Mindfulness Training for Heart Failure

(MYH-II Trial)

Overseen By Janice Tripolone, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The Miriam Hospital

Disqualifiers: Severe cognitive impairment, Psychiatric, others

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

Compensation: Varies

Number of Visits: 10

Duration: 8 weeks

176 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether mindfulness training, a practice focused on being present and aware, can help people with heart failure and mild memory issues improve self-care. Participants will receive either their usual care or the same care plus weekly mindfulness sessions by phone for eight weeks. It suits those with heart failure, mild cognitive struggles, and phone access. As an unphased trial, this study provides a unique opportunity to explore innovative self-care strategies.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that mindfulness training is generally safe. Studies have found that heart patients respond well to mindfulness programs. In one study, participants using mindfulness techniques reported feeling less stressed and anxious, with no major negative effects. Another study found that mindfulness helped lower blood pressure in individuals with hypertension and was well-accepted by those who tried it. Overall, mindfulness training appears to be a safe option with few reported side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about mindfulness training for heart failure because it offers a novel approach to managing this condition. Unlike traditional treatments that focus on medications or surgical interventions, mindfulness training emphasizes mental well-being and stress reduction, which can positively influence heart health. This method involves a series of 30-minute, phone-delivered sessions over eight weeks, making it accessible and convenient for patients. By potentially improving emotional resilience and reducing stress, mindfulness training could complement existing therapies, offering a holistic benefit that's not addressed by conventional treatments.

What evidence suggests that mindfulness training might be an effective treatment for heart failure?

Research has shown that mindfulness training, which participants in this trial may receive, can benefit people with heart problems. One study found that mindfulness programs reduced anxiety, depression, and stress in individuals with coronary heart disease. Another review found that these programs might improve the quality of life for patients with heart failure. Early trials also suggested that mindfulness can enhance overall well-being for those with heart issues. While more research is needed, these findings are encouraging for anyone interested in using mindfulness to manage heart failure and improve self-care. ^{2 6 7 8 9}

Who Is on the Research Team?

Elena Salmoirago-Blotcher, MD, PhD

Principal Investigator

Cardiovascular Institute, The Miriam Hospital, Brown University

Are You a Good Fit for This Trial?

This trial is for adults over 18 with heart failure and mild cognitive issues who can speak English or Spanish. They must have a phone and not be planning to move during the study. People with severe mental health issues, enrolled in another study, or with very poor hearing or severe heart failure aren't eligible.

Inclusion Criteria

You have mild problems with memory and thinking, as shown by a test score of 26 or lower.

I am older than 18 years.

Access to a telephone

Exclusion Criteria

You are currently practicing mind and body exercises at least once a month.

Planning to move out of the area during the study period

I have not had thoughts of harming myself.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive phone-delivered mindfulness training (MT) sessions once a week for 8 weeks, integrated with daily guided individual practice, plus enhanced usual care (EUC)

8 weeks

8 visits (phone)

Follow-up

Participants are monitored for cognitive function, psycho-behavioral factors, cardiac vagal control, and HF biomarkers at 3 and 9 months since baseline

6 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Enhanced Usual Care
• Mindfulness Training

Trial Overview The trial examines if mindfulness training plus enhanced usual care helps patients manage their heart conditions better than just enhanced usual care alone. Participants will either receive this new combination of treatments or continue with their regular care.

How Is the Trial Designed?

Group I: Mindful Training + Enhanced Usual Care Experimental Treatment 1 Intervention

Participants will receive a 30-minute, individual, phone-delivered session once a week for 8 weeks.

Group II: Enhanced Usual Care alone Experimental Treatment 1 Intervention

Usual care.

Who Is Running the Clinical Trial?

The Miriam Hospital

Lead Sponsor

Trials

252

Recruited

39,200+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

A Stress Reduction, Meditation, and Mindfulness Program significantly reduced perceived stress in heart failure patients, with scores dropping from 22.8 to 14.3 in the intervention group compared to an increase in the control group (p<0.001).

The program also led to notable improvements in quality of life, mindfulness, sleep quality, and physical performance (measured by a 6-minute walk test), highlighting its efficacy in enhancing overall well-being in patients with chronic heart failure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of a Stress Reduction, Meditation, and Mindfulness Program in Patients with Chronic Heart Failure: A Randomized Controlled Trial. Cavalcante, VN., Mesquita, ET., Cavalcanti, ACD., et al.[2023]

In a study involving 324 patients with heart disease, 12 weeks of online mindfulness training resulted in a borderline significant improvement in exercise capacity, as measured by the 6-minute walk test, compared to usual care alone.

