Anxiety, Depression, Mindfulness, Psychological Distress, Stress
Conditions
Keywords
Mindfulness, Digital Health, Older Korean Immigrants, Mental Health, Feasibility Study
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALAI-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 technology familiarity. A distinguishing feature of this intervention is the integration of an artificial intelligence-based personalization system that uses physiological signals (e.g., photoplethysmography-derived stress indicators) to assess users' real-time stress levels and deliver tailored mindfulness content. The intervention is designed to enhance accessibility by reducing common barriers such as language, stigma, and limited access to culturally appropriate mental health services.
Sponsors
University of South Florida
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This study uses a single-arm interventional model, in which all enrolled participants receive the same mobile application-based mindfulness intervention. There is no comparison or control group. Outcomes are assessed using a within-subject (pre-post) design, with measurements collected at baseline and immediately following the 8-week intervention period. This model is appropriate for a pilot feasibility study aimed at evaluating acceptability, adherence, and preliminary signals of efficacy prior to conducting a larger randomized controlled trial.
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Psychological Well-Being and Mental Health Outcomes | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility and Acceptability of the AI-Enabled Mobile Mindfulness Intervention | Enrollment through completion of the intervention at Week 8 | Feasibility and acceptability of the AI-enabled mobile mindfulness intervention will be evaluated using study process indicators, including recruitment rate, refusal rate, retention rate, and adherence to the intervention. Adherence will be assessed using app usage data, including frequency and duration of use, supplemented by weekly participant check-ins regarding engagement and challenges with app use. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSoonhyung Kwon
University of South Florida School of Social Work
Outcome results
None listed