Mobile Application Mindfulness

NCT07550166 | Enrolling By Invitation

• 1 other identifier: STUDY008220
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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.

Conditions

Stress; Psychological Distress; Mindfulness; Anxiety; Depression

Keywords

Mindfulness; Digital Health; Older Korean Immigrants; Mental Health; Feasibility Study

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Feasibility and Acceptability of the AI-Enabled Mobile Mindfulness Intervention

  Enrollment through completion of the intervention at Week 8

Study Arms (1)

Artificial Intelligence-Based Mobile Mindfulness Intervention

EXPERIMENTAL

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

Interventions

AI-Enabled Mobile App-Based Mindfulness Intervention BEHAVIORAL

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.

Artificial Intelligence-Based Mobile Mindfulness Intervention

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of South Florida: lead

Study Sites (2)

The Korean Association of West Florida

Tampa, Florida, 33620, United States

Location

University of South Florida School of Social Work

Tampa, Florida, 33620, United States

Location

Related Publications (5)

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Depression; Psychological Well-Being

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior; Personal Satisfaction

Study Officials

• Soonhyung Kwon

  University of South Florida School of Social Work

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 17, 2026
• First Posted: April 24, 2026
• Study Start: August 1, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• 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.
• 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.

Locations

US (2)