Trial Outcomes & Findings for Developing an Online Mindfulness-based Intervention to Reduce Minority Stress and HIV Risk Among Young Adult MSM - Aim 3 (NCT NCT05855655)

Last Updated: 2025-11-24

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

68 participants

Primary outcome timeframe

During recruitment period of study, up to 2 months

Results posted on

2025-11-24

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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).
Overall Study STARTED	34	34
Overall Study Post-intervention Assessment	34	33
Overall Study 6-month Follow-up	30	33
Overall Study COMPLETED	30	33
Overall Study NOT COMPLETED	4	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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).
Overall Study Withdrawal by Subject	0	1
Overall Study Lost to Follow-up	4	0

Baseline Characteristics

Developing an Online Mindfulness-based Intervention to Reduce Minority Stress and HIV Risk Among Young Adult MSM - Aim 3

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mindfulness-Based Queer Resilience (MBQR) n=34 Participants 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 n=34 Participants 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).	Total n=68 Participants Total of all reporting groups
Age, Continuous	27.50 Years STANDARD_DEVIATION 4.12 • n=45 Participants	27.15 Years STANDARD_DEVIATION 4.30 • n=12929 Participants	27.32 Years STANDARD_DEVIATION 4.18 • n=6349 Participants
Sex/Gender, Customized Female	0 Participants n=45 Participants	0 Participants n=12929 Participants	0 Participants n=6349 Participants
Sex/Gender, Customized Male	29 Participants n=45 Participants	31 Participants n=12929 Participants	60 Participants n=6349 Participants
Sex/Gender, Customized Gender Nonbinary, Nonconforming, Genderqueer	5 Participants n=45 Participants	3 Participants n=12929 Participants	8 Participants n=6349 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	12 Participants n=45 Participants	7 Participants n=12929 Participants	19 Participants n=6349 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	22 Participants n=45 Participants	27 Participants n=12929 Participants	49 Participants n=6349 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=45 Participants	0 Participants n=12929 Participants	0 Participants n=6349 Participants
Race/Ethnicity, Customized Race · American Indian or Native American	2 Participants n=45 Participants	0 Participants n=12929 Participants	2 Participants n=6349 Participants
Race/Ethnicity, Customized Race · Asian	3 Participants n=45 Participants	5 Participants n=12929 Participants	8 Participants n=6349 Participants
Race/Ethnicity, Customized Race · Black	5 Participants n=45 Participants	4 Participants n=12929 Participants	9 Participants n=6349 Participants
Race/Ethnicity, Customized Race · Multiracial	2 Participants n=45 Participants	6 Participants n=12929 Participants	8 Participants n=6349 Participants
Race/Ethnicity, Customized Race · Native Hawaiian or Pacific Islander	0 Participants n=45 Participants	0 Participants n=12929 Participants	0 Participants n=6349 Participants
Race/Ethnicity, Customized Race · White	16 Participants n=45 Participants	14 Participants n=12929 Participants	30 Participants n=6349 Participants
Race/Ethnicity, Customized Race · Other	6 Participants n=45 Participants	5 Participants n=12929 Participants	11 Participants n=6349 Participants
Sexual Orientation Gay	26 Participants n=45 Participants	26 Participants n=12929 Participants	52 Participants n=6349 Participants
Sexual Orientation Straight	0 Participants n=45 Participants	0 Participants n=12929 Participants	0 Participants n=6349 Participants
Sexual Orientation Bisexual	1 Participants n=45 Participants	1 Participants n=12929 Participants	2 Participants n=6349 Participants
Sexual Orientation Pansexual	4 Participants n=45 Participants	1 Participants n=12929 Participants	5 Participants n=6349 Participants
Sexual Orientation Other	3 Participants n=45 Participants	6 Participants n=12929 Participants	9 Participants n=6349 Participants

PRIMARY outcome

Timeframe: During recruitment period of study, up to 2 months

Population: Overall Number of Participants Analyzed represents number of participants eligible for study from the online screener.

