Ignite Creation Date:
2025-12-25 @ 3:55 AM
Ignite Modification Date:
2025-12-26 @ 2:46 AM
Study NCT ID:
NCT07170202
Status:
RECRUITING
Last Update Posted:
2025-10-06
First Post:
2025-09-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Increasing Mindfulness Engagement Project
Sponsor:
Florida State University
Organization:
Study Overview
Official Title:
Translating Behavioral Economics Strategies to Culturally Tailor a Mobile Health Mindfulness Intervention to Reduce Risky Drinking Behaviors in Black College Student Men
Status:
RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TIMEProject
Brief 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. 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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 5K23AA030602 | NIH | None | https://reporter.nih.gov/quic… | View |