups will be asked to complete at least one app-based meditation or mindfulness session per day, lasting approximately 5 minutes or longer, at least 5 days per week for 4 weeks. Participants may complete additional or longer sessions but will not be required to make up missed sessions. Daily Remind messages will ask participants whether they completed a session and the approximate number of minutes practiced. Weekly check-ins will provide study reminders and opportunities to request technical assistance.

Remote questionnaires will be administered at baseline and at the end of Week 4. Primary outcomes will assess feasibility and acceptability through recruitment, retention, adherence, assessment completion, satisfaction, and usability. Secondary outcomes will examine preliminary changes in perceived stress, race-based stress, sleep, depression, and anxiety. Cultural relevance and brief open-ended participant feedback will also be collected. Some participants may be invited to complete an optional brief remote exit interview.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

40

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

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

Nie

Opis

Inclusion Criteria:

  • Self-identifies as a Black or African American woman
  • Ages 35-64 years
  • Able to read and speak English
  • Perceived Stress Scale-10 screening score greater than 14
  • Has access to a smartphone or tablet with internet access
  • Willing to complete remote baseline and post-intervention assessments
  • Willing to attempt the assigned app-based practice for 4 weeks
  • Willing to receive study communications

Exclusion Criteria:

  • Regular use of meditation or mindfulness applications within the previous 6 months
  • Any prior use of Exhale™
  • Significant hearing impairment that prevents engagement with audio-based application content
  • Self-reported difficulty navigating smartphone applications that would prevent participation

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: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Exhale™ Meditation App
Participants assigned to Exhale™ will use a culturally adapted meditation application designed for Black women. Participants will be asked to complete at least one meditation session per day, lasting approximately 5 minutes or longer, at least 5 days per week for 4 weeks. Participants will receive daily Remind messages, weekly study check-ins, and remote technical support as needed.
Behawioralne: Exhale™ Meditation App
A culturally adapted meditation application designed for Black women that provides guided meditation and mindfulness content addressing stress, rest, grounding, self-care, and culturally relevant experiences. Participants will manually select sessions and complete approximately 5 minutes or longer of practice at least 5 days per week for 4 weeks.
Aktywny komparator: Levelhead Mindfulness App
Participants assigned to Levelhead will use a general science-based mindfulness application. Participants will be asked to complete at least one mindfulness session per day, totaling approximately 5 minutes or longer, at least 5 days per week for 4 weeks. Participants will receive daily Remind messages, weekly study check-ins, and remote technical support as needed.
Behawioralne: Levelhead Mindfulness App
A general science-based mindfulness application that provides brief lessons addressing topics such as stress, focus, gratitude, and well-being. Participants will complete approximately 5 minutes or longer of mindfulness practice at least 5 days per week for 4 weeks.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Participant Retention Rate at Week 4
Ramy czasowe: Baseline through Week 4
Percentage of enrolled participants who complete the 4-week intervention and post-intervention assessment. The feasibility benchmark is greater than 75%.
Baseline through Week 4
Percentage of Eligible Individuals Who Consent and Enroll
Ramy czasowe: From recruitment opening through enrollment of the final participant, up to 6 months.
Recruitment rate will equal the number of eligible individuals who consent and enroll divided by the total number determined eligible, multiplied by 100. The feasibility benchmark is greater than 70%.
From recruitment opening through enrollment of the final participant, up to 6 months.
Percentage of Recommended Practice Days Completed
Ramy czasowe: During the 4-week intervention
Adherence will be calculated from participant self-reports as completed practice days divided by 20 recommended practice days, multiplied by 100. The benchmark is greater than 75%.
During the 4-week intervention
Assessment Completion Rate
Ramy czasowe: Baseline and Week 4
Percentage of expected baseline and post-intervention questionnaires completed by enrolled participants. The benchmark is greater than 75%.
Baseline and Week 4
Participant Satisfaction With Assigned App
Ramy czasowe: Week 4
Satisfaction will be measured with the assigned-app satisfaction questionnaire. Items are rated from 1 to 5, with higher scores indicating greater satisfaction. Results will be summarized overall and by intervention arm.
Week 4
Assigned-App Usability Measured by the System Usability Scale
Ramy czasowe: Week 4
The 10-item System Usability Scale produces a total score from 0 to 100. Higher scores indicate better perceived usability.
Week 4

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change in Perceived Stress Scale-10 Score
Ramy czasowe: Baseline to Week 4
The PSS-10 contains 10 items and produces a total score from 0 to 40. Higher scores indicate greater perceived stress. Change from baseline will be reported overall and by arm.
Baseline to Week 4
Change in Index of Race-Related Stress-Brief Score
Ramy czasowe: Baseline to Week 4
The 22-item IRRS-B produces a total score from 0 to 88. Higher scores indicate greater race-related stress. Change from baseline will be reported overall and by arm.
Baseline to Week 4
Change in POMS-SF Depression Subscale Score
Ramy czasowe: Baseline to Week 4
The six-item depression subscale produces a score from 0 to 24. Higher scores indicate greater depressive mood disturbance.
Baseline to Week 4
Change in POMS-SF Tension/Anxiety Subscale Score
Ramy czasowe: Baseline to Week 4
The six-item tension/anxiety subscale produces a score from 0 to 24. Higher scores indicate greater tension or anxiety.
Baseline to Week 4
Change in Insomnia Severity Index Score
Ramy czasowe: Baseline to Week 4
The seven-item Insomnia Severity Index produces a total score from 0 to 28. Higher scores indicate more severe insomnia symptoms.
Baseline to Week 4

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Participant-Reported Cultural Relevance and App Feedback
Ramy czasowe: Week 4 and, when applicable, within approximately 1 week after Week 4
Cultural relevance, perceived usefulness, barriers, benefits, and recommendations will be assessed through post-intervention items and brief open-ended feedback. Optional remote interviews may provide additional qualitative feedback.
Week 4 and, when applicable, within approximately 1 week after Week 4

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Arizona State University

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)

16 września 2026

Zakończenie podstawowe (Szacowany)

1 stycznia 2027

Ukończenie studiów (Szacowany)

1 stycznia 2027

Daty rejestracji na studia

Pierwszy przesłany

2 września 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

2 września 2026

Pierwszy wysłany (Rzeczywisty)

8 września 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

18 września 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

16 września 2026

Ostatnia weryfikacja

1 września 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • STUDY00023706

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu IPD

Individual participant data will not be made publicly available. Aggregate or de-identified summary findings may be disseminated through presentations, publications, or participant summaries. Any future sharing of de-identified participant data would require additional institutional review and must be consistent with the informed consent form and Arizona State University requirements.

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 .

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