Developing an Online Mindfulness-based Intervention to Reduce Minority Stress and HIV Risk Among Young Adult MSM

NCT05540652 | Completed Results

• 2 other identifiers: 2004002698K23AT011173
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

The overall aim of the research study is to develop and test a mindfulness-based program for young adult gay, bisexual, and queer men at risk for HIV (Brown University IRB approved protocol #2004002698). Researchers have completed Aim 1 of the broader study, which was to use qualitative, community engaged methods, along with a quantitative online survey, to inform intervention development with the study population. The next phase of the intervention development (Aim 2 - registered here), involves seeking feedback on the developed mindfulness program through an open-pilot with 18 participants from the same study population (young adult gay, bisexual, and queer men at risk for HIV).

Conditions

HIV; Minority Stress; Mental Health Wellness 1

Keywords

Mindfulness-based intervention; Sexual minority; LGBTQ; HIV prevention

Outcome Measures

Primary Outcomes (5)

• Feasibility of Online Mindfulness-Based Queer Resilience as Measured by Recruitment Rates

  The primary aim of the study is to evaluate feasibility and acceptability of Mindfulness-Based Queer Resilience. Feasibility will be assessed via three measures. One measure of feasibility will be participant recruitment rates. See other primary outcomes for other measures used.

  Baseline

• Feasibility of Online Mindfulness-Based Queer Resilience as Measured by Retention Rates

  The primary aim of the study is to evaluate feasibility and acceptability of Mindfulness-Based Queer Resilience. Feasibility will be assessed via three measures. One measure of feasibility will be participant retention rates (i.e., as measured by attrition). See other primary outcomes for other measures used.

  Through study completion, an average of 2 months

• Feasibility of Online Mindfulness-Based Queer Resilience as Measured by Session Attendance and Home Practice Completion

  The primary aim of the study is to evaluate feasibility and acceptability of Mindfulness-Based Queer Resilience. Feasibility was assessed via three measures. One measure of feasibility is engagement with the intervention content, which is calculated using the average number of weeks that participants (1) attended the MBQR sessions and (2) completed the home practices, reported here.

  Through intervention completion, an average of 2 months

• Acceptability of Online Mindfulness-Based Queer Resilience as Measured by the Client Satisfaction Questionnaire

  The primary aim of the study is to evaluate feasibility and acceptability of Mindfulness-Based Queer Resilience. One measure of acceptability will be via acceptability ratings using the validated 8-item Client Satisfaction Questionnaire (CSQ-8). Scores for the CSQ-8 range from 8 to 32, with higher values indicating higher satisfaction. See other primary outcomes for other measures used.

  Post-intervention assessment (i.e., at 8 weeks, after intervention delivery)

• Acceptability of Online Mindfulness-Based Queer Resilience as Measured by a Session Evaluation Form

  The primary aim of the study is to evaluate feasibility and acceptability of Mindfulness-Based Queer Resilience. One measure of acceptability will be via acceptability ratings using the session evaluation form. The survey includes 6 open-ended questions and 10 items on a 4-point Likert scale ranging from 1 (strongly agree) to 4 (strongly disagree). Example Likert items include "The MBQR program was well organized". Scores for the session evaluation form range from 10 to 40, with lower values indicating higher satisfaction. See other primary outcomes for other measures used.

  Post-intervention assessment (i.e., at 8 weeks, after intervention delivery)

Study Arms (1)

Mindfulness-Based Queer Resilience (MBQR)

EXPERIMENTAL

This is a single arm trial testing an internet delivered mindfulness-based intervention. All enrolled participants will receive the study intervention.

Behavioral: Mindfulness-Based Queer Resilience (MBQR)

Interventions

Mindfulness-Based Queer Resilience (MBQR) BEHAVIORAL

"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.

Mindfulness-Based Queer Resilience (MBQR)

Eligibility Criteria

• Age: 18 Years - 34 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Assigned male at birth
• 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)

You may not qualify if:

• Significant cognitive impairment
• Psychosis
• Imminent suicidal risk
• Substance abuse

Sponsors & Collaborators

• Brown University: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Brown University

Providence, Rhode Island, 02912, United States

Location

Results Point of Contact

• Title: Shufang Sun
• Organization: Brown University

shufang_sun@brown.edu

401-863-5735

Study Officials

• Shufang Sun, PhD

  Brown University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a single arm trial testing an internet delivered mindfulness-based intervention.

Study Record Dates

• First Submitted: September 12, 2022
• First Posted: September 15, 2022
• Study Start: August 8, 2022
• Primary Completion: December 15, 2022
• Study Completion: December 15, 2022
• Last Updated: November 19, 2025
• Results First Posted: November 19, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Fall 2023

Locations

US (1)