RecruitingNot ApplicableNCT06001814

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


Sponsor

Massachusetts General Hospital

Enrollment

50 participants

Start Date

Jul 21, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a mindfulness and behavior change program delivered via text message can reduce psychological distress and improve heart health in older adults living with HIV who have cardiovascular disease risk factors. **You may be eligible if...** - You are 50 years or older - You have been diagnosed with HIV and your viral load is undetectable on antiretroviral therapy - You are currently experiencing elevated psychological distress (a score of 10 or higher on a 10-question distress screening tool) - You have at least one cardiovascular risk factor (such as diabetes, smoking, high blood pressure, or high cholesterol) - You have a cell phone with text messaging capability - You speak English **You may NOT be eligible if...** - You do not speak English - You have cognitive impairments that prevent you from giving informed consent - You have untreated or poorly managed serious mental illness such as psychosis Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALOne-Mind One-Heart

One-Mind One-Heart will include mindfulness and behavior change skills to address psychological distress, physical activity, diet, and substance use.

OTHEREducation

Education will be provided on behavioral cardiovascular disease risk reduction strategies, such as increasing physical activity, reducing salt intake in diet, and reduce/stop alcohol and tobacco-use.


Locations(1)

Massachusetts General Hospital

Boston, Massachusetts, United States

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NCT06001814


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