Meditation Apps for Stress Management in Black Women
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.
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Sunny Kim, PhD
- 전화번호: 602-496-6789
- 이메일: sunny.kim@asu.edu
참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Exhale™ Meditation App
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.
|
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.
|
|
활성 비교기: Levelhead Mindfulness App
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.
|
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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Participant Retention Rate at Week 4
기간: 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%.
|
Baseline through Week 4
|
|
Percentage of Eligible Individuals Who Consent and Enroll
기간: 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%.
|
From recruitment opening through enrollment of the final participant, up to 6 months.
|
|
Percentage of Recommended Practice Days Completed
기간: 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%.
|
During the 4-week intervention
|
|
Assessment Completion Rate
기간: Baseline and Week 4
|
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
기간: 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.
|
Week 4
|
|
Assigned-App Usability Measured by the System Usability Scale
기간: Week 4
|
The 10-item System Usability Scale produces a total score from 0 to 100.
Higher scores indicate better perceived usability.
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Week 4
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in Perceived Stress Scale-10 Score
기간: 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.
|
Baseline to Week 4
|
|
Change in Index of Race-Related Stress-Brief Score
기간: 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.
|
Baseline to Week 4
|
|
Change in POMS-SF Depression Subscale Score
기간: Baseline to Week 4
|
The six-item depression subscale produces a score from 0 to 24.
Higher scores indicate greater depressive mood disturbance.
|
Baseline to Week 4
|
|
Change in POMS-SF Tension/Anxiety Subscale Score
기간: Baseline to Week 4
|
The six-item tension/anxiety subscale produces a score from 0 to 24.
Higher scores indicate greater tension or anxiety.
|
Baseline to Week 4
|
|
Change in Insomnia Severity Index Score
기간: 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.
|
Baseline to Week 4
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Participant-Reported Cultural Relevance and App Feedback
기간: Week 4 and, when applicable, within approximately 1 week after Week 4
|
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.
|
Week 4 and, when applicable, within approximately 1 week after Week 4
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- STUDY00023706
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
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