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

NCT ID: NCT06001814

Last Updated: 2025-09-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-21
• Study Completion Date: 2028-08-31

Brief 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.

Conditions

Hiv; Cardiovascular Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

One-Mind One-Heart

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

Group Type: EXPERIMENTAL

One-Mind One-Heart

Intervention Type: BEHAVIORAL

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

Education

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

Group Type: ACTIVE_COMPARATOR

Education

Intervention Type: OTHER

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.

Interventions

One-Mind One-Heart

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

Intervention Type: BEHAVIORAL

Education

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.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jacklyn D. Foley, Ph.D

Psychologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jacklyn Foley, PhD

Role: CONTACT

jdfoley@mgh.harvard.edu

857-347-5312

Facility Contacts

Jacklyn Foley, PhD

Role: primary

Other Identifiers

PA20-206

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

1K23HL167650-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2023P002014

Identifier Type: -

Identifier Source: org_study_id