Mindfulness-Based Intervention for Cardiovascular Health in Older Adults with HIV

(OM-OH Trial)

Overseen By Jacklyn Foley, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Must be taking: Antiretrovirals

Disqualifiers: Non-English, Cognitive impairments, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a mindfulness-based program, "One Mind One Heart," to reduce heart disease risks in older adults with HIV. The researchers aim to determine if mindfulness can lower stress and improve heart health by reducing behaviors that increase heart disease risk. Participants will either try this new program or receive standard health education. The trial seeks individuals aged 50 and over who have HIV, experience high stress levels, have at least one heart disease risk factor like diabetes or high blood pressure, and have a phone with text messaging capabilities. As an unphased trial, this study provides a unique opportunity to explore innovative ways to enhance heart health and manage stress.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that the One Mind One Heart intervention is safe for older adults with HIV?

Research shows that mindfulness-based activities, such as One Mind One Heart (OM-OH), are generally easy for people to handle. These activities have been used in various health settings with few reports of serious side effects. They aim to reduce stress and improve mental well-being, which can benefit heart health.

In studies on mindfulness for similar health issues, most participants report feeling better mentally and emotionally, with little evidence of harm. Since this trial focuses on using mindfulness to reduce stress and improve heart health in older people with HIV, past research suggests it is likely to be safe.

This is a pilot study, an early stage of research, indicating the treatment is considered safe enough for a small group. For any concerns, contact the trial team for more information. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for cardiovascular health, which often focus on medication or lifestyle changes like diet and exercise, One-Mind One-Heart (OM-OH) introduces a mindfulness-based approach. This treatment aims to reduce cardiovascular disease risk by addressing psychological and behavioral factors through mindfulness, which is a new mechanism of action in this field. Researchers are excited because mindfulness can potentially enhance mental well-being and promote healthier behaviors, providing a holistic and innovative angle in managing cardiovascular health, especially for older adults living with HIV.

What evidence suggests that the One Mind One Heart intervention could be effective for cardiovascular health in older adults with HIV?

Research shows that mindfulness can help lower stress and inflammation, both linked to a higher risk of heart disease in people with HIV. Inflammation plays a significant role in heart disease, and mindfulness practices have shown promise in reducing it. Past studies demonstrated that mindfulness-based activities can improve mental health and reduce habits leading to heart disease. In this trial, participants will join one of two groups: the One Mind One Heart program, which combines mindfulness with behavior changes to lower these risks, or an education session on behaviors important for reducing cardiovascular disease risk. While specific results for the One Mind One Heart program are still being gathered, it is based on strong evidence that mindfulness can improve heart health and reduce stress. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Current elevated psychological distress (score ≥10 on 10-item Kessler Psychological Distress Scale [K10] screener)

I am 50 years old or older.

I have at least one risk factor for heart disease, like diabetes, smoking, high blood pressure, or high cholesterol.

Exclusion Criteria

Untreated or under-treated serious mental illness (i.e., psychosis and bipolar disorder) based on clinical interview

I am able to understand and give informed consent.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Open Pilot

An open pilot with exit interviews and pre-post self-report assessments to inform the initial acceptability of OM-OH

4 weeks

Weekly visits (in-person or virtual)

Pilot Randomized Controlled Trial (RCT)

A pilot RCT to evaluate feasibility and acceptability of OM-OH compared to enhanced usual care

12 weeks

Bi-weekly visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• One Mind One Heart

Trial Overview 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.

How Is the Trial Designed?

Group I: One-Mind One-Heart Experimental Treatment 1 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: Education Active Control 1 Intervention

The education session will provide information on behaviors important for cardiovascular disease risk reduction.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

Telephone-delivered mindfulness training (MT) was found to be feasible and acceptable for people living with HIV, with 55% of participants completing at least half of the training calls, although this was lower than the 86% completion rate for health coaching (HC).

Both MT and HC groups reported improvements in medication adherence, mindfulness, and reductions in sexual risk behavior, anxiety, and depressive symptoms, but there were no significant differences in outcomes between the two interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telephone-Delivered Mindfulness Training to Promote Medication Adherence and Reduce Sexual Risk Behavior Among Persons Living with HIV: An Exploratory Clinical Trial. Carey, MP., Dunne, EM., Norris, A., et al.[2022]

An 8-week Mindfulness-based Stress Reduction (MBSR) program helped maintain CD4+ T lymphocyte counts in HIV-1 infected adults, while a 1-day control seminar led to declines in these immune cells, indicating potential benefits of mindfulness meditation for this population.

