A Reinforced Mindfulness-Based Intervention to Reduce Problematic Drinking Among Hispanic Emerging Adults

NCT07192094 | Recruiting DMC

• 1 other identifier: R01AA030976
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Acceptability

  Acceptability of the program will be assessed at post-intervention using a study-developed survey consisting of Likert-scale items (1 = Strongly Disagree to 5 = Strongly Agree). The survey evaluates multiple domains, including appropriateness and relevance, ease of participation and feasibility, engagement and interest, perceived benefit, satisfaction, facilitator feedback, and acceptability of the companion rewards program. Higher scores indicate greater acceptability, and results will be summarized descriptively at the item and domain levels.

  Post Intervention (within 1 week of completing the program)

• Feasibility - Retention

  Retention will be assessed as the proportion of enrolled participants who complete the post- and follow-intervention assessments. Unit of measure: percentage of enrolled participants.

  Post Intervention (within 1 week of completing the program) and follow-up (1-month post program completion)

• Feasibility - Attendance (intervention group only)

  Attendance will be assessed as the average number of sessions attended out of 8 total sessions. Unit of measure: mean number of sessions attended.

  Baseline through Week 8 (end of intervention)

Secondary Outcomes (3)

• Reduction in Heavy Episodic Drinking (PEth)

  Baseline to Post Intervention (8 weeks), 1 month follow up (12 weeks)

• Reduction in alcohol consumption (self-report)

  Baseline to Post Intervention (8 weeks), 1 month follow up (12 weeks)

• Change in Perceived Stress

  Baseline to Post Intervention (8 weeks), 1 month follow up (12 weeks)

Study Arms (2)

Mindfulness Sessions

EXPERIMENTAL

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 .

Behavioral: Mindfulness Sessions - 8 Week Program

Assessments Only

NO INTERVENTION

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 BEHAVIORAL

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).

Mindfulness Sessions

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• self-identified Hispanic,
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• UConn Health: collaborator
• Florida International University: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Academic Health Center 5 (AHC 5)

Miami, Florida, 33199, United States

RECRUITING

Related Publications (1)

• Hospital MM, Contreras-Perez ME, Alessi SM, Langwerden RJ, Morris SL, Wagner EF. Mindfulness as an early intervention for hazardous alcohol use among non-treatment seeking Latine emerging adults: A mini-review. Addict Behav. 2023 Oct;145:107759. doi: 10.1016/j.addbeh.2023.107759. Epub 2023 May 29.

  PMID: 37276788 BACKGROUND

MeSH Terms

Conditions

Binge Drinking

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Alcohol Drinking; Drinking Behavior; Behavior; Mental Disorders

Study Officials

• Michelle Hospital, PhD, LMHC

  Florida International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michelle Hospital, PhD, LMHC

CONTACT

305-505-9337; hospitam@fiu.edu

Staci Morris, Psy D

CONTACT

954-856-6854; morrisl@fiu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Director, Community-Based Research Institute; Research Associate Professor, Department of Biostatistics; Community Engagement Core Leader, FIU-RCMI

Model Details: The RCT will include a total of 120 participants. Participants will be randomly assigned to either the active adapted Mindfulness-Based Stress Reduction intervention group (n=60) or to an assessment-only control group (n=60).

Study Record Dates

• First Submitted: September 9, 2025
• First Posted: September 25, 2025
• Study Start: January 27, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: De-identified data will be submitted to the NIAAA Data Archive semi-annually. Data will become available to the research community consistent with the NIAAADA sharing schedule and will remain available indefinitely.
• Access Criteria: Qualified investigators may access the de-identified dataset through the NIAAA Data Archive. Investigators must obtain IRB approval at their own institution (and, if applicable, at FIU) and agree to the NIAAADA Data Use Terms and Conditions. For requests outside NIAAADA, data may be shared by the PI under a data-sharing agreement that prohibits participant re-identification, requires data destruction after analyses, restricts redistribution, and requires acknowledgment of the data source.

Locations

US (1)