Ignite Creation Date:
2024-05-06 @ 6:59 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05855655
Status:
RECRUITING
Last Update Posted:
2023-05-11
First Post:
2023-05-04
Brief Title:
Developing an Online Mindfulness-based Intervention to Reduce Minority Stress and HIV Risk Among Young Adult MSM - Aim 3
Sponsor:
Brown University
Organization:
Brown University
Study Overview
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 Aim 3 A Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MBQR
Brief 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 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 n30 or active control condition n30 Researchers aim to over-enroll YMSM of color eg BlackLatinx YMSM and anticipate the group to include approximately 50-60 BlackLatinx YMSM or YMSM of color Primary outcomes are HIV and STI testing and self-reported sexual risk behaviors Secondary outcomes are stress biomarker fingernail cortisol levels psychological health 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
Detailed Description:
In 2017 gay bisexual and other men who have sex with men MSM made up 70 of new HIV infections in the US 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 eg 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 ClinicalTrialsgov ID NCT05540652 Refine intervention protocol by administering adapted materials to distressed high-risk YMSM n18 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 n30 or active control condition n30 They will aim to over-enroll YMSM of color eg BlackLatinx YMSM and anticipate the group to include approximately 50-60 BlackLatinx YMSM or YMSM of color Primary outcomes are HIV and STI testing and self-reported sexual risk behaviors Secondary outcomes are stress biomarker fingernail cortisol levels psychological health 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
A key driver of such disparities experienced by YMSM is minority stress Experiences of identity-based discrimination lead to internalized stigma and maladaptive coping eg 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 ClinicalTrialsgov ID NCT05540652 Refine intervention protocol by administering adapted materials to distressed high-risk YMSM n18 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 n30 or active control condition n30 They will aim to over-enroll YMSM of color eg BlackLatinx YMSM and anticipate the group to include approximately 50-60 BlackLatinx YMSM or YMSM of color Primary outcomes are HIV and STI testing and self-reported sexual risk behaviors Secondary outcomes are stress biomarker fingernail cortisol levels psychological health 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| K23AT011173 | NIH | None | httpsreporternihgovquickSearchK23AT011173 |