Mobile Application (App)-Based Mindfulness Intervention for Older Korean Immigrants
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Psychological Well-Being and Mental Health Outcomes
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Artificial Intelligence-Based Mobile Mindfulness Intervention
Participants in this arm will receive an 8-week AI-enabled mobile app-based mindfulness intervention designed to promote psychological well-being and reduce mental health symptoms. The intervention is delivered through a smartphone application and includes guided mindfulness meditation, breathing exercises, sound-based relaxation, and brief reflective activities. Participants will be encouraged to engage with the application for approximately 10-15 minutes per day throughout the intervention period.
At the start of the study, participants will receive an orientation session on how to download and use the application. The application incorporates an artificial intelligence-based feature that utilizes physiological signals (e.g., photoplethysmography-derived stress indicators) to provide personalized mindfulness content tailored to the user's stress levels. Weekly check-ins will be conducted to support adherence, address technical issues, and encourage continued engagement.
All partic
干预措施: AI-Enabled Mobile App-Based Mindfulness Intervention (Behavioral)
结局指标
主要结局
Psychological Well-Being and Mental Health Outcomes
时间窗: Baseline (Week 0) to post-intervention (Week 8)
Change in positive psychological well-being and mental health outcomes will be assessed using validated self-report measures, including positive affect, optimism, life engagement, and mindful attention awareness, as well as anxiety, depressive symptoms, and perceived stress. Higher scores on positive psychological measures indicate greater well-being, while higher scores on mental health symptom measures indicate greater symptom severity.
次要结局
- Feasibility and Acceptability of the AI-Enabled Mobile Mindfulness Intervention(Enrollment through completion of the intervention at Week 8)