Cardiovascular Diseases, Hiv
Conditions
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.
Interventions
BEHAVIORALOne-Mind One-Heart
One-Mind One-Heart will include mindfulness and behavior change skills to address psychological distress, physical activity, diet, and substance use.
OTHEREducation
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.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of recruitment | 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 | Baseline (pre-intervention) | Less than 20% of participants are ineligible due to each criterion |
| Feasibility of randomization | Pre-intervention | 70% or more of participants are randomized and complete the first intervention session |
| Feasibility of the OM-OM intervention | Duration of intervention | 70% or more of participants attend all sessions and complete all homework |
| Feasibility of research assessments | 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 | Baseline; 12-week follow-up | 70% of more are collected |
| Acceptability of OM-OH intervention | 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 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Inflammation Biomarkers | 0- and 12-weeks post-intervention | Interleukin-6 and C-reactive protein measured in picograms per milliliter of blood |
| Dietary Risk Assessment (DRA) | 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. |
| Five Factor Mindfulness Questionnaire (FFMQ) | 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. |
| Fagerstrom Test For Nicotine Dependence (FTND) | 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. |
| Patient Health Questionnaire - 9 (PHQ-9) | 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) | 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) | 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 | 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) | 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) | 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. |
Countries
United States
Contacts
Primary ContactJacklyn Foley, PhD
Outcome results
None listed