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Can mindfulness lower heart risk in older HIV patients?

NCT ID NCT06001814

Symptom relief Sponsor: Massachusetts General Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study tests a program called One-Mind One-Heart that combines mindfulness and behavior change skills to help older adults with HIV reduce stress and improve heart health. The program includes text messages and covers topics like physical activity, diet, and substance use. The study will enroll 50 people aged 50 and older with HIV and high stress levels to see if the program is feasible and acceptable.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
mindfulness and behavior change program (One-Mind One-Heart)
What this could lead to
If it works, this could point toward a simple, low-cost way to lower heart disease risk in older people with HIV by reducing stress and promoting healthy habits.
What could go wrong
This is a very early, small pilot study with only 50 participants. It is designed to test feasibility, not effectiveness, so the program may not actually improve heart health.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

AIDS cardiovascular disorder HIV infectious disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cardiovascular diseases HIV

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

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