MBSRMindfulnessNCT07192094
A Reinforced Mindfulness-Based Intervention to Reduce Problematic Drinking Among Hispanic Emerging Adults
A study testing Mindfulness Sessions - 8 Week Program in people with MBSR and Young Adults, run by Florida International University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- MBSR, Young Adults, Heavy Episodic Drinking
- What is being tested?
- Mindfulness Sessions - 8 Week Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jan 2026to Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Academic Health Center 5 (AHC 5)
Miami, Florida, 33199
Michelle Hospital, Ph.d, LMHC, 305-505-9337, hospitam@fiu.edu
About this study
Official title: A Reinforced Mindfulness-Based Intervention to Reduce Problematic Drinking Among Hispanic Emerging Adults: Feasibility and Acceptability
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.
Read the detailed 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.
- Conditions
- MBSR, Young Adults, Heavy Episodic Drinking
- Being tested
- Mindfulness Sessions - 8 Week Program
- Keywords
- Young adults, College Students, Ages 18 - 25, Binge Drinking, Stress, Mindfulness, Stress Reduction, HRV, Contingency Management, MBSR, alcohol misuse
- Medical subject headings
- Binge Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Sessions - 8 Week ProgramBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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 . Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline through Week 8 (end of intervention)
Secondary outcomes (3)
Reduction in Heavy Episodic Drinking (PEth)
Change in levels of Phosphatidylethanol (PEth) from baseline to post-intervention and 1-month follow-up.
Measured: Baseline to Post Intervention (8 weeks), 1 month follow up (12 weeks)
Reduction in alcohol consumption (self-report)
Change average number of drinking days
Measured: 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
Measured: Baseline to Post Intervention (8 weeks), 1 month follow up (12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2025
- Study start27 Jan 2026
- Primary completionJul 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MBSRStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Florida International University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), UConn Health
- Responsible party
- Principal investigator, Michelle M. Hospital, PhD, LMHC, BBA, Florida International University
- Investigators
- Michelle Hospital, PhD, LMHC, Principal investigator, Florida International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07192094
- Sponsor's protocol ID
- R01AA030976
- Other IDs
- R01AA030976
- Acronym
- Mindfulness
- Status last verified
- Feb 2026
- First submitted
- 9 Sep 2025
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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.
PubMed 37276788
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Reinforced Mindfulness-Based Intervention to Reduce Problematic Drinking Among Hispanic Emerging Adults: Feasibility and Acceptability
- ClinicalTrials.gov ID
- NCT07192094
- Acronym / sponsor ID
- Mindfulness / R01AA030976
- Conditions
- MBSR, Young Adults, Heavy Episodic Drinking
- Keywords
- Young adults, College Students, Ages 18 - 25, Binge Drinking, Stress, Mindfulness, Stress Reduction, HRV
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Florida International UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), UConn Health
- Study start
- 27 Jan 2026 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 25 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Sessions | Experimental | Behavioral: Mindfulness Sessions - 8 Week ProgramAn 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 . |
| 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. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
- Five or more binge drinking episodes (5+ drinks in one sitting) in the past 30 days, which averages more than once per week.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness Sessions - 8 Week ProgramA 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). | Behavioural | Mindfulness Sessions |
Primary outcome
Acceptability
Time frame: Post Intervention (within 1 week of completing the program)
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.
Feasibility - Retention
Time frame: Post Intervention (within 1 week of completing the program) and follow-up (1-month post program completion)
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.
Feasibility - Attendance (intervention group only)
Time frame: Baseline through Week 8 (end of intervention)
Attendance will be assessed as the average number of sessions attended out of 8 total sessions. Unit of measure: mean number of sessions attended.
3 secondary outcomes
Reduction in Heavy Episodic Drinking (PEth)
Time frame: Baseline to Post Intervention (8 weeks), 1 month follow up (12 weeks)
Reduction in alcohol consumption (self-report)
Time frame: Baseline to Post Intervention (8 weeks), 1 month follow up (12 weeks)
Change in Perceived Stress
Time frame: Baseline to Post Intervention (8 weeks), 1 month follow up (12 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Background: PubMed 37276788Hospital 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michelle Hospital, PhD, LMHC principal investigator
Florida International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Sessions - 8 Week Program in people with MBSR and Young Adults, run by Florida International University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michelle Hospital, PhD, LMHC (305-505-9337, hospitam@fiu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability (time frame: Post Intervention (within 1 week of completing the program)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07192094, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.