Trial Outcomes & Findings for Developing an Online Mindfulness-based Intervention to Reduce Minority Stress and HIV Risk Among Young Adult MSM (NCT NCT05540652)

NCT ID: NCT05540652

Last Updated: 2025-11-19

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. See other primary outcomes for other measures used.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

19 participants

Primary outcome timeframe

Baseline

Results posted on

2025-11-19

Participant Flow

Participant milestones

Participant milestones
Measure
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.
Overall Study
STARTED
19
Overall Study
COMPLETED
18
Overall Study
NOT COMPLETED
1

Reasons for withdrawal

Reasons for withdrawal
Measure
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.
Overall Study
Withdrawal by Subject
1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Mindfulness-Based Queer Resilience (MBQR)
n=19 Participants
This is a single arm trial testing an internet delivered mindfulness-based intervention. All enrolled participants will receive the study intervention.
Age, Continuous
28.0 Years
STANDARD_DEVIATION 4.4
Sex/Gender, Customized
Male
12 Participants
Sex/Gender, Customized
Nonbinary, gender non-conforming, genderqueer, genderfluid
7 Participants
Race/Ethnicity, Customized
Race · American Indian or Alaskan Native
1 Participants
Race/Ethnicity, Customized
Race · Asian
3 Participants
Race/Ethnicity, Customized
Race · Black
1 Participants
Race/Ethnicity, Customized
Race · Native Hawaiian and other Pacific Islander
0 Participants
Race/Ethnicity, Customized
Race · White
11 Participants
Race/Ethnicity, Customized
Race · Other
3 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
4 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
15 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Sexual Orientation
Bisexual
0 Participants
Sexual Orientation
Gay
16 Participants
Sexual Orientation
Pansexual
1 Participants
Sexual Orientation
Straight
0 Participants
Sexual Orientation
Other
2 Participants

PRIMARY outcome

Timeframe: Baseline

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

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.

Outcome measures

Outcome measures
Measure
Mindfulness-Based Queer Resilience (MBQR)
n=71 Participants
This is a single arm trial testing an internet delivered mindfulness-based intervention. All enrolled participants will receive the study intervention.
Feasibility of Online Mindfulness-Based Queer Resilience as Measured by Recruitment Rates
19 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Mindfulness-Based Queer Resilience (MBQR)
n=19 Participants
This is a single arm trial testing an internet delivered mindfulness-based intervention. All enrolled participants will receive the study intervention.
Feasibility of Online Mindfulness-Based Queer Resilience as Measured by Retention Rates
Post-intervention follow-up
18 Participants
Feasibility of Online Mindfulness-Based Queer Resilience as Measured by Retention Rates
Exit interview
15 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Mindfulness-Based Queer Resilience (MBQR)
n=19 Participants
This is a single arm trial testing an internet delivered mindfulness-based intervention. All enrolled participants will receive the study intervention.
Feasibility of Online Mindfulness-Based Queer Resilience as Measured by Session Attendance and Home Practice Completion
Enactment of treatment skills
5.84 Weeks
Standard Deviation 2.14
Feasibility of Online Mindfulness-Based Queer Resilience as Measured by Session Attendance and Home Practice Completion
Session Attendance
5.32 Weeks
Standard Deviation 2.29

PRIMARY outcome

Timeframe: Post-intervention assessment (i.e., at 8 weeks, after intervention delivery)

Population: 1 participant was lost to follow-up before the post-intervention follow-up.

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.

Outcome measures

Outcome measures
Measure
Mindfulness-Based Queer Resilience (MBQR)
n=18 Participants
This is a single arm trial testing an internet delivered mindfulness-based intervention. All enrolled participants will receive the study intervention.
Acceptability of Online Mindfulness-Based Queer Resilience as Measured by the Client Satisfaction Questionnaire
26.17 Scores on a scale
Standard Deviation 5.17

PRIMARY outcome

Timeframe: Post-intervention assessment (i.e., at 8 weeks, after intervention delivery)

Population: 1 participant was lost to follow-up before the post-intervention follow-up.

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.

Outcome measures

Outcome measures
Measure
Mindfulness-Based Queer Resilience (MBQR)
n=18 Participants
This is a single arm trial testing an internet delivered mindfulness-based intervention. All enrolled participants will receive the study intervention.
Acceptability of Online Mindfulness-Based Queer Resilience as Measured by a Session Evaluation Form
16.17 Scores on a scale
Standard Deviation 5.25

Adverse Events

Mindfulness-Based Queer Resilience (MBQR)

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

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place