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

RecruitingNAAges 50 Years - anyAllMassachusetts General Hospital
NCT06001814 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 dis

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. age ≥50 years 2. clinical diagnosis of HIV per medical record or provision of current antiretroviral medication prescription 3. viral suppression - i.e., lower than detectable limit - per medical record or provision of viral load test from the past six months 4. current elevated psychological distress (score ≥10 on 10-item Kessler Psychological Distress Scale \[K10\]) screener) 5. ≥1 CVD risk factor (based on ACC/AHA Atherosclerotic Cardiovascular Disease Risk Score Calculator; e.g., diabetes, current smoker, hypertension, and high cholesterol 6. access to cell phone with text messaging capabilities Exclusion Criteria: 1. non-English-speaking 2. cognitive impairments preventing informed consent 3. untreated or under-treated serious mental illness (i.e., psychosis and bipolar disorder) based on clinical interview
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What it tests

  • One-Mind One-Heart
  • Education
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Where

1 site
Massachusetts General Hospital
Boston, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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