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Behavioural Intervention
Mindfulness-Based Intervention for Cardiovascular Health in Older Adults with HIV (OM-OH Trial)
N/A
Recruiting
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline; 12-week follow-up
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a new program called 'One Mind One Heart' (OM-OH) that uses mindfulness and behavior change techniques sent via text messages. It aims to help older people with HIV who are stressed and at risk for heart disease. The program hopes to reduce stress and inflammation, improving heart health.
Who is the study for?
This trial is for people over 50 with HIV who have controlled viral loads and are experiencing psychological distress. They must also have at least one risk factor for heart disease, like diabetes or high blood pressure, and be able to receive text messages on their cell phone.
What is being tested?
The 'One Mind One Heart' (OM-OH) program combines mindfulness and behavior change techniques delivered via text message to help reduce stress and lower the risk of heart disease in older adults with HIV. The study will compare OM-OH's effectiveness against standard care.
What are the potential side effects?
Since this intervention involves mindfulness practices and education without medications, side effects may be minimal but could include discomfort from confronting personal issues during the process.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 0 and 12-weeks post-intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0 and 12-weeks post-intervention
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Acceptability of OM-OH intervention
Acceptability of blood draws
Acceptability of text-enhanced delivery
+6 moreSecondary study objectives
Alcohol Use Disorder Identification Test - Concise (AUDIT-C)
Dietary Risk Assessment (DRA)
Fagerstrom Test For Nicotine Dependence (FTND)
+7 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: One-Mind One-HeartExperimental Treatment1 Intervention
One-Mind One-Heart (OM-OH) is intended to be a mindfulness-based, behavior change intervention to reduce psychological and behavioral cardiovascular disease risk.
Group II: EducationActive Control1 Intervention
The education session will provide information on behaviors important for cardiovascular disease risk reduction.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Mindfulness and behavior change interventions, such as those studied in the One Mind One Heart (OM-OH) trial, work by reducing psychological distress and systemic inflammation, both of which are significant contributors to cardiovascular disease (CVD). Mindfulness practices help lower stress levels by promoting relaxation and emotional regulation, which in turn can reduce the activation of the immune response and decrease pro-inflammatory markers.
Behavior change strategies, including improved diet, increased physical activity, and smoking cessation, directly target lifestyle factors that exacerbate CVD. These interventions are crucial for CVD patients as they address both the psychological and physiological aspects of the disease, potentially leading to better overall cardiovascular health and reduced risk of adverse events.
The Efficacy of Psychological Interventions on Health-Related Quality of Life for Patients With Heart Failure and Depression: A Systematic Review.
The Efficacy of Psychological Interventions on Health-Related Quality of Life for Patients With Heart Failure and Depression: A Systematic Review.
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Who is running the clinical trial?
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,942 Previous Clinical Trials
47,793,188 Total Patients Enrolled
Massachusetts General HospitalLead Sponsor
3,025 Previous Clinical Trials
13,413,818 Total Patients Enrolled