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NCT07807501
Meditation Apps for Stress Management in Black Women
Conditions: Psychological Stress
Sex: Female
Ages: 35 Years – 64 Years
Healthy volunteers: No
Phase: NA
Enrollment: 40
Sponsor: Arizona State University
Summary
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07807501). StuddyBuddy aggregates publicly available trial information.