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Behavioral Intervention
Online Mindfulness Program for HIV Prevention (MBQR Trial)
N/A
Recruiting
Led By Shufang Sun, Ph.D.
Research Sponsored by Brown University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
MBQR Trial Summary
This trial will develop and test a mindfulness-based program to reduce HIV risk in young adult gay, bisexual, and queer men. Primary outcomes include HIV and STI testing and self-reported sexual risk behaviors.
Who is the study for?
This trial is for young adult men and nonbinary individuals assigned male at birth, aged 18-34, living in the U.S., who have had condomless sex with a man in the past 6 months and are experiencing distress. Participants must be HIV-negative, able to read and speak English, and have access to an online conferencing device.Check my eligibility
What is being tested?
The study tests a mindfulness-based program called MBQR designed for gay, bisexual, and queer men at risk for HIV. It involves comparing two groups: one receiving MBQR intervention and another as an active control group. The focus is on reducing HIV/STI risks by improving psychological health and coping with minority stress.See study design
What are the potential side effects?
Since this intervention involves mindfulness practices rather than medication or medical procedures, side effects may include emotional discomfort or increased awareness of stressful feelings during exercises but typically do not involve physical side effects.
MBQR Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Acceptability of online MBQR as measured by a session evaluation form
Acceptability of online MBQR as measured by semi-structured qualitative exit interview
Acceptability of online MBQR as measured by the Client Satisfaction Questionnaire
+7 moreSecondary outcome measures
Anxiety symptoms
Depression symptoms: BDI-II
Depression symptoms: PHQ-9
+10 moreMBQR Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Mindfulness-Based Queer Resilience (MBQR)Experimental Treatment1 Intervention
MBQR is an online, Zoom-based mindfulness course that meets 2.5 hour per week for ten weeks, facilitated by queer mindfulness teachers, with weekly home practice and additional reflection and reading activities that can be completed by participants independently via study website portal. In addition to the 10 weekly sessions there is an all-day retreat (6hrs) that takes place around week 6. The participants also meet one-on-one with the instructor(s) at the beginning and middle of class for a 30-minute welcome call and check in.
Group II: Health EducationActive Control1 Intervention
The online Health Education course is a self-paced program that can be largely completed independently (no group meeting, no all-day) by control group participants. The ten weekly modules are estimated to take around 30 to 90 minutes each to complete and consist of readings, videos, infographics, and other related activities (e.g., reflections, quizzes).
Participants randomized to the control will be offered an optional MBQR-hybrid course after the 6-month follow-up assessment is complete. MBQR-hybrid is an online-based mindfulness course asynchronously facilitated by queer mindfulness teachers, with weekly home practice and additional reflection and reading activities that can be completed by participants independently via study website portal. Participants will also have the option of participating in weekly live 1-hour sessions. MBQR-hybrid is designed to be completed within a 3-months time frame (10 modules that can be paced to complete in a 10-14 weeks time frame).
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Who is running the clinical trial?
Brown UniversityLead Sponsor
456 Previous Clinical Trials
558,294 Total Patients Enrolled
National Center for Complementary and Integrative Health (NCCIH)NIH
833 Previous Clinical Trials
669,393 Total Patients Enrolled
Shufang Sun, Ph.D.Principal InvestigatorBrown University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have significant difficulty with my memory or thinking.I identify as a cisgender man or nonbinary.I have bipolar disorder symptoms and haven't received treatment.I was assigned male at birth.I am between 18 and 34 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Mindfulness-Based Queer Resilience (MBQR)
- Group 2: Health Education
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the enrollment criteria for this trial including those over three-quarters of a century old?
"This medical study specifically seeks out candidates between the ages of 18-34 years old."
Answered by AI
Is this medical research recruiting participants at the moment?
"Clinicaltrials.gov reports that this experiment is actively seeking volunteers, which was initially advertised on April 8th 2023 and most recently updated on May 4th of the same year."
Answered by AI
What is the sample size for this clinical trial?
"Affirmative. The information residing on clinicaltrials.gov indicates that the research project, which first opened recruitment doors on April 8th 2023, is currently searching for 60 individuals at a solitary location."
Answered by AI
What outcomes is this research endeavor striving to accomplish?
"The primary goal of this 6-month clinical trial is to measure the Impact of MBQR intervention on HIV/STI testing, as reported by self. Secondary outcomes assessed will include Fingernail cortisol levels via bio-samples taken at baseline, post-intervention and follow up; Depression symptoms evaluated using the BDI-II scale scored from 0 - 63; and Anxiety symptoms determined through a 7 item Likert Scale ranging from 0 - 21."
Answered by AI
Am I able to enroll in this medical study?
"To qualify for this trial, patients must possess a positive diagnosis of HIV and be between the ages of 18-34. A total of 60 participants are being accepted into this research study."
Answered by AI
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