Meditation Apps for Stress Management in Black Women

N/ANot Yet RecruitingNCT07807501

Arizona State University40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Interventions

Exhale™ Meditation AppBEHAVIORAL

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 AppBEHAVIORAL

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.

Eligibility

Sex: FEMALEMin age: 35 YearsMax age: 64 Years

Medical Language ↔ Plain English

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

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

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

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.