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

Cardiovascular Diseases Clinical Trial

— OM-OH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06001814
• Other study ID #: 2023P002014
• Secondary ID: PA20-2061K23HL16
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: August 2028

Study information

• Verified date: August 2023
• Source: Massachusetts General Hospital
• Contact: Jacklyn Foley, PhD
• Phone: 857-347-5312
• Email: jdfoley[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 2028
• Est. primary completion date: August 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Hiv

Intervention

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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of recruitment	70% or more of participants consent to screening, meet screening criteria, are eligible, and agree to participate in the study	Baseline (pre-intervention)
Primary	Feasibility of eligibility criteria	Less than 20% of participants are ineligible due to each criterion	Baseline (pre-intervention)
Primary	Feasibility of randomization	70% or more of participants are randomized and complete the first intervention session	Pre-intervention
Primary	Feasibility of the OM-OM intervention	70% or more of participants attend all sessions and complete all homework	Duration of intervention
Primary	Feasibility of research assessments	70% or more of weekly and follow-up research assessments are completed	Duration of intervention; 0 and 12-week follow-up
Primary	Feasibility of blood draws	70% of more are collected	Baseline; 12-week follow-up
Primary	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	0-weeks post-intervention
Primary	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	0-weeks post-intervention
Primary	Acceptability of blood draws	Rating of 7.5 or greater/10 on ease of collection; and rating of 2 or less/10 on pain	0- and 12-weeks post-intervention
Secondary	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.	0 and 12-weeks post-intervention
Secondary	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.	0 and 12-weeks post-intervention
Secondary	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.	0 and 12-weeks post-intervention
Secondary	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.	0 and 12-weeks post-intervention
Secondary	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.	0 and 12-weeks post-intervention
Secondary	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.	0 and 12-weeks post-intervention
Secondary	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.	0 and 12-weeks post-intervention
Secondary	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.	0 and 12-weeks post-intervention
Secondary	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.	0 and 12-weeks post-intervention
Secondary	Inflammation Biomarkers	Interleukin-6 and C-reactive protein measured in picograms per milliliter of blood	0- and 12-weeks post-intervention