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

HIV Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05540652
• Other study ID #: 2004002698
• Secondary ID: K23AT011173
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 8, 2022
• Est. completion date: September 30, 2023

Study information

• Verified date: February 2023
• Source: Brown University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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).

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 with be intervention feasibility and acceptability. Secondary outcomes will include HIV testing willingness, self-reported sexual risk behaviors, psychological health, stress biomarker and minority stress and coping. The study will examine recruitment and retention, number of sessions attended, self-reported at-home practice of mindfulness, completion of assessment, and acceptability of the intervention.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 18
• Est. completion date: September 30, 2023
• Est. primary completion date: December 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 34 Years

Eligibility

Inclusion Criteria:

• 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
• 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

Related Conditions & MeSH terms

• HIV
• Mental Health Wellness 1
• Minority Stress

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Brown University	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Brown University	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of online MBQR as measured by recruitment rates	The primary aim of the study is to evaluate feasibility and acceptability of MBQR. Feasibility will be assessed via three measures. One measure of feasibility will be participant recruitment rates. See other primary outcomes for other measures used.	3 months
Primary	Feasibility of online MBQR as measured by retention rates	The primary aim of the study is to evaluate feasibility and acceptability of MBQR. Feasibility will be assessed via three measures. One measure of feasibility will be participant retention rates (i.e., as measured by attendance and attrition). See other primary outcomes for other measures used.	3 months
Primary	Feasibility of online MBQR as measured by engagement: Enactment of treatment skills	The primary aim of the study is to evaluate feasibility and acceptability of MBQR. Feasibility will be assessed via three measures. One measure of feasibility will be engagement (i.e, enactment of treatment skills), which will be assessed by home practice completion.	3 months
Primary	Acceptability of online MBQR as measured by the Client Satisfaction Questionnaire	The primary aim of the study is to evaluate feasibility and acceptability of MBQR. 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). Scores for the CSQ-8 range from 8 to 32, with higher values indicating higher satisfaction. See other primary outcomes for other measures used.	3 months
Primary	Acceptability of online MBQR as measured by a session evaluation form	The primary aim of the study is to evaluate feasibility and acceptability of MBQR. 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. See other primary outcomes for other measures used.	3 months
Primary	Acceptability of online MBQR as measured by semi-structured qualitative exit interview	The primary aim of the study is to evaluate feasibility and acceptability of MBQR. Acceptability will be assessed using three measures. One such measure of acceptability will be via a semi-structured qualitative exit interview conducted with one-on-one with study participants via a videoconferencing platform (i.e., Zoom). Interviews will be transcribed and coded for analysis.	3 months
Secondary	Impact of MBQR intervention on depressive symptoms	Depressive symptoms will be assessed using the 9-item, self-reported Patient Health Questionnaire (PHQ-9). Participants will report on depressive symptoms using a four item Likert scale (0=Not at all, 1=Several days, 2=More than half the days, 3=Nearly every day). The PHQ-9 will be completed at baseline, weekly during the intervention, and then once post-intervention. Scores range from 0-27 with cut points indicating minimal (1-4), mild (5-9), moderate (10-14), moderately severe (15-19), and severe (20-27) depression. Since the questionnaire relies on patient self-report, all responses should be verified by a clinician.	3 months
Secondary	Impact of MBQR intervention on anxiety	Anxiety will be assessed using the 7-item, self-reported Generalized Anxiety Disorder Assessment (GAD-7). Participants will report on anxiety symptoms using a four item Likert scale (0=Not at all, 1=Several days, 2=More than half the days, 3=Nearly every day). The GAD-7 will be completed at baseline, weekly during the intervention, and then once post-intervention. Scores range from 0-21, with scores of 5, 10, and 15 serving as cut-off points for mild, moderate and severe anxiety, respectively. When used as a screening tool, further evaluation is recommended when the score is 10 or greater. Since the questionnaire relies on patient self-report, all responses should be verified by a clinician.	3 months
Secondary	Impact of MBQR intervention on sexual risk behaviors	Questions to evaluate sexual risk behaviors were adapted from Emory University's American Men's Internet Survey. The full set of questions assessing sexual risk behaviors will be asked at baseline and again post-intervention. A sub set of the questions will be administered weekly during the intervention.	3 months
Secondary	Mindful Attention Awareness Scale (MAAS)	The Mindful Attention Awareness Scale (MAAS) is a 15-item self-report measure of attention control and mindfulness. Scores range from 15 to 90 with higher scores reflecting higher levels of dispositional mindfulness.	3 months
Secondary	Self-Compassion	Assessed using the 26-item validated Self-Compassion Scale (SCS); Participants indicate how they typically act towards themselves in difficult times using a 5-point Likert scale with 1 being "Almost Never" to 5 being "Almost Always". The total self-compassion score is calculated by reverse scoring the negative sub-scale items - self-judgment, isolation, and over-identification (i.e., 1 = 5, 2 = 4, 3 = 3, 4 = 2, 5 = 1) then computing a total mean. Researchers can choose to analyze their data either by using individual sub-scale sores or by using a total score.	3 months
Secondary	Safe Sex Self-Efficacy	Safe sex self-efficacy will be assessed using the Safe Sex Self-Efficacy Scale (SSES), which is a 13-item questionnaire that use a Likert-type response scale (1=Not at all confident to 5=extremely confident) to assess the respondent's self-efficacy for carrying out healthy sexual behaviors with a primary partner. Total scores range from 13 to 65 with higher scores reflecting greater self-efficacy.	3 months
Secondary	Difficulties in Emotion Regulation Scale Short Form (DERS)	The Difficulties in Emotion Regulation Short Form Scale is an 18-item self-report measure of six facets of emotion regulation. Items are rated on a scale of 1-5, with 1 being ("almost never [0-10%]"); 2 ("sometimes [11-35%]"); 3 ("about half the time [36-65%]"); 4 ("most of the time [66-90%]); and 5 being ("almost always [91-100%]"). Higher scores indicate more difficulty in emotion regulation.	3 months
Secondary	Internalized Stigma/Homophobia	Internalized Stigma/Homophobia will be assessed using the self-report 9-item Internalized Homophobia Scale (IHS) that measures perceived and experienced stigma in the past 12 months using a four point scale (1=Never, 2=Rarely, 3=Sometimes, 4=Often). Scores range from 9 to 36 with higher scores indicating higher internalized stigma.	3 months