Mindfulness Training for Heart Failure
(MYH-II Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: The Miriam Hospital
Disqualifiers: Severe cognitive impairment, Psychiatric, others
No Placebo Group
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.
12345Is 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.
12356How 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.
12357Eligibility 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.
+2 more
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.
+7 more
Trial 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)
Participant Groups
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.
2Treatment groups
Experimental Treatment
Group I: Mindful Training + Enhanced Usual CareExperimental Treatment1 Intervention
Participants will receive a 30-minute, individual, phone-delivered session once a week for 8 weeks.
Group II: Enhanced Usual Care aloneExperimental Treatment1 Intervention
Usual care.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
The Miriam HospitalProvidence, RI
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Who Is Running the Clinical Trial?
The Miriam HospitalLead Sponsor
National Institute on Aging (NIA)Collaborator
References
Impact of a Stress Reduction, Meditation, and Mindfulness Program in Patients with Chronic Heart Failure: A Randomized Controlled Trial. [2023]Heart Failure is a significant public health problem leading to a high burden of physical and psychological symptoms despite optimized therapy. To evaluate primarily the impact of a Stress Reduction, Meditation, and Mindfulness Program on stress reduction of patients with Heart Failure. A randomized and controlled clinical trial assessed the effect of a stress reduction program compared to conventional multidisciplinary care in two specialized centers in Brazil. The data collection period took place between April and October 2019. Thirty-eight patients were included and allocated to the intervention or control groups. The intervention took place over 8 weeks. The protocol assessed the scales of perceived stress, depression, quality of life, anxiety, mindfulness, quality of sleep, a 6-minute walk test, and biomarkers analyzed by a blinded team, considering a p-value
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]Heart failure (HF) self-care is a robust predictor of prognosis in HF patients. Cognitive impairment is a common comorbidity in HF patients and constitutes a major challenge to HF self-care. Mindfulness training (MT) has been shown to improve cognitive function and interoception, two components essential to promoting effective HF self-care.
Meditation interventions among heart failure patients: An integrative review. [2022]There has been growing interest in meditation techniques as an intervention in chronic disease populations. Little is known of the effect meditation practice has on outcomes among patients with heart failure.
Integrative Medical Care Plus Mindfulness Training for Patients With Congestive Heart Failure: Proof of Concept. [2017]Congestive heart failure (CHF) has a high rate of morbidity and mortality. It is often accompanied by other medical and psychosocial comorbidities that complicate treatment and adherence. We conducted a proof of concept pilot project to determine the feasibility of providing integrative group medical visits plus mindfulness training for patients recently discharged with CHF. Patients were eligible if they had been discharged from an inpatient stay for CHF within the 12 months prior to the new program. The Compassionate Approach to Lifestyle and Mind-Body (CALM) Skills for Patients with CHF consisted of 8 weekly visits focusing on patient education about medications, diet, exercise, sleep, and stress management; group support; and training in mind-body skills such as mindfulness, self-compassion, and loving-kindness. Over two 8-week sessions, 8/11 (73%) patients completed at least 4 visits. The patients had an average age of 57 years. The most common comorbidities were weight gain, sleep problems, and fatigue. After the sessions, 100% of patients planned to make changes to their diet, exercise, and stress management practices. Over half of the patients who met with a pharmacist had a medication-related problem. Improvements were observed in depression, fatigue, and satisfaction with life. Integrative group visits focusing on healthy lifestyle, support, and skill-building are feasible even among CHF patients and should be evaluated in controlled trials as a patient-centered approach to improving outcomes related to improving medication management, depression, fatigue, and quality of life.
Mind Your Heart: Exploring Feasibility, Acceptability, and Preliminary Effects of Phone-Delivered Mindfulness Training on Medication Adherence in Outpatients With Chronic Heart Failure. [2023]Mindfulness training (MT) may promote medication adherence in outpatients with heart failure.
[Prevent burnout in health care with mindfulness and compassion]. [2019]There is a growing body of evidence that mindfulness and compassion are effective in reducing stress in health care. Focus meditation brings back the wandering mind to our breath and body. This attention skill can be practiced as STOP-sign: 'Stop, Take a breath, Observe and Priority first' when facing an emergency. Insight meditation helps us to observe our thoughts, let them pass and bring clarity. This noting technique can be practiced as SOAL: 'Stop, Observe, Accept, and Let go' when there is emotional distress. Better emotional regulation may also protect us from over-identification to negative affect. Mindfulness promotes transformation from empathy to compassion with focus on intention and motivation to alleviate. Compassion training may generate positive affect as antidote to empathy fatigue. Self-compassion embraces our difficulties in our life with the insight of common humanity and improves self-care. Group training at work place can be effective for implementation in health care.
Web-Based Mindfulness Intervention in Heart Disease: A Randomized Controlled Trial. [2018]Evidence is accumulating that mindfulness training has favorable effects on psychological outcomes, but studies on physiological outcomes are limited. Patients with heart disease have a high incidence of physiological and psychological problems and may benefit from mindfulness training. Our aim was to determine the beneficial physiological and psychological effects of online mindfulness training in patients with heart disease.