The Increasing Mindfulness Engagement Project (TIMEProject)

Florida State University

Status: Enrolling

Conditions: Acceptability; Healthy Participants; Feasibility Studies

Treatments: Other: Mindfulness Smartphone Application

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07170202

5K23AA030602 (U.S. NIH Grant/Contract)

STUDY00004768

Details and patient eligibility

About

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. 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:

1. Use a mindfulness and gaming mobile health application for 28-days.
2. Complete a pre-study survey, post-study survey, follow-up interview, and 3-month follow-up survey in addition to daily brief surveys.

Full 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.

Enrollment: 40 estimated patients

Sex: Male

Ages: 18 to 29 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• US-born
• Black
• biological man
• undergraduate college student
• criteria for binge drinking (5 drinks in about 2 hours) or heavy drinking (more than 14 drinks per week).

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

---

40 participants in 3 patient groups

Reciprocity

Other group

Description:

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

Treatment:

Other: Mindfulness Smartphone Application

Episodic Future Thinking

Other group

Description:

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

Treatment:

Other: Mindfulness Smartphone Application

No text message

Other group

Description:

Participants receive no text message in this arm

Treatment:

Other: Mindfulness Smartphone Application