Healthy ParticipantsTIMEProjectNCT07170202
The Increasing Mindfulness Engagement Project
A study testing Mindfulness Smartphone Application in people with Healthy Participants and Feasibility Studies, run by Florida State University at 1 site in United States.
Trial summary
The goal of this clinical trial is to examine the feasibility and acceptability of different types of text messages and a integrated gaming app to increase engagement in a mindfulness mobile health application. 1. Does receiving text messages increase engagement in a mindfulness app? 2. Read more about this study
- Who is it for?
- Ages 18 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants, Feasibility Studies, Acceptability
- What is being tested?
- Mindfulness Smartphone Application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2025to 6 Aug 2027
- 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 18 to 29 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-29 years old First-generation college student Undergraduate college student Living in the United States Meet criteria for binge drinking (5 drinks in about 2 hours) or heavy drinking (more than 14 drinks per week).
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Florida State University Center for Translational Behavioral Science
Tallahassee, Florida, 32305
Laura Reid Marks, PhD, laura.reidmarks@med.fsu.edu
About this study
Official title: Translating Behavioral Economics Strategies to Culturally Tailor a Mobile Health Mindfulness Intervention to Reduce Risky Drinking Behaviors in Emerging Adult College Student Students
The goal of this clinical trial is to examine the feasibility and acceptability of different types of text messages and a integrated gaming app to increase engagement in a mindfulness mobile health application.
- Does receiving text messages increase engagement in a mindfulness app?
- Does an integrated gaming app increase engagement in a mindfulness app?
Read more
Researchers will examine whether participants engage more in a mindfulness mobile health application if they receive text messages and if they engage in additional gaming app on their smartphone. Participants will:
- Use a mindfulness and gaming mobile health application for 28-days.
- Complete a pre-study survey, post-study survey, follow-up interview, and 3-month follow-up survey in addition to daily brief surveys.
Read the detailed description
Participants who are eligible to participate in the pilot micro-randomized trial (MRT) will be screened and onboarded via Zoom. They will be given baseline measures and trained on using the mindfulness app with integrated gaming app on their smartphone. Micro-randomizations will be used to address scientific questions related to the delivery and personalization of episodic future thinking and reciprocity engagement strategies in addition to gamification across the 28-day trial. The proposed pilot MRT will micro-randomize participants in the morning into one of three options: (i) episodic future thinking text-based prompts, (ii) reciprocity text-based prompts, or (iii) no prompts with equal probability. Participants will receive mobile-based ecological momentary assessments in the evening. EMA data will be paired with usage data from the mindfulness app (e.g., time spent in app, number of sessions, completion of mindfulness videos) to assess the conditions under which participants are receptive to engagement strategies. After 28 days, a follow-up survey questionnaire will be administered and an individual interview will be conducted with each participant. A 3-month follow-up survey will also be administered to participants who complete the study. Our primary outcome in engagement in the mindfulness app, and our secondary outcomes are stress and alcohol use.
- Conditions
- Healthy Participants, Feasibility Studies, Acceptability
- Being tested
- Mindfulness Smartphone Application
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Smartphone ApplicationOther
A mindfulness mobile health smartphone application that has mindfulness information and practice videos.
| Study group | Role | What they receive |
|---|---|---|
| Reciprocity | Other | Reciprocity text messages include giving participants a message with an solicited reward (e.g., credits in gaming app, $1). Receives: Other: Mindfulness Smartphone Application |
| Episodic Future Thinking | Other | Episodic Future Thinking text messages include giving participants a message that encourages them to think vividly about their future Receives: Other: Mindfulness Smartphone Application |
| No text message | Other | Participants receive no text message in this arm Receives: Other: Mindfulness Smartphone Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mobile Health Engagement
We will assess engagement in our mindfulness mobile health application by measuring paradata (i.e., time spent in the app, whether or not the app was opened, which content was viewed in the app).
Measured: 1 month
Secondary outcomes (2)
Change in Alcohol Use
Participants will utilize recall and report the total number of days they consumed alcohol over the last 30 day period
Measured: Baseline; 1 month; 3 months
Change in Stress
Perceived Stress Scale is a 10 question Likert Scale that utilizes a 0-4 range ( 0=no stress and 4=the worst stress ever). With Score Ranges possible from 0-40 that assess the participants perceived stress over the last 30days.
