An interventional study of Exhale™ Meditation App and Levelhead Mindfulness App in Psychological Stress, sponsored by Arizona State University. Not yet recruiting. Open to female participants aged 35 Years to 64 Years. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Arizona State University · Not applicable, Interventional, and Treatment
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.
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.
844 studies on the registry are indexed under Stress, Psychological; 136 are open to participants now.
This study's planned enrollment of 40 is below the median of 84 across 688 interventional studies indexed under Stress, Psychological.
Browse Stress, Psychological studies →Arizona State University is the lead sponsor of 238 studies on the registry; 42 are open to participants now.
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Exclusion Criteria:
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.
Behavioral: Exhale™ Meditation 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.
Behavioral: Levelhead Mindfulness 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.
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.
Participant Retention Rate at 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: Baseline through Week 4
Percentage of Eligible Individuals Who Consent and Enroll
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: From recruitment opening through enrollment of the final participant, up to 6 months.
Percentage of Recommended Practice Days Completed
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: During the 4-week intervention
Assessment Completion Rate
Percentage of expected baseline and post-intervention questionnaires completed by enrolled participants. The benchmark is greater than 75%.
Time frame: Baseline and Week 4
Participant Satisfaction With Assigned App
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
Assigned-App Usability Measured by the System Usability Scale
The 10-item System Usability Scale produces a total score from 0 to 100. Higher scores indicate better perceived usability.
Time frame: Week 4
Change in Perceived Stress Scale-10 Score
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
Change in Index of Race-Related Stress-Brief Score
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
Change in POMS-SF Depression Subscale Score
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
Change in POMS-SF Tension/Anxiety Subscale Score
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
Change in Insomnia Severity Index Score
The seven-item Insomnia Severity Index produces a total score from 0 to 28. Higher scores indicate more severe insomnia symptoms.
Time frame: Baseline to Week 4
Participant-Reported Cultural Relevance and App Feedback
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.
Time frame: Week 4 and, when applicable, within approximately 1 week after Week 4
No study locations are listed for this record.
Plan to share: No — 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.
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Mar 2027, 4 months later.
Of 457 non-industry interventional studies with no phase under Stress, Psychological, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 26. This study's planned 4 months is below that.
Counting every sponsor, half of 470 studies reached it within 13 months; a quarter within 5 and three quarters within 26.
Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 5, 2026: start Sep 2026 → Nov 2026, primary completion Jan 2027 → Mar 2027 and completion Jan 2027 → May 2027.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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