Mindfulness training also significantly reduced heart rate in patients, suggesting it may be a beneficial addition to standard treatments for improving physiological health in heart disease patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Web-Based Mindfulness Intervention in Heart Disease: A Randomized Controlled Trial. Younge, JO., Wery, MF., Gotink, RA., et al.[2018]

Meditation practices have been shown to significantly improve psychosocial factors, quality of life, and reduce heart failure symptom burden in patients, based on a review of six studies involving 320 heart failure patients.

Despite the positive findings, the studies varied widely in their design and outcome measures, highlighting the need for more standardized and larger trials to better understand the effects of meditation on heart failure outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meditation interventions among heart failure patients: An integrative review. Viveiros, J., Chamberlain, B., O'Hare, A., et al.[2022]

A pilot project involving 11 patients recently discharged from heart failure hospitalization showed that integrative group medical visits combined with mindfulness training are feasible, with 73% of participants attending at least 4 out of 8 sessions.

After the program, all patients expressed intentions to improve their diet, exercise, and stress management, and notable improvements were observed in depression, fatigue, and life satisfaction, suggesting potential benefits for CHF management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrative Medical Care Plus Mindfulness Training for Patients With Congestive Heart Failure: Proof of Concept. Kemper, KJ., Carmin, C., Mehta, B., et al.[2017]

Mindfulness and compassion practices, such as focus and insight meditation, are effective in reducing stress among healthcare professionals, helping them manage emotional distress and improve emotional regulation.

Training in mindfulness and compassion can transform empathy into compassion, which may counteract empathy fatigue and enhance self-care, making group training in healthcare settings a beneficial approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Prevent burnout in health care with mindfulness and compassion]. Yu, W.[2019]

The Mind Your Heart-II (MYH-II) study will investigate the effects of mindfulness training on heart failure self-care in 176 patients with chronic heart failure and mild cognitive impairment, aiming to improve cognitive function and interoception over an 8-week period.

If successful, mindfulness training could enhance self-care practices in heart failure patients, potentially leading to better clinical outcomes by improving cognitive function and vagal control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mind Your Heart-II: Protocol for a behavioral randomized controlled trial of mindfulness training to promote self-care in patients with comorbid heart failure and cognitive impairment. Keirns, NG., Ouaddi, S., Dunsiger, S., et al.[2023]

Mindfulness training (MT) delivered via phone was found to be feasible and well-accepted by participants, with a 100% retention rate and 91% attendance over 8 weeks among 33 outpatients with heart failure.

While MT did not improve medication adherence or depression levels, it significantly enhanced cognitive function, functional capacity, and mindfulness skills, indicating potential benefits for heart failure patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mind Your Heart: Exploring Feasibility, Acceptability, and Preliminary Effects of Phone-Delivered Mindfulness Training on Medication Adherence in Outpatients With Chronic Heart Failure. Salmoirago-Blotcher, E., Walaska, K., Trivedi, D., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9524963/

The efficacy of mindfulness-based intervention for heart ... We conduct a systematic review and meta-analysis to explore the impact of mindfulness-based intervention on heart diseases.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3734636/

Mindfulness-based stress reduction program in coronary ... Conclusion: The MBSR program is effective in reducing symptoms of anxiety and depression, perceived stress, BP and BMI in patients with CHD.

3. nature.com nature.com/articles/s41598-019-54932-2

Randomized Trial of Mindfulness-Based Stress Reduction ... This pilot RCT provides preliminary evidence of MBSR's potential to improve short term psychosocial well-being in cardiac patients during their first year of ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2352906718301763

Effectiveness of mindfulness-based stress reduction ... The results of studies on quality of life have shown that patients with heart failure have lower quality of life than healthy people and even than patients with ...

5. ahajournals.org ahajournals.org/doi/10.1161/jaha.117.002218

Meditation and Cardiovascular Risk Reduction Studies of meditation suggest a possible benefit on cardiovascular risk, although the overall quality and, in some cases, quantity of study data are modest.

6. ahajournals.org ahajournals.org/doi/10.1161/HYPERTENSIONAHA.120.16160

Effect and Acceptability of Mindfulness-Based Stress ... The mindfulness-based stress reduction program (MBSR) may reduce blood pressure (BP) in patients with hypertension or elevated BP.

7. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2769761

Effect of a Brief Mindfulness-Based Program on Stress in ... This randomized clinical trial examines the effect of a brief mindfulness-based program on stress reduction among health care professionals ...

8. frontiersin.org frontiersin.org/journals/psychology/articles/10.3389/fpsyg.2024.1435243/full

Effect of mindfulness-based interventions on anxiety, ... This study aims to quantify the effect of mindfulness-based interventions (MBIs) on anxiety, depression and stress in CAD patients.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11367009/

The Utilization and Potential of Mindfulness-Based Stress ... This article primarily focuses on applying mindfulness-based stress reduction in PCI patients with coronary heart disease and its future prospects.