Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| K23AT011173 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
Not provided
Not provided
Not provided
Not provided
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 Aims 1 and 2 of the broader study. Aim 1 used qualitative, community engaged methods, along with a quantitative online survey, to inform intervention development with the study population. Aim 2 involved 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). The next phase of the intervention development (Aim 3 - registered here) will enroll and randomize a sample of 60 distressed, high-risk YMSM into one of two groups: MBQR intervention (n=30) or active control condition (n=30). Researchers aim to over-enroll YMSM of color (e.g., Black/Latinx YMSM) and anticipate the group to include approximately 50-60% Black/Latinx YMSM (or YMSM of color). Outcomes of feasibility and acceptability include rates of recruitment and retention, number of sessions attended, self-reported at-home practice of mindfulness, completion of assessment, and exit interviews.
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. (Previously Completed - see ClinicalTrials.gov ID: NCT05540652) 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. (This is the focus of this Clinical Trial Registration) Examine the feasibility and acceptability of the internet-delivered mindfulness-based intervention (iMBI), called "Mindfulness-based Queer Resilience (MBQR)", for HIV prevention. Researchers will enroll and randomize a sample of 60 distressed, high-risk YMSM into one of two groups: MBQR intervention (n=30) or active control condition (n=30). They will aim to over-enroll YMSM of color (e.g., Black/Latinx YMSM) and anticipate the group to include approximately 50-60% Black/Latinx YMSM (or YMSM of color). The study will examine outcomes of feasibility and acceptability, such as rates of recruitment and retention, number of sessions attended, self-reported at-home practice of mindfulness, completion of assessment, and exit interviews.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness-Based Queer Resilience (MBQR) | Experimental | MBQR is an online, Zoom-based mindfulness course that meets 2.5 hour per week for ten weeks, facilitated by queer mindfulness teachers, with weekly home practice and additional reflection and reading activities that can be completed by participants independently via study website portal. In addition to the 10 weekly sessions there is an all-day retreat (6hrs) that takes place around week 6. The participants also meet one-on-one with the instructor(s) at the beginning and middle of class for a 30-minute welcome call and check in. |
|
| Health Education | Active Comparator | The online Health Education course is a self-paced program that can be largely completed independently (no group meeting, no all-day) by control group participants. The ten weekly modules are estimated to take around 30 to 90 minutes each to complete and consist of readings, videos, infographics, and other related activities (e.g., reflections, quizzes). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness-Based Queer Resilience (MBQR) | Behavioral | This work aims to develop an internet-delivered MBI to address minority stress and its negative HIV-related health consequences experienced by young men who have sex with men (YMSM). This aim will examine the feasibility and acceptability of the internet-delivered mindfulness-based intervention (iMBI), called "Mindfulness-based Queer Resilience (MBQR)", for HIV prevention. The study will enroll and randomize a sample of 60 distressed, high-risk YMSM into one of two groups: MBQR intervention (n=30) or active control condition (n=30). |
| 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. The recruitment rate will be calculated by comparing the total number of participants screened eligible to those who were successfully enrolled in the study. See other primary outcomes for other measures used. | During recruitment period of study, up to 2 months |
| Feasibility of Online Mindfulness-Based Queer Resilience as Measured by Retention Rates: HIV/STI Testing Submission | 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, as measured by number of participants completing assessments. Data for one of the three assessments (i.e., HIV/STI testing submission) is reported here. Number of participants analyzed for each timepoint represent the number of participants who submitted any of the three assessments. See other primary outcomes for other measures used. | Baseline, Post-intervention (week 10), and 6-month Follow-up |
| Feasibility of Online Mindfulness-Based Queer Resilience as Measured by Retention Rates: Nail Sample Submission | 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, as measured by number of participants completing assessments. Data for one of the three assessments (i.e., nail sample submission for cortisol level testing) is reported here. Number of participants analyzed for each timepoint represent the number of participants who submitted any of the three assessments. See other primary outcomes for other measures used. | Baseline, Post-intervention (week 10), and 6-month Follow-up |
| Feasibility of Online Mindfulness-Based Queer Resilience as Measured by Retention Rates: Survey Submission |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria: Participants will be excluded from the study if they are determined to have symptoms that would prevent them from giving meaningful consent or participate in study activities including any of the following criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Shufang Sun, Ph.D. | 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 2024
