Mobile Application Mindfulness

Официальное название

Mobile Application (App)-Based Mindfulness Intervention for Older Korean Immigrants

Обзор

The goal of this clinical trial (single-arm pilot trial) is to learn whether a mobile application-based mindfulness intervention can improve mental health outcomes in older Korean immigrants aged 60 years and older. The main questions it aims to answer are whether the 8-week mobile app-based mindfulness intervention is feasible and acceptable, as indicated by recruitment, retention, and adherence rates, and whether participation in the intervention leads to improvements in positive psychological well-being (e.g., positive affect, optimism, life engagement, and mindfulness) and reductions in adverse mental health outcomes (e.g., anxiety, depressive symptoms, and perceived stress). Participants will complete baseline and post-intervention assessments, receive training on how to use the mobile mindfulness application, engage with the app for approximately 8 weeks (recommended 10-15 minutes per day), and participate in weekly check-ins to support engagement and address any challenges encountered during the intervention.

Подробное описание

This study is an 8-week single-arm pilot trial designed to evaluate the feasibility, acceptability, and preliminary efficacy of a mobile application-based mindfulness intervention for older Korean immigrants in the United States. Older Korean immigrants experience significant mental health disparities and face multiple barriers to accessing traditional mental health services, including language limitations, cultural stigma, and limited availability of culturally tailored care. This study aims to address these gaps by delivering an accessible, culturally appropriate mindfulness intervention through a mobile application.

A total of approximately 60 participants aged 60 years and older will be recruited from community-based organizations. Eligible participants will complete baseline assessments that include demographic characteristics, cognitive screening, and validated measures of psychological well-being and mental health outcomes. Following baseline assessment, participants will receive an orientation session on how to download and use the mobile application and will engage in the intervention for 8 weeks using their personal smartphones. Participants will be encouraged to use the application for approximately 10-15 minutes per day, with flexibility to accommodate individual preferences. Weekly check-ins via phone or text will be conducted to support engagement and address any technical or usability concerns.

The intervention includes guided mindfulness and meditation practices, breathing exercises, sound-based relaxation, and optional cognitive reflection activities. The application also incorporates an artificial intelligence-based biometric feature that assesses physiological stress and provides personalized mindfulness content based on users' stress levels. This feature is intended for general wellness and self-awareness purposes.

Feasibility and acceptability will be assessed using recruitment rates, refusal rates, retention rates, and adherence to the intervention. Preliminary efficacy will be evaluated by examining changes from baseline to post-intervention in positive psychological well-being (e.g., positive affect, optimism, life engagement, and mindful attention awareness) and adverse mental health outcomes (e.g., anxiety, depressive symptoms, and perceived stress). Data will be analyzed using descriptive statistics and longitudinal modeling approaches to examine within-person changes over time.

This study will provide critical preliminary data on the use of mobile health technology to deliver culturally tailored mindfulness interventions for older immigrant populations and inform the design of future randomized controlled trials.

Вмешательства

• Поведенческое AI-Enabled Mobile App-Based Mindfulness Intervention
  This intervention is an 8-week, AI-enabled mobile app-based mindfulness program specifically designed for older Korean immigrants. It delivers culturally and linguistically tailored mindfulness content through a smartphone application, including guided meditation, breathing exercises, sound-based relaxation, and brief reflective activities. Participants are encouraged to engage with the intervention for approximately 10-15 minutes per day, with flexibility to support individual preferences and t

Первичные конечные точки

• Psychological Well-Being and Mental Health Outcomes [Срок оценки: Baseline (Week 0) to post-intervention (Week 8)]

Вторичные конечные точки (1)

• Feasibility and Acceptability of the AI-Enabled Mobile Mindfulness Intervention [Срок оценки: Enrollment through completion of the intervention at Week 8]

Критерии участия

Критерии включения

Aged 60 years or older Self-identified as a Korean immigrant Able to read and understand Korean or English Owns or has access to a smartphone compatible with the mobile application Willing and able to provide informed consent Willing to participate in an 8-week mobile mindfulness intervention and complete study assessments

Критерии исключения

Significant cognitive impairment that would interfere with participation (e.g., based on screening) Severe psychiatric conditions (e.g., active psychosis or severe depression requiring immediate clinical intervention) Current participation in another behavioral or psychological intervention study Physical or sensory limitations that would prevent use of a mobile application Any condition that, in the opinion of the investigators, would make participation unsafe or not feasible

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 2 центра

• The Korean Association of West Florida — Tampa
• University of South Florida School of Social Work — Tampa

Публикации

• Mahlo L, Windsor TD. Feasibility, Acceptability, and Preliminary Efficacy of an App-Based Mindfulness-Meditation Program Among Older Adults. Gerontologist. 2021 Jul 13;61(5):775-786. doi: 10.1093/geront/gnaa093. PMID 32663286
• Gu J, Strauss C, Bond R, Cavanagh K. How do mindfulness-based cognitive therapy and mindfulness-based stress reduction improve mental health and wellbeing? A systematic review and meta-analysis of mediation studies. Clin Psychol Rev. 2015 Apr;37:1-12. doi: 10.1016/j.cpr.2015.01.006. Epub 2015 Jan 31. PMID 25689576
• Greenwood H, Krzyzaniak N, Peiris R, Clark J, Scott AM, Cardona M, Griffith R, Glasziou P. Telehealth Versus Face-to-face Psychotherapy for Less Common Mental Health Conditions: Systematic Review and Meta-analysis of Randomized Controlled Trials. JMIR Ment Health. 2022 Mar 11;9(3):e31780. doi: 10.2196/31780. PMID 35275081
• Jang Y, Chiriboga DA, Park NS, Yoon H, Cho YJ, Hong S, Nam S, Rhee MK, Bernstein KS, Kim MT. The role of self-rated mental health in seeking professional mental health services among older Korean immigrants. Aging Ment Health. 2021 Jul;25(7):1332-1337. doi: 10.1080/13607863.2020.1758908. Epub 2020 Apr 30. PMID 32349527
• Kim MT, Kim KB, Han HR, Huh B, Nguyen T, Lee HB. Prevalence and Predictors of Depression in Korean American Elderly: Findings from the Memory and Aging Study of Koreans (MASK). Am J Geriatr Psychiatry. 2015 Jul;23(7):671-83. doi: 10.1016/j.jagp.2014.11.003. Epub 2014 Nov 25. PMID 25554484

Идентификаторы

NCT: NCT07550166 · STUDY008220

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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