NCT07170202

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. 1.Does receiving text messages increase engagement in a mindfulness app?
  2. 2.Does an integrated gaming app increase engagement in a mindfulness app?
  3. 3.Use a mindfulness and gaming mobile health application for 28-days.
  4. 4.Complete a pre-study survey, post-study survey, follow-up interview, and 3-month follow-up survey in addition to daily brief surveys.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
8mo left

Started Sep 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress50%
Sep 2025Mar 2027

First Submitted

Initial submission to the registry

September 5, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 12, 2025

Completed
18 days until next milestone

Study Start

First participant enrolled

September 30, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

October 6, 2025

Status Verified

October 1, 2025

Enrollment Period

1.2 years

First QC Date

September 5, 2025

Last Update Submit

October 1, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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).

    1 month

Secondary Outcomes (2)

  • Change in Alcohol Use

    Baseline; 1 month; 3 months

  • Change in Stress

    Baseline; 1 month; 3 months

Study Arms (3)

Reciprocity

OTHER

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

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

Other: Mindfulness Smartphone Application

No text message

OTHER

Participants receive no text message in this arm

Other: Mindfulness Smartphone Application

Interventions

A mindfulness mobile health smartphone application that has mindfulness information and practice videos.

Episodic Future ThinkingNo text messageReciprocity

Eligibility Criteria

Age18 Years - 29 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Florida State University Center for Translational Behavioral Science

Tallahassee, Florida, 32305, United States

RECRUITING

Study Officials

  • Laura Reid Marks, PhD

    Florida State University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 5, 2025

First Posted

September 12, 2025

Study Start

September 30, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

March 1, 2027

Last Updated

October 6, 2025

Record last verified: 2025-10

Locations