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| ID | Type | Description | Link |
|---|---|---|---|
| K23AT011173 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
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| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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) |
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Inclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Shufang Sun, PhD | Brown University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brown University | Providence | Rhode Island | 02912 | United States |
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.
Fall 2023
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
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| Overall Study |
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| ID | Title | Description |
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| BG000 | 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. |
| Units | Counts |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Overall Number of Participants Analyzed represents number of participants eligible for study from the online screener. | Posted | Count of Participants | Participants | Baseline |
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From enrollment until end of follow-up, up to 2 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shufang Sun | Brown University | 401-863-5735 | shufang_sun@brown.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 21, 2022 | Sep 15, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 24, 2022 | Sep 23, 2025 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 24, 2022 | Sep 15, 2025 | ICF_002.pdf |
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This is a single arm trial testing an internet delivered mindfulness-based intervention.
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| 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) |
| Years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Sexual Orientation | Count of Participants | Participants |
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| Units | Counts |
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| Participants |
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| Primary | 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. | Posted | Count of Participants | Participants | Through study completion, an average of 2 months |
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| Primary | 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. | Posted | Mean | Standard Deviation | Weeks | Through intervention completion, an average of 2 months |
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| Primary | 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. | 1 participant was lost to follow-up before the post-intervention follow-up. | Posted | Mean | Standard Deviation | Scores on a scale | Post-intervention assessment (i.e., at 8 weeks, after intervention delivery) |
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| Primary | 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. | 1 participant was lost to follow-up before the post-intervention follow-up. | Posted | Mean | Standard Deviation | Scores on a scale | Post-intervention assessment (i.e., at 8 weeks, after intervention delivery) |
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