Psychological StressNCT07807501
Meditation Apps for Stress Management in Black Women
A study testing Exhale™ Meditation App and Levelhead Mindfulness App in people with Psychological Stress, run by Arizona State University.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 64 years, women only
- Conditions the study is for
- Psychological Stress
- What is being tested?
- Exhale™ Meditation App and Levelhead Mindfulness App
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 16 Nov 2026to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 64 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Feasibility, Acceptability, and Preliminary Effects of Culturally-Adapted and Generic Meditation Apps for Stress Reduction in Middle-Aged Black Women
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.
Read the 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.
- Conditions
- Psychological Stress
- Being tested
- Exhale™ Meditation App, Levelhead Mindfulness App
- Keywords
- Black women, African American women, meditation, mindfulness, mobile health, digital health, culturally adapted intervention, race-based stresss, stress management, feasibility, acceptibility
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exhale™ Meditation AppBehavioural
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 AppBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Levelhead Mindfulness App |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: 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%.
Measured: 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%.
Measured: 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%.
Measured: 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.
Measured: 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.
Measured: Week 4
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start16 Nov 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological StressStudies of the same condition, open and under way.
- More trials run by Arizona State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sunny Wonsun Kim, Ph.D, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07807501
- Sponsor's protocol ID
- STUDY00023706
- Status last verified
- Nov 2026
- First submitted
- 2 Sep 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility, Acceptability, and Preliminary Effects of Culturally-Adapted and Generic Meditation Apps for Stress Reduction in Middle-Aged Black Women
- ClinicalTrials.gov ID
- NCT07807501
- Acronym / sponsor ID
- STUDY00023706
- Conditions
- Psychological Stress
- Keywords
- Black women, African American women, meditation, mindfulness, mobile health, digital health, culturally adapted intervention, race-based stresss
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Study start
- 16 Nov 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 8 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Exhale™ Meditation App | Experimental | Behavioral: Exhale™ Meditation AppParticipants 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. |
| Levelhead Mindfulness App | Active comparator | Behavioral: Levelhead Mindfulness AppParticipants 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. |
Who may qualify
- Ages
- 35 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exhale™ Meditation AppA 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. | Behavioural | Exhale™ Meditation App |
| Levelhead Mindfulness AppA 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. | Behavioural | Levelhead Mindfulness App |
Primary outcome
Participant Retention Rate at Week 4
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Week 4
The 10-item System Usability Scale produces a total score from 0 to 100. Higher scores indicate better perceived usability.
5 secondary outcomes
Change in Perceived Stress Scale-10 Score
Time frame: Baseline to Week 4
Change in Index of Race-Related Stress-Brief Score
Time frame: Baseline to Week 4
Change in POMS-SF Depression Subscale Score
Time frame: Baseline to Week 4
Change in POMS-SF Tension/Anxiety Subscale Score
Time frame: Baseline to Week 4
Change in Insomnia Severity Index Score
Time frame: Baseline to Week 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: 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.
Related trials for Psychological Stress
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Not yet recruiting
Financial Tools Access and Navigation (FinTAN)
Serious Mental Illness, Financial Hardship
Not yet recruiting
Acute Effects of Mat Pilates on Blood Pressure Response to Mental Stress in Higher Education Teachers
Behavior
Active, not recruiting
Economic Empowerment and Health Promotion of Uganda Grandmother-caregivers.
Financial Burden, Health Behavior
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Exhale™ Meditation App and Levelhead Mindfulness App in people with Psychological Stress, run by Arizona State University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sunny Kim, PhD (602-496-6789, sunny.kim@asu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant Retention Rate at Week 4 (time frame: Baseline through Week 4). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.