Mindfulness and Behavior Change to Improve Cardiovascular Health of Older People With HIV
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: One-Mind One-Heart, Education.
- Who it may be relevant to
- Registry conditions: Hiv, Cardiovascular Diseases. Basic parameters: from 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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)]
- Feasibility of eligibility criteria [Time frame: Baseline (pre-intervention)]
- Feasibility of randomization [Time frame: Pre-intervention]
- Feasibility of the OM-OM intervention [Time frame: Duration of intervention]
- Feasibility of research assessments [Time frame: Duration of intervention; 0 and 12-week follow-up]
- Feasibility of blood draws [Time frame: Baseline; 12-week follow-up]
- Acceptability of OM-OH intervention [Time frame: 0-weeks post-intervention]
- Acceptability of text-enhanced delivery [Time frame: 0-weeks post-intervention]
- Acceptability of blood draws [Time frame: 0- and 12-weeks post-intervention]
Secondary outcome measures (10)
- Five Factor Mindfulness Questionnaire (FFMQ) [Time frame: 0 and 12-weeks post-intervention]
- Patient Health Questionnaire - 9 (PHQ-9) [Time frame: 0 and 12-weeks post-intervention]
- Generalized Anxiety Disorder - 7 (GAD-7) [Time frame: 0 and 12-weeks post-intervention]
- Perceived Stress Scale (PSS) [Time frame: 0 and 12-weeks post-intervention]
- HIV/AIDS Stress Scale [Time frame: 0 and 12-weeks post-intervention]
- Alcohol Use Disorder Identification Test - Concise (AUDIT-C) [Time frame: 0 and 12-weeks post-intervention]
- Physical Activity and Sedentary Behavior Questionnaire (PASBQ) [Time frame: 0 and 12-weeks post-intervention]
- Dietary Risk Assessment (DRA) [Time frame: 0 and 12-weeks post-intervention]
- Fagerstrom Test For Nicotine Dependence (FTND) [Time frame: 0 and 12-weeks post-intervention]
- Inflammation Biomarkers [Time frame: 0- and 12-weeks post-intervention]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Massachusetts General Hospital — Boston
Identifiers
NCT: NCT06001814 · 2023P002014 · PA20-206 · 1K23HL167650-01A1