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

Trial Summary

What is the purpose of this trial?

This projects studies the role of mindfulness training (MT) to improve self-care among patients with heart failure and cognitive impairment.

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.

What data supports the effectiveness of the treatment Mindfulness Training for Heart Failure?

Research shows that mindfulness training can help heart failure patients by reducing stress, improving cognitive function, and promoting better self-care. It has also been found to enhance medication adherence and improve symptoms like depression and fatigue, leading to a better quality of life. ^{1 2 3 4 5}

Is mindfulness training safe for humans?

Mindfulness training is generally considered safe for humans and has been shown to help reduce stress and improve emotional well-being in various conditions, including heart failure. ^{1 2 3 5 6}

How is mindfulness training different from other treatments for heart failure?

Mindfulness training is unique because it focuses on improving cognitive function and self-awareness, which can help heart failure patients manage their condition better. Unlike traditional treatments that may focus on medication or physical interventions, mindfulness training aims to reduce stress and improve mental well-being, potentially enhancing medication adherence and self-care. ^{1 2 3 5 7}

Research Team

Elena Salmoirago-Blotcher, MD, PhD

Principal Investigator

Cardiovascular Institute, The Miriam Hospital, Brown University

Eligibility Criteria

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.

I have been diagnosed with heart failure.

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

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]

References

1. Brazil pubmed.ncbi.nlm.nih.gov

Impact of a Stress Reduction, Meditation, and Mindfulness Program in Patients with Chronic Heart Failure: A Randomized Controlled Trial. [2023]

2. United States 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. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Meditation interventions among heart failure patients: An integrative review. [2022]

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

Integrative Medical Care Plus Mindfulness Training for Patients With Congestive Heart Failure: Proof of Concept. [2017]

5. United States 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. [2023]

6. Sweden pubmed.ncbi.nlm.nih.gov

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

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

Web-Based Mindfulness Intervention in Heart Disease: A Randomized Controlled Trial. [2018]