Developing an Online Mindfulness-based Intervention to Reduce Minority Stress and HIV Risk Among Young Adult MSM
NCT ID: NCT05540652
Last Updated: 2025-11-19
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
19 participants
INTERVENTIONAL
2022-08-08
2022-12-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Developing an Online Mindfulness-based Intervention to Reduce Minority Stress and HIV Risk Among Young Adult MSM - Aim 3
NCT05855655
Feasibility of the Mindfulness-Based Stress Reduction Intervention for Black Women Living With HIV
NCT04193605
A Trauma-Informed Intervention for the Newly HIV-Diagnosed
NCT07055360
HIV Prevention and Trauma Treatment for Men Who Have Sex With Men With Childhood Sexual Abuse Histories
NCT01395979
Being Responsible for Ourselves HIV Risk Reduction for Black MSM
NCT02561286
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
A key driver of such disparities experienced by YMSM is minority stress. Experiences of identity-based discrimination lead to internalized stigma and maladaptive coping (e.g., emotion dysregulation, avoidant coping, impulsivity) The "downstream" effects of minority stress are poor mental health (depression and anxiety), increased sexual risk, and lack of engagement in key health services such as HIV testing due to anxiety related to identity disclosure to providers and anticipation of stigmatizing encounters. Recent evidence also suggests discrimination exposure is linked to heightened physiological stress response (cortisol level) that represents depletion of coping resources and increased risk for development of stress-linked psychological disorders (depression, anxiety). Therefore, reducing minority stress represents a promising transdiagnostic approach to reduce the burden of HIV and mental health issues experienced by YMSM.
Research suggests that Mindfulness-Based Interventions (MBIs) target mechanisms relevant to minority stress, including self-acceptance, emotional dysregulation, and avoidant coping. Therefore, as an individual-level intervention, MBIs may serve as an innovative HIV prevention intervention by lowering the syndemic risk among YMSM through reducing psychological symptoms, improving coping, and enhancing HIV-related behavioral health. However, no evidence-based MBIs have been tested for HIV prevention, and clinical and research evidence suggests further adaptation is warranted to improve its relevance and optimize engagement for YMSM.
This study aims to develop an internet-delivered MBI to address minority stress and its negative HIV-related health consequences experienced by YMSM. Specifically, the researchers propose to adapt, refine, and pilot-test an evidence-based MBI, Mindfulness-based Stress Reduction (MBSR), to promote mental and sexual health and HIV testing engagement among distressed, high-risk YMSM. Aims 1-3 will support the subsequent production and evaluation of the adapted intervention. To maximize reach, scalability, and availability to a population that experience challenges seeking in-person counseling and health services, the intervention will also be adapted for internet-based delivery.
Aim 1. (Previously Completed) Adapt MBSR for distressed, high-risk YMSM using internet delivery, guided by the ADAPT-ITT model. Researchers conducted iterative phases of formative research including online-based focus groups with YMSM, solicitation of feedback from stakeholders, and revision of intervention protocols. This process resulted in the first-draft of an internet-delivered, mindfulness-based intervention protocol for use with YMSM, known as "Mindfulness-Based Queer Resilience (MBQR)".
Aim 2. (This is the focus of this Clinical Trial Registration) Refine intervention protocol by administering adapted materials to distressed, high-risk YMSM (n=18) through internet-based open pilot and gather feedback. Following integration of feedback, this process will result in a finalized protocol of an internet-delivered, mindfulness-based intervention protocol for YMSM.
Aim 3. (Future research) Examine the feasibility and acceptability of an internet-delivered mindfulness-based intervention (iMBI) for HIV prevention. A sample of 40 distressed, high-risk YMSM will be randomized into the adapted iMBI or an active control condition. Primary outcome will be intervention feasibility and acceptability.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Mindfulness-Based Queer Resilience (MBQR)
This is a single arm trial testing an internet delivered mindfulness-based intervention. All enrolled participants will receive the study intervention.
Mindfulness-Based Queer Resilience (MBQR)
"Mindfulness-based Queer Resilience (MBQR)" is an internet delivered group-based, LGBTQ affirmative mindfulness program designed to address minority stress and promote mental and sexual health among young adult gay, bisexual, and queer men. The intervention group will meet once a week for up to 2.5 hours for nine weeks. Participants will receive free training in meditation, mindful movements, and in directing mindfulness-based skills towards enhancing things like stress recovery, sleep, resilience, cognitive performance and social relationships. MBQR was adapted from the Mindfulness-Based Stress Reduction program. Customization of the curriculum was developed by queer researchers and teachers, with input from the LGBTQ community.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Mindfulness-Based Queer Resilience (MBQR)
"Mindfulness-based Queer Resilience (MBQR)" is an internet delivered group-based, LGBTQ affirmative mindfulness program designed to address minority stress and promote mental and sexual health among young adult gay, bisexual, and queer men. The intervention group will meet once a week for up to 2.5 hours for nine weeks. Participants will receive free training in meditation, mindful movements, and in directing mindfulness-based skills towards enhancing things like stress recovery, sleep, resilience, cognitive performance and social relationships. MBQR was adapted from the Mindfulness-Based Stress Reduction program. Customization of the curriculum was developed by queer researchers and teachers, with input from the LGBTQ community.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Being 18 to 34 years of age
* Identify as a cisgender man
* Reside in the United States
* Can read and speak in English
* Engaged in condomless anal sex with another man in the past 6-months
* Endorse distress, measured by the PHQ-9 and GAD-7
* Possess a device (phone, tablet, computer) that allows for online conferencing
* HIV-negative or status unknown (self-report)
Exclusion Criteria
* Psychosis
* Imminent suicidal risk
* Substance abuse
18 Years
34 Years
MALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Center for Complementary and Integrative Health (NCCIH)
NIH
Brown University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Shufang Sun, PhD
Role: PRINCIPAL_INVESTIGATOR
Brown University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Brown University
Providence, Rhode Island, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2004002698
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.