NCT06001814Recruiting
Mindfulness and Behavior Change to Improve Cardiovascular Health of Older People With HIV
Source: ClinicalTrials.gov · Last updated 22 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 3 Aug 2023
- Start date
- 21 Jul 2025
- Primary completion date
- 30 Jun 2028
- Lead sponsor
- Massachusetts General Hospital
- Diseases
- HIV
- NCT number
- NCT06001814
What you commit to
- Study type: Interventional
- Planned participants: 50
- From 21 Jul 2025 to the primary completion date, 30 Jun 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- untreated or under-treated serious mental illness (i.e., psychosis and bipolar disorder) based on clinical interview
Other
- non-English-speaking
- cognitive impairments preventing informed consent
Who the study is looking for
- 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
Age in the registry: 50 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.