Meditation Apps for Stress Management in Black Women

NCT07807501 | Not Yet Recruiting

• 1 other identifier: STUDY00023706
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Psychological Stress

Keywords

Black women; African American women; meditation; mindfulness; mobile health; digital health; culturally adapted intervention; race-based stresss; stress management; feasibility; acceptibility

Outcome Measures

Primary Outcomes (6)

• 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%.

  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%.

  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%.

  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%.

  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.

  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.

  Week 4

Secondary Outcomes (5)

• Change in Perceived Stress Scale-10 Score

  Baseline to Week 4

• Change in Index of Race-Related Stress-Brief Score

  Baseline to Week 4

• Change in POMS-SF Depression Subscale Score

  Baseline to Week 4

• Change in POMS-SF Tension/Anxiety Subscale Score

  Baseline to Week 4

• Change in Insomnia Severity Index Score

  Baseline to Week 4

Other Outcomes (1)

• Participant-Reported Cultural Relevance and App Feedback

  Week 4 and, when applicable, within approximately 1 week after Week 4

Study Arms (2)

Exhale™ Meditation App

EXPERIMENTAL

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

Levelhead Mindfulness App

ACTIVE COMPARATOR

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

Interventions

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.

Exhale™ Meditation App

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.

Levelhead Mindfulness App

Eligibility Criteria

• Age: 35 Years - 64 Years
• Gender Eligibility Details: self-identify as female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Arizona State University: lead

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Central Study Contacts

Sunny Kim, PhD

CONTACT

602-496-6789; sunny.kim@asu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants will be randomized in a 1:1 ratio to one of two parallel active behavioral intervention arms: Exhale™ or Levelhead. Both groups will follow the same 4-week schedule, practice dose, assessment schedule, and participant-contact procedures.

Study Record Dates

• First Submitted: September 2, 2026
• First Posted: September 8, 2026
• Study Start: September 16, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: September 18, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share