Measured: Baseline; 1 month; 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2025
- Study start30 Sep 2025
- Primary completion2 Jul 2027 (estimated)
- Study completion6 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- The study is a pilot micro-randomized trial where participants are micro-randomized daily in a 28-day trial to receive different types of messages (episodic-future thinking, reciprocity, or no text message) and enticed by a gaming app to examine the feasibility and acceptability of these strategies to engage participants in a mindfulness mobile health application.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Laura Marks, Florida State University
- Investigators
- Laura Reid Marks, PhD, Principal investigator, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07170202
- Sponsor's protocol ID
- STUDY00004768
- Other IDs
- 5K23AA030602
- Acronym
- TIMEProject
- Status last verified
- Jul 2026
- First submitted
- 5 Sep 2025
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translating Behavioral Economics Strategies to Culturally Tailor a Mobile Health Mindfulness Intervention to Reduce Risky Drinking Behaviors in Emerging Adult College Student Students
- ClinicalTrials.gov ID
- NCT07170202
- Acronym / sponsor ID
- TIMEProject / STUDY00004768
- Conditions
- Healthy Participants, Feasibility Studies, Acceptability
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 30 Sep 2025 (actual)
- Primary completion
- 2 Jul 2027 (estimated)
- Study completion
- 6 Aug 2027 (estimated)
- First posted
- 12 Sep 2025 (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 is to examine the feasibility and acceptability of different types of text messages and a integrated gaming app to increase engagement in a mindfulness mobile health application.
- Does receiving text messages increase engagement in a mindfulness app?
- Does an integrated gaming app increase engagement in a mindfulness app?
Researchers will examine whether participants engage more in a mindfulness mobile health application if they receive text messages and if they engage in additional gaming app on their smartphone. Participants will:
- Use a mindfulness and gaming mobile health application for 28-days.
- Complete a pre-study survey, post-study survey, follow-up interview, and 3-month follow-up survey in addition to daily brief surveys.
Detailed description
Participants who are eligible to participate in the pilot micro-randomized trial (MRT) will be screened and onboarded via Zoom. They will be given baseline measures and trained on using the mindfulness app with integrated gaming app on their smartphone. Micro-randomizations will be used to address scientific questions related to the delivery and personalization of episodic future thinking and reciprocity engagement strategies in addition to gamification across the 28-day trial. The proposed pilot MRT will micro-randomize participants in the morning into one of three options: (i) episodic future thinking text-based prompts, (ii) reciprocity text-based prompts, or (iii) no prompts with equal probability. Participants will receive mobile-based ecological momentary assessments in the evening. EMA data will be paired with usage data from the mindfulness app (e.g., time spent in app, number of sessions, completion of mindfulness videos) to assess the conditions under which participants are receptive to engagement strategies. After 28 days, a follow-up survey questionnaire will be administered and an individual interview will be conducted with each participant. A 3-month follow-up survey will also be administered to participants who complete the study. Our primary outcome in engagement in the mindfulness app, and our secondary outcomes are stress and alcohol use.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- The study is a pilot micro-randomized trial where participants are micro-randomized daily in a 28-day trial to receive different types of messages (episodic-future thinking, reciprocity, or no text message) and enticed by a gaming app to examine the feasibility and acceptability of these strategies to engage participants in a mindfulness mobile health application.
| Arm | Type | Receives |
|---|---|---|
| Reciprocity | Other | Other: Mindfulness Smartphone ApplicationReciprocity text messages include giving participants a message with an solicited reward (e.g., credits in gaming app, $1). |
| Episodic Future Thinking | Other | Other: Mindfulness Smartphone ApplicationEpisodic Future Thinking text messages include giving participants a message that encourages them to think vividly about their future |
| No text message | Other | Other: Mindfulness Smartphone ApplicationParticipants receive no text message in this arm |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 18-29 years old First-generation college student Undergraduate college student Living in the United States Meet criteria for binge drinking (5 drinks in about 2 hours) or heavy drinking (more than 14 drinks per week).
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Mindfulness Smartphone ApplicationA mindfulness mobile health smartphone application that has mindfulness information and practice videos. | Other | Episodic Future Thinking, No text message, Reciprocity |
Primary outcome
Mobile Health Engagement
Time frame: 1 month
We will assess engagement in our mindfulness mobile health application by measuring paradata (i.e., time spent in the app, whether or not the app was opened, which content was viewed in the app).
2 secondary outcomes
Change in Alcohol Use
Time frame: Baseline; 1 month; 3 months
Change in Stress
Time frame: Baseline; 1 month; 3 months
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 13 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
Laura Reid Marks, PhD principal investigator
Florida State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Smartphone Application in people with Healthy Participants and Feasibility Studies, run by Florida State University at 1 site 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 0 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: looking for participants now, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Contact Laura Reid Marks, PhD ((850)644-2334, laura.reidmarks@med.fsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mobile Health Engagement (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jul 2026.