An interventional study of Mindfulness Sessions - 8 Week Program in MBSR, Young Adults and Heavy Episodic Drinking, sponsored by Florida International University. Recruiting at 1 site in United States. Open to participants aged 18 Years to 25 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-25.
Sponsored by Florida International University · Not applicable, Interventional, and Prevention
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.
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.
71 studies on the registry are indexed under Binge Drinking; 20 are open to participants now.
This study's planned enrollment of 120 is close to the median of 120 across 64 interventional studies indexed under Binge Drinking.
Browse Binge Drinking studies →Florida International University is the lead sponsor of 104 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Participants will be flagged for exclusion criteria if they report any of the following:
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
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.
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).
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline through Week 8 (end of intervention)
Reduction in Heavy Episodic Drinking (PEth)
Change in levels of Phosphatidylethanol (PEth) from baseline to post-intervention and 1-month follow-up.
Time frame: Baseline to Post Intervention (8 weeks), 1 month follow up (12 weeks)
Reduction in alcohol consumption (self-report)
Change average number of drinking days
Time frame: Baseline to Post Intervention (8 weeks), 1 month follow up (12 weeks)
Change in Perceived Stress
Change in self reported stress using validated instruments in RedCap
Time frame: Baseline to Post Intervention (8 weeks), 1 month follow up (12 weeks)
Plan to share: Yes — Individual participant data (IPD) from the randomized clinical trial portion of the study (i.e., the Clinical Adaptation Trial) will be shared, not the formative research data. De-identified data will be submitted to the NIAAA Data Archive (NIAAADA) in accordance with NOT-AA-22-003. Shared data will include baseline, intervention, and follow-up assessment variables, as well as derived outcome measures.
Supporting information: Study protocol, Informed consent form
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.
Data sharing details ↗ · nda.nih.gov
Started Jan 2026 (actual). Primary completion is estimated for Jul 2028, 30 months after the start.
Of 38 interventional studies with no phase under Binge Drinking, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 49. This study's planned 30 months is below that.
How these figures are worked out, and which studies are left out of them.
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