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Mindfulness-Based Queer Resilience (MBQR) | MBQR is an online, Zoom-based mindfulness course that meets 2.5 hour per week for ten weeks, facilitated by queer mindfulness teachers, with weekly home practice and additional reflection and reading activities that can be completed by participants independently via study website portal. In addition to the 10 weekly sessions there is an all-day retreat (6hrs) that takes place around week 6. The participants also meet one-on-one with the instructor(s) at the beginning and middle of class for a 30-minute welcome call and check in. |
| FG001 | Health Education | The online Health Education course is a self-paced program that can be largely completed independently (no group meeting, no all-day) by control group participants. The ten weekly modules are estimated to take around 30 to 90 minutes each to complete and consist of readings, videos, infographics, and other related activities (e.g., reflections, quizzes). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Mindfulness-Based Queer Resilience (MBQR) | MBQR is an online, Zoom-based mindfulness course that meets 2.5 hour per week for ten weeks, facilitated by queer mindfulness teachers, with weekly home practice and additional reflection and reading activities that can be completed by participants independently via study website portal. In addition to the 10 weekly sessions there is an all-day retreat (6hrs) that takes place around week 6. The participants also meet one-on-one with the instructor(s) at the beginning and middle of class for a 30-minute welcome call and check in. |
| Units | Counts |
|---|---|
| Participants |
|
| 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. The recruitment rate will be calculated by comparing the total number of participants screened eligible to those who were successfully enrolled in the study. 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 | During recruitment period of study, up to 2 months |
|
From enrollment until end of follow-up, up to 6 months
Not provided
Not provided
| 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) | MBQR is an online, Zoom-based mindfulness course that meets 2.5 hour per week for ten weeks, facilitated by queer mindfulness teachers, with weekly home practice and additional reflection and reading activities that can be completed by participants independently via study website portal. In addition to the 10 weekly sessions there is an all-day retreat (6hrs) that takes place around week 6. The participants also meet one-on-one with the instructor(s) at the beginning and middle of class for a 30-minute welcome call and check in. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shufang Sun | Brown University | 401-863-5735 | shufang_sun@brown.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 31, 2023 | Oct 20, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 31, 2023 | Oct 20, 2025 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 4, 2023 | Oct 20, 2025 | ICF_002.pdf |
Not provided
| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
Not provided
Not provided
The methodological approach includes a 2-arm trial of MBQR vs. a health education control group, with up to n=30 per arm (total Aim 3 sample size = up to 60 participants enrolled and randomized). The study is intended to evaluate the acceptability and feasibility of MBQR.
Not provided
Not provided
Not provided
Not provided
|
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, as measured by number of participants completing assessments. Data for one of the three assessments (i.e., post-intervention and 6-month follow-up survey submission) are reported here. Number of participants analyzed for each timepoint represent the number of participants who submitted any of the three assessments. See other primary outcomes for other measures used. |
| Baseline, Post-intervention (week 10), and 6-month Follow-up |
| Feasibility of Online Mindfulness-Based Queer Resilience as Measured by Engagement | 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 engagement with the MBQR program (i.e, adherence to the prescribed intervention), which will be assessed by class attendance data. The average number of sessions that participants attended the MBQR sessions is reported here. | During intervention period (10 weeks) |
| 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. Acceptability will be assessed using three measures. One such measure of acceptability will be via acceptability ratings using the validated 8-item Client Satisfaction Questionnaire (CSQ-8). Participants rated each item on a four-point Likert scale. Total 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 (week 10) |
| 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. Acceptability will be assessed using three measures. One such measure of acceptability will be via a session evaluation form that provides both qualitative and quantitative feedback on the study intervention using 10 questions, rated on a four-point Likert scale, and 6 free response questions. The quantitative data is reported here. Total scores range from 10 to 40, with higher values indicating higher satisfaction. See other primary outcomes for other measures used. | Post-intervention (week 10) |
| BG001 | Health Education | The online Health Education course is a self-paced program that can be largely completed independently (no group meeting, no all-day) by control group participants. The ten weekly modules are estimated to take around 30 to 90 minutes each to complete and consist of readings, videos, infographics, and other related activities (e.g., reflections, quizzes). |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Sexual Orientation | Count of Participants | Participants |
