跳至主要内容
临床试验/NCT06001814
NCT06001814招募中不适用

Mindfulness and Behavior Change to Improve Cardiovascular Health of Older People With HIV

Massachusetts General Hospital2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年7月21日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
2
主要终点
Feasibility of the OM-OM intervention

研究概览

简要总结

Older people with HIV (OPWH) are disproportionately impacted by cardiovascular disease (CVD) attributable to behavioral risk factors, and chronic HIV immune dysregulation resulting inflammation. Systemic inflammation is exacerbated by psychological distress via activating the immune response and driving pro-inflammatory CVD risk behaviors. There is promising evidence to suggest that mindfulness could be an effective intervention to reduce psychological distress and support behaviorally- and inflammatory-mediated CVD risk reduction. This project aims to refine and synthesize mindfulness and behavior change content from evidence-based protocols (mindfulness-based stress reduction and diabetes prevention program) to develop and pilot test a new text message-enhanced intervention called "One Mind One Heart" (OM-OH) using feedback from semi-structured interviews with OPWH in psychological distress (N=20), and my multidisciplinary mentorship team (Aim 1). An open pilot (N=5) with exit interviews and pre-post self-report assessments, will inform the initial acceptability of OM-OH and further refine OM-OH as needed (Aim 2). Finally, a pilot randomized controlled trial (RCT; N=50) will be conducted to a.) evaluate benchmarks of feasibility and acceptability of study methods and refined OM-OH compared to enhanced usual care, and b.) investigate potential for effects on psychological distress, inflammation, and behavioral CVD risk (Aim 3). Findings will provide the foundation for an R01 application to conduct an efficacy trial of OM-OH to reduce inflammatory-mediated CVD risk among OPWH.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • age ≥50 years
  • clinical diagnosis of HIV per medical record or provision of current antiretroviral medication prescription
  • viral suppression - i.e., lower than detectable limit - per medical record or provision of viral load test from the past six months
  • current elevated psychological distress (score ≥10 on 10-item Kessler Psychological Distress Scale [K10]) screener)
  • ≥1 CVD risk factor (based on ACC/AHA Atherosclerotic Cardiovascular Disease Risk Score Calculator; e.g., diabetes, current smoker, hypertension, and high cholesterol
  • access to cell phone with text messaging capabilities

排除标准

  • non-English-speaking
  • cognitive impairments preventing informed consent
  • untreated or under-treated serious mental illness (i.e., psychosis and bipolar disorder) based on clinical interview

结局指标

主要结局

Feasibility of the OM-OM intervention

时间窗: Duration of intervention

70% or more of participants attend all sessions and complete all homework

Acceptability of text-enhanced delivery

时间窗: 0-weeks post-intervention

Rating of 7.5 or greater/10 on: ease, and confidence of use; and rating of 2 or less/10 on interference of technical problems

Acceptability of blood draws

时间窗: 0- and 12-weeks post-intervention

Rating of 7.5 or greater/10 on ease of collection; and rating of 2 or less/10 on pain

Feasibility of eligibility criteria

时间窗: Baseline (pre-intervention)

Less than 20% of participants are ineligible due to each criterion

Feasibility of blood draws

时间窗: Baseline; 12-week follow-up

70% of more are collected

Acceptability of OM-OH intervention

时间窗: 0-weeks post-intervention

Rating of 7.5 or greater/10 on: session satisfaction, helpfulness, and utility; overall program satisfaction; plan to use the skills; and would recommend the intervention program to a friend

Feasibility of randomization

时间窗: Pre-intervention

70% or more of participants are randomized and complete the first intervention session

Feasibility of recruitment

时间窗: Baseline (pre-intervention)

70% or more of participants consent to screening, meet screening criteria, are eligible, and agree to participate in the study

Feasibility of research assessments

时间窗: Duration of intervention; 0 and 12-week follow-up

70% or more of weekly and follow-up research assessments are completed

次要结局

  • Five Factor Mindfulness Questionnaire (FFMQ)(0 and 12-weeks post-intervention)
  • Alcohol Use Disorder Identification Test - Concise (AUDIT-C)(0 and 12-weeks post-intervention)
  • Inflammation Biomarkers(0- and 12-weeks post-intervention)
  • Patient Health Questionnaire - 9 (PHQ-9)(0 and 12-weeks post-intervention)
  • Generalized Anxiety Disorder - 7 (GAD-7)(0 and 12-weeks post-intervention)
  • Perceived Stress Scale (PSS)(0 and 12-weeks post-intervention)
  • HIV/AIDS Stress Scale(0 and 12-weeks post-intervention)
  • Physical Activity and Sedentary Behavior Questionnaire (PASBQ)(0 and 12-weeks post-intervention)
  • Dietary Risk Assessment (DRA)(0 and 12-weeks post-intervention)
  • Fagerstrom Test For Nicotine Dependence (FTND)(0 and 12-weeks post-intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jacklyn D. Foley, Ph.D

Psychologist

Massachusetts General Hospital

研究点 (2)

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