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 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.

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.

Is mindfulness-based intervention safe for people with HIV?

Mindfulness-based interventions, like Mindfulness-Based Stress Reduction (MBSR), have been studied in people with HIV and are generally considered safe. These interventions have shown benefits in reducing stress and improving emotional well-being without reported safety concerns. ^{1 2 3 4 5}

How is the One Mind One Heart treatment different from other treatments for cardiovascular health in older adults with HIV?

The One Mind One Heart treatment is unique because it focuses on mindfulness-based interventions, which aim to reduce stress and improve emotional well-being, potentially benefiting cardiovascular health. Unlike standard medical treatments, this approach emphasizes mental and emotional health as a way to support physical health in people living with HIV. ^{2 3 4 6 7}

What data supports the effectiveness of the treatment One Mind One Heart (OM-OH) for cardiovascular health in older adults with HIV?

Research shows that mindfulness-based interventions, like the One Mind One Heart treatment, can help reduce stress and improve emotional well-being in people living with HIV. Additionally, yoga, a component of mindfulness practices, has been shown to lower blood pressure in HIV-infected adults with cardiovascular risk factors. ^{2 3 4 7 8}

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

I am able to understand and give informed consent.

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

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

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 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]

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]

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]

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]

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]

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]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Yoga lifestyle intervention reduces blood pressure in HIV-infected adults with cardiovascular disease risk factors. [2021]

2. England pubmed.ncbi.nlm.nih.gov

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

3. United States 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. [2022]

4. United States 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. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Effect of Yoga on Antiretroviral Adherence Postincarceration in HIV+ Individuals. [2023]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Mindfulness meditation training effects on CD4+ T lymphocytes in HIV-1 infected adults: a small randomized controlled trial. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

The application of mindfulness for individuals living with HIV in South Africa: A hybrid effectiveness-implementation pilot study. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Mindfulness-Based Interventions for Adults Living with HIV/AIDS: A Systematic Review and Meta-analysis. [2023]