Meditation Apps for Stress Management in Black Women
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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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 studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Sunny Kim, PhD
- Telefonní číslo: 602-496-6789
- E-mail: sunny.kim@asu.edu
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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.
|
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.
|
|
Aktivní komparátor: 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.
|
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 je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Participant Retention Rate at Week 4
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: Week 4
|
The 10-item System Usability Scale produces a total score from 0 to 100.
Higher scores indicate better perceived usability.
|
Week 4
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in Perceived Stress Scale-10 Score
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Participant-Reported Cultural Relevance and App Feedback
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- STUDY00023706
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .