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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Feasibility of Online Mindfulness-Based Queer Resilience as Measured by Recruitment Rates
研究概览
简要总结
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).
详细描述
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)".
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 34 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Feasibility of Online Mindfulness-Based Queer Resilience as Measured by Recruitment Rates
时间窗: Baseline
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.
Feasibility of Online Mindfulness-Based Queer Resilience as Measured by Retention Rates
时间窗: 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.
Feasibility of Online Mindfulness-Based Queer Resilience as Measured by Session Attendance and Home Practice Completion
时间窗: 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.
Acceptability of Online Mindfulness-Based Queer Resilience as Measured by the Client Satisfaction Questionnaire
时间窗: Post-intervention assessment (i.e., at 8 weeks, after intervention delivery)
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.
Acceptability of Online Mindfulness-Based Queer Resilience as Measured by a Session Evaluation Form
时间窗: Post-intervention assessment (i.e., at 8 weeks, after intervention delivery)
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.
次要结局
未报告次要终点