Clinical trial NCT06001814: Mindfulness and Behavior Change to Improve Cardiovascular Health of Older People With HIV
Official title: Mindfulness and Behavior Change to Improve Cardiovascular Health of Older People With HIV
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Hiv
Cardiovascular Diseases
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2023-08-21
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of recruitment
timeFrame: Baseline (pre-intervention)
measure: Feasibility of eligibility criteria
timeFrame: Baseline (pre-intervention)
measure: Feasibility of randomization
timeFrame: Pre-intervention
measure: Feasibility of the OM-OM intervention
timeFrame: Duration of intervention
measure: Feasibility of research assessments
timeFrame: Duration of intervention; 0 and 12-week follow-up
measure: Feasibility of blood draws
timeFrame: Baseline; 12-week follow-up
measure: Acceptability of OM-OH intervention
timeFrame: 0-weeks post-intervention
measure: Acceptability of text-enhanced delivery
timeFrame: 0-weeks post-intervention
measure: Acceptability of blood draws
timeFrame: 0- and 12-weeks post-intervention
Secondary outcomes:
measure: Five Factor Mindfulness Questionnaire (FFMQ)
timeFrame: 0 and 12-weeks post-intervention
measure: Patient Health Questionnaire - 9 (PHQ-9)
timeFrame: 0 and 12-weeks post-intervention
measure: Generalized Anxiety Disorder - 7 (GAD-7)
timeFrame: 0 and 12-weeks post-intervention
measure: Perceived Stress Scale (PSS)
timeFrame: 0 and 12-weeks post-intervention
measure: HIV/AIDS Stress Scale
timeFrame: 0 and 12-weeks post-intervention
measure: Alcohol Use Disorder Identification Test - Concise (AUDIT-C)
timeFrame: 0 and 12-weeks post-intervention
measure: Physical Activity and Sedentary Behavior Questionnaire (PASBQ)
timeFrame: 0 and 12-weeks post-intervention
measure: Dietary Risk Assessment (DRA)
timeFrame: 0 and 12-weeks post-intervention
measure: Fagerstrom Test For Nicotine Dependence (FTND)
timeFrame: 0 and 12-weeks post-intervention
measure: Inflammation Biomarkers
timeFrame: 0- and 12-weeks post-intervention
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References: