NCT06001814 · Massachusetts General Hospital
Mindfulness and Behavior Change to Improve Cardiovascular Health of Older People With HIV
(OM-OH)
What this study 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.
View original scientific description
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.
Interventions
BEHAVIORAL
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.
OTHER
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.
Primary outcome measures
Feasibility of recruitment
Time frame: Baseline (pre-intervention)
70% or more of participants consent to screening, meet screening criteria, are eligible, and agree to participate in the study
Feasibility of eligibility criteria
Time frame: Baseline (pre-intervention)
Less than 20% of participants are ineligible due to each criterion
Feasibility of randomization
Time frame: Pre-intervention
70% or more of participants are randomized and complete the first intervention session
Feasibility of the OM-OM intervention
Time frame: Duration of intervention
70% or more of participants attend all sessions and complete all homework
Feasibility of research assessments
Time frame: Duration of intervention; 0 and 12-week follow-up
70% or more of weekly and follow-up research assessments are completed
Feasibility of blood draws
Time frame: Baseline; 12-week follow-up
70% of more are collected
Acceptability of OM-OH intervention
Time frame: 0-weeks post-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
Acceptability of text-enhanced delivery
Time frame: 0-weeks post-intervention
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
Acceptability of blood draws
Time frame: 0- and 12-weeks post-intervention
Rating of 7.5 or greater/10 on ease of collection; and rating of 2 or less/10 on pain
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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
Where
- Boston, Massachusetts
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 22, 2025 · Source of record for eligibility and locations