Outcome measures

Outcome measures
Measure	Pre-randomization n=223 Participants Number of participants under "Pre-randomization" represents numbers of individuals prior to randomization to either MBQR or control arms (e.g., number of individuals deemed eligible for study after screener).	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).
Feasibility of Online Mindfulness-Based Queer Resilience as Measured by Recruitment Rates	68 Participants	—

PRIMARY outcome

Timeframe: Baseline, Post-intervention (week 10), and 6-month Follow-up

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Pre-randomization n=34 Participants Number of participants under "Pre-randomization" represents numbers of individuals prior to randomization to either MBQR or control arms (e.g., number of individuals deemed eligible for study after screener).	Health Education n=34 Participants 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).
Feasibility of Online Mindfulness-Based Queer Resilience as Measured by Retention Rates: HIV/STI Testing Submission Baseline · Completed all assessments	34 Participants	34 Participants
Feasibility of Online Mindfulness-Based Queer Resilience as Measured by Retention Rates: HIV/STI Testing Submission Post-intervention · Completed all assessments	26 Participants	29 Participants
Feasibility of Online Mindfulness-Based Queer Resilience as Measured by Retention Rates: HIV/STI Testing Submission 6-month Follow-up · Completed all assessments	27 Participants	28 Participants

PRIMARY outcome

Timeframe: Baseline, Post-intervention (week 10), and 6-month Follow-up

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.

Outcome measures

Outcome measures
Measure	Pre-randomization n=34 Participants Number of participants under "Pre-randomization" represents numbers of individuals prior to randomization to either MBQR or control arms (e.g., number of individuals deemed eligible for study after screener).	Health Education n=34 Participants 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).
Feasibility of Online Mindfulness-Based Queer Resilience as Measured by Retention Rates: Nail Sample Submission Baseline	30 Participants	28 Participants
Feasibility of Online Mindfulness-Based Queer Resilience as Measured by Retention Rates: Nail Sample Submission Post-intervention	23 Participants	26 Participants
Feasibility of Online Mindfulness-Based Queer Resilience as Measured by Retention Rates: Nail Sample Submission 6-month Follow-up	23 Participants	24 Participants

PRIMARY outcome

Timeframe: Baseline, Post-intervention (week 10), and 6-month Follow-up

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.

Outcome measures

Outcome measures
Measure	Pre-randomization n=34 Participants Number of participants under "Pre-randomization" represents numbers of individuals prior to randomization to either MBQR or control arms (e.g., number of individuals deemed eligible for study after screener).	Health Education n=34 Participants 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).
Feasibility of Online Mindfulness-Based Queer Resilience as Measured by Retention Rates: Survey Submission Post-intervention	33 Participants	31 Participants
Feasibility of Online Mindfulness-Based Queer Resilience as Measured by Retention Rates: Survey Submission Baseline	34 Participants	34 Participants
Feasibility of Online Mindfulness-Based Queer Resilience as Measured by Retention Rates: Survey Submission 6-month Follow-up	28 Participants	32 Participants

PRIMARY outcome

Timeframe: During intervention period (10 weeks)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Pre-randomization n=34 Participants Number of participants under "Pre-randomization" represents numbers of individuals prior to randomization to either MBQR or control arms (e.g., number of individuals deemed eligible for study after screener).	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).
Feasibility of Online Mindfulness-Based Queer Resilience as Measured by Engagement	7.18 Sessions Standard Deviation 3.43	—

PRIMARY outcome

Timeframe: Post-intervention (week 10)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Pre-randomization n=34 Participants Number of participants under "Pre-randomization" represents numbers of individuals prior to randomization to either MBQR or control arms (e.g., number of individuals deemed eligible for study after screener).	Health Education n=33 Participants 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).
Acceptability of Online Mindfulness-Based Queer Resilience as Measured by the Client Satisfaction Questionnaire	26.61 Scores on a scale Standard Deviation 3.60	18.25 Scores on a scale Standard Deviation 5.47

PRIMARY outcome

Timeframe: Post-intervention (week 10)

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Pre-randomization n=34 Participants Number of participants under "Pre-randomization" represents numbers of individuals prior to randomization to either MBQR or control arms (e.g., number of individuals deemed eligible for study after screener).	Health Education n=33 Participants 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).
Acceptability of Online Mindfulness-Based Queer Resilience as Measured by a Session Evaluation Form	33.27 Scores on a scale Standard Deviation 4.89	26.22 Scores on a scale Standard Deviation 5.92

Adverse Events

Mindfulness-Based Queer Resilience (MBQR)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Health Education

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Shufang Sun

Brown University

Phone: 401-863-5735

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place