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

NCT06001814 | Recruiting DMC

• 3 other identifiers: 2023P002014PA20-2061K23HL167650-01A1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (9)

• Feasibility of recruitment

  70% or more of participants consent to screening, meet screening criteria, are eligible, and agree to participate in the study

  Baseline (pre-intervention)

• Feasibility of eligibility criteria

  Less than 20% of participants are ineligible due to each criterion

  Baseline (pre-intervention)

• Feasibility of randomization

  70% or more of participants are randomized and complete the first intervention session

  Pre-intervention

• Feasibility of the OM-OM intervention

  70% or more of participants attend all sessions and complete all homework

  Duration of intervention

• Feasibility of research assessments

  70% or more of weekly and follow-up research assessments are completed

  Duration of intervention; 0 and 12-week follow-up

• Feasibility of blood draws

  70% of more are collected

  Baseline; 12-week follow-up

• Acceptability of OM-OH intervention

  Rating of 7.5 or greater/10 on: session satisfaction, helpfulness, and utility; overall program satisfaction; plan to use the skills; and would recommend the intervention program to a friend

  0-weeks post-intervention

• Acceptability of text-enhanced delivery

  Rating of 7.5 or greater/10 on: ease, and confidence of use; and rating of 2 or less/10 on interference of technical problems

  0-weeks post-intervention

• Acceptability of blood draws

  Rating of 7.5 or greater/10 on ease of collection; and rating of 2 or less/10 on pain

  0- and 12-weeks post-intervention

Secondary Outcomes (10)

• Five Factor Mindfulness Questionnaire (FFMQ)

  0 and 12-weeks post-intervention

• Patient Health Questionnaire - 9 (PHQ-9)

  0 and 12-weeks post-intervention

• Generalized Anxiety Disorder - 7 (GAD-7)

  0 and 12-weeks post-intervention

• Perceived Stress Scale (PSS)

  0 and 12-weeks post-intervention

• HIV/AIDS Stress Scale

  0 and 12-weeks post-intervention

Study Arms (2)

One-Mind One-Heart

EXPERIMENTAL

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

Behavioral: One-Mind One-Heart

Education

ACTIVE COMPARATOR

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

Other: Education

Interventions

One-Mind One-Heart BEHAVIORAL

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

One-Mind One-Heart

Education 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.

Education

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age ≥50 years
• clinical diagnosis of HIV per medical record or provision of current antiretroviral medication prescription
• viral suppression - i.e., lower than detectable limit - per medical record or provision of viral load test from the past six months
• current elevated psychological distress (score ≥10 on 10-item Kessler Psychological Distress Scale \[K10\]) screener)
• ≥1 CVD risk factor (based on ACC/AHA Atherosclerotic Cardiovascular Disease Risk Score Calculator; e.g., diabetes, current smoker, hypertension, and high cholesterol
• access to cell phone with text messaging capabilities

You may not qualify if:

• non-English-speaking
• cognitive impairments preventing informed consent
• untreated or under-treated serious mental illness (i.e., psychosis and bipolar disorder) based on clinical interview

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Cardiovascular Diseases

Interventions

Educational Status

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Central Study Contacts

Jacklyn Foley, PhD

CONTACT

857-347-5312; jdfoley@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Psychologist

Study Record Dates

• First Submitted: August 3, 2023
• First Posted: August 21, 2023
• Study Start: July 21, 2025
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)