Meditation Apps for Stress Management in Black Women

ConditionPsychological Stress

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexFemale

Age35-64

SponsorArizona State University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

Exhale™ Meditation App
Behavioral
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.
Levelhead Mindfulness App
Behavioral
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.

Treatment groups

40 Participants

are divided into 2 treatment groups

Group A: Exhale™ Meditation AppExperimental treatment 1 intervention

Group B: Levelhead Mindfulness AppActive comparator 1 intervention

Trial outcomes

Primary outcomes

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

Secondary outcomes

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

Other outcomes

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

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Arizona State University

Lead sponsor

Source ClinicalTrials.gov

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