Mindfulness and Behavior Change to Improve Cardiovascular Health of Older People With HIV (OM-OH)

Mass General Brigham

Status: Enrolling

Conditions: Cardiovascular Diseases; Hiv

Treatments: Other: Education; Behavioral: One-Mind One-Heart

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06001814

2023P002014

1K23HL167650-01A1 (U.S. NIH Grant/Contract)

PA20-206 (Other Grant/Funding Number)

Details and patient eligibility

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

One-Mind One-Heart

Experimental group

Description:

One-Mind One-Heart (OM-OH) is intended to be a mindfulness-based, behavior change intervention to reduce psychological and behavioral cardiovascular disease risk.

Treatment:

Behavioral: One-Mind One-Heart

Education

Active Comparator group

Description:

The education session will provide information on behaviors important for cardiovascular disease risk reduction.

Treatment:

Other: Education