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

Developing and Testing Internet-Based Mindfulness Intervention to Reduce Minority Stress and Promote HIV-Related Behavioral Health Among Young Adult Sexual Minority Men: An Open Pilot

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).

Study Overview

• Status: Completed
• Conditions: HIV; Mental Health Wellness 1; Minority Stress
• Intervention / Treatment: Behavioral: Mindfulness-Based Queer Resilience (MBQR)

Detailed Description

In 2017, gay, bisexual, and other men who have sex with men (MSM) made up 70% of new HIV infections in the U.S., and young adult MSM (age 18-34; YMSM) account for the majority of HIV cases. YMSM also experience prevalent, often co-occurring mental health issues, including depression, anxiety, and substance use, creating a "syndemic" condition surrounding HIV risk and suboptimal HIV testing.

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.

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02912
      • Brown University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 34 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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)

Exclusion Criteria: Participants will be excluded from the study if they are determined to have symptoms preventing them from giving meaningful consent or study activities such as:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mindful Attention Awareness Scale (MAAS)	The Mindful Attention Awareness Scale (MAAS) is a 15-item self-report measure of attention control and mindfulness. Scores range from 15 to 90 with higher scores reflecting higher levels of dispositional mindfulness.	3 months
Self-Compassion	Assessed using the 26-item validated Self-Compassion Scale (SCS); Participants indicate how they typically act towards themselves in difficult times using a 5-point Likert scale with 1 being "Almost Never" to 5 being "Almost Always". The total self-compassion score is calculated by reverse scoring the negative sub-scale items - self-judgment, isolation, and over-identification (i.e., 1 = 5, 2 = 4, 3 = 3, 4 = 2, 5 = 1) then computing a total mean. Researchers can choose to analyze their data either by using individual sub-scale sores or by using a total score.	3 months
Difficulties in Emotion Regulation Scale Short Form (DERS)	The Difficulties in Emotion Regulation Short Form Scale is an 18-item self-report measure of six facets of emotion regulation. Items are rated on a scale of 1-5, with 1 being ("almost never [0-10%]"); 2 ("sometimes [11-35%]"); 3 ("about half the time [36-65%]"); 4 ("most of the time [66-90%]); and 5 being ("almost always [91-100%]"). Higher scores indicate more difficulty in emotion regulation.	3 months
Internalized Stigma/Homophobia	Internalized Stigma/Homophobia will be assessed using the self-report 9-item Internalized Homophobia Scale (IHS) that measures perceived and experienced stigma in the past 12 months using a four point scale (1=Never, 2=Rarely, 3=Sometimes, 4=Often). Scores range from 9 to 36 with higher scores indicating higher internalized stigma.	3 months
Safe Sex Self-Efficacy	Safe sex self-efficacy will be assessed using the Safe Sex Self-Efficacy Scale (SSES), which is a 13-item questionnaire that use a Likert-type response scale (1=Not at all confident to 5=extremely confident) to assess the respondent's self-efficacy for carrying out healthy sexual behaviors with a primary partner. Total scores range from 13 to 65 with higher scores reflecting greater self-efficacy.	3 months
Impact of Mindfulness-Based Queer Resilience intervention on depressive symptoms	Depressive symptoms will be assessed using the 9-item, self-reported Patient Health Questionnaire (PHQ-9). Participants will report on depressive symptoms using a four item Likert scale (0=Not at all, 1=Several days, 2=More than half the days, 3=Nearly every day). The PHQ-9 will be completed at baseline, weekly during the intervention, and then once post-intervention. Scores range from 0-27 with cut points indicating minimal (1-4), mild (5-9), moderate (10-14), moderately severe (15-19), and severe (20-27) depression. Since the questionnaire relies on patient self-report, all responses should be verified by a clinician.	3 months
Impact of Mindfulness-Based Queer Resilience intervention on anxiety	Anxiety will be assessed using the 7-item, self-reported Generalized Anxiety Disorder Assessment (GAD-7). Participants will report on anxiety symptoms using a four item Likert scale (0=Not at all, 1=Several days, 2=More than half the days, 3=Nearly every day). The GAD-7 will be completed at baseline, weekly during the intervention, and then once post-intervention. Scores range from 0-21, with scores of 5, 10, and 15 serving as cut-off points for mild, moderate and severe anxiety, respectively. When used as a screening tool, further evaluation is recommended when the score is 10 or greater. Since the questionnaire relies on patient self-report, all responses should be verified by a clinician.	3 months
Impact of Mindfulness-Based Queer Resilience intervention on sexual risk behaviors	The primary outcome will be assessed using the Sexual Risk Behaviors Scale (SRBS), adapted from Emory University's American Men's Internet Survey. The SRBS consists of 16 items assessing various sexual risk behaviors: 2 items require self-rated percentages, 8 are multiple-choice, 5 request numeric responses from the participant, and 1 is a yes/no question. Due to the varied question formats and scoring directions (with higher scores indicating increased risk for some items and decreased risk for others), a total scale score was not calculated; instead, each item was analyzed individually.	3 months

Collaborators and Investigators

• Sponsor: Brown University
• Collaborators: National Center for Complementary and Integrative Health (NCCIH)
• Investigators: Principal Investigator: Shufang Sun, PhD, Brown University

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2022
• Primary Completion (Actual): December 15, 2022
• Study Completion (Actual): December 15, 2022

Study Registration Dates

• First Submitted: September 12, 2022
• First Submitted That Met QC Criteria: September 12, 2022
• First Posted (Actual): September 15, 2022

Study Record Updates

• Last Update Posted (Estimated): November 19, 2025
• Last Update Submitted That Met QC Criteria: November 5, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: HIV prevention; Sexual minority; Mindfulness-based intervention; LGBTQ
• Other Study ID Numbers: 2004002698; K23AT011173 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Following data collection, cleaning, and analysis, we plan to publish de-identified quantitative data at an open science data repository (e.g., Open Science Framework). De-identified qualitative data will be available upon request to the study PI.
• IPD Sharing Time Frame: Fall 2023
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No