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Recruiting NCT07170202

The Increasing Mindfulness Engagement Project

No phase Interventional Healthy Participants Feasibility Studies Acceptability

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mindfulness Smartphone Application.
Who it may be relevant to
Registry conditions: Healthy Participants, Feasibility Studies, Acceptability. Basic parameters: 18 years — 29 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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

Overview

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.

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.

Interventions

  • Other Mindfulness Smartphone Application
    A mindfulness mobile health smartphone application that has mindfulness information and practice videos.

Primary outcome measures

  • Mobile Health Engagement [Time frame: 1 month]
Secondary outcome measures (2)
  • Change in Alcohol Use [Time frame: Baseline; 1 month; 3 months]
  • Change in Stress [Time frame: Baseline; 1 month; 3 months]

Eligibility criteria

Inclusion criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Single group
Masking
Double blind
Primary purpose
Other

Study locations

United States · 1 center
  • Florida State University Center for Translational Behavioral Science — Tallahassee

Identifiers

NCT: NCT07170202 · STUDY00004768 · 5K23AA030602

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