StressNCT07550166
Mobile Application Mindfulness
A study testing AI-Enabled Mobile App-Based Mindfulness Intervention in people with Stress and Anxiety, run by University of South Florida at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress, Anxiety, Depression
- What is being tested?
- AI-Enabled Mobile App-Based Mindfulness Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Aug 2025to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
The Korean Association of West Florida
Tampa, Florida, 33620
University of South Florida School of Social Work
Tampa, Florida, 33620
About this study
Official title: 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.
Read the 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.
- Conditions
- Stress, Anxiety, Depression, Psychological Distress, Mindfulness
- Being tested
- AI-Enabled Mobile App-Based Mindfulness Intervention
- Keywords
- Mindfulness, Digital Health, Older Korean Immigrants, Mental Health, Feasibility Study
- Medical subject headings
- Anxiety Disorders, Depression, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-Enabled Mobile App-Based Mindfulness InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: AI-Enabled Mobile App-Based Mindfulness Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Week 0) to post-intervention (Week 8)
Secondary outcomes (1)
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.
Measured: Enrollment through completion of the intervention at Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2026
- Study start1 Aug 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Soonhyung Kwon, Principal investigator, University of South Florida School of Social Work
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07550166
- Sponsor's protocol ID
- STUDY008220
- Status last verified
- Apr 2026
- First submitted
- 17 Apr 2026
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 32663286Gu 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.
PubMed 25689576Greenwood 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.
PubMed 35275081Jang 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.
PubMed 32349527Kim 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.
PubMed 25554484
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Application (App)-Based Mindfulness Intervention for Older Korean Immigrants
- ClinicalTrials.gov ID
- NCT07550166
- Acronym / sponsor ID
- STUDY008220
- Conditions
- Stress, Anxiety, Depression, Psychological Distress, Mindfulness
- Keywords
- Mindfulness, Digital Health, Older Korean Immigrants, Mental Health, Feasibility Study
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 24 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Artificial Intelligence-Based Mobile Mindfulness Intervention | Experimental | Behavioral: AI-Enabled Mobile App-Based Mindfulness InterventionParticipants 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 |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AI-Enabled Mobile App-Based Mindfulness InterventionThis 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. | Behavioural | Artificial Intelligence-Based Mobile Mindfulness Intervention |
Primary outcome
Psychological Well-Being and Mental Health Outcomes
Time frame: 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.
1 secondary outcome
Feasibility and Acceptability of the AI-Enabled Mobile Mindfulness Intervention
Time frame: Enrollment through completion of the intervention at Week 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Background: PubMed 32663286Mahlo 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.
- Background: PubMed 25689576Gu 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.
- Background: PubMed 35275081Greenwood 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.
- Background: PubMed 32349527Jang 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.
- Background: PubMed 25554484Kim 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Soonhyung Kwon principal investigator
University of South Florida School of Social Work
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-Enabled Mobile App-Based Mindfulness Intervention in people with Stress and Anxiety, run by University of South Florida at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychological Well-Being and Mental Health Outcomes (time frame: Baseline (Week 0) to post-intervention (Week 8)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07550166, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.