Mindfulness and Behavior Change to Improve Cardiovascular Health of Older People With HIV
Hiv · Cardiovascular Diseases
What this study involves
The registry says this study is recruiting. Individual locations may have different availability.
- Study type
- Interventional
- Phase
- Not applicable
- Age range
- 50 years - Not specified
- Sex eligible
- All sexes
- Healthy volunteers
- Accepted
- Participants
- 50 Estimated
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
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
Treatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Random assignment
- Masking
- Single masked
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.
Behavioral: One-Mind One-Heart
Education
The education session will provide information on behaviors important for cardiovascular disease risk reduction.
Other: Education
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.
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.
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary 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
Secondary measures
Five Factor Mindfulness Questionnaire (FFMQ)
Time frame: 0 and 12-weeks post-intervention
The FFQ assesses trait mindfulness.There are five sub scales: observing, describing, acting with awareness, non-judging, and non-reactivity. The FFMQ sub scale summary scores can be calculated by dividing the total in each category by the number of items in that category. The FFMQ sum score can be divided by 39 to get an average item score. Higher scores indicated greater trait mindfulness.
Patient Health Questionnaire - 9 (PHQ-9)
Time frame: 0 and 12-weeks post-intervention
PHQ-9 assesses depressive symptoms. Total scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, moderately severe and severe depressive symptoms, respectively.
Generalized Anxiety Disorder - 7 (GAD-7)
Time frame: 0 and 12-weeks post-intervention
GAD-7 assesses anxiety symptoms. Total scores of 5, 10, and 15 represent cut points for mild, moderate, and severe anxiety symptoms, respectively.
Perceived Stress Scale (PSS)
Time frame: 0 and 12-weeks post-intervention
The PSS assessed perceived stress. Scores on the PSS range from 0 to 40 with higher scores indicating higher perceived stress. Scores ranging from 0-13 would be considered low stress. Scores ranging from 14-26 would be considered moderate stress. Scores ranging from 27-40 would be considered high perceived stress.
HIV/AIDS Stress Scale
Time frame: 0 and 12-weeks post-intervention
The HIV/AIDS Stress Scale assesses HIV-related stress. The total score ranges from 0-68, with higher scores indicating higher levels of HIV-related stress.
Alcohol Use Disorder Identification Test - Concise (AUDIT-C)
Time frame: 0 and 12-weeks post-intervention
The AUDIT-C is scored on a scale of 0-12 (scores of 0 reflect no alcohol use). In men, a score of 4 or more is considered positive for hazardous drinking; in women, a score of 3 or more is considered positive for hazardous drinking. Generally, the higher the AUDIT-C score, the more likely it is that the patient's drinking is affecting his/her health and safety.
Physical Activity and Sedentary Behavior Questionnaire (PASBQ)
Time frame: 0 and 12-weeks post-intervention
The PASBQ assesses frequency and time spent in physical activity and sedentary behaviors. These time will be compared to Centers for Disease Control and Prevention (CDC) to determine if current guidelines are being met (yes/no) for 150 minutes of moderate aerobic activity (or 75 minutes of vigorous aerobic activity) and 2 or more days of muscle strengthening activities.
Dietary Risk Assessment (DRA)
Time frame: 0 and 12-weeks post-intervention
The DRA assesses dietary patterns. A total DRA score and 4 subscales (Nuts, Oils, Dressings, and Spreads; Vegetables, Fruit, Whole Grains, and Beans; Drinks, Desserts, Snacks, Eating Out, and Salt; and Fish, Meat, Poultry, Dairy, and Eggs) can be derived. Subscales are scored independently by assigning score values accordingly: 2 for response choices in the "Desirable" column; 1 for response choices in the "Could be improved" column; and 0 for response choices in the "Needs to be improved" column. Sum the 4 subscales to obtain a total DRA score ranging 0 to 46. For all scoring, a higher score represents a more healthful dietary pattern.
Fagerstrom Test For Nicotine Dependence (FTND)
Time frame: 0 and 12-weeks post-intervention
The FTND assesses dependence on nicotine. Scores for all item are summed. Scores of �1-2: low dependence; 3-4 low to moderate dependence; 5-7 moderate dependence; 8+ high dependence.
Inflammation Biomarkers
Time frame: 0- and 12-weeks post-intervention
Interleukin-6 and C-reactive protein measured in picograms per milliliter of blood
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (1)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
1 locations
Massachusetts General HospitalBoston, Massachusetts, United StatesRecruiting
Study team and timeline
- Lead sponsor
- Massachusetts General Hospital
- Study start
- Jul 21, 2025 Actual
- Primary completion
- Jun 30, 2028 Estimated
- Study completion
- Aug 31, 2028 Estimated
- First posted
- Aug 21, 2023 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
Official study title
Mindfulness and Behavior Change to Improve Cardiovascular Health of Older People With HIV
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026