NCT Number: NCT07807501
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.
Trial opening soon.
Get Notified35 year–64 year
Female
Interventional
Not applicable
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 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%.
Time frame: 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%.
Time frame: 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%.
Time frame: Baseline and Week 4
Percentage of expected baseline and post-intervention questionnaires completed by enrolled participants. The benchmark is greater than 75%.
Time frame: 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.
Time frame: Week 4
The 10-item System Usability Scale produces a total score from 0 to 100. Higher scores indicate better perceived usability.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to Week 4
The six-item depression subscale produces a score from 0 to 24. Higher scores indicate greater depressive mood disturbance.
Time frame: Baseline to Week 4
The six-item tension/anxiety subscale produces a score from 0 to 24. Higher scores indicate greater tension or anxiety.
Time frame: 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.
Time frame: 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.
Trial opening soon.
Get NotifiedArizona State University
Other
Feasibility, Acceptability, and Preliminary Effects of Culturally-Adapted and Generic Meditation Apps for Stress Reduction in Middle-Aged Black Women
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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