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NCT Number: NCT06001814

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

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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location status: Recruiting

Location contact

Jacklyn Foley, PhD

CONTACT

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

  2. Feasibility of eligibility criteria

    Time frame: Baseline (pre-intervention)

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

  3. Feasibility of randomization

    Time frame: Pre-intervention

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

  4. Feasibility of the OM-OM intervention

    Time frame: Duration of intervention

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

  5. 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

  6. Feasibility of blood draws

    Time frame: Baseline; 12-week follow-up

    70% of more are collected

  7. 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

  8. 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

  9. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. Inflammation Biomarkers

    Time frame: 0- and 12-weeks post-intervention

    Interleukin-6 and C-reactive protein measured in picograms per milliliter of blood

Study contacts

Contact information is provided by the study sponsor or research team.

Jacklyn Foley, PhD

CONTACT

[email protected]

857-347-5312

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Acronym: OM-OH

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Aug 21, 2023
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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