The positive effect of MBSR on CD4+ counts was linked to participants' adherence to the program, suggesting that consistent practice of mindfulness meditation may help buffer against immune decline in stressed individuals with HIV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness meditation training effects on CD4+ T lymphocytes in HIV-1 infected adults: a small randomized controlled trial. Creswell, JD., Myers, HF., Cole, SW., et al.[2021]

A 20-week yoga intervention significantly reduced resting blood pressure in HIV-infected adults with mild to moderate cardiovascular disease risk, showing a decrease of 5 mmHg systolic and 3 mmHg diastolic compared to no change in the standard care group.

While yoga did not lead to improvements in body weight, fat mass, lipid levels, or overall quality of life, it was found to be a safe and effective nonpharmacological option for managing blood pressure in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Yoga lifestyle intervention reduces blood pressure in HIV-infected adults with cardiovascular disease risk factors. Cade, WT., Reeds, DN., Mondy, KE., et al.[2021]

Mindfulness-based interventions (MBIs) significantly reduced depressive symptoms in people living with HIV/AIDS, with a moderate effect size (d+ = 0.37) based on a meta-analysis of 16 studies involving 1059 participants.

Participants in MBIs also experienced improvements in overall psychological symptoms and quality of life over time, although no significant changes were found in immunological outcomes like CD4 counts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-Based Interventions for Adults Living with HIV/AIDS: A Systematic Review and Meta-analysis. Scott-Sheldon, LAJ., Balletto, BL., Donahue, ML., et al.[2023]

Mindfulness-based stress reduction (MBSR) shows promise in reducing emotional distress among HIV-positive individuals, based on a systematic review of 11 studies, including six randomized trials.

While MBSR may have a small to moderate effect on emotional well-being, the evidence regarding its impact on disease progression is mixed, highlighting the need for more rigorous and long-term studies to fully assess its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction for people living with HIV/AIDS: preliminary review of intervention trial methodologies and findings. Riley, KE., Kalichman, S.[2018]

A randomized controlled trial with 40 long-term HIV-infected patients showed that a mindfulness-based cognitive therapy (MBCT) program significantly improved quality of life, emotional status, and immune function over 3 months.

Patients in the MBCT group experienced a notable increase in CD4 cell count, indicating enhanced immune status, alongside large effect sizes for improvements in psychological stress, depression, and anxiety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Mindfulness-Based Cognitive Therapy on the Quality of Life, Emotional Status, and CD4 Cell Count of Patients Aging with HIV Infection. Gonzalez-Garcia, M., Ferrer, MJ., Borras, X., et al.[2019]

A 12-session weekly yoga intervention for 37 individuals returning from incarceration and living with HIV led to improved adherence to antiretroviral therapy (ART), while adherence decreased in the control group receiving treatment as usual.

Although the yoga intervention did not significantly affect viral load, heart rate, or blood pressure, the study suggests that larger trials with participants who have lower ART adherence are needed to fully assess the benefits of yoga in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Yoga on Antiretroviral Adherence Postincarceration in HIV+ Individuals. Wimberly, AS., Gross, R., Layde, M.[2023]

Mindfulness Based Stress Reduction (MBSR) showed medium effect size improvements in immune functioning (CD4 and T-cell counts) among HIV-infected individuals in South Africa, suggesting potential health benefits, although the small sample size limited statistical significance.

Participants reported improvements in mindfulness skills, particularly in 'Observing' and 'Non-reactivity', with large effect sizes, indicating that MBSR can be adapted for this context, but further research with a larger sample is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The application of mindfulness for individuals living with HIV in South Africa: A hybrid effectiveness-implementation pilot study. McIntyre, TL., Elkonin, D., de Kooker, M., et al.[2020]

Citations

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Higher cardiovascular disease risks in people living with HIV Recent studies have demonstrated the pooled prevalence of coronary artery disease (CAD) [6,7], cardiac dysfunction [8,9], dyslipidaemia [10], ...

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HIV and cardiovascular disease HIV-related cardiovascular disease research is predominantly from Europe and North America. Of the estimated 37·9 million people living with HIV worldwide, ...

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HIV and cardiovascular disease - PMC CD4+ T-cell depletion among people with HIV is associated with higher rates and risk of incident acute myocardial infarction, heart failure, peripheral artery ...

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Special Populations: HIV and the Older Person | NIH Compared to people without HIV, people with HIV have a twofold higher risk of developing atherosclerotic cardiovascular disease (ASCVD), and ...

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HIV and cardiovascular disease The sub-Saharan Africa Survey of Heart Failure. (THESUS-HF)106 showed that HIV infection conferred a 62% greater risk of all-cause mortality at ...