What side effects are associated with this type of intervention?

Mindfulness and behavior change interventions, such as those studied in the OM-OH trial, are generally considered safe with minimal side effects. Commonly reported side effects include temporary discomfort during meditation, such as increased awareness of stress or anxiety, which typically diminishes with continued practice. Some individuals may experience emotional distress as they become more aware of their thoughts and feelings. However, these interventions are non-invasive and do not carry the same risks as pharmacological treatments, making them a favorable option for managing psychological distress and inflammation in cardiovascular disease.

What prior FDA approvals exist?

The One Mind One Heart (OM-OH) trial investigates the use of mindfulness and behavior change to reduce psychological distress and inflammation, which are risk factors for cardiovascular disease (CVD). While there are no specific FDA approvals for mindfulness and behavior change therapies for CVD, several pharmacological treatments have been approved to manage CVD risk factors. These include statins for lowering cholesterol, antihypertensive drugs like ACE inhibitors and beta-blockers for managing blood pressure, and antiplatelet agents like aspirin for preventing blood clots. These treatments aim to reduce the overall risk of cardiovascular events by addressing key physiological factors.

What other types of research exist?

Promising alternatives to OM-OH for CVD patients include: 1) Mindfulness-Based Stress Reduction (MBSR) programs, which have shown broad symptom improvement and reduction in psychological distress. 2) Acupuncture, which has been effective in reducing stress and inflammation. 3) Dietary interventions like the Mediterranean or MIND diets, which are associated with reduced inflammation and improved cardiovascular health. 4) Physical activity programs, particularly those incorporating yoga or tai chi, which have demonstrated benefits in reducing stress and improving cardiovascular outcomes.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0 and 12-weeks post-intervention for reporting.

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 more

Secondary study objectives

Alcohol Use Disorder Identification Test - Concise (AUDIT-C)

Dietary Risk Assessment (DRA)

Fagerstrom Test For Nicotine Dependence (FTND)

+7 more

Awards & 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.

Do I qualify?Apply below to find out

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.