Psychological Stress
Conditions
Keywords
Black women, African American women, meditation, mindfulness, mobile health, digital health, culturally adapted intervention, race-based stresss, stress management, feasibility, acceptibility
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.
Detailed description
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.
Interventions
BEHAVIORALExhale™ Meditation 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.
BEHAVIORALLevelhead Mindfulness App
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.
Sponsors
Arizona State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
FEMALE
Age
35 Years to 64 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participant Retention Rate at Week 4 | 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%. |
| Percentage of Eligible Individuals Who Consent and Enroll | 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%. |
| Percentage of Recommended Practice Days Completed | 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%. |
| Assessment Completion Rate | Baseline and Week 4 | Percentage of expected baseline and post-intervention questionnaires completed by enrolled participants. The benchmark is greater than 75%. |
| Participant Satisfaction With Assigned App | 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. |
| Assigned-App Usability Measured by the System Usability Scale | Week 4 | The 10-item System Usability Scale produces a total score from 0 to 100. Higher scores indicate better perceived usability. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Perceived Stress Scale-10 Score | 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. |
| Change in Index of Race-Related Stress-Brief Score | 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. |
| Change in POMS-SF Depression Subscale Score | Baseline to Week 4 | The six-item depression subscale produces a score from 0 to 24. Higher scores indicate greater depressive mood disturbance. |
| Change in POMS-SF Tension/Anxiety Subscale Score | Baseline to Week 4 | The six-item tension/anxiety subscale produces a score from 0 to 24. Higher scores indicate greater tension or anxiety. |
| Change in Insomnia Severity Index Score | 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. |
Contacts
CONTACTSunny Kim, PhD
Outcome results
None listed