HIVNCT05540652
Developing an Online Mindfulness-based Intervention to Reduce Minority Stress and HIV Risk Among Young Adult MSM
A study testing Mindfulness-Based Queer Resilience (MBQR) in people with HIV and Minority Stress, run by Brown University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 34 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- HIV, Minority Stress, Mental Health Wellness 1
- What is being tested?
- Mindfulness-Based Queer Resilience (MBQR)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Aug 2022to 15 Dec 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 34 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 14Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Conditions
- HIV, Minority Stress, Mental Health Wellness 1
- Being tested
- Mindfulness-Based Queer Resilience (MBQR)
- Keywords
- Mindfulness-based intervention, Sexual minority, LGBTQ, HIV prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Queer Resilience (MBQR)Behavioural
"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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Mindfulness-Based Queer Resilience (MBQR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Post-intervention assessment (i.e., at 8 weeks, after intervention delivery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2022
- Study start8 Aug 2022
- Primary completion15 Dec 2022
- Study completion15 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIVStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single arm trial testing an internet delivered mindfulness-based intervention.
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Shufang Sun, PhD, Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05540652
- Sponsor's protocol ID
- 2004002698
- Other IDs
- K23AT011173
- Status last verified
- May 2025
- First submitted
- 12 Sep 2022
- Last updated
- 19 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05540652
- Acronym / sponsor ID
- 2004002698
- Conditions
- HIV, Minority Stress, Mental Health Wellness 1
- Keywords
- Mindfulness-based intervention, Sexual minority, LGBTQ, HIV prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 8 Aug 2022 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 15 Sep 2022 (actual)
- Results
- Posted 19 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single arm trial testing an internet delivered mindfulness-based intervention.
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-Based Queer Resilience (MBQR) | Experimental | Behavioral: 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. |
Who may qualify
- Ages
- 18 to 34 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- 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
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-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. | Behavioural | Mindfulness-Based Queer Resilience (MBQR) |
Primary outcome
Feasibility of Online Mindfulness-Based Queer Resilience as Measured by Recruitment Rates
Time frame: Baseline
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.
Feasibility of Online Mindfulness-Based Queer Resilience as Measured by Retention Rates
Time frame: Through study completion, an average of 2 months
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.
Feasibility of Online Mindfulness-Based Queer Resilience as Measured by Session Attendance and Home Practice Completion
Time frame: Through intervention completion, an average of 2 months
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.
Acceptability of Online Mindfulness-Based Queer Resilience as Measured by the Client Satisfaction Questionnaire
Time frame: Post-intervention assessment (i.e., at 8 weeks, after intervention delivery)
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.
Acceptability of Online Mindfulness-Based Queer Resilience as Measured by a Session Evaluation Form
Time frame: Post-intervention assessment (i.e., at 8 weeks, after intervention delivery)
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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.
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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. This study is not recruiting at the moment.
Shufang Sun, PhD principal investigator
Brown 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-Based Queer Resilience (MBQR) in people with HIV and Minority Stress, run by Brown 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 14 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: finished, as of the sponsor's last update on 19 Nov 2025. 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?
Yes. Results are posted in the registry (first posted 19 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Online Mindfulness-Based Queer Resilience as Measured by Recruitment Rates (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Nov 2025.