Mobile Application Mindfulness

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Depression; Stress; Anxiety; Psychological Distress; Mindfulness
• Intervention / Treatment: Behavioral: AI-Enabled Mobile App-Based Mindfulness 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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33620
      • The Korean Association of West Florida
    • Tampa, Florida, United States, 33620
      • University of South Florida School of Social Work

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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

Behavioral: 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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Psychological Well-Being and Mental Health Outcomes	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.	Baseline (Week 0) to post-intervention (Week 8)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility and Acceptability of the AI-Enabled Mobile Mindfulness Intervention	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.	Enrollment through completion of the intervention at Week 8

Collaborators and Investigators

• Sponsor: University of South Florida
• Investigators: Principal Investigator: Soonhyung Kwon, University of South Florida School of Social Work

Publications and helpful links

General Publications

• Mahlo, L., & Windsor, T. D. (2021). Feasibility, acceptability, and preliminary efficacy of an app-based mindfulness-meditation program among older adults. The Gerontologist, 61(5), 775-786.
• Gu, J., Strauss, C., Bond, R., & Cavanagh, K. (2015). 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. Clinical Psychology Review, 37, 1-12.
• Greenwood, H., Krzyzaniak, N., Peiris, R., Clark, J., Scott, A. M., Cardona, M., & Glasziou, P. (2022). Telehealth versus face-to-face psychotherapy for less common mental health conditions: A systematic review and meta-analysis of randomized controlled trials. JMIR Mental Health, 9(3), e31780.
• Jang, Y., Chiriboga, D. A., Park, N. S., Rhew, S. J., Kim, M. T., & Kim, B. J. (2021). The role of self-rated mental health in seeking professional mental health services among older Korean immigrants. Aging & Mental Health, 25(7), 1332-1337.
• Kim, M. T., Kim, K. B., Han, H.-R., Huh, B., Nguyen, T., & Lee, H. B. (2015). Prevalence and predictors of depression in Korean American elderly: Findings from the Memory and Aging Study of Koreans (MASK). The American Journal of Geriatric Psychiatry, 23(7), 671-683.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: April 17, 2026
• First Submitted That Met QC Criteria: April 17, 2026
• First Posted (Actual): April 24, 2026

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 17, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Mental Health; Mindfulness; Digital Health; Feasibility Study; Older Korean Immigrants
• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Behavior; Personal Satisfaction; Anxiety Disorders; Depression; Psychological Well-Being
• Other Study ID Numbers: STUDY008220

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data (IPD) underlying the results reported in publications, including demographic characteristics and outcome measures related to psychological well-being and mental health, will be available in a de-identified format. Data sharing will be limited to protect participant confidentiality and comply with ethical and regulatory requirements.
• IPD Sharing Time Frame: Data will be available beginning 6 months after publication of the primary study results and will remain available for up to 3 years following publication.
• IPD Sharing Access Criteria: Access to de-identified data will be restricted to qualified researchers who provide evidence of Institutional Review Board (IRB) approval (or exemption) and submit a scientifically sound research proposal. Requests will be reviewed by the study investigators, and approved users must sign a data use agreement to ensure appropriate use and protection of participant confidentiality. Data will be shared through a secure data transfer method.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No