Actively Recruiting

Phase Not Applicable
Age: 50Years +
All Genders
Healthy Volunteers
NCT06001814

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

Led by Massachusetts General Hospital · Updated on 2025-09-22

50

Participants Needed

1

Research Sites

162 weeks

Total Duration

On this page

Sponsors

M

Massachusetts General Hospital

Lead Sponsor

N

National Heart, Lung, and Blood Institute (NHLBI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 50Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 50 years or older
  • Clinical diagnosis of HIV or current use of antiretroviral medication
  • Viral suppression below detectable limits per medical records or viral load test within past six months
  • Current elevated psychological distress with a score of 10 or higher on the 10-item Kessler Psychological Distress Scale (K10)
  • At least one cardiovascular disease risk factor such as diabetes, current smoking, hypertension, or high cholesterol
  • Access to a cell phone capable of receiving text messages
Not Eligible

You will not qualify if you...

  • Non-English-speaking
  • Cognitive impairments that prevent giving informed consent
  • Untreated or under-treated serious mental illness such as psychosis or bipolar disorder based on clinical interview

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Actively Recruiting

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Research Team

J

Jacklyn Foley, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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