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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
50
One-Mind One-Heart will include mindfulness and behavior change skills to address psychological distress, physical activity, diet, and substance use.
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.
Massachusetts General Hospital
Boston, Massachusetts, United States
RECRUITINGFeasibility of recruitment
70% or more of participants consent to screening, meet screening criteria, are eligible, and agree to participate in the study
Time frame: Baseline (pre-intervention)
Feasibility of eligibility criteria
Less than 20% of participants are ineligible due to each criterion
Time frame: Baseline (pre-intervention)
Feasibility of randomization
70% or more of participants are randomized and complete the first intervention session
Time frame: Pre-intervention
Feasibility of the OM-OM intervention
70% or more of participants attend all sessions and complete all homework
Time frame: Duration of intervention
Feasibility of research assessments
70% or more of weekly and follow-up research assessments are completed
Time frame: Duration of intervention; 0 and 12-week follow-up
Feasibility of blood draws
70% of more are collected
Time frame: Baseline; 12-week follow-up
Acceptability of OM-OH 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
Time frame: 0-weeks post-intervention
Acceptability of text-enhanced delivery
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
Time frame: 0-weeks post-intervention
Acceptability of blood draws
Rating of 7.5 or greater/10 on ease of collection; and rating of 2 or less/10 on pain
Time frame: 0- and 12-weeks post-intervention
Five Factor Mindfulness Questionnaire (FFMQ)
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.
Time frame: 0 and 12-weeks post-intervention
Patient Health Questionnaire - 9 (PHQ-9)
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.
Time frame: 0 and 12-weeks post-intervention
Generalized Anxiety Disorder - 7 (GAD-7)
GAD-7 assesses anxiety symptoms. Total scores of 5, 10, and 15 represent cut points for mild, moderate, and severe anxiety symptoms, respectively.
Time frame: 0 and 12-weeks post-intervention
Perceived Stress Scale (PSS)
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.
Time frame: 0 and 12-weeks post-intervention
HIV/AIDS Stress Scale
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.
Time frame: 0 and 12-weeks post-intervention
Alcohol Use Disorder Identification Test - Concise (AUDIT-C)
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.
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Time frame: 0 and 12-weeks post-intervention
Physical Activity and Sedentary Behavior Questionnaire (PASBQ)
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.
Time frame: 0 and 12-weeks post-intervention
Dietary Risk Assessment (DRA)
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.
Time frame: 0 and 12-weeks post-intervention
Fagerstrom Test For Nicotine Dependence (FTND)
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.
Time frame: 0 and 12-weeks post-intervention
Inflammation Biomarkers
Interleukin-6 and C-reactive protein measured in picograms per milliliter of blood
Time frame: 0- and 12-weeks post-intervention