Mindfulness and behavior-change program to improve heart health in older adults with HIV
Official title: Mindfulness and Behavior Change to Improve Cardiovascular Health of Older People With HIV
Run by Massachusetts General Hospital · NCT06001814 · Data updated 2026-11-12
This project will test a text-message–enhanced mindfulness and behavior-change program to see if it reduces stress and cardiovascular risk in people aged 50+ living with HIV who have elevated psychological distress.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 50 Years and up |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Status | Recruiting |
| Started | July 21, 2025 |
| Main results expected | June 30, 2028 |
| Study ends | August 31, 2028 |
| Registry record updated | November 10, 2026 |
| Trial ID | NCT06001814 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are English-speaking adults aged 50 or older living with HIV who are virally suppressed, report elevated psychological distress (K10 ≥10), have at least one cardiovascular disease risk factor, and have a cell phone that can receive text messages.
✕Probably not a fit
People who are non-English-speaking, have cognitive impairment preventing informed consent, have untreated or under-treated serious mental illness (like active psychosis or bipolar disorder), or cannot receive text messages are unlikely to benefit from this pilot.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The project refines components from mindfulness-based stress reduction and the diabetes prevention program into a combined intervention called One Mind One Heart (OM-OH) and adds supportive text messages. Investigators will use semi-structured interviews with 20 older people with HIV and elevated psychological distress and input from a multidisciplinary team to adapt the content. They will then run a small open pilot (N=5) to test feasibility and gather exit feedback. The work is conducted at Massachusetts General Hospital and targets participants who are virally suppressed, have at least one cardiovascular risk factor, and can receive text messages.
Why it matters
Potential benefit: If successful, OM-OH could lower psychological distress and change behaviors linked to inflammation and cardiovascular risk, potentially improving heart health for older people with HIV.
How similar studies have gone: Mindfulness interventions have shown promise for reducing psychological distress and supporting behavior change in prior studies, but combining MBSR and diabetes-prevention content with text-message support specifically for cardiovascular risk in older people with HIV is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Massachusetts General Hospital
Boston, Massachusetts, United States Recruiting
Study contacts
- Study coordinator: Jacklyn Foley, PhD
- Email: jdfoley@mgh.harvard.edu
- Phone: 857-347-5312
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.