|
|
|
| Primary | Feasibility of Online Mindfulness-Based Queer Resilience as Measured by Retention Rates: HIV/STI Testing Submission | 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, as measured by number of participants completing assessments. Data for one of the three assessments (i.e., HIV/STI testing submission) is reported here. Number of participants analyzed for each timepoint represent the number of participants who submitted any of the three assessments. See other primary outcomes for other measures used. | One participant from the control arm withdrew from the study between baseline and post-intervention assessments. Four participants from the MBQR arm were lost-to-follow-up at 6-month follow-up. | Posted | Count of Participants | Participants | Baseline, Post-intervention (week 10), and 6-month Follow-up |
|
|
|
| Primary | Feasibility of Online Mindfulness-Based Queer Resilience as Measured by Retention Rates: Nail Sample Submission | 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, as measured by number of participants completing assessments. Data for one of the three assessments (i.e., nail sample submission for cortisol level testing) is reported here. Number of participants analyzed for each timepoint represent the number of participants who submitted any of the three assessments. See other primary outcomes for other measures used. | One participant from the control arm withdrew from the study between baseline and post-intervention assessments. Four participants from the MBQR arm were lost-to-follow-up at 6-month follow-up. | Posted | Count of Participants | Participants | Baseline, Post-intervention (week 10), and 6-month Follow-up |
|
|
|
| Primary | Feasibility of Online Mindfulness-Based Queer Resilience as Measured by Retention Rates: Survey Submission | 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, as measured by number of participants completing assessments. Data for one of the three assessments (i.e., post-intervention and 6-month follow-up survey submission) are reported here. Number of participants analyzed for each timepoint represent the number of participants who submitted any of the three assessments. See other primary outcomes for other measures used. | One participant from the control arm withdrew from the study between baseline and post-intervention assessments. Four participants from the MBQR arm were lost-to-follow-up at 6-month follow-up. | Posted | Count of Participants | Participants | Baseline, Post-intervention (week 10), and 6-month Follow-up |
|
|
|
| Primary | Feasibility of Online Mindfulness-Based Queer Resilience as Measured by Engagement | 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 engagement with the MBQR program (i.e, adherence to the prescribed intervention), which will be assessed by class attendance data. The average number of sessions that participants attended the MBQR sessions is reported here. | The health education program was hosted on a website and did not include weekly sessions; therefore, class attendance data are not applicable, and no data were collected for that arm. | Posted | Mean | Standard Deviation | Sessions | During intervention period (10 weeks) |
|
|
|
| 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. Acceptability will be assessed using three measures. One such measure of acceptability will be via acceptability ratings using the validated 8-item Client Satisfaction Questionnaire (CSQ-8). Participants rated each item on a four-point Likert scale. Total scores for the CSQ-8 range from 8 to 32, with higher values indicating higher satisfaction. See other primary outcomes for other measures used. | One participant from the control arm withdrew from the study during intervention period (i.e., before post-intervention assessments) and did not complete the post-intervention assessment. | Posted | Mean | Standard Deviation | Scores on a scale | Post-intervention (week 10) |
|
|
|
| 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. Acceptability will be assessed using three measures. One such measure of acceptability will be via a session evaluation form that provides both qualitative and quantitative feedback on the study intervention using 10 questions, rated on a four-point Likert scale, and 6 free response questions. The quantitative data is reported here. Total scores range from 10 to 40, with higher values indicating higher satisfaction. See other primary outcomes for other measures used. | One participant from the control arm withdrew from the study during intervention period (i.e., before post-intervention assessments) and did not complete the post-intervention assessment. | Posted | Mean | Standard Deviation | Scores on a scale | Post-intervention (week 10) |
|
|
|
| 0 |
| 34 |
| 0 |
| 34 |
| 0 |
| 34 |
| EG001 | Health Education | The online Health Education course is a self-paced program that can be largely completed independently (no group meeting, no all-day) by control group participants. The ten weekly modules are estimated to take around 30 to 90 minutes each to complete and consist of readings, videos, infographics, and other related activities (e.g., reflections, quizzes). | 0 | 34 | 0 | 34 | 0 | 34 |
Not provided
Not provided
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
| Post-intervention |
|
|
| 6-month Follow-up |
|
|
| Post-intervention |
|
|
| 6-month Follow-up |
|
|
| Post-intervention |
|
|
| 6-month Follow-up |
|
|