Mindfulness App for Healthy Subjects

(TIMEProject Trial)

Overseen By FSU CTBS

Age: 18 - 65

Sex: Male

Trial Phase: Academic

Sponsor: Florida State University

Disqualifiers: Non-US born, Not 18-29, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 4 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how text messages and a gaming app might boost engagement with a mindfulness app. Researchers aim to determine if different types of text messages or a gaming app increase usage of the mindfulness app. Participants will use the mindfulness app for 28 days and complete several surveys and interviews. Ideal participants are US-born Black biological men who are undergraduate college students and meet specific drinking criteria, such as binge drinking or heavy drinking. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance mindfulness practices.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this method is safe for increasing engagement in a mindfulness app?

Research shows that mindfulness apps are generally safe for users. Previous studies have found that these apps can help reduce negative thoughts and improve focus. No major safety issues have been reported with using mindfulness apps.

This trial tests how text messages and a game app might increase mindfulness app usage. The treatment involves receiving messages that either provide small rewards or encourage future-oriented thinking. These activities are low-risk and safe. Participants will use the app for 28 days and complete surveys to help researchers understand the app's effects.

Overall, the mindfulness app and its additional features are expected to be safe and easy to use, with minimal risk. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to enhance mindfulness through digital interventions. The study uses text messages with unique approaches like "Reciprocity," which provides participants with unexpected rewards, and "Episodic Future Thinking," which encourages vivid contemplation of the future. Unlike traditional mindfulness practices, which often require in-person sessions or guided meditation, this trial leverages the convenience and accessibility of a mobile app to engage participants. This method could potentially make mindfulness practices more engaging and widespread, especially for those who find it challenging to commit to traditional mindfulness routines.

What evidence suggests that this trial's methods could be effective for increasing engagement in a mindfulness app?

Studies have shown that text messages can increase the use of mindfulness apps. In this trial, participants may receive text messages offering rewards or encouraging future-oriented thinking, as part of the "Reciprocity" and "Episodic Future Thinking" arms, respectively. Research also suggests that adding a game element to these apps can enhance their appeal. A gaming feature might motivate users to continue mindfulness exercises. Although the evidence is still developing, these strategies appear promising for boosting mindfulness app usage. ^{1 2 5 6 7}

Who Is on the Research Team?

Laura Reid Marks, PhD

Principal Investigator

Florida State University

Are You a Good Fit for This Trial?

This trial is for healthy individuals interested in using a mindfulness smartphone app. Participants must be willing to use the app and complete various surveys and interviews before, during, and after the study period of 28 days.

Inclusion Criteria

US-born

Black

Meets criteria for binge drinking (5 drinks in about 2 hours) or heavy drinking (more than 14 drinks per week)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (virtual via Zoom)

Onboarding and Training

Participants are onboarded and trained on using the mindfulness app with integrated gaming app on their smartphone

1 week

1 visit (virtual via Zoom)

Treatment

Participants use the mindfulness and gaming mobile health application for 28 days with micro-randomizations and receive ecological momentary assessments

4 weeks

Follow-up

Participants complete a follow-up survey and an individual interview

1 week

1 visit (virtual via Zoom)

3-Month Follow-up

Participants complete a 3-month follow-up survey to assess long-term outcomes

3 months

What Are the Treatments Tested in This Trial?

Interventions

• The Increasing Mindfulness Engagement Project

Trial Overview The study tests if text messages or an integrated gaming feature can boost how much people use a mindfulness app. Participants will engage with these features over four weeks to determine their impact on app usage.

How Is the Trial Designed?

Group I: Reciprocity Experimental Treatment 1 Intervention

Reciprocity text messages include giving participants a message with an solicited reward (e.g., credits in gaming app, $1).

Group II: No text message Experimental Treatment 1 Intervention

Participants receive no text message in this arm

Group III: Episodic Future Thinking Experimental Treatment 1 Intervention

Episodic Future Thinking text messages include giving participants a message that encourages them to think vividly about their future

Who Is Running the Clinical Trial?

Florida State University

Lead Sponsor

Trials

234

Recruited

41,100+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07170202

The Increasing Mindfulness Engagement Project 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 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07170202?lastUpdPost=2020-10-10_

Study Details | NCT07170202 | The Increasing Mindfulness ... Researchers will examine whether participants engage more in a mindfulness mobile health application if they receive text messages and if they ...

3. app.trialscreen.org app.trialscreen.org/trials/increasing-mindfulness-engagement-project-trial-nct07170202

The Increasing Mindfulness Engagement Project This Interventional study is looking for people with Healthy Participants, Feasibility Studies in Tallahassee United States to take part.

4. htsyndication.com htsyndication.com/us-fed-news/article/clinical-trial%3A-the-increasing-mindfulness-engagement-project/555757607

Clinical Trial: The Increasing Mindfulness Engagement ... 05. Brief Summary: The goal of this clinical trial is to examine the feasibility and acceptability of different types of text messages and a ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6329416/

Effects of a Mindfulness Meditation App on Subjective Well ... This study aimed to investigate a newly developed MT app called Wildflowers, which was codeveloped with the laboratory for use in mindfulness research.

6. bmcdigitalhealth.biomedcentral.com bmcdigitalhealth.biomedcentral.com/articles/10.1186/s44247-025-00155-7

Acceptability, engagement, outcomes, and dose–response ... In this study, we evaluated a mindfulness app in adults waiting for psychological services. A non-randomized clinical trial was conducted with a 4-week ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10955957/

The impact of mindfulness apps on psychological ... Mindfulness apps showed positive effects on repetitive negative thinking, attention regulation, and decentering/defusion, but mixed results in ...