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

Florida International University (FIU)

Status: Not yet enrolling

Conditions: Young Adults; MBSR; Heavy Episodic Drinking

Treatments: Behavioral: Mindfulness Sessions - 8 Week Program

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07192094

R01AA030976 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

The primary objective of this Randomized Control Trial (RCT) will be to maximize the ecological validity of a cultural, and developmental adaptation of the Mindfulness-Based Stress Reduction (MBSR) program for Hispanic (self-identified) emerging adult (EA) participants (ages 18-25 years old).

The study team will recruit individuals (n=120, 60 Intervention, 60 Control ) from the target population, Hispanic EA (18-25) all of whom will meet the following eligibility 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, and are actively enrolled at FIU as a student.

The intervention will consist of eight weekly 1.5-hour group sessions led by a trained facilitator at FIU's MMC campus and participants will be randomly assigned (1:1 allocation) to either the active Mindfulness-Based Stress Reduction intervention group (n=60) or to an assessment-only control group (n=60).

Procedures for data collection, compensation, and biomarkers will be as follows: Participants who enroll in the full RCT will be compensated with gift cards for their time and effort in completing data collection activities at designated timepoints -. baseline, 1-month post-baseline, post-intervention (approximately 2 months post-baseline), and 1-month follow-up (approximately 3 months post-baseline).

Biomarker collection will include a fingerprick blood sample to test for the alcohol biomarker phosphatidylethanol (PEth), as well as assessments of heart rate variability (HRV) and blood pressure (BP) as physiological indicators of stress.

To enhance engagement and reinforce attendance, an evidence-based fixed escalating Contingency Management schedule will be implemented at the conclusion of each mindfulness session. The sessions will be recorded, transcribed, and coded for appropriate developmental and cultural content by the research team. The risks associated with participation are minimal, but can include discomfort from assessments, biomarker collections, and potential breach of confidentially but these are minimal and typical routine procedures. Anticipated benefits include participant enjoyment of the sessions, engagement in self-study, learning mindfulness techniques for managing stress, and potential positive outcomes from the intervention.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 25 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Mindfulness Sessions

Experimental group

Description:

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 .

Treatment:

Behavioral: Mindfulness Sessions - 8 Week Program

Assessments Only

No Intervention group

Description:

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.