Recruiting

Mindfulness Program

Sponsor:

Florida International University

Code:

NCT07192094

Conditions

MBSR

Young Adults

Heavy Episodic Drinking

Eligibility Criteria

Sex: All

Age: 18 - 25

Healthy Volunteers: Accepted

Interventions

Mindfulness Sessions - 8 Week Program

Study Details

Brief summary:

This study is a trial to evaluate a mindfulness program designed for Hispanic young adults. Participants will be randomly assigned to one of two groups: (1) an in-person, 8-week mindfulness program (one 1.5-hour session per week at FIU's MMC campus), or (2) an assessment-only control group. Regardless of group assignment. Participants will be asked to complete online surveys at baseline, after an 8-week period, and again one month later. They will also be asked to provide a fingerpick blood sample and have their heart rate and blood pressure measured at four timepoints: baseline, 1 month, 2 months, and 3 months after baseline. Participation will involve up to 16 hours over approximately 14 weeks. This includes time for completing baseline assessments, participating in the 8-week intervention (if assigned), and completing post-program and follow-up assessments. There are no serious risks of participating in this study, but some of the questions during the assessments, interview, or the fingerpick may cause you discomfort. The main benefit from participating in this clinical trial is that participants may experience personal benefits from learning mindfulness techniques.

Conditions

MBSR

Young Adults

Heavy Episodic Drinking

Study ID

NCT07192094

Start date

Jan 27, 2026

Status verified date

Feb, 2026

Completion date

Jul, 2028

Anticipated

Primary completion date

Jul, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 25

Healthy Volunteers: Accepted

Inclusion Criteria:

  • self-identified Hispanic,
  • 18-25 years old,
  • engaged in 2 or more occasions of heavy episodic drinking occasions (HED) (4/5 drinks in one sitting for females/males) during the previous 30-days
  • actively enrolled FIU student. Exclusion Criteria

Participants will be flagged for exclusion criteria if they report any of the following:

  • Five or more binge drinking episodes (5+ drinks in one sitting) in the past 30 days, which averages more than once per week.
  • Weekly or more frequent use of other substances, including non-prescribed prescription drugs, illegal drugs, inhalants, or synthetic drugs.

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Mindfulness Sessions

An adapted Mindfulness-Based Stress Reduction (MBSR) intervention group (n=60). The intervention is an adapted MBSR 8-week program (1.5 hour/week), and the sessions will be delivered by a facilitator on FIU MMC Campus. Participants will also complete 3 quantitative study assessments and undergo biomarker collections at 4 timepoints .

no intervention: Assessments Only

Assessment-only control group (n=60). Participants randomly assigned to the control condition will not receive the mindfulness intervention but will complete all study assessments and biomarker collections at the same timepoints as the intervention group (i.e., baseline, post-intervention, 1-month follow-up, and biomarker collections at four timepoints). These participants will not attend any mindfulness group sessions but will be compensated for their participation in data collection activities.

Interventions

Mindfulness Sessions - 8 Week Program

A culturally, and developmentally adapted Mindfulness-Based Stress Reduction (MBSR) program for Hispanic (self-identified) emerging adult (EA) participants (ages 18-25 years old) over 8 weeks (1.5 hours/week).

Primary outcome measure

  • Acceptability [ Time Frame: Post Intervention (within 1 week of completing the program) ]
  • Feasibility - Retention [ Time Frame: Post Intervention (within 1 week of completing the program) and follow-up (1-month post program completion) ]
  • Feasibility - Attendance (intervention group only) [ Time Frame: Baseline through Week 8 (end of intervention) ]

Central Contacts and Locations

Central contacts

Michelle Hospital, PhD, LMHC

305-505-9337hospitam@fiu.edu

Staci Morris, Psy D

954-856-6854morrisl@fiu.edu

Locations

Academic Health Center 5 (AHC 5)

Recruiting

Miami, Florida, United States, 33199

Contacts

Michelle Hospital, Ph.d, LMHC

305-505-9337hospitam@fiu.edu

More Information

Sponsor

Florida International University

Last update posted

Feb 25, 2026

Last verified

Feb, 2026

Keywords

  • Young adults
  • College Students
  • Ages 18 - 25
  • Binge Drinking
  • Stress
  • Mindfulness
  • Stress Reduction
  • HRV
  • Contingency Management
  • MBSR
  • alcohol misuse

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Florida International University on 2026-02-25.